BACTEC 9050 System Users Manual Rev G Sept 2010

BACTEC™ 9050 System User’s Manual

Change History REVISION

DATE

PAGES

REASON

New

4/96

All

A

8/96

i – ii, v – vi, 7 – 10, 13 – 14, 53 – 58, 77 – 78, 87 – 88

Minor additions to clarify service issues

B

12/96

All

Software version 1.10; cabinet interlock & EROs

C

7//97

i, ii, 11 – 12, 51 – 52

Software version 1.21; add heat spec.

D

6/98

i, ii, 11 – 20, 29 – 30, 51 – 52

Add required info. for Myco/F Lytic medium

E

2004/09

All

General updates

F

2009/08

i, ii

Add print spec to artwork

G

2010/09

i, ii

Correct AR address

New product release

This product is covered by the following patent: US 5,518,923

BACTEC is a registered trademark of Becton, Dickinson and Company. © Copyright Becton, Dickinson and Company, 1996 – 2010. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated into any language or computer language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior written permission of BD, 7 Loveton Circle, Sparks, Maryland, 21152, United States of America.

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Preface

Contents 1 - Introduction 1.1 1.2 1.3 1.4 1.5 1.6

1.7

BACTEC 9050 Overview ... 1 Instrument Overview ... 3 Software Overview ... 5 1.3.1 Built-in-Test (Patent Pending) ... 6 Manual Structure... 7 Use of this Manual ... 8 Conventions ... 9 1.6.1 General... 9 1.6.2 Symbols Used on the Equipment... 10 1.6.3 Notes, Cautions, and Warnings ... 10 Summary of Warnings and Cautions ... 11

2 - Installation and Setup 2.1 2.2 2.3 2.4

2.5

General Requirements ... 15 Instrument Specifications ... 16 Installation ... 18 Instrument Setup... 18 2.4.1 General... 18 2.4.2 Setup Parameters ... 19 System Start-up ... 23

3 - Controls and Indicators 3.1 3.2 3.3

3.4 3.5

General... 25 On/Off Switch... 27 Keypad and LCD Display ... 27 3.3.1 SILENCE ALARM Key ... 28 3.3.2 HOME ROTOR Key ... 28 3.3.3 Alarm Indicator ... 29 3.3.4 Brightness Dial ... 29 3.3.5 Soft Keys ... 29 3.3.6 New Positive Indicator... 29 3.3.7 DOWN/UP ARROW Keys... 30 3.3.8 Display Area ... 30 Door Interlock Switch ... 30 Floppy Disk Drive ... 31 3.5.1 Floppy Disk Indicator... 31 3.5.2 Floppy Disk Eject Button... 31

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Contents 3.6 3.7

Barcode Scanner... 31 Audible Tones and Alarms ... 32

4 - Operation 4.1 4.2 4.3 4.4 4.5

4.6 4.7 4.8 4.9

General... 33 Preparing Specimens ... 34 4.2.1 Media Quality Control ... 34 Daily Checks ... 35 Entering New Vials ... 35 Positive and Negative Specimens... 39 4.5.1 General... 39 4.5.2 Notification of Positive and Negative Vials ... 39 4.5.3 Removing Positive Vials ... 40 4.5.4 Removing Negative Vials ... 42 Printing System Status Reports... 43 Resolving Station Errors... 45 Identifying Anonymous Vials ... 47 Power Failures and Manual Operation... 49

5 - Reference 5.1 5.2 5.3

5.4

General... 51 Software Menu Tree ... 52 Display Types ... 52 5.3.1 Main Status Screen... 53 5.3.2 Main Activity Screen... 54 Icon Charts ... 55

6 - Maintenance 6.1 6.2

6.3

iv

General... 59 6.1.1 Instrument Symbols ... 60 Routine Maintenance ... 60 6.2.1 Air Filter Replacement ... 60 6.2.2 Temperature Verification (QC)... 61 6.2.3 Barcode Scanner Window ... 62 6.2.4 Decontamination... 63 Module Replacement... 64 6.3.1 Front Cabinet Components ... 65 6.3.1.1 Damper Cylinder... 65 6.3.1.2 Door Sensor Switch Replacement ... 67

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Contents 6.3.1.3 Rotor ... 68 6.3.1.4 RTD... 71 6.3.2 Front Panel Components ... 74 6.3.2.1 Front Panel Removal ... 74 6.3.2.2 Barcode Scanner Replacement... 76 6.3.2.3 Floppy Disk Drive Replacement... 77 6.3.2.4 Keypad/LCD Display Replacement ... 79 6.3.3 Rear Cabinet Components... 81 6.3.3.1 Rear Cabinet Shell... 81 6.3.3.2 Electrical Guard ... 83 6.3.3.3 AC Power Distribution Board ... 84 6.3.3.4 Blower ... 85 6.3.3.5 Computer Board ... 86 6.3.3.6 DC Power Distribution Board ... 87 6.3.3.7 Detector Board ... 89 6.3.3.8 Fan ... 91 6.3.3.9 Heater ... 93 6.3.3.10 I/O Board ... 94 6.3.3.11 Main Transformer... 96 6.3.3.12 On/Off Switch, Line Filter, and Interlock Switch 99 6.3.3.13 Power Supply (5V/+15V/–15V) Board ... 100 6.3.3.14 Power Supply (40V) Board ... 101

7 - Troubleshooting 7.1

7.2

General... 103 7.1.1 Instrument Service... 103 7.1.2 Instrument Symbols ... 103 Error/Alert Messages... 104

Appendix A - Limited Warranty ... 115 Appendix B - Replacement Parts ... 117 Appendix C - Software Update Log ... 119 Appendix D - International Contacts ... 121 Appendix E - Supplemental Forms ... 123 Glossary and Abbreviations ... 127 Index ... 133

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Contents

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Preface

Figures Figure

Description

Page

1-1 1-2 1-3 1-4

BACTEC Fluorescent Test Technology ... 2 BACTEC 9050 Instrument ... 4 Main Status Screen... 6 Symbols Used on the BACTEC 9050 Instrument ... 10

2-1

Main Status Screen... 19

3-1 3-2 3-3 3-4

BACTEC 9050 Instrument Layout... 26 On/Off Switch... 27 Keypad and LCD Display ... 28 Floppy Disk Drive Controls and Indicators ... 31

4-1 4-2 4-3 4-4 4-5 4-6

Entering New Vials ... 38 Removing Positive Vials ... 40 Removing Negative Vials ... 42 System Status Report ... 44 Resolving Station Errors ... 46 Identifying Anonymous Vials... 48

5-1 5-2

Main Status Screen... 53 Main Activity Screen... 55

6-1 6-2 6-3 6-4 6-5 6-6 6-7 6-8 6-9 6-10 6-11 6-12 6-13 6-14 6-15 6-16 6-17 6-18 6-19 6-20 6-21

Air Filter Replacement ... 61 Barcode Scanner Window ... 62 Damper Cylinder Removal ... 66 Door Sensor Switch Removal... 67 Rotor Removal... 69 Rotor Removal – Pushing Down Driver Motor ... 70 RTD Removal (A)... 72 RTD Removal (B) ... 73 RTD Removal (C)... 73 Front Panel Removal (A) ... 74 Front Panel Removal (B) ... 75 Barcode Scanner Removal ... 76 Floppy Disk Drive Removal ... 77 Floppy Disk Drive Pin 1 Identification (typical)... 78 Keypad/LCD Display Removal (A) ... 79 Keypad/LCD Display Removal (B) ... 80 Rear Cabinet Shell Removal (A) ... 81 Rear Cabinet Shell Removal (B)... 82 Electrical Guard Removal... 83 AC Distribution Board Removal ... 84 Blower Removal... 85

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Figures Figure 6-22 6-23 6-24 6-25 6-26 6-27 6-28 6-29 6-30 6-31 6-32

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Page

Computer Board Removal ... 86 DC Power Distribution Board Removal ... 88 Detector Board Removal... 90 Fan Removal... 92 Heater Removal ... 94 I/O Board Removal... 95 Main Transformer Removal (A)... 97 Main Transformer Removal (B) ... 97 Main Transformer Removal (C) ... 98 Power Supply (5V/±15V) Removal ... 100 Power Supply (40V) Removal... 101

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Introduction 1.1

BACTEC 9050 Overview

The BACTEC 9050 instrument is designed for the rapid detection of bacteria and fungi in clinical cultures of blood. Samples are drawn from patients and injected directly into BACTEC culture vials. Vials are then entered into the instrument as soon as possible to insure performance efficacy. When microorganisms are present, they metabolize nutrients in the culture medium, releasing carbon dioxide into the medium. A dye in the sensor reacts with CO2. This modulates the amount of light that is absorbed by a fluorescent material in the sensor. The instrument’s photo detectors measure the level of fluorescence, which corresponds to the amount of CO released by organisms. Then the measurement is interpreted by the system according to preprogrammed positivity parameters. (See Figure 1-1.) 2

At system start-up, the BACTEC 9050 instrument performs self-diagnostics and loads its operating instructions. Then the instrument begins automated testing. A row of Light Emitting Diodes (LEDs) behind the vials illuminate, activating the vials’ fluorescent sensors. The instrument’s photo detectors then take the readings. A test cycle is completed every ten minutes. Positive cultures are immediately flagged by an indicator light on the front of the instrument, an optional audible alarm, and are displayed on the LCD screen.

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When positive vials are identified, the lab technologist pulls them from the instrument for confirmation of results, and for isolation and identification of the organism.

Organism metabolic activity releases CO2... Which reacts with dye in vial sensor. LED, modulated by dye, activates fluorescent material in sensor. Photo detector reads fluorescence. Raw data from detector is sent to computer… Where positivity analysis is performed. Positive vial indicator lights, audible alarm sounds, positive stations are displayed.

CO 2 Test Results

LED Photo Detector Computer Raw Data Positivity Analysis

Figure 1-1. BACTEC Fluorescent Test Technology

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An instrument is capable of monitoring a total of 50 BACTEC culture vials. The practical capacity is 5 culture sets per day with a 5-day test protocol. The vials are arranged in 3 concentric rings designated A, B, and C. The vials are continuously incubated at 35° C, and are agitated for maximum recovery of organisms. Major features of the BACTEC 9050 instrument include: •Automated, continuous, unattended testing of cultures through non-invasive fluorescent technology •Minimum user interaction and handling •Immediate notification of positives through an indicator lamp, indication on the LCD display, and an audible alarm •Simple user interface, with picture icons to guide you through setup and routine operations •Incubation and agitation for all cultures •Proven BACTEC culture media

1.2

Instrument Overview

The BACTEC 9050 instrument (hardware) components are described in the following paragraphs and are shown in Figure 1-2. Controls and indicators for these modules are discussed in Section 3 – Controls and Indicators. The major subsystems of the instrument include the following: Rotor The rotor contains 50 wells called “vial stations,” into which vials are placed for incubation and testing. The rotor contains three rings of vial stations designated A, B, and C. Each station is numbered uniquely (1 - 50), but the system provides the ring letter designation (A, B, or C) to help you quickly identify where to place or remove vials. One row of stations (one station in each ring) contains the test LEDs that activate vial sensors and the photo detectors which take the actual readings. The rotor is mounted at a 20° angle and rotates to provide agitation to culture vials. Agitation of cultures can improve both time to detection and recovery of organisms. The rotor’s drive motor stops agitation when the cabinet door is opened. The temperature inside the instrument is preset to maintain the internal temperature at 35° C ± 1.5° C. Over- and under-temperature alarm setpoints are preset at 35.5° C and 34.5° C, respectively.

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Temperature Standards Vial Stations

Door

Rotor

Temperature QC Vial

Floppy Disk Drive

Keypad and LCD Display Barcode Scanner

Figure 1-2. BACTEC 9050 Instrument Keypad and LCD Display The LCD Display is a 240 X 64 pixel Liquid Crystal Display that presents information about system status and function key definitions that enable you to perform system operations. Key definitions and status information are identified by picture icons that represent the type of information or operation that can be performed. A comprehensive list of system icons is presented in Section 5 – Reference. The keypad enables you to perform operations such as entering and removing vials, adjusting setup parameters, etc. Four of the keys, marked with printed icons, perform fixed functions regardless of the current display or operation. Six other keys, teal in color, are software (soft) keys whose functions vary depending on the current active display. Each display shows icons representing the current Soft key assignments at the bottom of the screen. To perform the function represented by the icon, you press the corresponding Soft key below the icon. Barcode Scanner A barcode scanner is located on the front of the instrument to provide the ability to scan vial labels for specimen identification. The scanner turns on automatically whenever a barcode needs to be scanned.

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Introduction

Computer The system computer stores all the system software, including the software which controls instrument operations and the user interface, which enables you to perform instrument operations, view vial statuses, print reports, etc. Floppy Disk Drive A floppy disk drive is located on the front of the instrument to enable the installation of software updates and to copy important data files to floppy disk. External Ports Ports on the rear of the instrument allow the user to connect an optional Remote Alarm unit and an optional printer. Two other ports are for Field Service diagnostic use. Instrument Calibration Components of the BACTEC 9050 instrument are selected and designed to maintain electrical and optical integrity throughout the product’s life. All instruments are calibrated at the factory prior to shipment, and should not require recalibration during the usable life of the instrument, unless certain components are replaced. Calibration helps to insure that any fluorescent series medium vial in any station will have initial and final fluorescent values within a specified range.

1.3

Software Overview

The system software presents a simplified user interface on the LCD Display, with picture icons to represent all the functions, operations, setup parameters, and status conditions (see Section 5 – Reference for charts of all icons). Routine system operations are performed by pressing the teal soft key that corresponds to the definition shown on the screen. There are three basic types of displays: Main Status Screen – When the instrument door is closed, this screen appears. It shows the number of vials that are positive, negative, ongoing, available, and stations that are in error or anonymous. Also shown are the current date and time and the instrument temperature. Software keys allow you to configure the setup parameters, review system errors, or print the System Status Report. See Figure 1-3.

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Configuration Screens – Accessible from the Main Status Screen, the Configuration Screens allow you to set the protocol length, the time and time format, the date and date format, the audible alarm volume, the instrument identification number, the DVE (Delayed Vial Entry) threshold (feature not available for use in the USA), to select the desired language for reports, to write data to a floppy disk, and to update system software. Activity Screens – When the instrument door is opened, software key definitions appear that enable you to enter new vials, remove positive vials, remove negative vials, identify anonymous vials, and resolve station error conditions.

Figure 1-3. Main Status Screen

1.3.1 Built-in-Test The system software is designed to continuously monitor the electrical and optical performance of all stations simultaneously. This functionality, called BIT (for Built-in-Test), automatically monitors each station every ten minutes for basic operational characteristics. These tests continually verify that signal output for each station is within design limits; this includes both empty stations and stations with ongoing vials. Two different signal levels are used to verify operation of the station over the established signal range. Tests are performed on dark readings (the output from the station when its excitation LEDs are off) and on fluorescence unit readings (the output from the station when a vial is present and the excitation LEDs are on). Dark readings are evaluated to be below a maximum established range. When they exceed that range, the software declares the station in error. High dark readings may indicate a light leak in the cabinet or an electrical failure within the instrument. Fluorescence unit readings are evaluated to be within a specified maximum and minimum range which has been established for the instrument during calibration at the factory. Should an out of range

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reading occur, the software declares that station in error. This may occur due to an electrical or optical component failure. Additionally, the fluorescence readings are evaluated for consistency while vials are in stations. If consecutive fluorescence unit readings vary by more than a predetermined amount, the station is declared in error. This feature determines the stability and the acceptability of a station for use during protocol. These protection features verify that calibration has been maintained for all stations within the system, and insure that the user is alerted of electronic or optical changes or failures which may be significant enough to affect results. The function of BIT can be demonstrated by entering a vial into the instrument, and then removing that vial from the station without scanning it out. The resulting error is the response of the BIT function. The user may resolve the error by using the resolve errors soft key.

1.4

Manual Structure

This user’s manual contains the following sections: Section 1 – Introduction – provides an overview of the BACTEC 9050 instrument and its uses in the microbiology laboratory, its major hardware and software components. An overview of this manual’s structure and conventions is also included. Section 2 – Installation and Setup – gives specifications for installing the BACTEC 9050 instrument and instrument setup. Section 3 – Controls and Indicators – explains the use and meaning of all controls and indicators of the system. Section 4 – Operation – provides instructions for routine daily activities. Section 5 – Reference – provides reference material on the user interface. Section 6 – Maintenance – explains all system maintenance, including parts replacements. Depending on the serial number of your instrument, some parts replacements should be performed by service personnel only. Section 7 – Troubleshooting – provides a convenient guide for identifying and correcting system malfunctions.

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The Glossary explains several instrument and computer terms used in this manual, as well as abbreviations. The Appendices contain warranty information, replacement parts list, a software update form, and a listing of Becton Dickinson international contacts. The Index provides a listing of major topics and associated page numbers.

1.5

Use of this Manual

This user’s manual is designed as a reference tool for technologists, supervisors, and other personnel who operate and maintain the BACTEC 9050 instrument on a regular basis. Every attempt has been made to include all information which would be required during normal use and maintenance of the system. Should a question arise which is not answered in this manual, please contact the following parties (USA): For assistance with mechanical, electrical, or software performance problems: Field Service 1–800–544–7434 For procedural or software operation questions: Technical Services 1–800–638–8663 International contacts are listed in Appendix D. Other documentation which may be of interest to the user includes: BACTEC 9050 Installation and Setup, MA–0102 – This document contains important information about preparing your laboratory for, and installing the BACTEC 9050 instrument. BACTEC 9050 5–Minute Operator Training Guide, MA–0104 – This document presents instructions on how to perform routine operations on the BACTEC 9050 instrument, in a step-by-step, interactive tutorial format. BACTEC Blood Collection Instructions, MA–0108 – This document presents information on collection of specimens for use with the BACTEC fluorescent instrument series. BACTEC Media Package Inserts – These documents contain important information on the use, storage, inoculation, performance, and limitations of each type of BACTEC medium. They are included with each carton of media, and are available upon request from the Technical Services Department.

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1.6

Conventions

1.6.1 General Keys The four keys that have fixed functions are the UP ARROW (Increase) Key, the DOWN ARROW (Decrease) Key, the HOME ROTOR Key, and the SILENCE ALARM Key. These keys are marked with symbols representing their functions, and operate identically regardless of the active display or operation. Six other keys, the Software (Soft) Keys are teal in color, and have functions that vary depending on the active display. Each display shows icons representing the current Soft key assignments at the bottom of the screen. To perform the function represented by the icon, press the corresponding Soft key. The four fixed function keys are always identified in your BACTEC 9050 documentation by CAPITAL LETTERS (e.g., SILENCE ALARM key). The software keys are always identified by lowercase letters in quotes, and the words soft key (e.g., “vial entry” soft key). End of Section The end of each section of this manual is marked with an octagonal symbol. <

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1.6.2 Symbols Used on the Equipment The following symbols appear on the BACTEC 9050 instrument: Serial Port (Field Service use)

Remote Alarm Port

Power On

Ground Stud

Printer Port

Keyboard Port (Field Service use)

Power Off

       Figure 1-4. Symbols Used on the BACTEC 9050 Instrument Top figure: Symbols for Serial Port, Remote Alarm Port, Printer Port, Keyboard Port, Power On and Off; Bottom figures: From Left – Symbol for electrical hazard, Symbol for protective conductor terminal; Symbol for “refer to accompanying documentation” for instructions (specifically, the Maintenance section of the user’s manual); Symbol for biohazard

1.6.3 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 system use worthy of special attention is presented as a NOTE.

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CAUTION Information on an activity which potentially could cause damage to the instrument or system is presented as a CAUTION.

WARNING INFORMATION ON AN ACTIVITY WHICH POTENTIALLY COULD CAUSE INJURY TO THE USER IS PRESENTED AS A WARNING.

1.7

Summary of Warnings and Cautions

Special messages presented in this manual which relate to operator and instrument safety, and which appear as CAUTION and WARNING boxes in the manual, are summarized below. Please read this section completely before you begin to operate your BACTEC 9050 instrument. For all instruments with serial numbers from 1000 – 1695, parts replacements should be performed by service personnel only. Instrument power should be turned off, and the power cord should be disconnected, before beginning any module replacement procedure. The intake filters on the sides of the instrument must remain unobstructed at all times. Restricted air flow may cause excessive temperatures in the instrument, which can affect organism recovery and possibly cause hardware malfunctions. Because of its size and weight, two persons should lift the BACTEC 9050 instrument. It is mandatory that all system users become thoroughly familiar with all controls and indicators before attempting to operate the instrument.

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The door sensor helps protect you from possible injury from the movement of the rotor. Do not tamper with the door sensor in any way, or attempt to defeat its function. Never attempt to insert or remove vials when the rotor is in motion. “Universal Precautions”1 should be followed in handling all items contaminated with blood or other body fluids. 1 Recommendations for Prevention of HIV Transmission in Health

Care Settings. MMWR 1987; 36 (Supplement #2S): (Inclusive Page Numbers). Vials should be handled with extreme care at all times, and should not be forced into or out of stations. Vial necks are susceptible to breakage if they are struck against another object. When the system notifies you of alerts and errors, you should immediately respond to the condition. All maintenance and repair other than the procedures described in Section 6 – Maintenance, must be performed by qualified service personnel. For all instruments with serial numbers from 1000 – 1695, parts replacements should be performed by service personnel only. All portions of the body that could possibly come in contact with the affected instrument surfaces must be completely covered before beginning the decontamination process. After the rotor is removed, DO NOT lay it down on either the front or back sides. (On the rear, the tabs can snap off.) Stand the rotor upright and wedge both sides so it does not roll. If any error sub-codes other than those listed here appear, contact Field Service for assistance. If the recommended corrective actions do not solve the problem, contact BD at the numbers provided in Appendix 11. WARNINGS/CAUTIONS relating to the use of BACTEC MYCO/F LYTIC culture vials with the BACTEC 9050 instrument: Biosafety Level 2 practice, containment equipment, and facilities are recommended for preparing acid-fast stains and for culturing clinical specimens. For activities involving the propagation and manipulation of Mycobacterium tuberculosis or Mycobacterium species grown in culture, Biosafety Level 3 practice, containment equipment, and facilities are required as recommended by CDC.

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