B71495AF Instructions For Use DXC 700 AU
B71495AF Instructions For Use DXC 700 AU
B71495AF Instructions For Use DXC 700 AU
B71495AF
April 2021
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.
Instructions for Use
BECKMAN COULTER DxC 700 AU
PN B71495AF (April 2021)
© 2021 Beckman Coulter, Inc.
All Rights Reserved.
Trademarks
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein
are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other
countries.
All other trademarks are the property of their respective owners.
EC REP
Beckman Coulter Ireland Inc.
Lismeehan, O’Callaghan’s Mills,
Co. Clare, Ireland
Phone: +353-65-683-1100
FAX: +353-65-683-1122
Rx Only
Original Instructions
Quick Start
1 Revision History
— View the Revision History
4 Related manuals:
— Related Manuals
5 Printable Manuals
— Download a copy from the web: https://www.beckmancoulter.com/wsrportal/
page/techdocSearch.
— Order a hard copy: Contact Beckman Coulter Customer Support at 1-800-526-3821
from the United States and Canada, or your local Beckman Coulter Representative.
List of Flags:
IFU - Flags
Startup Procedures:
B71495AF iii
Quick Start
Manual Orders:
IFU, Sample Programming and Processing - Order for Routine and Emergency
Samples
STAT Samples:
IFU, Sample Programming and Processing - Priority STAT Samples
Contamination Parameters:
Reference Manual, Parameters
iv B71495AF
Revision History
This document applies to the latest software listed and higher versions. When a subsequent
software version changes the information in this document, a new issue will be released.
B71495AF, 04/2021
Software version 1.0
B71495AE, 04/2019
Software version 1.0
B71495AF v
Revision History
B71495AD, 06/2018
Software version 1.0
vi B71495AF
Revision History
B71495AC, 10/2017
Software version 1.0
"When your system is set to Multiple Loads STAT Table operation (automation systems
only), the STAT Pause [F2] function in the STAT Status screen is disabled except during
PAUSE and REAGENT PAUSE modes."
The blinking STAT TABLE ROTATION LED indicates that the system is aspirating the
samples on the STAT Table. You can interrupt patient sample analysis to perform calibration
and QC analysis. Press the STAT Pause [F2] from the STAT Status screen and remove the
patient samples that are currently on the STAT Table.
After the calibration or QC analysis is completed, replace the removed patient samples in
their original positions on the STAT table and resume the patient sample analysis.
B71495AB, 03/2017
Software version 1.0
This document was created to add the CE mark to the title page.
B71495AF vii
Revision History
viii B71495AF
Warranty
The system is covered by and subject to the provisions of the warranty included in your
contractual agreement for the system or its reagents.
B71495AF ix
Warranty
x B71495AF
Service and Coverage
If any problems occur in the system during the warranty period, call your Beckman Coulter
Representative. Provide the serial number or system ID number and a complete description
of the problem.
Telephone Service: USA and Canada
For United States and Canada customers, call Beckman Coulter Customer Support toll-free
at (800) 854-3633. Beckman Coulter Customer Support is available 24 hours a day to
customers in the continental United States, Alaska, Hawaii, and Canada.
For international customers, contact your local Beckman Coulter Customer Support.
B71495AF xi
Service and Coverage
xii B71495AF
Contents
Quick Start, iii
Revision History, v
Warranty, ix
Service and Coverage, xi
Safety Notice, xxv
Introduction, xxxix
CHAPTER 1: System Overview, 1-1
Hardware Overview, 1-1
Hardware Component Overview, 1-1
Breakers, 1-2
Operation Buttons, 1-3
Status Light, 1-4
Rack Feeder Module, 1-5
STAT Table, 1-6
Sample Transfer Component, 1-9
Reagent Transfer Component, 1-10
Mix Bar Component, 1-11
Cuvette Wheel Component, 1-12
Photometry Component, 1-13
Wash Nozzle Component, 1-13
Reagent Refrigerator Component, 1-15
Syringe Component, 1-16
Tank Storage, 1-17
Wash Solution Roller Pump, 1-18
ISE Module (Optional), 1-19
Console, 1-21
Touch Screen, Mouse, and Keyboard, 1-23
Software Overview, 1-23
Minimum Software Requirements, 1-23
Organization of Operation, 1-24
Navigation Button Area, 1-25
Action Button Area, 1-26
Main Workspace, 1-27
Status Area and Analyzer Modes, 1-29
Event Display Area, 1-30
Sub Workspace, 1-30
Using the System Help, Quick Start Page, and Event Log, 1-31
CHAPTER 2: Daily Startup, 2-1
Introduction, 2-1
Startup Procedure, 2-1
B71495AF xiii
Contents
xiv B71495AF
Contents
B71495AF xv
Contents
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Contents
xviii B71495AF
Contents
Manually Clean the Sample Pot Tubing and Bypass Tubing, 6-193
CHAPTER 7: Flags, 7-1
Flags, 7-1
Summary of Flags (Alphabetical Order), 7-1
Summary of Flags (Priority Order), 7-3
Flag Details, 7-5
d: QC result is excluded by operator, 7-5
e: Data edited by the operator, 7-6
(: Reagent probe cleaning solution is insufficient, 7-6
Wa: Test has been analyzed with an erroneous cuvette, 7-6
R: Insufficient reagent detected, 7-7
#: Insufficient sample detected, 7-7
%: Clot detected, 7-8
?: Unable to calculate a result, 7-8
M: Duplicate sample ID, 7-9
n: LIH test not performed, 7-9
l: Result may be affected by lipemia , 7-9
i: Result may be affected by icterus, 7-9
h: Result may be affected by hemolysis, 7-9
Y: Reagent Blank OD exceeds the high limit set at the last
photometric read point, 7-10
U: Reagent Blank OD exceeds the lower limit set at the last
photometric read point, 7-10
y: OD at the first photometric point for reagent blank or patient
sample is high, 7-10
u: OD at the first photometric point for reagent blank or patient
sample is low, 7-11
@: OD is higher than 3.0, 7-11
$: Not enough data to determine linearity of reaction, 7-12
D: OD of reaction is higher than the maximum OD range, 7-13
B: OD of reaction is lower than the minimum OD range, 7-14
*: Linearity error in rate method, 7-15
&: Prozone test data is abnormal, 7-15
Z: Prozone error, 7-16
E: Error in reaction rate for rate assay, 7-16
Fx: Result (OD) is higher than the analytical measuring range, 7-16
Gx: Result (OD) is lower than the analytical measuring range, 7-16
!: Unable to calculate concentration, 7-17
): Reagent lot number used for sample analysis is different from
the lot number used for RB/Calibration, 7-18
a: Reagent expired, 7-18
ba: No calibration data or calibration is expired, 7-18
bh: Reagent blank or calibration failed, and the result was
calculated with historical data, 7-18
B71495AF xix
Contents
xx B71495AF
Contents
B71495AF xxi
Contents
xxii B71495AF
Contents
APPENDIX B: End-User License Agreement and Open Source Software Notice, B-1
End-user License Agreement, B-1
Open Source Software Notice, B-4
Glossary
B71495AF xxiii
Contents
xxiv B71495AF
Safety Notice
Read all product manuals and consult with Beckman Coulter-trained personnel before you
operate the system. Do not perform any procedure before you carefully read all
instructions. Always follow the product labels and the recommendation from the
manufacturer. For more information, contact Beckman Coulter.
Warning
Warning indicates a potentially hazardous situation which, if not avoided, could cause
death or serious injury. Warning can indicate the possibility of erroneous data that
could cause an incorrect diagnosis.
Caution
Caution indicates a potentially hazardous situation which, if not avoided, can cause
minor or moderate injury. Caution can also alert against unsafe practices, or indicate
the possibility of erroneous data that could cause an incorrect diagnosis.
Important
Note
Tip
Use Statement
• The system is for indoor use only.
• Use the system in a manner specified by Beckman Coulter, as the protection provided
by the system can be impaired and incorrect results or system failure can occur.
Notice to Users
• In the unlikely event that a serious incident occurs with this product, we will notify the
users and the administrative authorities of the country in writing.
• If a user discovers a serious incident, the user should contact a Beckman Coulter
Representative.
B71495AF xxv
Safety Notice
Symbols Glossary
Symbols Glossary
Table 1 Symbols Glossary
Symbol Description
CE Marking
OSHA, CEC
The moving parts symbol indicates that there are moving parts in the area. Only operate
the system when all covers are in position and use caution to reduce the risk of personal
injury. While the system is operating, do not touch the moving parts of the system. Do
not insert fingers or hands into any system opening.
ISO 7010. Graphical Symbols for electrical equipment in medical practices. #W024
Use caution to avoid injury to hands when close to equipment with moving mechanical
parts.
RCM Symbol
This symbol indicates compliance with the Australian Communications Media Authority
(ACMA) requirements (safety and EMC) for Australia and New Zealand.
xxvi B71495AF
Safety Notice
Symbols Glossary
This symbol indicates that this electronic information product contains certain toxic or
制造。
日期 / Mfg. Date
hazardous elements, and can be used safely during its environmental protection use
period. The number in the middle of the logo indicates the environmental protection
use period (in years) for the product. The outer circle indicates that the product can be
recycled. The logo also signifies that the product should be recycled immediately after
its environmental protection use period has expired. The date on the label indicates the
date of manufacture.
These labels and materials declaration table (the Table of Hazardous Substance's Name
and Concentration) meet People's Republic of China Electronic Industry Standard SJ/
T11364-2006 Marking for Control of Pollution Caused by Electronic Information Products
requirements.
This symbol indicates that the product does not contain any toxic or hazardous
substances or elements. The "e" stands for electrical, electronic, and environmental
electronic information products. This logo indicates that this electronic information
product does not contain any toxic or hazardous substances or elements, and is green
and is environmental. The outer circle indicates that the product can be recycled. The
logo also signifies that the product can be recycled after being discarded, and should
not be casually discarded.
RxOnly Symbol
Recognized by the US FDA as an alternate to "Caution: Federal law restricts this device
to sale by or on the order of a licensed practitioner.
21 CFR 801.109(b)(1)
B71495AF xxvii
Safety Notice
Symbols Glossary
This label is required by the Waste Electrical and Electronic Equipment (WEEE) Directive
of the European Union. The presence of this label indicates that:
1. The device was put on the European Market after August 13, 2005.
2. The device is not to be disposed of via the municipal waste collection system of any
member state of the European Union.
Customers must understand and follow all laws regarding the correct decontamination
and safe disposal of electrical equipment. For Beckman Coulter products bearing this
label, contact your dealer or your local Beckman Coulter Representative for more
information on the take-back program that facilitates the correct collection, treatment,
recovery, recycling, and safe disposal of these products.
This system is considered an industrial waste, subject to special controls for infectious
waste. Before disposal of the system, refer to the Waste Disposal and Public Cleaning
Law for compliance procedures.
"ON" (power)
To indicate connection to the mains, at least for mains switches or their positions, and
all those cases where safety is involved.
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5007
"ON"/"OFF" (push-push)
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5010
This symbol can be used for switches that are used as an on and off switch, without
disconnecting power.
xxviii B71495AF
Safety Notice
Symbols Glossary
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5264
Stop
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5110A
"OFF" (power)
To indicate disconnection from the mains, at least for mains switches or their positions,
and all those cases where safety is involved.
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5008
Fuse
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5016
Dangerous voltage
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5036
This symbol can also indicate an area of the system to not access under any
circumstances, due to possibility of high voltages and the risk of electrical shock.
B71495AF xxix
Safety Notice
Symbols Glossary
To identify any terminal which is intended for connection to an external conductor for
protection against electric shock in case of a fault, or the terminal of a protective earth
(ground) electrode.
IEC 60417: Graphical symbols for use on equipment - Overview and application, #5019
ISO 7010. Graphical Symbols for electrical equipment in medical practices. #W017
This symbol indicates that there is a hot surface or component (such as a lamp) in the
area that, if touched, can cause a burn.
21 CFR 1040
The panel marking indicates that there is Class 2 laser light radiation beyond the panel it
is placed on. Use caution and do not stare into the beam when laser light is in the area.
IEC 60825: Safety of laser products - Part 1: Equipment classification and requirements,
clause 7.4
Manufacturer
ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1: General Requirements. #5.1.1
This symbol identifies who the legal manufacturer of the product is.
EC REP
Authorised representative in the European Community
ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1: General Requirements. #5.1.2
xxx B71495AF
Safety Notice
Symbols Glossary
Indicates the manufacturer's catalogue number so that the medical device can be
identified.
ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1: General Requirements. #5.1.6
ISO 15223-1: Medical devices. Symbols to be used with medical device labels, labelling
and information to be supplied. General requirements, clause 5.5.1
Caution
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a variety of
reasons, be presented on the medical device itself.
ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1: General Requirements. #5.4.4
ISO 7010. Graphical Symbols for electrical equipment in medical practices. #W009
This label indicates a caution to operate only with all covers in position to decrease risk
of personal injury or biohazard.
This label indicates the use of biohazardous materials in the area. Use caution when
working with possible infectious samples.
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats.
Handle and dispose of biohazardous materials according to your laboratory procedures.
Indicates the need for the user to consult the instructions for use.
ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1: General Requirements. #5.4.3
B71495AF xxxi
Safety Notice
Summary of Hazards
ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1: General Requirements. #5.1.3
Serial number
Indicates the manufacturer's serial number so that a specific medical device can be
identified.
ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1: General Requirements. #5.1.7
ISO 7010. Graphical Symbols for electrical equipment in medical practices. #W004
The laser radiation symbol indicates that there can be laser light radiation in the area.
Take precautions to prevent exposure.
Summary of Hazards
This section describes the possible hazards of the system. The hazards of individual
procedures in this manual are included in the warnings or cautions within the instructions.
Read this section before you operate this system.
Follow the power requirements in the system specifications. Follow the procedures and
safety warnings throughout this manual.
If you use the system in a manner not specified by Beckman Coulter, the protection
provided by the system can be impaired and incorrect results or system failure can occur.
xxxii B71495AF
Safety Notice
Summary of Hazards
Follow all laboratory procedures and policies for handling infectious and pathogenic
materials.
Avoid skin contact with reagents and other chemical preparations. Wear Personal
Protective Equipment (PPE) to work with reagents and other chemical preparations used
with the system. For more information, refer to the related SDS (Safety Data Sheet).
Follow your laboratory procedure for biohazardous and hazardous material disposal.
Electric Shock
Do not replace or service any components where you can contact hazardous parts that can
cause electric shock. Beckman Coulter must perform this maintenance. To completely
power off the system, turn off the main breaker that is located on the left side of the
analyzer module.
Electrical Ground
Never operate the system until the power cord is connected correctly to an electrical
ground.
• Do not use mobile or cordless telephones and transceivers in the same room as the
system.
• Do not use medical equipment that can be susceptible to malfunctions caused by
Electric Magnetic Field (EMF) near the system.
Flammable Materials
Do not use this system near flammable materials.
Moving Parts
While the system is in operation, do not touch or go close to any moving parts. Close
protective guards and covers during operation. Failure to close covers correctly can cause
injury or incorrect results.
Liquid Waste
Handle all liquid waste as potentially infectious.
Some liquid waste can require special treatment before disposal. Follow your laboratory
procedure.
Some substances in the reagents, control samples, calibrators, and wash solutions have
disposal regulations. Follow your laboratory procedure.
Solid Waste
Handle all solid waste as potentially infectious.
Some solid waste can require special treatment before disposal. Follow your laboratory
procedure.
Handle any used or replaced parts (such as tubing, mix bars, probes, cuvettes, and wash
nozzles) as infectious waste materials. Follow your laboratory procedure.
xxxiv B71495AF
Safety Notice
DxC 700 AU Hazards
— Collect urine samples using correct preservatives and remove any suspended
matter using centrifugation before analysis (CLSI GP16-A2).
— Confirm that any anticoagulants or collection devices that employ a barrier are
compatible with the test reagent being used. Refer to the reagent Instructions for
Use for suitable and validated sample types. Use caution when using sample tubes
containing barriers or gels. Confirm the suitability of all collection devices in use.
— For information about whether a serum separating agent is correct or not, contact
the chemical reagent manufacturer or distributor.
— When using sample containers or tubes containing a separating medium, confirm
that there is enough serum to avoid contaminating or blocking the sample probe
with the separating medium.
— Confirm that there is enough sample for correct sampling to occur. The small
amount of wash water left on the sample probe can dilute the volume of sample
left in the sample tube.
• To prevent water leaks, confirm that Beckman Coulter has fitted water supply and
drainage hoses according to local guidelines.
• To confirm system performance, maintain and inspect the system periodically by
replacing the parts according to the instructions in this guide.
— Have and follow a maintenance schedule for this system.
— Create a maintenance routine for the computer software and hardware, including
frequent backing up of data containing analysis settings, results history, and the
event log list file.
— Do not store backups onsite. Keep one copy on-site for reference and one copy
offsite.
• Before using the system for the first time, set parameters for the reagent and sample
quantity, measurement wavelength, calibrator values, and so on. Enter test specific
parameters from the reagent setting sheet to have optimum system performance.
Enter any updates to these settings into the system immediately.
• Dedicate the computer hardware to only running the system software. Do not connect
the computer hardware to the Internet, unless instructed to do so by Beckman Coulter.
• Keep the analyzer covers closed except for startup procedures and maintenance. If the
covers are open for extended periods of time, excess condensation can be generated in
the reagent refrigerators and cause errors.
• Be sure all consumables are unopened before use. If the consumables appear to be
opened or contaminated, contact Beckman Coulter.
Labels
• Stripes - Orange stripes affixed to the system surface indicate the movement areas of
the hardware components. Avoid these areas during operation.
• Warning Labels - Identify areas of the system where hazards exist and where caution
should be taken to avoid serious injury or death.
• Instruction Labels - Instruction labels are affixed on the system at relevant locations to
alert the operator to operate the system correctly.
xxxvi B71495AF
Safety Notice
Restricted Use
The type, pressure, and volume of the HFC chemicals are described on the label.
Restricted Use
• Samples and reagents: Refer to the reagent Instructions for Use used for measurement.
• Consumables: Refer to Chapter 6 Maintenance in this IFU.
• Computer Connectivity (LIS, Automation, Pro Services): Refer to System Overview >
Hardware Overview > Computers section.
B71495AF xxxvii
Safety Notice
DxC 700 AU Laser Labels
xxxviii B71495AF
Introduction
Intended Use
The BECKMAN COULTER DxC 700 AU measures analytes in samples, in combination with
appropriate reagents, calibrators, quality control (QC) samples, and other accessories. This
system is for in vitro diagnostic use only. Applications include colorimetric, latex
agglutination, ion selective electrode and homogeneous enzyme immunoassay.
This product measures the chemical components in the sample (serum, plasma, urine, and
whole blood (HbA1c only)) by mixing (stirring) the sample and reagent. Refer to the
reagent Instructions for Use for details of the measurement specifications.
Related Manuals
Other documents are available with the System Help and on the Beckman Coulter website:
https://www.beckmancoulter.com/wsrportal/page/techdocSearch.
Manuals include:
• Reference Manual
• ISE Addendums (Japan Only)
• Reagent instructions
B71495AF xxxix
Introduction
Related Manuals
xl B71495AF
CHAPTER 1
System Overview
Hardware Overview
This section provides a description and diagram with location of each hardware component
and module.
B71495AF 1-1
System Overview
Hardware Overview
Note
The rack feeder module is not installed with the DxC 700 AU when the DxC 700 AU
connects to a Laboratory Automation System.
Breakers
The main system breaker circuit board allows the power in specific areas of the system to
be isolated. The main breaker (main power switch) automatically shuts down all the
breaker switches. In normal conditions, all of the breaker switches are in the on position.
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1
System Overview
Hardware Overview
Main breaker and sub breakers are on the left side of the analyzer module.
Operation Buttons
Figure 1.4
B71495AF 1-3
System Overview
Hardware Overview
1. ON button (green) - The ON button turns on the analyzer and computer, and the system
initializes.
2. RESET button (white) - The RESET button supplies the main power to the system, and is
used after the ANALZYER STOP button was pressed or a power failure occurred. To be
sure there is correct synchronization after the ANALYZER STOP button was pressed, turn
off the computer by performing an End Process. In rare cases, an End Process takes a
long time or cannot be performed because there is no response from the analyzer. In
these cases, select Ctrl + Alt + Delete, then select Shutdown to turn off the computer. To
reboot the system, press the RESET button, and then press the ON button. After pressing
the ANALYZER STOP button, wait 5 seconds before pressing the RESET button, then wait
5 seconds before pressing the ON button. The RESET button also resets the Power
Failure Detected event by clearing the existing event and resetting the event for
notification at the next power failure.
3. ANALYZER STOP button (black)- The ANALYZER STOP button immediately stops the
operation of the analyzer.
4. DIAG/TABLE ROTATION button (Diagnostic and Table Rotation) - The DIAG/TABLE
ROTATION button rotates the STAT table for loading samples on the STAT table. In the
Maintenance menu, this button initiates the maintenance or diagnostic function.
5. STAT START button - The STAT START button starts the Quick STAT operation (for STAT
table analysis).
6. STAT TABLE ROTATION LED (amber LED) - This light is located above the STAT START
button and the DIAG/TABLE ROTATION button, and is on or blinks when the STAT table is
busy.
(Not pictured) TRAY ROTATION button - The TRAY ROTATION button rotates the reagent trays
when loading reagents in MEASURE mode. For more information, refer to Reagent
Refrigerator Component or Replace or Add Reagents in MEASURE Mode.
(Not pictured) ROTATION LED (amber LED) - The ROTATION LEDs are located above the TRAY
ROTATION button, and are on or blink when the reagent components are busy.
(Not pictured) DIAG button (yellow) - The DIAG button (yellow) is located at the center in
the rear of the analyzer module. In the Maintenance menu, this button initiates the
maintenance or diagnostic function.
Status Light
The status light indicates the analyzer mode by color. For red, the LED blinks. For green,
yellow, and blue, the LED is on steadily.
Table 1.1 Status Light Indication of Analyzer Mode
Color of Status Light Analyzer Mode
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System Overview
Hardware Overview
Important
If you cannot see colors or have difficulty seeing colors correctly, use the monitor
instead of the status light to confirm the analyzer mode.
Note
At the beginning of INITIAL mode, the status light is off for a maximum of 3 minutes.
Note
Change in the appearance of the status light might lag a maximum of 20 seconds
behind the real change in the analyzer mode.
Racks are loaded on the rack input area. A bar code reader reads the rack ID and sample ID,
and the information is automatically transferred to the system computer. Covers prevent
dirt or dust from getting into samples during analysis. Keep the upper cover closed during
normal operation. Keep the covers over the rack input area closed when you are not using
the system.
Note
When the DxC 700 AU connects to a Laboratory Automation System, the system is not
installed with a rack feeder module.
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System Overview
Hardware Overview
STAT Table
Use the STAT table to process priority STAT samples. The STAT table is the fastest method
for processing a sample.
The STAT table compartment is maintained between 4 °C and 12 °C even after you turn off
the system using an End Process.
The STAT table has 22 outer positions for processing patient samples, calibrators, and
control samples, and 8 inner positions for performing ISE calibration, ISE maintenance
procedures, and reagent blank.
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System Overview
Hardware Overview
Caution
To avoid injury, do not touch or open the STAT table cover while the amber STAT
TABLE ROTATION LED is blinking.
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System Overview
Hardware Overview
Important
An event is generated if the small STAT table cover is opened when the STAT TABLE
ROTATION LED is blinking. Do not open the large STAT table cover before the system
completes the sample dispensing from racks in the sample transfer lane or samples in
the STAT table. If you open the cover too soon, the system goes into STOP mode.
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System Overview
Hardware Overview
Note
When you program bar code mode for the STAT table, the STAT table can only read bar
code labels on samples placed on the outer positions of the STAT table.
Note
Always keep the large and small STAT table covers closed to maintain the temperature
and sample integrity. Although the STAT table compartment is cooled, do not use it to
store samples or leave samples for an extended time.
Note
Only open the small STAT table cover to add or remove samples as required. Excessive
opening and closing can damage the cover hinges.
Note
Patient samples include rerun samples. The system does not provide specific STAT table
positions to rerun samples. You assign the STAT table positions to both first-run and
rerun samples as Patient in the STAT Table Setting dialog (STAT Status > STAT Table
Setting [F6]).
When there is an ISE module installed, sample is aspirated from the tube or cup and
dispensed into the ISE sample pot for analysis.
B71495AF 1-9
System Overview
Hardware Overview
Caution
Open and close the analyzer cover by using the handle located at the bottom of the
cover. Use caution when closing it because of the pinching action of the adjoining
portions of the cover.
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System Overview
Hardware Overview
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System Overview
Hardware Overview
1. Cuvette wheel
The cuvette wheel contains a total of 165 cuvettes in a single wheel. The wash nozzle
component automatically cleans the cuvettes. The weekly photocal maintenance procedure
monitors the cuvette integrity. From photocal results, clean and replace cuvettes as
required.
Caution
Cuvettes with the same outer dimensions might have different interior dimensions.
The DxC 700 AU uses cuvette PN MU846500 with an interior dimension of 5 mm x 5
mm. These cuvettes are different from the other AU systems. Do not use a cuvette
from another AU system on the DxC 700 AU. Use of a cuvette other than the DxC 700
AU cuvette on the DxC 700 AU causes erroneous results.
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System Overview
Hardware Overview
Cuvettes are continuously monitored in MEASURE mode by the real-time water blank check
method. The real-time water blank check method compares the water blank reading
obtained during analysis to the previous water blank reading. If the water blank reading
check fails the specification, the system generates a Photometry Error During Cuvette
Wash event. If the system detects a cuvette overflow and unstable photometry, the system
generates a Photometry Error During Cuvette Wash event. For more information,
refer to Recovering from a Photometry Error During a Cuvette Wash Event.
Photometry Component
The photometry component includes a halogen lamp, lenses, a diffraction grating, and a
photodetector to measure the amount of light transmitted through the reaction mixture in
the cuvette. The diffraction grating splits the light into 13 wavelengths.
1. Lamp
Warning
Never touch the photometer lamp or look directly into the photometer lamp when
the lamp is illuminated. The lamp is hot when the system is on.
B71495AF 1-13
System Overview
Hardware Overview
Each wash nozzle is a 3-way nozzle used to clean the cuvettes. The longest nozzle aspirates
liquid, the middle nozzle dispenses, and the shortest nozzle aspirates any overflow liquid.
The aspiration nozzle aspirates any remaining liquid in the cuvette. The dry nozzle uses the
fluorocarbon polymer tip to bring any remaining moisture to the bottom of the cuvette,
then aspirates to dry the interior of the cuvette completely.
The dispensing sequence of the wash nozzles, from right to left in the diagram:
• Nozzle 1 and 2 - Diluted Wash Solution
• Nozzle 3 to 6 - Warm deionized water
• Nozzle 7 - Aspiration
• Nozzle 8 and 9 - Drying
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Hardware Overview
Place the reagent bottle on the corresponding tray (R1 or R2) in the R1 refrigerator or R2
refrigerator.
The R1 refrigerator has 60 positions and the R2 refrigerator has 48 positions. Each
refrigerator uses applicable adapters or partitions for various sizes of reagent bottles: 15
mL, 30 mL, 60 mL, and 120 mL.
Each bottle position can be designated as reagent ID (bar code labeled) or fixed (not bar
code labeled). During a reagent check, reagent bottles are detected, reagent IDs are read,
and reagent volume is calculated.
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System Overview
Hardware Overview
Important
Confirm that the reagent bottles are placed in the refrigerator with the reagent ID
facing outwards. Confirm that all reagent bottle caps are removed before placing them
in the refrigerator.
Syringe Component
This system has a sample syringe (S), and two reagent syringes(R1 and R2). If the ISE
module is installed, the system has a syringe for the ISE Buffer Solution. Syringes are used
to dispense the required volume of sample or reagent.
A wash syringe dispenses deionized water for the internal sample probe wash.
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Hardware Overview
Tank Storage
The tank storage area has a deionized water tank, a wash solution tank, a wash solution
reservoir, and a diluted wash solution tank.
The system uses diluted wash solution (1%) to clean the cuvettes and mix bars. The system
uses deionized water to dilute the wash solution, rinse analyzer components, and make
dilutions.
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System Overview
Hardware Overview
The diluted wash solution tank has a capacity of 2 liters. A float sensor detects when the
volume in the tank is low. The tank automatically fills with wash solution from the wash
solution reservoir and deionized water to make the diluted wash solution (1%).
The wash solution reservoir has a capacity of 2 liters. A float sensor detects when the
volume in the tank is low. The tank automatically fills with wash solution from the wash
solution tank.
The wash solution tank has a capacity of 5 liters. When the volume in the wash solution
tank decreases to a certain level, the system generates an event to alert the operator to
replace the tank with a new tank.
The deionized water tank has a capacity of 10 liters. A float sensor detects when the volume
in the tank is low and opens a valve to fill it automatically.
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The system has a common sample probe and sample syringe for photometric and ISE
analysis.
The ISE has an ISE Buffer Solution bottle, ISE MID Standard Solution bottle, and ISE
Reference Solution bottle.
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Console
The console is available as an option for the DxC 700 AU and is used when the DxC 700 AU
connects to a Laboratory Automation System. For a standalone DxC 700 AU, the computer is
located in the rack feeder module, and the monitor, keyboard, and manual bar code reader
are attached to the side of the rack feeder module with a monitor arm.
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Hardware Overview
Monitor
The monitor displays the operating software, and the keyboard and mouse allow operator
input.
Computer
The system uses a personal computer to perform data processing. The computer includes a
hard disk to store programs, analysis parameters, an analysis database, USB drives, and a
DVD R/W component. An external hard disk option is also available.
Printer (Optional)
The manual bar code reader reads bar code labels for input to the software. You can scan a
sample ID in the Sample ID field in the Test Order tab (TEST > Rack (Patient) > Test Order or
STAT > STAT (Patient) > Test Order).
You can scan the 2-dimensional bar code on the calibrator value assignment sheet to load
the calibration information, including concentration values, on the system. You can scan the
bar code label located on the ISE reagent bottle when you replace the ISE reagent.
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Software Overview
1. ESC key 9. Num Lock lamp (along with Caps Lock and
2. Function keys Scroll Lock lamps)
3. Start key 10. Num Lock key
4. Pause key 11. Stop or Standby key
5. Stop Feeder key 12. Home key
6. Print Screen key 13. End Process key
7. Menu List key 14. Numeric key pad
8. Event Clear key 15. ↑, ↓, ←, → keys
Software Overview
To use this product safely, refer to the following chapters for more information:
• Safety Notice section - Safety Precautions for safe and accurate analysis.
• Appendix B - End User License Agreement and Open Source Software Notice.
B71495AF 1-23
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Software Overview
Organization of Operation
The interface contains six areas: the navigation button area, action button area, status area,
event log display area, main workspace, and sub workspace.
The following list describes the six areas of the interface in more detail.
1. Navigation button area - The display area for the navigation buttons (HOME (Home),
MENU (Menu List), RESULT (Results), TEST (Test Order), STAT (STAT Status), REAGENT
(Reagent), MAINT. (Maintenance), QC (Quality Control), CONFIG. (Configuration
Parameters), EVENT (Event Log), BROWSER (Browser), HELP (Help), END (End), and
LOGOUT (Logout)).
2. Main workspace - The display and operation for the selected menu or button.
3. Action button area - The display area for the action buttons (Start, Pause, Stop Feeder,
Stop/Reset, and Start STAT).
4. Event display area - The display area for the event generated during system operations,
and the Event Clear button.
5. Status area - The display area for the analyzer mode and the status of the printer, the
LIS connection, and PROService.
6. Sub workspace - The display area for USER MENU, ERROR MESSAGES, EVENT DETAILS,
NOTEPAD, and System Help.
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Software Overview
HOME
MENU
RESULT
TEST
STAT
REAGENT
MAINT.
QC
CONFIG.
EVENT
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Software Overview
BROWSER
HELP
End Shuts down the system (End Process). Shutting down the
system turns off the auxiliary power supply, including the
lamp and computer.
END
12/27/2015 11:16:16 Time Display Displays the current date and time.
area
A button that is gray indicates that the menu item is functioning normally. Select a button
that is yellow or red to review any problems related to the menu item.
Pause Pauses analysis. The system pauses at the first test for which no R1
reagent is dispensed.
Stop Stops transportation of racks from the rack input area. The system
Feeder keeps analyzing samples in racks that have already been transported
from the rack input area.
Stop Stops analysis. The Stop button switches to the Reset button after
being selected.
Reset Puts the system back to STANDBY mode from STOP mode. The Reset
button switches to the Stop button after being selected.
Start STAT Starts STAT analysis.
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Main Workspace
The main workspace is the display and operation area for the screen that is selected, for
example, the STAT (Patient) screen.
Screen button area The buttons that open the screens that are used for the menu item. Select a
button to open a screen.
Above the screen button area, the main workspace displays breadcrumb
navigation text and double arrows that take you back in sequence to screens
that you recently visited.
Tab button area If the screen has sub menus, the system displays them in tabs. You can move
through the tabs to perform various changes to the values for the screen.
Previous and Next The buttons that move to previous or next object.
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Software Overview
Operation area The operation screen for the selected screen or tab.
Note
Some screens might include a long, oval, blue button at the top
right of the operation area that allows you to go directly to a
screen that provides functions related to the current screen.
Function button area The function buttons. The number in square brackets [Fx] corresponds to the
function key on the keyboard. For a description of the function buttons in the
main workspace, refer to Table 1.10 Home Screen Main Workspace Function
Buttons.
Create Index [F1] Displays the Create Index dialog, where you can create a new index or load an
existing one.
Change Operator [F2] Displays the Change Operator dialog, where you can enter a new operator
name or select a pre-programmed comment to append to lists that you print.
For example, refer to Print Results. From the Change Operator dialog, you can
access the Default Start Sample No. dialog, where you can set the first number
that is selectable for sample numbers when ordering tests.
Realtime Online [F6] Displays the Realtime Online dialog, where you can pause or resume realtime
communication with the LIS. You can access this button only when you
program TCP/IP for System Maintenance. Use this button to pause realtime
communication with the LIS and manually order tests. To resume realtime
communication with the LIS, select this button again in STANDBY mode.
Disabled Tests [F7] Displays the Disabled Tests dialog, where you can prevent a test from being
performed on patient samples even after the test has been ordered.
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About DxC 700 AU [F8] Displays the About DxC 700 AU dialog, which displays software version,
copyright, trademark, and patent information about the product.
Analyzer Modes
The system displays the analyzer modes in the status area. For example:
B71495AF 1-29
System Overview
Software Overview
Sub Workspace
The tabs in the sub workspace provide various useful functions.
Note
Yellow You can start analysis. Review the message carefully and take the corrective
action.
To display a dialog with information and the corrective actions for the message, select the
message. Select OK to go to the screen and take corrective actions, or select Cancel to close
the dialog.
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NOTEPAD Tab
The NOTEPAD tab allows the operator to write any text memo. For example, you can leave
instructions for the next operator or leave a reminder for yourself.
The system saves the text that you enter as a text file that is saved even after rebooting the
computer.
Using the System Help, Quick Start Page, and Event Log
B71495AF 1-31
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Software Overview
Select the system HELP button to display a system help explanation of the
current software view. The system help is displayed in a web browser window
on the right-hand side of the screen.
The system help window also contains the IFU, the Reference Manual, and
other related manuals.
In the Maintenance chapter of the system help IFU, some steps in the
maintenance procedures include short video demonstrations to accompany the
text. Select the Play/Pause button in a video window to view the video.
EVENT Button Displays the Event Log screen. In the EVENT DETAILS tab in the sub workspace,
the system displays the event description and the corrective actions. Select the
event to display the event description and the corrective action in the EVENT
DETAILS tab.
Note
Input Help Displays the allowable input information for text fields. Move the cursor over
the input area for the system to display the available range of input.
Navigation Button Displays the name of the navigation buttons. Move the cursor over the
Help navigation button for the system to display the name of the button.
Quick Start Page in the To see useful information such as the following items, refer to Quick Start.
IFU
• Links for Training and Education Resources
• How to Use the Software
• Printable Manuals
• IFU Frequently Asked Questions (FAQ)
• Revision History
When the system help IFU is open, you can find the Quick Start page at the
beginning of the Table of Contents.
System Help
When you select the system HELP button, the system help is displayed with an explanation
of the current software view. The system help is displayed inside a web browser. Within
system help, you can explore the entire IFU, Reference Manual, and related manuals.
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The arrangement of system help components changes according to the size of the system
help display. At larger sizes, all the system help components are visible.
When the system help area is smaller, the navigation pane moves out of view to show more
of the information pane. To view the navigation pane, select the system help menu button.
The navigation pane moves into view. To close the navigation pane, select the system help
menu button again.
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Software Overview
Navigation Controls
To help you find the information you need, navigation controls are available in the
informational content, and in the web browser controls.
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Home
If you select the Beckman Coulter logo, the home page of the document is displayed.
Navigation Pane
The navigation pane contains the table of contents, a Glossary (if available), an Index (if
available), and a Search function. When you select items in the Contents, Glossary, or Index,
the information is displayed in the information pane.
Related Links
Pages can contain convenient links at the bottom of the page that allow you to view related
information.
B71495AF 1-35
System Overview
Software Overview
Indicate the location of the topic currently appearing in the information pane.
The breadcrumb links allow you to select higher-level subjects related to the current topic.
Select any breadcrumb link to open its topic.
Previous/Next
Previous and Next buttons allow you to view the previous and next pages in the document.
Search Bar
The search bar allows you to find content in a document by typing in one or more words
and selecting the Search button. A list of pages is displayed from which you can choose. The
search words you entered display highlighted in the text of the pages that contain those
words.
Note
To hide or show the highlighted search terms, select the "Toggle Search Highlighting"
button.
The web browser that contains system help includes additional navigation controls that you
can use to return to the information you need quickly.
Favorites
To find frequently used information easily, add it to your Favorites. To add a favorite link,
navigate to the page you want. Then select the Favorites button . When prompted, you
can also locate or add a Favorites folder to contain your favorite links.
Tabs
To keep multiple pages of information available, you can add a tab for each page. To add a
tab, select an existing tab. With the mouse, right-click on the tab and select Duplicate Tab. A
new tab is displayed. Navigate to the information you need. Select any available tab to
switch between pages of information.
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You can move and resize the web browser to make information larger or easier to view.
• To fill the screen with the web browser, select the Maximize button .
• To return the browser to the previous size, select the Restore button .
• To resize the browser window manually, select the border of the browser window and
drag it to a new position.
• To hide the browser window completely, select the Close button .
Videos
The videos are displayed directly in the system help IFU text, for example to explain a step
in a procedure. Select the play button at the bottom of a video window to view the video.
Videos do not display in the Acrobat PDF version of the IFU. In the PDF version of the IFU, a
message is displayed to indicate where video is available in the system help, like this
example:
Refer to the video in system help.
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Software Overview
1-38 B71495AF
CHAPTER 2
Daily Startup
Introduction
These procedures confirm that your system has adequate supplies and calibrated reagent
for your patient sample run, and include maintenance steps and quality control procedures
for continued optimal performance.
Startup Procedure
2 If the system shut down without an End Process command, the system displays the
System Start dialog.
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Daily Startup
Turn on the System
Note
To set a new index by date and time, select the date and time in New Index.
7 Select OK.
Note
If you set a new index in Turn on the System, proceed to Perform Daily Inspections and
Preparations.
If your system is on, use this procedure to create an index and select a group of tests for
processing.
An index is a data file identified by the date and time and used to retrieve reagent blank,
calibration, QC, and patient results. Create an index daily, on each shift, or as needed.
A maximum of 100,000 samples or 300 indexes can be saved on the hard drive. A maximum
of 9,999 samples can be processed in an index.
2 Select New Index. The system displays the current date and time in the New Index field.
Note
To set a new index by date and time, select the date and time in New Index.
4 Select OK.
Warning
Performing daily inspections and preparations can expose you to biohazards. Wear
Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats.
Handle and dispose of biohazards according to laboratory procedures.
Caution
Open and close the analyzer cover by using the handle located at the bottom of the
cover. Use caution when closing it because of the pinching action of the adjoining
portions of the cover.
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Perform Daily Inspections and Preparations
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Table 2.2 Dilution Ratio for Daily Inspection and Preparation Solutions
Solution Dilution Ratio
2% Wash solution 1:50
Sodium hypochlorite solution (1.0%) 1:5
Caution
Note
Follow your laboratory procedure for replacing the diluted wash solution in the bottles.
Beckman Coulter recommends replacing the diluted wash solution daily.
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Daily Startup
Perform Daily Inspections and Preparations
inside the right front door of the analyzer module. The procedure is identical for all
syringes.
The sample and reagent syringes measure the volume of sample or reagent to be used in a
reaction.
The wash syringe dispenses only deionized water for cleaning the interior of the sample
probe.
The ISE buffer syringe measures the correct volume of buffer to dilute the ISE sample.
If a syringe leaks, the leak causes possible failures to the syringe, probe, and analytes being
tested.
Although the syringes are different sizes and serve different functions, you can inspect for
correct performance using the same methods.
Inspect all components of the syringes, including the fixing nut and piston fixing screw for
leaks and correct installation.
Materials Required:
• Clean, dry, lint-free absorbent tissue
Caution
Do not allow a strong alkali, such as the wash solution, to contact the syringe. If a
strong alkali contacts the syringe, cracks can occur.
If a strong alkali contacts the syringe, remove the syringe and rinse it with water.
3 Visually inspect each syringe for any cracks or leaks. Use the clean, dry, lint-free
absorbent tissue to confirm that the top and bottom connections for the syringe and the
bottom fixing screw have no leaks. If you find a crack or a leak, replace the syringe. For
more information, refer to Replace the Sample Syringe or Reagent Syringe, Replace the
Wash Syringe and Replace the ISE Buffer Syringe or Syringe Case.
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Perform Daily Inspections and Preparations
1. Reagent syringes (R1 and R2) (blue) 4. Wash syringe (R) (blue)
2. ISE buffer syringe 5. Possible leakage locations
3. Sample syringe (S) (yellow)
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Perform Daily Inspections and Preparations
1. Piston 3. R syringe
2. Seal assembly 4. Possible leakage locations
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Perform Daily Inspections and Preparations
4 Confirm that the fixing nuts and piston fixing screws are tight. If a leak persists after you
tighten the screws, replace the syringe.
Caution
If your skin, eyes, or mouth contact any liquid, immediately rinse the affected
area with water. Follow your laboratory procedure.
Materials Required:
• Clean, dry, lint-free absorbent tissue
B71495AF 2-9
Daily Startup
Perform Daily Inspections and Preparations
Caution
If your skin, eyes, or mouth contact any liquid, immediately rinse the affected area
with water. Follow your laboratory procedure.
4 Use the clean, dry, lint-free absorbent tissue to wipe the peripheral part of the tubing
and the roller pump to inspect for leaks. Wipe any fluid with the clean, dry, lint-free
absorbent tissue.
5 Confirm that the tubing connectors are tight. If a connector is loose, turn it clockwise to
tighten. Wait 5 minutes, then inspect for leaks again. If the leak persists, replace the
tubing. For more information, refer to Replace the Wash Solution Roller Pump Tubing.
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Daily Startup
Perform Daily Inspections and Preparations
If the mix bars or probes are bent or damaged, or if the probes are clogged, correct analysis
cannot be achieved.
Before you begin analysis, inspect the sample probe, reagent probes, and mix bars for
damage or deterioration. Confirm that each probe operates correctly.
Materials Required:
• Alcohol prep pads (70% Isopropyl alcohol)
3 Inspect each probe for contaminants or crystallization. If a probe is dirty, wipe the
surface with an alcohol prep pad (70% Isopropyl alcohol).
Important
4 Confirm that the probe is aligned to the center of the wash well directly above the small
hole on the metal. If it is not, contact Beckman Coulter.
1 Inspect each mix bar. If a mix bar is bent, scratched, or there are chips in the fluororesin
coating, replace the mix bar. For more information, refer to Replace the Mix Bars.
2 Inspect each mix bar for contaminants or crystallization. If the mix bar is dirty, wipe the
mix bar with an alcohol prep pad (70% Isopropyl alcohol).
3 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
4 Select Prime Washing Line. The system displays the Prime Washing Line dialog.
6 Select OK.
8 As the system dispenses water, confirm that each probe dispenses a thin, straight
stream of water, and that water flows in the wash wells.
9 As the system activates the mix bar component, confirm that the mix bars align
correctly in the wash wells. If a mix bar does not align correctly, contact Beckman
Coulter.
3 Fill the bottle with deionized water or diluent and put the bottle back on the analyzer.
Materials Required:
• 2% Wash solution
• Sodium hypochlorite solution (1.0%)
• 60 mL reagent bottle (2)
Note
Sodium hypochlorite solution (1.0%) is only required for laboratories using the DxC 700
AU with higher than average numbers of samples or dialysis patients.
If you process an average number of samples and they are not highly viscous, fill the bottles
with approximately 50 mL:
• Position 64. Det.-1/W2: 2% wash solution
• Position 65. Det.-2: 2% wash solution
If you have a high volume of samples or use the analyzer for dialysis patient samples, fill the
bottles with approximately 50 mL:
• Position 64. Det.-1/W2: 2% wash solution
• Position 65. Det.-2: sodium hypochlorite solution (1.0%)
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle solution. If the solution contacts skin or clothes, rinse the affected area
thoroughly with water. If the solution contacts the eyes or mouth, immediately flush
with water. Seek medical attention. Refer to the Safety Data Sheets (SDS) for more
information. Follow your laboratory procedure to wipe up spills immediately.
Caution
When using sodium hypochlorite solution (1.0%) as a sample probe wash solution,
follow these precautions:
• Prepare fresh sodium hypochlorite solution and completely replace the solution in the
bottle once a day.
B71495AF 2-13
Daily Startup
Perform Daily Inspections and Preparations
• If you do not plan to use the analyzer for two days or longer, remove the solution from
the analyzer and discard the solution to prevent analyzer corrosion.
• If solution spills on the analyzer, clean the area with an absorbent tissue, and wipe dry
with a clean absorbent tissue.
• Do not mix the solution with other chemicals. If the solution becomes contaminated,
follow your laboratory procedure to dispose of the solution.
Important
This procedure applies to the system that uses 62.CLN-1 and 49.CLN-1 positions next to
the refrigerators as the reagent probe cleaning solution-1 bottle position. If you select
the option of the reagent probe cleaning solution-1 bottle position in the refrigerator,
refer to Replace the Reagent Probe Cleaning Solutions (Optional Configuration).
Materials Required:
• Cleaning Solution: refer to the DxC 700 AU Reagent Contamination Prevention
Parameters document on the Beckman Coulter website.
• 60 mL reagent bottle (4)
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle solution. If the solution contacts skin or clothes, rinse the affected area
thoroughly with water. If the solution contacts the eyes or mouth, immediately flush
with water. Seek medical attention. Refer to the Safety Data Sheets (SDS) for more
information. Follow your laboratory procedure to wipe up spills immediately.
3 Fill each bottle with approximately 50 mL of the fresh cleaning solution used in your
laboratory.
Important
This procedure applies to the optional configuration for the reagent probe cleaning
solution-1 bottle position. If you select the standard position for the reagent probe
cleaning solution-1 bottle, refer to Replace the Reagent Probe Cleaning Solutions
(Standard Configuration).
Materials Required:
• Cleaning Solution: refer to the DxC 700 AU Reagent Contamination Prevention
Parameters document on the Beckman Coulter website.
• 60 mL reagent bottle (4 - 12)
The number of bottles depends on how many positions are assigned to the CLN-1
solution.
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle solution. If the solution contacts skin or clothes, rinse the affected area
thoroughly with water. If the solution contacts the eyes or mouth, immediately flush
with water. Seek medical attention. Refer to the Safety Data Sheets (SDS) for more
information. Follow your laboratory procedure to wipe up spills immediately.
Caution
Do not set any acidic cleaning solution in the refrigerators. If any acidic solution is set
in the refrigerators, it has the potential to affect other reagents.
B71495AF 2-15
Daily Startup
Inspect the Analyzer Status
2 Remove each reagent probe cleaning solution-2 bottle from the 63.CLN-2 and 50.CLN-2
positions, and discard the solution in the bottles.
3 Fill each bottle with approximately 50 mL of the fresh cleaning solution-2 used in your
laboratory.
7 Fill each bottle with approximately 50 mL of the fresh cleaning solution-1 used in your
laboratory.
12 Fill each bottle with approximately 50 mL of the fresh cleaning solution-1 used in your
laboratory.
The system monitors the ISE module and reagents when the ISE module is installed.
2-16 B71495AF
2
Daily Startup
Perform the ISE Startup (Option)
1 Select HOME.
The system displays the Home (Analyzer Status) screen.
2 Confirm that system components are within acceptable limits (green). Investigate any
yellow or red conditions.
a. Inspect the analyzer top status. Investigate any yellow or red conditions. For more
information, refer to Analyzer Top Status.
b. Inspect the rack feeder status. Investigate any yellow or red conditions. For more
information, refer to Rack Feeder Status.
c. Inspect the analyzer tanks status. Investigate any yellow or red conditions. For more
information, refer to Analyzer Tanks Status.
d. Inspect the ISE reagents status. Investigate any yellow or red conditions. For more
information, refer to ISE Reagents Status.
e. Inspect the printer, LIS, and PROService status. Investigate any red conditions. For
more information, refer to Printer, LIS, and PROService Status.
Important
If the volume of the ISE Buffer Solution, ISE MID Standard Solution, or ISE Reference
Solution reaches the alarm test level, the system generates an event message like the
following message: ISE xxxxxx Insufficient, where xxxxxx is the name of the ISE
reagent.
When the system generates the event, replace the reagent. For more information, refer
to Replace the ISE Reagents.
You can program the number of tests for each ISE reagent that generates the event.
Select REAGENT > Reagent Management > ISE > ISE Parameter Setting [F4]. For more
information, refer to the DxC 700 AU Reference Manual.
Note
Confirm that the ISE reagent volumes are sufficient for typical daily analysis before you
start the sample processing.
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Daily Startup
Perform the ISE Startup (Option)
2 Confirm that the ISE reagents are within the Onboard Remaining limit.
3 Confirm that the solution volume is sufficient for typical daily analysis.
4 Replace reagents as required. For more information, refer to Replace the ISE Reagents.
Caution
ISE Reference Solution is highly concentrated. Do not allow the ISE Reference Solution
(including that left in bottle, cap, and aspiration tubing) to contact the ISE Buffer
Solution or ISE MID Standard Solution.
B71495AF 2-19
Daily Startup
Perform the ISE Startup (Option)
Caution
Do not add new reagent to existing bottles. Adding new reagent to existing bottles
can affect results.
Materials Required:
• ISE Buffer Solution
• ISE MID Standard Solution
• ISE Reference Solution
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2
Daily Startup
Perform the ISE Startup (Option)
7 Place the cursor in the ID field. If the cursor is not in the ID field, select ID.
8 Scan the bar code label on the bottle with a manual bar code reader.
The system displays the lot number, expiration date, and volume.
Note
If a manual bar code reader is not available, use the keyboard to enter the lot
number and expiration date.
Note
Confirm that the lot number and expiration date are consistent with the label on
the bottle.
9 Place the new bottle of reagent next to the analyzer and remove the cap.
10 Pull out the reagent bottle to replace.
Note
The system generates a NO ISE xxx SOLUTION BOTTLE event (xxx is the solution
replaced). Select the Event Clear button to clear the event.
11 Loosen the cap of the reagent bottle and remove the aspiration tubing.
Important
12 Place the aspiration tubing in the new bottle and tighten the cap.
B71495AF 2-21
Daily Startup
Perform the ISE Startup (Option)
13 Place the new bottle on the analyzer and push the bottle into position.
14 To load an additional ISE Reagent bottle, repeat steps 6 to 13.
15 Select OK. The system closes the Replace ISE Reagent dialog.
Note
When you select ISE Maintenance in this tab, you go directly to the ISE
Maintenance: Maintenance tab. You do not have to go to the Home screen first.
17 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
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Daily Startup
Perform the ISE Startup (Option)
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle ISE Cleaning Solution. If the ISE Cleaning Solution contacts skin or clothes,
rinse the affected area thoroughly with water. If the ISE Cleaning Solution contacts
the eyes or mouth, immediately flush with water. Seek medical attention. Refer to the
Safety Data Sheets (SDS) for more information. Follow your laboratory procedure to
wipe up spills immediately.
Note
If you do not plan to use the system for a long period, clean the ISE at the end of the
day.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE Cleaning Solution
• Hitachi Cup
Caution
11 When the cleaning operation is complete, open the small STAT table cover, remove the
Hitachi cup from the STAT table, and discard it.
B71495AF 2-23
Daily Startup
Perform the ISE Startup (Option)
Caution
When the analysis is in process or the ISE status is Busy, do not open the STAT table
covers to add Standard Solutions to the STAT table or place hands in the path of the
sample probe.
Note
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE High Serum Standard
• ISE Low Serum Standard
• ISE High Urine Standard
• ISE Low Urine Standard
• Hitachi Cup (4 cups)
3 If you calibrate the ISE immediately after the Clean the ISE procedure, perform a total
prime to clear the lines of ISE Cleaning Solution.
a. Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
b. Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
c. Select Total Prime. The system displays the Total Prime dialog.
d. Select OK.
e. Press the DIAG/TABLE ROTATION button to start the prime. The DIAG/TABLE
ROTATION LED turns on after the prime is complete.
f. Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
5 Press the DIAG/TABLE ROTATION button to rotate the STAT table until the S-H, S-L, U-H,
and U-L positions are accessible.
6 Fill a Hitachi cup with approximately 500 µL of Standard Solution as required for
processing (determined by your laboratory processing serum, urine, or both sample
types).
Table 2.4 Position Labels for ISE Serum and Urine Standard Solutions
Solution Position Label
7 Place the Hitachi cups into the corresponding positions on the STAT table.
8 Close the small STAT table cover.
9 Select MAINT. > ISE Maintenance > Calibration.
The system displays the ISE Maintenance: Calibration tab.
10 Select Serum Start, Urine Start, or Serum/Urine Start depending on the sample types to
calibrate.
The system displays a dialog for starting the calibration.
12 When calibration is complete, confirm that the result for each electrode is within the
ranges for the calibrated sample types.
The system highlights acceptable results in green and results that exceed the values for
the calibration slope in the <Acceptable Calibration Range> table in yellow.
To determine calibration quality, compare the current results with previous results for
consistency.
13 Open the small STAT table cover, remove the Hitachi cups from the STAT table, and
discard them.
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Daily Startup
Monitor the Reagent Status
Check all positions Determines the remaining volume of reagent at all positions, including
the bottle positions outside of the reagent refrigerator. Select this option
as part of the daily startup, when changing any settings, changing the
Group, and loading numerous reagents.
Check specified Determines the remaining volumes of reagent at the specified positions.
positions Select this option when replacing a reagent bottle. If the reagent is an
R1/R2, perform a reagent check for both the R1 and R2 reagent.
Check changed Determines the remaining reagent for any reagent ID that is new or has
positions been moved or removed since the previous reagent check.
Reset only Select this option when the reagent refrigerator cover was only opened
and closed without changing any reagent. The system resets to the latest
volumes (tests) in the system memory.
Check loaded positions Select this option after adding or replacing a reagent bottle by opening
the small reagent refrigerator cover during analysis. The system detects a
bottle and reads the bar code label (for reagent ID positions) on the newly
loaded reagent. The system also detects a bottle and reads the bar code
label (for reagent ID positions) for the two reagents on either side of the
newly loaded reagent to confirm that the newly loaded reagent is in the
correct position. During the first dispense from the newly loaded reagent,
the system determines then displays the remaining reagent volume. The
system assigns a bottle sequence number to the newly loaded bottle.
Read reagent ID Select this option for the system to read the reagent bar code label.
Note
Note
When turning on the system, all tests initially show fewer than 30 tests without a
volume indicator bar.
3 Select one of the reagent check options (refer to Figure 2.17 Reagent Check Dialog), and
then select Start.
B71495AF 2-27
Daily Startup
Monitor the Reagent Status
The system starts the reagent check. As the system progresses in the reagent check, the
system indicates the status as Checking in the Reagent Status section (refer to Figure
2.16 Reagent Management: Main Tab), with the progress bar to indicate the progress.
When the reagent check is complete, the status changes to Checked.
Note
Select Check all positions once for daily startup to confirm all required reagents are
onboard with sufficient volume for processing.
4 Review the Reagent Status section. For more information, refer to Figure 2.16 Reagent
Management: Main Tab and Figure 2.18 Reagent Status Section. The colors on the
screen indicate the status of the reagent refrigerator and reagent check.
If the system displays the status in yellow or red, review the Comment column in the
Details tab.
Checking Red
Checked Green
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Daily Startup
Monitor the Reagent Status
Green
5 Review the Test Status section. For more information, refer to Figure 2.16 Reagent
Management: Main Tab and Figure 2.19 Test Status. Confirm that required reagents are
available and that all reagents have sufficient volume. Identify reagents to load.
1 Test name 1 The system displays test names in the output order
programmed in the Group. ISE and non-dedicated LIH
reagents are not displayed.
2 Test name 2 If you program the same reagent for two tests, the system
displays the second test name.
3 Number of tests or volume The number of tests remaining or volume in mL. Select Tests/
remaining Vol. to change the display. Select Type to view the number of
tests or volume for the specified sample type.
B71495AF 2-29
Daily Startup
Monitor the Reagent Status
5 Color
— Yellow - A reagent assigned to the Group is missing from
the R1 or R2, the Onboard Remaining is expired, the
reagent is expired, the volume is insufficient, or the
bottle is empty.
— Green - Required reagents are loaded.
— White - The test operation is programmed to No for the
sample type displayed in the Reagent Management:
Main tab (REAGENT > Reagent Management >
Main). To change the sample type, select Type.
6 Change the selection in Type to view each sample type in use from the Main tab.
7 Select Details to review the Onboard Remaining, Number of Tests, and Expiration
columns to confirm that reagent volumes and reagent expirations are adequate for
sample processing. For more information, refer to Replace the Reagents.
Review the Comment column and perform necessary corrective actions.
Note
You can select the title in the column header to sort the display by the following
columns: Test Name or Pos., Number of Tests, Onboard Remaining, Expiration, RB
Stability Remaining, Cal stability Remaining, and Comment.
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Daily Startup
Monitor the Reagent Status
Switch between being able to sort by Test Name or by Pos. by selecting Test (the
default) or Position in Reagent Display.
R1/R2 R1-1 and R2-1 are standard. R1-2 is for a 3-part reagent test.
Number of Tests Quantity of tests remaining in the bottle. The blue indicator bar is
proportional to the level in the bottle (0 to 100%).
Onboard Remaining Hours (H) or Days (D) remaining until the reagent onboard stability expires.
Bottle No. (SN) A unique 4-digit number to identify each bottle of reagent.
RB Stability Hours (H) or Days (D) remaining until the reagent blank stability expires.
Remaining
Cal Stability Hours (H) or Days (D) remaining until the calibration stability expires.
Remaining
Initialize Onboard Select a reagent bottle in fixed position and then select this button to reset
Stability the onboard stability period of the reagent bottle to the initial value
programmed in the Test and Test Method screen.
ID Edit Edits the 20-digit reagent ID. Use this option to edit the reagent ID after a
reagent ID read error.
Previous Setting Displays the most recent reagent bottle position. Available only in PAUSE
mode.
Edit [F1] Edits the test name, lot number, bottle number, bottle size, and position
setting.
B71495AF 2-31
Daily Startup
Monitor the Reagent Status
Load [F2] Select this button when replacing empty reagent bottles or adding new
reagent bottles in MEASURE mode. For more information, refer to Replace or
Add Reagents in MEASURE Mode.
Caution
Reagent History [F6] Displays the lot number, bottle number, position, and Onboard Remaining
(hours) for 100 lines of data for R1 and R2 reagents.
List Display [F7] Select this button to confirm the list of the reagent bottles on the R1/R2
reagent trays. Use this list when replacing a reagent bottle in REAGENT
PAUSE mode. The system highlights in blue the reagent bottle that is
positioned under the small reagent refrigerator cover.
Only bottles to load: The system displays only the reagent bottles that you
select in the Load dialog.
Note
The time remaining displays in hours (H) up to 72 hours, and days (D) over 72 hours.
If two tests are programmed to use one reagent, the RB Stability Remaining and Cal
Stability Remaining display as lower Test No./higher Test No.
8 Scroll to positions for the probe cleaning solutions. Confirm that there is sufficient
volume of each solution required.
— R1-61 DIL: Deionized water or diluent for a dilution cuvette for Pre-Dilution or
Rerun Dilution.
— R1-xx CLN-1: If you program Contamination Parameters, the system uses cleaning
solution 1.
— R1-63 CLN-2: If you program Contamination Parameters, the system uses cleaning
solution 2.
— R2-xx CLN-1: If you program Contamination Parameters, the system uses cleaning
solution 1.
— R2-50 CLN-2: If you program Contamination Parameters, the system uses cleaning
solution 2.
— R1-64 DET-1: 2% Wash Solution for automatic sample probe cleaning.
— R1-65 DET-2: 2% Wash Solution or sodium hypochlorite solution (1.0%) for
automatic sample probe cleaning.
xx: The position number that you assigned to the reagent cleaning solution bottle.
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Daily Startup
Monitor the Reagent Status
9 Select Type from the Details tab to view any additional sample types in use.
If the analyzer is in MEASURE mode and more than one sequence of bottles is onboard, the
analyzer switches to the next bottle sequence when the current bottle sequence is empty,
and not when the calibration or reagent is expired. If the reagent becomes empty during
MEASURE mode, you can replace the reagent by changing the analyzer mode to REAGENT
PAUSE mode. For more information, refer to Replace or Add Reagents in MEASURE Mode.
Caution
Bubbles in the reagent bottle can interfere with analysis. Inspect the reagent bottles
for bubbles. Remove bubbles with a cotton-tipped applicator before loading the
reagent.
Caution
Do not add new reagent to existing bottles. Adding new reagent to existing bottles
can affect results.
Important
Condensation can form on refrigerated reagent bottles. Inspect the reagent bottle
opening and the bar code label area for condensation. Remove condensation with a
clean, dry, lint-free absorbent tissue before loading the reagent.
If the bar code label is dirty or has moisture on it, the system cannot read the label.
Inspect the bar code label and wipe off any dirt or moisture. If the system still cannot
read the label, enter the reagent ID manually. For more information, refer to Edit a
Reagent ID.
Important
The R1 and R2 reagent trays use partitions among the 15 mL, 30 mL, 60 mL, and 120 mL
bottles, and adapters to hold 15 mL and 30 mL reagent bottles securely in position.
B71495AF 2-33
Daily Startup
Monitor the Reagent Status
For two-part reagents, the reagent label indicates whether the reagent goes into the R1 or
R2 refrigerator.
3 Remove the onboard expired, expired, insufficient volume, and empty reagent bottles
from each refrigerator.
The system displays the reagent positions on the Details tab. The system indicates
assigned (fixed) positions with an asterisk highlighted in blue in the column to the left
of the Pos. column. For more information, refer to Assign a Reagent Position.
4 Place the new bottles in the correct refrigerator. Use adapters and partitions as needed.
For more information, refer to Reagents.
Caution
Confirm that 15 mL reagent bottles are placed on the reagent tray with the bar
code label facing out. Incorrectly loaded bottles can damage the bottle or the
reagent probe.
Note
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Daily Startup
Calibrate Tests
If the bottle has a reagent ID, place the bottle in any available (not assigned)
position in the R1 or R2 refrigerator.
If the bottle does not have a reagent ID, place the bottle in the correct assigned
position. The system indicates assigned (fixed) positions with an asterisk highlighted
in blue in the column to the left of the Pos. column. For more information, refer to
Assign a Reagent Position.
8 When the reagent check is complete, review the Main and Detail tabs to confirm that all
reagents are ready for processing.
Calibrate Tests
Important
Calibrator set points can vary with new lots. Be sure to inspect the calibrator value
assignment sheets to ensure the correct set points are in use.
For calibrator information, refer to the calibrator IFU and value assignment sheet.
For rack analysis, after a reagent check the system automatically orders tests for reagent
blank and calibration for tests that satisfy the following four conditions.
For rack and STAT analysis, if you select Auto CAL/QC Order [F4], the system orders tests for
reagent blank and calibration for tests that satisfy the following four conditions.
• The reagent blank or calibration is expired.
• The reagent blank or calibration expires soon (default setting is 180 minutes).
• There is a new bottle or lot number for the reagent (if you are using Advanced
Calibration).
• The reagent blank or calibration failed.
Note
To request changes to the default setting for calibration expires soon from 180 minutes,
contact Beckman Coulter.
B71495AF 2-35
Daily Startup
Process Quality Control (QC)
Note
To determine the tests to calibrate, review the Comment column in the Reagent
Management: Details tab (REAGENT > Reagent Management > Details).
Calibration includes a reagent blank and calibration. You can perform calibration using
the blue and yellow racks or the STAT table.
Note
Load calibrators in the blue and yellow racks. For more information, refer to Order and
Perform Calibration from the Racks.
Use the STAT table to load calibrators to perform calibration after you load a reagent in
MEASURE mode. For more information, refer to Order and Perform Calibration from the
STAT Table.
If the DxC 700 AU connects to a Laboratory Automation System, use the STAT table to
load calibrators. For more information, refer to Order and Perform Calibration and
Quality Control (QC) from the STAT Table (Laboratory Automation System).
Note
Before a panel is available to order, program calibration panels in the Panel: RB/ACAL
tab (CONFIG. > Panel > RB/ACAL). You can program a maximum of 100 panels (including
daily, weekly, and monthly calibration requirements). For more information, refer to
Create a Reagent Blank or Calibration Panel.
Note
Before a test is available to order by bottle sequence number when you select
Individual Order [F3], program the test for Advanced Calibration in the Calibration
Setup: General tab (CONFIG. > Calibration Setup > General). For more information,
refer to the DxC 700 AU Reference Manual.
Important
Quality control material mean, range, and standard deviation can vary for each test
with new lots. Be sure the correct values for control material lot are in use.
Perform Quality Control on the schedule determined by your laboratory protocol. Run
control samples with each new calibration, with each new reagent lot, and after specific
maintenance or troubleshooting activities. If you find any trends or sudden shift in results,
2-36 B71495AF
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Daily Startup
Process Quality Control (QC)
review all operating settings. Follow your laboratory guidelines for corrective action if the
QC results do not recover within the specified limits.
Note
Process QC from the green racks. For more information, refer to Order and Perform
Quality Control (QC) from the Racks.
Use the STAT table to load control samples to perform quality control after you load a
reagent in MEASURE mode. For more information, refer to Order and Perform Quality
Control (QC) from the STAT Table.
If the DxC 700 AU connects to a Laboratory Automation System, use the STAT table to
process QC. For more information, refer to Order and Perform Calibration and Quality
Control (QC) from the STAT Table (Laboratory Automation System).
Note
The system automatically orders the default QC panel for QC analysis from racks after a
reagent check.
Select Auto CAL/QC Order [F4] to order automatically the same tests for QC analysis as
ordered for calibration. This function is available for QC analysis both from the racks
and the STAT table.
Note
Program a QC panel in the Panel: QC tab (CONFIG. > Panel > QC). For more information,
refer to Create a QC Panel. The following specific panel numbers are designated as
default QC panels for each sample type and Group.
B71495AF 2-37
Daily Startup
Calibrate Tests and Process Quality Control from the Racks (Standalone)
Calibrate Tests and Process Quality Control from the Racks (Standalone)
• Order and Perform Calibration from the Racks
• Order and Perform Quality Control (QC) from the Racks
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Daily Startup
Calibrate Tests and Process Quality Control from the Racks (Standalone)
Note
If the system does not automatically order tests, select Auto CAL/QC Order [F4].
The system orders tests for reagent blank and calibration. The system also orders
the same tests for QC analysis.
3 Confirm that the ordered tests are correct for all sample types.
4 If the ordered tests are correct, continue to step 11.
5 To change the ordered tests, select Edit [F1].
6 To select a panel, select Panel. Select a panel, and then select OK.
Note
Selecting from the RB column orders only a reagent blank. Selecting from the CAL
column orders a reagent blank and calibration.
8 To order a different sample type, change the sample type in Type. Then repeat steps 6
and 7.
9 To order sequential bottles of the same test, select Individual Order [F3].
— In Type, select the sample type.
— To select a specific test and bottle sequence, select the RB or CAL column.
— To order all bottles for the selected test, select Select All by Test.
— To order all bottles for all tests, select Select All.
— To order a different sample type, repeat test selection by changing the sample type
in Type.
— To save the order, select Close.
— To cancel the order, select Cancel.
10 Select Save [F2] to save the order. Select Close [F1] to cancel the order.
Note
To order the same tests for QC as ordered for calibration, select QC Same Order
[F5].
11 Select Display Cup Set [F6] to display the reagent blank, calibrators, racks, and positions
required for reagent blank and calibrators.
Load the reagent blanks and calibrators according to the list in the blue and yellow
racks. Select Close to close the dialog.
B71495AF 2-39
Daily Startup
Calibrate Tests and Process Quality Control from the Racks (Standalone)
Note
In the Display Cup Set dialog, the Volume (μL) is the volume required for the
ordered tests. The dead volume is not included.
Note
If calibrator Bar code Operation is enabled, the system does not display a rack ID for
the calibrator racks.
12 Load the racks in the rack input area. Load the blue rack first, followed by the yellow
racks.
13 Select Start.
1 Select TEST > Rack (QC). The system displays the Sample Program: Rack (QC) screen.
Note
The system automatically orders the default QC panel when you perform a reagent
check or quality control.
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Daily Startup
Calibrate Tests and Process Quality Control from the Racks (Standalone)
The system automatically orders the same tests for QC as ordered for the reagent
blank and calibration when you select Auto CAL/QC Order [F4] or QC Same Order
[F5] in TEST > Rack (Calibration) or STAT > STAT (Calibration).
Note
If you use sequential bottles for the same test and have selected Multiple Bottles in
the QC Program by Panel button, the system automatically programs the same QC
order for all bottles for the test. This order by panel occurs after a reagent check,
after performing quality control, and when ordering by selecting a panel.
3 Confirm that the ordered tests are correct for all sample types.
4 If the ordered tests are correct, continue to step 12.
5 To change the ordered tests, select Edit [F1].
6 To clear the tests for the default QC panel orders, select Clear All Tests [F6].
7 To select a panel, select Panel. Select a panel, and then select OK.
Note
If you use sequential bottles for the same test and have selected Multiple Bottles in
the QC Program by Panel button, the system automatically programs the same QC
order for all bottles for the test.
9 To order a different sample type, change the sample type in Type. Then repeat steps 6 to
8.
10 To order sequential bottles of the same test, select Individual Order [F3].
Note
If you have selected Multiple Bottles in the QC Program by Panel button, skip this
step.
B71495AF 2-41
Daily Startup
Calibrate Tests and Process Quality Control from the STAT Table (Standalone)
11 Select Save [F2] to save the order. Select Close [F1] to cancel the order.
12 Select Display Cup Set [F7] to display the required control samples, racks, and positions.
13 Load the control samples in the green racks according to the list. Select Close.
Note
In the Display Cup Set dialog, the Volume (μL) is the volume required for the
ordered tests. The dead volume is not included.
Note
If QC Bar Code Operation is enabled, the system does not display a rack ID for the
QC racks.
Calibrate Tests and Process Quality Control from the STAT Table (Standalone)
If you load a reagent bottle when in MEASURE mode, perform calibration or QC for the
reagent from the STAT table.
Program the Bar Code or Cup Positions Option for Calibration and QC from the STAT Table
Program patient samples, calibrators, and control samples in bar code (Bar Code) or
position assignment (Cup Pos.) for analysis from the STAT table.
Tip
For analysis from racks, program bar code operation for patient samples, calibrators,
and control samples in the Analysis Mode (CONFIG. > Analysis Mode), Calibrator Setup
(CONFIG. > Calibrator Setup), or QC Setup (CONFIG. > QC Setup) screens.
If you select Bar Code in the STAT Table Setting dialog (STAT Status > STAT Table Setting [F6]),
the system reads the bar code to identify the sample kind (patient sample, calibrator, or
control sample). For Sample Kind select Free, then place patient samples, calibrators, and
control samples in any Free position.
If you select Cup Pos. for calibration or QC in the STAT Table Setting dialog (STAT Status >
STAT Table Setting [F6]), program the cup positions for the calibration or QC in the STAT
Table Setting dialog. The system allows you to run the calibration or QC in those assigned
positions only. For example, if you assign positions 1, 2, and 3 for the calibration, you can
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Daily Startup
Calibrate Tests and Process Quality Control from the STAT Table (Standalone)
use only those three positions for the calibration. For more information, refer to the DxC
700 AU Reference Manual.
1 Select STAT > STAT Status > STAT Table Setting [F6].
The system displays the STAT Table Setting dialog.
2 Select Edit.
3 In the [STAT Test Order] section, select Bar Code or Cup Pos. for calibration and QC.
4 In the [STAT Table Pos. Setting] section, the default selection for Group is the group that
is selected for Group of Tests in the Create Index dialog (HOME > Create Index [F1]).
Change the selection for Group as needed.
7 Select Save.
B71495AF 2-43
Daily Startup
Calibrate Tests and Process Quality Control from the STAT Table (Standalone)
3 Select Auto CAL/QC Order [F4]. In the STAT (Calibration) dialog, select OK.
The system automatically orders tests under any of the following conditions:
— The reagent blank or calibration is expired.
— The reagent blank or calibration expires soon (default setting is 180 minutes).
— There is a new bottle or lot number for the reagent (if you are using Advanced
Calibration).
— The reagent blank or calibration failed.
The system displays tests for calibration and reagent blank in blue.
Note
The calibration is ordered, but the QC is not when you select Auto CAL/QC Order
[F4].
4 Confirm that the ordered tests are correct for all sample types.
5 If the ordered tests are correct, continue to step 12.
6 To change the ordered tests, select Edit [F1].
7 To select a panel, select Panel. Select a panel and then select OK.
8 To select a specific test, select the test from the RB or CAL column.
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Calibrate Tests and Process Quality Control from the STAT Table (Standalone)
Note
Selecting from the RB column orders only a reagent blank. Selecting from the CAL
column orders a reagent blank and calibration.
9 To order a different sample type, change the sample type in Type. Then repeat steps 7
and 8.
10 To order sequential bottles of the same test, select Individual Order [F3].
— In Type, select the sample type.
— To select a specific test and bottle sequence, select the RB or CAL column.
— To order all bottles for the selected test, select Select All by Test.
— To order all bottles for all tests, select Select All.
— To order a different sample type, repeat test selection by changing the sample type
in Type.
— To save the order, select Close.
— To cancel the order, select Cancel.
Note
If you select Cup Pos. for calibration in the STAT Table Setting dialog (STAT Status >
STAT Table Setting [F6]), and if you order tests for the calibration that require more
calibrators than the assigned positions, the system displays the STAT (Calibration)
dialog, which indicates that the test order is unavailable. Select OK. The test order is
canceled.
11 Select Save [F2] to save the order. Select Close [F1] to cancel the order.
Note
To order the same tests for QC as ordered for calibration, select QC Same Order
[F5].
12 Select CAL/QC Position [F6] to display the calibrators, control samples, and volumes that
are required for the ordered tests.
Note
In the CAL/QC Position dialog, the Volume (μL) is the volume required for the
ordered tests. The dead volume is not included.
Note
If you have selected the Cup Pos. option for calibration in the STAT Table Setting
dialog (STAT Status > STAT Table Setting [F6]), the system displays calibrator
positions on the STAT table in the CAL/QC Position dialog.
B71495AF 2-45
Daily Startup
Calibrate Tests and Process Quality Control from the STAT Table (Standalone)
13 Load the required reagent blank and calibrators on the STAT table. Press the DIAG/
TABLE ROTATION button to rotate the table.
— Place the reagent blank sample in the inner STAT table position RB1.
— If you have selected the Bar Code option for calibration, place the calibrators with
bar code labels in any positions for which you set the sample kind to Free in the
STAT Table Setting dialog (STAT Status > STAT Table Setting [F6]). The system
displays the available positions as Free in the Kind column on the STAT Status
screen.
— If you have selected the Cup Pos. option for calibration, place the calibrators in the
correct positions according to the Pos. column in the STAT Status screen or the
CAL/QC Position dialog (STAT > STAT (Calibration) > CAL/QC Position [F6]).
Order and Perform Quality Control (QC) from the STAT Table
Confirm that you have programmed the options for performing QC from the STAT Table.
Refer to Program the Bar Code or Cup Positions Option for Calibration and QC from the
STAT Table.
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Calibrate Tests and Process Quality Control from the STAT Table (Standalone)
Note
The system automatically orders the same tests for QC as ordered for the reagent
blank and calibration when you select QC Same Order [F5] in STAT > STAT
(Calibration). The calibration is ordered, but the QC is not when you select Auto
CAL/QC Order [F4]. The system highlights the tests in blue. Refer to Order and
Perform Calibration from the STAT Table.
3 If there are tests ordered (highlighted in blue), confirm that the orders are correct for all
sample types.
6 To select a panel, select Panel. Select a panel, and then select OK.
Note
If you use sequential bottles for the same test and have selected Multiple Bottles in
the QC Program by Panel button, the system automatically programs the same QC
order for all bottles for the test.
8 To order a different sample type, change the sample type in Type. Then repeat steps 6
and 7.
9 To order sequential bottles of the same test, select Individual Order [F3].
Note
If you have selected Multiple Bottles in the QC Program by Panel button, skip this
step.
B71495AF 2-47
Daily Startup
Order and Perform Calibration and Quality Control (QC) from the STAT Table (Laboratory Automation System)
Note
If you select Cup Pos. for QC in the STAT Table Setting dialog (STAT Status > STAT
Table Setting [F6]), and if you order tests for the QC that require more tests than
the assigned positions, the system displays the STAT (QC) dialog, which indicates
that the test order is unavailable. Select OK. The test order is canceled.
10 Select Save [F2] to save the order. Select Close [F1] to cancel the order.
11 Select CAL/QC Position [F7] to display the list of control samples and volumes required
for the ordered tests.
Note
In the CAL/QC Position dialog, the Volume (μL) is the volume required for the
ordered tests. The dead volume is not included.
Note
If you have selected the Cup Pos. option for QC in the STAT Table Setting dialog
(STAT Status > STAT Table Setting [F6]), the system displays QC positions on the STAT
table in the CAL/QC Position dialog.
12 Load the required control samples on the STAT table. Press the DIAG/TABLE ROTATION
button to rotate the table.
— If you have selected the Bar Code option for QC in the STAT Table Setting dialog
(STAT Status > STAT Table Setting [F6]), place the control samples with bar code
labels in the positions for which you set the sample kind to Free for the STAT Table
Setting [F6] option of the STAT Status screen. The system displays the available
positions as Free in the Kind column on the STAT Status screen.
— If you have selected the Cup Pos. option for QC in the STAT Table Setting dialog
(STAT Status > STAT Table Setting [F6]), place the control samples in the correct
positions according to the Pos. column in the STAT Status screen or the CAL/QC
Position dialog (STAT > STAT (QC) > CAL/QC Position [F7]).
Order and Perform Calibration and Quality Control (QC) from the STAT Table
(Laboratory Automation System)
When the DxC 700 AU connects to a Laboratory Automation System, you can perform
calibration and QC only from the STAT table. DxC 700 AU provides a Multiple Loads STAT
Table operation. With Multiple Loads STAT Table operation, the system can process
multiple loads of up to 200 calibrators and up to 100 control samples in a single run. The
system can process 22 calibrators and control samples per load.
2-48 B71495AF
2
Daily Startup
Order and Perform Calibration and Quality Control (QC) from the STAT Table (Laboratory Automation System)
When Multiple Loads STAT Table operation is enabled, your only option for sample
identification is the use of bar code labels without any pre-assignment of sample kinds to
the positions.
A Beckman Coulter Representative configures the system for Multiple Loads STAT Table
operation during system installation at your request.
Important
The system does not process patient samples in the same run as calibrators or controls
on the STAT Table. Run patient samples after calibrations and QC analysis are
completed.
Important
Within a run, all calibrators must precede any control samples. The following are some
examples:
Table 2.10 Acceptable Calibrator and QC Load Order for Multiple Loads STAT Table
Operation
Load Example 1 Example 2 Example 3
Third Control samples only Control samples only Control samples only
Note
In the second load of Example 1, you can place calibrators and control samples
in any order on the STAT table.
Table 2.11 Unacceptable Calibrator and QC Load Order for Multiple Loads STAT Table
Operation
Load Example 1 Example 2
Note
The system analyzes all calibrators first, and then control samples.
B71495AF 2-49
Daily Startup
Order and Perform Calibration and Quality Control (QC) from the STAT Table (Laboratory Automation System)
3 Select Auto CAL/QC Order [F4]. In the STAT (Calibration) dialog, select OK.
The system automatically orders tests under any of the following conditions:
— The reagent blank or calibration is expired.
— The reagent blank or calibration expires soon (default setting is 180 minutes).
— There is a new bottle or lot number for the reagent (if you are using Advanced
Calibration).
— The reagent blank or calibration failed.
Note
The calibration is ordered, but the QC is not when you select Auto CAL/QC Order
[F4].
2-50 B71495AF
2
Daily Startup
Order and Perform Calibration and Quality Control (QC) from the STAT Table (Laboratory Automation System)
4 Confirm that the ordered tests are correct for all sample types.
5 If the ordered tests are correct, continue to step 12.
6 To change the ordered tests, select Edit [F1].
7 To select a panel, select Panel. Select a panel, and then select OK.
8 To select a specific test, select the test from the RB or CAL column.
Note
Selecting from the RB column orders only a reagent blank. Selecting from the CAL
column orders a reagent blank and calibration.
9 To order a different sample type, change the sample type in Type. Then repeat steps 7
and 8.
10 To order sequential bottles of the same test, select Individual Order [F3].
— In Type, select the sample type.
— To select a specific test and bottle sequence, select the RB or CAL column.
— To order all bottles for the selected test, select Select All by Test.
— To order all bottles for all tests, select Select All.
— To order a different sample type, repeat test selection by changing the sample type
in Type.
— To save the order, select Close.
— To cancel the order, select Cancel.
11 To save the order, select Save [F2], or to cancel the order, select Close [F1].
12 To order the same tests for QC as ordered for calibration, select QC Same Order [F5].
Note
The system automatically has ordered the same tests for QC as ordered for the
reagent blank and calibration when you select QC Same Order [F5] in the STAT
Status: STAT (Calibration) screen. The calibration is ordered, but the QC is not when
you select Auto CAL/QC Order [F4]. The system highlights the tests in blue.
15 If there are tests ordered (highlighted in blue), confirm that the orders are correct for all
sample types.
16 If the ordered tests are correct, continue to Prepare and Load Calibrators and Control
Samples.
B71495AF 2-51
Daily Startup
Order and Perform Calibration and Quality Control (QC) from the STAT Table (Laboratory Automation System)
17 If there are no tests ordered or to change the ordered tests, select Edit [F1].
18 To select a panel, select Panel. Select a panel, and then select OK.
Note
If you use sequential bottles for the same test and have selected Multiple Bottles in
the QC Program by Panel button, the system automatically programs the same QC
order for all bottles for the test.
20 To order a different sample type, change the sample type in Type, then repeat steps 18
and 19.
21 To order sequential bottles of the same test, select Individual Order [F3].
Note
If you have selected Multiple Bottles in the QC Program by Panel button, skip this
step.
22 To save the order, select Save [F2], or to cancel the order, select Close [F1].
1 Select CAL/QC Position [F7] to display the reagent blank, calibrators, control samples,
and volumes that are required for the ordered tests.
Note
In the CAL/QC Position dialog, the volume (μL) is the volume required for the
ordered tests. The dead volume is not included.
2-52 B71495AF
2
Daily Startup
Order and Perform Calibration and Quality Control (QC) from the STAT Table (Laboratory Automation System)
Load the reagent blank sample in the inner wheel of the STAT table labeled RB1.
3 Confirm that the STAT TABLE ROTATION LED is off, and open the upper STAT table
cover.
Note
The blinking STAT TABLE ROTATION LED indicates that the system is aspirating the
samples on the STAT Table. You can interrupt patient sample analysis to perform
calibration and QC analysis. To remove patient samples that are currently
processing in the STAT table, change the system mode to Pause by selecting the
Pause button from the action button area. After the system changes mode to Pause,
select STAT Pause [F2] from the STAT Status screen and remove the patient samples
that are currently on the STAT Table.
4 Confirm again that the STAT TABLE ROTATION LED is off, and open the large STAT table
cover.
5 Place the first load of calibrators or control samples on the STAT table.
You can place a maximum of 22 calibrators or control samples on the STAT table per
load.
Note
Keep the STAT table clean. If you spill the sample on the STAT table, wipe it off
immediately.
2 If this is the only table required for calibrators and QC, or if the table is for the last load
of calibrators and QC, select Last Table in the dialog.
3 Select Start.
The STAT TABLE ROTATION LED starts blinking, and the system starts calibration or QC
analysis on the STAT table.
The STAT TABLE ROTATION LED turns off when aspiration of calibrators or control
samples completes.
B71495AF 2-53
Daily Startup
Order and Perform Calibration and Quality Control (QC) from the STAT Table (Laboratory Automation System)
1 Use one of the following methods to place another load of calibrators or control samples
on the STAT table:
• Reuse the STAT table used for the previous load:
1. Confirm that the STAT TABLE ROTATION LED is off, and open the large STAT
table cover.
2. Remove the processed calibrators or control samples from the STAT table.
3. Place another load of calibrators or control samples on the STAT table.
4. Close the large STAT table cover.
• Use another STAT table:
1. Prepare another STAT table for the next load of calibrators or control samples.
2. Place the next load of calibrators or control samples on the STAT table that is
prepared for the next load.
3. Confirm that the STAT TABLE ROTATION LED is off (aspiration is complete),
and open the large STAT table cover.
4. Pull up the two white latches in the STAT table compartment until they make a
clicking noise.
5. Lift the STAT table used for the previous load from the STAT table compartment
by holding the knob.
6. Set the STAT table for the new load in the STAT table compartment, adjusting
the STAT table position using the positioning pins.
7. Push down the two white latches until they make a clicking noise to secure the
STAT table.
8. Close the large STAT table cover.
Note
Keep the STAT table clean. If you spill the sample on the STAT table, wipe it off
immediately.
2 If the next load is going to be the last one, go to Analyze the Last Load of Calibrators or
Control Samples.
If the next load is not going to be the last one, repeat Place Another Load of Calibrators
or Control Samples on the STAT Table.
2-54 B71495AF
2
Daily Startup
Start Analysis
Note
If you start calibration or QC analysis for the last table without selecting the Last
Table box, select Last Table/Cancel Last Table [F1] before the system completes the
aspiration for the last sample.
3 Select Start.
The STAT TABLE ROTATION LED starts blinking, and the system starts calibration or QC
analysis on the STAT table.
The STAT TABLE ROTATION LED turns off when aspiration of calibrators or control
samples completes.
4 Confirm that the STAT TABLE ROTATION LED is off, and remove the processed
calibrators or control samples from the STAT table.
Start Analysis
The reaction time is approximately 8 minutes and 33 seconds for the first result to be
obtained after the sample is dispensed. The system can sample another test every 4.5
seconds.
When the DxC 700 AU connects to a Laboratory Automation System, add an extra 4.5
seconds for each sample. The extra time allows the sample to move from the sample
aspiration position, and a new sample to advance to the sample aspiration position.
Note
B71495AF 2-55
Daily Startup
Start Analysis
Note
Select Edit to edit the starting sample number. Editing the starting sample number
is only necessary in Sequential mode.
3 Confirm the operator initials or name in Operator Name. To change the operator initials
or name, select Cancel, then change the operator initials or name in Home > Change
Operator [F2].
Note
When the operator option is selected in CONFIG > List Format > Print Information,
the initials or name of the operator print on the report.
4 Select Start.
If the system does not detect any errors, the system starts analysis. The mode changes
from STANDBY to MEASURE 1.
1 Confirm that the amber STAT TABLE ROTATION LED is not on or blinking, and then
open the small STAT table cover.
2-56 B71495AF
2
Daily Startup
Start Analysis
Review the Error List in the Start STAT dialog. Confirm that the required samples are on
the STAT table.
3 Confirm the operator initials or name in Operator Name. To change the operator initials
or name, select Cancel, then change the operator initials or name in Home > Change
Operator [F2].
Note
When the operator option is selected in CONFIG > List Format > Print Information,
the initials or name of the operator print on the report.
6 If there are no errors specific to the STAT table after the STAT table check, analysis
starts. If there are STAT table errors, review the errors in the Start STAT dialog. Select
Start to begin analysis, or select Cancel to perform corrective actions.
B71495AF 2-57
Daily Startup
Start Analysis
2-58 B71495AF
CHAPTER 3
System Setup
Program a New Test
Program the new test using the reagent setting sheet. For more information, refer to the
DxC 700 AU Reference Manual.
Caution
Changing the test name affects all results associated with that test number.
Any previously reported results (with the old test name) are assigned the new
test name. Use caution when changing the test name.
Do not change the test name without noting the time and date that the
change occurred and then confirming any results printed before this time are
reviewed and correctly identified.
Tests are processed on a sample in the test number order (1 to 120) displayed,
with some exceptions. For information on contamination prevention, refer to
the DxC 700 AU Reference Manual.
c. (Optional) In Long Name, enter the name (maximum of 20 characters).
d. For all countries and regions except Japan: In Reagent ID, enter the first 3 digits of
the reagent ID, or refer to the reagent IFU for the reagent ID 3-digit code.
For Japan, the reagent ID includes the manufacturer ID and test code. In
Manufacturer ID, enter the first 3 digits of the reagent ID. In Test Code, enter the 2
digits of the reagent ID following the first 3 digits. Refer to the reagent IFU for the
manufacturer ID and test code.
e. In Alarm Tests, enter the remaining test number to generate a Reagent
Insufficient event. The default is 32.
Note
f. In Multi Reagent Switch, select Yes. The Multi Reagent Switch allows the analyzer to
switch to a new sequence of R1 or R2 when either the R1 or R2 of a sequence
becomes empty.
g. Confirm that the information is correct, and then select Save [F1].
Note
In the QC tab, you can program default QC panels (numbers 87 to 99) for each
sample type and Group. The default QC panel is the automatic QC order made
for the rack analysis after a reagent check.
d. In Panel Name, select a panel.
e. Select the test. The system displays the selected tests in blue.
f. Confirm that the information is correct, and then select Save [F1].
For more information about panels, refer to Create a Panel.
3-2 B71495AF
3
System Setup
Program a New Test
Note
The system can display the parameters for a maximum of 6 tests at a time for
verification. Select List Display [F7]. In Type, select the sample type. Select
Forward or Backward icons to display other tests. Select Close to close the
dialog.
5 Select Range.
a. In Test Name, select the test name.
b. In Type, select the sample type.
c. Select Edit [F1].
d. Select Set Decimal Places [F5], and then select 0 to 4 for the decimal place for the
results.
e. Select Close.
f. In Value/Flag:
— Select Value to access Specific Ranges to set the high (H flag) and low ranges (L
flag).
— Select Flag to access Level to set a positive limit (P flag) or negative limit (N
flag). This setting is typically used for drugs of abuse testing.
g. Use Specific Ranges to set a reference interval to generate high (H) and low (L) flags.
— In 1 to 6, enter a range determined by sex, age, and other type.
— In 7, Standard demographics, enter a generic reference interval. The system uses
the generic reference interval for samples without patient demographic
information (age and sex).
— In 8, Not within expected values, the system uses the Not within expected values
reference interval for a sample with patient demographic information (age or
sex), but the age or sex information did not satisfy the age and sex defined in
the specific range 1 to 6.
h. (Optional) Use Critical Limits to set limits to generate an event and a pl or ph flag.
i. Select Select to select the unit from the preprogrammed list, then select OK. Or, for
Unit, enter the unit.
If the units are formatted on the report, the system prints the units.
j. Confirm that the information is correct, and then select Save [F1].
B71495AF 3-3
System Setup
Program a New Test
Note
If Bar Code Operation is not enabled, enter the Calibrator Name. If Bar Code
Operation is enabled, enter the Calibrator Name and Calibrator ID. The Lot No.
and Expiration are optional fields.
c. Confirm that the information is correct.
9 Select General.
a. In Test Name, select the test name.
b. In Type, select the sample type.
c. Refer to the reagent setting sheet to determine the Calibration Type, and enter
calibration-specific parameters.
— If the Calibration Type is AB, AA, 2AB, 3AB, 4AB, 5AB, 6AB or 7AB:
— Refer to the reagent setting sheet for the parameters for Formula, Slope
Check, Factor Range, Allowable Range Check, Advanced Calibration, and
Stability.
— For Counts (replicates), enter a number from 1 to 4. For more information,
refer to the DxC 700 AU Reference Manual.
— Select the calibrator from Calibrator.
— For Conc, enter the calibrator concentration from the calibrator insert
(available in the calibrator kit).
— If the Calibration Type is MB:
— Refer to the reagent setting sheet for the parameters for Formula,
Allowable Range Check, Advanced Calibration, MB Type Factor, and Stability.
— For Counts (replicates), enter a number from 1 to 4. For more information,
refer to the DxC 700 AU Reference Manual.
d. Confirm that the information is correct, and then select Save [F1].
Note
If you process calibration on the STAT table, program the STAT Table Setting. For
information on programming the STAT table for calibration, refer to the DxC 700 AU
Reference Manual. If the DxC 700 AU connects to a Laboratory Automation System,
calibration from the STAT table is the only option.
Note
If using the QC menu to access the Controls tab, after you select QC, you might have
to select OK at a dialog that is displayed before you can select QC Setup > Controls.
3-4 B71495AF
3
System Setup
Program a New Test
Note
If Bar Code Operation is not enabled, enter the Control Name. If Bar Code
Operation is enabled, enter the Control Name and Control ID. The Lot No. and
Expiration are optional fields.
c. Confirm that the information is correct.
13 Select Preset.
a. In Test Name, select the test name.
b. In Type, select the sample type.
c. In Control, select the control material.
d. In Multi/Single, select Multi or Single.
e. Use the QC package insert or known values to enter the Mean, SD, and Range. The
system determines that QC is in or out of these preset ranges when the QC Mode is
set to Preset (on the Check tab).
Note
If you process QC on the STAT table, program the STAT Table QC screen. For
information on programming the STAT table for QC, refer to the DxC 700 AU
Reference Manual. If the DxC 700 AU connects to a Laboratory Automation System,
QC from the STAT table is the only option.
Important
Do not change any parameters for items in Basic Condition, Print Information, or
Layout. These parameters affect the format of the printout.
B71495AF 3-5
System Setup
Program a New Test
Note
If you select a required report or list and all of the available spaces for tests are
highlighted in blue, you do not have to make changes.
Note
Before the tests print on the printout, add the new test to any required real-
time printouts (reagent blank, calibration, QC, and patient samples).
c. Confirm that the information is correct, and then select Save [F1].
Important
When the test number on the laboratory information system and the online
test number are different, the data cannot transmit correctly.
c. Confirm that the information is correct, and then select Save [F1].
3-6 B71495AF
3
System Setup
Create a Panel
Create a Panel
A panel is a group of tests that are typically ordered at the same time. Using a panel reduces
the quantity of selections needed, as a single panel is selected instead of multiple tests. A
maximum of 100 panels (Number 0 to Number 99) can be programmed for patient
samples, reagent blanks, calibration, and QC. A maximum of 99 tests can be programmed in
a panel. The quantity of sample blank tests, LIH, and sample type limits the quantity of tests
that can be programmed in a panel.
B71495AF 3-7
System Setup
Create a Panel
6 Select the tests to include in the panel. The system displays selected tests in blue.
7 Confirm that the information is correct, and then select Save [F1].
6 Select the tests to include in the panel. The system displays the test in yellow (ACAL +
RB), pink (One Point), or blue (RB Only), which is determined by programming in the
tab that displays when you select CONFIG. > Calibration Setup > General. Select
Calibration Options [F5] to change between the available options.
Note
The programming in the tab that displays when you select CONFIG. > Calibration
Setup > General determines the calibration options available in Calibration Options
[F5].
3-8 B71495AF
3
System Setup
Create a Panel
Note
You can select ISE tests when the ISE calibration type is ACAL. For more information,
contact Beckman Coulter.
7 Confirm that the information is correct, and then select Save [F1].
Create a QC Panel
QC panels 87 to 99 are the default QC panels that are automatically ordered in TEST > Rack
(QC). The QC panel numbers 87 to 99 correspond to a specific Group and sample type:
• Number 87: Serum: For Group 1
• Number 88: Serum: For Group 2
• Number 89: Serum: For Group 3
• Number 90: Urine: For Group 1
• Number 91: Urine: For Group 2
• Number 92: Urine: For Group 3
• Number 93: Other-1: For Group 1
• Number 94: Other-1: For Group 2
• Number 95: Other-1: For Group 3
• Number 96: Other-2: For Group 1
• Number 97: Other-2: For Group 2
• Number 98: Other-2: For Group 3
• Number 99: Whole blood: For all Groups
You can only select ISE tests when the sample type is Serum or Urine.
B71495AF 3-9
System Setup
Program Calibrator Concentrations
6 Select the tests to include in the panel. The system displays selected tests in blue.
7 Confirm that the information is correct, and then select Save [F1].
For more information on how to program calibrator material and calibration parameters,
refer to the DxC 700 AU Reference Manual.
3-10 B71495AF
3
System Setup
Program Calibrator Concentrations
Important
Confirm the calibrator concentration values in the Calibration Setup screen. It is critical
that correct calibrator values are loaded.
1 Select HOME.
3 For Operator Name, enter the operator initials or name, or select Select to choose the
name of the operator from Comment Master, then select OK.
4 Select OK.
Note
The system records an operator initials or name in User Name in Calibrator Info.
Loading History when you load calibrator information from the two-dimensional
bar code.
B71495AF 3-11
System Setup
Program Calibrator Concentrations
Note
Note
If you do not select a calibrator, the system displays the first position in the Load
Calibrator Information dialog. You can change the position when you perform step
13.
3-12 B71495AF
3
System Setup
Program Calibrator Concentrations
9 In the section labeled Step 1, select the empty text field at the top.
10 With the manual bar code reader, scan the two-dimensional bar code label on the Value
Assignment sheet.
The system displays the scanned information in the second field in the section labeled
Step 1.
B71495AF 3-13
System Setup
Program Calibrator Concentrations
11 If there are more two-dimensional bar code labels to scan, scan them.
12 Confirm that the scanned calibrator information is correct.
You can confirm the saved calibrator information by selecting CONFIG. > Calibration
Setup > Calibrators > Set Conc Value [F5] or CONFIG. > Calibration Setup > General.
If you find that you have scanned the wrong two-dimensional bar code labels, repeat
this procedure from the beginning.
In the section labeled Step 2, the system displays the calibrator position that you have
selected in the Calibration Setup: Calibrators tab (CONFIG. > Calibration Setup >
Calibrators).
13 Confirm the position, and use the Forward and Back icons to change the position if
necessary.
14 To register the calibrator ID in the Calibration Setup: Calibrators tab, select ID Update.
16 Select Close.
3-14 B71495AF
3
System Setup
Program Calibrator Concentrations
Important
Confirm the calibrator concentration value in the Configuration: You can confirm the
saved calibrator information by selecting CONFIG. > Calibration Setup > General. It is
critical that all calibrator values are entered correctly.
5 To display or edit a different calibrator, select the calibrator name from Calibrator.
6 Enter the concentration values in Conc for each test (listed in Test Name) for the
calibrator. You can only enter concentration values for tests programmed to the
calibrator in the tab that displays when you select CONFIG. > Calibration Setup > General.
7 To review or change the concentration for any other calibrator, repeat steps 5 and 6.
8 Select Close.
10 Confirm that the information is correct, and then select Save [F1].
B71495AF 3-15
System Setup
Program Preset QC Mean and Range
You can confirm the saved calibrator information by selecting CONFIG. > Calibration
Setup > General.
3-16 B71495AF
3
System Setup
Program a User Menu
7 Use the QC package insert or known values to enter the Mean, SD, and Range. The
system determines that QC is in or out of these preset ranges when the QC Mode is set
to Preset (on the Check tab).
a. In Mean, enter the QC mean.
b. In SD, enter a 1 SD value.
c. In Range, enter the value of the range. The range is the high value minus the low
value.
8 Confirm that the information is correct, and then select Save [F1].
Note
To print the Mean, SD, and Range of the tests entered, select Print [F8] on the
Preset tab.
You can assign an operator-defined menu name, but the system displays the original menu
name outside the User Menu.
1 Select CONFIG. > User Menu. The system displays the default menus.
B71495AF 3-17
System Setup
Program a User Menu
6 Select Save.
7 Confirm that the information is correct, and then select Save [F1].
4 Select Delete.
The system deletes the selected menu.
B71495AF 3-19
System Setup
Program a User Menu
3-20 B71495AF
CHAPTER 4
Sample Programming and Processing
Sample Preparation
Confirm that there is sufficient sample for analysis along with the dead volume. To display
the volume needed for the ordered tests, select TEST > Rack (Patient) > Test Order or STAT >
STAT (Patient) > Test Order. The system displays the sample volume required for ordered
tests at the bottom right-hand side of the screen. The sample volume does not include the
dead volume.
The minimum dead volume required for sample detection varies depending on the sample
cup or tube. For information about dead volumes for tubes and cups, refer to Cups or Tubes
Specifications.
After centrifuging sample tubes, confirm that there is sufficient volume of serum or plasma.
If the serum or plasma level is too low, transfer it to a smaller cup or cup nested (inserted)
in a tube. For validated cups and nested cups available for racks or the STAT table, refer to
Cups or Tubes Specifications.
Follow your laboratory procedure to dispense the sample into the center of the cup or tube.
Confirm that the sample surface is level without bubbles present before analysis.
Specimen Preparation
Warning
If the following requirements are not met, results are affected and system errors
occur.
• Do not have fibrous material or fibrin in the sample, except for whole blood.
• Confirm that no air bubbles are in the samples, including samples transferred to the DxC
700 AU from a Laboratory Automation System.
• Dispense sample volume in the quantity required for analysis and the dead volume. For
information about dead volumes for tubes and cups, refer to Cups or Tubes
Specifications.
• In Test Volume and Methods, you can set the sample volume dilution to 0 μL (default) or
10 μL. When the Dilution is 0 μL, the system does not dilute the sample and it adds an
extra 3 μL per test to the sample volume to ensure dispensing accuracy. For example, if
the sample volume of a test is 3 μL, the system aspirates 6 μL per test and dispenses 3 μL.
If 10 tests are ordered on a sample, the system adds a total of 30 μL to the sample
volume. When the Dilution is 10 μL, the system adds 10 μL of water to the sample and
does not aspirate any extra sample volume per test.
• After sample aspiration, the sample probe is rinsed in the wash well, and a small amount
of water is transferred to the sample when the next test is aspirated. If the initial sample
volume is small, and 20 or more tests are being analyzed on the sample, add an extra 200
μL to the required sample volume to avoid diluting the sample.
B71495AF 4-1
Sample Programming and Processing
Maximum Sample Volume Limits for Sample Tubes and Cups in Racks
• Confirm that a volume of serum or plasma sufficient for analysis plus the needed dead
volume is in a primary tube. The dead volume required in a primary tube is 4 mm above
the non-sample (cells or gel) layer.
• When the serum quantity is small, perform analysis after transferring the sample to a
smaller cup or cup nested (inserted) in a tube. For more information, refer to Cups or
Tubes Specifications.
• When the serum quantity is small, the system can aspirate blood cells below the serum
and results can be affected.
If your laboratory uses different height tubes on a Laboratory Automation System, Beckman
Coulter sets the sample probe to descend to the highest tube at the time of installation. Be
sure the dead volume of tubes meet minimum requirements.
Maximum Sample Volume Limits for Sample Tubes and Cups in Racks
Maximum sample volume limits are provided to prevent sample from spilling when the
rack moves from the rack input area to the rack output area on the analyzer. If sample spills
onto the rack belt and lane surfaces, rack jams and rack transfer errors may occur.
Determine the maximum sample volume limits for the validated sample tubes and cups
used in your laboratory. Refer to Maximum Sample Volume Limits for Tubes in Racks and
Maximum Sample Volume Limits for Other Containers in Racks.
Use the following instructions to confirm that the sample levels in the tubes and cups do
not exceed the maximum sample volume limits in the before placing the tubes or cups in
racks for analysis.
Important
• If the sample level is above the maximum sample volume limit, Beckman Coulter
recommends removing sample until the sample level in the tube or cup is at or below the
recommended level. If a sample exceeding the maximum sample volume limit was not
removed before analysis, inspect the rack transfer lanes on the analyzer after analysis to
determine whether any sample spilled onto the rack transfer lanes. If any sample spilled
onto the rack transfer lanes or racks, clean the area by wiping with an alcohol prep pad
(70% isopropyl alcohol) or lint-free absorbent tissue moistened with hot water.
• Confirm that all tubes and cups are pushed completely down into the rack.
4-2 B71495AF
4
Sample Programming and Processing
Place the Sample Cups or Tubes in the Rack
Rack Preparation
Before you start analysis, dispense a sample into sample cups or tubes and set these cups or
tubes in the correct rack. The racks come in five different colors. Each rack color has a
specified purpose or application. Racks are placed on the rack input area. A maximum of 15
racks, or 150 samples can be placed on the rack input area. Racks can be continuously
loaded on the rack input area as space is available.
Rack Types
The system identifies the rack type from the combination of magnets set into the rack
bottom. The rack colors, applications, and magnet combinations are shown in the following
table.
Table 4.1 Rack Color, Application, and Magnet Position
Color Rack Application Magnet
1, 2, 3
B71495AF 4-3
Sample Programming and Processing
Place the Sample Cups or Tubes in the Rack
1, 2, 3
The rack positions are numbered 1 to 10. The magnets are located on the bottom of the
rack at the position number 1 end.
1. The system analyzes different sample types (serum, urine, other-1, other-2, and whole
blood) in one rack. The system recognizes the sample type with the test order
information. This is the default setting.
2. The system analyzes only the same sample type in one rack. The system recognizes the
sample type by the rack ID range that you assign to each sample type. This is an
optional setting that you can request.
By default, the system analyzes different sample types in one rack, but you can request for a
Beckman Coulter Representative to program the system during installation to analyze only
the same sample type in one rack. To determine if your system has the default setting, look
at the [Rack ID Limit] section of the Analysis Mode screen (CONFIG. > Analysis Mode). You
cannot edit the values in the [Rack ID Limit] section if it is in default mode. For more
information, contact Beckman Coulter.
4-4 B71495AF
4
Sample Programming and Processing
Place the Sample Cups or Tubes in the Rack
Warning
For sequential mode, place samples in numeric sample number order according to the
order without leaving any empty positions in the racks. If there are empty positions in
the racks, the ordered sample number and the sample number determined during
analysis do not coincide, and concordance errors can occur. Beckman Coulter does not
recommend running patient samples in sequential mode as positive patient
identification cannot be maintained.
The system identifies calibrator numbers 1 to 200 by the rack ID and position. For example,
calibrator numbers 1 to 10 are placed in rack ID 0001, calibrator numbers 11 to 20 are
placed in rack ID 0002, and so on.
If you enable calibrator Bar Code Operation, assign a calibrator ID to the calibrator. Place
calibrators with bar code labels in any position in the yellow racks.
The system identifies control numbers 1 to 100 by the rack ID and position. For example,
control numbers 1 to 10 are placed in rack ID 0001, control numbers 11 to 20 are placed in
rack ID 0002, and so on.
If you enable QC Bar Code Operation, assign a QC ID to the control sample. Place control
samples with bar code labels in any position in the green racks.
For sequential mode, place samples in sequential order by their order number. The system
automatically assigns sample numbers from the tubes or cups detected, so you can leave
empty spaces in the rack.
B71495AF 4-5
Sample Programming and Processing
Place the Sample Cups or Tubes in the Rack
For example, if you order three samples and place the samples in positions 1, 3, and 5, the
system assigns E001 to the sample in position 1, E002 to the sample in position 3, and E003
to the sample in position 5.
Warning
When you use red racks for sequential mode, use a test summary to confirm that the
results correspond to the samples as processed in the rack.
Warning
Beckman Coulter recommends using bar code labels for samples to guarantee positive
patient identification.
Warning
Insert the sample tubes or cups correctly into the rack. If the tube or cup is not
pushed down to the bottom of the rack, cup detection does not work correctly
and rack jams can occur.
2 Look at each opening in the rack and confirm that you align the bar code label in the
center. The bar code label can only deviate 2 mm from the center. If the bar code label is
not aligned with the opening in the rack, lift it out and place it in correctly.
Warning
For sample tubes with bar code labels, do not rotate the tube while it is in the
rack. Rotating can cause bar code label contamination or damage, resulting in bar
code label read errors. Rotate sample tubes after they have been removed from
the racks.
4-6 B71495AF
4
Sample Programming and Processing
Place the Sample Cups or Tubes in the Rack
Warning
Use only NE racks. An NE rack has a window on the side to facilitate a smooth
insertion of different types of sample cups into the rack, and does not
compromise bar code label readability.
B71495AF 4-7
Sample Programming and Processing
Place Racks on the Rack Input Area
Warning
Never look directly into the bar code readers. The laser light can cause serious eye
damage.
4-8 B71495AF
4
Sample Programming and Processing
Place Racks on the Rack Input Area
Place the first rack to the right of the positions that are located where the letter A is in
the diagram. The rack input area does not operate correctly when you place it in a
position that is located where the letter A is in the diagram.
3 For calibration and QC, place the blue rack, and then the yellow racks, and then the
green racks. Place the white racks for routine patient samples.
B71495AF 4-9
Sample Programming and Processing
Order for Routine and Emergency Samples
Assign deionized water or diluent to position 1 or 2 in the blue reagent blank rack in RB
Sample Information for each sample type in the Calibration Setup: Calibrators tab
(CONFIG. > Calibration Setup > Calibrators).
Important
When several yellow racks are required for calibration, set the yellow racks one
after the other.
When several green racks are required for QC analysis, set the green racks one after
the other.
The system stops loading racks when it detects an open loading position on the rack
input area.
4-10 B71495AF
4
Sample Programming and Processing
Order for Routine and Emergency Samples
To run an emergency sample, order the sample as Emergency, and place the sample in a red
rack. Place the red rack in front of routine white racks on the rack input area.
Select the test. The test selection turns blue (processed with first-run
sample volume). If needed, select Test Dilution [F8] until the test
selection turns light blue (diluted) or orange (concentrated).
1 Select TEST > Rack (Patient) > Test Order. The system displays the group of tests that you
have selected in the Create Index dialog.
B71495AF 4-11
Sample Programming and Processing
Order for Routine and Emergency Samples
4 For bar code operation, enter the sample bar code number in Sample ID.
Note
5 If you dilute the sample manually, enter the sample dilution rate in Sample Dilution Rate.
6 Select the tests to run on the sample. The system highlights the tests in blue when it is
ordered. Select the test again to cancel the order. The system highlights tests in gray that
are not available for the selected sample type.
When selecting a panel, either:
— Select Panel to open the panel dialog and select a panel (or multiple panels).
— Use the keyboard to enter a panel number in Panel, and then select Enter.
Each time you select a test, the system updates the Selected Tests and Sample Volume
columns.
4-12 B71495AF
4
Sample Programming and Processing
Order for Routine and Emergency Samples
Note
When a test that you want to select is not available in the current Group, select the
Change Group Display. The system displays tests for all Groups in the list.
Note
Caution
The Sample Volume (μL) indicates the sample dispensing volume that the system
uses for analysis. The Sample Volume (μL) does not include the dead volume.
7 Select the Demographics tab to enter any required patient demographic information.
8 Confirm that the information on the Demographics tab and the Test Order tab is correct,
and then select Save [F2].
Note
To change the Sample Type for the system that identifies the sample type with rack
ID.
Note
Select Pending List [F4] to view a list of samples that have been ordered, but have
not been processed on the analyzer. Select a Sample No. or Sample ID, then select
Go to view the specific sample order.
If you order tests for one sample, the system orders the tests for all of the samples in the
batch. If you enter patient information for a single sample in the Demographics tab, the
system orders the patient information for all samples in the batch. If using bar code mode,
B71495AF 4-13
Sample Programming and Processing
Order for Routine and Emergency Samples
the Sample ID entered for the first sample automatically increases by one digit for
subsequent samples.
1 Select TEST > Rack (Patient) > Test Order. The system displays the group of tests that you
selected in the Create Index dialog.
2 Select the tests or panel for batch order for one sample. For more information on
manually ordering tests, refer to Enter Manual Orders for Routine and Emergency
Samples.
Note
If bar code mode is in use, enter the first sample ID in the batch.
4 Select Number of Samples to enter the number of samples required in the batch, or
select Last Sample No. to enter the last sample number in the batch.
5 Select OK.
4-14 B71495AF
4
Sample Programming and Processing
Order for Routine and Emergency Samples
Delete an Order
You can delete an order before the system processes the sample.
Figure 4.9 Delete Test Order Dialog (Displays with the default setting: The system analyzes
different sample types in one rack)
Figure 4.10 Delete Test Order Dialog (Displays with the optional setting: The system analyzes
only the same sample type in one rack)
3 To delete orders, make selections for Sample Kind and Type. Enter values in Search by
Sample No. or Search by Sample ID, or leave the asterisk to delete all orders for the
selected sample kind.
Note
B71495AF 4-15
Sample Programming and Processing
Order for Routine and Emergency Samples
4 Select Delete.
3 In Sample Kind, select the sample kind and type to download from the Laboratory
Information System.
4-16 B71495AF
4
Sample Programming and Processing
Processing Emergency Samples
4 In Sample No., enter the starting and ending sample numbers to download from the
laboratory information system.
5 Select OK.
A message displays while the system downloads the orders. When the download is
complete, the system closes the message dialog.
The quickest way to process a sample is from the STAT Table. For more information, refer to
Priority STAT Samples.
For STAT table operation, there are two sample identification modes: bar code (Bar Code)
and position assignment (Cup Pos.). When you select Cup Pos. in the STAT Table Setting
dialog (STAT > STAT Status > STAT Table Setting [F6]), the system allows you to run the
patient samples placed only in the positions assigned for the patient samples. For example,
if you assign the positions 1, 2, and 3 to the patient samples, you can use only these three
positions for the patient samples.
The system cannot process whole blood samples from the STAT table.
B71495AF 4-17
Sample Programming and Processing
Priority STAT Samples
The system displays the group of tests that you have selected in the Create Index dialog.
3 If you have selected the Bar Code option for patient samples in the STAT Table Setting
dialog (STAT Status > STAT Table Setting [F6]), enter the sample ID (number on the bar
code label) in Sample ID.
4 If you have selected the Cup Pos. option for patient samples in the STAT Table Setting
dialog (STAT Status > STAT Table Setting [F6]), enter the cup position in Cup Pos.
5 If you dilute the sample manually, enter the sample dilution rate in Sample Dilution Rate.
6 Select the tests to run on the sample. The system highlights the tests in blue when it is
ordered. Select the test again to cancel the order. The system highlights tests in gray that
are not available for the selected sample type.
When selecting a panel, either:
— Select Panel to open the panel dialog and select a panel (or multiple panels).
— Use the keyboard to enter a panel number in Panel, and then select Enter.
Each time you select a test, the system updates the Selected Tests and Sample Volume
columns.
Note
When a test that you want to select is not available in the current Group, select the
Change Group Display. The system displays tests for all Groups in the list.
4-18 B71495AF
4
Sample Programming and Processing
Priority STAT Samples
Note
Caution
The Sample Volume (μL) indicates the sample dispensing volume that the system
uses for analysis. The Sample Volume (μL) does not include the dead volume.
7 Select the Demographics tab to enter any required patient demographic information.
8 Confirm that the information is correct, and then select Save [F2].
When your system is set to Multiple Loads STAT Table operation (automation systems
only), the STAT Pause [F2] function in the STAT Status screen is disabled except during
PAUSE and REAGENT PAUSE modes.
STAT Check Determines the presence of a cup or tube and reads the sample ID (if the system is using
[F3] bar code mode) for all 22 STAT table positions.
Display Jumps to the STAT: STAT (Patient) tab when a patient position is selected.
Sample
Assignment
[F4]
CAL/QC Displays the calibrators and control samples required for the ordered tests.
Position [F5]
STAT Table Allows you to specify the sample identification mode (Bar Code or Cup Pos.) for patient
Setting [F6] samples, calibration, and QC. Allows you to assign positions 1 through 22 in Sample
Kind as Patient, Cal., QC or Free, and to assign Cal. and QC positions to a calibrator and
control sample.
B71495AF 4-19
Sample Programming and Processing
Priority STAT Samples
This information only displays when you select Cup Pos. in the [Test Order STAT]
section of the STAT Table Setting dialog (STAT > STAT Status > STAT Table Setting [F6]).
For more information, refer to Program the Bar Code or Cup Positions Option for
Calibration and QC from the STAT Table.
Sample ID Allows you to edit of the sample ID for the selected position.
Edit [F8]
2 Review the Pos., Kind, and Status columns for available positions on the STAT table.
Note
You can place patient samples only in the positions for which you set the sample
kind to Free (bar-coded samples only) in the STAT Table Setting dialog (STAT Table
Setting [F6]). The system displays the available positions as Free (bar-coded
samples only) under the Kind column in the STAT Status screen.
4-20 B71495AF
4
Sample Programming and Processing
Priority STAT Samples
Note
When the amber STAT TABLE ROTATION LED is blinking, select STAT Pause [F2] to
put the STAT table in PAUSE mode. To continue analysis, confirm that the STAT table
cover is closed and select Start STAT in the software interface.
When your system is set to Multiple Loads STAT Table operation (automation
systems only), the STAT Pause [F2] function in the STAT Status screen is disabled
except during PAUSE and REAGENT PAUSE modes.
Important
If the STAT table is in PAUSE mode for an extended time, the analyzer changes to
PAUSE mode. The time for the mode change depends on the reason that the STAT
TABLE ROTATION LED is continuously blinking slowly:
— Sample contamination settings
— Reagent blank or calibrator programmed on the STAT table
— Auto-QC programmed on the STAT table
Important
Caution
When you open the small STAT table cover to load STAT samples, keep the upper
cover closed. This precaution prevents injury and prevents the entire STAT table
from opening.
4 Load the samples in the available positions. Press the DIAG/TABLE ROTATION button to
rotate the STAT table as required.
9 Confirm that the system displays the Cup column as Present for the corresponding
positions, and review the Status and Comment columns.
The amber STAT TABLE ROTATION LED blinks until the system completes sample
aspiration. You can open the small STAT table cover when the amber STAT TABLE
ROTATION LED is not blinking to remove existing samples and load new samples. If you
B71495AF 4-21
Sample Programming and Processing
Priority STAT Samples
open the small STAT table cover when the amber STAT TABLE ROTATION LED is
blinking, the system generates a STAT Small Cover Open event.
Before processing priority STAT samples in Cup Position mode on the STAT table, select
STAT > STAT (Patient) > Test Order and order the STAT samples. For more information, refer
to Enter Manual Orders for Priority STAT Samples. The system displays the cup position for
each patient sample in the STAT Status tab.
2 Review the Pos., Kind, Type, and Sample No. columns for the patient samples on the
STAT table.
Note
When the amber STAT TABLE ROTATION LED is blinking, select STAT Pause [F2] to
put the STAT table in PAUSE mode. To continue analysis, confirm that the STAT table
cover is closed and select Start STAT in the software interface.
When your system is set to Multiple Loads STAT Table operation (automation
systems only), the STAT Pause [F2] function in the STAT Status screen is disabled
except during PAUSE and REAGENT PAUSE modes.
4-22 B71495AF
4
Sample Programming and Processing
Perform Quick STAT Operation
Important
If the STAT table is in PAUSE mode for an extended time, the analyzer changes to
PAUSE mode. The time for the mode change depends on the reason that the STAT
TABLE ROTATION LED is continuously blinking slowly:
— Sample contamination settings
— Reagent blank or calibrator programmed on the STAT table
— Auto-QC programmed on the STAT table
Important
9 If there are STAT table errors, the system displays errors in the Start STAT dialog.
Review the errors, then select Start to start analysis, or select Cancel to perform
corrective actions.
10 Confirm that the system displays Present for the corresponding positions in the Cup
column, and review the Status and Comment columns.
The amber STAT TABLE ROTATION LED blinks until the system completes sample
aspiration. You can open the small STAT table cover when the amber STAT TABLE
ROTATION LED is not blinking to remove existing samples and load new samples.
B71495AF 4-23
Sample Programming and Processing
Perform Quick STAT Operation
Quick STAT operation is available for patient samples on the STAT table with the following
settings:
• Bar code mode is selected for patient samples. (For more information, refer to the
information about the parameters for the Analysis Mode screen in the DxC 700 AU
Reference Manual.)
• Automatic ACAL and QC are disabled for the test in the ACAL and QC tabs (CONFIG. >
AUTO ACAL/QC Setup > ACAL and QC). (These features are unavailable by default.)
• Automatic rerun is disabled for the STAT table. (To disable automatic rerun for the
STAT table, select Disabled for STAT in the Auto Rerun section in the Analysis Mode
screen (CONFIG. > Analysis Mode.))
When the system is programmed with these settings, the STAT START button on the
analyzer module is on. For more information, contact Beckman Coulter.
Note
Quick STAT operation is available for patient samples only. If the system detects
calibrators or control samples on the STAT table during Quick STAT operation, the
system skips the calibrators or control samples and analyzes patient samples only.
1 Confirm that the STAT START button beside the STAT cover is on. If the STAT START button
is off, the Quick STAT operation is not available.
Note
You can place patient samples only in the positions for which you set the sample
kind to Free in STAT Table Setting [F6].
Note
The system completes the analysis faster if you place the patient samples in Free
positions with smaller position numbers.
4-24 B71495AF
4
Sample Programming and Processing
Perform a Rerun
Note
You can pause analysis and load more patient samples on the STAT table. Select
STAT Pause [F2] in STAT > STAT Status and confirm that the amber STAT TABLE
ROTATION LED turns off. Place the additional patient samples in available Free
positions with greater position numbers than those for the existing samples. Press
the STAT START button to resume analysis.
When your system is set to Multiple Loads STAT Table operation (automation
systems only), the STAT Pause [F2] function in the STAT Status screen is disabled
except during PAUSE and REAGENT PAUSE modes.
Perform a Rerun
You can rerun samples in racks or on the STAT table automatically (Auto Rerun) or
manually (Manual Rerun).
Auto Rerun
Auto Rerun is enabled when you do all of the following:
• Program Auto Rerun to Enabled in the CONFIG.: Analysis Mode screen (CONFIG. >
Analysis Mode).
• Program rerun criteria in the CONFIG.: Rerun Test Parameters screen (CONFIG. > Rerun
Test Parameters).
• Program Auto Rerun Order to Yes in the Rerun Check Parameters: Flag tab (CONFIG. >
Rerun Check Parameters > Flag).
B71495AF 4-25
Sample Programming and Processing
Perform a Rerun
The system then automatically orders rerun tests using the programmed rerun criteria and
reruns the samples in the first-run white or red rack, or the first-run positions on the STAT
table.
If you select Yes in Rerun Data Over-Writes First-Run Data Automatically in the Rerun Check
Parameters: Flag tab, the system automatically overwrites the first-run data with the rerun
data.
If the DxC 700 AU connects to a Laboratory Automation System, the Laboratory Information
System determines the rerun criteria. The DxC 700 AU handles samples that have been
processed and transported from the Laboratory Automation System as first-run samples
and analyzes the samples with a rerun order from the Laboratory Information System. The
DxC 700 AU handles samples that have been processed on the STAT table as rerun samples
and analyzes the samples on the STAT table with a rerun order from the Laboratory
Information System. When the DxC 700 AU connects to a Laboratory Automation System,
Auto Rerun is available only on the STAT table.
Manual Rerun
Manual Rerun is enabled when you set Auto Rerun to Disabled in the CONFIG.: Analysis
Mode screen (CONFIG. > Analysis Mode).
If you program rerun criteria in the Rerun Test Parameters and Rerun Check Parameters
screens (CONFIG. > Rerun Test Parameters and Rerun Check Parameters), and set Auto Rerun
Order to Yes in the Flag tab, the system automatically selects rerun tests using the
programmed rerun criteria. You can modify the selected rerun tests as required.
If you set Auto Rerun Order to No in the Flag tab, select rerun tests individually, or select
Select Auto Rerun Orders in TEST > Rack (Patient) > Test Order to get automatically rerun
tests selected using the programmed rerun criteria.
Rerun orders can be generated using rerun criteria programmed in the Rerun Test
Parameters screen and Rerun Check Parameters screen, or sent from the LIS. For more
information, contact Beckman Coulter.
Perform the following procedure to rerun samples in white or red racks manually.
Note
Process rerun samples in the white or red rack from the first run, or place the rerun
samples in another white or red rack. If using the same white or red rack from the first run,
and not all samples in the rack have a rerun order, NO TESTS ORDERED FOR THIS SAMPLE
NO. events might occur, depending on the system programming. Contact Beckman Coulter
for more information.
4-26 B71495AF
4
Sample Programming and Processing
Perform a Rerun
Note
Caution
The Sample Volume (μL) indicates the sample dispensing volume that the system
uses for analysis. The Sample Volume (μL) does not include the dead volume.
Caution
For Rack ID or Sequential mode, keep the samples in the first-run positions in the
first-run rack to avoid sample concordance errors. For Bar Code mode, you can
place the rerun samples in any order in a new rack.
Note
When you process a rerun that includes all of the samples from the first-run in the
first-run positions in the first-run rack, NO TESTS ORDERED FOR THIS SAMPLE
NO. events occur for the samples without rerun orders.
3 Select Start.
Perform the following procedure to rerun samples on the STAT table when Manual Rerun is
enabled (Auto Rerun is disabled).
Note
Caution
The Sample Volume (μL) indicates the sample dispensing volume that the system
uses for analysis. The Sample Volume (μL) does not include the dead volume.
3 Review the Pos., Kind, Type, and Status columns. Place the samples in the positions on
the STAT table. Press the DIAG/TABLE ROTATION button to rotate the STAT table as
required.
B71495AF 4-27
Sample Programming and Processing
Perform a Rerun
Caution
For Cup Pos. mode, keep the rerun samples in the first-run positions on the STAT
table to avoid concordance errors. For Bar Code mode, you can keep the rerun
samples in the first-run positions or place the rerun samples in the positions for
which you set the sample kind to Patient or Free in STAT Table Setting [F6]. The
system displays the available positions as Patient or Free under the Kind
column in the STAT Status screen.
7 If there are no errors specific to the STAT table after the STAT check, the system starts
analysis. If there are STAT table errors, review the errors listed in the Start STAT dialog.
Select Start to start analysis, or select Cancel to perform corrective actions.
8 Confirm that the system displays the Cup column as Present for the corresponding
positions, and review the Status and Comment columns.
The amber STAT TABLE ROTATION LED keeps blinking until the system completes
sample aspiration. You can open the small STAT table cover to remove or load samples
when the amber STAT TABLE ROTATION LED is not blinking. If you open the small STAT
table cover when the amber STAT TABLE ROTATION LED is blinking, the system
generates a STAT Small Cover Open event.
The rerun sample pending list includes the rack ID number, first-run sample number,
sample ID, and patient information.
1 For rack analysis: Select TEST > Rack (Patient) > Test Order.
For STAT analysis: Select STAT > STAT (Patient) > Test Order.
4-28 B71495AF
4
Sample Programming and Processing
Perform a Rerun
1 For rack analysis, select TEST > Rack (Patient) > Test Order.
For STAT analysis, select STAT > STAT (Patient) > Test Order.
Table 4.5 Test Order Tab Options for Rerun Tests
Option Description
Test Total The system displays the total number of unprocessed first-run and
rerun tests.
Select Auto Rerun Orders The system selects rerun tests using the rerun criteria programmed in
the Rerun Test Parameters and Rerun Check Parameters screens
(CONFIG. > Rerun Test Parameters and Rerun Check Parameters).
Use this button when Auto Rerun Order is No in the Flag tab.
Rerun [F3] The system displays the Rerun dialog. You can order a rerun test by
sample or by batch.
Pending List [F4] The system displays a list of unprocessed first-run and rerun samples.
Test Dilution [F8] You can specify the dilution or concentration for each test. Program the
dilution and concentration parameters in the Rerun Test Parameters
screen. Select the test. The test selection turns blue (normal). If
needed, select Test Dilution [F8] until the test selection turns light
blue (diluted) or orange (concentrated).
Note
2 For rack analysis: In Sample Kind, select Switch to select Routine or Emergency.
For STAT analysis: If you have selected the Cup Pos. option for patient samples in the
STAT Table Setting dialog (STAT Status > STAT Table Setting [F6]), enter the cup position
number on the STAT table in Cup Pos.
4 In Sample No., enter the sample number. Or, select Search by Sample ID to search the
sample by sample ID.
a. If you select Configuration Parameters > Rerun Check Parameters > Flag and select Yes
in Auto Rerun Order, the system automatically selects rerun tests using the
programmed rerun criteria. If you do not modify the selected rerun tests or
program dilution by sample or test, proceed to step 10.
b. Proceed to step 5 in the following cases:
— The system does not automatically select rerun tests because you set Auto
Rerun Order to No in the Flag tab.
B71495AF 4-29
Sample Programming and Processing
Perform a Rerun
— You want to modify the selected rerun tests or program dilution of the selected
rerun tests by sample or test.
5 Select Rerun [F3]. The system displays the Rerun dialog. The Rerun dialog displays the
result from the first run and flags (if any) under each test name.
Note
To view tests with auto rerun orders select any of the following:
— RESULT > Sample Status > Rerun [F3]
— RESULT > Detail > Rerun [F3]
— TEST > Rack (Patient) > Test Order > Rerun [F3]
— STAT > STAT (Patient) > Test Order > Rerun [F3]
4-30 B71495AF
4
Sample Programming and Processing
Search for Results to View, Print, or Send to LIS
Option Description
Test Dilution You can specify dilution or concentration for each test. Program the
dilution and concentration parameters in the Rerun Test Parameters
screen.
Sample Dilution Rate Enter the dilution rate (1 to 999) if you manually dilute a sample. The
system calculates the result at the dilution rate.
6 In Sample Dilution Rate, enter the dilution rate (1 to 999) if you manually dilute the
sample.
Note
To get rerun tests selected using the programmed rerun criteria, you can select
Select Auto Rerun Orders in a Test Order screen (TEST > Rack (Patient) > Test Order
or STAT > STAT (Patient) > Test Order).
8 Select a test if you specify dilution or concentration for each test. Select Test Dilution to
switch among normal (blue), diluted (light blue), and concentrated (orange). The
system dilutes or concentrates the sample for the test using the parameters
programmed in the Rerun Test Parameters screen.
9 Select OK to order the selected rerun tests. Select Cancel to clear the selected rerun
tests.
Note
Select Delete all Rerun Tests for this sample and then select OK to delete all the
rerun tests selected and ordered for the sample.
10 Select Start.
Note
The system displays data from the current index by default. If no samples have been
processed on the current index, the system displays a Data Not Found message.
Select OK.
B71495AF 4-31
Sample Programming and Processing
Search for Results to View, Print, or Send to LIS
2 The system displays the data from the current index with all samples selected
(highlighted in blue).
— Select Clear All Samples to clear the selection of all samples from the list.
— Select Select All Samples to highlight all samples the system displays in the list.
— Select Abnormal to display only abnormal data.
— Select Rerun Data to display only rerun data.
To print the selected data from the current index, refer to Print Results.
3 Select Find [F3] to search for data. The system displays the Find dialog.
4-32 B71495AF
4
Sample Programming and Processing
Search for Results to View, Print, or Send to LIS
4 In Index, select the start index and the last index to search for data in a specific index or
index range.
Note
If you select a specific index, select the same index in both fields.
6 Select Data Not Yet Transferred to LIS and Data Not Yet Printed if necessary.
— Selecting Data Not Yet Transferred to LIS searches only for samples not transferred
to the LIS.
— Selecting Data Not Yet Printed searches only for samples not printed.
Note
If Search by Sample No. is empty, the system does not use the search criteria for
the search.
B71495AF 4-33
Sample Programming and Processing
Search for Results to View, Print, or Send to LIS
— In Search by Sample ID, enter the sample ID range to search. To search for all
samples, leave the asterisk.
— For Type, select the sample type to search.
Note
This procedure is not necessary if you select Search all patient samples.
— In Search by Sample No., enter the sample number range to search. To search all
samples, leave the asterisk.
Note
If Search by Sample No. is empty, the system does not use the search criteria
for the search.
— In QC/Cal. No., enter the QC number (1 to 100) or the calibrator number (1 to 200).
To search all QC and calibrator numbers, leave the asterisk.
— To search samples with a specific QC or calibrator ID, enter the QC or calibrator bar
code number in Search by Control/Calibrator ID.
9 Select Search by Patient Info. to search by the patient demographics. The system
displays the Search by Patient Info. dialog.
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Sample Programming and Processing
Search for Results to View, Print, or Send to LIS
Note
To send the results to a Laboratory Information System, refer to Send Results to LIS.
Print Results
Note
List formats are programmed for your laboratory during installation and as needed.
For more help with formatting a new or existing list format, contact Beckman Coulter.
For more information on the format and print options, refer to the DxC 700 AU
Reference Manual.
1 In the Sample Manager: Main tab (RESULT > Sample Manager > Main), select the results
of patient samples, reagent blanks, calibrators, or control samples that you want to
print.
To use the search feature to select the results, refer to Search for Results to View, Print,
or Send to LIS.
Important
Before transferring data to the Laboratory Information System, confirm that the DxC
700 AU is on line and connected to a Laboratory Information System.
The Send to LIS [F7] option is only available when Realtime or Batch for Results Transfer is
programmed in CONFIG. > Online > Setup.
B71495AF 4-35
Sample Programming and Processing
Perform Replicates
1 In the Sample Manager: Main tab (RESULT > Sample Manager > Main), select the results
of patient samples, reagent blanks, calibrators, or control samples that you want to send
to the LIS.
To use the search feature to select the results, refer to Search for Results to View, Print,
or Send to LIS.
2 Select Send to LIS [F7]. The system displays the Send to LIS dialog.
Perform Replicates
You can perform replicates for system verification such as calibration linearity verifications.
This procedure uses primarily the bar code mode. Non-bar code mode is optional.
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Sample Programming and Processing
Perform Replicates
c. If necessary, select Edit [F1]. Select Output Conc. and then select Save [F1].
d. For rack analysis (using the white or red rack), select Test > Rack (Patient) > Test
Order.
For STAT table analysis, select STAT > STAT (Patient) > Test Order.
The system displays the Test Order tab.
B71495AF 4-37
Sample Programming and Processing
Perform Replicates
Note
After creating an index for replicates, the system keeps displaying Exit
Replicates? in the status area until you exit replicates.
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4
Sample Programming and Processing
Perform Replicates
Note
In sequential mode, you can optionally enter a value in Sample ID. Enter a
maximum of 26 alphanumeric characters to identify the sample.
3. If you dilute the sample manually, enter the sample dilution rate in Sample
Dilution Rate.
4. Select the tests to run on the sample. The tests selected are highlighted in blue.
b. For STAT table analysis:
B71495AF 4-39
Sample Programming and Processing
Perform Replicates
Note
Enter a maximum of 20 sample or test replicates. Refer to the example for each
method selected.
a. If you selected the Replicate Order by Replicate Sequence test in step 1.f, the system
automatically selects Sample Replicates. Enter the number of Sample Replicates.
This entry applies the same number of replicates to all tests ordered. For example,
any one of the following bullets show a valid programming with a total of ≤20
replicates for each sample.
— A (5), B (5), C (5), D (5)
— A (10), B (10)
— A (20)
Figure 4.26 Replicates Dialog with Test Item Replicates Button Selected
b. If you selected Replicate Order by Test in step 1.f, select Sample Replicates or Test
Item Replicates.
— If you selected the Sample Replicates, enter the number of Sample Replicates.
This entry applies the same number of replicates to all tests ordered. For
example, any one of the following bullets show a valid programming with a
total of ≤20 replicates for each sample.
— A (5), B (5), C (5), D (5)
— A (10), B (10)
— A (20)
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4
Sample Programming and Processing
Perform Replicates
— If you selected Test Item Replicates, enter the number of test replicates for each
selected test. The Replicate number for each selected test can be different. For
example, any one of the following bullets shows a valid programming with a
total of ≤20 replicates for each sample.
— A (5), B (4), C (6), D (2)
— A (10), B (5)
— A (20)
Figure 4.28 Replicates Dialog with Test Item Replicates Button Selected
5 Select OK.
The system displays in the Test Order tab the number of replicates, in parentheses, after
each test.
Note
The system applies the replicate number to all tests ordered. Only selected tests
highlighted in blue are processed.
B71495AF 4-41
Sample Programming and Processing
Perform Replicates
Figure 4.29 Display of the Number of Sample Replicates in the Test Order Tab
Figure 4.30 Display of the Number of Test Item Replicates in the Test Order Tab
Note
8 To start analysis, select Start for Rack Analysis, or select STAT Start in the software
interface for STAT table analysis.
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Sample Programming and Processing
Perform Replicates
Note
If you cannot find the index or the index is grayed out, perform the
following substeps to get the desired index.
B71495AF 4-43
Sample Programming and Processing
Perform Replicates
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4
Sample Programming and Processing
Perform Replicates
The data statistics include the number of data points, mean, SD, CV (%), range,
and maximum and minimum results.
a. Select Test Name to display tests in test number order from 1 to 120. Select
Number of Data to display tests from the highest to lowest number of data
points. Select CV (%) to display tests from the highest to lowest CV.
b. Select up to 12 tests to display data statistics in the Chart View, Data View,
or Histogram tabs.
b. Confirm the analysis results in the Sample Manager (Result > Sample Manager),
Sample Status (Result > Sample Status), and Reaction Monitor (Result > Sample
Manager > Reaction Monitor) screens.
The system displays the number of replicates in parentheses after each test or sample
number, for example, ALT(2) or 0001(2).
10 Exit replicates.
a. Select HOME in STANDBY mode.
b. Select Exit Replicates? in the status area.
B71495AF 4-45
Sample Programming and Processing
Perform Replicates
c. Select OK.
The system creates an index and the Exit Replicates? button no longer displays in the
status area.
11 If you have changed to non-bar code mode, program the sample identification mode
back to the original setting: CONFIG. > Analysis Mode.
12 If you have performed step 1.d, program the Analytical Measuring Range Error Option
back to the original setting: CONFIG. > Format > Sample Program Format.
4-46 B71495AF
CHAPTER 5
System Monitoring and Results
Monitoring Analysis
The system status is continuously updated while the system is operating. Progress is
constantly monitored.
Monitor Results
Confirm that daily reagent blank, calibration, and QC results are acceptable before reporting
sample results. Review all results including reagent blank, calibration, QC, and samples for
flags. Take corrective actions before reporting any results with flags. Select EVENT to review
any generated events and take corrective actions for them.
For more information on monitoring the results, refer to the DxC 700 AU Reference Manual.
Note
The system displays the sample data prefix in front of the sample number.
B71495AF 5-1
System Monitoring and Results
Monitoring Analysis
Note
Rerun samples are identified on the Sample Status screen (RESULT > Sample Status)
with 0001 (Rerun), on the Realtime Display screen (RESULT > Realtime Display) with
0001-R, and on print reports with (R) by the rerun tests.
Cup Position The rack ID and cup position highlighted in the rack color.
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System Monitoring and Results
Monitoring Analysis
Order The time the cup in the rack passed the cup detector on the rack transport
belt.
Find [F2]
Displays the Find dialog. Search for samples by sample number, sample ID,
or patient name.
Note
Rerun [F3] Displays the Rerun dialog. You can order a rerun test for the samples that
you select.
Switch to Static View Switches between Switch to Static View [F4] and Switch to Realtime
[F4] View [F4]. Selecting Switch to Static View [F4] temporarily prevents the
sample status list from being updated. Use this function to review the status
or
of processed samples. The sample status list does not reflect any updates on
Switch to Realtime the sample status while Switch to Static View [F4] is selected. Selecting
View [F4] Switch to Realtime View [F4] resumes updating the sample status list.
Sample Manager Shortcut to the Results: Sample Manager screen (RESULT > Sample
Manager). For more information, refer to Search for Results to View, Print,
or Send to LIS.
ISE Calibration Shortcut to the ISE Maintenance: Calibration tab (MAINT. > ISE
Maintenance > Calibration). For more information, refer to Inspect the
ISE Status.
B71495AF 5-3
System Monitoring and Results
Monitoring Analysis
Note
The system displays the sorting order of the list by highlighting the title of the field
for Sample No., Cup Position, Sample ID, Order, Status, Results, or Calibrator Name /
Control Name.
Note
You can program two operator-defined patient demographic items. For more
information, refer to the DxC 700 AU Reference Manual.
2 Select a sample, and then select Detail to view detailed sample information.
The system displays the test name with the result when the result is complete or an
estimated completion time for tests currently in progress.
Note
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System Monitoring and Results
Monitoring Analysis
The system monitors the ISE module and reagents when the ISE module is installed.
1 Select HOME.
The system displays the Home (Analyzer Status) screen.
B71495AF 5-5
System Monitoring and Results
Monitoring Analysis
2 Confirm that system components are within acceptable limits (green). Investigate any
yellow or red conditions.
a. Inspect the analyzer top status. Investigate any yellow or red conditions. For more
information, refer to Analyzer Top Status.
b. Inspect the rack feeder status. Investigate any yellow or red conditions. For more
information, refer to Rack Feeder Status.
c. Inspect the analyzer tanks status. Investigate any yellow or red conditions. For more
information, refer to Analyzer Tanks Status.
d. Inspect the ISE reagents status. Investigate any yellow or red conditions. For more
information, refer to ISE Reagents Status.
e. Inspect the printer, LIS, and PROService status. Investigate any red conditions. For
more information, refer to Printer, LIS, and PROService Status.
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System Monitoring and Results
Monitoring Analysis
Lamp: displays the number of hours that the lamp has been on.
Incubator Status
Table 5.5 Incubator Status
Color Status
Green Normal
Yellow The temperature is outside the normal temperature range (37 °C ± 0.3 °C), or a
cuvette failed the photocal.
Red A cuvette failed the photocal.
Note
If a cuvette failed the photocal, the status can be yellow or red, depending on the
system programming by Beckman Coulter.
B71495AF 5-7
System Monitoring and Results
Monitoring Analysis
Note
When the DxC 700 AU connects to a Laboratory Automation System, the system does
not display the rack feeder module.
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5
System Monitoring and Results
Monitoring Analysis
Deionized Water Tank, Diluted Wash Solution Tank, Wash Solution Tank, and Wash Solution
Reservoir Status
The system displays the status of the liquid volume in the deionized water tank (D.I. Water),
diluted wash solution tank (Diluted Wash Sol.), wash solution tank (Wash Solution), and
wash solution reservoir (Wash Sol. Reservoir).
Table 5.10 Deionized Water Tank, Diluted Wash Solution Tank, and Wash Solution Reservoir
Status
Color Status
Green Normal
Yellow Over-full
Red Insufficient
B71495AF 5-9
System Monitoring and Results
Monitoring Analysis
Note
The status becomes over-full when the top float sensor in the tank moves up to the
maximum position. The status becomes insufficient when the bottom float sensor in the
tank moves down to the minimum position.
Concentrated Liquid Waste Tank, Diluted Liquid Waste Tank, and Vacuum Tank Status
The system displays the status of the liquid volume in the concentrated liquid waste tank
(Conc. Waste), diluted liquid waste tank (Waste), and vacuum tank.
Table 5.12 Concentrated Liquid Waste Tank, Diluted Liquid Waste Tank, and Vacuum Tank
Status
Color Status
Green Normal
Red Full
Note
Contact Beckman Coulter if the system displays red for any of these tanks.
Note
Note
Some printer errors cause the system to display the printer in red, a red message on the
Home screen, and a print error in the Start dialog. While printing, Printer Control [F5] is
displayed in the function button area on the Home screen. To clear the error and
resume normal operation, select Printer Control [F5] for options to resume (print any
information that did not print) or cancel the print.
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System Monitoring and Results
Monitoring Analysis
Remote assistance is available on your DxC 700 AU after you sign up for the PROService
agreement. For more information on the PROService agreement, contact Beckman Coulter.
Remote Desktop Sharing allows a Beckman Coulter Support Representative to view and
control the DxC 700 AU software screen with your permission. A notification is displayed on
your console when a Beckman Coulter Support Representative requests to start Remote
Desktop Sharing.
1 Select OK to accept the Remote Desktop Sharing request. A Beckman Coulter Support
Representative views and controls the DxC 700 AU software screen.
2 Select Cancel to reject the Remote Desktop Sharing request. A Beckman Coulter Support
Representative does not view or control the DxC 700 AU software screen.
The system displays the status of liquid volume in the ISE Reference Solution bottle, ISE
MID Standard Solution bottle, ISE Buffer Solution bottle. For more information, refer to
Replace the ISE Reagents.
B71495AF 5-11
System Monitoring and Results
Monitoring Analysis
If you select the REF, MID, or BUF button, the system displays the Reagent Management: ISE
tab (REAGENT > Reagent Management > ISE).
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5
System Monitoring and Results
Monitoring Analysis
STOP Yellow The ISE is in Stop status. Select ISE Ready [F4] to return
the ISE to Ready status.
b. Inspect the electrode status. The electrode status indicates if the most recent slope
value is in range for Na, K, and Cl.
Table 5.16 Electrode Status
Color Description
Green The slope value is within the acceptable range, and ISE calibration was
performed within 24 hours.
Yellow
— The slope value is not within the acceptable range.
— ISE calibration has not been performed within 24 hours. The system
uses the most recent ISE calibration results.
B71495AF 5-13
System Monitoring and Results
Monitoring Analysis
c. Inspect the reagent status. The reagent status indicates if the ISE Buffer Solution,
ISE MID Standard Solution, and ISE Reference Solution are sufficient.
Table 5.17 ISE Reagent Status
Color Description
Green The reagent level is above the reagent low level sensor, indicating reagent
is sufficient.
Yellow The reagent is below the reagent low level sensor, indicating reagent is not
sufficient.
3 Inspect the <Result> table. The <Result> table contains records of slope values that the
system obtains from calibration. You can also view slope charts in graph form for Na, K,
and Cl.
a. The numbers in the Date/Time column indicate the dates and times for the
calibrations.
b. The values in the Slope column indicate the calibration slopes for Na, K, and Cl. A
larger slope value indicates a steeper slope (a larger potential).
Confirm that the results fall within the ranges listed in the <Acceptable Calibration
Range> table that is displayed below the <Result> table.
c. The values in the MID Solution Factor column indicate the values that the system
obtains from the concentration of the ISE MID Standard Solution to establish a
reference for measuring Na, K, and Cl ion concentrations.
d. To view slope charts in graph form, select Graph Display [F5].
e. To inspect the slope chart for each sample type, select Switch to alternate between
Serum and Urine.
5-14 B71495AF
5
System Monitoring and Results
Disable a Test
The system displays the 30 most recent slope values in the chart. Identify the Na, K,
and Cl slope charts by color. On the left of the chart, the system displays the
maximum and minimum Na, K, and Cl slope values.
Although Cl slope values are negative values, the slope chart displays their absolute
values.
Disable a Test
You can prevent a test from being performed on patient samples even after the test has
been ordered. This function is useful when the preceding calibration or QC fails for a test
and you want to make the test unavailable (disabled) on patient samples. The unavailable
(disabled) test remains available for reagent blank, calibration, and QC.
You can make a test unavailable (disabled) or available (enabled) during MEASURE mode by
selecting the test and then selecting OK in the Disabled Tests dialog.
The system displays and prints the unavailable (disabled) test with a / flag, indicating that
the test was ordered but not performed.
Settings in the Disabled Tests dialog are active until you create a new index or shut down
the system (End Process). You can also enable a test that has been disabled. For more
information, refer to Enable a Test That Has Been Disabled.
2 Select tests to make unavailable (disabled). The system displays the unavailable
(disabled) tests in blue.
Note
If one or more tests are disabled, the system displays a Some tests are
disabled message in the ERROR MESSAGE section.
Review the results using the Sample Status screen or the printout. For more information,
refer to Sample Status Screen.
Review all results for flags and events, and confirm that all corrective actions are taken.
Review Events
Review events that occur during analysis:
5-16 B71495AF
5
System Monitoring and Results
Review Results for Flags and Events
The Level column displays the event level (numbers and color).
Table 5.18 Event Level
Level Color Description
Level 1 Red A fatal system abnormality exists.
Level 2 Yellow An abnormality influencing the data exists.
Level 3 Green No system abnormality. The system displays the operation log.
The Count (at the top-right) indicates the quantity of events within the specified date range.
The system can store and display a maximum of 4,096 cases. You can scroll using the scroll
bar.
B71495AF 5-17
System Monitoring and Results
Review Results for Flags and Events
Note
The Event log detail is only available in the Event Log. DxC 700 AU Instructions for Use
and DxC 700 AU Reference Manual do not contain event log descriptions and corrective
actions.
Each sample prints with a flag for Normal (N) through Abnormal High (ABN-H) and
Abnormal Low (ABN-L) for levels of:
• Lipemia (LIP)
• Icterus (ICT)
• Hemolysis (HEM)
The system generates each flag determined by the parameters in the Test Volume and
Methods: LIH tab (CONFIG. > Test Volume and Methods > LIH) for the LIH test.
Table 5.19 Sample Specific LIH Flags
Name Flags
LIP (lipemia) N, +, ++, +++, ++++, +++++, ABN-H, ABN-L
ICT (icterus) N, +, ++, +++, ++++, +++++, ABN-H, ABN-L
HEM (hemolysis) N, +, ++, +++, ++++, +++++, ABN-H, ABN-L
A result of ABN-H (abnormal high) or ABN-L (abnormal low) means that the mathematical
logic in determining the amount of interference has failed in one or more internal
evaluations. Visually inspect the sample to determine the amount of lipemia, icterus, and
hemolysis present in the sample.
When the level of interfering substances exceeds the criteria programmed for a specific test
in the Test Volume and Methods: General or ISE tabs (CONFIG. > Test Volume and Methods >
General or ISE), the system attaches an l, i, or h flag to the result affected by lipemia, icterus,
or hemolysis.
When LIH testing is not performed on a sample, the system attaches an n flag to the result.
The n flag differentiates LIH testing not being performed, and LIH not influencing the test.
The system typically generates an n flag when the LIH reagent is empty, or the LIH test was
not ordered.
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5
System Monitoring and Results
Review Results for Flags and Events
Warning
The concentrations listed in the table are for reference. Depending on the matrix
effect with an individual serum sample, some results may not meet the listed
concentrations.
Note
The interference information from the Direct Bilirubin IFU (example) is provided as an
example. For the current interference information on direct bilirubin, refer to the Direct
Bilirubin IFU.
B71495AF 5-19
System Monitoring and Results
Reagent Management
Reagent Management
Reagents
Most Beckman Coulter reagents are liquid and ready to place in the reagent refrigerator
after removing the cap. If a reagent requires preparation, refer to the reagent IFU before
loading the reagent into the reagent refrigerator.
The R1 and R2 reagent trays use partitions among the 15 mL, 30 mL, 60 mL, and 120 mL
bottles, and adapters to hold 15 mL and 30 mL reagent bottles securely in position.
The DxC 700 AU contains two reagent refrigerators, R1 and R2. You can use the 15 mL and
30 mL bottle adaptors in either refrigerator. Partitions, however, are specific to each
refrigerator and cannot be interchanged. The partitions for the R1 refrigerator are taller
than the ones for the R2.
Replace adapters when the pins are damaged, or when the adapter no longer clicks into
place on the reagent tray.
The R1 refrigerator holds up to 60 reagent bottles, and the R2 refrigerator holds up to 48.
120 mL reagent bottles occupy two positions on the reagent tray, and reduce the maximum
quantity of bottles respectively.
You can continue to use your current adapter without interruption, because there is no
difference in performance between the current white reagent adapter and the new blue
reagent adapter.
If the transparency of the commercial reagent bottle is too high for the bottle sensor to
detect, apply a label as shown in Figure 5.16 Apply a Label to a Reagent Bottle. The part
number for the labels is MU987900.
5-20 B71495AF
5
System Monitoring and Results
Reagent Management
When you use commercial reagent bottles, the test count displayed on the Reagent
Management screen can differ from the remaining test count. The system uses the liquid
level in the bottle to calculate the test count. Because the bottle is different from the
Beckman Coulter reagent bottles, the calculation may be incorrect.
Caution
Bubbles in the reagent bottle can interfere with analysis. Inspect the reagent bottles
for bubbles. Remove bubbles with a cotton-tipped applicator before loading the
reagent.
Caution
Do not add new reagent to existing bottles. Adding new reagent to existing bottles
can affect results.
Caution
When you fill Beckman Coulter bottles with reagent, wash solution, or deionized
water, do not exceed the maximum volume. The maximum volume depends on the
bottle size. If a reagent bottle is filled over the maximum liquid level limit, bubbles
can occur and cause a level detection error.
B71495AF 5-21
System Monitoring and Results
Reagent Management
1. 15 mL bottle 6. 12 mm
2. 8 mm 7. Maximum liquid level
3. 30 mL bottle 8. 120 mL bottle
4. 4 mm 9. 10 mm
5. 60 mL bottle
Note
Beckman Coulter recommends installing adapters while the system is in STANDBY and
not during REAGENT PAUSE.
1 Insert the short pin of the adapter into the hole in the reagent tray.
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5
System Monitoring and Results
Reagent Management
2 Align the long pin of the adapter with the position of the oval hole in the reagent tray.
3 Press the adapter down until you feel a click.
4 Confirm that the adapter is secure on the reagent tray. The top of the reagent tray (with
the position numbers) must be level with the top of the adapter protrusion.
B71495AF 5-23
System Monitoring and Results
Reagent Management
Note
Before assigning a position, confirm that the reagent status is Checked. If the
reagent status is Unchecked, select Reagent Check [F5], and then select Reset.
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5
System Monitoring and Results
Reagent Management
c. (Optional) In Lot No., enter a lot number according to your laboratory procedure.
d. (Optional) In Bottle No. (SN), enter a bottle number according to your laboratory
procedure.
e. In Bottle Size, select the reagent bottle size.
f. Select OK.
7 If the reagent has an R2 bottle, repeat steps 3 to 6 with Content selected for R2.
8 Confirm that the system indicates assigned (fixed) positions with an asterisk in the
column to the left of the Pos. column.
10 Select Check Specified positions, and then select the positions that you assigned.
11 Select Start.
The system performs a reagent check at the specified positions, and updates the test
count on the Details tab.
Edit a Reagent ID
Edit the reagent ID after a reagent ID read error occurs on a reagent bottle with a bar code.
A notification event occurs during the reagent check, and the system displays Reagent ID
Read Error in the Comment column in Reagent Management > Details until the reagent ID
is edited, or the reagent bottle is removed from the refrigerator.
3 Place the cursor on the position with the reagent ID read error.
4 Select ID Edit.
5 Type in the 20-digit reagent ID from the reagent bottle. Select OK.
The system updates the onboard stability, expiration, lot number, and bottle number
with a No Volume to Process comment.
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System Monitoring and Results
Reagent Management
8 Select both the R1 and R2 positions for the reagent with the edited reagent ID.
9 The system performs the reagent check and updates the RB Stability Remaining and Cal
Stability Remaining.
Note
During reagent blank, calibrator, or control sample analysis, you cannot shift the system
to REAGENT PAUSE mode to replace or add reagents.
The system checks the volumes remaining in the reagent bottles at every aspiration. When
the volumes reach the alarm test level, the system generates a Rx Reagent
Insufficient (test, p) event.
Rx Reagent tray R1 or R2
Test The name of the reagent
P The reagent position
Important
Always replace empty reagent bottles or add new reagent bottles to the position
assigned in the Load dialog (which displays when you select Load [F2]). Load the
reagent bottle in the position that the orange stripe indicates close to the TRAY
ROTATION button for R1 or R2.
Important
Prepare the R1 and R2 reagent trays with partitions and adapters for 30 mL and 15 mL
bottle sizes in advance. Note the empty bottle positions and bottle size based on
adapters to facilitate adding new reagent bottles in MEASURE mode. The small size of
the reagent loading area in MEASURE mode makes it more difficult to add partitions or
adapters during MEASURE mode. Refer to Reagents or Add Adapters to the Reagent
Tray.
B71495AF 5-27
System Monitoring and Results
Reagent Management
Caution
For fixed reagent positions, the system does not read the reagent ID. It identifies the
reagent as a reagent assigned to the position. Confirm that the correct reagent is in
the assigned position.
Caution
Do not leave the system paused for an extended time. When you pause the analyzer
for an extended time, the concentration of the samples in the sample cups increases
from evaporation and the evaporation can affect results.
Caution
Do not remove or add racks while the system is paused, as it can cause concordance
errors.
The system displays the analyzer mode as PAUSE until the system completes all
samples in progress. When the analyzer changes to PAUSE mode, you can add reagent
and perform a reagent check.
Important
After replacing or adding a reagent in MEASURE mode, you can perform a calibration or
quality control (QC) from the STAT table, if necessary.
Be aware that if you complete either the STAT table calibration step or the STAT table
QC step later in this procedure, the system continues to load the racks on the Rack
Input Area after the STAT table status changes to Dispensed.
1 If you need to verify the results of calibration and quality control before restarting
patient sample processing, complete the following sub-steps:
a. Select Feeder Stop.
b. Select OK.
c. Wait until the system is in MEASURE 2 mode.
d. Remove all of the racks from the rack input area.
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System Monitoring and Results
Reagent Management
1. Load [F2]
4 If you are replacing empty reagent bottles, select Insufficient and expires soon and select
Test, then select the tests to replace.
The system highlights the selected fields in blue.
5 If you are adding new reagent bottles, select All Bottles and select Position, then select
empty positions to add the bottles to.
The system highlights the selected fields in blue.
B71495AF 5-29
System Monitoring and Results
Reagent Management
Important
Make all selections for loading reagent bottles before selecting Load.
If Load [F2] is selected during the 5-minute transition to REAGENT PAUSE mode, the
original selections are canceled. Only the selections from the final Load [F2] dialog
are registered, and only these reagent bottle(s) can be replaced.
6 Select Load.
The system closes the Load dialog. The system shifts from MEASURE to REAGENT PAUSE
mode. It takes a maximum of 5 minutes for the system to shift completely to REAGENT
PAUSE mode.
Important
While the system shifts from MEASURE mode to REAGENT PAUSE mode, the system
displays MEASURE REAG. PAUSE xx min. in the status area. When the system
shifts completely to REAGENT PAUSE mode the system displays MEASURE REAG.
PAUSE in the status area.
xx min. The remaining minutes for the system to shift completely into REAGENT PAUSE
mode.
Note
If the system remains in REAGENT PAUSE mode for more than 15 minutes, the
system mode shifts to PAUSE mode. The reagent that is loading during the mode
shift is available after the mode shift.
Note
To confirm the positions and the reagents to replace or add, select List Display [F7],
then select the Display positions selected for loading box.
Note
To print the list of reagents to load, select the Details tab, then select Print [F8].
Caution
To avoid injury by the moving components, do not open the upper cover.
Caution
Do not open the large reagent cover. If you open the large reagent cover during
REAGENT PAUSE mode, the system goes into PAUSE mode or STOP mode. If the
system is in PAUSE mode, you cannot perform a reagent check or restart
MEASURE mode when the system displays MEASURE => PAUSE in the status area.
Wait until the system displays PAUSE in the status area (up to 22 minutes). If the
system changes to STOP mode, all samples in progress are aborted. Select the
Reset button to reset the system to STANDBY mode. You need to reload
incomplete samples for processing.
Caution
Do not open the small reagent refrigerator cover while the ROTATION LED (amber
LED) by the TRAY ROTATION button is blinking. The ROTATION LED (amber LED)
blinks when the reagent components are moving.
14 Select Start.
Note
For more information about performing a calibration, refer to Order and Perform
Quality Control (QC) from the STAT Table or Order and Perform Calibration and Quality
Control (QC) from the STAT Table (Laboratory Automation System).
B71495AF 5-31
System Monitoring and Results
ISE Reagent Management
If you did not perform step 1 at the beginning of this procedure, the system continues to
load the racks from the Rack Input Area.
Important
If the calibration or quality control fails, rerun the samples that measure after
calibration or quality control.
17 Restart analysis.
— If you did not perform either the STAT table calibration step or the STAT table QC
step, select Start.
— If you performed either the STAT table calibration or the STAT table QC and
completed step 1 at the beginning of this procedure, verify the calibration or
quality control result. Then reload the racks and select Start if the results of the
calibration and quality control are acceptable.
5-32 B71495AF
5
System Monitoring and Results
ISE Reagent Management
The system displays the remaining volumes (in number of tests), by the blue indicator bar
and number.
The indicator represents the full amount of reagent in the bottle, then decreases by
increment.
The number represents the number of tests that are available with the remaining ISE
reagent.
The system displays "> xxx" before the number of tests decreases to the number listed in
the following table, Number of Tests to Start the Count Down.
When the number of tests decreases to the number listed in the following table, Number of
Tests to Start the Count Down, the system begins to display the number of available tests
and then counts down by increment.
Table 5.22 Number of Tests to Start the Count Down
Serum Tests Urine Tests
ISE Reference Solution 408 300
ISE MID Standard Solution 123 48
ISE Buffer Solution 94 66
Program the ISE Parameters (Onboard Stability Period and Alarm Tests)
B71495AF 5-33
System Monitoring and Results
ISE Reagent Management
3 Enter the number of days and hours for each ISE reagent in Onboard Stability Period.
Note
4 Enter the number of tests to generate an event for insufficient ISE reagent for each ISE
reagent in Alarm Tests.
Caution
ISE Reference Solution is highly concentrated. Do not allow the ISE Reference Solution
(including that left in bottle, cap, and aspiration tubing) to contact the ISE Buffer
Solution or ISE MID Standard Solution.
Caution
Do not add new reagent to existing bottles. Adding new reagent to existing bottles
can affect results.
Materials Required:
• ISE Buffer Solution
• ISE MID Standard Solution
• ISE Reference Solution
5-34 B71495AF
5
System Monitoring and Results
ISE Reagent Management
3 When the system is in MEASURE mode, the system displays a dialog with a message of
Unable to replace ISE reagent bottles during MEASURE mode. Move to
Reagent PAUSE mode?
Select Yes.
The system goes into REAGENT PAUSE mode. It takes a maximum 5 minutes to complete
transition to REAGENT PAUSE mode, then the system turns off the ISE operation LED.
For more information about the ISE operation LED, refer to ISE Reagent Bottles.
B71495AF 5-35
System Monitoring and Results
ISE Reagent Management
Caution
Do not remove an ISE reagent bottle from the analyzer while the system is in
MEASURE mode (while the LED is blinking). If you remove an ISE reagent bottle,
the system pauses the ISE analysis.
7 Select the Previous arrow or Next arrow to select the ISE reagent to be replaced.
8 Place the cursor in the ID field. If the cursor is not in the ID field, select ID.
9 Scan the bar code label on the bottle with a manual bar code reader.
The system displays the lot number, expiration date, and volume.
Note
If a manual bar code reader is not available, use the keyboard to enter the lot
number and expiration date.
Note
Confirm that the lot number and expiration date are consistent with the label on
the bottle.
10 Place the new bottle of reagent next to the analyzer and remove the cap.
11 Pull out the reagent bottle to replace.
The system changes ISE status to STOP.
Note
The system generates a NO ISE xxx SOLUTION BOTTLE event (xxx is the solution
replaced). Select the Event Clear button to clear the event.
12 Loosen the cap of the reagent bottle and remove the aspiration tubing.
Important
13 Place the aspiration tubing in the new bottle and tighten the cap.
14 Place the new bottle on the analyzer and push the bottle into position.
5-36 B71495AF
5
System Monitoring and Results
ISE Reagent Management
17 The system displays BUSY in ISE status. Wait until the system displays Ready in ISE
Status.
18 Select ISE Maintenance. Refer to Figure 5.28 Reagent Management: ISE Tab.
The system displays the ISE Maintenance: Maintenance tab.
Note
When you select ISE Maintenance in this tab, you go directly to the ISE
Maintenance: Maintenance tab. You do not have to go to the Home screen first.
19 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
Note
If the system displays the ISE Busy message, wait until the preparation for replacing
ISE reagent is finished.
21 Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
B71495AF 5-37
System Monitoring and Results
System Shutdown (End Process)
You can initiate a system shutdown after you start a W2 or photocal. If you initiate a system
shutdown after you start a W2 or photocal, the W2 or photocal completes, and then the
system shuts down. For more information, refer to Perform a W2 or Perform a Photocal.
1 Select END.
The system displays the End dialog.
Note
Important
Follow your laboratory procedure for turning off the deionized water supply.
5-38 B71495AF
5
System Monitoring and Results
Stop Feeder
Stop Feeder
You can stop the rack input area to insert an emergency or routine rack before other racks
during analysis.
Even after you stop the rack input area, the system continues to analyze samples in the
racks that the rack input area has already fed.
When the DxC 700 AU connects to a Laboratory Automation System, selecting Stop Feeder
does not stop the supply of samples to the system. For more information, refer to the
Laboratory Automation System manual.
Caution
Do not leave the rack input area stopped for an extended time. When you stop the
rack input area for an extended time, the concentration of the samples in the sample
cups increases from evaporation and can affect results.
1 Select Stop Feeder. The system displays the Stop Feeder dialog.
2 Select OK. The system displays the rack feed operation stop message. Racks that were
moved from the rack input area continue analysis.
1 When the rack input area is stopped, use normal ordering procedures. For more
information, refer to Order for Routine and Emergency Samples.
Stop Analysis
Select Stop to stop analysis.
Caution
If you stop the system during MEASURE mode, any data that is not complete is lost
and you must reanalyze the samples.
B71495AF 5-39
System Monitoring and Results
Power Off the System by Pressing the ANALYZER STOP Button
Caution
If you select Stop, press the ANALYZER STOP button or a power loss occurs, sample
can remain in the sample probe, and reagents can remain in the cuvettes. Perform a
W1 to clean the sample probe and cuvettes after you restart the system. For more
information, refer to Perform a W1.
When the DxC 700 AU connects to a Laboratory Automation System, selecting Stop stops
sample aspiration for the samples being routed to the DxC 700 AU. For more information,
refer to the Laboratory Automation System manual.
1 Select Stop during analysis operation. The system displays the Stop dialog with a
confirmation message.
2 Select OK. All analysis operation stops, and the system changes to STOP mode.
2 Select OK.
The system returns to STANDBY mode, ready to perform sample analysis.
1 Press the ANALYZER STOP button (black). The operation of the analyzer and the ISE
module immediately stop.
The computer remains On and must be turned off.
2 Select [Ctrl] + [ALT] + [Delete] from the keyboard to display the windows screen.
5-40 B71495AF
5
System Monitoring and Results
Identify and Reanalyze Samples after a Cuvette Overflow
Return to STANDBY Mode After Powering Off the System by Pressing the ANALYZER STOP Button
3 Press the ON button (green). The lamp turns on and the software loads. The system
displays a dialog to confirm retrieving the database.
4 Select OK.
5 In the New Index dialog, select Index to continue analysis in the current index.
6 The system is in WARM UP mode for 1.5 hours. After the required 20-minute lamp warm
up time, wait until the temperature of the cuvette wheel is 37 °C, and then select MAINT.
> Analyzer Maintenance. Select Standby [F4] to return to STANDBY mode.
The analyzer changes to STOP mode immediately after the system generates the
Photometry error during cuvette wash (###) event.
Note
For example, in Photometry error during cuvette wash (###), the ### is the
cuvette number (1 to 165) with a photometric error.
Warning
The tests performed during the 60 minutes before the Photometry error during
cuvette wash (###) event can have an incorrect result caused by the overflow.
The results are invalid and must be reanalyzed. If you have reported results or
transferred the results to the Laboratory Information System, take corrective actions
according to your laboratory procedure.
The 60-minute timeframe is the time that the analyzer was in MEASURE mode. If the
analyzer went into STANDBY mode and did not remain in MEASURE mode for 60
consecutive minutes before the event, add STANDBY mode time to the 60-minute
timeframe. For example, if the analyzer was in STANDBY mode for 20 minutes total,
add 20 minutes to the 60 minutes and search for samples affected by the overflow in
the past 80 minutes.
B71495AF 5-41
System Monitoring and Results
Identify and Reanalyze Samples after a Cuvette Overflow
1 Select EVENT.
2 Search for the event message Photometry error during cuvette wash (###).
4 Search for the MEASURE START messages. Calculate the time between the Photometry
error during cuvette wash (###) event and the most recent MEASURE START
message.
— If the time between the event and measure message is 60 minutes or longer, the
timeframe for searching samples with invalid data is 60 minutes.
— If the time between the event and the measure message is shorter than 60 minutes,
determine the time in MEASURE mode, and add it to the next time in MEASURE
mode, and continue adding the time until the total time in MEASURE mode is 60
minutes. Add the total time in STANDBY between the MEASURE modes and the
Photometry error during cuvette wash (###) event, and add it to 60
minutes. The result is the timeframe for searching samples with invalid data.
5 Specify the start date and time for the search to identify all the affected indexes. In the
following example, the timeframe for the search is 82 minutes (22 minutes of STANDBY
time between 10:33 and 10:55 is added to 60 minutes of MEASURE time). Calculate
backwards from the Photometry error during cuvette wash (###) event
(2015/03/21 11:32) by 82 minutes to obtain the starting date and time for the search.
The starting date and time for the search is then 2015/03/21 10:10.
5-42 B71495AF
5
System Monitoring and Results
Identify and Reanalyze Samples after a Cuvette Overflow
The affected indexes include the index that was generated immediately before the
starting date and time and all the indexes after the starting date and time. In this
example, the two indexes in bold type are the affected indexes.
Note
This information is only an example. Typically, a new index is created once a day or
once a shift.
The ending search date and time is the time when the system generated the
Photometry error during cuvette wash (###) event. In this example, the time
the system generated the event is 2015/03/21 11:32.
6 Select RESULT > Sample Manager > Reaction Monitor > Main.
B71495AF 5-43
System Monitoring and Results
Identify and Reanalyze Samples after a Cuvette Overflow
7 In Index, select the affected index or the oldest index among the affected indexes
obtained in step 5. In this example, select 2015/03/21 09:23.
8 Select all of the available boxes for sample types and kinds that the system has
processed.
11 Enter the starting date and time for search obtained in step 5 in From. In this example,
enter 10/19/2015 11:06.
12 Enter the ending date and time for search obtained in step 5 in To. In this example, enter
10/22/2015 13:06.
If you do not specify the date range, the system selects all samples within the index.
14 Select OK.
5-44 B71495AF
5
System Monitoring and Results
Identify and Reanalyze Samples after a Cuvette Overflow
16 Select List Display [F3]. The system displays a list of samples with invalid data.
Reanalyze these samples.
B71495AF 5-45
System Monitoring and Results
Identify and Reanalyze Samples after a Cuvette Overflow
• Inspect for viruses on a separate computer for CD-Rs or USB flash drives and confirm
that no viruses are detected after saving data.
• When using a CD-R, write data on the CD-R and set it to unrecordable.
Note
Virus pattern files are information files necessary for virus detection. Update
antivirus software with the latest virus pattern files from the antivirus software
manufacturer regularly. Contact the antivirus manufacturer if needed.
1 Select Output from the List Display dialog. The system displays the Output dialog.
4 Select OK. The Data Output dialog displays the save progress. The name of the saved file
is MeasureList_YYYYMMDD_HHMM.csv, with YYYYMMDD_HHMM as the name of the index.
YYYYMMDD_HHMM is the output date and time.
Note
6 Data is saved as a csv file. Use a separate computer to open the file and view or print the
list of samples with invalid data.
5-46 B71495AF
5
System Monitoring and Results
Replace Reagent Probe Cleaning Solution-1 (Optional Configuration) in MEASURE Mode
2 Select OK.
3 Select Close.
Note
During reagent blank, calibrator, or control sample analysis, you cannot shift the system
to REAGENT PAUSE mode to replace reagent probe cleaning solution-1.
The system checks the volume remaining in each of the reagent probe cleaning solution-1
bottles at every aspiration. When the volumes reach the alarm test level, the system
generates a Rx Probe Cleaning Solution Insufficient (CLN-1) event.
Rx Reagent tray R1 or R2
CLN-1 The reagent probe cleaning solution-1
Important
Always replace empty bottles to the position assigned in the Load dialog (which displays
when you select Load [F2]). Load the reagent probe cleaning solution-1 bottle in the
position that the orange stripe indicates close to the Tray Rotation button for R1 or R2.
Caution
As the fixed positions are assigned for the reagent probe cleaning solution-1, the
system does not read the ID bar code. It identifies the reagent probe cleaning
solution-1 as a cleaning solution assigned to the position. Confirm that the correct
reagent probe cleaning solution-1 is in the assigned position.
B71495AF 5-47
System Monitoring and Results
Replace Reagent Probe Cleaning Solution-1 (Optional Configuration) in MEASURE Mode
Caution
Do not leave the system paused for an extended time. When you pause the analyzer
for an extended time, the concentration of the samples in the sample cups increases
from evaporation and the evaporation can affect results.
Caution
Do not remove or add racks while the system is paused, as it can cause concordance
errors.
The system displays the analyzer mode as PAUSE until the system completes all
samples in progress. When the analyzer changes to PAUSE mode, you can add reagent
and perform a reagent check.
1. Load [F2]
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5
System Monitoring and Results
Replace Reagent Probe Cleaning Solution-1 (Optional Configuration) in MEASURE Mode
3 If you are replacing empty reagent probe cleaning solution-1 bottles, select Insufficient
and expires soon and select Test, then select CLN-1 to replace.
The system highlights the selected fields in blue.
Important
Make all selections for loading reagent bottles before selecting Load.
If Load [F2] is selected during the 5-minute transition to REAGENT PAUSE mode, the
original selections are canceled. Only the selections from the final Load [F2] dialog
are registered, and only these reagent bottles can be replaced.
4 Select Load.
The system closes the Load dialog. The system shifts from MEASURE to REAGENT PAUSE
mode. It takes a maximum of 5 minutes for the system to shift completely to REAGENT
PAUSE mode.
Important
While the system shifts from MEASURE mode to REAGENT PAUSE mode, the system
displays MEASURE REAG. PAUSE xx min. in the status area. When the system
shifts completely to REAGENT PAUSE mode, the system displays MEASURE REAG.
PAUSE in the status area.
xx min. The remaining minutes for the system to shift completely into REAGENT PAUSE
mode.
B71495AF 5-49
System Monitoring and Results
Replace Reagent Probe Cleaning Solution-1 (Optional Configuration) in MEASURE Mode
Note
To confirm the positions and the reagent probe cleaning solution-1 to replace or
add, select List Display [F7], then select the Display positions selected for loading
box.
Note
To print the list of reagent probe cleaning solution-1 to load, select the Details tab,
then select Print [F8].
Caution
To avoid injury by the moving components, do not open the upper cover.
Caution
Do not open the large reagent cover. If you open the large reagent cover during
REAGENT PAUSE mode, the system goes into PAUSE mode or STOP mode. If the
system is in PAUSE mode, you cannot perform a reagent check or restart
MEASURE mode when the system displays MEASURE => PAUSE in the status area.
Wait until the system displays PAUSE in the status area (up to 22 minutes). If the
system changes to STOP mode, all samples in progress are aborted. Select the
Reset button to reset the system to STANDBY mode. You need to reload
incomplete samples for processing.
Caution
Do not open the small reagent refrigerator cover while the ROTATION LED (amber
LED) by the TRAY ROTATION button is blinking. The ROTATION LED (amber LED)
blinks when the reagent components are moving.
5-50 B71495AF
5
System Monitoring and Results
Replace Reagent Probe Cleaning Solution-1 (Optional Configuration) in MEASURE Mode
9 If you have more reagent probe cleaning solution to replace, press the Tray Rotation
button.
The system rotates the reagent tray until the next position for loading the reagent
moves to the orange stripe close to the Tray Rotation button for R1 or R2.
12 Select Start.
The system performs the reagent check.
B71495AF 5-51
System Monitoring and Results
Replace Reagent Probe Cleaning Solution-1 (Optional Configuration) in MEASURE Mode
5-52 B71495AF
CHAPTER 6
Maintenance
Introduction
The maintenance frequency described in this chapter is determined by analysis of 4,000 or
less tests per day.
Increase the amount of maintenance required depending on the quantity of tests and local
environmental conditions.
Manage the periodic ISE maintenance schedule either periodically or by the quantity of
samples analyzed. The ISE maintenance frequency described in this chapter is determined
by analysis of 200 ISE samples per day.
Calibration for all tests may be required after replacement of key parts such as syringes or
probes. After any part replacement or significant maintenance, Beckman Coulter
recommends that you perform QC analysis. If any shifts are observed, calibrate all onboard
tests.
Warning
Operate the analyzer with the covers down. If you need the covers up during
maintenance, keep all body parts away from the probes and other moving parts of
the analyzer. Serious injury can occur and you can damage the analyzer.
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats
when performing any procedure. To avoid injury, observe and follow all the warnings
and cautions throughout this manual.
Caution
Failure to perform maintenance according to the instructions within this manual can
cause problems with system performance and invalidate the service agreement.
Caution
B71495AF 6-1
Maintenance
Maintenance Warnings and Cautions
Caution
When you press the DIAG/TABLE ROTATION button the first time after you select a
maintenance procedure option, the system initializes. To avoid injury, do not touch
any moving parts until the system indicates that the analyzer is ready (as indicated by
events, modes, and LEDs).
6-2 B71495AF
B71495AF
Important
Maintenance
Clean the Sample Probe and Mix Bars
Perform a W2
6-3
6-4 Table 6.3 Weekly Maintenance (Continued)
Table 6.6 Monthly, Every Two months, or Every Three Months (ISE Option): The maintenance frequency depends on the amount of samples
processed per day in your laboratory. For more information, refer to Replace ISE Tubing.
Monthly, Every Two months, or Every Three Months (ISE Month and Year:
Option)
Replace ISE Tubing
B71495AF
Table 6.7 Every Two Months or Every 20,000 Samples (ISE Option)
B71495AF
Every Two Months or Every 20,000 Samples (ISE Option) Month and Year:
Inspect and Add ISE Internal Reference Solution (ISE
Option)
Table 6.9 Every Three Months or Every 20,000 Samples (ISE Option)
Every Three Months or Every 20,000 Samples (ISE Option) Month and Year:
Table 6.12 Every Two Years or Every 150,000 Samples (ISE Option)
Every Two Years or Every 150,000 Samples (ISE Option) Month and Year:
Maintenance
Procedure: Replace the ISE REF Electrode and Packing (ISE
Option)
6-5
6-6 Table 6.13 Yearly Maintenance
Perform a W1
Save Parameters
Maintenance
6-7
Maintenance
Program the Operator Name
To enter the operator initials or name for the person performing the maintenance
procedure, perform the following procedure in advance:
1 Select HOME.
Note
The operator initials or name entered in Home > Change Operator [F2] displays
from Maintenance History [F2] in the Analyzer Maintenance and ISE Maintenance
screens. The operator initials or name is included in the maintenance history record
when the maintenance history record is copied to an external memory device or
CD-R. Refer to View Maintenance History and Copy Maintenance History Record to
External Memory Device or CD-R.
When the operator option is selected in CONFIG > List Format > Print Information,
the initials or name of the operator print on the report.
3 For Operator Name, enter the initials or name of the operator, or select Select to choose
the name of the operator from Comment Master, then select OK.
4 Select OK.
Maintenance Log
The Maintenance Log displays the maintenance frequency, the maintenance procedure, the
date the maintenance was performed, and the next date the maintenance is due.
6-8 B71495AF
6
Maintenance
Maintenance Log
1 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
or
Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
Note
The system begins to display daily procedures in yellow 3 hours before the
maintenance is due.
The system displays the maintenance procedures that are overdue or about to expire in
yellow. The system displays the number of times some components have been used in
the Next Due (Cycle Count) column. Select Update to reset the count after the
component has been replaced.
B71495AF 6-9
Maintenance
Maintenance Log
Note
If you select either Display pending Procedures only or Procedures due soon, the
system does not list the unscheduled and as needed procedures.
Note
The system displays the number 0, 1, or 2 at the end of each procedure in the
maintenance log.
4 In Frequency, select the performance interval (Day, Week, Month, or Year). Enter the
interval value from 1 to 180.
6-10 B71495AF
6
Maintenance
Maintenance Log
5 Select OK. The system displays the added maintenance procedure in the Maintenance
Log according to the frequency selected.
If you delete any maintenance procedure, the system deletes the history data also.
5 Select OK.
1 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
or
Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
2 Select the maintenance procedure that you performed in the maintenance log.
Note
You can select multiple maintenance procedures to update all the records
simultaneously.
4 Select OK.
1 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
or
Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
2 Select the maintenance procedure in the maintenance log to approve the record.
Note
You can select multiple maintenance procedures to approve all the records
simultaneously.
5 Select OK.
3 Select OK.
6-12 B71495AF
6
Maintenance
Maintenance Log
2 Select Copy to Disk. The system opens the Copy to Disk dialog.
7 Select OK. The system saves the history data in CSV form.
Select Maintenance Schedule [F3]. The system opens the Maintenance Schedule dialog.
B71495AF 6-13
Maintenance
Accessing Maintenance Operations
If you select ISE, the dialog also displays the ISE maintenance procedures. The colors on the
grid indicate the status of the maintenance procedure.
1 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
or
Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
2 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
or
Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
B71495AF 6-15
Maintenance
Parts List for Analyzer Maintenance
Hitachi Cup
• MU853200
• Sample Cup 2.5 mL
Perform a Photocal - -
Clean the Pre-dilution Bottle Sodium hypochlorite solution
• 66039 (Outside Japan)
(0.5%)
• Commercial item (Japan)
• Cleaning Solution diluted
1:10 (Outside Japan)
• Sodium hypochlorite
solution (5%) diluted 1:10
(Japan)
6-16 B71495AF
6
Maintenance
Parts List for Analyzer Maintenance
B71495AF 6-17
Maintenance
Parts List for Analyzer Maintenance
Note
The sonicator is available through Beckman Coulter. Contact Beckman Coulter for more
information.
6-18 B71495AF
6
Maintenance
Parts List for Analyzer Maintenance
B71495AF 6-19
Maintenance
Dilution Ratios for Maintenance Solutions
0.5% 1:10
1.0% 1:5
Caution
6-20 B71495AF
6
Maintenance
Weekly Maintenance
Note
Follow your laboratory procedure for replacing the diluted wash solution in the bottles.
Beckman Coulter recommends replacing the diluted wash solution daily.
Weekly Maintenance
Perform the following procedures weekly.
• Clean the Sample Probe and Mix Bars
• Perform a W2
• Perform a Photocal
• Clean the Pre-dilution Bottle
Note
If the sample probe or mix bars are contaminated or stained, carryover between
samples can occur. Clean the sample probe and mix bars weekly to prevent
contamination and to provide correct analysis and results.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Alcohol prep pads (70% Isopropyl alcohol)
• Stylet 0.2φ (diameter)
Important
Do not bend or damage the sample probe when you replace it.
B71495AF 6-21
Maintenance
Weekly Maintenance
5 After all the liquid drips from the probe, lift the probe from the arm.
6 Wipe the tip of the probe with an alcohol prep pad (70% Isopropyl alcohol).
7 Carefully insert the stylet into the probe to remove any potential obstruction.
8 Reinstall the probe into the arm, attach the connector to the top of the probe, and
tighten the connector.
9 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
10 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
11 Select Replace Sample Probe. The system displays the Replace Sample Probe dialog.
13 Press the DIAG/TABLE ROTATION button. Confirm that a thin straight stream of water is
dispensed from the probe, and that the water does not spray or dispense at an angle. If
the water sprays or dispenses at an angle occurs, replace the probe. For more
information, refer to Replace a Sample or Reagent Probe.
6-22 B71495AF
6
Maintenance
Weekly Maintenance
14 Clear the Analyzer Maintenance box to deactivate the maintenance operation buttons.
15 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Alcohol prep pads (70% Isopropyl alcohol)
1 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
2 Lift the mix bars up to remove them and wipe them with an alcohol prep pad (70%
Isopropyl alcohol).
B71495AF 6-23
Maintenance
Weekly Maintenance
Caution
When cleaning the mix bars, confirm that the mix bars are not bent and that the
coating is not scratched. Replace the mix bars if they are damaged. When
inserting the mix bars into the mix bar component, do not scratch the mix bars.
Scratched or damaged mix bars can cause sample and/or reagent carryover and
affect results.
3 Insert the six mix bars in the positions labeled R1/S and the three mix bars in the
positions labeled R2 for each mix bar component.
Caution
Do not scratch the mix bar when inserting the mix bar into the mix bar
component. Scratched or damaged mix bars can cause sample or reagent
carryover and affect results.
6-24 B71495AF
6
Maintenance
Weekly Maintenance
Caution
The shapes of the mix bars differ between mix bar component. Placing the spiral
and L-shaped mix bars in the wrong mix bar component can affect analysis results.
The following are the correct placements of each type of mix bar:
— R1 and S positions: Spiral-shaped mix bar
— R2 positions: L-shaped mix bar
4 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
5 Select Replace Mix Bar. The system displays the Replace Mix Bar dialog.
8 Press the DIAG/TABLE ROTATION button. Watch the R1/S mix bar component perform a
sequence to confirm correct operation. If an abnormal noise occurs during mixing,
replace the mix bar. For more information, refer to Replace the Mix Bars.
9 Select Replace Mix Bar. The system displays the Replace Mix Bar dialog.
12 Press the DIAG/TABLE ROTATION button. Watch the R2 mix bar component perform a
sequence to confirm correct operation. If an abnormal noise occurs during mixing,
replace the mix bar. For more information, refer to Replace the Mix Bars.
15 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Perform a W2
To obtain correct analysis results, clean the cuvettes once a week. The sample probe,
reagent probes, mix bars, and waste lines are thoroughly cleaned during the W2 process.
The W2 prepares the cuvettes for the photocal by thoroughly cleaning them. The sample
probe, reagent probes, mix bars, and waste lines also benefit from the cleaning procedure.
Perform a photocal to inspect the integrity of the cuvettes. Clean or replace cuvettes that
show an abnormal value during a photocal. For more information, refer to Perform a
Photocal.
Warning
The mixing of sodium hypochlorite solution (0.5%) and hydrochloric acid causes the
formation of chlorine gas, which is highly toxic. Do not mix sodium hypochlorite
solution (0.5%) and hydrochloric acid. Confirm that all W2 cleaning solution
containers on the analyzer contain the same cleaning solution. Clearly label
containers designated for sodium hypochlorite solution (0.5%) and hydrochloric acid
and confirm that all positions requiring W2 cleaners contain the same cleaning
solution.
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle hydrochloric acid or sodium hypochlorite solution (0.5%). If the
hydrochloric acid or sodium hypochlorite solution (0.5%) contacts skin or clothes,
rinse the affected area thoroughly with water. If the hydrochloric acid or sodium
hypochlorite solution (0.5%) contacts the eyes or mouth, immediately flush with
water. Seek medical attention. Refer to the Safety Data Sheets (SDS) for more
information. Follow your laboratory procedure to wipe up spills immediately.
6-26 B71495AF
6
Maintenance
Weekly Maintenance
Warning
Do not spill cleaning solution on the system. If cleaning solution is spilled on the
system, follow your laboratory procedure to wipe up spills immediately.
Caution
For each procedure, prepare a fresh sodium hypochlorite solution (0.5%). Prepare a
fresh solution to maintain effective cleaning. Without effective cleaning, analysis
results can be affected.
The ISE Enhanced Cleaning procedure is optional during the W2. To run the ISE Enhanced
Cleaning procedure separately from the W2, refer to Enhanced Cleaning of Electrode Line.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Three 60-mL bottles labeled with either of the following solutions:
— 1N hydrochloric acid
— Sodium hypochlorite solution (0.5%)
• Cleaning Solutions:
— Approximately 180 mL of 1N hydrochloric acid or 180 mL of sodium hypochlorite
solution (0.5%)
Materials required for ISE (optional module) Enhanced Cleaning during W2:
• Hitachi Cup
• ISE Cleaning Solution
3 Fill the 60-mL bottles with approximately 60 mL of the cleaning solution selected for
the procedure of the week. If sodium hypochlorite solution was used previously for the
W2, use hydrochloric acid for the current procedure.
Do not fill into the neck of the bottle.
Warning
The mixing of sodium hypochlorite solution (0.5%) and hydrochloric acid causes
the formation of chlorine gas, which is highly toxic. Do not mix sodium
hypochlorite solution (0.5%) and hydrochloric acid. Confirm that all W2 cleaning
solution containers on the analyzer contain the same cleaning solution. Clearly
label containers designated for sodium hypochlorite solution (0.5%) and
hydrochloric acid and confirm that all positions requiring W2 cleaners contain the
same cleaning solution.
B71495AF 6-27
Maintenance
Weekly Maintenance
1. W2 3. 61. Diluent/W2
2. 64. Det. -1/W2
Warning
Do not spill cleaning solution on the system. If cleaning solution is spilled on the
system, follow your laboratory procedure to wipe up spills immediately.
6 Fill a Hitachi cup with 1.5 mL ISE Cleaning Solution if ISE Cleaning (Enhanced) is
selected. Place the cup in the CLEAN position on the STAT table.
7 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
6-28 B71495AF
6
Maintenance
Weekly Maintenance
9 Decide whether to start the photocal immediately when the W2 is complete, without
operator input. Also, the weekly ISE Cleaning (Enhanced) procedure can be run with the
W2 without adding any time to the procedure.
• If you want to start the photocal after the W2 completes, select After W2 ends,
perform the Photocal.
• To start the ISE cleaning procedure during the W2, select ISE Cleaning (Enhanced).
10 Select OK. The W2 starts and takes 30 minutes to complete. You can view the time
countdown in the mode display area. If you selected After W2 ends, perform the
Photocal in step 9, the photocal starts automatically. If you did not select After W2 ends,
perform the Photocal, when the W2 completes, the analyzer enters STANDBY mode.
Caution
The cleaning solution bottles can generate gas. After the W2 is complete,
immediately remove the W2 cleaning solution bottles from the system.
11 Open the upper cover and remove all maintenance materials used for the W2
procedure. Put the diluent and detergent bottles back on the system.
Perform a Photocal
When the W2 is finished, perform a photocal. You can start the photocal from the W2
dialog. If you selected the photocal in the W2 procedure, refer to View the Photocal Results.
The photocal confirms the integrity of the cuvettes. The photocal detects dirt, stains, or
scratches and identifies cuvettes that require cleaning or replacing.
B71495AF 6-29
Maintenance
Weekly Maintenance
If you did not select the photocal with the W2 procedure, you can start the photocal using
the following procedure.
Important
For optimal results, only perform a photocal measurement when the photometer lamp
is stabilized after the system starts up. The photometer lamp needs approximately 20
minutes to stabilize (warm up) after the system starts up.
Note
6-30 B71495AF
6
Maintenance
Weekly Maintenance
7 Select OK. The photocal starts. The photocal takes 30 minutes to complete. The system
automatically moves to STANDBY mode after the photocal is complete. The Maintenance
Log is automatically updated.
Note
Note
The system automatically saves the first photocal value after you update the
maintenance log for Replace a Photometer Lamp in the Consumables tab. The
system uses this photocal value as the reference value in Photocal Monitor > Detail
[F5] > Graph.
If a cuvette fails the photocal, the system generates an audible alarm. Perform the following
corrective action.
2 Clean or replace any cuvettes failing the Mean Check or Cuvette Check.
B71495AF 6-31
Maintenance
Weekly Maintenance
— The system displays cuvettes with a Mean Check Error in yellow. The cuvette is
probably dirty and can be cleaned. For more information, refer to Clean or Replace
Individual Cuvettes.
— The system displays cuvettes with a Cuvette Check Error in purple. The cuvette is
probably scratched and needs replacement. For more information, refer to Clean or
Replace Individual Cuvettes.
3 Replace the photometer lamp if any cuvettes failed the Lamp Check.
— The system displays cuvettes with a Lamp Check Error in red. The photometer
lamp is deteriorating and needs replacement. For more information, refer to
Replace the Photometer Lamp.
Note
If a cuvette fails the photocal after cleaning, replace the cuvette with a new cuvette
and repeat the photocal.
7 If you need to print the photocal results, select Print [F8]. The system displays the Print
dialog.
To maintain the reliability of the analyzer and prevent contamination, clean the pre-dilution
bottle once each week.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
6-32 B71495AF
6
Maintenance
Monthly Maintenance
Materials Required:
• Sodium hypochlorite solution
• Extra 60 mL bottles (optional)
5 Wash the pre-dilution bottle by filling it with sodium hypochlorite solution (0.5%).
6 Rinse the bottle well using deionized water to remove any sodium hypochlorite solution
(0.5%) residue which can affect analysis results.
Note
Beckman Coulter recommends allowing the pre-dilution bottle to air dry completely
before reuse. Use two 60 mL bottles for pre-dilution and alternate the bottles
weekly.
7 Fill the bottle with deionized water and place it on the analyzer.
8 Close the upper cover of the analyzer.
9 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
10 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Monthly Maintenance
Perform the following procedures monthly.
• Clean the Sample Probe Wash Well, Reagent Probe Wash Wells, and Whole Blood Wash
Well
• Clean the Mix Bar Wash Wells
• Clean the Wash Nozzle Component and Inspect the Tube Mounting Joints
• Clean the Deionized Water Tank, Deionized Water Filter, and Sample Probe Filter
B71495AF 6-33
Maintenance
Monthly Maintenance
Clean the Sample Probe Wash Well, Reagent Probe Wash Wells, and Whole Blood Wash Well
Dirty wash wells can cause incorrectly cleaned probes, which can then contaminate
reagents or samples.
To maintain the reliability of the analyzer and prevent contamination, clean the wash wells
monthly.
6-34 B71495AF
6
Maintenance
Monthly Maintenance
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Sodium hypochlorite solution (0.5%)
• Cotton-tipped applicator
• Disposable pipette
5 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
6 Select Clean Wash Well. The system displays the Clean Wash Well dialog.
7 Select OK.
8 Press the DIAG/TABLE ROTATION button. The sample and reagent probes initialize. All
probes move from their home positions over the wash wells to the cuvettes.
Caution
Do not spill sodium hypochlorite solution outside the wash well. Follow your
laboratory procedure to wipe up spills immediately.
Important
While cleaning the interior of the wash well, avoid touching the sample probe and
reagent probe.
9 Using a pipette, dispense the sodium hypochlorite solution (0.5%) into each sample
probe wash well, reagent probe wash wells, and whole blood wash well.
11 Press the DIAG/TABLE ROTATION button. All probes move back to the home position over
the wash wells.
12 Select Prime Washing Line. The system displays the Prime Washing Line dialog.
13 Select OK.
B71495AF 6-35
Maintenance
Monthly Maintenance
14 Press the DIAG/TABLE ROTATION button. After initialization, the system primes water
through the probes and wash wells. Inspect the probe wash wells visually for correct
drainage. If drainage is poor, repeat steps 5 to 13.
17 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Dirty wash wells can cause incorrectly cleaned mix bars, which can cause carryover
problems.
To maintain the reliability of the analyzer and prevent contamination, clean the wash wells
monthly.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Sodium hypochlorite solution (0.5%)
• Cotton-tipped applicator
• Disposable pipette
6-36 B71495AF
6
Maintenance
Monthly Maintenance
Caution
Do not spill sodium hypochlorite solution outside the wash well. Follow your
laboratory procedure to wipe up spills immediately.
5 Using a pipette, dispense the sodium hypochlorite solution (0.5%) into each mix bar
wash well.
7 Turn the mix bar components so that the mix bars are over the mix bar wash wells.
8 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
9 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
10 Select Replace Mix Bar. The system displays the Replace Mix Bar dialog.
B71495AF 6-37
Maintenance
Monthly Maintenance
13 Press the DIAG/TABLE ROTATION button. The R1/S mix bar component initializes and
performs a sequence.
14 Visually inspect the mix bar wash wells for correct water drainage. If drainage is poor,
repeat steps 3 to 12.
15 Select Replace Mix Bar. The system displays the Replace Mix Bar dialog.
18 Press the DIAG/TABLE ROTATION button. The R2 mix bar component initializes and
performs a sequence.
19 Visually inspect the mix bar wash wells for correct water drainage. If drainage is poor,
repeat steps 3 to 17.
22 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Clean the Wash Nozzle Component and Inspect the Tube Mounting Joints
The wash nozzle component includes nine nozzles that aspirate liquid out of the cuvettes,
dispense diluted wash solution and deionized water into the cuvettes, and dry the cuvettes.
If any of the nozzles become clogged, their functionality can suffer, resulting in inefficient
cleaning of the cuvettes.
6-38 B71495AF
6
Maintenance
Monthly Maintenance
Inspect the mounting joints for cracks or leaks. If any damage exists, the aspiration and
dispense by nozzles can be affected.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Clean, dry, lint-free absorbent tissue
• Sonicator filled with deionized water
• Stylet φ0.3 (diameter) when the sonicator is not available
Remove the Wash Nozzle Component and Inspect the Tube Mounting Joints
6 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
7 Select Replace Wash Nozzle. The system displays the Replace Wash Nozzle dialog.
8 Select OK.
9 Press the DIAG/TABLE ROTATION button. The liquid drains from the tubing.
Note
Before loosening a manifold, drain the water remaining in the wash nozzles. If you
loosen any manifold without draining the remaining water, the water spills out of
the nozzle. If the water spills onto the cuvettes, refer to Clean the Cuvettes and the
Cuvette Wheel.
B71495AF 6-39
Maintenance
Monthly Maintenance
10 Loosen the four manifolds and remove them from their mounting positions.
Refer to the video in system help.
6-40 B71495AF
6
Maintenance
Monthly Maintenance
Important
Six O-rings are inside the water supply tube mounting joint of the wash nozzle
component. After removing the manifold, confirm that there are six O-rings seated
inside the six grooves in the manifold base.
Figure 6.22 Manifold Base of the Water Supply Tube Mounting Joint
If an O-ring is missing, inspect the manifold to confirm that the O-ring is not
attached to the surface of the manifold. If it cannot be found, install a new O-ring in
the groove in the manifold base. For more information, refer to Replace the O-rings
in the Water Supply Tube Mounting Joint.
Important
Inspect the packing inside each manifold of the three tube mounting joints. If the
packing is damaged, replace the packing. For more information, refer to Replace the
Packing in the Wash Nozzle Tube Mounting Joints.
B71495AF 6-41
Maintenance
Monthly Maintenance
Important
Do not loosen or remove the positioning screws on either side of the knob when
you loosen the knob on the wash nozzle component. The positioning screws are
used for positioning the wash nozzle component.
6-42 B71495AF
6
Maintenance
Monthly Maintenance
13 Remove the wash nozzle component along with the tubing and inspect the joints for
cracks. If a crack is found, contact Beckman Coulter to have the cracked joint replaced.
Important
Do not damage the nozzles when using a sonicator to clean the wash nozzle
component.
1 Sonicate the wash nozzle component in deionized water for 15 minutes. Only submerge
the nozzle portion. Do not get the springs above the nozzles wet. If water does get into
the springs, dry them well using a clean, dry, lint-free absorbent tissue, or canned air.
After cleaning the nozzles in water, wipe any drops using a clean, dry, lint-free
absorbent tissue.
Note
2 Remove the wash nozzle component from the sonicator, and dry thoroughly with a
clean, dry, lint-free absorbent tissue.
3 Inspect the O-rings inside the water supply tube mounting joint. Confirm that all six O-
rings are correctly inserted in individual grooves. Confirm that the O-rings are not
ripped or over-stretched. Look for dust or detergent crystals around each O-ring. If
faults are found with the O-rings, replace the O-rings.
B71495AF 6-43
Maintenance
Monthly Maintenance
For more information, refer to Replace the O-rings in the Water Supply Tube Mounting
Joint.
4 Return the wash nozzle component to its original position. Place the wash nozzle
component over the positioning screws, then tighten the knob to hold the wash nozzle
component in position.
Important
Do not hit the nozzle tips on the cuvette wheel cover when installing the wash
nozzle component.
5 Return each of the manifolds to their original position. Match the colored dot on the
manifold with the one next to its position. Tighten the manifolds without cross
threading them. Confirm that the manifolds are finger-tight to prevent a cuvette wheel
overflow, but do not over-tighten.
6-44 B71495AF
6
Maintenance
Monthly Maintenance
Important
6 Select Prime Wash Nozzle. The system displays the Prime Wash Nozzle dialog.
8 Press the DIAG/TABLE ROTATION button. The air in the tubing is purged as the wash
nozzle component moves up and down.
Important
Confirm that the wash nozzle component moves freely without interference and
that no leaks occur. If leaks occur, remove the water supply manifold, and confirm
that there are six O-rings correctly placed in the grooves. Inspect each O-ring, and
replace damaged O-rings.
11 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
B71495AF 6-45
Maintenance
Monthly Maintenance
Clean the Deionized Water Tank, Deionized Water Filter, and Sample Probe Filter
The deionized water filter and sample probe filter are used to prevent particles from
entering the internal deionized water system. Clean the deionized water tank to avoid
bacterial contamination of the system.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Clean, dry, lint-free absorbent tissue
• Basin
• Sonicator filled with deionized water
• Extra deionized water tank, filled with 5 L of deionized water
• Sodium hypochlorite solution (1.0%)
Important
Before you start this procedure, turn off the system. If this procedure is performed with
the system on (in STANDBY mode), the system supplies deionized water through the
supply tubing, the float sensor in the deionized water tank activates, and water drains
continuously from the tubing.
Important
Always use new gloves for this procedure to prevent the deionized water tank from
becoming contaminated from previously used gloves.
1 To shut down the system, select END. For more information, refer to System Shutdown
(End Process).
6-46 B71495AF
6
Maintenance
Monthly Maintenance
Important
When the float sensor and tubing are removed from the tank, deionized water can
drip. If the deionized water drips, immediately wipe off the water with a clean, dry
lint-free absorbent tissue.
6 Pull the deionized water tank out of the analyzer. Confirm that the tubing clears the top
of the tank and wrap them in a clean absorbent tissue.
7 Unscrew the cap of the tank and remove the float sensor and water supply tubing.
B71495AF 6-47
Maintenance
Monthly Maintenance
6-48 B71495AF
6
Maintenance
Monthly Maintenance
13 Locate the sample probe filter case directly to the left of the deionized water tank and
remove it from the bracket.
14 Press the gray button of the quick disconnect joints and pull to remove the tubing from
the top and bottom of the filter case.
15 Unscrew the filter case over the basin and remove the sample probe filter.
Important
When working with the sample probe filter, do not lose the O-ring.
B71495AF 6-49
Maintenance
Monthly Maintenance
1. Tubing 4. Bracket
2. Quick disconnect joint 5. Basin
3. Sample probe filter case 6. Quick disconnect button
1 Place the deionized water filter and the sample probe filter in the sonicator filled with
deionized water.
Important
When working with the sample probe filter, do not lose the O-ring.
6-50 B71495AF
6
Maintenance
Monthly Maintenance
Caution
Do not connect the filter case to the joints upside down. If you connect the filter
case upside down, debris can cause data errors.
6 Reconnect the quick disconnects by forcing the tubing into their connections until you
hear a distinct click.
Important
Fill the deionized water tank with 5 L of deionized water before turning the system
on. If the deionized water tank is empty and the pump turns on, a malfunction can
result when the system is turned on.
2 Place the float sensor into the deionized water tank. Tighten the cap.
3 Place the tank into the system and reinsert all water supply tubing into the top of the
tank. Push the tank into place.
4 Reconnect each quick disconnect to the tank by forcing the tubing into its connection
until you hear a distinct click.
1 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
2 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
B71495AF 6-51
Maintenance
Every Three Months Maintenance
3 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
4 Select Prime Washing Line. The system displays the Prime Washing Line dialog.
6 Press the DIAG/TABLE ROTATION button. Watch the sample probe tubing, reagent probe
tubing, and water supply tubing for the wash nozzle component as the system performs
the prime. Repeat the prime until all bubbles are removed from the tubing by pressing
the DIAG/TABLE ROTATION button.
9 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Caution
Do not run the analyzer without filters in position. If filters are missing, heaters and
the power supplies get dusty, which can cause a short circuit and fire.
Materials Required:
• Air filters
• Vacuum
For more information on materials required, refer to Parts List for Analyzer Maintenance.
1 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
2 To shut down the system, select END. For more information, refer to System Shutdown
(End Process).
6-52 B71495AF
6
Maintenance
Every Three Months Maintenance
3 Press the ANALYZER STOP button (black) to completely turn off the power, including the
fans. An analyzer stop is necessary to avoid the risk of the fans bringing dust into the
analyzer while the filters are removed.
7 Vacuum the dust from the filters or clean the filters with water and allow the filters to
completely dry.
Replace the air filters if they are torn.
The air filters can be cleaned with a vacuum without being removed from the analyzer.
If the filter is moved from its original position after cleaning, reposition the filter to its
original flat condition and position.
Important
If you are cleaning the filters with water, confirm that the filters are completely dry
before replacing them on the system to avoid moisture from getting into the
system.
11 Press the ON button (green). The lamp turns on and the software loads. The system
displays a dialog to confirm retrieving the database.
12 The system is in WARM UP mode for 1.5 hours. After the required 20-minute lamp warm
up time, wait until the temperature of the cuvette wheel is 37 °C.
13 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
15 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Caution
When replacing the roller pump tubing, wear appropriate PPE to prevent your hands
from contacting the wash solution. Do not let the wash solution drip on the
surrounding area. If the solution contacts skin or clothes, rinse the affected area
thoroughly with water. If the solution contacts the eyes or mouth, immediately flush
with water. Seek medical attention. Refer to the Safety Data Sheets (SDS) for more
information. Follow your laboratory procedure to wipe up spills immediately.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Roller pump tubing
Perform the following procedure to avoid wash solution leaking from the connection tubing
while the wash solution roller pump tubing is disconnected.
5 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
6-54 B71495AF
6
Maintenance
Every Three Months Maintenance
6 Select Replace Roller Pump tubing. The system displays the Replace Roller Pump Tubing
dialog.
7 Select OK.
8 Press the DIAG/TABLE ROTATION button. The roller pump rotates in the reverse direction
to drain the wash solution back to the wash solution reservoir.
10 Remove the roller pump tubing from the relay tubing by unscrewing the connectors.
B71495AF 6-55
Maintenance
Six-Month Maintenance
11 Connect the connectors of the new roller pump tubing to each relay tubing.
12 Stretch the roller pump tubing around the roller pump, and slide the connectors into
the grooves under the roller pump. Confirm that the ID numbers on the relay tubing
match the ID numbers on the roller pump plate.
13 Press the DIAG/TABLE ROTATION button. The roller pump rotates in the normal direction
to fill the tubing with wash solution.
16 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Six-Month Maintenance
Perform the following procedures every six months.
• Clean the Cuvettes and the Cuvette Wheel
6-56 B71495AF
6
Maintenance
Six-Month Maintenance
The cuvettes are checked weekly during the photocal procedure. This procedure is
performed every 6 months to keep the cuvettes in optimal condition. Perform this
procedure every 6 months or if a wheel overflow occurs. In the US market, Beckman Coulter
performs this procedure as part of the preventive maintenance.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Cotton-tipped applicator
• 2% Wash solution
• Sonicator
• Clean, dry, lint-free absorbent tissue
• Plastic containers to hold cuvettes in the sonicator
Caution
Cuvettes with the same outer dimensions might have different interior dimensions.
The DxC 700 AU uses cuvette PN MU846500 with an interior dimension of 5 mm x 5
mm. These cuvettes are different from the other AU systems. Do not use a cuvette
from another AU system on the DxC 700 AU. Use of a cuvette other than the DxC 700
AU cuvette on the DxC 700 AU causes erroneous results.
Perform this procedure on a work surface protected with clean, dry, lint-free absorbent
tissue.
B71495AF 6-57
Maintenance
Six-Month Maintenance
Important
When hanging the wash nozzle component on the hook, do not damage the wash
nozzles. Avoid contact between the wash nozzles and the cuvette wheel cover.
Do not loosen or remove the positioning screws on either side of the knob when
you loosen the knob on the wash nozzle component. The positioning screws are
used for positioning the wash nozzle component.
1. Hook 4. Knob
2. Wash nozzle component 5. Rear cover
3. Positioning screws
6 Manually rotate the mix bar components approximately 60 degrees so the mix bars are
not over the cuvette wheel cover.
6-58 B71495AF
6
Maintenance
Six-Month Maintenance
7 Carefully lift the cuvette wheel cover and remove it from the analyzer.
Important
When removing the cuvette wheel cover, do not damage the sample probe, reagent
probes, or mix bars.
8 Remove the two black screws located on the cuvette wheel, refer to 3 in Figure 6.36
Remove the Cuvette Wheel. Tighten the screws into the two holes in the cuvette wheel,
refer to 2 in Figure 6.36 Remove the Cuvette Wheel.
9 Loosen the second set of black screws securing the cuvette wheel, refer to 4 in Figure
6.36 Remove the Cuvette Wheel.
B71495AF 6-59
Maintenance
Six-Month Maintenance
Caution
Do not loosen or remove the positioning pins. The positioning pins keep the
cuvette wheel in correct alignment. Incorrect results or system errors can occur.
10 Use the two screws as handles, and lift the cuvette wheel carefully from the analyzer.
Caution
When removing the cuvette wheel, do not touch the peripheral components.
Caution
When handling cuvettes, do not scratch the cuvettes. If a cuvette is scratched, the
photometric data is inaccurate, and the cuvette must be replaced.
Caution
6-60 B71495AF
6
Maintenance
Six-Month Maintenance
Caution
Cuvettes with the same outer dimensions might have different interior
dimensions. The DxC 700 AU uses cuvette PN MU846500 with an interior
dimension of 5 mm x 5 mm. These cuvettes are different from the other AU
systems. Do not use a cuvette from another AU system on the DxC 700 AU. Use of
a cuvette other than the DxC 700 AU cuvette on the DxC 700 AU causes erroneous
results.
Use the reverse end of a cotton-tipped applicator to push each cuvette from the bottom
to remove it from the wheel. Remove all 165 cuvettes.
B71495AF 6-61
Maintenance
Six-Month Maintenance
Caution
When handling cuvettes, do not scratch the cuvettes. If a cuvette is scratched, the
photometric data is inaccurate, and the cuvette must be replaced.
1 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
Important
Do not use wash solution to clean the cuvette wheel. If the wash solution is used to
clean the cuvette wheel, the metallic plating on the wheel can be removed.
Important
6 Rinse the cuvette wheel with deionized water and dry thoroughly with a clean, dry, lint-
free absorbent tissue.
7 Insert the cuvettes into the wheel. Confirm that each cuvette is gently pushed down
completely into the wheel.
Caution
When handling cuvettes, do not scratch the cuvettes. If a cuvette is scratched, the
photometric data is inaccurate, and the cuvette must be replaced.
Caution
Confirm that 165 cuvettes are correctly installed in the cuvette wheel. If one of
the cuvettes is missing, the mixture, reagent, or wash solution spills into the
cuvette wheel, causing a cuvette wheel overflow and preventing successful
analysis.
6-62 B71495AF
6
Maintenance
Yearly Maintenance
Caution
Do not scratch the cuvettes when replacing cuvettes on the cuvette wheel. Never
touch the photometric surface of a cuvette. If the photometric surface is stained,
analysis data is inaccurate. Wear gloves when handling the cuvettes.
8 Dry the incubation bath with a lint-free absorbent tissue if the incubation bath is wet.
The incubation bath is only wet if a cuvette overflow occurs.
9 Put the cuvette wheel back in the original position by aligning the cuvette numbers on
the wheel with the cuvette numbers on the incubation bath of the analyzer.
10 Remove the two screws used as handles to remove the wheel and return to the
positions on the cuvette wheel.
15 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Caution
After cleaning cuvettes, perform a photocal to confirm that the cuvettes were
cleaned correctly.
Important
To obtain optimal analysis data, do not start the photocal until the lamp is stable
after turning on the system. The lamp requires 20 minutes to stabilize after you
press the ON button (green).
Yearly Maintenance
Perform the following procedures yearly.
• Replace the O-rings in the Water Supply Tube Mounting Joint
B71495AF 6-63
Maintenance
Yearly Maintenance
When installing the water supply tube mounting joint of the wash nozzle component,
inspect the following items.
• All six O-rings are seated in a groove, refer to Figure 6.39 Manifold Base of the Water
Supply Tube Mounting Joint.
• Particles such as dust or wash solution crystals are not be observed on or around the
O-rings.
Figure 6.39 Manifold Base of the Water Supply Tube Mounting Joint
1. O-ring
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• O-rings
• Clean, dry, lint-free absorbent tissue
• Pair of tweezers
5 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
6 Select Replace Wash Nozzle. The system displays the Replace Wash Nozzle dialog.
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Yearly Maintenance
7 Select OK.
8 Press the DIAG/TABLE ROTATION button. The liquid drains from the tubing.
Note
Before loosening a manifold, drain the water remaining in the wash nozzles. If you
loosen any manifold without draining the remaining water, the water spills out of
the nozzle. If the water spills onto the cuvettes, refer to Clean the Cuvettes and the
Cuvette Wheel.
9 Loosen the manifold for the water supply tube mounting joint and remove from the
mounting position.
10 Using a pair of tweezers, remove each O-ring from the groove. Wipe away any
crystallization or foreign matter found around O-ring grooves.
13 Select Prime Wash Nozzle. The system displays the Prime Wash Nozzle dialog.
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Maintenance
As Needed Maintenance
16 Confirm that there are no leaks from the tube mounting joint. If you detect a leak,
unscrew the manifold for the water supply tube mounting joint, and confirm that the O-
rings are installed correctly.
Important
If you use the O-rings for a long time without cleaning or if you put the joint
manifold back without the O-rings correctly set, wash solution crystals can form,
causing errors with the cuvettes. Inspect the O-rings along with the monthly
maintenance of the wash nozzle component.
20 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
As Needed Maintenance
Perform the following procedures as needed:
• Clean the R1 or R2 Reagent Probes
• Replace a Sample or Reagent Probe
• Replace the Sample or Reagent Probe Tubing
• Replace the Mix Bars
• Replace the Packing in the Wash Nozzle Tube Mounting Joints
• Replace the Sample Syringe or Reagent Syringe
• Replace the Wash Syringe
• Clean the Interior of the Reagent Refrigerators and STAT Table Compartment
• Clean or Replace the Anti-static Brushes
• Perform a W1
• Replace Rack ID Labels
• Clean or Replace Individual Cuvettes
• Replace the Photometer Lamp
• Replace the Wash Solution Tank
• Replace the Deionized Water Filter, Sample Probe Filter, and O-ring
• Clean the Rack
• Clean the Rack Input and Output Areas
• Save Parameters
• Online Software Updates (Optional)
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Caution
If reagent probes are contaminated or stained, carryover between reagents can occur.
To prevent contamination and to provide correct analysis and results, clean the
reagent probes as needed.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Alcohol prep pads (70% Isopropyl alcohol)
• Stylet φ0.3 (diameter)
3 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
4 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
5 Select Replace Reagent Probe/Syringe. The system displays the Replace Reagent Probe/
Syringe dialog.
6 Select the R1, R2, or R1,R2 box. For Times, enter 3, and then select OK.
9 Unscrew the connector above the probe. Allow the fluid to drain completely.
Important
When handling the probe, do not bend or damage the probe tip.
B71495AF 6-67
Maintenance
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14 Press the DIAG/TABLE ROTATION button. Watch the dispense to confirm that you
reinstalled the probe correctly.
15 If the water is spraying or not dispensing straight from the probe tip, replace the probe.
For more information, refer to Replace a Sample or Reagent Probe.
18 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
If cleaning does not remove contamination from the probes, replace the probes.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Sample probe
• Reagent probe
Important
Confirm that the sample or reagent probe is above the wash well and then replace it
with a new one. Deionized water drips from the probe tip as the connector is
unscrewed.
Important
When handling the probe, do not bend or damage the probe tip.
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5 Allow water to drip from the probe, then lift the probe from the arm.
6 Place the new probe into its position and tighten the connector over the top. Firmly
tighten the connector so that no leaks occur.
Note
If the probe connector does not fit, confirm that you are replacing the correct probe
type. The sample probe has a smaller diameter than the reagent probe.
7 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
8 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
The system displays a dialog for the selected maintenance operation button.
12 Press the DIAG/TABLE ROTATION button. Deionized water is dispensed from the probe
tip. Confirm that the deionized water is dispensed in a thin straight stream, and does
not spray or dispense at an angle.
15 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Replace the sample probe or reagent probe tubing using the same procedure.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Sample probe tubing
• R1 probe tubing
• R2 probe tubing
Important
Before disconnecting the tubing, confirm that the probe is positioned over the wash
well. Dripping from the probe can occur.
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5 Tighten the new tubing connectors to secure both ends of the probe tubing. Tighten the
connectors firmly so that no liquid leaks.
6 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
7 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
8 Select Prime Washing Line. The system displays the Prime Washing Line dialog.
10 Press the DIAG/TABLE ROTATION button. Confirm that the tubing is not leaking and that
the probe is dispensing correctly.
13 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
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Maintenance
As Needed Maintenance
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• S and R1: Spiral shape mix bar
• R2: L shape mix bar
Caution
Do not operate the mix bar component when replacing a mix bar. Replacement of the
mix bar during operation can cause an injury.
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5 Insert a new mix bar in the correct position: the spiral-shaped mix bar in the position
labeled R1/S and the L-shaped mix bar in the position labeled R2. Rotate the mix bar
slightly to insert it completely.
Caution
Do not scratch the mix bar when inserting the mix bar into the mix bar
component. Scratched or damaged mix bars can cause sample or reagent
carryover and affect results.
B71495AF 6-73
Maintenance
As Needed Maintenance
Caution
The shapes of the mix bars differ between mix bar component. Placing the spiral
and L-shaped mix bars in the wrong mix bar component can affect analysis results.
The following are the correct placements of each type of mix bar:
— R1 and S positions: Spiral-shaped mix bar
— R2 positions: L-shaped mix bar
6 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
7 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
8 Select Replace Mix Bar. The system displays the Replace Mix Bar dialog.
9 Select the required mix bar component. The R1 Mix Component is for R1/S mix bars,
and the R2 Mix Component is for R2 mix bars.
11 Press the DIAG/TABLE ROTATION button. The selected mix bar component initializes and
performs a sequence three times.
14 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Packing
• Pair of tweezers
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4 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
5 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
6 Select Replace Wash Nozzle. The system displays the Replace Wash Nozzle dialog.
7 Select OK.
Note
Before loosening a manifold, drain the water remaining in the wash nozzles. If you
loosen any manifold without draining the remaining water, the water spills out of
the nozzle. If the water spills onto the cuvettes, refer to Clean the Cuvettes and the
Cuvette Wheel.
Important
12 Install all the wash nozzle tube mounting joints into their original positions.
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Maintenance
As Needed Maintenance
Important
Install the tube mounting joints in the correct positions. The tube mounting joints
are color-coded to match where the placement of each joint belongs on the
analyzer.
Important
Tighten the cap of each tube mounting joint firmly when replacing the tube
mounting joints, otherwise leaks can result.
13 Select Prime Wash Nozzle. The system displays the Prime Wash Nozzle dialog.
14 Press the DIAG/TABLE ROTATION button. Confirm that the wash nozzle component is
operating correctly.
17 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
For replacing the ISE buffer syringe, refer to Replace the ISE Buffer Syringe or Syringe Case.
The procedures for replacing the sample syringe and reagent syringes are identical.
If a leak, crack, or any other damage is found with a syringe, replace the syringe.
If syringe performance is questionable because of abnormal data, remove and inspect the
syringe.
Replace a damaged syringe immediately, even if 400,000 cycles have not passed since the
syringe was replaced.
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Beckman Coulter recommends running control samples after replacing a syringe to confirm
the performance of the new syringe.
Materials Required:
• Sample syringe (S syringe)
• Reagent syringe (R syringe)
• Clean, dry, lint-free absorbent tissue
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Caution
B71495AF 6-77
Maintenance
As Needed Maintenance
3 Loosen the bottom piston fixing screw and the top fixing nut to remove the syringe from
the mounting grooves.
Refer to the video in system help.
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Caution
If your skin, eyes, or mouth contact any liquid, immediately rinse the affected
area with water. Follow your laboratory procedure.
Important
When removing the syringe, hold the bottom with a clean, dry, lint-free absorbent
tissue. Do not bend the tubing when removing the syringe.
5 Loosen the connectors on the top and side of the syringe to remove the tubing.
Note
B71495AF 6-79
Maintenance
As Needed Maintenance
Caution
Do not allow a strong alkali, such as the wash solution, to contact the syringe. If a
strong alkali contacts the syringe, cracks can occur.
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If a strong alkali contacts the syringe, remove the syringe and rinse it with water.
4 Tighten the top fixing nut until you hear a clicking sound.
5 Tighten the bottom piston fixing screw.
Caution
Do not tighten the bottom piston fixing screw first, and do not press the piston
when you tighten the bottom fixing screw.
1 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
2 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
3 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
4 After replacing the syringe, select the maintenance operation button. The system
displays a dialog for the selected maintenance operation button.
Table 6.25 Syringes and Corresponding Maintenance Operation Buttons
Syringe Maintenance Operation Button
5 In the dialog, select the quantity of cycle times, and then select OK.
Table 6.26 Sample and Reagent Prime Cycle Times
Maintenance Operation Button Setting
7 For the reagent syringe and tubing: If there are bubbles in the syringe after the prime,
repeat the prime until all bubbles are cleared. If you cannot clear the bubbles after the
prime, perform the corrective actions. For more information, refer to Corrective Actions
if Prime Fails for Reagent Syringe.
or
B71495AF 6-81
Maintenance
As Needed Maintenance
For the sample syringe and tubing: If the prime fails (air is still detected), the system
displays a Sample Syringe Prime Incomplete event. Repeat the prime. If the
system generates the event again, replace the syringe.
Note
The sample syringe prime can take from 12 to 44 minutes to complete. The sample
syringe primes until all air bubbles are removed and no air is detected by the
pressure change detection method of the system.
10 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
1 Loosen the bottom piston fixing screw and the top fixing nut to remove the syringe from
the mounting grooves.
Caution
If your skin, eyes, or mouth contact any liquid, immediately rinse the affected
area with water. Follow your laboratory procedure.
Important
When removing the syringe, hold the bottom with a clean, dry, lint-free absorbent
tissue. Do not bend the tubing when removing the syringe.
3 Slowly move the syringe piston up and down by hand. Confirm that there are no
bubbles on the syringe tip.
If bubbles are there, move the piston up and down until the bubbles are purged.
Refer to the video in system help.
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4 Reinstall the syringe into the mounting groove. Align the syringe piston into the drive
shaft.
5 Tighten the top fixing nut until you hear a clicking sound.
6 Tighten the bottom piston fixing screw.
Caution
Do not tighten the bottom piston fixing screw first, and do not press the piston
when you tighten the bottom fixing screw.
9 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
If syringe performance is questionable because of abnormal data, remove and inspect the
syringe.
B71495AF 6-83
Maintenance
As Needed Maintenance
Replace a damaged syringe immediately, even if 400,000 cycles have not passed since the
syringe was replaced.
Beckman Coulter recommends running control samples after replacing a syringe to confirm
the performance of the new syringe.
Materials Required:
• Clean, dry, lint-free absorbent tissue
• R Syringe
• Seal Assembly (Silver screw with packing)
• Alcohol prep pads (70% Isopropyl alcohol)
For more information on materials required, refer to Parts List for Analyzer Maintenance.
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2 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
1. Wash syringe
4 Loosen the bottom piston fixing screw and the top fixing nut to remove the syringe from
the mounting grooves.
B71495AF 6-85
Maintenance
As Needed Maintenance
Important
When removing the syringe, hold the bottom with a clean, dry, lint-free absorbent
tissue. Do not bend the tubing when removing the syringe.
6 Loosen the connector on the top of the syringe to remove the tubing.
Note
1 Prepare a new wash syringe by attaching a new seal assembly to a new R syringe.
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4 Install the syringe into the mounting groove. Align the syringe piston into the drive
shaft.
5 Tighten the top fixing nut until you hear a clicking sound.
6 Tighten the bottom piston fixing screw.
B71495AF 6-87
Maintenance
As Needed Maintenance
Caution
Do not tighten the bottom piston fixing screw first, and do not press the piston
when you tighten the bottom fixing screw.
1 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
2 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
3 Select Replace Wash Syringe. The system displays the Replace Wash Syringe dialog.
6 Watch the syringe prime and confirm that it is not leaking. If there is leaking, repeat the
Install a New Wash Syringe procedure.
Refer to the video in system help.
1 Select Replace Sample Syringe. The system displays the Replace Sample Syringe dialog.
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5 If bubbles are still present, tap the top of the wash syringe with your finger.
Caution
Do not touch the moving piston. Injury can result if your finger is caught in the
syringe component.
It is not necessary to remove bubbles around the seal assembly or small bubbles less
than 1 mm in diameter. Small bubbles have no effect on the accuracy of the syringe
dispensing.
8 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Clean the Interior of the Reagent Refrigerators and STAT Table Compartment
Condensation forms inside the reagent refrigerators and STAT table compartment, caused
by exposure to the outside air.
Keep the reagent refrigerator covers and STAT table compartment cover in position to
diminish the amount of condensation formed.
Caution
When you wipe the bar code reader glass window inside the reagent refrigerators and
STAT table compartment, clean up and dry the glass window completely. If the glass
window is smudged from wiping, reagent ID or sample ID read errors can occur.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Clean, dry, lint-free absorbent tissue
• Alcohol prep pads (70% Isopropyl alcohol)
6 Wipe off the condensation and stains on the wall, bottom, and central area inside the
reagent refrigerators with a dry, clean absorbent tissue.
7 Wipe the same components again with an alcohol prep pad (70% Isopropyl alcohol) to
clean the refrigerator. Then, rinse with deionized water and dry with a clean, dry, lint-
free absorbent tissue.
8 Place the reagents and reagent tray to its original position for each refrigerator. Set the
tray onto the metal pin. Press down on the white securing pins to secure the reagent
tray.
12 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
6 Wipe off the condensation and stains on the wall, bottom, and central area inside the
STAT table compartment with a dry, clean absorbent tissue. Also wipe off the
condensation and stains on the removed STAT table.
7 Wipe the wall, bottom, and central area inside the STAT table compartment and the
STAT table with an alcohol prep pad (70% Isopropyl alcohol).
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8 Place the STAT table in the STAT table compartment. Align the guide hole on the STAT
table with the guide pin and then press down on the white securing pins to secure the
STAT table.
12 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Caution
To avoid infection, always wear gloves to clean or replace the anti-static brushes.
When the DxC 700 AU connects to a Laboratory Automation System, the anti-static brushes
are not part of the analyzer.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Anti-static brushes
• Alcohol prep pads (70% Isopropyl alcohol)
B71495AF 6-91
Maintenance
As Needed Maintenance
6 Follow the same procedure with the brush component on the other side of the rack
transport.
7 Clean any stains on the brushes with an alcohol prep pad (70% Isopropyl alcohol) from
the base to the end of the bristle tips.
8 If the anti-static brushes are still stained after cleaning or indicate wear, replace them.
9 Dispose of the old brushes in a receptacle for biohazard waste.
10 Reinstall the anti-static brush and tighten the fixing screw on top.
11 Put the dark acrylic cover back on the rack feeder.
12 Close all the analyzer doors and covers.
13 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
14 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Perform a W1
If the analyzer was put into STOP mode during analysis, reagents and sample remain in the
cuvettes for longer than normal operation. A W1 cleans the entire cuvette wheel
automatically using the wash nozzle component.
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2 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
3 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
5 Select OK. The system starts the W1. The W1 takes approximately 19 minutes. After the
W1 is complete, the system automatically updates the maintenance log.
Important
Rack ID labels can deteriorate with time. If a rack ID read error occurs on an older label
and the label shows no anomalies, the label is assumed to have deteriorated from
discoloration or reduction in reflectivity. If the rack ID label is deteriorated, replace all
the labels that have been used for the same time as the concerned label.
• The bar code label is faint, or scratched caused by abrasion or scraping.
• A label is stained or blurred caused by adhesion of foreign matters (liquid or solid).
• A label is peeled or torn.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• New Rack ID labels
Important
If it is difficult to remove a label, dampen the label with water and use a tool to scrape it
off, such as a razor blade or scissors.
Never use an organic solvent such as ethyl alcohol (ethanol). Organic solvents alter the
quality of the plastic surface on a rack.
If you use water, wipe the water off completely so that no moisture remains on the
rack.
B71495AF 6-93
Maintenance
As Needed Maintenance
2 Attach a new rack ID label on the rack. Place the label on the beveled edge of the rack
with the numbers on the left (when looking at the rack).
For more information, refer to the DxC 700 AU Reference Manual.
Caution
When replacing rack ID labels, do not use labels with the same rack ID on more
than one rack. Using duplicate rack IDs can cause concordance errors between
samples.
Caution
Confirm that 165 cuvettes are correctly installed in the cuvette wheel. If one of the
cuvettes is missing, the mixture, reagent, or wash solution spills into the cuvette
wheel, causing a cuvette wheel overflow and preventing successful analysis.
Caution
Do not scratch the cuvettes when replacing cuvettes on the cuvette wheel. Never
touch the photometric surface of a cuvette. If the photometric surface is stained,
analysis data is inaccurate. Wear gloves when handling the cuvettes.
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Note
Cuvettes with the same outer dimensions might have different interior dimensions. The
DxC 700 AU uses cuvette PN MU846500 with an interior dimension of 5 mm x 5 mm.
These cuvettes are different from the other AU systems. Do not use a cuvette from
another AU system on the DxC 700 AU. Use of a cuvette other than the DxC 700 AU
cuvette on the DxC 700 AU causes erroneous results.
Clean or replace individual cuvettes that fail the weekly photocal procedure. If only a few
cuvettes need cleaning or replacing after a cuvette wheel overflow, you can use this
procedure.
Materials Required:
• Cuvettes
• Cotton-tipped applicator
• Clean, dry, lint-free absorbent tissue
• 2% Wash solution
• Plastic container
• Sonicator
For more information on materials required, refer to Parts List for Analyzer Maintenance.
B71495AF 6-95
Maintenance
As Needed Maintenance
6 Manually rotate the mix bar components approximately 60 degrees so they are not over
the cuvette cover.
7 Lift the cuvette wheel cover, carefully remove it from the analyzer, and set it aside.
Refer to the video in system help.
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Note
If you have difficulty inserting the applicators into the cuvette or lifting the cuvette
with the applicators, dampen the cotton tip with deionized water before using the
applicators.
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Maintenance
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11 Put the new or cleaned cuvette into its position. Gently push the cuvette completely into
the wheel.
13 Manually turn the mix bar components back to their original position.
14 Put the wash nozzle component back in its original position.
Refer to the video in system help.
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15 Select MAINT. > Analyzer Maintenance > Maintenance. The system displays the Analyzer
Maintenance: Maintenance tab.
16 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
17 Select Prime Washing Line. The system displays the Prime Washing Line dialog. Select
OK.
18 Press the DIAG/TABLE ROTATION button. Watch as the wash nozzle component moves,
and confirm that the downward motion is not inhibited.
19 Clear the Analyzer Maintenance box to deactivate the maintenance operation buttons.
20 Perform a photocal on the individual cuvette. For more information, refer to Perform a
Photocal.
Beckman Coulter recommends replacing the photometer lamp every 1,000 hours.
Replacement of the lamp at 1,000 hours ensures continuous and reliable lamp performance
without unexpected system down-time.
Replace the lamp when a cuvette displays in orange for a Lamp Check Error in the Photocal
Monitor tab, or when troubleshooting indicates the need for a new lamp, even if 1,000
hours have not passed since the lamp was replaced.
After replacing the lamp, the system requires a photocal to evaluate the quality and
intensity of the new lamp.
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Warning
To prevent electric hazards, shut down the system (End Process) before replacing the
photometer lamp. For more information, refer to System Shutdown (End Process).
Wait a minimum of 5 minutes after the system completes the shutdown process. Do
not touch the lamp with your bare hands until the photometer lamp has cooled down
completely. The lamp is hot and can cause burns.
Important
Never touch the glass of the photometer lamp with your bare hands. If oil from skin or
fingerprints are left on the glass, wipe them off with a clean, dry, lint-free absorbent
tissue.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Photometer lamp
1 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
2 To shut down the system, select END. For more information, refer to System Shutdown
(End Process).
Important
Do not bump the cover against the reagent probe when removing the lamp cover.
6 Loosen the two knobs on the terminals, then disconnect the lamp lead wires.
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7 Remove the lamp by turning the lamp holder counterclockwise, then pulling the lamp
from the lamp receptacle. Handle the lamp by the lead wires.
Important
Never touch the glass of the photometer lamp with your bare hands. If oil from skin
or fingerprints are left on the glass, wipe them off with a clean, dry, lint-free
absorbent tissue.
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8 Remove the lamp holder and collar from the lamp and keep them for future use.
9 Obtain a new lamp. Handle the lamp using only the wires. If you touch the bulb, you can
damage it.
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10 Slide the collar along the lead wires with the opening of the notch toward the rear of the
lamp. Align the notched collar with the notch of the guide key of the lamp.
11 Insert the lamp into the receptacle with the notches lined up on the top. Slide the
notches into the keyed protrusion of the receptacle.
12 Slide the lamp holder along the wires behind the lamp and tighten to hold it in position.
Caution
Confirm that the lamp holder is securely in position. If the lamp holder is loose,
accurate analysis data is not obtained.
13 Connect the lead wires to the terminals and tighten with the knobs. Each lead wire can
be connected to either terminal.
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Important
After replacing the lamp, perform a photocal to confirm that the lamp does not
have any defects. To obtain accurate analysis data, wait 20 minutes to stabilize the
lamp after turning on the system, then perform the photocal.
17 Select MAINT. > Analyzer Maintenance > Consumables. The system displays the Analyzer
Maintenance: Consumables tab.
20 Select OK to indicate the lamp was replaced and reset the lamp used time.
Note
The system automatically saves the first photocal value after you update the
maintenance log for Replace a Photometer Lamp in the Consumables tab. The
system uses this photocal value as the reference value in Photocal Monitor > Detail
[F5] >Graph.
21 Allow the lamp 20 minutes to warm up and come to the correct intensity before
continuing to the next step.
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Errors can occur after the photocal. If numerous cuvettes fail the photocal, the lamp was
incorrectly replaced or the lamp is defective. If only a few cuvettes fail the photocal, the
cuvettes are dirty or stained. Clean the cuvettes. If the system still reports an error after
cleaning, replace the cuvettes. For more information, refer to Clean or Replace
Individual Cuvettes.
The system can continue analysis after the wash solution tank becomes empty if there is
sufficient wash solution in the wash solution reservoir.
The system consumes the wash solution approximately 0.5 liter to perform analysis of
4,000 tests.
Inspect the volume of wash solution remaining in the wash solution reservoir, and replace
the empty wash solution tank with a new one before the wash solution reservoir becomes
empty.
Warning
Wear Personal Protective Equipment (PPE), such as gloves, eye shields, and lab coats,
to handle a solution. Refer to the Safety Data Sheets (SDS) for more information.
• If the solution contacts the eyes or mouth, immediately flush with water. Seek medical
attention.
• If the solution contacts skin or clothes, rinse the affected area thoroughly with water.
• If the wash solution splashes or spills outside the tank, follow your laboratory procedure
to wipe up spills immediately.
• If any spill is left untreated, it can generate toxic gas and can cause parts of the analyzer
to corrode.
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Wash solution tank containing 5 liters of wash solution
B71495AF 6-105
Maintenance
As Needed Maintenance
4 Loosen the tank cap, and remove the cap and aspiration tubing from the tank.
Important
The aspiration tubing can drip when you remove it from the tank. Follow your
laboratory procedure to wipe up spills immediately.
Replace the Deionized Water Filter, Sample Probe Filter, and O-ring
For more information on materials required, refer to Parts List for Analyzer Maintenance.
Materials Required:
• Sample Probe Filter
• Deionized Water Filter
• O-ring
For information on how to remove the filters, refer to Clean the Deionized Water Tank,
Deionized Water Filter, and Sample Probe Filter.
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Maintenance
As Needed Maintenance
1 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
2 When the filters are removed for cleaning, inspect them. If the filters cannot be cleaned
successfully, replace them.
3 Replace the O-ring. For more information, refer to Clean the Deionized Water Tank,
Deionized Water Filter, and Sample Probe Filter.
4 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
B71495AF 6-107
Maintenance
As Needed Maintenance
If the rack ID label is peeling, it can also cause a rack jam. Replace the rack ID label. Refer to
Replace Rack ID Labels.
When the rack is damaged, or the magnet on the bottom of the rack is missing, replace the
rack.
Materials Required:
• Clean, dry, lint-free absorbent tissue
• Hot water
Wipe the racks with lint-free absorbent tissue moistened with hot water.
Tip
6-108 B71495AF
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Maintenance
As Needed Maintenance
— Do not fill the cup or tube completely to the top with sample. The sample surface in
the cup or tube must be lower than 15 mm from the top of the cup or tube.
— Keep clean or replace the anti-static brush if it gets dirty. Refer to Clean or Replace the
Anti-static Brushes.
— Carefully place the cups or tubes filled with sample into the racks to avoid sample
spilling from the cup or tube onto the rack. Beckman Coulter recommends using a rack
tray when the sample racks are loaded on the rack feeder module.
— When disposing of sample cups or tubes, do not turn the rack upside down with the
cups or tubes in the rack as sample can drip onto the rack.
Caution
When you clean the rack input and output areas, do not touch the sensors.
B71495AF 6-109
Maintenance
As Needed Maintenance
4 Close the upper and front cover of the rack input area.
5 Loosen two silver screws, then remove the cover over the rack buffer area and auto
rerun rack feeder.
6 Wipe the bottom and sides of the rack buffer area, auto rerun rack feeder, and rack
output area with an alcohol prep pad (70% Isopropyl alcohol) or lint-free absorbent
tissue moistened with hot water.
7 Place the cover over the rack buffer area and auto rerun rack feeder, then tighten the
silver screws.
Figure 6.67 Rack Output Area, Auto Rerun Rack Feeder, and Rack Buffer Area
Save Parameters
Beckman Coulter recommends saving parameters when programming changes are made or
following your laboratory procedures.
If multiple DxC 700 AUs are in the laboratory, Beckman Coulter recommends saving the
parameter files for each DxC 700 AU to external media.
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Maintenance
As Needed Maintenance
A notification is displayed on your console every time software updates are available. You
can initiate software updates by giving permission to install.
The system indicates the PROService icon on the Home screen in blue and shows the text of
"New file available" below the PROService title.
4 Select Install for System Software. The system displays the Available Installer dialog to
confirm that you want to download the new software.
5 Select OK.
The system displays the Available Installer dialog to inform you that installing software
updates requires rebooting the computer and indicates the estimated time to complete
the installation.
6 Select Install. The system performs an End process, and then shuts down.
8 Select Install. The system displays a progress bar indicating how much of the installation
has completed.
When the installation is completed, the system displays a dialog informing you that the
installation has completed.
9 Select OK. The system displays an entry field asking you to enter your name and check
the Approve box.
11 Select OK.
B71495AF 6-111
Maintenance
As Needed Maintenance
The system displays the SoftwareInstallationTool Dialog asking you to reboot the
computer.
12 Select OK.
The system restarts.
Note
You can confirm the software update by selecting Approval History [F2] in MAINT. >
Version Information.
If the installation of the software updates fails, the system displays the following message:
1 Select OK. The system starts to reinstall and displays a progress bar indicating how
much of the installation has completed.
When the installation is completed, the system displays a dialog informing you that the
installation has completed.
2 Select OK. The system displays the SoftwareInstallationTool Dialog asking to reboot the
computer.
Note
4 Select OK.
The system restarts.
6-112 B71495AF
6
Maintenance
ISE Maintenance (All Countries and Regions Except Japan)
Important
B71495AF 6-113
Maintenance
Parts List for ISE Maintenance
Hitachi Cup
• MU853200
• Sample Cup 2.5 mL
6-114 B71495AF
6
Maintenance
Parts List for ISE Maintenance
Hitachi Cup
• MU853200
• Sample Cup 2.5 mL
Deionized water -
Sonicator Commercial item
Table 6.31 Every Two Months or Every 20,000 Samples ISE Maintenance
Maintenance Procedure Part Part Number
Inspect and Add ISE Internal ISE Internal Reference Solution
• AUH1017 (US)
Reference Solution
• 66314 (Outside US and
Japan)
Table 6.32 Every Three Months or Every 20,000 Samples ISE Maintenance
Maintenance Procedure Part Part Number
Manually Clean the Drain Well Sodium hypochlorite solution
• 66039 (Outside Japan)
(0.5%)
• Commercial item (Japan)
• Cleaning Solution diluted
1:10 (Outside Japan)
• Sodium hypochlorite
solution (5%) diluted 1:10
(Japan)
B71495AF 6-115
Maintenance
Parts List for ISE Maintenance
Table 6.34 Every Two Years or Every 150,000 Samples ISE Maintenance
Maintenance Procedure Part Part Number
Replace the ISE REF Electrode REF Electrode (with the packing) MU919700
and Packing
REF Electrode Packing MU920200
Plastic tweezers Commercial item
6-116 B71495AF
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Maintenance
ISE Daily Maintenance
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle ISE Cleaning Solution. If the ISE Cleaning Solution contacts skin or clothes,
rinse the affected area thoroughly with water. If the ISE Cleaning Solution contacts
the eyes or mouth, immediately flush with water. Seek medical attention. Refer to the
Safety Data Sheets (SDS) for more information. Follow your laboratory procedure to
wipe up spills immediately.
Note
If you do not plan to use the system for a long period, clean the ISE at the end of the
day.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE Cleaning Solution
• Hitachi Cup
B71495AF 6-117
Maintenance
ISE Daily Maintenance
2 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
Caution
11 When the cleaning operation is complete, open the small STAT table cover, remove the
Hitachi cup from the STAT table, and discard it.
Caution
When the analysis is in process or the ISE status is Busy, do not open the STAT table
covers to add Standard Solutions to the STAT table or place hands in the path of the
sample probe.
Note
For more information on materials required, refer to Parts List for ISE Maintenance.
6-118 B71495AF
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Maintenance
ISE Daily Maintenance
Materials Required:
• ISE High Serum Standard
• ISE Low Serum Standard
• ISE High Urine Standard
• ISE Low Urine Standard
• Hitachi Cup (4 cups)
3 If you calibrate the ISE immediately after the Clean the ISE procedure, perform a total
prime to clear the lines of ISE Cleaning Solution.
a. Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
b. Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
c. Select Total Prime. The system displays the Total Prime dialog.
d. Select OK.
e. Press the DIAG/TABLE ROTATION button to start the prime. The DIAG/TABLE
ROTATION LED turns on after the prime is complete.
f. Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
6 Fill a Hitachi cup with approximately 500 µL of Standard Solution as required for
processing (determined by your laboratory processing serum, urine, or both sample
types).
Table 6.36 Position Labels for ISE Serum and Urine Standard Solutions
Solution Position Label
7 Place the Hitachi cups into the corresponding positions on the STAT table.
8 Close the small STAT table cover.
9 Select MAINT. > ISE Maintenance > Calibration.
The system displays the ISE Maintenance: Calibration tab.
B71495AF 6-119
Maintenance
ISE Weekly Maintenance
10 Select Serum Start, Urine Start, or Serum/Urine Start depending on the sample types to
calibrate.
The system displays a dialog for starting the calibration.
12 When calibration is complete, confirm that the result for each electrode is within the
ranges for the calibrated sample types.
The system highlights acceptable results in green and results that exceed the values for
the calibration slope in the <Acceptable Calibration Range> table in yellow.
To determine calibration quality, compare the current results with previous results for
consistency.
13 Open the small STAT table cover, remove the Hitachi cups from the STAT table, and
discard them.
6-120 B71495AF
6
Maintenance
ISE Weekly Maintenance
To confirm the ion selectivity of the electrodes, perform a selectivity check of the Na and K
electrodes every week.
Important
Do not leave the bottle of ISE Selectivity Check Solution open. Concentration or
crystallization of the ISE Selectivity Check Solution can occur.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE (K+) and (Na+) Selectivity Check Solution
• Hitachi Cup (2 cups)
6 Fill the Hitachi cups with approximately 500 µL of ISE (Na+) Selectivity Check Solution
and 500 µL of ISE (K+) Selectivity Check Solution separately.
7 Place the ISE (Na+) Selectivity Check Solution in the SEL-Na position. Place the ISE (K+)
Selectivity Check Solution in the SEL-K position.
B71495AF 6-121
Maintenance
ISE Weekly Maintenance
10 Select Check Start. The system displays the Selectivity Check dialog.
11 Select OK.
12 Confirm the selectivity check data is below the acceptable limit of 160.0 mmol/L for Na
and 6.00 mmol/L for K.
If the Na or K selectivity check test result is over the acceptable selectivity check limit,
the background for the Na or K result displays in yellow.
If the Na or K selectivity check test result is over the acceptable selectivity check limit,
first confirm the ISE (Na+) Selectivity Check Solution and ISE (K+) Selectivity Check
Solution open bottle stability and expiration with the ISE reagent IFU. Repeat the
procedure with new or freshly filled cups of ISE (Na+) Selectivity Check Solution and
ISE (K+) Selectivity Check Solution. Confirm the ISE calibration results. If the ISE
calibration passes and the selectivity check fails, replace the Na or K electrode.
For more information, refer to Replace the Na, K, or Cl Electrode.
13 Perform a MID/REF Prime three times to clear the electrode flow cell of any ions
remaining from the selectivity check procedure.
a. Select the Maintenance tab.
b. Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
c. Select MID/REF Prime, and then select OK.
d. Press the DIAG/TABLE ROTATION button to start the prime. The DIAG/TABLE
ROTATION LED turns on after the prime is complete.
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Maintenance
ISE Weekly Maintenance
e. Initiate the MID/REF prime two more times by pressing the DIAG/TABLE ROTATION
button.
f. Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
14 After completing the operation, open the small STAT table cover, and then remove the
Hitachi cups from the STAT table.
This cleaning procedure requires 30 minutes to complete. If the ISE enhanced cleaning is
performed with the W2, both procedures are complete in approximately 30 minutes. For
more information, refer to Perform a W2.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE Cleaning Solution
• Hitachi Cup
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle ISE Cleaning Solution. If the ISE Cleaning Solution contacts skin or clothes,
rinse the affected area thoroughly with water. If the ISE Cleaning Solution contacts
the eyes or mouth, immediately flush with water. Seek medical attention. Refer to the
Safety Data Sheets (SDS) for more information. Follow your laboratory procedure to
wipe up spills immediately.
6 Fill the Hitachi cup with approximately 1.5 mL of ISE Cleaning Solution.
7 Place the Hitachi cup in the CLEAN position on the STAT table.
B71495AF 6-123
Maintenance
ISE Maintenance Every Two Weeks or Every 3,000 Samples
8 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
9 Select Cleaning (Enhanced), and then select OK. The system starts the enhanced cleaning
operation. This process requires 30 minutes to complete.
10 After performing the enhanced cleaning operation, open the small STAT table cover, and
then remove the ISE Cleaning Solution.
Manually Clean the ISE Mix Bar, Liquid Level Sensors, Nozzles, and Sample Pot
To obtain accurate results and optimum system performance without unexpected system
downtime, perform the following ISE maintenance procedure every two weeks or every
3,000 samples, whichever comes first. Clean according to your laboratory procedures and
after careful monitoring of calibration and QC data.
Figure 6.73 ISE Mix Bar, Liquid Level Sensors, Nozzles, and Sample Pot
6-124 B71495AF
6
Maintenance
ISE Maintenance Every Two Weeks or Every 3,000 Samples
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Bypass. The system displays the Drain Bypass dialog.
6 Select OK.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Alcohol prep pads (70% Isopropyl alcohol)
• Clean, dry, lint-free absorbent tissue
1 Disconnect the level sensor connector 714 and mixing motor connector 706.
2 Loosen the knob securing the mixing component. Gently lift the mixing component to
unseat it.
Important
3 Use an alcohol prep pad (70% Isopropyl alcohol) to wipe the two nozzles, the liquid
level sensors, and the mix bar.
Refer to the video in system help.
B71495AF 6-125
Maintenance
ISE Maintenance Every Two Weeks or Every 3,000 Samples
Important
Do not change the orientation position of the two nozzles attached to the mixing
component. Do not apply excess pressure to the tubing.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Freshly prepared 1% wash solution
6-126 B71495AF
6
Maintenance
ISE Maintenance Every Two Weeks or Every 3,000 Samples
• Deionized water
• Clean, dry, lint-free absorbent tissue
• Sonicator
• Beaker
1 Loosen the retaining knob securing the sample pot, and lift the pot from the peg.
2 Disconnect the sample pot tubing from the sample pot by unscrewing the connector.
3 Submerge the sample pot into a beaker filled with 1% wash solution.
4 Place the beaker in the sonicator filled with deionized water and sonicate for 10
minutes.
1 Reattach the sample pot tubing to the sample pot by screwing the connector.
2 Reinstall the sample pot. Align the hole on the top of the sample pot with the peg and
slide the screw post into the groove on the opposite side. Tighten the retaining knob.
3 Put the mixing component back on the two positioning pins. Tighten the knob to secure
the mixing component.
B71495AF 6-127
Maintenance
ISE Maintenance Every Two Weeks or Every 3,000 Samples
Important
When reinstalling the mixing component, confirm that the tubing is not pinched
between the mixing component and its stand.
Important
The connectors are specially keyed to fit each plug. To avoid damage to the pins, do
not force a connector into its plug. If the pins are damaged, the mix bar does not
rotate, or the liquid level sensors do not function.
4 Reconnect the level sensor connector 714 and mixing motor connector 706.
5 Select Total Prime. The system displays the Total Prime dialog.
6 Select OK.
7 Press the DIAG/TABLE ROTATION button. The DIAG/TABLE ROTATION LED turns on after
the prime is complete.
8 During the prime, confirm that buffer solution and MID Standard solution are correctly
dispensed into the sample pot and flow to waste without generating events.
11 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
12 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
6-128 B71495AF
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Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
Important
You may need to replace the ISE tubing more frequently than specified in the preceding
table after running more than 1,000 samples or large volumes of dialysis samples, LIH
(lipemic, icteric, or hemolyzed) samples, or serum samples containing separator
material.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE Tubing 3
ISE Tubing 3 contains a flow cell tubing and a MID Standard roller pump tubing.
B71495AF 6-129
Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
Important
Always drain the flow cell before moving the lock lever to release the electrode block. If
the ISE Reference Solution is not drained, ISE Reference Solution can flow up into the
electrodes and cause problems with the electrode measuring capability. ISE Reference
Solution only flows past the REF electrode (not Na, K, or Cl electrode) in normal
operation. ISE Reference Solution is more concentrated than the ISE MID Standard
Solution or samples that flow through the flow cell.
1 Remove the tubing from the pinch valve grooves by pulling it out and then up.
6-130 B71495AF
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Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
2 Remove the roller pump tubing from the bracket of the mixture aspiration roller pump.
3 Disconnect the level sensor connector 714 and mixing motor connector 706.
4 Loosen the knob securing the mixing component. Gently lift the mixing component to
remove it.
B71495AF 6-131
Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
Important
Do not change the orientation position of the two nozzles attached to the mixing
component. Do not apply excess pressure to the tubing.
6 Loosen the retaining knob securing the sample pot, and lift the pot from the peg.
7 Disconnect the sample pot tubing from the sample pot by unscrewing the connector.
8 Disconnect the other end of the sample pot tubing from the electrode block inlet.
6-132 B71495AF
6
Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
Important
The system uses four O-rings in the electrode block. The O-ring attaches to the
outlet side of each electrode and the metal part that contacts the Cl electrode
B71495AF 6-133
Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
(location A in the ISE Tubing Block Diagram). Do not lose the O-rings when removing
the electrodes.
Caution
When lifting the electrodes, use your hand to support the electrodes. Do not lift
out the electrodes by the wires when they are still connected.
13 While holding the REF electrode block, disconnect the tubing (labeled 6) from the REF
electrode block.
6-134 B71495AF
6
Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
14 Remove the drain tubing with metal plate from the hook over the drain well.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Flow cell tubing contained in ISE Tubing 3
6 Install the three electrodes on the electrode block. Install the electrodes according to
the label of Cl, Na, and K from the electrode block inlet side to the REF electrode block
side.
Important
Confirm that all four O-rings are in position before using the lock lever to secure the
electrodes. The O-rings are necessary to create an airtight seal for the flow cell.
7 Align the electrodes in a straight stack with the pegs in the holes.
8 Move the lock lever to the right to lock the electrodes in position.
9 Connect the sample pot tubing of the flow cell tubing to the electrode block inlet.
10 Connect the sample pot tubing of the flow cell tubing to the sample pot by screwing on
the connector.
Important
To attach the sample pot tubing to the sample pot, finger-tighten the connector.
11 Reinstall the sample pot. Align the hole on the top of the sample pot with the peg and
slide the screw post into the groove on the opposite side. Tighten the retaining knob.
12 Put the mixing component back on the two positioning pins. Tighten the knob to secure
the mixing component.
13 Reconnect the level sensor connector 714 and mixing motor connector 706.
B71495AF 6-135
Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
Important
The connectors are specially keyed to fit each plug. To avoid damage to the pins, do
not force a connector into its plug. If the pins are damaged, the mix bar does not
rotate, or the liquid level sensors do not function.
Important
When reinstalling the mixing component, confirm that the tubing is not pinched
between the mixing component and its stand.
14 Place the roller pump tubing of the flow cell tubing on the mixture aspiration roller
pump. Confirm that the tubing connector numbers match to their corresponding
numbers on the pump bracket. Hook one end of the tubing to the bracket, stretch the
tubing around the pump, and hook the other end in the bracket.
Important
15 Insert the tubing into the grooves of the pinch valve. Confirm that the tubing is inserted
completely into the groove. Put tubing labeled 6 in the bottom groove of the pinch valve,
and put tubing labeled 5 in the top groove of the pinch valve.
6-136 B71495AF
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Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
Materials Required:
• MID Standard roller pump tubing contained in ISE Tubing 3.
1 Remove the roller pump tubing from the bracket of the MID Standard roller pump.
2 Disconnect the roller pump tubing by twisting apart the connectors at each end.
3 Connect a new roller pump tubing. Turn the connectors at both ends to secure it.
4 Place the roller pump tubing on the MID Standard roller pump. Confirm that the tubing
connector numbers match to their corresponding numbers on the pump bracket. Hook
one end of the tubing to the bracket, stretch the tubing around the pump, and hook the
other end to the bracket.
B71495AF 6-137
Maintenance
ISE Maintenance Monthly, Every Two Months, or Every Three Months
Important
1 Select Prime Bypass. The system displays the Prime Bypass dialog.
2 Select OK.
3 Press the DIAG/TABLE ROTATION button to start the prime. The two roller pumps are
activated to prime liquid through the ISE. The roller pumps rotate for approximately
one minute to remove air from the tubing.
4 Select Total Prime. The system displays the Total Prime dialog.
5 Select OK.
6 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
Note
If bubbles are in the tubing after priming, confirm that the electrodes and tubing
are installed correctly, and the electrodes are secured with the lock lever.
6-138 B71495AF
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Maintenance
ISE Maintenance Every Two Months or Every 20,000 Samples
9 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
10 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE Internal Reference Solution
5 Inspect the ISE Internal Reference Solution level. If the level is on or above the reference
line, continue with step 15. If the level is below the reference line, open the REF
electrode cap and add ISE Internal Reference Solution above the reference line.
Important
10 Select Total Prime. The system displays the Total Prime dialog.
11 Select OK.
12 Press the DIAG/TABLE ROTATION button to start the prime. The DIAG/TABLE ROTATION
LED turns on after the prime is complete.
15 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
16 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
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Maintenance
ISE Every Three Months Maintenance or Maintenance Every 20,000 Samples
1. Drain well
Materials Required:
• Sodium hypochlorite solution (0.5%)
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
B71495AF 6-141
Maintenance
ISE Every Three Months Maintenance or Maintenance Every 20,000 Samples
1 Remove the drain tubing from the hook over the drain well.
Refer to the video in system help.
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab
coats, to handle hydrochloric acid or sodium hypochlorite solution (0.5%). If the
hydrochloric acid or sodium hypochlorite solution (0.5%) contacts skin or clothes,
rinse the affected area thoroughly with water. If the hydrochloric acid or sodium
hypochlorite solution (0.5%) contacts the eyes or mouth, immediately flush with
water. Seek medical attention. Refer to the Safety Data Sheets (SDS) for more
information. Follow your laboratory procedure to wipe up spills immediately.
3 Pour the sodium hypochlorite solution (0.5%) into the drain well directly from the top.
Refer to the video in system help.
6-142 B71495AF
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Maintenance
ISE Every Three Months Maintenance or Maintenance Every 20,000 Samples
4 Allow the sodium hypochlorite solution (0.5%) to sit for approximately 10 minutes.
5 Pour deionized water into the drain well to rinse out the sodium hypochlorite solution.
6 Put the drain tubing on the hook over the drain well.
Refer to the video in system help.
7 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
Note
You may need to repeat this step five times. If bubbles are in the tubing after
priming, confirm that the electrodes and tubing are installed correctly, and the
electrodes are secured with the lock lever.
B71495AF 6-143
Maintenance
ISE Six-Month Maintenance or Every 40,000 Samples
10 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
Tip
You can find the Lot No. and the bar code containing both the electrode ID and lot No.
on the electrode package. You need this information to document on the maintenance
log.
Replace the electrode when calibration or Selectivity Check results are out of range. Before
replacing the electrode, perform appropriate troubleshooting, repeat the calibration or
Selectivity Check, and confirm the results are still out of range. Replacement of the
electrode at every 40,000 samples or every six months, whichever comes first, ensures
continuous and reliable electrode performance without unexpected system down-time. If
the electrodes have deteriorated, the system cannot obtain accurate analysis results.
For more information, refer to ISE Tubing Block Diagram.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Na Electrode
• K Electrode
• Cl Electrode
• O-ring
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
2 Program the initials or name of the operator who performs the maintenance procedure.
To program the operator name, refer to Program the Operator Name.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
Important
Always drain the flow cell before moving the lock lever to release the electrode block. If
the ISE Reference Solution is not drained, ISE Reference Solution can flow up into the
electrodes and cause problems with the electrode measuring capability. ISE Reference
Solution only flows past the REF electrode (not Na, K, or Cl electrode) in normal
operation. ISE Reference Solution is more concentrated than the ISE MID Standard
Solution or samples that flow through the flow cell.
Caution
When lifting the electrodes, use your hand to support the electrodes. Do not lift
out the electrodes by the wires when they are still connected.
B71495AF 6-145
Maintenance
ISE Six-Month Maintenance or Every 40,000 Samples
Caution
Handle the lead wires from the very end so they do not come apart.
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Important
The system uses four O-rings in the electrode block. The O-ring attaches to the
outlet side of each electrode and the metal part that contacts the Cl electrode
(location A in the ISE Tubing Block Diagram). Do not lose the O-rings when removing
the electrodes.
5 Connect the blue wire to the Cl electrode, yellow wire to the Na electrode, and red wire
to the K electrode.
8 Install the three electrodes on the electrode block. Install the electrodes according to
the label of Cl, Na, and K from the electrode block inlet side to the REF electrode block
side.
Important
Confirm that all four O-rings are in position before using the lock lever to secure the
electrodes. The O-rings are necessary to create an airtight seal for the flow cell.
9 Move the lock lever to the right to lock the electrodes in position.
10 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
B71495AF 6-147
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ISE Six-Month Maintenance or Every 40,000 Samples
Note
You may need to repeat this step five times. If bubbles are in the tubing after
priming, confirm that the electrodes and tubing are installed correctly, and the
electrodes are secured with the lock lever.
15 Select OK. The system displays the Electrode Lot No. dialog.
16 Scan the bar code on the electrode package. The system then displays the scanned ID
and Lot No. in each field. If the bar code is not read successfully, leave the ID field blank
and manually enter the lot No. in the Lot No. field.
17 Select OK.
18 Wait a minimum of 5 minutes after closing the covers, and then perform a calibration.
Important
To obtain the best possible analysis data, perform two calibration measurements to
confirm the electrode stability:
Table 6.38 Acceptable Differences Between First and Second MID Solution Factors
Na K Cl
— If the difference between the first and second MID Solution factors is smaller than
or equal to the value in the preceding table, the electrode is stable.
— If the difference between the first and second MID Solution factors is larger than
the value in the preceding table or if the slope of the first calibration curve is 0,
bubbles may remain in the flow cell. Perform a MID/REF prime.
1. Lift the upper cover.
2. Open the ISE cover.
3. Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4. Select the ISE Maintenance box. The system activates the maintenance
operation buttons.
5. Select MID/REF Prime. The system displays the MID/REF Prime dialog.
6. Select OK.
7. Press the DIAG/TABLE ROTATION button.
8. Close all the analyzer doors and covers.
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9. Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
10. Repeat the ISE calibration two more times and compare the results to the chart.
— If the slopes of the first and second calibration curves are both 0, the electrodes
might not have been installed correctly.
Repeat the Replace the Na, K, or Cl Electrode procedure to confirm that you have
installed the electrodes correctly.
Tip
You can find the Lot No. and the bar code containing both the electrode ID and lot No.
on the electrode package. You need this information to document on the maintenance
log.
Replace the electrode when calibration or Selectivity Check results are out of range. Before
replacing the electrode, perform appropriate troubleshooting, repeat the calibration or
Selectivity Check, and confirm the results are still out of range. Replacement of the
electrode at 150,000 samples or 2 years, whichever comes first, ensures continuous and
reliable electrode performance without unexpected system down-time.
If all calibration measurement values of Na, K, and Cl fluctuate, higher or lower than
previous measurements, or if the system displays an event message after replacing the REF
electrode, contact Beckman Coulter.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• REF Electrode (with the packing)
• REF Electrode Packing
• Plastic tweezers
Important
Do not use force to install or uninstall the REF electrode. When installing or uninstalling
the electrode, do not break the electrode.
B71495AF 6-149
Maintenance
ISE Maintenance Every Two Years or Every 150,000 Samples
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
Important
Always drain the flow cell before moving the lock lever to release the electrode block. If
the ISE Reference Solution is not drained, ISE Reference Solution can flow up into the
electrodes and cause problems with the electrode measuring capability. ISE Reference
Solution only flows past the REF electrode (not Na, K, or Cl electrode) in normal
operation. ISE Reference Solution is more concentrated than the ISE MID Standard
Solution or samples that flow through the flow cell.
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2 Remove the Na, K, and Cl electrodes from the electrode block to keep these electrodes
away from the REF electrode. Any contact with the ISE Reference Solution can
deteriorate the Na, K, and Cl electrodes.
Important
The system uses four O-rings in the electrode block. The O-ring attaches to the
outlet side of each electrode and the metal part that contacts the Cl electrode
(location A in the ISE Tubing Block Diagram). Do not lose the O-rings when removing
the electrodes.
Caution
When lifting the electrodes, use your hand to support the electrodes. Do not lift
out the electrodes by the wires when they are still connected.
B71495AF 6-151
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ISE Maintenance Every Two Years or Every 150,000 Samples
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1 Confirm that no air bubbles are in the REF electrode tip. If air bubbles are found in the
tip, remove the bubbles by pointing the electrode tip downward while tapping it with a
finger.
Note
Dampen the REF electrode tip with deionized water if you have difficulty inserting
the REF electrode into the REF electrode block.
4 Insert the cap screw into the REF electrode block and screw it in carefully. Finish
tightening the cap screw by a quarter or half turn to orient the REF electrode correctly.
11 Select OK.
12 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
B71495AF 6-153
Maintenance
ISE Maintenance Every Two Years or Every 150,000 Samples
Note
You may need to repeat this step five times. If bubbles are in the tubing after
priming, confirm that the electrodes and tubing are installed correctly, and the
electrodes are secured with the lock lever.
15 Select Replace the ISE REF Electrode and the Packing from the maintenance log.
17 Select OK. The system displays the Electrode Lot No. dialog.
18 Scan the bar code on the electrode package. The system then displays the scanned ID
and Lot No. in each field. If the bar code is not read successfully, leave the ID field blank
and manually enter the lot No. in the Lot No. field.
19 Select OK.
20 Wait a minimum of 5 minutes after closing the covers, and then perform a calibration.
Important
To obtain the best possible analysis data, perform two calibration measurements to
confirm the electrode stability:
Table 6.39 Acceptable Differences Between First and Second MID Solution Factors
Na K Cl
— If the difference between the first and second MID Solution factors is smaller than
or equal to the value in the preceding table, the electrode is stable.
— If the difference between the first and second MID Solution factors is larger than
the value in the preceding table or if the slope of the first calibration curve is 0,
bubbles may remain in the flow cell. Perform a MID/REF prime.
1. Lift the upper cover.
2. Open the ISE cover.
3. Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4. Select the ISE Maintenance box. The system activates the maintenance
operation buttons.
5. Select MID/REF Prime. The system displays the MID/REF Prime dialog.
6. Select OK.
7. Press the DIAG/TABLE ROTATION button.
8. Close all the analyzer doors and covers.
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9. Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
10. Repeat the ISE calibration two more times and compare the results to the chart.
— If the slopes of the first and second calibration curves are both 0, the electrodes
might not have been installed correctly.
Repeat the Replace the Na, K, or Cl Electrode procedure to confirm that you have
installed the electrodes correctly.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Sample Pot
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Bypass. The system displays the Drain Bypass dialog.
6 Select OK.
1 Disconnect the level sensor connector 714 and mixing motor connector 706.
2 Loosen the knob securing the mixing component. Gently lift the mixing component to
unseat it.
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6 Reattach the sample pot tubing to the new sample pot by screwing the connector.
7 Reinstall the sample pot. Align the hole on the top of the sample pot with the peg and
slide the screw post into the groove on the opposite side. Tighten the retaining knob.
8 Put the mixing component back on the two positioning pins. Tighten the knob to secure
the mixing component.
B71495AF 6-157
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ISE As Needed Maintenance
Important
When reinstalling the mixing component, confirm that the tubing is not pinched
between the mixing component and its stand.
9 Reconnect the level sensor connector 714 and mixing motor connector 706.
Important
The connectors are specially keyed to fit each plug. To avoid damage to the pins, do
not force a connector into its plug. If the pins are damaged, the mix bar does not
rotate, or the liquid level sensors do not function.
10 Select Total Prime. The system displays the Total Prime dialog.
11 Select OK.
12 Press the DIAG/TABLE ROTATION button. The DIAG/TABLE ROTATION LED turns on after
the prime is complete.
13 During the prime, confirm that buffer solution and MID Standard solution are correctly
dispensed into the sample pot and flow to waste without generating events.
16 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
17 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
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For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Brush
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
Important
Always drain the flow cell before moving the lock lever to release the electrode block. If
the ISE Reference Solution is not drained, ISE Reference Solution can flow up into the
electrodes and cause problems with the electrode measuring capability. ISE Reference
Solution only flows past the REF electrode (not Na, K, or Cl electrode) in normal
operation. ISE Reference Solution is more concentrated than the ISE MID Standard
Solution or samples that flow through the flow cell.
1 Disconnect the level sensor connector 714 and mixing motor connector 706.
2 Loosen the knob securing the mixing component. Gently lift the mixing component to
unseat it.
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ISE As Needed Maintenance
Important
The system uses four O-rings in the electrode block. The O-ring attaches to the
outlet side of each electrode and the metal part that contacts the Cl electrode
(location A in the ISE Tubing Block Diagram). Do not lose the O-rings when removing
the electrodes.
Caution
When lifting the electrodes, use your hand to support the electrodes. Do not lift
out the electrodes by the wires when they are still connected.
7 Pass the brush through the hole in the metal part that contacts the Cl electrode (location
A in ISE Tubing Block Diagram). Contamination can lodge in the flow cell of the
electrode block.
B71495AF 6-161
Maintenance
ISE As Needed Maintenance
10 Move the lock lever to the right to lock the electrodes in position.
11 Attach the sample pot tubing to the electrode block inlet.
Refer to the video in system help.
12 Put the mixing component back on the two positioning pins. Tighten the knob to secure
the mixing component.
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13 Reconnect the level sensor connector 714 and mixing motor connector 706.
Important
The connectors are specially keyed to fit each plug. To avoid damage to the pins, do
not force a connector into its plug. If the pins are damaged, the mix bar does not
rotate, or the liquid level sensors do not function.
Important
When reinstalling the mixing component, confirm that the tubing is not pinched
between the mixing component and its stand.
14 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
Note
You may need to repeat this step five times. If bubbles are in the tubing after
priming, confirm that the electrodes and tubing are installed correctly, and the
electrodes are secured with the lock lever.
17 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
18 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
B71495AF 6-163
Maintenance
ISE As Needed Maintenance
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Clean, dry, lint-free absorbent tissue
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
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Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
Important
Always drain the flow cell before moving the lock lever to release the electrode block. If
the ISE Reference Solution is not drained, ISE Reference Solution can flow up into the
electrodes and cause problems with the electrode measuring capability. ISE Reference
Solution only flows past the REF electrode (not Na, K, or Cl electrode) in normal
operation. ISE Reference Solution is more concentrated than the ISE MID Standard
Solution or samples that flow through the flow cell.
Caution
When lifting the electrodes, use your hand to support the electrodes. Do not lift
out the electrodes by the wires when they are still connected.
B71495AF 6-165
Maintenance
ISE As Needed Maintenance
1. O-ring
5 Use a squeeze bottle to dispense deionized water to clean the O-ring and O-ring groove
of the electrode. Deionized water that gets into the electrode flow cell does not cause a
problem.
6 Wipe the side face (location B in ISE Tubing Block Diagram) of the REF electrode block
that contacts the K electrode using a clean, dry, lint-free absorbent tissue dampened
with deionized water.
7 Using a clean, dry, lint-free absorbent tissue, sufficiently dry the K electrode, O-ring, and
REF electrode block surfaces.
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9 Install the three electrodes on the electrode block. Install the electrodes according to
the label of Cl, Na, and K from the electrode block inlet side to the REF electrode block
side.
Important
The system uses four O-rings in the electrode block. The O-ring attaches to the
outlet side of each electrode and the metal part that contacts the Cl electrode
(location A in ISE Tubing Block Diagram). Do not lose the O-rings when removing the
electrodes.
10 Move the lock lever to the right to lock the electrodes in position.
11 Confirm that Drain Flow Cell is selected.
12 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
Note
You may need to repeat this step five times. If bubbles are in the tubing after
priming, confirm that the electrodes and tubing are installed correctly, and the
electrodes are secured with the lock lever.
15 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
16 Wait a minimum of 5 minutes after closing the covers, and then perform a calibration.
B71495AF 6-167
Maintenance
ISE As Needed Maintenance
Important
To obtain the best possible analysis data, perform two calibration measurements to
confirm the electrode stability:
Table 6.40 Acceptable Differences Between First and Second MID Solution Factors
Na K Cl
— If the difference between the first and second MID Solution factors is smaller than
or equal to the value in the preceding table, the electrode is stable.
— If the difference between the first and second MID Solution factors is larger than
the value in the preceding table or if the slope of the first calibration curve is 0,
bubbles may remain in the flow cell. Perform a MID/REF prime.
1. Lift the upper cover.
2. Open the ISE cover.
3. Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4. Select the ISE Maintenance box. The system activates the maintenance
operation buttons.
5. Select MID/REF Prime. The system displays the MID/REF Prime dialog.
6. Select OK.
7. Press the DIAG/TABLE ROTATION button.
8. Close all the analyzer doors and covers.
9. Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
10. Repeat the ISE calibration two more times and compare the results to the chart.
— If the slopes of the first and second calibration curves are both 0, the electrodes
might not have been installed correctly.
Repeat the Replace the Na, K, or Cl Electrode procedure to confirm that you have
installed the electrodes correctly.
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For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• REF Electrode Block
• 2% Wash solution
• Plastic tweezers
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
B71495AF 6-169
Maintenance
ISE As Needed Maintenance
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
Important
Always drain the flow cell before moving the lock lever to release the electrode block. If
the ISE Reference Solution is not drained, ISE Reference Solution can flow up into the
electrodes and cause problems with the electrode measuring capability. ISE Reference
Solution only flows past the REF electrode (not Na, K, or Cl electrode) in normal
operation. ISE Reference Solution is more concentrated than the ISE MID Standard
Solution or samples that flow through the flow cell.
Important
The system uses four O-rings in the electrode block. The O-ring attaches to the
outlet side of each electrode and the metal part that contacts the Cl electrode
(location A in the ISE Tubing Block Diagram). Do not lose the O-rings when removing
the electrodes.
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Caution
When lifting the electrodes, use your hand to support the electrodes. Do not lift
out the electrodes by the wires when they are still connected.
3 Disconnect the REF electrode wire (green) from the REF electrode.
Caution
Handle the REF electrode wire (green) from the end to avoid damage to the wire.
6 Remove the REF electrode packing in the block with a pair of plastic tweezers.
7 While holding the REF electrode block by hand, pull the REF electrode block-side drain
tubing (labeled 6) out of the REF electrode block.
8 Remove the REF solution tubing (refer to Figure 6.98 ISE REF Electrode Block)
connected to the lower side of the REF electrode block.
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Maintenance
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Important
To prevent the REF electrode block from becoming deformed from ultrasonic
cleaning, follow these precautions. If the REF electrode block has been deformed or
cracked, replace it.
— Do not perform ultrasonic cleaning for more than 10 minutes.
— Use a cleaning liquid at room temperature.
— Use a sonicator rated at 600 W or less. If the output of the sonicator is uncertain,
contact the manufacturer of the sonicator.
— If a sonicator is not available, soak it in the 2% wash solution for more than 30
minutes.
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Confirm that 2% wash solution can flow through the flow path in the REF electrode
block.
10 Thoroughly rinse the REF electrode block in deionized water, and dry with a clean, dry,
lint-free absorbent tissue. If you are replacing the REF electrode block, obtain a new
REF electrode block.
11 Attach the REF electrode block-side drain tubing (labeled 6) and the REF solution
tubing (refer to Figure 6.98 ISE REF Electrode Block) to the cleaned or a new REF
electrode block.
B71495AF 6-173
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12 Confirm that no air bubbles are in the REF electrode tip. If air bubbles are found in the
tip, remove the bubbles by pointing the electrode tip downward while tapping it with a
finger.
13 Insert the REF electrode packing into the REF electrode block. Confirm that the packing
is not cracked or broken. If so, replace the packing.
14 Place the cap screw on the REF electrode, then place the REF electrode in the REF
electrode block so that the electrode tip is centered in the packing.
Note
Dampen the REF electrode tip with deionized water if you have difficulty inserting
the REF electrode into the REF electrode block.
15 Insert the cap screw into the REF electrode block and screw it in carefully. Finish
tightening the cap screw by a quarter or half turn to orient the REF electrode correctly.
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23 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
Note
You may need to repeat this step five times. If bubbles are in the tubing after
priming, confirm that the electrodes and tubing are installed correctly, and the
electrodes are secured with the lock lever.
26 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
27 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
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ISE As Needed Maintenance
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• ISE Cleaning Solution diluted 1:10
• ISE MID Standard Solution
• Pipette (2 pieces) (that is commercially available and can collect more than 1 mL of
liquid)
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
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Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle ISE Cleaning Solution. If the ISE Cleaning Solution contacts skin or clothes,
rinse the affected area thoroughly with water. If the ISE Cleaning Solution contacts
the eyes or mouth, immediately flush with water. Seek medical attention. Refer to the
Safety Data Sheets (SDS) for more information. Follow your laboratory procedure to
wipe up spills immediately.
1 Disconnect the level sensor connector 714 and mixing motor connector 706.
2 Loosen the knob securing the mixing component. Gently lift the mixing component to
unseat it.
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5 For the first 2 minutes, pipette the ISE Cleaning Solution into the sample pot while
manually turning the right roller pump component clockwise until most of the ISE
Cleaning Solution empties from the sample pot into the tubing. Continue filling the
sample pot with the ISE Cleaning Solution while turning the roller pump component.
Do not completely empty the sample pot before adding more ISE Cleaning Solution.
Confirm that the tubing is filled with the ISE Cleaning Solution.
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6 Let the ISE Cleaning Solution remain in the tubing for 5 minutes.
7 Manually turn the roller pump to clear the ISE Cleaning Solution from the tubing.
8 Pipette 10 mL of ISE MID Standard Solution into the sample pot and manually turn the
roller pump to clear the ISE MID Standard Solution. Repeat 3 times.
9 Put the mixing component back on the two positioning pins. Tighten the knob to secure
the mixing component.
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Important
When reinstalling the mixing component, confirm that the tubing is not pinched
between the mixing component and its stand.
10 Reconnect the level sensor connector 714 and mixing motor connector 706.
Important
The connectors are specially keyed to fit each plug. To avoid damage to the pins, do
not force a connector into its plug. If the pins are damaged, the mix bar does not
rotate, or the liquid level sensors do not function.
11 Insert the tubing into the grooves of the pinch valve. Confirm that the tubing is inserted
completely into the groove. Put tubing labeled 6 in the bottom groove of the pinch valve,
and put tubing labeled 5 in the top groove of the pinch valve.
12 Select MID/REF Prime. The system displays the MID/REF Prime dialog.
13 Select OK.
17 Select OK.
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If syringe performance is questionable because of abnormal data, remove and inspect the
syringe.
Materials Required:
• R Syringe
• Buffer syringe case
• Clean, dry, lint-free absorbent tissue
Caution
Do not remove the piston from a new syringe. If you remove the piston, the
performance of the syringe can be unreliable.
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4 Pull the syringe case forward to remove it from the mounting grooves.
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Caution
If your skin, eyes, or mouth contact any liquid, immediately rinse the affected
area with water. Follow your laboratory procedure.
Important
When removing the syringe case, hold the bottom with a clean, dry, lint-free
absorbent tissue. Do not bend the tubing when removing the syringe case.
5 Tilt the syringe case upside down before removing the syringe. Tilting the syringe case
prevents air from entering the tubing lines and keeps the water from leaking into the
syringe case.
6 Remove the case body by turning it counterclockwise while holding the case head. Pull
the syringe from the case head.
Do not lose the O-ring, which can drop from the case head. If the O-ring remains in the
case head, carefully remove it with a pair of tweezers.
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ISE As Needed Maintenance
1. Case head
2. O-ring
3. Syringe
4. Case body
4 Reinstall the syringe by placing the case head into the mounting groove. Align the
syringe piston into the drive shaft.
5 Tighten the top fixing nut until you hear a clicking sound.
6 Tighten the bottom piston fixing screw.
1 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
2 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
6-184 B71495AF
6
Maintenance
ISE As Needed Maintenance
3 Select Buffer Prime. The system displays the Buffer Prime dialog.
4 Select OK.
6 If there are bubbles in the syringe after priming, repeat the prime until all bubbles are
cleared. If you cannot clear the bubbles after the prime, perform the corrective actions.
For more information, refer to Corrective Actions if Prime Fails for the ISE Buffer
Syringe.
9 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
1 Loosen the bottom piston fixing screw and the top fixing nut to remove the syringe case
from the mounting grooves.
2 Pull the syringe case forward to remove it from the mounting grooves.
Caution
If your skin, eyes, or mouth contact any liquid, immediately rinse the affected
area with water. Follow your laboratory procedure.
Important
When removing the syringe, hold the bottom with a clean, dry, lint-free absorbent
tissue. Do not bend the tubing when removing the syringe.
Important
Do not apply excessive force to the fixing screws when you remove the syringe case.
Excessive force to the fixing screws damages the syringe case.
3 Slowly move the syringe piston up and down by hand. Confirm that there are no
bubbles on the syringe tip.
If you see bubbles, move the piston up and down until the bubbles are purged.
B71495AF 6-185
Maintenance
ISE As Needed Maintenance
Caution
Do not move the piston by hand with the case body and case head disconnected.
If you move the syringe piston with the case body and case head disconnected,
the accuracy is not retained because of the deformation of the piston. This
deformation can decrease the time a syringe is in use before requiring
replacement.
Note
This figure illustrates the disconnected case body and case head to show the
location to inspect for bubbles. Do not disconnect the case body from the case head
to confirm that there are no bubbles.
4 Reinstall the syringe by placing the syringe case into the mounting groove. Align the
syringe piston into the drive shaft.
5 Tighten the top fixing nut until you hear a clicking sound.
6 Tighten the bottom fixing nut.
6-186 B71495AF
6
Maintenance
ISE As Needed Maintenance
Warning
Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats,
to handle ISE Cleaning Solution. If the ISE Cleaning Solution contacts skin or clothes,
rinse the affected area thoroughly with water. If the ISE Cleaning Solution contacts
the eyes or mouth, immediately flush with water. Seek medical attention. Refer to the
Safety Data Sheets (SDS) for more information. Follow your laboratory procedure to
wipe up spills immediately.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Mix Bar
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
B71495AF 6-187
Maintenance
ISE As Needed Maintenance
1 Disconnect the level sensor connector 714 and mixing motor connector 706.
2 Loosen the knob securing the mixing component. Gently lift the mixing component to
unseat it.
Important
When removing the mix bar, hold the connecting tubing in position on the mixing
component.
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6
Maintenance
ISE As Needed Maintenance
1 Put the mixing component back on the two positioning pins. Tighten the knob to secure
the mixing component.
Important
When reinstalling the mixing component, confirm that the tubing is not pinched
between the mixing component and its stand.
2 Reconnect the level sensor connector 714 and mixing motor connector 706.
Important
The connectors are specially keyed to fit each plug. To avoid damage to the pins, do
not force a connector into its plug. If the pins are damaged, the mix bar does not
rotate, or the liquid level sensors do not function.
3 Perform a total prime to prime the ISE with fresh ISE Buffer Solution, ISE MID Standard
Solution, and ISE Reference Solution.
During the prime, confirm that buffer solution and MID Standard solution are correctly
dispensed into the sample pot and flow to waste without generating events. Also,
confirm that the mix bar rotates without contacting the sample pot. The mix bar makes
a mechanical noise when it contacts the sample pot.
a. Select Total Prime. The system displays the Total Prime dialog.
b. Select OK.
c. Press the DIAG/TABLE ROTATION button to start the prime. The DIAG/TABLE
ROTATION LED turns on after the prime is complete.
B71495AF 6-189
Maintenance
ISE As Needed Maintenance
5 Clear the ISE Maintenance box to deactivate the maintenance operation buttons.
6 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
CRS calibration is available when MCAL Factor Type is programmed to CRS Calibration in
CONFIG. > Calibration Setup > ISE.
Caution
When analysis is in process or the ISE status is Busy, do not add Standard Solutions or
place hands in the path of the sample probe.
Note
Note
Before performing CRS Calibration, be sure to clean and calibrate the ISE first. For more
information, refer to Clean the ISE and Calibrate the ISE.
Materials Required:
• CRS Standard Solution High
• CRS Standard Solution Mid
• CRS Standard Solution Low
• Hitachi Cup (3 cups)
6-190 B71495AF
6
Maintenance
ISE As Needed Maintenance
1. CRS-L 3. CRS-H
2. CRS-M
Table 6.41 CRS Standard Solution Position
CRS Standard Solution Position
B71495AF 6-191
Maintenance
ISE As Needed Maintenance
Factor Factors A and B for Na, K, and Cl that were calculated from each round
of CRS calibration results.
Factor A Acceptable Range Upper and lower limits of factor A. The system highlights factors
exceeding the range in yellow.
6-192 B71495AF
6
Maintenance
ISE As Needed Maintenance
16 Remove the Hitachi cups from the STAT table and discard.
17 Close all the analyzer doors and covers.
Note
You can perform Replace ISE Tubing instead of performing Manually Clean the Sample
Pot Tubing and Bypass Tubing procedure. For more information, refer to Replace ISE
Tubing.
Note
The sample pot tubing and bypass tubing can become clogged and cause erroneous
calibration or QC results after running the following samples:
• Large-volume dialysis patient samples
• LIH (lipemic, icteric, or hemolyzed) sample
• Serum sample that contains fibrin because centrifugal separation was not correctly
conducted
• Serum sample that contains separator material which was aspirated because the serum
volume was too low, or centrifugal separation was not correctly conducted.
Note
If the sample pot tubing or bypass tubing frequently becomes clogged, confirm that
samples are correctly prepared.
Important
Always prepare the ISE for maintenance procedures. The preparation procedure
prevents the automatic ISE MID Standard Solution periodic (hourly) priming cycle from
dispensing ISE MID Standard Solution.
B71495AF 6-193
Maintenance
ISE As Needed Maintenance
3 Select MAINT. > ISE Maintenance > Maintenance. The system displays the ISE
Maintenance: Maintenance tab.
4 Select the ISE Maintenance box. The system activates the maintenance operation
buttons.
5 Select Drain Flow Cell. The system displays the Drain Flow Cell dialog.
6 Select OK.
Note
The first time you press the DIAG/TABLE ROTATION button, liquid is drained from
the flow cell. Each additional time you press the DIAG/TABLE ROTATION button, the
system primes ISE MID Standard Solution through the flow cell.
6-194 B71495AF
6
Maintenance
ISE As Needed Maintenance
1 Disconnect the level sensor connector 714 and mixing motor connector 706.
2 Loosen the knob securing the mixing component. Gently lift the mixing component to
remove it and place it on the mixing component holder.
3 Loosen the retaining knob securing the sample pot, and lift the pot from the peg.
4 Disconnect the sample pot tubing from the sample pot by unscrewing the connector. Put
the sample pot aside.
5 Disconnect the other end of the sample pot tubing from the electrode block inlet.
6 Remove the bypass tubing labeled 5 from the top groove of the pinch valve.
7 Disconnect the bypass tubing from the Y-connector near the mixture aspiration roller
pump.
For more information on materials required, refer to Parts List for ISE Maintenance.
Materials Required:
• Freshly prepared 1% wash solution
• Deionized water
• Clean, dry, lint-free absorbent tissue
• Sonicator
• Beaker
• Squeeze bottle with disposable pipette tip or syringe with disposable pipette tip
1 Fill the sample pot tubing and bypass tubing with 1% wash solution. Use a disposable
pipette tip attached to a squeeze bottle or a syringe to fill the sample pot tubing and
bypass tubing.
1. Attach the pipette tip or syringe to either end of the sample pot tubing.
2. Force the 1% wash solution through the sample pot tubing.
3. Attach the pipette tip or syringe to the end of the bypass tubing.
4. Force the 1% wash solution through the bypass tubing.
B71495AF 6-195
Maintenance
ISE As Needed Maintenance
2 Submerge the sample pot tubing and bypass tubing into a beaker filled with 1% wash
solution.
3 Place the beaker in the sonicator filled with deionized water and sonicate for 10
minutes.
4 Rinse the sample pot tubing and bypass tubing with deionized water.
1. Attach the pipette tip or syringe to either end of the sample pot tubing.
2. Force deionized water through the sample pot tubing.
3. Attach the pipette tip or syringe to the end of the bypass tubing.
4. Force deionized water through the bypass tubing.
5. Confirm that the lines have been flushed thoroughly.
5 Use a clean, dry, lint-free absorbent tissue to dry the sample pot tubing and bypass
tubing before reconnecting them.
Note
If the sample pot tubing or bypass tubing remains clogged, or the system continues
to generate erroneous calibration or QC results, perform the Replace ISE Tubing
procedure. For more information, refer to Replace ISE Tubing.
6-196 B71495AF
6
Maintenance
ISE As Needed Maintenance
4 Connect the bypass tubing to the Y-connector located near the mixture aspiration roller
pump.
5 Insert the bypass tubing in the top groove of the pinch valve. Confirm that the tubing is
inserted completely into the groove.
6 Put the mixing component back on the two positioning pins. Tighten the knob to secure
the mixing component.
7 Reconnect the level sensor connector 714 and mixing motor connector 706.
Important
The connectors are specially keyed to fit each plug. To avoid damage to the pins, do
not force a connector into its plug. If the pins are damaged, the mix bar does not
rotate, or the liquid level sensors do not function.
Important
When reinstalling the mixing component, confirm that the tubing is not pinched
between the mixing component and its stand.
2 Press the DIAG/TABLE ROTATION button to reprime the lines with ISE MID Standard
Solution. Confirm that liquid is correctly dispensed from the sample pot to the flow cell
and that there are no bubbles in the REF electrode block side drain tubing labeled 6.
Note
You may need to repeat this step five times. If bubbles are in the tubing after
priming, confirm that the electrodes and tubing are installed correctly, and the
electrodes are secured with the lock lever.
3 Select Total Prime. The system displays the Total Prime dialog.
4 Select OK.
5 Press the DIAG/TABLE ROTATION button to start the prime. The DIAG/TABLE ROTATION
LED turns on after the prime is complete.
8 Update the Maintenance Log. For more information, refer to Update the Maintenance
Log.
B71495AF 6-197
Maintenance
ISE As Needed Maintenance
9 To confirm that the ISE is working correctly after the maintenance procedure, perform a
calibration.
6-198 B71495AF
CHAPTER 7
Flags
Flags
The system generates flags when the system encounters a condition that can affect the
result. This condition can range from minor warnings to severe errors that require
attention immediately. Review each flag and identify the root cause, and perform the
corrective action.
Do not report any result with an unresolved or unexpected flag. When in doubt, always
consider rerunning the sample analysis, and diluting or condensing the sample if necessary.
This chapter contains a list of all flags in priority order, suggestions of their cause, and
action to take.
The priority determines what flags you see if a result generates multiple flags. A maximum
of four flags can display.
B71495AF 7-1
Flags
Flags
7-2 B71495AF
7
Flags
Flags
B71495AF 7-3
Flags
Flags
7-4 B71495AF
7
Flags
Flag Details
Flag Details
B71495AF 7-5
Flags
Flag Details
Important
7-6 B71495AF
7
Flags
Flag Details
B71495AF 7-7
Flags
Flag Details
%: Clot detected
Possible Cause Corrective Action
The sample probe is blocked or partially blocked
1. Review all other results that were generated
during sample aspiration.
on the same sample before generating the flag
to confirm validity and consistency (no
extremely low or high values).
2. Confirm that the sample is free of clots, and
remove any that are in the sample. If
necessary, centrifuge the sample and rerun
analysis.
3. If the error still occurs, clean or replace the
sample probe. For more information, refer to
Clean the Sample Probe and Mix Bars or
Replace a Sample or Reagent Probe.
7-8 B71495AF
7
Flags
Flag Details
M: Duplicate sample ID
Possible Cause Corrective Action
A duplicate sample ID has been read within the
1. Confirm that the results of the samples with
samples in process.
the duplicate sample ID are correct.
2. Follow laboratory procedure.
B71495AF 7-9
Flags
Flag Details
Y: Reagent Blank OD exceeds the high limit set at the last photometric read point
Possible Cause Corrective Action
Reagent blank OD is higher than the Reagent OD
1. Inspect the reagent expiration and onboard
Limit range defined for the last photometric point.
The Reagent OD Limit range is programmed in expiration date.
CONFIG. > Test Volume and Methods > 2. Confirm that the reagent has been prepared
General. correctly.
3. Replace the reagent and rerun analysis.
Possible causes for this problem are:
4. Confirm that the Reagent OD Limit range
• Reagent expired. programmed in CONFIG. > Test Volume and
• Reagent contamination. Methods > General is correct.
• Incorrectly prepared reagents.
• Incorrect range programmed.
U: Reagent Blank OD exceeds the lower limit set at the last photometric read point
Possible Cause Corrective Action
Reagent blank OD is lower than the Reagent OD
1. Inspect the reagent expiration and onboard
Limit range defined for the last photometric point.
The Reagent OD Limit range is programmed in expiration date.
CONFIG. > Test Volume and Methods > 2. Confirm that the reagent has been prepared
General. correctly.
3. Replace the reagent and rerun analysis.
Possible causes for this problem are:
4. Confirm that the Reagent OD Limit range
• Reagent expired. programmed in CONFIG. > Test Volume and
• Reagent contamination. Methods > General is correct.
• Incorrectly prepared reagents.
• Incorrect range programmed.
y: OD at the first photometric point for reagent blank or patient sample is high
Possible Cause Corrective Action
The first photometric point OD of the reagent
1. Inspect the reagent expiration and onboard
blank or the OD at P0 of patient sample is higher
than the Reagent OD Limit range defined for the expiration date.
first photometric point. Reagent OD Limit is 2. Confirm that the reagent has been prepared
programmed in CONFIG. > Test Volume and correctly.
Methods > General. 3. Replace the reagent and rerun analysis.
Possible causes for this problem are: 4. Confirm that the Reagent OD Limit range
programmed in CONFIG. > Test Volume and
• Reagent expired.
Methods > General is correct.
• Reagent contamination.
• Incorrectly prepared reagents.
• Incorrect range programmed.
7-10 B71495AF
7
Flags
Flag Details
u: OD at the first photometric point for reagent blank or patient sample is low
Possible Cause Corrective Action
The first photometric point OD of the reagent
1. Inspect the reagent expiration and onboard
blank or the OD at P0 of patient sample is lower
than the Reagent OD Limit range defined for the expiration date.
first photometric point. The Reagent OD Limit 2. Confirm that the reagent has been prepared
range is programmed in CONFIG. > Test Volume correctly.
and Methods > General. 3. Replace the reagent and rerun analysis.
Possible causes for this problem are: 4. Confirm that the Reagent OD Limit range
programmed in CONFIG. > Test Volume and
• Reagent expired.
Methods > General is correct.
• Reagent contamination.
• Incorrectly prepared reagents.
• Incorrect range programmed.
B71495AF 7-11
Flags
Flag Details
7-12 B71495AF
7
Flags
Flag Details
B71495AF 7-13
Flags
Flag Details
7-14 B71495AF
7
Flags
Flag Details
• Unusually high result. 3. Clean all mix bars and inspect them for
• Contaminated reagent. damage. For more information, refer to
Inspect the Sample Probe, Reagent Probes,
• Dirty or defective mix bars.
and Mix Bars. Replace any that have scratches
• Reagent or sample probe alignment problem.
or chips in the fluororesin coating. For more
• Outer cuvette walls or the cuvette wheel is
information, refer to Replace the Mix Bars.
wet.
• Defective cuvettes. 4. Confirm that the sample probe and reagent
• Deteriorated lamp. probe alignment. If the probe is bent, replace
the probe. For more information, refer to
• The concentration is close to zero for
toxicology analysis using the RATE reaction Replace a Sample or Reagent Probe.
method. 5. Confirm that the cuvette wheel is not wet. If
the cuvette wheel is wet, perform appropriate
corrective actions. For more information, refer
to Recovering from a Cuvette Wheel Overflow
and Clean the Cuvettes and the Cuvette
Wheel.
6. Perform a photocal to assess the lamp and
cuvette integrity. Replace the lamp or cuvettes
as required and perform another photocal. For
more information, refer to Replace the
Photometer Lamp, Clean or Replace Individual
Cuvettes or Perform a Photocal.
7. No action required. If the method is RATE, the
reverse reaction check is performed. If the
concentration is close to zero, the reaction
curve is flat and triggers the * flag. Confirm
that there is no other cause for the * flag
before reporting the result.
B71495AF 7-15
Flags
Flag Details
Z: Prozone error
Possible Cause Corrective Action
One of the mathematical logic checks in CONFIG. Dilute the sample and rerun analysis.
> Data Check Parameters failed. This is often
caused by an abnormally high concentration of
analyte in a sample.
7-16 B71495AF
7
Flags
Flag Details
— Reagent quality
— Calibration
— Sample integrity
— General system issues
3. Analyze the reaction data including the
reaction data processed immediately before
and after the flagged result. In the presence of
any abnormality, inspect the cuvettes and
cuvette wheel for a possible overflow. If the
cuvette wheel is wet, perform appropriate
corrective actions. For more information, refer
to Recovering from a Cuvette Wheel Overflow
and Clean the Cuvettes and the Cuvette
Wheel.
4. If the flag is generated on Na, K, or Cl, rerun a
sufficient number of samples which preceded
the appearance of the ! flag in order to
confirm that the system did not report
incorrect results. It is possible that air in the
flow cell affected samples before the system
generated the ! flag.
B71495AF 7-17
Flags
Flag Details
): Reagent lot number used for sample analysis is different from the lot number used for RB/
Calibration
Possible Cause Corrective Action
The reagent lot number does not match the
1. Calibrate the reagent used for the test that
calibrated reagent lot number.
generated the flag.
2. Calculate the results manually by selecting
RESULT > Sample Manager > Main. Select
Recalculate Data [F5].
3. Perform a QC.
a: Reagent expired
Possible Cause Corrective Action
The reagent has either expired or has been on Replace the reagents and perform a reagent check
board beyond the period defined in CONFIG. > and a calibration if necessary.
Test Volume and Methods.
bh: Reagent blank or calibration failed, and the result was calculated with historical data
Possible Cause Corrective Action
Reagent blank or calibration failed, and the result
1. Perform a calibration. For more information,
was calculated with historical data. Results can be
erroneous and must not be reported. refer to Calibrate Tests.
2. Review calibration in MENU > Calibration >
Calibration Monitor.
3. Rerun samples using a valid calibration.
7-18 B71495AF
7
Flags
Flag Details
B71495AF 7-19
Flags
Flag Details
P: Positive
Possible Cause Corrective Action
Qualitative result: Sample result exceeds the upper Follow laboratory procedure.
value. The upper value is programmed in CONFIG.
> Test Volume and Methods > Range. Select
Flag in the Value/Flag to enable programming in
the Level High field. Results over the Level High
generate the P flag.
7-20 B71495AF
7
Flags
Flag Details
N: Negative
Possible Cause Corrective Action
Qualitative result: Sample result is lower than the Follow laboratory procedure.
low value. The low value is programmed in
CONFIG. > Test Volume and Methods > Range.
Select Flag in the Value/Flag to enable
programming in the Level Low field. Results
under the Level Low generate the N flag.
B71495AF 7-21
Flags
Flag Details
7-22 B71495AF
7
Flags
Flag Details
1Q: QC data exceeds the range entered in Single Check Level field
Possible Cause Corrective Action
One point of QC data exceeds the SD defined in If QC results fall outside the acceptable range,
the Single Check Level in CONFIG. > QC Setup > investigate the cause before deciding whether to
Check. For more information, refer to the DxC 700 report patient results. If any trends or sudden
AU Reference Manual. shifts in values are detected, review all operating
parameters. Follow laboratory procedure for out-
of-range QC results such as:
B71495AF 7-23
Flags
Flag Details
6Q: A preset number of consecutive QC results fall on one side of the mean
Possible Cause Corrective Action
Results for a preset number (7 to 10) of If QC results fall outside the acceptable range,
consecutive data points fall either above or below investigate the cause before deciding whether to
the mean. The setting is programmed in Multi report patient results. If any trends or sudden
Check Level in CONFIG. > QC Setup > Check. For shifts in values are detected, review all operating
more information, refer to the DxC 700 AU parameters. Follow laboratory procedure for out-
Reference Manual. of-range QC results such as:
7-24 B71495AF
7
Flags
Flag Details
r: Result has been transferred to Laboratory Information System through online communication
Possible Cause Corrective Action
Result transferred to the Laboratory Information No action required.
System.
B71495AF 7-25
Flags
Application of Flags (F, G, p, J, K, H, L, P, and N) During Calculation of Final Result Flowchart
Beckman Coulter programs Manufacturer Factor, and the system displays the setting in
CONFIG. > Test Volume and Methods. A is a multiplication factor and B is an addition and
subtraction factor.
If you manually diluted the sample, enter the dilution rate in Sample Dilution Rate in TEST >
Rack (Patient) > Test Order or TEST > STAT (Patient) > Test Order.
The concentration is corrected using Pre-Dilution Rate defined in CONFIG. > Test Volume and
Methods (for first run) or in CONFIG. > Rerun Test Parameters (for rerun).
7-26 B71495AF
7
Flags
Application of Flags (F, G, p, J, K, H, L, P, and N) During Calculation of Final Result Flowchart
The concentration is also corrected for the sample and reagent volumes defined in Test
Volume and Methods (for first run) or in Rerun Test Parameters (for rerun).
Example 1
The concentration of this sample fell within the analytical measuring range and neither G
nor F flag was generated. The final result became 300.
Example 2
The concentration of this sample fell within the analytical measuring range and neither F
nor G flag was generated. The final result became 600 after the concentration was
multiplied by the sample dilution rate of 2.
Example 3
The concentration of this sample exceeded the upper limit of the analytical measuring
range and an F flag was generated. The final result became 300F after the concentration
was corrected with the correlation factor A of 0.5.
B71495AF 7-27
Flags
Application of Flags (F, G, p, J, K, H, L, P, and N) During Calculation of Final Result Flowchart
7-28 B71495AF
CHAPTER 8
Troubleshooting
Introduction
Regular preventative maintenance is essential for optimum system performance. Many
problems outlined in this chapter are caused by neglecting to perform preventative
maintenance and required care.
For each aspect of troubleshooting, you can find useful information by referring to the
corresponding section of the maintenance chapter.
For more information, refer to Maintenance.
4 Review reagent blank data in MENU > Calibration > Calibration Monitor > RB History and
RB Detail.
Calibration Data
1 Select EVENT to review the Event Log for any calibration events.
7 Review calibration data in MENU > Calibration > Calibration Monitor > Calibration History
and Calibration Detail.
B71495AF 8-1
Troubleshooting
QC Data
QC Data
8-2 B71495AF
8
Troubleshooting
Troubleshooting Reagents, Calibrators, Control Samples, and Patient Samples
— Inspect the reagent probes. For more information, refer to Inspect the Sample
Probe, Reagent Probes, and Mix Bars.
— Clean the reagent probes. For more information, refer to Clean the R1 or R2
Reagent Probes.
— Clean the reagent probe wash wells. For more information, refer to Clean the
Sample Probe Wash Well, Reagent Probe Wash Wells, and Whole Blood Wash Well.
— Replace the reagent probes. For more information, refer to Replace a Sample or
Reagent Probe.
• Reagent Syringes
— Inspect the reagent syringes. For more information, refer to Inspect the Syringes
for Leaks.
— Replace the reagent syringes. For more information, refer to Replace the Sample
Syringe or Reagent Syringe.
— Replace the sample syringe and wash syringe. For more information, refer to
Replace the Sample Syringe or Reagent Syringe.
Corrective Actions
• Review all Reagent Blank Issues and Corrective Actions.
• Review all Calibration Issues and Corrective Actions.
• Confirm the control sample:
— Confirm that the correct control sample was poured for the QC analysis.
— Confirm the integrity of the control sample: preparation (if required), expiration
date, open-bottle stability, time at room temperature, and contamination.
— Confirm that the control sample was placed in the correct position in the green
rack.
— Confirm that the lot number of the control sample in use and range programmed
in CONFIG. > QC Setup > Controls are correct.
— Rerun with fresh control samples.
8-4 B71495AF
8
Troubleshooting
Troubleshooting Reagents, Calibrators, Control Samples, and Patient Samples
• If there is any suspended matter present in urine to be tested, centrifuge the sample
before testing.
• If a sample requires pretreatment depending on the analysis test, refer to the relevant
reagent IFU.
• A minimum quantity of sample is required for analysis. Confirm that a sufficient
quantity of sample is available for analysis. For more information, refer to Sample
Preparation.
• Do not fill cups or tubes up to the rim with sample. If you overfill cups or tubes, sample
may splash during rack transport and lead to rack jams.
• To prevent sample evaporation, do not leave samples uncovered for an extended time.
Evaporation can cause biased results.
• Bubbles on the surface of samples, control samples, and calibrators, can cause level
sensing problems or erroneous results. Confirm that all bubbles are removed from the
surface of the sample before placing onto the system.
• Confirm that the sample cups are placed correctly on the racks and the racks are placed
correctly on the rack input area. For more information, refer to Place the Sample Cups
or Tubes in the Rack.
• Inspect the serum for the extent of hemolysis, lipemia, bilirubin, and other sample
quality issues according to your laboratory procedure.
• If the sample has evaporated or deteriorated, or if the control sample was incorrectly
prepared, obtain a new sample or correctly prepare the control sample and rerun
analysis.
• Precautions when using whole blood (HbA1c):
— Clean the outside of the sample probe with an alcohol prep (70% Isopropyl
alcohol) as required to remove coagulated blood adhering to the outside of the
sample probe. Coagulated blood causes increased water being carried on the
outside of the sample probe.
— If the blood has coagulated, obtain a new sample.
— If the blood cells have precipitated, mix the whole blood by inverting gently.
B71495AF 8-5
Troubleshooting
Mechanical Problems
Mechanical Problems
Syringe Problems
Inspect for:
• Water leaking at syringes: Tighten the tube connectors of the sample and reagent
syringes.
Also, confirm that there is no damage to sample and reagent syringes, and that there is
no abrasion on the pistons. For more information, refer to Replace the Sample Syringe
or Reagent Syringe.
• Bubbles in the tubing connected to the syringe: Select MAINT. > Analyzer Maintenance
> Maintenance. Then select Prime Washing Line and press the DIAG/TABLE ROTATION
button to start removing air from the tubing. For more information, refer to Replace
the Sample Syringe or Reagent Syringe.
• General Syringe Troubleshooting:
— Confirm that the top and bottom screws are tightened.
— Confirm that the bottom screw is finger tight against the piston. Over-tightening
damages the syringe.
— Confirm that there is a smooth resistant pull.
— Confirm that the correct size syringe (sample or reagent) is in the correct position.
— Confirm that the syringe is installed on the system correctly.
— Inspect the tubing connected to the syringe head for scratches, bending, or leaks.
— Confirm that the creases in the fluorocarbon polymer tip of the syringe do not
have any buildup or flaking of the fluorocarbon polymer tip.
— Confirm that the probes are not blocked. For more information, refer to Clean the
Sample Probe and Mix Bars and Clean the R1 or R2 Reagent Probes. If the probes
are blocked, syringe operation is affected.
Probe Problems
Inspect for:
• General Probe Troubleshooting:
— Confirm that water dispenses in a straight stream.
— Confirm that the metal screw cap for the probe connection is tight.
8-6 B71495AF
8
Troubleshooting
Mechanical Problems
Clean the wash nozzles. For more information, refer to Clean the Wash Nozzle
Component and Inspect the Tube Mounting Joints.
• After washing the cuvettes, a large amount of water remains in the cuvettes: Inspect
the tube mounting joints and tighten if the manifolds are loose. The wash nozzles can
clog. Clean the wash nozzles.
— For more information on how to clean the wash nozzles, refer to Clean the Wash
Nozzle Component and Inspect the Tube Mounting Joints.
— Remove the excess water from inside the cuvettes, refer to Clean the Cuvettes and
the Cuvette Wheel.
• The tubing in the wash solution tank floats: Straighten the tubing, then insert it toward
the tank bottom so that it does not contact the tank opening.
• The system has trouble with the float sensor in the wash solution tank or the diluted
wash solution tank: Connect the float sensor connector firmly, and move the float
sensor and tubing in the tank so that they do not contact each other. If these changes
do not correct the problem, contact Beckman Coulter to replace the float sensor.
• Some cuvettes are contaminated with foreign matter: Clean the cuvettes. If abnormal
data is not corrected after cleaning the cuvettes or if any cuvettes are broken, replace
those cuvettes. For more information, Clean the Cuvettes and the Cuvette Wheel or
Clean or Replace Individual Cuvettes.
• The cuvette wheel was removed from the analyzer for an extended time, then placed
on the analyzer: Do not use the analyzer immediately. It is necessary to leave the
cuvette wheel in the dry bath incubator for a minimum of an hour for the cuvettes to
stabilize to temperature specifications of 37 °C ± 0.3 °C.
Mixing Problems
• The mix bars are contaminated: Clean the mix bars. For more information, refer to
Clean the Sample Probe and Mix Bars.
• The fluororesin coating on the mix bars is chipped: Replace the mix bars. For more
information, refer to Replace the Mix Bars.
• The mix bar component malfunctions, and there is abnormal noise from the system
during the mixing motion: If there is an audible abnormal noise coming from the mix
bar component, inspect for bent mix bars. If the mix bar is bent, replace the mix bar.
For more information, refer to Replace the Mix Bars. If the mix bars are not bent,
contact Beckman Coulter.
• The wash water and wash solution are not correctly drained from the mix bar wash
wells: Contact Beckman Coulter.
8-8 B71495AF
8
Troubleshooting
Mechanical Problems
• The mix bars are not positioned correctly causing contact between the mix bars and
the mix bar wash well or the cuvettes: If the mix bar is bent, replace the mix bar. For
more information, refer to Replace the Mix Bars. If the mix bar is not bent, contact
Beckman Coulter.
• The mix bars are not correctly installed on the mix bar component, causing insufficient
mixing of the sample and reagents: Install the mix bars correctly. For more information,
refer to Replace the Mix Bars.
B71495AF 8-9
Troubleshooting
Mechanical Problems
• For more information on how to clean the deionized water filter, refer to Clean the
Deionized Water Tank, Deionized Water Filter, and Sample Probe Filter.
• For more information on how to clean the sample probe filter, refer to Clean the
Deionized Water Tank, Deionized Water Filter, and Sample Probe Filter.
• For more information on how to replace the deionized water filter, refer to Replace the
Deionized Water Filter, Sample Probe Filter, and O-ring.
• For more information on how to replace the sample probe filter, refer to Replace the
Deionized Water Filter, Sample Probe Filter, and O-ring.
1 Select HOME and inspect the coolant temperature for the reagent refrigerator.
2 Open the reagent refrigerator and confirm that the reagent bottles are cool.
3 If the problem persists, contact Beckman Coulter.
1 Select HOME and inspect the coolant temperature of the STAT table compartment.
2 Confirm that the large and small STAT table covers are correctly installed. If the covers
are opened frequently or for extended periods of time, the STAT table compartment
temperature increases.
Rack Problems
Inspect for the following general problems:
• Confirm that the rack is clean and that the surface is not sticky. Refer to Clean the Rack.
• Inspect bar code label positioning.
— For more information on attaching the bar code label to the sample rack, refer to
the DxC 700 AU Reference Manual.
— For more information on placing the sample cups or tubes in the rack, refer to
Place the Sample Cups or Tubes in a Rack.
• Confirm that the rack was loaded correctly.
For more information on loading racks, refer to Place Racks on the Rack Input Area.
• Confirm that the correct number of magnets are in the bottom of the rack. Compare the
configuration of magnets on the underside of the rack with the magnets on another
rack of the same color. The configuration for the two racks must be identical. Discard
the rack if a magnet is missing.
• If a rack jam occurs, refer to Rack Jams.
8-10 B71495AF
8
Troubleshooting
System Problems
White Position 1
Green Position 3
Red Position 2
System Problems
B71495AF 8-11
Troubleshooting
System Problems
• Deionized water tank empty event: The ion-exchange capability of the deionizer can be
insufficient. Replace the deionizer if it does not meet required specifications. Inspect
the deionized water filter. If it has become dirty or blocked, clean or replace it.
— For more information on cleaning the Deionized Water Filter and the Sample
Probe Filter, refer to Clean the Deionized Water Tank, Deionized Water Filter, and
Sample Probe Filter.
— For more information on replacing the Deionized Water Filter and the Sample
Probe Filter, refer to Replace the Deionized Water Filter, Sample Probe Filter, and
O-ring.
• For all other sources of noise, contact Beckman Coulter.
8-12 B71495AF
8
Troubleshooting
System Problems
Warning
Never look directly into the bar code readers. The laser light can cause serious
eye damage.
B71495AF 8-13
Troubleshooting
System Problems
8-14 B71495AF
8
Troubleshooting
System Problems
3 Select the Analyzer Maintenance box. The system activates the maintenance operation
buttons.
5 Select OK to dispense water from the reagent probe and sample probe. If the deionized
water does not dispense normally, a reagent probe or sample probe might be
incorrectly installed. Inspect the reagent probe or sample probe installation. If it is
necessary to replace the probe, refer to Replace a Sample or Reagent Probe.
If the probe is not bent but still aligned incorrectly, contact Beckman Coulter.
Flag [#] (Sample Level Detection Error) Generated during the Sample Dispense Operation
Determine if the sample volume is too low: Confirm that there is sufficient sample for the
ordered tests. Consider the dead volume for the different cups. For more information, refer
to Cups or Tubes Specifications.
Rack Jams
Inspect for:
B71495AF 8-15
Troubleshooting
Computer Problems
• Contamination on the rack: Confirm that nothing has fallen onto the rack and that the
rack ID bar code label, or sample ID bar code labels have not peeled off, causing the
rack to jam. Refer to Rack Problems.
• Rack feeder module is sticky or dusty: Clean surfaces with deionized water using a lint-
free, dampened absorbent tissue.
• Object attaching to the magnet on the bottom of a rack: Inspect for small metal objects
such as staples or paper clips on the magnets on the bottom of a rack. If foreign matter
attaches to the magnet, remove it from the magnet.
Printer Problems
Refer to the printer manual for assistance with all printer troubleshooting.
• Printer is disconnected. Inspect the plug and socket and connecting lead.
• The power to the printer is not turned on. Confirm that the power to the printer is
turned on.
• Printer toner is empty and requires replacement.
• Confirm that the online button is on.
• Confirm that paper is loaded correctly.
Computer Problems
Tip
The incubator remains red in the Home screen until the temperature returns
to 37 °C ± 0.3 °C.
8-16 B71495AF
8
Troubleshooting
Recovering from Powering Off the System by Pressing the ANALYZER STOP Button or Power Loss
• If you are unable to recover from a software crash, contact Beckman Coulter.
Recovering from Powering Off the System by Pressing the ANALYZER STOP Button or
Power Loss
If you press the ANALYZER STOP button, or there is a power failure, the analyzer
immediately stops operation. Power to the incubator and reagent refrigerator is also turned
off.
B71495AF 8-17
Troubleshooting
Recovering from Powering Off the System by Pressing the ANALYZER STOP Button or Power Loss
Caution
If you press the ANALYZER STOP button, or there is a power failure during MEASURE
mode, any data that is not complete is lost and you must reanalyze the samples.
Caution
If you press the ANALYZER STOP button, or there is a power failure, sample can
remain in the sample probe, and reagents can remain in the cuvettes. Perform a W1
to clean the sample probe and cuvettes after you restart the system. For more
information, refer to Perform a W1.
Important
If the system is without power for a lengthy time after you press the ANALYZER STOP
button, or there is a power failure, confirm the reagent integrity before resuming
analysis.
1 Press the ANALYZER STOP button (black). The operation of the analyzer and the ISE
module immediately stop.
The computer remains On and must be turned off.
2 Select [Ctrl] + [ALT] + [Delete] from the keyboard to display the windows screen.
Return to STANDBY Mode After Powering Off the System by Pressing the ANALYZER STOP Button
3 Press the ON button (green). The lamp turns on and the software loads. The system
displays a dialog to confirm retrieving the database.
4 Select OK.
8-18 B71495AF
8
Troubleshooting
RTWB Troubleshooting Overview Flowchart
5 In the New Index dialog, select Current Index to continue analysis in the current index.
6 The system is in WARM UP mode for 1.5 hours. After the required 20-minute lamp warm
up time, wait until the temperature of the cuvette wheel is 37 °C, and then select MAINT.
> Analyzer Maintenance > Maintenance. Select Standby [F4] to return to STANDBY mode.
B71495AF 8-19
Troubleshooting
RTWB Troubleshooting Overview Flowchart
8-20 B71495AF
8
Troubleshooting
Recovering from a Photometry Error During a Cuvette Wash Event
The analyzer goes to STOP mode immediately after the system generates a Photometry
Error During a Cuvette Wash event.
Overflow Causes
The following can cause a cuvette wheel overflow:
• A wash nozzle is clogged or partially clogged. When the wash nozzle is clogged, liquid
is not aspirated from the cuvette completely and eventually liquid spills over the side. A
clogged wash nozzle can occur when the wash nozzles are not cleaned correctly, or
when particles such as glass are aspirated into the nozzle.
• A wash nozzle is bent or damaged.
• Damaged or missing O-rings inside the water supply tube mounting joint.
• The reagent probe is bent. A bent probe could be dispensing outside of the cuvette.
• The sample probe is bent. A bent probe could be dispensing outside of the cuvette.
• Cuvettes are chipped or cracked caused by alignment problems with the reagent
probes or wash nozzles.
• The wash nozzle tubing is not connected to the nozzle.
B71495AF 8-21
Troubleshooting
Recovering from an Unstable Photometry Error
Recognizing an Overflow
The system generates a Photometry Error During a Cuvette Wash event. The
overflow could have occurred 60 minutes before the system generated the event. Results
obtained during the 60 minutes before the event are invalid and need reanalysis. The 60-
minute timeframe is the time the analyzer was in MEASURE mode. For detailed instructions,
refer to Identify and Reanalyze Samples after a Cuvette Overflow.
The flags *, ?, @, $, D, B, and ! can indicate a cuvette wheel overflow. The data, events, or
flags vary depending on the severity of the overflow. An overflow can affect one or all tests.
Items to inspect:
• QC flags or events
• Reagent blank flags
• Analyzer not performing as normal operation
• Numerous cuvettes fail after a photocal
Lift the cuvette wheel cover. The cuvettes are frosty or white. If they are dark, black, or wet
when removed, the cuvette wheel has overflowed.
Warning
• Align the wash nozzle component over the cuvettes. Visually inspect and confirm that
the wash nozzles are centered over the cuvettes and inspect the alignment.
• Sonicate and clean the wash nozzles with a stylet to remove any debris.
• Inspect the reagent and sample probes to confirm the probes are correctly aligned.
Rotate the sample and reagent probes over the cuvette wheel.
• Inspect for chipped or cracked cuvettes. Replace them if necessary. For more
information, refer to Clean the Cuvettes and the Cuvette Wheel.
• Confirm that the wash nozzle tubing connections are secure.
• Confirm that the O-rings inside the water supply tube mounting joint are in position
and not damaged.
8-22 B71495AF
8
Troubleshooting
Recovering from an Unstable Photometry Error
supplied to clean the cuvettes, bubbles in the bottom of the cuvettes, dirty or scratched
cuvettes, or a deteriorating lamp can cause unstable photometry.
Perform the following procedures in this section. After the error is identified and corrected,
perform a photocal. For more information, refer to Perform a Photocal. If the error still
occurs, contact Beckman Coulter.
1 Inspect the cuvettes identified by the Photometry Error During a Cuvette Wash
event to determine if there is sufficient diluted wash solution in the cuvette.
If the remaining diluted wash solution volume is insufficient or empty, there is a
possibility of system malfunction. Contact Beckman Coulter.
B71495AF 8-23
Troubleshooting
Recovering from an Unstable Photometry Error
2 Inspect the cuvette to determine if there are any bubbles at the bottom of the cuvette.
3 If bubbles exist in the cuvette, inspect the water and wash solution supply tubing on the
wash nozzle component to determine if there are bubbles. The aspiration tubing has
bubbles in normal operation.
4 If bubbles exist in the water and wash solution supply tubing on the wash nozzle
component, tighten the tube mounting joints and remove the bubbles by performing a
W1 or Prime Wash Nozzle.
For more information, refer to Perform a W1 and Replace the O-rings in the Water
Supply Tube Mounting Joint.
8-24 B71495AF
8
Troubleshooting
Recovering from an Unstable Photometry Error
1. Water supply tube mounting joint 2. Wash nozzle tube mounting joint
manifold (A total of six O-rings are manifolds
used inside) 3. Wash nozzle component
5 Inspect the cuvette to determine if it is dirty or scratched. Clean or replace the cuvette
as required. For more information, refer to Clean or Replace Individual Cuvettes.
B71495AF 8-25
Troubleshooting
Laboratory Automation System Problems
Confirm that the number of hours the lamp has been in use. If the lamp has been in use for
over 1,000 hours, replace the lamp.
For information on how to replace the photometer lamp, refer to Replace the Photometer
Lamp.
For problems with the laboratory automation system, refer to the laboratory automation
systems manual.
When problems exist on the laboratory automation system, you can analyze samples from
the STAT table.
8-26 B71495AF
APPENDIX A
System Specifications
Installation
Before installation of the system, refer to the System Specifications for installation
requirements. A Beckman Coulter Field Service Engineer must be present when the
analyzer is removed from the shipping crate. A qualified Beckman Coulter Field Service
Engineer must install the system. If the analyzer must be relocated, contact Beckman
Coulter Customer Support.
System verification at the installation performed by Beckman Coulter Field Service Engineer:
1. Photocal
2. Water testing
3. Dye testing
4. ISE performance (ISE Calibration, ISE Selectivity Check, ISE Accuracy test) if the ISE is
installed
5. Temperature of the cuvette wash water.
System Specifications
This section summarizes DxC 700 AU information such as size, required clearances, power
requirements, and temperature requirements. For more information on other
configurations, contact Beckman Coulter.
Placement
To operate this system safely and accurately, confirm that the location in the laboratory:
• Is not subject to direct sunlight.
• Is not excessively dusty or subject to large amounts of airborne particles. This system
withstands up to pollution degree 2 as defined by IEC and UL standards.
• Is level, with a gradient less than 1/200.
• Is not subject to vibration.
• Has a floor that can support a minimum of 700 kg (1,540 pounds). This weight
includes the personal computer attached to the system.
• Is located less than 6,561 feet or 2,000 meters above sea level.
• Contains no corrosive gases.
B71495AF A-1
System Specifications
System Specifications
• Have a power source with maximum voltage fluctuations (± 10%) and transient
overvoltage less than 2500 V.
Note
Warning
Connect all the grounding terminals provided on the system and distribution panel to
ground. Failure to ground the terminals can cause electric shock and system
malfunction.
Caution
A-2 B71495AF
A
System Specifications
System Specifications
Clearance
The system includes the analyzer and the optional rack feeder module.
This system requires space of a minimum of 500 mm (20 inches) from the wall around it for
safe installation and maintenance.
B71495AF A-3
System Specifications
System Specifications
Dimensions
Table A.1 Dimensions
Module Dimensions
Length Height Depth Weight
mm mm mm kg
Analyzer Module 1250 1300 890 465
Rack Feeder 730 940 1040 165
Module
Water Supply
Table A.2 Water Supply
Specification Requirement
Deionized water conductivity 2.0 µS/cm or less (water transmitted through a
filter of 0.5 µm or less)
Water pressure 0.49×105 to 3.92×105 Pa (or 7 to 57 psi)
Water consumption Average: 28 L/hour (50/60 Hz)
Caution
If the tap water temperature exceeds the optimal temperature range for the
deionizer, consult the deionizer manufacturer. When using the existing water supply
tubing and deionizer, confirm that it is micro-organism free.
A-4 B71495AF
A
System Specifications
System Specifications
Note
The water pressure for this system operates at a range from 0.49 x 105 to 3.92 x 105 Pa.
For the correct water pressure for the deionizer, contact the deionizer manufacturer.
Beckman Coulter recommends use of a reverse osmotic membrane as the deionizer. For
more information, contact Beckman Coulter.
Warning
Follow your laboratory procedure for disposal of all liquid and infectious waste.
The system discharges liquid waste by forced drain and moist air containing the
components of liquid waste.
• Concentrated liquid waste: Compound liquid of sample and reagent retrieved from
cuvettes and diluted wash solution.
• Diluted liquid waste: Liquid waste used for washing cuvettes, mix bars, and so on.
Requirements:
• Place the drain hole within 10 m (33 feet) from this system.
• Connect the drain to an infectious waste collection tank as required by law.
• The drain must be located no higher than 1.5 m and the exhaust no higher than 0.1 m
above the system installation floor.
• Keep the ends of exhaust air hoses and the liquid waste hoses, which are inserted into
the drain, above the liquid level of the drain.
• Confirm that the liquid waste hoses are not bent or crushed.
• Drainage capability for concentrated and diluted liquid waste is:
— Concentrated liquid waste: 10 L/hour
— Diluted liquid waste: 18 L/hour
Environmental Requirements
When the specified room temperature and humidity ranges fluctuate, the system data may
not be reliable. When the system is in operation, confirm that the following requirements
are met.
B71495AF A-5
System Specifications
System Specifications
Confirm that the system is not exposed to direct airflow from air conditioners.
Table A.4 Temperature and Humidity
Specification Requirement
Temperature 18 to 32 °C (64 to 90 °F)
Temperature fluctuation Within 4 °C (7.2 °F) during analysis
Humidity 20 to 80% RH (without condensation)
Note
The installation site must be well ventilated. For more information, refer to Clearance.
Power Requirements
Table A.5 Power Requirements
Specification Requirement
Voltage, Frequency
AC 208 V 50/60 Hz (USA)
AC 230 V 50/60 Hz (Europe)
AC 220 V 50/60 Hz (Asia)
AC 240 V 50/60 Hz (Australia)
AC 200 V 50/60 Hz (Japan)
A-6 B71495AF
A
System Specifications
General Specifications
Regulatory Compliance
This system complies with IEC60825-1: 2007.
General Specifications
Method of Analysis
Discrete method
Configuration
Analyzer Module
Console
Caution
Do not move or adjust the computer from the original position. During installation,
Beckman Coulter installs the computer in the correct position. For proper ventilation,
the space requirement around the computer is at least 76 mm.
Option
Rack feeder module1
ISE
Printer
PROService kit
Rack tray
DTS (Direct Track Sampling) kit
Water supply equipment
External storage device
LAN connections kit
1 The rack feeder module is specific for the DxC 700 AU.
B71495AF A-7
System Specifications
General Specifications
Type of Sample
Serum, plasma, urine, other fluids with viscosities in the same range as serum, whole
blood (HbA1c).
Throughput
Maximum 800 photometric tests/hour or 1200 tests/hour (photometric + ISE)
Maximum 100 tests/hour for analysis of only HbA1c
When the DxC 700 AU connects to a Laboratory Automation System, throughput depends
on the Laboratory Automation System.
A-8 B71495AF
B71495AF
Warning
Use only sample cups and tubes listed in the specifications and validated by Beckman Coulter. If other cups or tubes are
used, analysis cannot be performed or errors can result.
Note
BD indicates a Becton Dickinson PN. The BD tube or its equivalent can be used.
Important
If the system is programmed to use the pre-dilution option with a pre-dilution rate of 3 or 5, a larger dead volume is required
to ensure accurate sample dispensing. Refer to the Pre-Dilution Rate Volumes table in the DxC 700 AU Reference Manual for
the sample volumes required for each pre-dilution rate. The system can be programmed for pre-dilution rates other than 3
and 5, or to dispense a smaller rerun sample volume than the first-run sample volume without affecting the dead volume
requirement. Refer to the Rerun Test Parameters Screen in the DxC 700 AU Reference Manual for more information.
System Specifications
the STAT table
Auto aliquot tube 13 mm 2910034 80 80 300
Serum Separator 13 x 100 mm BD 367986 4 mm above the 4 mm above the non- 4 mm above the non-
Tube non-sample (cells or sample (cells or gel) layer sample (cells or gel) layer
gel) layer
A-9
A-10 Table A.8 Cup or Tube Available for Racks or STAT Table (Continued)
Cup, Size PN Tube PN Dead Volume (µL) Dead Volume (µL) for 3
and 5 Pre-Dilution Rate
Access 2 cup, 1.0 mL 81915 13 x 75 mm BD 367960 140 140
BD 367884
BD 366668
BD 367886
BD 367815
BD 367884
BD 366668
BD 367886
System Specifications
EZ Nest cup 1270016000 16 x 75 mm BD 364976 50 120
EZ Nest cup 1270016000 16 x 100 mm BD 367988 50 120
A-11
A-12 Table A.10 Cup Nested (Inserted) in Tube Available for STAT Table
BD 367884
BD 366668
BD 367884
BD 366668
Figure A.4
The maximum sample volume limit for commercial tubes meeting DxC 700 AU specifications is the same. Most importantly,
confirm there is 15 mm of space between the sample level and the top of the tube.
Figure A.5
Sampling Specifications
Note
When the DxC 700 AU connects to a Laboratory Automation System, the DxC 700 AU
does not use racks. Refer to the Laboratory Automation System specifications for tubes
and cups that can be used on the system.
Sample Capacity
Maximum 150 samples (15 racks)
Sample Volume
Table A.11 Sample Volume
Sample Volume
Normal dispensing 1.0 to 25.0 µL/test, in steps of 0.1 µL
Dispensing with dilution 1.0 to 20.0 µL/test, in steps of 0.1 µL
Rack Type
NE racks are required on the system.
• Blue rack
• Yellow rack
• Green rack
• White rack
• Red rack
Reagent Specifications
A-16 B71495AF
A
System Specifications
Reaction System Specifications
Refrigeration
Refrigeration temperature: 4 to 12 °C (39.2 to 53.6 °F)
Type of Reagent
• Normal concentration reagent
• Highly concentrated reagent
Reaction Temperature
Dry bath: 37± 0.3 °C (98.6± 0.5 °F)
B71495AF A-17
System Specifications
Analytical Method Specifications
Reaction Time
Maximum 8 minutes 33 seconds
Mixing System
Rotating mixing bar system
Reaction Cell
Glass square cuvette
• Optical path length: 5 mm
Reaction Line
Rotary disk system: 165 cuvettes
Photometric Points
28
Type of Measurement
• End point assay
• Rate assay
• Fixed point assay
• Electrode method (ISE) (option)
Photometer
Multi-wavelength diffraction grating spectrophotometer
Photometric Modes
Monochromatic or bichromatic
Wavelengths
340 to 800 nm (13 steps of 340, 380, 410, 450, 480, 520, 540, 570, 600, 660, 700, 750, and
800 nm)
A-18 B71495AF
A
System Specifications
Data Processing Specifications
Photodetector
Silicon photodiode array
Light Source
Halogen lamp 12 V/20 W
Photometric resolution
0.0001 Abs
Storage Capacity
Table A.14 Data Storage Capacity
Data Hard Disk Storage Capacity
Patient Samples 100,000 samples
9999 samples/index
Reaction Monitor data: A maximum of 40,000 tests per index and a maximum
of 400,000 tests in multiple indexes
Calculation
• Calibration
B71495AF A-19
System Specifications
Input and Output Specifications
— Analytical method
— End point assay
— Rate assay
— Fixed point assay
— Electrode method (ISE)
— Calibration method
— ACAL AA
— ACAL AB
— ACAL 2 AB to ACAL 7 AB
— 4 MC to 10 MC
— MCAL MB
— MCAL 2 MB to MCAL 7 MB
— Calibration curve type
— Straight line
— Polygonal line
— Quadratic expression
— Tertiary expression (2 types)
— EIA-TYPE 1 to 4
— Spline
• Correction
— Water blank correction
— Reagent blank correction
— Sample blank correction
— Data correction
Test Summary
• Patient sample test summary
• Emergency sample test summary
• Rerun sample test summary
• Control sample test summary
• Calibration test summary
A-20 B71495AF
A
System Specifications
ISE Specifications
ISE Specifications
Reagents
• ISE Buffer Solution: 2L bottle
• ISE MID Standard Solution: 2L bottle
• ISE Reference Solution: 1L bottle
Measurement Method
Indirect (diluted) ion-selective electrode
Measurement Items
Na, K, and Cl ions in serum or urine
Throughput
200 samples per hour
Sample Volume
20 µL plus 10 µL deionized water
Dilution Ratio
32.4 times (deionized water 10 µL, ISE Buffer Solution 618 µL)
B71495AF A-21
System Specifications
ISE Specifications
Calibration Curve
Automatic calibration curve:
Data Correction
Enables manual calibration chart correction (MCAL) and automatic calibration chart
correction (ACAL, 3-point regression CAL).
Drift Correction
Automatic correction:
Measures the electrical potential of ISE MID Standard Solution for each sample to perform
drift correction.
A-22 B71495AF
APPENDIX B
End-User License Agreement and Open Source
Software Notice
End-user License Agreement
Important
1. GRANT OF LICENSE. Subject to all of the terms and conditions of this Agreement, BCI
grants to You a non-exclusive, non-sublicensable and non-transferable license ("
License ") to use the computer programs, including any updates or upgrades (in object
code form only) contained in the BCI Product ("Programs") and the associated user
documentation (" Documentation ")(together with the Programs referred to herein,
collectively, as the (" Software ")) only as incorporated within the BCI Product and only
in accordance with the Documentation. You have no right to receive, use or examine any
source code or design documentation relating to the Programs. The Software is licensed
and not sold. As between the parties, BCI and its licensors retains all right, title and
interest in and to the Software and any and all derivative works, except as expressly and
unambiguously licensed herein, and BCI reserves all rights in the Software not granted
to You. In order to use the Software, You may be required to input a registration number
or product authorization key and register Your copy of the Software with BCI to obtain
the necessary license key or license file. Except as otherwise expressly provided under
the Agreement, You shall only use the Software in connection with the use of BCI
Product provided to You from BCI or a third party on BCI's behalf and only for Your
internal business purposes.
2. RESTRICTIONS. Other than as expressly permitted under applicable law, You shall not
(and shall not allow others to): (i) copy the Software, except as reasonably required to
use the Programs strictly in accordance with this Agreement, (ii) alter, adapt, translate
or create derivative works based upon the Software, or include the Programs in any
other products or software, (iii) decompile, disassemble, reverse engineer or otherwise
attempt to discover or reconstruct the source code (or underlying ideas, sequence,
structure organization or algorithms) of any of the Programs, or attempt to do so,
except to the limited extent the foregoing is expressly permitted by applicable law, in
B71495AF B-1
End-User License Agreement and Open Source Software Notice
End-user License Agreement
which case You must first notify BCI in writing and request interoperability information
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End-User License Agreement and Open Source Software Notice
End-user License Agreement
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End-User License Agreement and Open Source Software Notice
Open Source Software Notice
accordance with the laws of the State of California and the United States without regard
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Please be informed that the Software contains the following third-party components:
Table B.1 Table 1
No. License Component Notes
1 Jam STAPL Jam STAPL Byte-Code Player, Version Copyright (C) Altera Corporation
Software 2.2, Module: jbicomp.c 1997-2001.
License
Jam STAPL Byte-Code Player, Version Copyright (C) Altera Corporation
2.2, Module: jbicomp.h 1997-2001.
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End-User License Agreement and Open Source Software Notice
Open Source Software Notice
License:
THE JAM SOFTWARE PROGRAM AND EXECUTABLE FILES, AND RELATED SPECIFICATION
DOCUMENTATION ("PROGRAMS") (AVAILABLE FOR DOWNLOADING FROM THIS WEB
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B71495AF B-5
End-User License Agreement and Open Source Software Notice
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End-User License Agreement and Open Source Software Notice
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The Programs and any accompanying documentation are provided with RESTRICTED
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manufacturer is Altera Corporation, 101 Innovation Drive, San Jose, CA 95134 and its
licensors.
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Glossary
ACAL (Auto Calibration) — The AB type Control Material — Material used to
(or ACAL) uses calibrator to calculate a confirm the performance characteristics
calibration factor automatically and of an in vitro diagnostic medical device.
create a calibration curve each time the
system calibrates. The calibration types Critical Limits — Operator-defined
are defined in parameters as AB (single boundaries of critical values. If the limit
point), AA, or 2AB-7AB (multi-point) for is exceeded, the system generates an
each test. audible alarm and a ph (high) or pl (low)
flag.
Alarm Tests — The number of tests that
can be performed using the remaining Cuvette — A glass vessel the system uses
reagent. The system generates a as the reaction vessel, containing the
Reagent Insufficient event when the sample and reagent.
remaining reagent volume decreases to Dead Volume (Reagent) — Reagent
the number of tests. volume that the reagent probe cannot
Advanced Calibration — The system can aspirate, and remains in the bottle. The
calibrate a maximum of 5 bottles or lot dead volume depends on the size of the
numbers of the same reagent before reagent bottle.
the system uses the reagent. Dead Volume (Sample) — Sample volume
Analytical Measuring Range — The range that the sample probe cannot aspirate,
the system can measure for a reagent. If and remains in the tube or cup. The
the range is exceeded, the system dead volume depends on the type of
generates an F (over) or G (under) flag. cup or tube.
B71495AF Glossary-1
Glossary
End Point Assay (END) — The three types Group of Tests — An operator-defined
of end point assays: group of tests that are selected in the
New Index dialog. The tests in the
• 1-point assay is a general end-point selected Group have reagents on board
assay that determines the optical
the analyzer and are available to
density of the reaction mixture
from the optical density perform analysis. You can program
measured at a specified three Groups in CONFIG. > Group of
photometric measuring point. Tests. For example, designate the tests
• 2-Point assay (self-blank method) frequently used for patient sample
provides sample blank analysis to Group 1, and the tests used
adjustment. The optical density for specific analysis to Group 2. Perform
values before dispensing reagent patient sample analysis under Group 1
are eliminated as the sample and switch to Group 2 for specific
blank. This optical density value analysis as required.
is then subtracted from the
values calculated after dispensing Index — A data file identified by date and
the second reagent. Any time, used to retrieve reagent blank,
contribution to the final reaction calibration, QC, and patient results.
optical density from the sample
(turbidity, icterus, and so on) is LAG_TIME Check — If a reaction is
removed to improve terminated too quickly, effective data at
measurement reliability. two points or more may not be
• Sample blank correction measures acquired. In this situation, the system
the blank item and then subtracts can be set up to calculate the analysis
the value from the measured result using the data in the lag phase.
optical density, to calculate the
Used for tests in the rate assay method.
optical density of the reaction.
This method requires an extra Refer to the individual method
blank. parameters to determine the correct
setting for the test.
END1 does not use the reagent blank
absorbance as the reference for LIH Testing - Serum Index — Evaluates
measurement data at each and performs test of lipemia (L), icterus
photometric point. (I), and hemolysis (H) in serum and
plasma. LIH is the symbol used for
testing lipemia (L), icterus (I), and
Fixed Point Assay (FIXED) — A method of
hemolysis (H).
calculation that determines the
difference between the optical densities Linearity — Ability of a measuring
at two specific time points within a method to generate results that are
reaction. FIXED1 does not use the proportional to the analyte
reagent blank absorbance as the concentration in a sample.
reference for measurement data at
each photometric point. MCAL (MB) — A type of calibration that
does not use any calibrator material. A
Flag — Symbols that display on analysis preset MB factor has been determined
results, indicating that a problem or an and is entered per the reagent setting
error has occurred during analysis. A sheet provided for this type of test.
result with a flag must be reviewed and
have corrective actions performed Optical Density (OD) — The
before reporting results. measurement of the amount of light
absorbed by a solution in the cuvette
with the use of a photometer. The
Glossary-2 B71495AF
higher the optical density the lower the tests. It also becomes the Y-intercept of
transmittance. calibration curves created by ACAL.
Photocal Measurement — Evaluates the Reagent — A combination of chemicals
integrity of the cuvettes used to obtain that react with the target analyte in the
accurate analysis results. Confirm the sample. The DxC 700 AU uses one (R1),
photocal data obtained from a photocal two (R1 and R2), or three reagents
measurement from MAINT. > Analyzer (R1-1, R1-2, and R2) per analyte.
Maintenance > Photocal Monitor. For
more information, refer to Perform a Reagent ID — The analyzer identifies
Photocal. reagents placed on board the analyzer
using the bar code label.
QC Monitor — The QC Monitor gives an
instant visual summary of QC analysis Reflex Testing — A function to generate a
results. rerun order automatically for the
Related Test by linking the Related Test
Quality Control (QC) Analysis — The to the Deciding Test. Reflex testing
process of analyzing samples with occurs when the Deciding Test has
known concentrations of analytes to resulted in a rerun, fl, or fh flag.
test the quality of reagents, calibrators,
analyzer, and procedures. Related Test — The system automatically
orders the test for rerun when the
Rate Assay (RATE) — Deciding Test has resulted in a rerun, fl,
or fh flag. A maximum of five tests can
• Normal rate assay measures the be programmed as Related Test in
variation in the rate of
combination with a Deciding Test.
absorbance per minute by
calculating the average change in Rerun — A process whereby the analyzer
absorbance between two tests the samples again, either manually
photometric points, using the
or automatically.
least squares method.
• Double rate assay determines the Sample Diluent — Solution the system
rate of absorbance variation per uses for a manual or automatic dilution
minute by calculating the average of samples.
of the absorbance variations
between two measuring points, Sample ID — An alphanumeric code
using the least squares method. assigned and used to identify each
The rate of absorbance before sample. The system reads the sample
dispensing reagent 2 is bar code label attached to the sample
subtracted from the value
cup to identify the sample ID .
calculated after dispensing the
second reagent. Sample Number (Sample No.) — A 4-digit
RATE1 does not use the reagent blank number the analyzer generates and
absorbance as the reference for uses to identify each sample. The
measurement data at each system displays a sample data prefix in
photometric point. front of the sample number indicating
the sample kind and type.
Reagent Blank (RB) — In the analysis, the Standard Deviation — Measurement of
reagent blank serves as the reference statistical dispersion. In multiple
value for the reagents at each measurements of the same sample, the
photometric point of individual analysis standard deviation measures how
spread out the values are.
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