BD BACTEC FX40 Instrument User Manual
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BD BACTEC FX40 Instrument User Manual

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BACTEC™ FX40
Instrument User's Manual
 
B ecton, Dickinson and Company
7 Loveton Circle
Sparks, Maryland 21152 USA
Benex Limited
Pottery Road, Dun Laoghaire
Co. Dublin, Ireland
Australian Sponsor:
Becton Dickinson Pty Ltd.
66 Waterloo Road
Macquarie Park NSW 2113
Australia
8090414(09) 2021-07
441980
English
bd.com/e-labeling

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Questions and answers

Tara Thornburg
February 10, 2025

Under what circumstances would a vial falsely signal as positive?

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1 comments:
Mr. Anderson
February 11, 2025

A BD BACTEC FX40 vial can falsely signal as positive if it is contaminated. Contamination flags a positive culture, indicating that the isolate is thought to be clinically insignificant.

This answer is automatically generated

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Aleyamma Mathews
April 20, 2025

Verification procedure for Bactec FX40 plastic Myco/F Lytic vials

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Summary of Contents for BD BACTEC FX40

  • Page 1 B ecton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA Benex Limited Pottery Road, Dun Laoghaire Co. Dublin, Ireland Australian Sponsor: Becton Dickinson Pty Ltd. 66 Waterloo Road Macquarie Park NSW 2113 Australia 8090414(09) 2021-07 441980 English bd.com/e-labeling...
  • Page 2 2021-07 Revision number being amended for document management alignment. BD, the BD Logo, BACTEC, EpiCenter, Modem, Peds Plus, and Synapsys are trademarks of Becton, Dickinson and Company or its affiliates. © 2021 BD. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or...

  • Page 3: Table Of Contents

    Table of Contents 1 –Introduction ........................9 Intended Use ..........................9 Principles of the Procedure ......................9 System Overview........................11 1.3.1 Instrument Overview ....................11 1.3.2 Control Electronics ...................... 12 1.3.3 Incubation Subsystem ....................12 1.3.4 Vial Agitation ....................... 12 1.3.5 Measurement Subsystem....................
  • Page 4 BD BACTEC™ FX40 Instrument User’s Manual 3.2.1 Location ........................43 3.2.2 Operation ........................43 System Indicators........................43 3.3.1 Location ........................43 3.3.2 Indication ........................44 Door Handle ..........................44 3.4.1 Location ........................44 3.4.2 Operation ........................44 Barcode Scanner ........................44 3.5.1 Location ........................44 3.5.2 Operation ........................45 Tablet PC / Touchscreen ......................45 3.6.1...
  • Page 5 Printing Reports ......................... 67 Removing Positive, Negative, and Ongoing Vials ..............68 4.10 Responding to Alarms and Errors ..................... 73 4.11 Power Failures........................... 73 4.12 Operation with a BD EpiCenter™ System ................. 74 4.12.1 Normal Operations ...................... 74 4.12.2 Isolation Mode ......................75 4.12.3...
  • Page 6 BD BACTEC™ FX40 Instrument User’s Manual Maintenance ..........................123 5.5.1 Test Display .......................123 5.5.2 Block/Unblock Stations Display .................125 5.5.3 Utilities Display ......................126 5.5.3.1 Upgrade Software ..................127 5.5.3.2 Save DB and Log ..................127 5.5.3.3 Save Log ....................127 5.5.3.4 Reboot......................127 5.5.3.5 Change Password ..................127 5.5.3.6...
  • Page 7 Contents Error/Alert Messages ......................139 Unusable Stations, Affected Vials, and Partially Seated Vials ..........................161 7.3.1 General........................161 7.3.2 Unusable Stations ..................... 161 7.3.3 Affected Vials ......................163 8 –Limited Warranty......................165 9 –Contacts........................167 10 –Replacement Parts ....................169 11 – Glossary........................171...
  • Page 8 BD BACTEC™ FX40 Instrument User’s Manual...

  • Page 9: Introduction

    1 – Introduction Intended Use The BD BACTEC™ FX40 instrument is designed for the rapid detection of bacteria and fungi in clinical specimens, blood and blood products. Samples are drawn from patients or bagged blood/blood products and injected directly into BD BACTEC™ culture vials, which are placed into the instrument for incubation and testing.
  • Page 10 And positivity analysis is performed. Positive vial is announced by audible alert, onscreen indications, and the Positive Vial system indicator. Positive Test Results indicated multiple ways Photo Detector Test Readings Positivity Analysis Figure 1-1 – BD BACTEC™ FX40 Fluorescent Technology...

  • Page 11: System Overview

    From 1 to 4 BD BACTEC™ FX40 instruments can be connected to a single tablet PC and can share a printer and barcode reader. This cluster can be linked to a BD EpiCenter™ system to create a larger installation with full connectivity between BD BACTEC™...

  • Page 12: Control Electronics

    The tablet PC also performs positivity analysis. One tablet can control up to four BD BACTEC™ FX40 instruments in a cluster.

  • Page 13: Usb Ports

    Three standard USB ports are located on the rear of the instrument. One free USB port is located on the tablet’s right side (the port on the left side connects to the BD BACTEC™ FX40 instrument). USB ports are used primarily to connect peripheral devices such as a barcode scanner and printer, and to save files to and update system software from flash media.

  • Page 14: Media Overview

    The database maintains the test measurements for each vial, vial identification and association data, and patient demographic information. Data is stored in the BD BACTEC™ FX40 database in both standalone and BD EpiCenter™ configurations. In addition, associated instrument errors, and operating conditions (e.g., test times, instrument temperature, etc.) are stored in the database.

  • Page 15: Built-In Test

    1 – Introduction BD BACTEC™ Lytic/10 Anaerobic /F Non-resin medium containing the blood lysing agent saponin. The lysis of red cells provides nutrients for microbial growth and reduced blood background. The lysis of white cells releases phagocytized organisms. Indicated for 3.0 to 10.0 mL (8.0 to 10.0 mL optimal) blood volume.

  • Page 16: Use Of This Manual

    This user's manual is designed as an integral part of instrument operation for technologists, supervisors, and other personnel who operate and maintain the BD BACTEC™ FX40 instrument on a regular basis. Every attempt has been made to include all information that would be required during normal use and maintenance of the system.

  • Page 17: Symbols And Connections Used On The Equipment

    The following symbols and connections are used on the BD BACTEC™ FX40 instrument: Figure 1-4 – Instrument Rear Connections (bottom left) From left to right: USB Host connector (to tablet computer); USB connectors (3); Network (BD EpiCenter™) connector; Serial (LIS) connector; Remote Alarm connector Figure 1-5 –...
  • Page 18 BD BACTEC™ FX40 Instrument User’s Manual Figure 1-6 – Tablet Connections (left side) Figure 1-7 – Tablet Connections (right side) From top to bottom: USB connection (to instrument); From top to bottom: USB connection; HDMI output; and headphone/speaker input; reset switch, power switch, network connector.

  • Page 19: Notes, Cautions, And Warnings

    1 – Introduction    Figure 1-9 – Other Symbols Used on the Equipment From left to right: Refer to accompanying documentation for instructions; Fuse; Biohazard; WEEE 1.5.3 Notes, Cautions, and Warnings Throughout this manual, important information is presented in boxes offset from the regular text, and is labeled as either a NOTE, CAUTION, or WARNING.
  • Page 20 BD BACTEC™ FX40 Instrument User’s Manual...

  • Page 21: Installation

    2 – Installation General This section provides specifications for installation and setup of the BD BACTEC™ FX40 instrument. The following major topics are included: • Instrument Specifications • Instrument Installation • Site Preparation • Software Setup WARNINGS PROTECTION PROVIDED BY THIS EQUIPMENT MAY BE IMPAIRED IF THE EQUIPMENT IS USED IN A MANNER NOT CONSISTENT WITH THE INSTRUCTIONS IN THIS MANUAL.
  • Page 22 BD BACTEC™ FX40 Instrument User’s Manual Air Intake Air Exhaust Figure 2-1 – Air Intake and Exhaust Areas Air intake on bottom of instrument through air filter and exhaust through louvers on rear of instrument...

  • Page 23: Instrument Specifications

    2 – Installation Instrument Specifications Physical Dimensions Single Instrument Stack Height 39.1 cm (15.4 in) 77.5 cm (30.5 in) Width 67.5 cm (26.6 in) 67.5 cm (26.6 in) Depth 58.5 cm (23.0 in) 58.5 cm (23.0 in) Clearance (rear, left, right) 0 cm, 7 cm, 38* cm 0 cm, 7 cm, 38* cm * if tablet is mounted...

  • Page 24: Instrument Installation

    TIP HAZARD! DO NOT LEAN OR PLACE WEIGHT ON THE INSTRUMENT DOOR WHILE IT IS OPEN. The BD BACTEC™ FX40 instrument should be installed in an area that is free from undue vibration, direct sunlight, high humidity, dust, temperature extremes, external air sources, and corrosive or explosive vapors or gases.

  • Page 25: Software Setup

    2 – Installation Software Setup The instrument ships with all setup parameters preset to factory default values. However, before using the instrument for culture testing, you should review the setup parameters to see if they are suitable for your laboratory. These parameters are set in the Configuration function, and are grouped as follows: •...

  • Page 26: Lab Configuration

    BD BACTEC™ FX40 Instrument User’s Manual To save configuration changes, select Save (shown below). To enter a password, tap the password field to display the onscreen keyboard (see Section 3.10). Tap in the password field to access onscreen keyboard Figure 2-3 – Password Window Enter the Supervisor password (default: BACTECFX).
  • Page 27 (i.e., vials with the same accession number) are flagged by station indicators that correspond to their status (Ongoing, Negative, etc.). In a BD EpiCenter™ configuration, enabling Show Related Vials at one instrument enables the feature for all instruments.
  • Page 28 = day; mm = numeric month; Mmm = alphabetic month; yyyy = year;  HH = hours (24-hour clock); hh = hours (12-hour clock); MM = minutes Chinese is not a supported language in workgroups that include an BD BACTEC™ FX instrument. Only BD BACTEC™ FX40 supports Chinese at this time.
  • Page 29 2 – Installation In a BD EpiCenter™ configuration, selecting a country (locale) at one instrument selects that locale for all instruments. Media Window: Media configuration is used to set default protocol values for each medium type you will be using for culture testing.

  • Page 30: Reports Configuration

    Options include: • No Printer • Compatible USB Printer (If a BD BACTEC™ FX40 supported printer is connected to the USB port, its name will appear in the Printer Selection drop-down list.) Select Save, or Select Undo to clear changes and return to saved values.

  • Page 31: Instr(Ument) Configuration

    2.4.3 Instr(ument) Configuration Instrument configuration settings are unique to each individual instrument within a cluster or workgroup cluster with BD EpiCenter™ connectivity. See Figure 2-6. To modify default instrument values, refer to the field requirements listed below. When changes are complete, select Save and enter the Supervisor password.
  • Page 32 Network port. The icon is green if a device is connected to the Network port. Figure 2-6 – Instrument Configuration Display (BD BACTEC™ FX40 Serial Number icon red) Address Read-only fields showing network configuration information.

  • Page 33: Lis Configuration

    2.4.4 LIS Configuration LIS configuration enables you to set up communications with a Laboratory Information System (LIS). Communications should only be enabled/disabled by a BD representative. To modify default values, refer to the field requirements listed below. When changes are complete, select Save.
  • Page 34 BDMODEM radio button Select BDMODEM to use the BD Modem™ Communications protocol for communications with the BD BACTEC™ FX40 instrument. This protocol is the default selection when LIS is enabled. Refer to the LIS Vendor Interface Document for additional information.
  • Page 35 If Vial Tracking is disabled, only the final result is uploaded. Log Comms checkbox The Log Comms function is designed to assist BD representatives in troubleshooting LIS communications problems. It enables the representative to record low-level communication messages in a separate file on a USB flash drive. Log Comms can only be enabled when LIS Communications is enabled.
  • Page 36 Check this checkbox to enable ASTM packed frames. Uncheck the checkbox to disable ASTM packed frames. BD Modem™ Window fields: The BD Modem™ window appears only when BDMODEM is selected in the Physical Layer window. The first two fields are used to determine where specific data is in the LIS record.

  • Page 37: Time Configuration

    Time and date configuration settings can only be changed in a standalone configuration. Time and date may not be changed in a BD EpiCenter™ configuration. To modify default values, refer to the field requirements listed below. When changes are complete, select Save.
  • Page 38 BD BACTEC™ FX40 Instrument User’s Manual Figure 2-8 – Time Configuration Display Figure 2-9 – Set Date and Time Window...
  • Page 39 2 – Installation Daylight Saving Time Window: Daylight Saving Time checkbox The Daylight Saving Time field is represented by a day/night icon with an arrow between the two. Select whether the system clock is automatically set forward one hour for Daylight Saving Time (checked) or is set at Standard Time (unchecked).
  • Page 40 BD BACTEC™ FX40 Instrument User’s Manual...

  • Page 41: Controls And Indicators

    3 – Controls and Indicators General This section describes the meaning and use of the controls and indicators of the BD BACTEC™ FX40 instrument. The overall layout of the instrument and most of the controls and indicators are shown in Figure 3-1.
  • Page 42 BD BACTEC™ FX40 Instrument User’s Manual System Indicators Door Handle Power Switch Figure 3-1 – BD BACTEC™ FX40 Instrument External Controls/Indicators Top: Front view; Bottom: Rear view...

  • Page 43: Power Switch

    3 – Controls and Indicators Power Switch 3.2.1 Location The instrument's power (On/Off) rocker switch is on the rear of the instrument at the lower right (to the left of the rubber bumper as you face the instrument rear). See Figure 3-1 and 3-2 for the power switch location. 3.2.2 Operation When in the “O”...

  • Page 44: Indication

    BD BACTEC™ FX40 Instrument User’s Manual 3.3.2 Indication The system indicators inform you of various states in the instrument, as shown below. Indicator Color State Meaning Amber System Alert (Indicator remains on until the condition is corrected/addressed.) See Section 7 for additional information.

  • Page 45: Operation

    3 – Controls and Indicators 3.5.2 Operation NOTE Accepted barcode symbologies include Code 128, Codabar, Code 39, and Interleaved 2 of 5. The scanner turns on when the instrument is ready to read a barcode. To scan a barcode, place the vial in the scanner’s red beam with the barcode label facing the scanner.

  • Page 46: Operation

    BD BACTEC™ FX40 Instrument User’s Manual 3.6.2 Operation After the instrument completes its startup process, the Status Display appears. Other displays appear as you perform various operations. More information on displays is presented in Section 5. Figure 3-4 – Tablet Computer in Bracket Station Indicators 3.7.1 Location...

  • Page 47: Indication

    3 – Controls and Indicators 3.7.2 Indication The color (red, green, or yellow) and state (on, flashing, or off) indicate the conditions shown in the table below for a given station. Indicator Color State Meaning Flashing Positive vial Green Flashing Negative vial Yellow Flashing...

  • Page 48: Audible Tones And Alarms

    BD BACTEC™ FX40 Instrument User’s Manual Audible Tones and Alarms A variety of sounds are generated by the BD BACTEC™ FX40 instrument as you perform operations. Each of the sounds is unique and designed to keep the operator informed of the operational states of the instrument.

  • Page 49: Remote Alarm

    Figure 3-6 – Keyboard Display 3.11 Remote Alarm The BD Remote Alarm unit is a small box that sounds an audible alarm when critical System Alerts occur, and when positive vials are detected. Controls and indicators are described in the operating instructions, furnished separately.
  • Page 50 BD BACTEC™ FX40 Instrument User’s Manual...

  • Page 51: Operation

    4 – Operation General This section provides instructions for routine operation of the BD BACTEC™ FX40 instrument. The following major topics are discussed: • Using the Instrument • Daily Maintenance • Collecting and Preparing Specimens • Entering Vials • Recalling, Entering, and Modifying Data •...

  • Page 52: Status Display

    (Each of the activities is discussed in greater detail later in this section.) Demographic information (accession only in BD EpiCenter™ configuration) can be added to vial records in the Culture display, accessed through the Culture button. The View Stations display (Figure 4-3), accessed by selecting the View Stations button, shows the status of each station in a representational view of the instrument stations.

  • Page 53: Vial And Station Statuses And States

    4 – Operation 4.2.4 Vial and Station Statuses and States Vials can have both a status and a state, but it is the status that conveys information about the presence or absence of microbial growth (or the practical availability of a station). The states are used for reporting purposes only.
  • Page 54 BD BACTEC™ FX40 Instrument User’s Manual Vial and station statuses in the View Stations display are: Status Icon Meaning How Indicated Available There is no vial in station Station Indicators: GREEN Vial Entry icon in color on Status display Vial Entry button active on Status display...

  • Page 55: Daily Maintenance

    Select the Alarm button to verify that the audible alarm is functioning. 10 Finally, select the Status button to illuminate the system status indicators. All the indicators (amber, red, and green) should illuminate. If any indicator does not light, contact your local BD representative for service.

  • Page 56: Collecting And Preparing Specimens

    BD BACTEC™ FX40 Instrument User’s Manual Blocking Stations If any of the station indicators does not light, the station should be blocked and the vial should be moved to an available station using the Vial Entry activity. To block a station: Open the instrument door.

  • Page 57: Entering Vials

    4 – Operation Collection Specimens should be collected aseptically from the patient and inoculated into the vials. Refer to the Media Package Insert for specific recommendations on specimen collection. Vials should be labeled and sent to the laboratory at once. Preparation At least one aerobic culture vial and one anaerobic vial should be prepared.
  • Page 58 BD BACTEC™ FX40 Instrument User’s Manual Note that for both methods, the Vial Entry process is not completed until the scanned vial is placed into an available station. That is when the vial database is updated with the new vial data. The Vial Entry tone signifies that the Vial Entry process for that vial is complete.
  • Page 59 4 – Operation Once vials are placed in their stations, BD recommends that you do not move them to other stations. Avoid opening the door unnecessarily. The door should not remain open longer than four minutes. NOTE Good clinical practice dictates that for optimal performance, blood culture vials should be sent to the laboratory as soon as possible upon collection.
  • Page 60 BD BACTEC™ FX40 Instrument User’s Manual Anonymous activity. NOTE Once an anonymous vial has been placed in the instrument, do not remove the vial and reenter it without identifying it the ID Anonymous activity. All test readings are discarded if you remove the vial without identifying it.

  • Page 61: Recalling, Entering, And Modifying Data

    Vials can exist unattached to accessions. These are called orphan vials. Note that in a BD EpiCenter™ configuration, you cannot enter Patient ID or Patient Name at the instrument. However, you can recall patient records by these fields. Also, you cannot enter Hospital Service or Collection Date/Time at the instrument.
  • Page 62 BD BACTEC™ FX40 Instrument User’s Manual Associating vials to an accession: From the Status display, select the Culture button. The Culture – Patient display appears. Select the Specimen tab to access the Culture – Specimen display. In the Accession field, enter the desired accession.

  • Page 63: Specimen Data

    Select Save to save the information. 4.6.3 Specimen Data Note that in a BD EpiCenter™ configuration, you cannot enter Hospital Service or Collection Date/ Time at the instrument. This operation can only be performed at the BD EpiCenter™ system. Recalling specimen records: From the Status display, tap the “culture”...
  • Page 64 If all specimens are disassociated from the patient record, the patient record is removed from the database. Note that in a BD EpiCenter™ configuration, you cannot disassociate a specimen from a patient record. This operation can only be performed at the BD EpiCenter™ system.

  • Page 65: Patient Data

    Note that in a BD EpiCenter™ configuration or in a standalone configuration with LIS enabled, you cannot enter or edit Patient ID or Patient Name at the instrument. In a BD EpiCenter™ configuration, this operation can only be performed at the BD EpiCenter™ system. In a standalone configuration with LIS enabled, this operation can only be performed at the LIS system.
  • Page 66 BD BACTEC™ FX40 Instrument User’s Manual Figure 4-7 – Select Patient Window If you enter no characters, the search returns all patient records with blank patient names. It does not return all patient names. If there is more than one match for a patient name search, the Select Patient window pops up (Figure 4-7).

  • Page 67: Testing Vials

    Select Save to save the patient data. Testing Vials Vial testing in the BD BACTEC™ FX40 instrument is automatic and is interrupted only by drawer openings and/or some system alert conditions. Test cycles are initiated every ten minutes. A minimum of one hour of test results is required in order for any vial to be declared positive.

  • Page 68: Removing Positive, Negative, And Ongoing Vials

    Many positive cultures will be detected in the first 24 hours after inoculation. However, ongoing vials must still be kept for several days to ensure maximum recovery. With the BD BACTEC™ FX instrument, vials are typically held for 5 days (except Myco/F Lytic, Mycosis IC/F, Platelet Aerobic/F, and Platelet Anaerobic/F vials) before they are discarded as negative.
  • Page 69  instrument re-entry? re-entered into the If same workgroup same ≤20 workgroup minutes. If moved If BD EpiCenter™ to a If different different workgroup If BD Synapsys™ workgroup If same workgroup >20 minutes and  If BD EpiCenter™...
  • Page 70 BD BACTEC™ FX40 Instrument User’s Manual When reentering a NEGATIVE vial that has been out of the instrument for less than 5 hours, the protocol length should be extended beyond the vial's Time In Protocol to reenter it as Ongoing. If you do not extend the vial's protocol length, the status transitions back to Negative after the third reading.
  • Page 71 Culture - Specimen display shows the related vials in the Vial Window (not applicable to Positive / Anonymous vials). In a BD EpiCenter™ configuration, the instrument cannot Show Related Vials when it is in degraded mode. Remove any related vials if desired, and either confirm or scan the sequence number, depending on the system prompt.
  • Page 72 BD BACTEC™ FX40 Instrument User’s Manual • Remove and scan all the negative vials. (If any vial sequence numbers were entered manually, the system asks you to verify that the sequence number is correct. You must manually confirm that the sequence number on the vial is the same as the one shown on the screen, and tap the “Verified”...

  • Page 73: Responding To Alarms And Errors

    CAUTION If the recommended corrective actions do not solve the problem, contact BD. System alerts can be viewed and printed in the System Alerts display. Refer to Section 5.3.5. 4.11 Power Failures When power to the system is lost, the tablet displays a message that power has been lost and initiates an orderly shutdown of the user interface.

  • Page 74: Operation With A Bd Epicenter™ System

    Vial status is transferred. Readings and status information for vials using replacement barcodes where the medium type has not been selected are not transferred from the instrument to the BD EpiCenter™ system until the medium type is selected.

  • Page 75: Isolation Mode

    All instruments in a BD EpiCenter™ configuration must use the same version of instrument software. Maintenance The Host Query button on the Maintenance – Test display is disabled when BD EpiCenter™ is enabled. 4.12.2 Isolation Mode Isolation mode is the state that exists when communication between the BD BACTEC™ FX40 instrument and the tablet PC is lost.
  • Page 76 BD BACTEC™ FX40 Instrument User’s Manual • The instrument and tablet PC both return to Directed mode (normal operating state) from Isolation mode when communication between the two is reestablished. During the transition, data collected by the instrument while in Isolation mode is transferred to the tablet PC and processed.

  • Page 77: Degraded Mode Operations

    BD BACTEC™ FX40 user interface has stopped working To return to normal Directed mode, check USB and power cables and reconnect if needed. If needed, try rebooting the tablet. If these actions do not correct the problem, contact your local BD representative.
  • Page 78 When communications are reestablished, the instrument and its master database are reconciled and the instrument resynchronizes with BD EpiCenter™, updating any changes that have occurred at each system. This includes statuses for sequenced vials, instrument status, and test readings. When the reconciliation is complete, operations that were disabled (e.g., Vial Entry, Identify Anonymous) become...

  • Page 79: Reference

    5 – Reference General This section presents reference material on the BD BACTEC™ FX40 instrument user interface. All the screens, icons, reports, and functions in the user interface are described in the order in which they are accessed from the Status display. The following information is presented: •...
  • Page 80 BD BACTEC FX40™ Instrument User’s Manual Current Positives (Section 5.4.7) Loaded Vials (Section 5.4.8) Maintenance QC Report (Section 5.4.9) No Growth Accession (Section 5.4.10) Orphan Vials (Section 5.4.11) Partial Seated Stations (Section 5.4.12) Pending Report (Section 5.4.13) Unloaded Negative Vials (Section 5.4.14) Unloaded Positive Vials (Section 5.4.15)

  • Page 81: Status Display

    • Approximate station occupancy • Communications status with LIS or BD EpiCenter™ system See Figure 5-1 for a sample Status display. The screen is divided into areas that represent the instruments in a cluster. The icons are grayed out if there are no vials/stations that correspond to the status/activity.
  • Page 82 BD BACTEC FX40™ Instrument User’s Manual Status Display Buttons and Indicators: Remove Positives button/ Remove Negatives button/ Positive Vial indicator Negative Vials indicator Identify Anonymous button/ Vial Entry button/ Anonymous Vials indicator Available Stations indicator Drawer Full indicator Testing indicators...

  • Page 83: Positive Removal Display

    5 – Reference 5.3.1 Positive Removal Display The Positive Removal display appears when you initiate the remove positive vials activity, either by pulling a positive vial or by selecting Remove Positives. It provides information about the positive vial that was scanned, and enables you to view a list of vials related to the current one (if Show Related Vials is enabled in Configuration –...

  • Page 84: Negative Removal Display

    BD BACTEC FX40™ Instrument User’s Manual Figure 5-2 – Positive Removal Display Positive Removal Buttons: Verified button Appears only if the vial sequence number was entered manually. Select to confirm to the system that the displayed vial sequence number is correct.
  • Page 85 5 – Reference To access Negative Removal: • Open a drawer and remove a negative vial, or • Open a drawer and select Remove Negatives on the Status display Negative Removal Fields: Accession Read-only field that shows the accession number of the vial. Sequence Read-only field that shows the vial barcode sequence number.

  • Page 86: Id(Entify) Anonymous Display

    BD BACTEC FX40™ Instrument User’s Manual Wrong button Appears only if the vial sequence number was entered manually and Batch Removal is disabled. Select to inform the system that the displayed vial sequence number is incorrect. Message WE06 then appears (see Section 7).
  • Page 87 5 – Reference Status The current status of the vial. Statuses include: Ongoing, Positive. These statuses are explained in Section 4.2.4. Protocol The default protocol for the medium type entered is shown. To change this protocol, select Modify and refer to that information below. Figure 5-4 –...

  • Page 88: Vial Entry Display

    To save the current information, place the vial into an available station. To clear the display without saving any information, select Clear. Vial Entry cannot be performed at an instrument in degraded mode in a BD EpiCenter™ configuration. See Figure 5-5 for a sample Vial Entry display.
  • Page 89 5 – Reference To access Vial Entry: Open the door and scan a new vial sequence or accession barcode, or Open a drawer and select Vial Entry on the Status display Vial Entry Fields: Barcoding Icon At the top left of the display either a single or double barcode appears. The single barcode indicates that only sequence barcode scans are accepted on the Vial Entry display (i.e., Accession Barcoding is disabled).

  • Page 90: System Alerts Display

    BD BACTEC FX40™ Instrument User’s Manual Protocol The default protocol for the medium type entered is shown. To change this protocol, select Modify and refer to that information below. Last Location If the vial was previously entered in the instrument, this field shows the station number from which the vial was removed.
  • Page 91 5 – Reference The System Alerts button is grayed out when there are no alerts to display. See Figure 5-6 for a sample System Alerts display. To access System Alerts: From the Status display, select System Alerts System Alerts Buttons: Info button Active if a single message is highlighted, inactive if no message or more than one message is highlighted.

  • Page 92: View Stations Display

    Select to print the Alert List report. The report contains the latest 100 system alerts in the instrument database, even if the alerts have been removed from the System Alerts display. Reports cannot be printed at an instrument in degraded mode in a BD EpiCenter™ configuration.

  • Page 93: Culture - Patient Display

    5 – Reference Location Read-only field showing the current selected station. That station is also highlighted with a gray box surrounding it. To select a Location (station), select the station in the left portion of the display. Figure 5-7 – View Stations Display View Stations Buttons: “FX40”...
  • Page 94 When LIS is enabled, the Culture – Patient display is confined to Search mode. Note that in a BD EpiCenter™ configuration, you cannot enter Patient ID or Patient Name at the instrument. Also you cannot disassociate a specimen (accession) from a Patient ID. These operations can only be performed at the BD EpiCenter™...
  • Page 95 Specimen Window. If all specimens are disassociated from the patient record, the record is removed from the database. This button is active only when BD EpiCenter™ communications is disabled. Save button Select to save any new or modified information to the database.

  • Page 96: Culture - Specimen Display

    Note that in a BD EpiCenter™ configuration, you cannot enter Hospital Service or Collection Date\Time at the instrument. This operation can only be performed at the BD EpiCenter™ system. You cannot access Culture displays in an instrument that is in degraded mode.
  • Page 97 Date and Time window appears. Refer to Section 2.4.5 for instructions on setting date and time. This button is active only when BD EpiCenter™ communications is disabled. Add button Select to add patient data to the displayed specimen record. This button is active only when an orphan accession is displayed and when BD EpiCenter™...

  • Page 98: Culture - Vial Display

    BD BACTEC FX40™ Instrument User’s Manual Save button Select to save any new or modified information to the database. Clear button Select to clear the information currently on the display (all 3 tabs). Exit button Select to exit the display and return to the Status display.
  • Page 99 5 – Reference Culture – Vial Display Fields: Accession Scan or type in the accession number up to 20 alphanumeric characters, excluding the following: * ? [ ] ! # | Accession number cannot be 12 digits long AND begin with the numbers “44.” Sequence Scan or type in the vial barcode sequence number located on the vial label.
  • Page 100 BD BACTEC FX40™ Instrument User’s Manual Location This field shows the last known station for the vial. If the vial is still in the instrument, it shows the current station (see In Instrument indicator below). If the vial has been removed from the instrument, it shows the last known station.

  • Page 101: Plot Display

    5 – Reference Save button Select to save any new or modified information to the database. Clear button Select to clear the information currently on the display (all 3 tabs). Exit button Select to exit the display and return to the Status display. 5.3.10 Plot Display The Plot display enables you to generate a line graph, or plot, of the test readings of a specified non-pending station.
  • Page 102 BD BACTEC FX40™ Instrument User’s Manual Plot readings Fluorescence units and Positivity readings are plotted on the y-axis (vertically). Readings are indicated by red x's and are labeled Fluorescence. Positivity is indicated by blue squares. These readings occur every 10 minutes unless testing or communications is interrupted (e.g., by a door opening).

  • Page 103: Reports Menu

    5 – Reference Tap and Drag: You can tap an area of the plot and drag to select an area to zoom in Figure 5-11 – Plot Display Reports Menu The Reports Menu enables you to select reports to be printed. To access the Reports menu, select the Reports tab.
  • Page 104 Yes to the initial WE35 message, then respond OK on the resulting CS22 message box. Reports cannot be printed at an instrument in degraded mode in a BD EpiCenter™ configuration. Reports only contain information for the instrument at which they are requested. For system-wide data, you should print the report from the BD EpiCenter™...

  • Page 105: Affected Vials

    5 – Reference The following criteria may be used (depending on the report): Time Range Enables you to select a starting and ending date for the report. This is a data filtering parameter, meaning it allows you to restrict what information is reported. Sort By Enables you to select an alternate sort order (up to 2) for the report.

  • Page 106: Alert List

    BD BACTEC FX40™ Instrument User’s Manual Select Print to print the report Kirk Memorial Hospital Sorted By - Accession,Sequence 1313 Mockingbird Lane Selected Status - All Affected Vials Reported By - Reading Gap Failure Instrument - 1 Reading Gap Failure Software Version - 0.10Y...
  • Page 107 5 – Reference Select Print to print the report. Kirk Memorial Hospital 1313 Mockingbird Lane Instrument - 1 Alert List Software Version - 0.10Y Date/Time - 03/15/13 04:18 p.m. ID Set Time Clear Time Description 26 3/15/2013 15:56 3/15/2013 15:59 FX40 A: Door open too long.

  • Page 108: Contaminant Vials

    BD BACTEC FX40™ Instrument User’s Manual 5.4.3 Contaminant Vials The Contaminant Vial Report lists all the vials in the database that have been marked as “contaminant.” The report prints in landscape mode. The report provides the following information: Header: Selection/Sorting/Reporting Criteria, Hospital Information (if configured), Instrument...

  • Page 109: Culture Summary

    5 – Reference 5.4.4 Culture Summary The Culture Summary report lists total counts for contaminant, positive, and negative cultures, as well as percent of total cultures for each of these counts. To qualify for inclusion, cultures must have a state of Removed (all vials related by accession number must be removed from the instrument), be within the selected date and time range, and have a final status of positive, manual positive, negative, manual negative, or be ongoing and removed from the instrument.

  • Page 110: Current Inventory

    BD BACTEC FX40™ Instrument User’s Manual Kirk Memorial Hospital 1313 Mockingbird Lane Reported By - None: Culture Summary Instrument - 1 Software Version - 0.10Y From 01/29/13 12:00 a.m. To 03/15/13 04:18 p.m. Date/Time - 03/15/13 04:18 p.m. Positive Negative...

  • Page 111: Current Negatives

    5 – Reference Kirk Memorial Hospital Sorted By - Accession,Sequence 1313 Mockingbird Lane Selected Status - All Current Inventory Reported By - None: Instrument - 1 Software Version - 0.10Y Date/Time - 03/15/13 04:18 p.m. Accession Patient Name Patient ID Sequence Test/Proto Status Service Location TIP/TTD...

  • Page 112: Current Positives

    BD BACTEC FX40™ Instrument User’s Manual Kirk Memorial Hospital Sorted By - Accession,Sequence 1313 Mockingbird Lane Selected Status - All Current Negatives Reported By - None: Instrument - 1 Software Version - 0.10Y Date/Time - 03/15/13 04:19 p.m. Accession Patient Name...

  • Page 113: Loaded Vials

    5 – Reference Select Print to print the report. Kirk Memorial Hospital Sorted By - Accession,Sequence 1313 Mockingbird Lane Selected Status - All Current Positives Reported By - None: Instrument - 1 Software Version - 0.10Y Date/Time - 03/15/13 04:19 p.m. Accession Patient Name Patient ID...

  • Page 114: Maintenance Qc Report

    BD BACTEC FX40™ Instrument User’s Manual Report By: primary selection: None, Media, Hospital Service, State (vial), Status. If a criterion other than None is selected, any Media, Hospital Services, vial States, and Statuses that are contained in patient/specimen records appear in the secondary selection field. The default values are All Media, Hospital Services, States, and Statuses.
  • Page 115 5 – Reference Kirk Memorial Hospital 1313 Mockingbird Lane Maintenance QC Report Instrument - 1 Software Version - 0.10Y Date/Time - 03/15/13 04:19 p.m. FX40 serial number FFPP03 FX40 serial number Pass Fail Temperature 35.1 (33.5 - 36.5) _____ _____ QC Thermometer Reading _________ _____ _____...

  • Page 116: No Growth Accession

    BD BACTEC FX40™ Instrument User’s Manual 5.4.10 No Growth Accession The No Growth Accession Reports list all the accessions whose related vials show no growth (and are not marked manual positive) in the selected time interval. The time intervals are:...

  • Page 117: Orphan Vials

    5 – Reference Figure 5-22 – Sample No Growth Accession Report 5.4.11 Orphan Vials The Orphan Vials Report lists all the vials in all the instrument's database that have no accession number. The report prints in landscape mode. The report provides the following information: Header: Selection/Sorting/Reporting Criteria, Hospital Information (if configured), Instrument Number, Instrument Software Version, Report Title, and Date and Time Printed Body of Report (columns from left to right): Accession, Patient Name (30 characters), Patient ID,...

  • Page 118: Partially Seated Stations

    BD BACTEC FX40™ Instrument User’s Manual Select the desired report criteria by selecting the radio button next to the criteria.  Sort By: Choose 1st and 2nd Sort By field of either: Accession, Hospital Service, Media (alphabetic), Patient ID, Patient Name, Sequence, Start of Protocol, Location, Status, or None.

  • Page 119: Pending Report

    5 – Reference Select the desired report in the menu. Select Print to print the report Figure 5-24 – Sample Partially Seated Stations Report 5.4.13 Pending Report The Pending Report lists all the vials that have been logged in at the Culture display but have not been placed in the instrument yet (orphan demographics).

  • Page 120: Unloaded Negative Vials

    BD BACTEC FX40™ Instrument User’s Manual Select Print to print the report. Kirk Memorial Hospital Sorted By - Accession,Sequence 1313 Mockingbird Lane Selected Status - All Pending Report Reported By - None: Instrument - 1 Software Version - 0.10Y Date/Time - 03/21/13 04:05 p.m.

  • Page 121: Unloaded Positive Vials

    5 – Reference  Report By: primary selection: None, Media, Hospital Service. If a criterion other than None is selected, any Media or Hospital Services that have been used in patient/specimen records appear in the secondary selection field. The default values are All Media and Hospital Services.

  • Page 122: Unloaded Vials

    BD BACTEC FX40™ Instrument User’s Manual  Sort By: Choose 1st and 2nd Sort By field of either: Accession, Hospital Service, Media (alphabetic), Patient ID, Patient Name, Sequence, Start of Protocol, Location, Status, or None. The default sort order is by Accession, then by Sequence....

  • Page 123: Maintenance

    5 – Reference Select the desired report criteria by selecting the radio button next to the criteria.  Time Range: Select the From: and To: buttons to select the start and end times. The default time range is from midnight yesterday. ...
  • Page 124 Select to sound the audible alarm. All instruments must be closed for this button to be active. The alarm sounds for 2.5 seconds at the middle volume setting, pauses, and repeats. If the alarm does not sound, note this in your Maintenance QC Report and contact BD. Status button Select to illuminate all the system status indicators for 5 seconds.

  • Page 125: Block/Unblock Stations Display

    5 – Reference Q.C. (report) button Select to print/reprint the Maintenance QC Report. This button is disabled when the instrument is in degraded mode. Block/Unblock button Select to access the Block/Unblock stations display. Refer to Block/Unblock Stations Display below. 5.5.2 Block/Unblock Stations Display The Block/Unblock Stations display enables you to block (remove from service) and unblock (return to service) stations in the drawers.

  • Page 126: Utilities Display

    BD BACTEC FX40™ Instrument User’s Manual Exit button Select to exit the Block/Unblock display and return to the Maintenance – Test display. Figure 5-30 – Block/Unblock Stations Display 5.5.3 Utilities Display To access Maintenance – Utilities: • From the Status display, select the Maintenance tab •...

  • Page 127: Upgrade Software

    5 – Reference 5.5.3.1 Upgrade Software There is no associated display for the Upgrade Software utility. For information on upgrading software, refer to Section 6.4.1. 5.5.3.2 Save DB and Log There is no associated display for the Save DB and Log utility. For information on saving the database and log files, refer to Section 6.4.2.

  • Page 128: Bd Utilities

    BD BACTEC FX40™ Instrument User’s Manual Change Password Buttons: OK button Select OK to save the new password and return to the Maintenance – Test display. Cancel button Select to exit the Change Password window without saving the new password.

  • Page 129: Maintenance

    The air filter should be cleaned monthly. All other procedures are on an as needed basis. Any maintenance or repair not described in this section should be performed by BD representatives only. No preventive maintenance is required to be performed by BD authorized service personnel.

  • Page 130: Monthly Maintenance

    BD BACTEC™ FX40 Instrument User’s Manual Figure 6-1 – Temperature QC Vial Location 6.2.2 Monthly Maintenance 6.2.2.1 Cleaning Air Filters All filters should be checked monthly and cleaned/replaced if needed (see below, Cleaning the air filters). If the instrument's environment is especially dusty, the air intake filters should be checked more frequently and cleaned or replaced if needed.
  • Page 131 6 – Maintenance Removing the air filter (Figures 6-2 and 6-3): Open the instrument door. Slide the air filter’s removal tab upward to enable grasping it (Figure 6-2). To remove the filter, pull the filter housing toward you by the tab. The housing is long, so continue to pull in a level manner until the housing is free of the instrument.

  • Page 132: As Needed Maintenance

    BD BACTEC™ FX40 Instrument User’s Manual 6.2.3 As Needed Maintenance 6.2.3.1 Blocking Stations Stations should be blocked if either station indicator fails to light during Daily Maintenance; or if the station does not correctly detect vial removals and insertions. Insert a station plug into any stations that you block AND stations that the instrument marks as unusable (cracked egg icon in View Stations display).

  • Page 133: Unblocking Stations

    If the spill extends into regions of the instrument not accessible for topical decontamination, or if it involves a broken vial, contact BD Technical Service and Support (USA) for further instructions (800.638.8663).
  • Page 134 BD BACTEC™ FX40 Instrument User’s Manual WARNING ALL PORTIONS OF THE BODY THAT COULD POSSIBLY COME INTO CONTACT WITH THE AFFECTED INSTRUMENT SURFACES MUST BE COMPLETELY COVERED BEFORE BEGINNING THE DECONTAMINATION PROCESS. PATHOGENIC MICROORGANISMS, INCLUDING HEPATITIS VIRUSES AND HUMAN IMMUNODEFICIENCY VIRUS, MAY BE PRESENT IN CLINICAL SPECIMENS.

  • Page 135: Cleaning The Barcode Scanner Window

    6 – Maintenance 6.2.6 Cleaning the Barcode Scanner Window There are no user-serviceable parts in the barcode scanner. After a period of use, you may find that the barcode scanner does not seem to scan barcode labels as easily as before. If this happens, you can try to solve the problem by cleaning the scanner’s window.

  • Page 136: Maintenance - Test

    • Change Password – change the default/existing password required to save configuration changes • BD Utilities – for BD use only Maintenance – Utilities Fields S/W Versions Drop-down list shows the current versions of instrument software modules. These modules include the Tablet PC (SCB), the FX40 Control Board (FCB), and the Row Board (RB).

  • Page 137: Upgrade Software

    When complete, two messages appear. Select OK in each message box. 6.4.3 Save Log To save the event log files to a flash drive: Insert a BD-supplied flash drive in the USB port. Select Save Log. The Busy icon appears.

  • Page 138: Change Password

    If the same password has been entered in the New Password and Confirm Password fields, and the new password conforms to the requirements, a message appears confirming that the password was changed. For additional information, refer to Section 5.5.3.5. Figure 6-6 – Change Password Window 6.4.6 BD Utilities This function is for BD use only.

  • Page 139: Troubleshooting

    General 7.1.1 Instrument Service If your BD BACTEC™ FX40 instrument malfunctions or operates unusually in any way, you may initially attempt to solve the problem by following the recommendations in this section. All other servicing attempts will terminate the responsibility of the manufacturer under the terms of the warranty.
  • Page 140 BD BACTEC™ FX40 Instrument User’s Manual The table of messages below suggests some possible causes of errors and alerts, and provides possible corrective actions. CAUTION If the recommended corrective actions do not solve the problem, contact BD. System alerts can be viewed and printed in the System Alerts display. Refer to Section 5.3.5.
  • Page 141 System parameters are set (and/or reset to the defaults) on the Startup-Configuration display (accessed by BD representatives only). Event Log Set during startup when the Alert clears when instrument creates Reinitialized. instrument detects corruption new event log.
  • Page 142 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Instrument X: One Instrument has detected a Alert clears when the instrument or more stations condition that could represent detects that the failure no longer has had a a measurement failure or exists.
  • Page 143 Error Message Possible Cause(s) Corrective Action(s) Unexpected FX40 An instrument that is not part Contact your local BD representative detected. of the system configuration to have the instrument added to the was detected. current system configuration. AC Power is lost.
  • Page 144 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Station X-X0: An individual reading or a A sector on the flash drive is corrupted Reading Collection reading collection is or a bad checksum is encountered on Database Object corrupted.
  • Page 145 Make sure all network cables are EpiCenter times determined that its time is not plugged in. are not synchronized with the synchronized. BD EpiCenter™ Time Service. Database recovery This will only cause Message is informational only. No file invalid. (potentially) the last action necessary.
  • Page 146 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Instrument X: Agitation speed is outside of Alert is reported on System Alerts Agitation Restarted normal range, or failed to stop display and report only. at a sensor or see a sensor Alert is cleared when agitation speed for 10 continuous seconds.
  • Page 147 Reenter scanned or entered and the replacement vial barcode is scanned; barcodes. media type is not defined in only original BD vial sequence or the instrument. BD-supplied replacement barcodes can be used for sequence numbers. BC01 If vial sequence number is entered manually, be careful to enter it correctly.
  • Page 148 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Culture Screen Messages Patient ID not You entered a patient ID that Make sure Patient ID is entered found. is not in the database. correctly and completely. You cannot...
  • Page 149 7 – Troubleshooting Error Message Possible Cause(s) Corrective Action(s) ID Anonymous Messages Positive A positive anonymous vial Scan the vial sequence barcode. anonymous vial was pulled from a station. Select Save to save the identification if pulled. Scan The station is shown at the you are keeping the vial out of the ID01 sequence and...
  • Page 150 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Vial pending Occurs if you select Exit on Select Yes to exit the ID Anonymous identification. the ID Anonymous display, display. Discard all with information related to a...
  • Page 151 If the flash drive is labeled correctly Software upgrade BD BACTEC™ FX40 (indicates correct software update device. instrument software. version), contact BD for a new software update flash drive. Password The current Password was UTIL11 incorrect, please Enter the correct current password.
  • Page 152 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Downgrading to an older version of FX40 System You attempted to install an Software is not older version of software than Installing an older version of UTIL14 allowed. Please what is currently on the instrument software is not permitted.
  • Page 153 7 – Troubleshooting Error Message Possible Cause(s) Corrective Action(s) Vial Entry Messages Scanned vial has You attempted to reenter a Vial should be subcultured. Vial may been out of the vial that has been out of the be reentered into instrument, but is instrument for instrument for more than 5 treated as a new vial.
  • Page 154 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) The vial’s last A positive vial is being Select Yes to return the vial as O. known status is re-entered into the instrument Select No to return the vial as P.
  • Page 155 7 – Troubleshooting Error Message Possible Cause(s) Corrective Action(s) Vial Removal Messages Appears if a related vial with a Compare the actual vial sequence Vial has a manually entered sequence is number to the one shown at the top of manually entered removed during Positive the message box.
  • Page 156 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Workflow Exception Messages WE02 Unexpected vial You have pulled a vial that Select Yes to remove the scanned vial pulled. Remove? doesn't correspond to the named in the message box.
  • Page 157 BD EpiCenter™ Identify the vial when communications Vial may only be configuration. with BD EpiCenter™ are returned reestablished. anonymously. Exit with vial Message appears if you Select Yes to exit without saving the information select “Exit”...
  • Page 158 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Remove any vial Appears when an empty Insert a station plug to prevent from station and station is blocked using Block/ inserting a vial in the blocked station.
  • Page 159 7 – Troubleshooting Error Message Possible Cause(s) Corrective Action(s) FX40 selected is Appears if an instrument that Message is informational. Vial or currently offline. is offline is selected in View station statuses may be different from Information shown Stations or Block/Unblock what is shown on the display because may not be ...
  • Page 160 BD BACTEC™ FX40 Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Vial can no longer This will be displayed if the Message is informational. No activity is be found in the user has attempted to modify possible since the vial is no longer...

  • Page 161: Unusable Stations, Affected Vials, And Partially Seated Vials

    (WE53) appears and asks you to physically verify that vials in the indicated stations are seated. BD strongly recommends that you respond to this message immediately. If a vial is in fact partially seated, then the condition can be corrected immediately by fully inserting the vial.
  • Page 162 BD BACTEC™ FX40 Instrument User’s Manual When all positive vials are removed, the instrument beeps 3 times to indicate that this activity is complete. Select Exit to return to the Status display. 10 If there are any negative vials in the drawer, select Remove Negatives on the Status display.

  • Page 163: Affected Vials

    If you reply Later, the message box closes and the normal station indicator patterns light. The next time the drawer is opened, the message reappears. BD strongly recommends that you address the WE53 message as soon as possible by responding Now. Because the message occurs when test readings are outside of specifications, they may indicate a potential problem with a vial or with a station, so resolving the situation as soon as possible is advisable.
  • Page 164 BD BACTEC™ FX40 Instrument User’s Manual To address a WE53 Partially Seated Vial message box: Select Now in the message box. Push the vials with the RED (solid) LEDs into their stations. There may be no audible sound, or, there may be the sound of an anonymous vial insertion if the vial was out of the station far enough that the station sensor thought the vial was removed.

  • Page 165: Limited Warranty

    Any damage to a BD BACTEC™ FX40 system resulting from the insertion or removal of cables that connect this instrument to systems other than those approved or supplied by BD or the failure of the owner to maintain reasonable care and precautions in the operation and maintenance of the system will void this warranty and terminate the obligations of the manufacturer as stated herein.
  • Page 166 BD BACTEC™ FX40 Instrument User’s Manual...

  • Page 167: Contacts

    9 – Contacts BD 7 Loveton Circle Sparks, Maryland 21152 USA Voice: 410.316.4000 • Fax: 410.527.0244 Technical Service and Support: 1.800.638.8663 bd.com 2100 Derry Road West Suite 100 Mississauga, Ontario Canada L5N 0B3 Voice: 866-979-9408 • Fax: 800-565-0897 Monte Pelvoux 111 • 9th Floor...
  • Page 168 BD BACTEC™ FX40 Instrument User’s Manual bd.com/e-labeling Key-code: 8090414 +800 135 79 135 00 800 161 220 577 99 +800 135 79 135 800 8996 880 030 728 0800 895 084 0800 606 287 00800 142 064 866 +31 20 796 5692...

  • Page 169: 10 -Replacement Parts

    10 – Replacement Parts Catalog Number Item 441519 Blank USB Flash Drive 441971 BD BACTEC™ FX40 Quick Reference Guide 442391 BD BACTEC™ FX40 Software Update Kit / User’s Manual CD 443383 BD BACTEC™ FX40 Instrument Fuse 443391 Barcode Scanner 443393 Tablet Computer 443403...
  • Page 170 BD BACTEC™ FX40 User’s Manual...

  • Page 171: Glossary

    BD BACTEC™ FX40 instruments attached to the same tablet PC contaminant means of flagging a positive culture to indicate that the isolate is thought to be...
  • Page 172 BD BACTEC™ FX40 instrument; current media types include: Type Code Abbreviation shown on reports Aerobic Plus Aer Plus...
  • Page 173 BD BACTEC™ culture vials; barcode value is exactly 12 digits and starts with 44; the third and fourth digits contain the medium type; the last 8 digits identify the vial Sequenced vial vial that has an associated sequence number (i.e.
  • Page 174 BD BACTEC™ FX40 Instrument User’s Manual Status vial status; statuses include: Type Abbreviation shown on reports Positive Positive Negative Negative Ongoing Ongoing Manual Man Pos Positive Manual Man Neg Negative Pending Pending test see media Time in Protocol: calculated from time of entry into the instrument (the vial’s Start of Protocol) until the current time (if in the instrument) or removal time (if removed from the instrument), in the format of days;hours:minutes (DD;HH:MM)

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