BD BACTEC FX User Manual
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BD BACTEC FX User Manual

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Instrument User's Manual
BACTEC™ FX
 
  
B ecton, Dickinson and Company
Sparks, MD 21152 USA
Pottery Road, Dun Laoghaire
Australian Sponsor:
Becton Dickinson Pty Ltd.
4 Research Park Drive
Macquarie University Research Park
North Ryde, NSW 2113 Australia
8005110(09) 2019-09
KEY-CODE: 8005110
R
Only
x
7 Loveton Circle
Benex Limited
Co. Dublin, Ireland
441427
English
bd.com/e-labeling

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Questions and answers

Joe Strain
January 24, 2025

We have offline rows on our Bactec FX40.

0
1 comments:
Mr. Anderson
February 10, 2025

To resolve offline rows on a BD BACTEC FX40:

1. Identify the affected rows (e.g., Rows G, H, J, or K).
2. Check if the Row Board is marked offline.
3. Reboot the instrument to restore communication.
4. If stations remain unusable, refer to Section 7.3.2 of the manual for further troubleshooting.
5. Move vials from the affected stations within 40 minutes to prevent them from becoming Affected Vials.

If the issue persists, consult the manual for additional corrective actions.

This answer is automatically generated

0
luisa sanchez santos
February 21, 2025

HOW TO RESOLVE ANNONYMOUS BOTTLES?

0
1 comments:
Mr. Anderson
February 21, 2025

To resolve anonymous vials with the BD BACTEC FX system:

1. Select a drawer that contains anonymous stations and open it.
2. Remove a vial from a FLASHING YELLOW or FLASHING YELLOW/FLASHING RED (alternating) station or select "Identify Anonymous" on the Status display.
3. The ID Anonymous display will appear, and the barcode scanner will turn on.
4. Identify the vial using the barcode scanner.

Once identified, the instrument will process the vial accordingly. Removing a vial without identifying it will discard all test readings.

This answer is automatically generated

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yacoob mohammed
March 24, 2025

how do you turn on/off epicenter

0
1 comments:
Mr. Anderson
March 24, 2025

To turn on or off the BD BACTEC FX instrument:

1. Locate the power switch:
- The Top (Single) instrument's power switch is behind the access panel to the right of the LCD/Touchscreen.
- The Bottom instrument's power switch is at the bottom right of the instrument.

2. Operation of the power switch:
- Move the switch to the “|” (On) position to turn on the instrument. The switch will illuminate green, and power will be applied.
- Move the switch to the “O” (Off) position to turn off the instrument. This removes power from the instrument.

For normal operation, the power should remain on at all times except during certain maintenance procedures.

This answer is automatically generated

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Related Manuals for BD BACTEC FX

Summary of Contents for BD BACTEC FX

  • Page 1 Sparks, MD 21152 USA  Benex Limited Pottery Road, Dun Laoghaire Co. Dublin, Ireland Australian Sponsor: Becton Dickinson Pty Ltd. 4 Research Park Drive Macquarie University Research Park North Ryde, NSW 2113 Australia 8005110(09) 2019-09  441427 English bd.com/e-labeling KEY-CODE: 8005110...
  • Page 2 Removing Positive, Negative and Ongoing Vials section. BD, the BD Logo, BACTEC, EpiCenter, Modem, and Synapsys are trademarks of Becton, Dickinson and Company or its affiliates. © 2019 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....................13 1.3.4 Vial Agitation ....................... 13 1.3.5 Measurement Subsystem ................... 13 1.3.6 Vial Presence Sensing....................
  • Page 4 BD BACTEC™ FX Instrument User’s Manual 3 – Controls and Indicators .................... 41 General ............................. 41 Power Switch ..........................43 3.2.1 Location ........................43 3.2.2 Operation ........................43 System Indicators........................44 3.3.1 Location ........................44 3.3.2 Indication........................44 Drawer Handles ........................45 3.4.1...
  • Page 5 Printing Reports ........................70 Removing Positive, Negative, and Ongoing Vials ..............71 4.10 Responding to Alarms and Errors ..................... 76 4.11 Power Failures .......................... 76 4.12 Operation with a BD EpiCenter System ..................76 4.12.1 Normal Operations...................... 76 4.12.2 Isolation Mode......................78 4.12.3...
  • Page 6 BD BACTEC™ FX Instrument User’s Manual 5.4.13 Pending........................131 5.4.14 Unloaded Negative Vials................... 133 5.4.15 Unloaded Positive Vials .................... 135 5.4.16 Unloaded Vials......................136 Maintenance..........................138 5.5.1 Test Display ......................138 5.5.2 Block/Unblock Stations Display ................140 5.5.3 Utilities Display......................141 5.5.3.1...
  • Page 7 Contents Unusable Stations, Affected Vials, and Partially Seated Vials ..........................179 7.3.1 General ........................179 7.3.2 Unusable Stations..................... 179 7.3.3 Affected Vials ......................181 7.3.4 Partially Seated Stations................... 181 Barcode Scanner ........................183 8 – Limited Warranty ....................185 9 – Contacts ......................... 187 10 –...
  • Page 8 BD BACTEC™ FX Instrument User’s Manual...

  • Page 9: Introduction

    1 – Introduction Intended Use The BD BACTEC™ FX 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 Row Board Test Readings Positivity Analysis Figure 1-1 – BD BACTEC FX Fluorescent Technology...

  • Page 11: System Overview

    Laboratory Information System (LIS). 1.3.1 Instrument Overview The BD BACTEC FX instrument is an automated system for detecting the presence of microorganisms in clinical samples, blood, and blood products. Inoculated vials are placed in one of the drawers in the instrument, each of which contains a 10 x 10 array of vial stations.

  • Page 12: Control Electronics

    BD BACTEC™ FX Instrument User’s Manual Figure 1-2 – BD BACTEC FX Instrument Stack and Single 1.3.2 Control Electronics The instrument has several controllers that are responsible for control and analysis of the following: • Temperature measurement and control •...

  • Page 13: Incubation Subsystem

    1 – Introduction 1.3.3 Incubation Subsystem The incubation subsystem is designed to maintain the temperature of the contents of any culture vial in any station at 35.0 ± 1.5 °C. The temperature is achieved by forced air convection over the media vials. Each drawer is a separately controlled incubation zone.

  • Page 14: Barcode Scanners

    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 FX 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: Media Overview

    1 – Introduction 1.3.13 Media Overview Several media are available for use with the BD BACTEC FX system. These include: BD BACTEC Standard/10 Aerobic /F Recommended for 3.0 to 10.0 mL (8.0 to 10.0 mL optimal) blood volume. BD BACTEC Plus Aerobic /F Contains resins for antibiotic neutralization.

  • Page 16: Built-In Test

    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 FX 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: Conventions

    (e.g., Accession). 1.5.2 Symbols and Connections Used on the Equipment The following symbols and connections are used on the BD BACTEC FX instrument: Figure 1-3 – Front Connections At center of photo, 9-pin serial connector (top); two USB connectors (middle); power switch (bottom).
  • Page 18 BD BACTEC™ FX Instrument User’s Manual Figure 1-5 – Bottom Rear Connections AC Power connector (top); Stack connector (bottom)  Figure 1-6 – Biohazard Symbol...

  • Page 19: Notes, Cautions, And Warnings

    1 – Introduction 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. These messages are formatted as shown below and bear the following significance: NOTE Important information about instrument use worthy of special attention is presented as a NOTE.
  • Page 20 BD BACTEC™ FX Instrument User’s Manual...

  • Page 21: Installation

    2 – Installation General This section provides specifications for installation and setup of the BD BACTEC FX instrument. The following major topics are included: • Instrument Specifications • Instrument Installation • 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™ FX Instrument User’s Manual Air Intake (indicated by arrows) Air Output (indicated by arrows) Figure 2-1 – Air Intake (left) and Output (right) Air is output (exhausted) from same location in top and bottom instruments.

  • Page 23: Instrument Specifications

    2 – Installation Instrument Specifications Physical Dimensions Single Instrument Stack Height 93.9 cm (37.0 in) 198.7 cm (78.25 in) Width 62.2 cm (24.5 in) 62.2 cm (24.5 in) Depth 86.9 cm (34.25 in) 86.9 cm (34.25 in) Clearance (rear, left, right) 1.3 cm, 0 cm, 0 cm 1.3 cm, 0 cm, 0 cm Clearance (front)

  • Page 24: Instrument Installation

    COUNTER WEIGHTS, MUST BE SECURED TO THE MOUNTING SURFACE BY YOUR LOCAL BD REPRESENTATIVE. The BD BACTEC FX 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 No clearance is required on the left or right sides of the instrument, however a minimum of 1.3 cm is required at the rear. If the instrument is placed against a wall that protrudes, make sure you allow sufficient space for personnel to access the drawer opposite the protruding wall.

  • Page 26: Lab Configuration

    BD BACTEC™ FX Instrument User’s Manual To save configuration changes, select Save (shown below). To enter a password, select the password field to display the onscreen keyboard (see Section 3.10). Select the 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 Figure 2-4 – Lab Configuration Display In a BD EpiCenter configuration, selecting a country (locale) at one instrument selects that locale for all instruments.
  • Page 29 Each laboratory should set its protocol lengths based on its own policies and conditions. In a BD EpiCenter configuration, selecting a protocol at one instrument selects that protocol for all instruments. Configuration – Lab Buttons: Undo button Select to clear changes and return to saved values.

  • Page 30: Reports Configuration

    IP (Address) For a Network Printer*, enter the IP (Internet Protocol) address of the printer. The default IP address is 192.168.2.150. This field does not appear if BD EpiCenter Printer is selected as the printer. *For Vx Works instruments only.
  • Page 31 2 – Installation Custom Fields Window: Organization 1 / Organization 2 Enter the desired name for your laboratory or hospital. There are two lines of text available, each of which accepts up to 25 characters. Select in the Organization 1 field to access the onscreen keyboard (see Section 3.10) to enter the desired hospital or laboratory name.

  • Page 32: Instr(Ument) Configuration

    You can choose a number from 1 to 99. If there is only a single instrument at your location, you should leave this value set at 1. Instrument number appears in report headers. Instrument numbers must be unique in a BD EpiCenter configuration. Barcode Reader Radio Buttons This field enables or disables the instrument barcode readers in an instrument stack.

  • 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 BD BACTEC™ FX Instrument User’s Manual Enabled radio button To enable communications with a compatible LIS system, select the Enabled radio button. Check the settings in the Port Parameters, Physical Layer, LIS Options, and BD Modem™ windows to complete the setup. Port Parameters Window fields: Com Port Select the Drop-down Arrow to select the desired com port.
  • Page 35 Physical Layer Window fields: ASTM 1381 radio button Select ASTM 1381 to use the ASTM 1381 LIS Communications protocol for communications with the BD BACTEC FX instrument. Refer to the LIS Vendor Interface Document for additional information. BD MODEM radio button Select BD MODEM to use the BD Modem Communications protocol for communications with the BD BACTEC FX instrument.
  • Page 36 ASTM packed frames. BD MODEM Window fields: The BD Modem window appears only when BD Modem is selected in the Physical Layer window. The first two fields are used to determine where specific data is in the LIS record. New Sequence Position checkbox...
  • Page 37 2 – Installation Hospital Service Field (33) checkbox The default setting is checked. 9000 Legacy Mode The default setting is unchecked. The following fields are used to define the expected characters in LIS messages. The default setting is 0x01. The default setting is 0x04. The default setting is 0x06.

  • Page 38: 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 39 2 – Installation Figure 2-9 – Set Date and Time Window 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™ FX Instrument User’s Manual Configuration – Time Buttons: Undo button Select to clear changes and return to saved values. Only active if field values are changed and are not saved. Save button Select to save changes. When the Enter Password window appears, select the blank password field.

  • 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 FX instrument. The overall layout of the instrument and most of the controls and indicators are shown in Figure 3-1.
  • Page 42 BD BACTEC™ FX Instrument User’s Manual System Indicators Drawer Handles Access Panel LCD  (Power Switch) Barcode Scanners Touchscreen Drawer Handles Power Switch Figure 3-1 – BD BACTEC FX Instrument Layout - Stack...

  • Page 43: Power Switch

    3 – Controls & Indicators Power Switch 3.2.1 Location Each instrument (Top/Single and Bottom) has its own power switch. The Top (Single) instrument's power (On/Off) rocker switch is on the front of the instrument, behind the access panel to the right of the LCD/Touchscreen. The Bottom instrument's power switch is on the front of the instrument, at bottom right.

  • Page 44: System Indicators

    BD BACTEC™ FX Instrument User’s Manual Power Switch Figure 3-3 – Lower Instrument Power Switch System Indicators 3.3.1 Location Each instrument (Top/Single and Bottom) has its own set of system indicators. The system indicators are located on the front of the instrument, at the bottom center of the top instrument, and at the top center of the bottom instrument.

  • Page 45: Drawer Handles

    3 – Controls & Indicators Drawer Handles 3.4.1 Location The drawers are designed to be grasped by handles to the right and left of the mullion, where the system indicator lights are projected. See Figure 3-1 for drawer handle locations. When a drawer is opened, agitation of all rows in the open drawer ceases immediately, and any measurements in progress are aborted.

  • Page 46: Lcd/Touchscreen

    BD BACTEC™ FX Instrument User’s Manual Figure 3-4 – Upper Barcode Scanner (On) LCD/Touchscreen 3.6.1 Location The Liquid Crystal Display (LCD) is located at the bottom center of the Top/Single instrument's front panel. It contains the displays that present information to you and the on-screen buttons that allow you to perform routine operations.

  • Page 47: Station Indicators

    3 – Controls & Indicators Station Indicators 3.7.1 Location Each accessible station has a set of LED indicators that inform you of the station or vial's status. The status indicators are located above each station. Station indicators are defined in the table below. Figure 3-5 shows the actual station 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.

  • Page 48: Usb Ports

    Note that a local printer should be connected to the instrument’s rear USB port. Audible Tones and Alarms A variety of sounds are generated by the BD BACTEC FX instrument as you perform operations. Each of the sounds is unique and designed to keep you informed about various operational states of the instrument.

  • Page 49: Digital Thermometer

    3 – Controls & Indicators The following keyboards can be accessed: • NUM -- Numeric • CAPS -- Alphabetic (toggles between UPPER CASE and lower case letters) • EXTND -- International characters (accented, extended character set) To switch between keyboards, select the key at the bottom corresponding to the desired character set. To enter text or numbers, select the desired characters.
  • Page 50 BD BACTEC™ FX Instrument User’s Manual NOTE Erratic readings, a faint display, or no display are all indicators that the battery must be replaced. The battery can be replaced without removal from the vial. Use a screwdriver to remove the battery cap by turning the cap counter-clockwise approximately 1/4 turn.

  • Page 51: Remote Alarm

    3 – Controls & Indicators 3.12 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 52 BD BACTEC™ FX Instrument User’s Manual...

  • Page 53: Operation

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

  • Page 54: 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 Drawer View display (Figure 4-3), accessed by selecting Drawer view, shows the status of each station in a representational view of the drawer.

  • Page 55: Instrument And Drawer Layout

    4 – Operation 4.2.3 Instrument and Drawer Layout Instruments are provided either as singles, which are countertop individual instruments with LCD; as stacks, which are two modules stacked on top of each other (only the top has a LCD); or a combination of the two.
  • Page 56 BD BACTEC™ FX Instrument User’s Manual Vial / Station counts Figure 4-2 – Vial Entry Display Figure 4-3 – Drawer View Display...
  • Page 57 4 – Operation Figure 4-4 – Instrument Drawer (open)
  • Page 58 BD BACTEC™ FX Instrument User’s Manual Vial and station statuses in the Drawer View display are: Status Icon Meaning How Indicated Station Indicators: GREEN vial entry icon in color on Status display Available There is no vial in station vial entry button active on Status display...

  • Page 59: Daily Maintenance

    10 Finally, select the Status button to illuminate the system status indicators. Both sides of all the indicators (yellow, red, and green) should illuminate. If any indicator does not light, contact your local BD representative for service. 11 Information can be recorded on the Maintenance QC Report.

  • Page 60: Collecting And Preparing Specimens

    BD BACTEC™ FX 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 correct drawer.

  • Page 61: Entering Vials

    When a vial is placed into the last available station in a drawer, the Activity Complete tone sounds (3 beeps). To continue entering vials, select another drawer with available stations. Vial Entry cannot be performed in an instrument in Isolation mode (Win FX), or an instrument in degraded mode in a BD EpiCenter configuration.
  • Page 62 A vial presence sensor immediately senses the insertion of a vial in a station and the instrument updates the station LED indication and the status shown on the LCD. Once vials are placed in their stations, BD recommends that you do not move them to other stations.
  • Page 63 Ongoing anonymous vials that reach the end of their protocol must be identified before the instrument will assign a Negative status. If an instrument in a BD EpiCenter configuration is in degraded mode, vials can only be entered as anonymous vials until communications with BD EpiCenter are re-established.

  • Page 64: 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 65 4 – Operation Associating vials to an accession: From the Status display, select Culture. The Culture – Patient display appears. Select the Specimen tab to access the Culture – Specimen display. In the Accession field, enter the desired accession. Scan the vial sequence barcode you want to attach. Select Save to save the association.

  • Page 66: 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, select Culture.
  • Page 67 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 68: 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 69 4 – Operation 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 4-6).

  • Page 70: Testing Vials

    Select Save to save the patient data. Testing Vials Vial testing in the BD BACTEC FX 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 71: 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 ...
  • Page 72 BD BACTEC™ FX Instrument User’s Manual Time the Does BD vial is out recommend Is positivity analysis of the subculturing Is protocol restarted? restarted? before vial  instrument re-entry? If re-entered into the If same workgroup same ≤20 workgroup minutes.
  • Page 73 4 – Operation 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. To adjust the protocol length of a reentered vial, select Modify and select the desired protocol by selecting the Up Arrow (increase protocol).
  • Page 74 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 75 4 – Operation • 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 select Verified.

  • Page 76: Responding To Alarms And Errors

    4.12 Operation with a BD EpiCenter System 4.12.1 Normal Operations In a BD EpiCenter configuration, the instrument and BD EpiCenter system routinely exchange information on instrument status, vial statuses, and test readings. Typically current information can be viewed at either the instrument or the BD EpiCenter system.
  • Page 77 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 78: Isolation Mode

    LIS system through the BD EpiCenter system. 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 FX instrument and a stack is lost.
  • Page 79 Depending upon the state that the user interface was in, the reboot process may take 5 minutes before the application is restarted. If the power cycle does not correct the problem, contact your local BD representative.

  • Page 80: Degraded Mode Operations

    BD BACTEC™ FX Instrument User’s Manual 4.12.3 Degraded Mode Operations If a BD BACTEC FX instrument loses communication with the BD FX master database, a system alert 30 is generated and the instrument enters a degraded mode of operation. In degraded mode, only the following operations can be performed: •...

  • Page 81: Reference

    5 – Reference General This section presents reference material on the BD BACTEC FX 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 82: Status Display

    • Testing status (active/inactive) • Approximate drawer full status • 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 instrument drawers. The icons within each represented drawer are grayed out if there are no vials/stations that correspond to the activity.
  • Page 83 5 – Reference Figure 5-1 – Status Display 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 Blue portion indicates how much of the drawer When the circle is empty, no...

  • Page 84: Positive Removal Display

    BD BACTEC™ FX Instrument User’s Manual Remove Positives button/ Remove Negatives button/ Positive Vial indicator Negative Vials indicator BD EpiCenter Enabled/healthy indicator Drawer View button Select to access: Drawer View display (5.3.6) BD EpiCenter Enabled/unhealthy indicator LIS Enabled/healthy indicator LIS Enabled/unhealthy indicator...
  • Page 85 5 – Reference Positive 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. Medium Read-only field that shows the medium type. Read-only field that shows the Time to Detection, in days; hours; minutes. Time to Detection is calculated as the amount of time between the vial’s Start of Protocol and when it is declared positive by the instrument.

  • Page 86: Negative Removal Display

    BD BACTEC™ FX Instrument User’s Manual 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. Wrong button Appears only if the vial sequence number was entered manually. Select to inform the system that the displayed vial sequence number is incorrect.
  • Page 87 5 – Reference Location Read-only field that shows the station number from which the negative vial was removed. Drawer X (where X is the current drawer) Counters for positive vials (+), negative vials (–), blocked/unusable stations (), ongoing vials (), anonymous vials (?), and available stations (O). Figure 5-3 –...

  • Page 88: Id(Entify) Anonymous Display

    BD BACTEC™ FX Instrument User’s Manual 5.3.3 ID(entify) Anonymous Display The ID Anonymous display enables you to identify ongoing anonymous and positive anonymous vials. You are informed of anonymous vials by the following: • Station indicators: FLASHING YELLOW – Ongoing Anonymous...
  • Page 89 5 – Reference Figure 5-4 – ID Anonymous Display Last Location This field shows the station number from which the anonymous vial was removed. TIP or TTD Read-only field that shows the Time in Protocol (for ongoing vials) or Time to Detection (for positive vials), in days;...

  • Page 90: 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 91 5 – Reference To access Vial Entry: Open a drawer 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-height or double-height barcode appears. The single-height barcode indicates that only sequence barcode scans are accepted on the Vial Entry display (i.e., Accession Barcoding is disabled).
  • Page 92 BD BACTEC™ FX Instrument User’s Manual Figure 5-5 – Vial Entry Display 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 93: System Alerts Display

    5 – Reference You can change a protocol up until the maximum protocol for that medium type is reached. Negative vials whose protocol is extended become Ongoing. Ongoing vials whose protocol is reduced, and that go out of protocol, become Negative when they receive their first test after reentry into the instrument.
  • Page 94 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 95: Drawer View Display

    5 – Reference 5.3.6 Drawer View Display The Drawer View display appears when you select the Drawer View button on the Status display. It provides an iconic view of all the drawer’s stations, showing the status of each station. Drawer View is updated dynamically when vial statuses change.
  • Page 96 BD BACTEC™ FX Instrument User’s Manual Figure 5-7 – Drawer View Display Drawer View Buttons: Drawer radio button Selected drawer is indicated by filled in radio button. Any currently open drawer is highlighted in green. To select a different drawer, select the empty radio button to the left of the letter (A, B, C, D).

  • Page 97: Culture - Patient Display

    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 system.
  • Page 98 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 99: Culture - Specimen Display

    When new information is added, or a field is changed, the field name appears highlighted until the information is saved. 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.
  • Page 100 BD BACTEC™ FX Instrument User’s Manual To access Culture – Specimen: From the Status display, select Culture From the Culture – Patient display, select the Specimen tab Culture – Specimen Display Fields: Accession For a new specimen record, enter up to 20 alphanumeric characters, excluding the following:...
  • Page 101 5 – Reference 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 communications is disabled.

  • Page 102: Culture - Vial Display

    BD BACTEC™ FX Instrument User’s Manual 5.3.9 Culture – Vial Display The Vial tab on the Culture display is primarily used to view or enter information about individual vials, and to perform specialized functions related to vials. The following functions can be performed: •...
  • Page 103 5 – Reference Figure 5-10 – Culture – Vial Display Status The current status of the vial. Statuses include: Pending, Ongoing, Positive, Negative. These statuses are explained in Section 4.2.4. In addition, you can select Manual Positive or Manual Negative in the drop-down box if you have determined through offline testing that a vial is positive or negative.
  • Page 104 BD BACTEC™ FX Instrument User’s Manual In Instrument indicator When this icon appears between the Location and TIP/TTD fields it indicates that the vial is currently in the instrument. TIP or TTD Read-only field that shows the Time in Protocol (for all vials other than Positive or Pending status) or Time to Detection (for positive vials), in days;...

  • Page 105: Plot Display

    5 – Reference 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. Both Fluorescence units and Positivity are shown on the graph. Plot displays all test readings for a vial that are stored in the database. The interpretation of plot graph information is not to be substituted for established laboratory procedures for determining the final positive or negative status of a culture.
  • Page 106 BD BACTEC™ FX Instrument User’s Manual The x-axis represents time. Time is shown as days; hours (dd;hh). The number of days and hours may vary depending on whether the data must be compressed due to the length of the protocol.

  • Page 107: Reports Menu

    5 – Reference Select and Drag: You can select 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 108 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 system (if configured).

  • Page 109: Affected Vials

    5 – Reference General Selection Criteria: Different reports have different criteria for selecting the data to be reported (filtering) or for sorting and/or organizing that data. If a specific criterion is not applicable to the selected report, the screen indicates “Time Range/Sort By/Report By does not apply.” The following criteria may be used (depending on the report): Time Range Enables you to select a starting and ending date for the report.
  • Page 110 BD BACTEC™ FX Instrument User’s Manual To print an Affected Vials Report: From the Status display, select the Reports tab to access the Reports menu. Select the desired report in the menu. Select the desired report criteria by selecting the radio button next to the criteria....

  • Page 111: Alert List

    5 – Reference 5.4.2 Alert List The Alert List report lists the latest 100 instrument alerts. The report provides the following information: Header: Hospital information (if configured), Instrument Number, Instrument Software Version, Report Title, and Date and Time Printed Body of Report (columns from left to right): Message ID number, Time that the Alert occurred (Set Time), Time that the Alert was cleared (Clear Time), Description of the Alert Applicable Selection Criteria: See Figure 5-14 for a sample Alert List report.

  • Page 112: Contaminant Vials

    BD BACTEC™ FX 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 113: Culture Summary

    5 – Reference Sorted By - Accession,Sequence Contaminant Vials Selected Status - All Reported By - Contaminant: Instrument - 1 Software Version - 2.20X From 04/20/2009 12:00 a.m. To 04/20/2009 09:19 a.m. Date/Time - 09/22/2009 09:18 a.m. Accession Patient Name Patient ID Sequence Test/Proto...
  • Page 114 BD BACTEC™ FX Instrument User’s Manual Applicable Selection Criteria: Time Range Report By See Figure 5-16 for a sample Culture Summary report. To print a Culture Summary Report: From the Status display, select the Reports tab to access the Reports menu.

  • Page 115: Current Inventory

    5 – Reference 5.4.5 Current Inventory The Current Inventory Report lists all the vials in all the instrument's stations. 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, Sequence, Test*/Protocol, Status*, State (column not labeled, body of report shows: ? for anonymous, vial icon for current, or blank for removed/pending), Service, Location, TIP/TTD (Time...
  • Page 116 BD BACTEC™ FX Instrument User’s Manual Sorted By - Accession,Sequence Current Inventory Selected Status - All Reported By - None: Instrument - 1 Software Version - 2.20X Date/Time - 04/20/2009 09:18 a.m. Accession Patient Name Patient ID Sequence Test/Proto Status...

  • Page 117: Current Negatives Report

    5 – Reference 5.4.6 Current Negatives Report The Current Negatives Report lists all the negative vials (out-of-protocol and manual negatives) in all the instrument's stations. 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, Sequence, Test*/Protocol, Status*, State (column not labeled, body of report shows: ? for...
  • Page 118 BD BACTEC™ FX Instrument User’s Manual Sorted By - Accession,Sequence Current Negatives Selected Status - Negative Reported By - None: Instrument - 1 Software Version - 2.20X Date/Time - 04/22/2009 09:18 a.m. Accession Patient Name Patient ID Sequence Test/Proto Status...

  • Page 119: Current Positives Report

    5 – Reference 5.4.7 Current Positives Report The Current Positives Report lists all the positive vials (instrument positive, manual positive, and anonymous positive) in all the instrument's stations. 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 120: Loaded Vials

    BD BACTEC™ FX Instrument User’s Manual Sorted By - Accession,Sequence Current Positives Selected Status - Positive Reported By - None: Instrument - 1 Software Version - 2.20X Date/Time - 02/22/2009 09:18 a.m. Accession Patient Name Patient ID Sequence Test/Proto Status...
  • Page 121 5 – Reference To print a Loaded Vials Report: From the Status display, select the Reports tab to access the Reports menu. Select the desired report in the menu. Select the desired report criteria by selecting the radio button next to the criteria. ...

  • Page 122: Maintenance Qc

    BD BACTEC™ FX Instrument User’s Manual 5.4.9 Maintenance QC The Maintenance QC Report provides a report on drawer temperatures and blocked stations, and provides spaces to log user verification and maintenance activities (such as verifying station and system LED indicators). The report typically prints on one page, but if needed the information may continue on a second page.
  • Page 123 5 – Reference Maintenance QC Report Instrument - 1 Software Version - 1.00X Date/Time - 04/15/2009 09:18 a.m. Upper Serial Number LJK001 Pass Fail Pass Fail Temperature 35.0 (33.5 - 36.5) Temperature 35.0 (33.5 - 36.5) QC Thermometer Reading ________ ______ ______ QC Thermometer Reading ________...

  • Page 124: No Growth Accession

    BD BACTEC™ FX 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 125: Orphan Vials

    5 – Reference Select Print to print the report. Sorted By - Accession,Sequence No Growth Accession Selected Status - All Reported By - None: Report Interval - 72 Hours Instrument - 1 Software Version - 2.20X Date/Time - 04/22/2009 09:18 a.m. Accession Patient Name Patient ID...
  • Page 126 BD BACTEC™ FX Instrument User’s Manual To print an Orphan Vials Report: From the Status display, select the Reports tab to access the Reports menu. Select the desired report in the menu. Select the desired report criteria by selecting the radio button next to the criteria....

  • Page 127: Partially Seated Stations

    5 – Reference 5.4.12 Partially Seated Stations The Partially Seated Stations Report lists all the vials that the instrument believes are partially seated (not fully inserted in their stations). 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 128 BD BACTEC™ FX Instrument User’s Manual Sorted By - Accession,Sequence Partially Seated Stations Selected Status - All Reported By - None: Instrument - 1 Software Version - 2.20X Date/Time - 04/22/2009 09:18 a.m. Accession Patient Name Patient ID Sequence Test/Proto...

  • Page 129: Pending

    5 – Reference 5.4.13 Pending 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). 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...
  • Page 130 BD BACTEC™ FX Instrument User’s Manual Select Print to print the report. Sorted By - Accession,Sequence Pending Report Selected Status - All Reported By - None: Instrument - 1 Software Version - 2.20X Date/Time - 04/22/2009 09:18 a.m. Accession Patient Name...

  • Page 131: Unloaded Negative Vials

    5 – Reference 5.4.14 Unloaded Negative Vials The Unloaded Negative Vials Report lists all the sequenced negative vials (out-of-protocol negative and manual negative) that have been removed from the instrument in a specified time period and have not been reentered. 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...
  • Page 132 BD BACTEC™ FX Instrument User’s Manual Select Print to print the report. Sorted By - Accession,Sequence Unloaded Negative Vials Selected Status - Negative Reported By - None: Instrument - 1 Software Version - 2.20X From 04/21/2009 12:00 a.m. To 04/22/2009 09:19 a.m Date/Time - 04/22/2009 09:19 a.m.

  • Page 133: Unloaded Positive Vials

    5 – Reference 5.4.15 Unloaded Positive Vials The Unloaded Positive Vials Report lists all the sequenced positive vials (instrument positive and manual positive) that have been removed from the instrument in a specified time period and have not been reentered. 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 134: Unloaded Vials

    BD BACTEC™ FX Instrument User’s Manual Sorted By - Accession,Sequence Unloaded Positive Vials Selected Status - Positive Reported By - None: Instrument - 1 Software Version - 2.20X From 04/21/2009 12:00 a.m. To 04/22/2009 09:19 a.m Date/Time - 04/22/2009 09:18 a.m.
  • Page 135 5 – Reference To print an Unloaded Vials Report: From the Status display, select the Reports tab to access the Reports menu. Select the desired report in the menu. Select the desired report criteria by selecting the radio button next to the criteria. ...

  • Page 136: Maintenance

    Select to sound the audible alarm. All drawers 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 137 LIS Host Query button Select to send a query to the LIS system requesting demographic information for orphan vials in the instrument. This button is disabled in a BD EpiCenter configuration. Q.C. (report) button Select to print/reprint the Maintenance QC Report.

  • Page 138: Block/Unblock Stations Display

    BD BACTEC™ FX Instrument User’s Manual 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. Blocking a station might be advised, for example, when a station indicator does not light.

  • Page 139: Utilities Display

    5 – Reference Figure 5-30 – Block/Unblock Stations Display 5.5.3 Utilities Display To access Maintenance – Utilities: • From the Status display, select the Maintenance tab • From the Maintenance – Test display, select the Utilities tab Figure 5-31 – Utilities Display...

  • Page 140: Upgrade Software

    BD BACTEC™ FX Instrument User’s Manual 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 141: Bd Utilities

    Select to exit the Change Password window without saving the new password. Figure 5-32 – Change Password Window 5.5.3.6 BD Utilities This function is for BD use only. Configuration You cannot access Configuration displays in an instrument that is in degraded mode.
  • Page 142 BD BACTEC™ FX Instrument User’s Manual...

  • Page 143: Maintenance

    6 – Maintenance General The BD BACTEC FX system requires little maintenance from the user to provide reliable performance. Daily activities include checking the following items: station, system, and audible indicators; instrument temperature; and printer paper supply. All other procedures are on an as needed basis. Once every 12 months, preventive maintenance is required to be performed by BD authorized service personnel.

  • Page 144: As Needed Maintenance

    BD BACTEC™ FX Instrument User’s Manual 6.2.2 As Needed Maintenance 6.2.2.1 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; or to reserve the station for a temperature QC vial.

  • Page 145: Unblocking Stations

    6 – Maintenance Entry to move any vial in that station to a new station. The Maintenance QC Report lists the blocked stations. 6.2.2.2 Unblocking Stations To unblock a blocked station: From the Test display, select Block/Unblock. The Block/Unblock display appears. Make sure the correct drawer is open (highlighted in green).
  • Page 146 BD BACTEC™ FX Instrument User’s Manual To remove the filter, lift it up slightly, and then pivot the bottom outward. Lower the filter out of the filter housing. To insert a clean filter, place the top edge under the top lip of the mounting bracket. Slide the filter up, pivot the bottom in toward the mounting bracket, and lower the filter into place.
  • Page 147 6 – Maintenance Removing the top cabinet air filter (Figure 6-3): The top cabinet air filter is located at the top front of the upper instrument. To reach the filter for removal, a stable stepladder should be used. Two small tabs are located on the top edge of the filter. Locate and grasp the tabs. Pull the filter up out of the instrument.
  • Page 148 BD BACTEC™ FX Instrument User’s Manual To replace the filter, align it with the slot from which it was removed and push it down into place. 10 Align the pins in the LCD bezel with the holes in the instrument, and push the bezel back into place.

  • Page 149: Replacing Vial Barcode Labels

    6 – Maintenance 6.2.4 Replacing Vial Barcode Labels Extra vial sequence barcode labels are included in the instrument start-up kit. These labels can be used to replace damaged or unreadable labels on culture vials. The barcode labels contain sequence numbers that uniquely identify each vial. Note that if you replace a vial barcode label, when you enter that vial into the instrument (either through Vial Entry or through Identify Anonymous), it asks you to select a media type.

  • Page 150: Cleaning And Decontamination

    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 (USA) for further instructions (800-638-8663).

  • Page 151: Maintenance - Test

    • Reboot – restart the instrument’s main computer • 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 System Control Board (SCB), the Electronics Drawer Board (EDB), the Drawer...

  • Page 152: Upgrade Software

    BD BACTEC™ FX Instrument User’s Manual Figure 6-6 – Maintenance – Utilities Menu 6.4.1 Upgrade Software Open the access panel to the right of the LCD Touchscreen. Insert the flash drive containing the software update in the USB port. Select Upgrade Software.

  • Page 153: Save Log

    When complete, a message appears. Select OK. 6.4.4 Reboot To reboot the BD BACTEC FX application / main computer: Select Reboot. A confirmation message asks if you want to reboot the application. Select Yes to reboot, or select No to cancel the reboot. A message window confirms that you select Yes when the confirmation message appears.
  • Page 154 BD BACTEC™ FX Instrument User’s Manual...

  • Page 155: Troubleshooting

    7 – Troubleshooting General: Instrument Service If your BD BACTEC FX 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 156 BD BACTEC™ FX 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 157 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 158 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) One or more Instrument has detected a Alert clears when the instrument stations has had a condition that could represent detects that the failure no longer exists. measurement...
  • Page 159 LIS interface offline. Alert is set when LIS library Communications problem between returns any of errors below to instrument and LIS system. Refer to the FX application. the BD LIS Interface specification. LIS_SYSTEM_ERROR: UNSUPPORTED_CONFIG: LIS_ASSERT_ERROR: DEBUG_PROBLEM: AC Power is lost.
  • Page 160 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Drawer X: Agitation failure has set the Reboot instrument. Measurement measurement system to Stations are marked as Unusable. System offline. offline after three consecutive Refer to Section 7.3.2 for additional...
  • Page 161 Message Possible Cause(s) Corrective Action(s) Reboot Reason. Message sent to System Alert If error recurs, contact BD. display only (Info detail For Reasons 4 and 5, if power is lost window). for more than 40 minutes, all vials in Instrument has rebooted for...
  • Page 162 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Drawer X: Contains The reading gap evaluator Any vials in the affected row(s) are a vial with a reading determines when a vial has a marked as Affected Vials. Refer to gap.
  • Page 163 7 – Troubleshooting Error Message Possible Cause(s) Corrective Action(s) Drawer X Rows A & When the Drawer Control Reboot instrument. B are Offline. Board fails to communicate Stations are marked as Unusable. Remove any vials with the Row Board that Refer to Section 7.3.2 for additional in unusable controls rows A and B, the...
  • Page 164 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Barcode Messages Invalid medium A vial sequence number was Make sure the correct vial barcode or type. Reenter scanned or entered and the replacement vial barcode is scanned;...
  • Page 165 7 – Troubleshooting 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 CS01 The value you entered is enter a partial ID to recall patient shown at the top of the information.
  • Page 166 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) ID Anonymous Messages Positive- A positive anonymous vial Scan the vial sequence barcode. Anonymous pulled. was pulled from a station. Select Save to save the identification if Scan sequence and...
  • Page 167 7 – Troubleshooting 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 readings with information related to a All readings to date for the vial are ID13 and exit workflow? pulled vial on the screen.
  • Page 168 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Maintenance Utilities Messages Database saved! A save operation was Message is informational. completed successfully UTIL01 (Maintenance – Utilities – Save DB). Database save A save operation was not Retry the save operation.
  • Page 169 Downgrading to an You attempted to install an Installing an older version of older version of older version of software than instrument software is not permitted. BACTEC FX what is currently on the System Software is instrument. not allowed. Please UTIL14...
  • Page 170 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Vial Entry Messages Vial out of You attempted to reenter a Vial should be subcultured. Vial may instrument for vial that has been out of the be reentered into instrument, but is...
  • Page 171 7 – Troubleshooting Error Message Possible Cause(s) Corrective Action(s) Vial Removal Messages Vial has a manually Appears if a related vial with a Compare the actual vial sequence entered sequence. manually entered sequence is number to the one shown at the top of Please visually removed during Positive the message box.
  • Page 172 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Workflow Exception Messages 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 173 7 – Troubleshooting Error Message Possible Cause(s) Corrective Action(s) Exit with vial Message appears if you Select Yes to exit without saving the information pending select Exit without saving data. on screen. Exit? data on Vial Entry, or if you Select No to return to the display with exit Positive or Negative data retained on the display.
  • Page 174 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Unexpected vial The system lights all negative Select OK to remove the message pulled during batch stations when batch removal box. removal. is enabled and the Remove Use the Vial Entry activity to return the Negative vials activity is vial if you did not intend to remove it.
  • Page 175 WE58 cannot be viewed by BD EpiCenter since the or modified. time it was recalled on the Consult manual. Culture screen.
  • Page 176 BD BACTEC™ FX Instrument User’s Manual Error Message Possible Cause(s) Corrective Action(s) Vial last known to Sequence vial is removed Select Yes to remove the vial from the be in station shown from a degraded mode old (offline) location. above, which is...

  • Page 177: Unusable Stations, Affected Vials, And Partially Seated Vials

    Unusable Stations to good stations. BD strongly recommends that you respond to these messages immediately, and follow the instructions below for Unusable Stations. If vials are left in Unusable stations for more than 40 minutes, the vials become marked as Affected vials.
  • Page 178 BD BACTEC™ FX Instrument User’s Manual 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. 11 Remove all negative vials using the negative removal activity (Section 4.9).

  • Page 179: Affected Vials

    If you select 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 selecting 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 180 BD BACTEC™ FX Instrument User’s Manual Close drawer and check for anonymous vials. If anonymous vials exist, identify them using the ID Anonymous activity. Close the drawer and wait for a test cycle to occur (indicated on Status display). When the test cycle is complete, open the drawer again.

  • Page 181: Barcode Scanner

    If the Top instrument’s barcode reader has malfunctioned, select the Bottom radio button. If the Bottom instrument’s barcode reader has malfunctioned, select the Top radio button. Select Save and enter the Supervisor password when prompted. Contact BD immediately to have the inoperable barcode reader repaired by your local BD representative.
  • Page 182 BD BACTEC™ FX Instrument User’s Manual...

  • Page 183: Limited Warranty

    This warranty gives you specific legal rights. Additionally, you may have other rights that vary by region. The BD BACTEC FX instrument is warranted to the original purchaser to be free from defects in materials and workmanship for a period of one year following installation. BD's sole responsibility under this warranty shall be to repair or replace any instrument or its components (except for expendable supplies) which under normal operating conditions, prove to be defective within one year of delivery.
  • Page 184 BD BACTEC™ FX Instrument User’s Manual...

  • Page 185: 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 •...
  • Page 186 BD BACTEC™ FX Instrument User’s Manual bd.com/e-labeling Key-code: 8005110 +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 187: Replacement Parts

    10 – Replacement Parts Catalog Number Item 440809 Air Filters, Cabinet 441370 Thermometer, Temperature QC (digital) 441398 BD BACTEC™ FX Software Update Kit 441407 Printer, USB 441519 Flash Drive, USB, Blank 445516 Plug, Bad Station (10) 445518 Tray, Vial (2)
  • Page 188 BD BACTEC™ FX Instrument User’s Manual...

  • Page 189: Glossary

    BD EpiCenter configuration, when a BD BACTEC FX instrument loses degraded mode communication with the BD EpiCenter master database, it enters a degraded mode of operation; only limited operations can be performed...
  • Page 190 Definition location synonym for station manually entered vial whose sequence number was entered using the onscreen keyboard vial culture vial for use in the BD BACTEC FX instrument; current media types include: Type Code Abbreviation shown on reports Aerobic Plus Aer Plus...
  • Page 191 BD BACTEC culture vials; barcode value is exactly 12 digits sequence and starts with 44; the third and fourth digits contain the medium type; the last 8...
  • Page 192 BD BACTEC™ FX Instrument User’s Manual Term Definition Time to Detection: calculated from the time of first entry into the instrument (the vial’s Start of Protocol) until the instrument declares the vial as positive, in the format of days;hours:minutes (DD;HH:MM); does not apply to manual positive...
  • Page 193 Barcode Messages 164 Barcode Reader 32 Barcode Scanner 45 Barcode Scanners 14 Batch Negative Removal 27 Batch Vial Removal 71 BD BACTEC FX air flow 21 Air Intake and Output 22 Daily Maintenance 59 Electrical Requirements 23 Environmental Requirements 23...
  • Page 194 BD BACTEC™ FX Instrument User’s Manual Physical Dimensions 23 Principles of the Procedure 9 service 155 site preparation 24 specifications 23 BD BACTEC FX Instrument Layout 42 BD EpiCenter Accession Barcoding 27 Batch Negative Removal 27 date and time 38 demographic data 64...
  • Page 195 13 – Index Control Electronics 12 Country 28 culture definition 189 Culture - Patient Display 99 Culture – Patient Display 97 Culture – Patient Display Buttons/Icons 98 Culture – Patient Display Fields 97 Culture – Specimen Display 99, 100, 101 Culture –...
  • Page 196 BD BACTEC™ FX Instrument User’s Manual fluorescent technology 9 Forcing vials negative 74 Forcing vials positive 74 definition 189 home position definition 189 Hospital Service definition 189 ID Anonymous Buttons 89, 90 ID Anonymous Display 89 ID Anonymous Fields 88, 89...
  • Page 197 13 – Index Lab Configuration 26 Language 27 dimming 46 LCD/Touchscreen 46 Loaded Vials Report 120, 121 location definition 190 maintenance 59 daily 143 Maintenance – Test Buttons 136, 137 Maintenance – Test Display 136, 137 Maintenance – Utilities display 139 Maintenance –...
  • Page 198 BD BACTEC™ FX Instrument User’s Manual Media configuration 29 Media Overview 15 Media Package Inserts 16 medium definition 190 Modifying patient data 69 Modifying specimen data 67 Modifying vial protocol 65 Negative 58 Negative Removal Buttons 87 Negative Removal Display 86, 87...
  • Page 199 13 – Index Positive Anonymous vial definition 191 Positive culture definition 191 Positive Removal Buttons 86 Positive Removal Display 84, 85 Positive Removal Fields 85 Positive vial definition 191 positive vials 84 Positivity analysis 14 Power Failures 75 Power Switch 43, 44 Printer 30, 51 printer 59 Procedure...
  • Page 200 BD BACTEC™ FX Instrument User’s Manual S/W Versions 151 Save DB and Log utility 140, 152 Save Log utility 140, 153 sensor definition 191 sequence definition 191 Sequenced vial definition 191 Serial Numbers 33 Show Related Vials 27 Software and Operation...
  • Page 201 13 – Index 14 158 15 158 16 158 17 159 18 159 20 159 21 159 22 159 23 159 25 160 26 160 30 160 31 160 32 160 33 160 34 160 36 161 37 161 38 162 39 162 40 162 41 162...
  • Page 202 BD BACTEC™ FX Instrument User’s Manual Unblocking Stations 145 Unloaded Negative Vials Report 131, 132 Unloaded Positive Vials Report 133, 134 Unloaded Vials Report 134, 135 Unusable 58 Unusable Station Removal Display 179 Unusable Stations 177 unusable stations 177, 178...
  • Page 203 13 – Index Workflow Exception Messages 172 WE02 172 WE03 172 WE04 172 WE05 172 WE06 172 WE07 172 WE14 173 WE16 173 WE17 173 WE20 173 WE21 173 WE24 173 WE28 174 WE29 174 WE30 174 WE31 174 WE34 174 WE35 175 WE36 175 WE53 175...
  • Page 204 BD BACTEC™ FX Instrument User’s Manual...

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