Bactec 9050
Bactec 9050
BACTEC 9050
System User’s
Manual
2004/09 Becton, Dickinson and Company
Document Number MA–0103 7 Loveton Circle
Revision: E Sparks, Maryland 21152
445845 1–800–638–8656
BENEX Limited
Bay K 1a/d
BACTEC™ 9050 System User’s Manual
Change History
REVISION DATE PAGES RE A S O N
Contents
1 - Introduction
1.1 BACTEC
BACTE C 9050
9050 Overvie
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1.2 Instrumen
Instrumentt Overview
Overview .... ........
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1.3 Softwa
Software
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1.3.1
1.3.1 Built-in-T
Built-in-Test
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(Patent Pending)
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1.4 Manual Structur
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1.5 Use of this Manual
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1.6 Conventions
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1.6.1
1.6.1 General....
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1.6.2
1.6.2 Symbols
Symbols Used on the the Equipment..
Equipment....... .........
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1.6.3
1.6.3 Notes,
Notes, Cautions,
Cautions, and Warnings Warnings .... ........
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1.7 Summar
Summaryy of Warnings
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2 - Installation and Setup
2.1 Genera
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2.2 Instrum
Instrument
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Specificatcation
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2.3 Installati
Installation
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2.4 Instrumen
Instrumentt Setup.....
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2.4.1
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2.4.2
2.4.2 Setup
Setup Parameters
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2.5 System
System Start-up
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3 - Controls and Indicators
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3.2 On/Off Switch
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3.3 Keypad
Keypad and LCDLCD Displa
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3.3.1
3.3.1 SILENCE
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3.3.2
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3.3.3
3.3.3 Alarm Indicator
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3.3.4
3.3.4 Brightness
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3.3.5
3.3.5 Soft Keys
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3.3.6
3.3.6 New Positi
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3.3.7
3.3.7 DOWN/UP
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3.3.8
3.3.8 Display
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BACTEC™ 9050 System User’s Manual
Contents
Contents
Contents
1.1
Introduction
When positive vials are identified, the lab technologist pulls them from
the instrument for confirmation of results, and for isolation and identi-
fication of the organism.
C
O
2
Test
Results
LED
Photo
Detector
Computer
Raw Data
Positivity
Analysis
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.
1.3.1 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.
Introduction
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.
Press the “configuration” soft key to advance to the next setup display,
or press the “exit” soft key to exit configuration mode.
Audible Alarm Volume (4/9)
Select the volume of the instrument’s audible alarm. The
default setting is 5, which is at the center of the volume
range. To increase or decrease the volume, use the UP
ARROW or DOWN ARROW key (a sample volume tone
sounds each time you adjust
a djust the setting). You
You can choose from 0 (audi-
ble alarm off) to 10 (loudest).
Press the “configuration” soft key to advance to the next setup display,
or press the “exit” soft key to exit configuration mode.
BACTEC™ 9050 System User’s Manual
Language (7/9)
Select the language in which you want the System Status
Report to print. The default setting is English. To scroll
through the available selections, use the UP ARROW or
DOWN ARROW key. YouYou can choose from the following lan-
guage selections:
English
Spanish
French
German
Italian
Chinese
Japanese
Polish
Press the “configuration” soft key to return to the first setup display, or
press the “exit” soft key to exit configuration mode.
Save Data to Disk (8/9)
Under certain circumstances, Becton Dickinson will advise
you to save system data to a floppy disk. These circum-
stances include some error conditions and system malfunc-
tions. To
To use the function, insert a blank, formatted, write-
enabled floppy disk in the disk drive. Then press the “perform action”
Installation and Setup
On/Off Switch
Figure
Figure 3-2.
3-2. On/O
On/Off
ff Switch
Switch
DOWN
ARROW
(Decrease Key) HOME
ROTOR
Key
Soft Keys
Figure 3-3.
3-3. Keyp
Keypad
ad and LCD Display
Display
3. 3. 1 SILENCE AL
ALARM Ke
Key
The SILENCE ALARM key is located at the top right of the Keypad/LCD
Display module. When pressed, it turns off the audible alarm for the
current “alert” alarm. It does not silence “door open” type audible
alarms. (See Section 3.7 –
3.7 – Audible Tones and Alarms,
Alarms, for an explanation
of alarm types and tones.)
3. 3. 3 Alarm Indicator
The Alarm Indicator is located on the right side of the Keypad/LCD Dis-
play, at the bottom. This light flashes yellow whenever the system
encounters an error condition that requires operator attention. The
indicator continues to flash until the condition is corrected.
When an alarm occurs, an icon (resembling the one above the Alarm
Indicator) appears in the soft key assignments area of the Main Status
Screen. Press the soft key corresponding to the System Alert icon. The
first error code is shown
sho wn on the display. Correct any error conditions as
soon as possible by following the directions on the door placard and in
Section 7 – Troubleshooting.
If there is an audible alarm sounding, you can silence it by pressing the
SILENCE ALARM Key.
3. 3. 6 New Posi
siti
tiv
ve Indicator
The New Positive Indicator is located on the left
l eft side of the Keypad/LCD
Display, at the bottom. This light flashes red whenever a new positive
culture is detected. The indicator continues flashing until all positive
vials are removed from the instrument. Refer to Section 4.5 for
4.5 for infor-
mation on removing positive vials.
BACTEC™ 9050 System User’s Manual
WARNINGS
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.
Controls and Indicators
To scan a vial barcode, place the vial in the alignment block in front of the
scanner. If necessary, rotate the vial slightly until the acknowledgment
beep sounds (indicating that the barcode was scanned successfully).
Informational
In Configuration mode,
Sample Three tones progressing
the audible alarm
audible alarm from high to low (“Figaro”)
volume was adjusted
Activity
All positives are removed Three short fast high beeps
complete
Door closed Door was closed Two short fast high beeps
Alarm
Negative cultures may exist as ongoing negatives (in protocol) and out-
of-protocol negatives. You are notified of these conditions as follows:
• Ongoing Negatives – On the Main Status display, the station is
displayed as a filled circle.
• Out-of-Protocol Negatives – On the Main Status display, the
station is displayed as a filled circle with a minus sign (–) in it.
Also, the negatives count in the Summary reflects the number
of final negatives in the instrument. No audible alarm sounds
for notification. When the door is opened, the “remove
negatives” soft key appears in the soft key assignment area of
the LCD Display.
Remove vial from specified station and Remove vial from specified station and
scan vial barcode, or leave vial in and press “force station available” soft key,
press DOWN ARROW to skip to next or leave vial in and press DOWN ARROW
positive station. to skip to next pos itive station.
or or
Repeat until all positives are removed. Repeat until all positives are removed.
Then press “exit” soft ke y. Then press “exit” soft ke y.
Operation
NOTE
The New Positive indicator remains lit until all new positive
vials are removed through the Remove Positives operation.
Rotor is in intermediate
Temperature standards
position
Activity error or
System alert
instrument full
Activity Icons
Icon Meaning
Configuration Icons
Set Protocol
Set time or date format
duration
WARNING
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.
BACTEC™ 9050 System User’s Manual
(Rear of Instrument
with Cover Removed)
Driver Motor
(Second Person
Pushes Down)
Figure 6-6.
6-6. Rotor Removal
Removal – Pushing
Pushing Down Driver Motor
Motor
Maintenance
6.3.1.4 RTD
The RTD (resistance temperature device, or temperature sensor) is
located behind the rotor on the right side (facing
( facing the front). To
To remove
the RTD, follow the steps below and refer to Figures 6-7, 6-8,
6-8, and 6-9.
Required Materials
Small Phillips Screwdriver
To Remove the RTD
1 Remove the rotor (Section 6.3.1.3)
6.3.1.3) and rear cabinet shell
(Section 6.3.3.1).
6.3.3.1).
2 Unscrew the small phillips screw on the black mounting clip.
3 Push the rubber grommet in the through-hole through to the
front of the instrument.
4 Unplug the maroon 3-wire connector from the I/O Board
(located near the front end of the I/O Board).
5 Feed the RTD cable through the through-hole to the front of
the instrument and remove the RTD.
6 Replace the RTD by reversing the above steps. Be sure to
replace the rubber grommet in the through-hole.
BACTEC™ 9050 System User’s Manual
Phillips Screw
Grommet
RTD Cable
(Push foam
out of way)
(Front of Instrument)
Phillips Screws
Maintenance
(Front of
Instrument)
Unplug 2 Cables
(Front of Instrument
[Front Panel Removed])
Remove 4 Screws
40 V Power 5V/+15V/-15V
Unplug Supply Board Power Supply Board
Connector
Unplug
Connector
Remove 4 Remove
Nuts 4 Nuts
Unplug Unplug
Connector
Maintenance
40 V Power 5V/+15V/-15V
Unplug Supply Board Power Supply Board
Connector
Unplug
Connector
Remove 4
Remove
Nuts
4 Nuts
Unplug Unplug
Connector
BACTEC™ 9050 System User’s Manual
7.1
7.1.1
General
Troubleshooting
Instrument Service
If your BACTEC 9050 instrument malfunctions or operates unusually in
any way, you may initially attempt to solve the problem by following the
procedures in this section. All other servicing attempts will terminate the
responsibility of the manufacturer under the terms of the warranty.
If you cannot repair a system malfunction, contact your local BD
representative (contact numbers are listed in Appendix D).
This section discusses error messages, which appear when the system has
encountered a known problem. These messages are listed in numerical
order, along with possible causes of the message and corrective actions.
From Left – Symbol for electrical hazard, Symbol for
BACTEC™ 9050 System User’s Manual
CAUTION
When the system notifies you of alerts and
errors, you should immediately respond to
the condition.
When the system encounters an alert or error condition, the error code
is either displayed on the screen or written into the System Alert list.
The error code is an abbreviation for the conditions described in the
listing below.
Codes in the E30 series (E30, E31, etc.) are not written into the System
Alert list, but are displayed on the screen when they occur. (They also
cause the Activity Error tone to sound [sequence of short high beep
and short low beep repeated four times].) These are activity (or
“workflow”) types of errors. In most cases, this means that some action
you have performed was not what the system expected, but you can
usually perform the correct action, as recommended below, without
exiting the current operation. These activity errors are flagged by the
Activity Error icon:
System alerts, which comprise all error codes except those in the E30
series, are reported in the System Alert list. These errors cause the Alert
tone (medium beep on for one second, off for 3 seconds, repeating) to
sound (if it is enabled). Also the System Alert icon appears on the Main
Status Screen. The errors must be reviewed to clear the system alert
condition. The System Alert list can be viewed from the Main Status
Screen by pressing the “system alert” soft key:
The error messages are listed in numerical order. Error sub-codes are
Troubleshooting
CAUTION
If any error sub-codes other than those listed
here appear, note the sub-code and contact
BD for assistance.
If the recommended corrective actions do not
solve the problem, contact BD.
POSSIBLE CAUSE(S)
Incubator temperature is too high (00000001) or too low (00000002).
• Door was kept open too long.
• Room temperature is not within recommended range.
• Air filters are dirty, restricting fresh air intake.
• RTD, heater, fan, or blower is defective.
CORRECTIVE ACTION(S)
Check current incubator temperature on LCD Display to see if
temperature is still too high or too low.
Minimize number and duration of door openings.
Make sure room temperature is within range specified in
Section 2 – Installation and Setup.
Clean or replace air filters.
Check thermometer vial to see if manual reading agrees with
displayed reading.
Reset manual thermostat (see Figure 6-26 for location of Reset
button).
00000001 – At temperatures in excess of 38° C, viability of
many organisms may have been lost. Recollection of speci-
mens should be considered.
BACTEC™ 9050 System User’s Manual
POSSIBLE CAUSE(S)
Rotor speed is too fast, too slow (00000002), or stopped (00000004).
• Something is impeding or jamming movement of rotor.
• A vial is not seated in the station.
CORRECTIVE ACTION(S)
Check for and remove anything that may be impeding or
jamming the movement of the rotor.
Make sure all vials are seated in stations.
All vials should be subcultured.
POSSIBLE CAUSE(S)
• Rotor is not mounted correctly.
Hold-d t (hubc )i ot ti ht
BACTEC™ 9050 System User’s Manual
Heater 445808
Knob 445803
Rotor 445802
Software
Version
Date
Installed
Installed
By
Notes
BACTEC™ 9050 System User’s Manual
7 Loveton Circle
i
International Contacts
BD
F
floppy disk drive
eject button, 31
indicator, 31
overview, 5
replacement, 77
H
HOME ROTOR key, 28
how to
collect specimens, 34
enter new vials, 35
identify anonymous vials, 47
perform media Quality Control, 34
prepare specimens, 34
print a System Status Report, 44
re-enter positive vials for further testing, 41
remove negative vials , 42
remove positive vials, 40
resolve station errors, 45
scan a vial barcode, 32, 37
I
icons, 53–58
installation
requirements, 15, 18
software, 23
instrument
alarms and errors, 45
barcode scanner, 4
calibration, 5, 7
computer, 5
configuration, 19
See also instrument: setup
daily checks , 35
decontamination, 63
dimensions, 16
BACTEC™ 9050 System User’s Manual
K
keypad
key designations, 9
key functions, 28
overview, 4
replacement, 79
soft keys, 29
L
LCD display
automatic dimming, 30
brightness dial, 29
information presented, 53
overview, 4
replacement, 79
types of displays, 53–55
M
maintenance
air filter replacement, 60
barcode scanner window, 62
decontamination, 63
Index
related documentation, 8
text box types , 10
warnings and cautions, 10
N
negative vials
general, 39
notification, 39
removing, 42
new positive indicator, 29, 41
O
On/Off switch, 27
P
parts replacements
AC power distribution board, 84
barcode scanner, 76
blower, 85
computer board, 86
damper cylinder, 65
DC power distribution board, 87
detector board, 89
door sensor switch, 67
electrical guard, 83
fan, 91
floppy disk drive, 77
front panel, 74
heater, 93
I/O board, 94
keypad/LCD display, 79
main transformer, 96
On/Off switch, 99
part catalog numbers, 117
power supply (40V) board, 101
power supply (5V/ +15V/–15V ) board, 100
rear cabinet shell, 81
rotor, 68
RTD, 71–73
ports, 5
positive vials
BACTEC™ 9050 System User’s Manual
power switch, 27
R
rings, 3
rotor
and door sensor switch, 30
icon, 53
overview, 3
removal, 68–70
vial loading to balance, 37
S
screen
See LCD display
setup
audible alarm volume, 21
date, 21
date format, 21
DVE media thresholds, 22
instrument number, 22
language, 22
test protocol duration, 20
time, 20
time format, 20
SILENCE A LARM key, 28
soft keys, 29
software
display types, 53–55
icons, 53–58
menu tree, 52
overview, 7
save data to disk , 22
setup, 19–22
types of displays, 55
update log, 119
updates, 23
specimen
collection, 34
preparation, 34
UNIVERSAL PRECAUTIONS , 34
stations, 3
Index
format, 20
setting, 20
tones, 32
V
vials. See culture vials
W
warnings, 11
warranty, 115