Beckman Coulter TQ-Prep Reference

COULTER® TQ-Prep™ Workstation

Reference

PN 4237395AA (June 2010)

Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821

WARNINGS AND PRECAUTIONS

READ ALL PRODUCT MANUALS AND CONSUL T WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMP T ING
TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL
INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS
TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE.

HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS

WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:

WARNING - Can cause injury.

CAUTION - Can cause damage to the instrument.

IMPORTANT - Can cause misleading results.

BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY
STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO,
PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR
ANY OTHER AUTOMATED LABORATORY ANALYZER.

WARNING Risk of operator injury if:

r All doors, covers and panels are not closed and secured in place prior to and during instrument operation.
r The integrity of safety interlocks and sensors is compromised.
r Instrument alarms and error messages are not acknowledged and acted upon.
r You contact moving parts.
r You mishandle broken parts.
r Doors, covers and panels are not opened, closed, removed and/or replaced with care.
r Improper tools are used for troubleshooting.

To avoid injury:

r Keep doors, covers and panels closed and secured in place while the instrument is in use.
r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors.
r Acknowledge and act upon instrument alarms and error messages.
r Keep away from moving parts.
r Report any broken parts to your Beckman Coulter Representative.
r Open/remove and close/replace doors, covers and panels with care.
r Use the proper tools when troubleshooting.

CAUTION System integrity might be compromised and operational failures might occur if:

r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals.
r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s

computer with software authorized by Beckman Coulter.

r You install software that is not an original copyrighted version. Only use software that is an original copyrighted

version to prevent virus contamination.

IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter

distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot
guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most
current information bulletins concerning the product. If you purchased this product from a third party and would like
further information concerning this topic, call your Beckman Coulter Representative.

REVISION STATUS

Issue A, 8/97

Software Version 1.1.

Issue AA, 06/10

Software Version 1.1.
Updates were made to the company corporate address.
Note: Changes that are part of the most recent revision are indicated in text by a bar in the

margin of the amended page.

PN 4237395AA

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 to the Beckman Coulter website. For
labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for
your instrument.

iii

REVISION STATUS

iv

PN 4237395AA

1.1 COULTER TQ-Prep Workstation, 1-1

1.2 Sample Processing Area, 1-2

1.3 Reagent Storage Area with OPTION Reagent, 1-4

3.1 Carousel Home and Tube Loading Positions, 3-1

LEGAL NOTICES, 2
REVISION STATUS, iii
CONTENTS, v
INTRODUCTION, ix

HOW TO USE YOUR COULTER TQ-PREP WORKSTATION MANUALS, ix
ABOUT THE REFERENCE MANUAL, x
CONVENTIONS, x

1 USE AND FUNCTION, 1-1

1.1 INTENDED USE, 1-1

CONTENTS

1.2 METHOD HISTORY, 1-1

1.3 SYSTEM COMPONENTS, 1-2
Sample Processing Area, 1-2

Carousel, 1-2
Indexing Base, 1-2
Dispensing Head, 1-2
Tube Detector, 1-3
Tube Lifter/Vortex Mixer,1-3
Reagent Delivery System, 1-3

Electronics, 1-3
Reagent Storage and Dispense Area, 1-3
Touch Screen, 1-4

1.4 OPTIONS, 1-4
LALS OPTION, 1-4

1.5 REAGENTS, 1-4
Reagent A, 1-4
Reagent B, 1-4
Reagent C, 1-5
OPTION Reagent, 1-5

1.6 MATERIAL SAFETY DATA SHEETS (MSDS),1-5

PN 4237395AA

-v

CONTENTS

2 INSTALLATION,2-1

2.1 SPECIAL REQUIREMENTS, 2-1
Space and Accessibility, 2-1
Electrical Input, 2-1
Ambient Temperature and Humidity, 2-1
Ventilation, 2-1

2.2 COULTER REPRESENTATIVE, 2-2
Delivery Inspection, 2-2
Operator Certification, 2-2

2.3 CUSTOMER INSTALLATION,2-2
Inspecting After Delivery, 2-2
Unpacking and Checking Instrument, 2-3
Connecting the OPTION Reagent Container,2-6
Connecting the Reagent A, B, and C Containers, 2-9
Connecting the WASTE Container, 2-14
Powering On the Instrument, 2-17
Checking Carousel Alignment, 2-19
Priming and Preparing the Instrument for Use, 2-21

3 OPERATION PRINCIPLES, 3-1

3.1 GENERAL PRINCIPLES, 3-1

3.2 NORMAL SAMPLE FLOW, 3-1

3.3 TYPES OF PRIMING, 3-2
User-Requested, 3-2
New Reagent, 3-3
Automatic, 3-3

-vi

PN 4237395AA

4 SPECIFICATIONS/CHARACTERISTICS, 4-1

4.1 PHYSICAL SPECIFICATIONS, 4-1
Dimensions, 4-1
Power, 4-1

Installation Category, 4-1
Input, 4-1

Consumption, 4-1
Noise, 4-1
Ambient Operating Temperature, 4-1
Humidity, 4-1
Recommended Reagents, 4-1
Reagent Usage, 4-2
Anticoagulant, 4-2
Specimen Type, 4-2
Sample Size, 4-2
Tube Size, 4-2
Mixing Speed, 4-2
Throughput, 4-2
Sample Processing Time, 4-2

CONTENTS

4.2 PERFORMANCE SPECIFICATIONS, 4-3
Accuracy of Delivery Volume of Distilled Water, 4-3
Precision (Reproducibility), 4-3
Calibration, 4-3

4.3 PERFORMANCE CHARACTERISTICS, 4-3

ALOG SHEETS,A-1
B OPERATOR CERTIFICATION PROCEDURE, B-1

B.1 PURPOSE AND SCOPE,B-1
B.2 OPERATOR CERTIFICATION PROCEDURE, B-1
B.3 PIPET CALIBRATION PROCEDURE, B-1

With Air-Displacement Pipet (Reverse Mode), B-2
With Positive-Displacement Pipet, B-6

B.4 TQ-PREP WORKSTATION PREC ISIO N PROC EDURE , B-10

REFERENCES, REFERENCES-1
GLOSSARY, GLOSSARY-1

PN 4237395AA

TRADEMARKS, 7

COULTER TQ-Prep Workstation Documentation, 8

-vii

CONTENTS

-viii

PN 4237395AA

1.1 COULTER TQ-Prep Workstation, 1-1

1.2 Sample Processing Area, 1-2

1.3 Reagent Storage Area with OPTION Reagent, 1-4

3.1 Carousel Home and Tube Loading Positions, 3-1

PN 4237395AA

-9

This introductory section contains the following topics:

INTRODUCTION

r How to use your COULTER
r About the Reference manual
r Conventions

®

TQ-Prep™ Workstation manuals

HOW TO USE YOUR COULTER TQ-PREP WORKSTATION MANUALS

Use the Reference manual for in-depth information about:

r What the instrument does
r The methods it uses
r Its specifications
r Information about installation.

A Master Index is included at the back of the Reference manual, which lists entries from the
entire documentation set.

Use the Operator’s Guide for the day-to-day running of your instrument:

r To run a gravimetric validation test
r To clean, to replace or adjust a component
r To troubleshoot the instrument.

Read the Controls and Indicators chapter to become familiar with the different parts of your
system. Then go through the detailed step-by-step procedures of daily startup, processing
samples and shutdown. The calibration chapter contains the gravimetric validation and
precision tests. The remaining chapters contain the cleaning, replacement and adjustment
procedures and troubleshooting tables. A Master Index is included at the back, which lists
entries from the entir e d o cumentation set.

PN 4237395AA

Use the Operating Summary after you are trained and familiar with using the system. It
contains:

r A brief summary of the daily startup, sample processing and shutdown procedures
r Descriptions of the touch screen symbols.

See the Documentation page on the back cover of this manual for the contents of each
manual. It can help you to determine which manual contains the information that you need.

-ix

INTRODUCTION

ABOUT THE REFERENCE MANUAL

ABOUT THE REFERENCE MANUAL

Your TQ-Prep Workstation Reference manual is a source of information on what the system
does.

This information is organized as follows:
S Chapter 1, Use and Function

Contains the intended use of the instrument, a brief history of the methods used, the
reagents used and a short description of the major components and options.

S Chapter 2, Installation

Contains the instrument requirements and instructions on how to install the instrument.

S Chapter 3, Operation Principles

Contains the description of the normal sample flow on the instrument.

S Chapter 4, Specifications/Characteristics

Details the instrument and performance speci fica tions and the performance
characteristics.

S Appendices

S References

S Glossary

S Index

CONVENTIONS

r All figures showing reagent containers on the software screens or in the instrument

r Within text and instructions, buttons and icons appear as they do on the touch screen:

The appendices provide reference material on the following topics:

r Log Sheets
r Operator Certification.

References used throughout the manuals.

Definitions of words, abbreviations and acronyms used throughout the manuals.

This is a Master Index that contains entries from all manuals in the documentation set.

include the OPTION reagent.

t Button - example:

-x

t Troubleshooting icon - example:

PN 4237395AA

1.1 INTENDED USE

The COULTER TQ-Prep Workstation, Figure 1.1, is a general purpose laboratory instrument
used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole
blood for quantitative immunofluorescence measurements on optical flow cytometers. The
system is intended For In Vitro Diagnostic Use.

USE AND FUNCTION

1

1

1.2 METHOD HISTORY

The ability to classify human white cells based on their expression of cell surface antigens has
provided investigators with valuable diagnostic and prognostic information.

Historical methods of isolating leukocytes for immunofluorescence include whole-blood
lysing techniques and density gradient separation techniques.

Such commercially available procedures require washing the sample to remove unbound
antibody and debris. The repeated trauma of mixing, vortexing and centrifugation can
selectively damage malignant or "activated" cells. In addition, nonrandom cell loss can occur

by adherence to containers or failure to form a complete pellet during centrifugation.
procedures are labor intensive, require exacting technique and become unmanageable when
processing large numbers of samples.

In 1987, the COULTER ImmunoPrep™ Reagent System and Q-Prep™ Workstation were
introduced for rapid, automated, whole-blood preparation for immunophenotyping and are

widely used in a variety of flow cytometry laboratories today.
ImmunoPrep Reagent System and Multi-Q-Prep™ Workstation were introduced, extending
the Q-Prep system automated preparation of whole blood from one sample at a time to up to
32 samples per batch.

The TQ-Prep Workstation automatically prepares 32 sample batches, like the Multi-Q-Prep
Workstation, but is designed for laboratories with high-workload requirements.

Figure 1.1 COULTER TQ-Prep Workstation

3

5, 6

Then in 1992, the COULTER

1, 2

4

Most

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1-1

USE AND FUNCTION

SYSTEM COMPONENTS

1.3 SYSTEM COMPONENTS

The system has three main work areas:

r Sample processing area
r Reagent storage and dispense area
r Touch screen.

Sample Processing Area

See Figure 1.2. The sample processing area consists of a 32-tube capacity removable car ousel,
an indexing base, dispensing head with tube detector, sensing and sequencing devices, a tube
lifter/vortex mixer , a reagent delivery system and electronics. The lid to the sample pr ocessing
area has a safety interlock switch so sample processing can only occur with the lid closed.

SAMPLE

PROCESSING

AREA LID

DISPENSING HEAD/

TUBE DETECTOR

KEY

HUB KEY

This label is to

CAROUSEL

7395020A

notify you that a

biohazardous

condition can exist

in this area if

blood is spilled

INDEXING

BASE

TUBE LIFTER/

VORTEX MIXER

Figure 1.2 Sample Processing Area

Carousel

Two sample carousels, each with a handle and 32-test tube slots, are provided with each unit.
The key located on the carousel aligns with the hub key on the indexing base to correctly
position the carousel for sample processing.

Indexing Base

The indexing base moves the carousel to its home position and moves the carousel during
sequential sample processing.

1-2

Dispensing Head

The retractable dispensing head adds a precise amount of multiple reagents to the sample.

PN 4237395AA

USE AND FUNCTION

SYSTEM COMPONENTS

Tube Detector

The tube detector is an optical flag switch located within the dispensing head that senses the
presence of a test tube in a carousel at the reagent dispense position.

Tube Lifter/Vortex Mixer

The tube lifter/vortex mixer uniformly first lifts the tube up into the dispensing head, then
mixes reagents in the sample.

Reagent Delivery System

Three (or four if you have the LALS OPTION) syringes dispense reagents to the dispensing
head via Teflon

Electronics

The system microprocessor (386) assembly controls the touch screen, disk drive, power
indicator, beeping device, and an internal communication link to the Control Interface card.

A microcontroller, located on the Control Interface card, controls the motors, sensors,
syringes, the cover/lid interlock switches, reagent level sense probes and an internal
communication link to the system microprocessor assembly.

®

tubing.

1

A universal input power module supplies all the necessary dc voltages to the system
components.

Reagent Storage and Dispense Area

The reagent storage and dispense area is covered and located behind the sample processing
area. See Figure 1.3. It contains:

r Storage tray for Reagent A, Reagent B, Reagent C, OPTION reagent (optional) and

WASTE contain ers.

r Cap assemblies.

t The three (or four) reagent cap assemblies are attached by tubing to their

corresponding syringes.

t The WASTE cap assembly is attached by tubing directly to the dispensing head.
t The Reagent A, B, and C, and the WASTE cap assemblies have liquid level sensors.

r Three dispensing syringes (or four if you have the LALS OPTION).

PN 4237395AA

1-3

USE AND FUNCTION

(

)

(

)

(

)

OPTIONS

LEVEL SENSE

CABLE CONNECTORS

WASTE

(RED FITTING)

OPTION REAGENT

(WHITE FITTING)

REAGENT
STORAGE

TRAY

SYRINGES

Touch Screen

The touch screen is the user interface on the instrument. You press a displayed button on the
touch screen to request a function.

1.4 OPTIONS

LALS OPTION

This option is for use on flow cytometers that measure a low angle of forward scatter (FALS)
light. The LALS OPTION includes a dispensing syringe, tubing and an OPTION reagent
container.

1.5 REAGENTS

Coulter recommends the use of the following reagents or their equivalents. The TQ-Prep
Workstation is designed for use with the ImmunoPrep Reagent System. All stated
performance characteristics in this manual are based on the use of the TQ-Prep Workstation
with these reagents. Refer to the reagents’ package insert for detailed information before using

the reagents.

ImmunoPrep A

GREEN FITTING

ImmunoPrep B

BLUE FITTING

ImmunoPrep C

YELLOW FITTING

Figure 1.3 Reagent Storage Area with OPTION Reagent

7395019A

1-4

Reagent A

ImmunoPrep A, a lysing reagent, causes simultaneous rapid destruction of the erythrocytes
while leaving the leukocytes intact.

Reagent B

ImmunoPrep B, a stabilizing reagent, stops the action of the lysing reagent (ImmunoPrep A).

PN 4237395AA

Reagent C

ImmunoPrep C, a fixing reagent, fixes the cell membranes. This preserves the form and
structure of the leukocytes.

OPTION Reagent

Use distilled or deionized water as the OPTION reagent if your system has the LALS OPTION.
This reagent is for use on flow cytometers to allow the measurement of a low angle of forward
scatter light.

1.6 MATERIAL SAFETY DATA SHEETS (MSDS)

To obtain an MSDS for Coulter reagents used on the TQ-Prep Workstation:

1. In the USA, either call Coulter Customer Operations (800-526-7694) or write to:
Coulter Corporation

Attn: MSDS Requests
P.O. Box 169015
Miami, FL 33116-9015

2. Outside the USA, contact your local Coulter Representative.

USE AND FUNCTION

MATERIAL SAFETY DATA SHEETS (MSDS)

1

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1-5

USE AND FUNCTION

MATERIAL SAFETY DATA SHEETS (MSDS)

1-6

PN 4237395AA

Your Coulter Representative will install the system; however , in some cases, you will be
instructed to install your system.

2.1 SPECIAL REQUIREMENTS

The system is intended for installation and operation in a conventional clinical laboratory
setting. Determine the system location before installation of the system. Consider the
following special requirements.

Space and Accessibility

In addition to the space required for the instrument, consider:

r Comfortable working height
r Access to the rear and left side of the instrument for maintenance and service. Allow

t At least 15 cm (6 in.) of space behind instrument for air flow. Only 7.5 cm (3 in.) if

the instrument is in a safety cabinet/laminar flow hood.

t At least 15 cm (6 in.) above instrument to lift sample processing area lid.
t Adequate space on the right side for access to power and screen contrast controls.
t Adequate space on the left side to remove reagent cover and replace reagent

containers. If your instrument is located in a safety cabinet/laminar flow hood, you
can remove the reagent cover permanently.

INSTALLATION

2

2

Electrical Input

CAUTION Do not use an extension cord. Overheating, melting and burning of the extension cord can occur if

you use an extension cord. Plug the power cord directly into an electrical outlet. Position the instrument
close enough to an electrical outlet so you do not need to use an extension cord.

This system requires:

r An independent, protected circuit.
r A ground path capable of carrying the full current of the circuit (confirmed third-wire,

earth ground).

r A transient-protected outlet.

Ambient Temperature and Humidity

Operate the system in a room with a temperature of 10 to 35°C (50 to 95°F) and relative
humidity of 30 to 85%, without condensation.

Ventilation

Position instrument ventilation fans at least 15 cm (6 in.) away from walls or obstructions
that could interfere with air flow. If in a safety cabinet/laminar flow hood, position instrument
ventilation fans 7.5 cm (3 in.) away from the back wall.

PN 4237395AA

2-1

INSTALLATION

COULTER REPRESENTATIVE

2.2 COULTER REPRESENTATIVE

Delivery Inspection

CAUTION Possible instrument damage could occur if you improperly uncrate the instrument, install it or set

it up. If you have not been directed to install the instrument, keep the instrument in its packaging until your
Coulter Representative uncrates it for installation and set up.

Your instrument is tested before it is shipped from the factory. International symbols and
special handling instructions printed on the cartons tell the carrier how to handle this
electronic instrument.

Carefully inspect all cartons when they arrive. If you see any sign of mishandling or damage,
file a claim with the carrier immediately. If the instrument is insured separately, file a claim
with the insurance company.

Operator Certification

After the system is installed, each operator should perform the Operator Certification
procedure in Appendix B before running samples.

2.3 CUSTOMER INSTALLATION

Inspecting After Delivery

CAUTION Possible instrument damage could occur if you improperly uncrate the instrument, install it or set

it up incorrectly. If you have been directed to install the instrument, follow the customer installation
instructions exactly, to set up your instrument.

Your instrument is tested before it is shipped from the factory. International symbols and
special handling instructions printed on the cartons tell the carrier how to handle this
electronic instrument.

Carefully inspect all cartons when they arrive. If you see any sign of mishandling or damage,
file a claim with the carrier immediately. If the instrument is insured separately, file a claim
with the insurance company.

2-2

PN 4237395AA

Unpacking and Checking Instrument

Open the carton and remove the

1

instrument.
Note: It is easier if two people lift the

instrument out of the carton.

INSTALLATION

CUSTOMER INSTALLATION

2

2

Remove the foam packing material,
unwrap the plastic packing and set the
instrument on a flat surface.

PN 4237395AA

2-3

INSTALLATION

CUSTOMER INSTALLATION

Lift the sample processing area lid.

3

Remove the foam packing material.

4

2-4

Close the sample processing area lid.

5

PN 4237395AA

6

Check the fittings at the top of the
syringes for visible damage.

The connections should be finger tight.
See the Replacing the Syringe procedure
in Chapter 7 in the Operator’s Guide for
more details.

INSTALLATION

CUSTOMER INSTALLATION

2

PN 4237395AA

2-5

INSTALLATION

CUSTOMER INSTALLATION

Connecting the OPTION Reagent Container

r If your instrument has the LALS

1

2

OPTION, per form steps 1 through
6 to connect the OPTION reagent
container.

r If your instrument does not have

the LALS OPTION, proceed to
Connecting Reagent A, B, and C
Containers.

r Remove the empty OPTION

reagent container and cap assembly
from its packaging.

3

r Check the cap assembly fittings for

visible damage.

Unscrew the cap assembly from the
empty OPTION reagent container.

2-6

PN 4237395AA

4

5

Fill the OPTION reagent container with
distilled or deionized water.

Screw the cap assembly with the white
fitting onto the OPTION reagent
container.

INSTALLATION

CUSTOMER INSTALLATION

2

PN 4237395AA

2-7

INSTALLATION

CUSTOMER INSTALLATION

Place the OPTION reagent container in

6

7

the instrument.

Screw the tubing connector from the
OPTION reagent onto the side fitting of
the OPTION syringe.

P

2-8

PN 4237395AA

Connecting the Reagent A, B, and C Containers

INSTALLATION

CUSTOMER INSTALLATION

2

1

2

Open a new ImmunoPrep Reagent
System.

Note: Store and use the reagents at r oom
temperature. Make sure the reagents are
at room temperature before they are
placed in the instrument.

Remove the reagent cap from a reagent.
Save the cap for later.

°C
30 86

16

°F

61

ImmunoPrep

Leukocyte Preparation System

COULTER® IMMUNOPREP

3

PN 4237395AA

Remove the protective seal so that the
cap assembly’s level sensor probe and
tubing fit easily through the container
opening.

2-9

INSTALLATION

CUSTOMER INSTALLATION

Remove the empty corresponding

4

5

reagent container and cap assembly
from its packaging.

Unscrew the cap assembly from the
empty reagent container . Save the empty
container for step 11.

6

Note: The cap assembly fittings are color
coded:

r Green - Reagent A
r Blue - Reagent B
r Yellow - Reagent C
r Red - WASTE
r White - OPTION Reagent.

Screw the cap assembly onto the full
reagent container.

2-10

PN 4237395AA

7

Place the full reagent container in the
instrument.

INSTALLATION

CUSTOMER INSTALLATION

C

B

A

2

8

Screw the tubing connector from the
reagent container onto the side fitting of
the corresponding syringe.

PN 4237395AA

2-11

INSTALLATION

CUSTOMER INSTALLATION

Locate the opening for the level sense

9

connector.

10

Note: The level sense fittings are color
coded to match the cap assemblies:

r Red - WASTE
r Green - Reagent A
r Blue - Reagent B
r Yellow - Reagent C

Connect the level sense connector from
the cap assembly to the instrument by:

a. Lining up the two red dots:

r Red dot on the level sense

connector

r Red dot on the

corresponding
color-coded opening.

b. Pushing the level sense

connector into the opening.

WASTE

C

B

A

2-12

PN 4237395AA

11

12

Screw the saved cap onto the empty
reagent container. Save this container
for future use, such as in the long-term
shutdown procedure.

Repeat steps 2 through 11 for the other
two ImmunoPrep reagents.

ImmunoPrep

Leukocyte Preparation System

INSTALLATION

CUSTOMER INSTALLATION

2

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2-13

INSTALLATION

CUSTOMER INSTALLATION

Connecting the WASTE Container

Remove the WASTE container and its

1

2

cap assembly from its packaging. Check
that the cap assembly is on tight.

Locate the tubing taped to the
instrument.

2-14

PN 4237395AA

3

Insert the tubing into the opening on
the WASTE container. Screw in the red
connector.

INSTALLATION

CUSTOMER INSTALLATION

2

4

Place the WASTE container in the
instrument.

PN 4237395AA

2-15

INSTALLATION

CUSTOMER INSTALLATION

Connect the level sense connector from

5

6

the WASTE container’s cap assembly to
the instrument by:

a. Lining up the two red dots:

b. Pushing the level sense

Remove the reagent cover from its
packaging and place it on the
instrument.

r Red dot on the level sense

connector

r Red dot on the

corresponding
color-coded opening.

connector into the opening.

Note: If your instrument is located in a
safety cabinet/laminar flow hood, you
do not need to use the reagent cover.

2-16

PN 4237395AA

Powering On the Instrument

Plug the power cord into the electrical

1

receptacle at the back of the instrume nt
and then into the wall receptacle.

Turn on the power switch.

2

INSTALLATION

CUSTOMER INSTALLATION

2

3

PN 4237395AA

Check that the front power indicator
light is on.

2-17

INSTALLATION

CUSTOMER INSTALLATION

After system initialization, the Power Up

4

screen appears briefly on the touch
screen.

Check that:

5

6

r The
r No troubleshooting icon appears

Adjust the contrast of the touch screen
for best viewing angle, as needed.

Main screen appears.

on the
troubleshooting icon does appear,
go to Chapter 8 in the Operator’s
Guide to correct the problem.

Main screen. If a

2-18

PN 4237395AA

Checking Carousel Alignment

Open the sample processing area lid.

1

INSTALLATION

CUSTOMER INSTALLATION

2

2

3

Place an empty carousel onto the
indexing base:

Note: To correctly secure the carousel,
line up the arrow on the carousel above
the hub key on the indexing base before
placement.

Close the sample processing area lid.

PN 4237395AA

2-19

INSTALLATION

CUSTOMER INSTALLATION

4

5

Press .

r When the carousel completes

processing, if any of these
conditions occur, then you need to
align the carousel as described in
Chapter 7 of the Operator’s Guide:

t or appears on the

touch screen.

t The instrument pauses and

beeps.

r If none of the above conditions

occur, continue with installation.

2-20

PN 4237395AA

Priming and Preparing the Instrument for Use

If your system has the LALS OPTION,

1

select the correct reagent mode (3 or 4
reagents).

Note: The displayed mode is the active
mode.

INSTALLATION

CUSTOMER INSTALLATION

2

2

3

Press .

Press to prime the instrument
with reagents and to set the reagent
counter to 300.

r The

Prime screen appears during

priming.

PN 4237395AA

r When priming is done, the

screen appears.

Main

2-21

INSTALLATION

CUSTOMER INSTALLATION

Perform the Gravimetric Validation test

4

5

listed in Chapter 5, Calibration, of the
Operator’s Guide.

Note: If your test tubes meet the
specification criteria in Chapter 4 and
none of these three troubleshooting

icons , or appears on
the touch screen during this test, then
your tubes are compatible with the
instrument.

Each system operator should perform
the Operator Certification pr ocedure in
Appendix B before running samples.

2-22

PN 4237395AA

3.1 GENERAL PRINCIPLES

r The TQ-Prep W orkstation automatically adds, in this order, lysing reagent, stabilizer and

fixative to a premixed sample of whole blood and anticoagulant with monoclonal
antibody. For systems that have the LALS OPTION, the OPTION reagent is added last.

r Up to 32 samples containing a premixed sample of blood and antibody are presented to

the reagent system fr om a c arousel capable of holding up to 32 samples.

r On completion of red cell lysis, the samples are removed from the device and presented

separately to a flow cytometer.

r The ImmunoPrep Reagent System is a rapid, gentle, no-wash erythrocyte lysing system

that maintains leukocyte morphology and cell surface integrity.

r Cell loss due to washing and centrifugation is eliminated. Because these steps are not

required, processing time is substantially reduced.

r Automation further provides reproducible standardized sample preparation.

3.2 NORMAL SAMPLE FLOW

1. At power up, startup diagnostics are run on the TQ-Prep Workstation. This includes:

r Moving all of the syringe plungers up and then down, to fill the syringes
r Moving the carousel to its home position (only if it is not at the home position

already)

r Moving the vortex mixer assembly up and down once

OPERATION PRINCIPLES

3

4

3

r Moving the dispensing head in and out once.

2. With the lid to the sample processing area open, a carousel loaded with samples pr epared
according to the reagent package insert, is placed onto the carousel indexing base. The
carousel is then in the home position, Figure 3.1.

CAROUSEL HOME POSITION TUBE LOADING POSITION

Figure 3.1 Carousel Home and Tu be Loading Positions

7395057A

PN 4237395AA

3-1

OPERATION PRINCIPLES

TYPES OF PRIMING

3. After you press , the carousel is indexed sequentially until tube position 1 is
located at the sample processing position under the dispensing head. The carousel is
then in the tube loading position, Figure 3.1.

Note: If you pressed , the carous el indexes when the run cycle starts after the
preincubation.

4. The tube lifter pushes the test tube up from its slot in the carousel and into the
dispensing head.

5. The tube detector senses the presence of a test tube and continues the processing.
Note: If no tube is detected, the carousel moves to the next position and step 4 occurs. If

the tube detector detects a second consecutive empty slot in the carousel, sample
processing ends for this carousel.

6. The vortex mixer premixes the sample for 2 seconds before the first reagent is added.

7. The vortex mixer stops mixing and an electronically controlled syringe adds 600 µL of
ImmunoPrep Reagent A to the sample. At the completion of the reagent dispensing, the
vortex mixer mixes the sample for 8 seconds.

8. The vortex mixer stops mixing and an electronically controlled syringe adds 265 µL of
ImmunoPrep Reagent B to the sample. At the completion of the reagent dispensing, the
vortex mixer mixes the sample for 10 seconds.

9. The vortex mixer stops mixing and an electronically controlled syringe adds 100 µL of
ImmunoPrep Reagent C to the sample. At the completion of the reagent dispensing, the
vortex mixer mixes the sample for 10 seconds.

10. In systems with the LALS OPTION, if you selected the OPTION reagent (4 reagent)
mode, the vortex mixer stops mixing and an electronically controlled syringe adds
500 µL of the OPTION reagent to the sample. At the completion of the reagent
dispensing, the vortex mixer mixes the sample for 8 seconds.

11. The tube lifter lowers, returning the test tube to its original position in the carousel.

12. The carousel indexes to the next position and repeats the process for up to 32 sample
tubes. Any empty tube slot is ignored unless two consecutive empty slots are detected.

13. The cycle is complete when the carousel has completed one full revolution or two
consecutive empty slots are detected.

3.3 TYPES OF PRIMING

User-Requested

r This prime dispenses 100 µL of each reagent through the dispensing tubing.
r Use it during troubleshooting to clear air bubbles from the dispensing tubing.

r Press to request this prime.

3-2

PN 4237395AA

OPERATION PRINCIPLES

TYPES OF PRIMING

New Reagent

r This prime dispenses enough reagent to replace the reagent currently in all the syringes,

in the tubing from the syringes to the dispensing head and in the tubing from the
syringes to the reagent containers.

r See Chapter 4, Specifications/Characteristics, for amounts of dispensed reagent.

r Press to request this prime.

Automatic

This prime dispenses 20 µL of each reagent automatically when you request a function
(sample processing, sample processing with preincubation, Gravimetric Validation, user
requested prime or new reagent prime) after the instrument has been inactive for at least 12
hours.

3

PN 4237395AA

3-3

OPERATION PRINCIPLES

TYPES OF PRIMING

3-4

PN 4237395AA

4.1 PHYSICAL SPECIFICATIONS

Dimensions

Height Width Depth Weight

39.1 cm (15.4 in.) 44.7 cm (17.6 in.) 44.2 cm (17.4 in.) 18.7 kg (41.5 lb)

Power

Installation Category

II (per IEC 1010-1 standard)

Input

100 to 240 Vac, 50-60 Hz

Consumption

Approximately 430 W

SPECIFICATIONS/CHARACTERISTICS

4

4

Noise

<70 decibels

Ambient Operating Temperature

10-35°C (50-95°F)

Humidity

30-85%, without condensation

Recommended Reagents

r The COULTER ImmunoPrep Reage nt System, whic h contains:

t ImmunoPrep A (erythrocyte lysing reagent)
t ImmunoPrep B (leukocyte stabilizing reagent)
t ImmunoPrep C (cell membrane fixing reagent)

r Distilled or deionized water for the OPTION reage nt used with the LALS OPTION

PN 4237395AA

4-1

SPECIFICATIONS/CHARACTERISTICS

PHYSICAL SPECIFICATIONS

Reagent Usage

Reagent A

Cycle Type

Automatic prime:
Occurs before any active function that is
requested after 12 hours of instrument
inactivity.

User requested prime:

Occurs after pressing .
New reagent prime:

Occurs after pressing .
Sample processing 600 265 100 500

(µL)

20 20 20 20

100 100 100 100

871 694 635 920

Reagent B

(µL)

Reagent C

(µL)

Anticoagulant

Use a salt of EDTA (ethylenediaminetetraacetic acid) as the anticoagulant.
The performance characteristics of the TQ-Prep Workstation were established using K

at a concentration of 1.5 mg of anticoagulant per mL of whole blood.

Specimen Type

Whole blood

OPTION Reagent

(µL)

EDTA

3

Sample Size

100 µL anticoagulated whole blood for use with monoclonal antibodies
CYTO-STAT

®

/COULTER CLONE® monoclonal antibody reagents

Tube Size

12 x 75 (+1/-2) mm test tube, round bottom, glass or plastic, that fits in the TQ-Prep
Workstation’s carousel. Plastic tubes are recommended.

Mixing Speed

1,200-1,800 rpm

Throughput

r Three-reagent mode - 80 tubes per hour
r Four reagent mode - 64 tubes per hour

Sample Processing Time

r ImmunoPrep A, B, and C: 38 seconds ±2 seconds
r ImmunoPrep A, B, and C, and OPTION reagent: 47 seconds ±2 seconds

4-2

PN 4237395AA

4.2 PERFORMANCE SPECIFICATIONS

Accuracy of Delivery Volume of Distilled Water

r Volume delivery of syringe for Reagent A: 600 µL ±5%

Lysing time: 8 seconds ±1 second

r Volume delivery of syringe for Reagent B: 265 µL ±5%

Stabilizing time: 10 seconds ±1 second

r Volume delivery of syringe for Reagent C: 100 µL ±5%

Fixative time: 10 seconds ±1 second

r Volume delivery of syringe for OPTION reagent: 500 µL ±10%

Mixing time: 8 seconds ±1 second

Precision (Reproducibility)

The precision (reproducibility) of the reagent delivery volumes is the coefficient of variation
(CV%) as listed below:

SPECIFICATIONS/CHARACTERISTICS

PERFORMANCE SPECIFICATIONS

4

r Reagent A = 5%
r Reagent B = 5%
r Reagent C = 5%
r OPTION Reagent =15%

Calibration

Gravimetric measurement of delivery volumes (*density of distilled or deionized water = 1.0
g/mL).

* The density of ImmunoPrep A and C is insignificantly different from distilled water. The
density of ImmunoPrep B is 1.04 g/mL

4.3 PERFORMANCE CHARACTERISTICS

The TQ-Prep system was tested with normal and abnormal specimens in comparison to the
COULTER Multi-Q-Prep system and substantially equivalent results were observed.

The precision (reproducibility) of the unit based on 32 replicate samples tested for CD4 have
a coefficient of variation (CV) of 1.2%.

PN 4237395AA

4-3

SPECIFICATIONS/CHARACTERISTICS

PERFORMANCE CHARACTERISTICS

4-4

PN 4237395AA

LOG SHEETS

A

This Appendix contains these log sheets:

Page
Reagent Log A-3
Maintenance and Operational Checks Log A-5
Action Log A-7

Make photocopies as needed.

A

PN 4237395AA

A-1

LOG SHEETS

A-2

PN 4237395AA

LOG SHEETS

COULTER® TQ-PREP™ WORKSTATION REAGENT LOG

TQ-Prep/ImmunoPrep Reagent System

Date Opened Lot Number Expiration Date Technician

A

PN 4237395AA

SERIAL NO. ___________________________

LAB. _________________________________

®

SCIENCE SERVING HUMANITY

A-3

LOG SHEETS

A-4

PN 4237395AA

LOG SHEETS

COULTER® TQ-PREP™ WORKSTATION MAINTENANCE AND OPERATIONAL CHECKS LOG

Every 6 Months or

Daily

Startup/QC Check Shutdown/Clean

Date Tech Date Tech Date Tech Procedure Date Tech

As Needed As Needed

Gravimetric

Validation Indicate Procedure

A

SERIAL NO. _________________________________

LAB. ___________________________________

____

PN 4237395AA

®

SCIENCE SERVING HUMANITY

A-5

LOG SHEETS

A-6

PN 4237395AA

Date Condition Noted

COULTER® TQ-PREP™ WORKSTATION ACTION LOG

Tech

(Initials) Date Action Taken

LOG SHEETS

A

Tech

(Initials)

SERIAL NO. _______________________________

LAB. ___________________________________

PN 4237395AA

__

®

SCIENCE SERVING HUMANITY

A-7

LOG SHEETS

A-8

PN 4237395AA

OPERATOR CERTIFICATION PROCEDURE

B

B.1 PURPOSE AND SCOPE

The TQ-Prep Workstation is a precision dispensing instrument designed to increase the
productivity of the flow cytometry laboratory. To achieve the expected test precision and
accuracy, correct pipeting technique is needed.

Coulter recommends that all operators complete this certification procedure before using the
system.

B.2 OPERATOR CERTIFICATION PROCEDURE

1. Use the Operator Certification form at the end of this appendix to record your results.

2. Calibrate a pipet using the appropriate Pipet Calibration Procedure (air-displac ement or

positive-displacement) listed below.

3. Use the pipet calibrated in step 2 above to perform the TQ-Prep Workstation Precision

Procedure.

B.3 PIPET CALIBRATION PROCEDURE

Use the pipet calibration procedur e corr esponding to the type of pipet used in your laboratory
to prepare samp les.

B

PN 4237395AA

B-1

OPERATOR CERTIFICATION PROCEDURE

1
0
0

PIPET CALIBRATION PROCEDURE

With Air-Displacement Pipet (Reverse Mode)

Securely fasten a new tip to the pipet.

1

Adjust the volume to 100 µL if it is not a

2

fixed volume pipet.

3

Tare a weigh boat on a microbalance.

1
0
0

B-2

PN 4237395AA

4

5

Press the plunger down to the first stop.

Place the tip 2 to 3 mm below the
surface of a container of deionized or
distilled water.

OPERATOR CERTIFICATION PROCEDURE

PIPET CALIBRATION PROCEDURE

B

6

PN 4237395AA

Continue to press the plunger down
2 to 3 mm more.

B-3

OPERATOR CERTIFICATION PROCEDURE

PIPET CALIBRATION PROCEDURE

Slowly release the plunger to overdraw

7

8

the required volume.

Remove the tip from the deionized or
distilled water while touching the tip to
an inside wall to remove any adhering
liquid.

B-4

9

While touching the tip to the tared
weigh boat, slowly dispense the water
by depressing the plunger to the first
stop only. There must be liquid
remaining inside the tip.

PN 4237395AA

OPERATOR CERTIFICATION PROCEDURE

PIPET CALIBRATION PROCEDURE

B

10

11

Record the weight in milligrams (mg)
on the Operator Certification form at
the end of this appendix.

Repeat steps 3 through 10 until you
have recorded 10 results on the form.

®

COULTER

TQ-PREP™ Workstation Operator Certification Form

Part I - Pipet Precision (Weight in milligrams of water dispensed)
Pipet Type: ____ Air Displacement ____ Positive Displacement

100.1

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

COULTER® TQ-PREP™ Workstation Operator Certification Form

Part I - Pipet Precision (Weight of water dispensed)
Pipet Type: ____ Air Displacement ____ Positive Displacement

100.1

1. __________mg

100.0

2. __________mg

100.0

3. __________mg

99.8

4. __________mg

99.9

5. __________mg

100.1

6. __________mg

100.0

7. __________mg

100.1

8. __________mg

100.0

9. __________mg

99.8

10. _________mg
Mean _______mg
SD _________mg

1. ____________

2. ____________

3. ____________

4. ____________

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

1. ____________

2. ____________mg

3. ____________mg

4. ____________mg

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

mg

12

PN 4237395AA

Calculate the mean and the standard
deviation (SD).

r The mean must be 100 ±0.5. Adjust

the pipet’ s volume to dispense if the
mean is not correct.

r The SD must be less than 1.0. This

represents your skill level. Repeat
this procedure until the SD is less
than 1.0.

COULTER® TQ-PREP™ Workstation Operator Certification Form

Part I - Pipet Precision (Weight of water dispensed)
Pipet Type: ____ Air Displacement ____ Positive Displacement

100.1

1. __________mg

100.0

2. __________mg

100.0

3. __________mg

99.8

4. __________mg

99.9

5. __________mg

100.1

6. __________mg

100.0

7. __________mg

100.1

8. __________mg

100.0

9. __________mg

99.8

10. _________mg

99.98

Mean _______mg

.11352924

SD _________mg

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

B-5

OPERATOR CERTIFICATION PROCEDURE

1
0
0

PIPET CALIBRATION PROCEDURE

With Positive-Displacement Pipet

Securely fasten a new tip to the pipet.

1

Adjust the volume to 100 µL if it is not a

2

fixed volume pipet.

3

Tare a weigh boat on a microbalance.

1
0
0

B-6

PN 4237395AA

4

5

Press the plunger all the way down.

Place the tip 2 to 3 mm below the
surface of a container of deionized or
distilled water.

OPERATOR CERTIFICATION PROCEDURE

PIPET CALIBRATION PROCEDURE

B

6

PN 4237395AA

Slowly release the plunger to draw the
required volume.

B-7

OPERATOR CERTIFICATION PROCEDURE

PIPET CALIBRATION PROCEDURE

Remove the tip from the deionized or

7

distilled water while touching the tip to
an inside wall to remove any adhering
liquid.

While touching the tip to the tared

8

weigh boat, slowly dispense the water
by depressing the plunger all the way
down.

B-8

9

Record the weight in milligrams on the
Operator Certification form at the end of
this appendix.

®

COULTER

TQ-PREP™ Workstation Operator Certification Form

Part I - Pipet Precision (Weight of water dispensed)
Type: ____ Air Displacement ____ Positive Displacement

100.1

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

1. ____________

2. ____________

3. ____________

4. ____________

1. ____________mg

2. ____________mg

3. ____________mg

4. ____________mg

PN 4237395AA

OPERATOR CERTIFICATION PROCEDURE

PIPET CALIBRATION PROCEDURE

B

10

11

Repeat steps 3 through 9 until 10 results
are listed.

Calculate the mean and the standard
deviation (SD).

r The mean must be 100 ±0.5. Adjust

the pipet’ s volume to dispense if the
mean is not correct.

r The SD must be less than 1.0. This

represents your skill level. Repeat
this procedure until the SD is less
than 1.0.

COULTER® TQ-PREP™ Workstation Operator Certification Form

Part I - Pipet Precision (Weight of water dispensed)
Pipet Type: ____ Air Displacement ____ Positive Displacement

100.1

1. __________mg

100.0

2. __________mg

100.0

3. __________mg

99.8

4. __________mg

99.9

5. __________mg

100.1

6. __________mg

100.0

7. __________mg

100.1

8. __________mg

100.0

9. __________mg

99.8

10. _________mg
Mean _______mg
SD _________mg

COULTER® TQ-PREP™ Workstation Operator Certification Form

Part I - Pipet Precision (Weight of water dispensed)
Pipet Type: ____ Air Displacement ____ Positive Displacement

100.1

1. __________mg

100.0

2. __________mg

100.0

3. __________mg

99.8

4. __________mg

99.9

5. __________mg

100.1

6. __________mg

100.0

7. __________mg

100.1

8. __________mg

100.0

9. __________mg

99.8

10. _________mg

99.98

Mean _______mg

.11352924

SD _________mg

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

1. __________mg

2. __________mg

3. __________mg

4. __________mg

5. __________mg

6. __________mg

7. __________mg

8. __________mg

9. __________mg

10. _________mg
Mean _______mg
SD _________mg

PN 4237395AA

B-9

OPERATOR CERTIFICATION PROCEDURE

TQ-PREP WORKSTATION PRECISION PROCEDURE

B.4 TQ-PREP WORKSTATION PRECISION PROCEDURE

Use the pipet calibrated above to

1

2

perform this procedure.

Completely mix a tube of normal donor
blood by inversion.

3

Pipet 100 µL of blood into a 12 x 75 mm
test tube.

100 µL
WHOLE
BLOOD

B-10

PN 4237395AA

4

5

Place the test tube into the TQ-Prep
Workstation carousel.

Repeat steps 2 through 4 until all 32
positions of the carousel are filled.

OPERATOR CERTIFICATION PROCEDURE

TQ-PREP WORKSTATION PRECISION PROCEDURE

32

23

1

4

5

7

8

31

30

9

B

6

Open the sample processing area lid.

26

25

24

23

22

21

20

15

16

17

18

19

PN 4237395AA

B-11

OPERATOR CERTIFICATION PROCEDURE

TQ-PREP WORKSTATION PRECISION PROCEDURE

Load the carousel.

7

8

Note: To correctly secure the carousel,
line up and place the arrow on the
carousel over the hub key on the
indexing base.

Close the sample processing area lid.

B-12

9

Press .

PN 4237395AA

10

When processing is done, remove the
carousel and assay the samples for
lymphocytes on a flow cytometer per
the instrument’s manual.

Acceptable results:

OPERATOR CERTIFICATION PROCEDURE

TQ-PREP WORKSTATION PRECISION PROCEDURE

B

11

a. The histograms must not show

unlysed erythrocytes.

b. All 32 tubes must recover the

same percent lymphocytes
±2% of the mean using the
same analysis region.

PN 4237395AA

B-13

OPERATOR CERTIFICATION PROCEDURE

TQ-PREP WORKSTATION PRECISION PROCEDURE

B-14

PN 4237395AA

OPERATOR CERTIFICATION PROCEDURE

TQ-PREP WORKSTATION PRECISION PROCEDURE

COULTER® TQ-PREP™ Workstation Operator Certification Form

Part I - Pipeting Precision (Weight of water dispensed)

Pipet Type: _____ Air Displacement _____ Positive Displacement

1. _________________ mg 1. _________________ mg 1. _________________ mg

2. _________________ mg 2. _________________ mg 2. _________________ mg

3. _________________ mg 3. _________________ mg 3. _________________ mg

4. _________________ mg 4. _________________ mg 4. _________________ mg

5. _________________ mg 5. _________________ mg 5. _________________ mg

6. _________________ mg 6. _________________ mg 6. _________________ mg

7. _________________ mg 7. _________________ mg 7. _________________ mg

8. _________________ mg 8. _________________ mg 8. _________________ mg

9. _________________ mg 9. _________________ mg 9. _________________ mg

10. ________________ mg 10. ________________ mg 10. ________________ mg
Mean ______________ mg Mean ______________ mg Mean ______________ mg

B

SD ________________ mg SD ________________ mg SD ________________ mg

Part II - COULTER TQ-Prep Workstation Precision (Percent L ymphocytes from FS vs. SS Histogram)

1. __________________ 13. __________________ 25. __________________

2. __________________ 14. __________________ 26. __________________

3. __________________ 15. __________________ 27. __________________

4. __________________ 16. __________________ 28. __________________

5. __________________ 17. __________________ 29. __________________

6. __________________ 18. __________________ 30. __________________

7. __________________ 19. __________________ 31. __________________

8. __________________ 20. __________________ 32. __________________

9. __________________ 21. __________________

10. __________________ 22. __________________

11. __________________ 23. __________________ Mean ________________

12. __________________ 24. __________________ SD __________________

Tech:___________________________________ ______________ Date: _________ _________

PN 4237395AA

®

SCIENCE SERVING HUMANITY

B-15

OPERATOR CERTIFICATION PROCEDURE

TQ-PREP WORKSTATION PRECISION PROCEDURE

B-16

PN 4237395AA

REFERENCES

1. Rose NR and Friedman H, eds. 1980. Manual of clinical immunology, 2d edition.

American Society for Microbiology. Washington, DC.

2. Guidelines for prophylaxis against pneumocystis carinii pneumonia for persons infected

with human immunodeficiency virus. Centers for Disease Control Morbidity and
Mortality Weekly Report. 38(S-5):1-9.

3. Mishell BB and Shiigi AM. 1980. Selected methods in cellular immunology. San

Francisco: WH Freeman and Co.

4. Caldwell CW and Taylor HM. 1986. A rapid no-wash technique for immunophenotypic

analysis by flow cytometry. Am J Clin Path. 86(5):600.

5. Barker JW. 1988. An innovative lymphocyte preparation system for flow cytometry. Am

Clin Lab 7(7):32.

6. Kotylo PK, Baenzinger JC, Yoder MC, Engle WA and Bolinger CD. 1990. Rapid analysis

of lymphocyte subsets in cord blood. Am J Clin Path 93(2):263-266.

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-1

REFERENCES

-2

PN 4237395AA

GLOSSARY

A Ampere, a unit of electric current.
Accuracy Ability of an instrument to agree with a predetermined reference value.
AG Automotive glass.
Air-displacement pipet A pipet that entraps a measured quantity of liquid then delivers the liquid by a piston stroke

mechanism.
Ambient temperature Temperature in the surrounding environment.
Button Touch screen icon enclosed in a box that starts a function when pressed.
Carousel home position The position used for carousel loading where the key (arrow) on the carousel is at the

12 o’clock position and the tube position 10 is at the dispensing head position.
CD4 Cluster designation for a T4 cell.
Centrifugation Separation of particulate matter from a suspending liquid with a centrifuge.
cm Centimeter, a unit of linear measurement.
CV (Coefficient of

Variation)
dc Direct current.
Deionized water (DI H

Density The mass of a substance per unit volume.

2

An expression, in percent, of the data spread as related to the mean.

CV% = (SD/Mean) x 100

0) Water freed of salts and some organisms by an ion-exchange process. Can be used
interchangeably with distilled water in these procedures.

Distilled water Water freed of solids and organisms by distillation. Can be used interchangeably with

deionized water in these procedures.

Erythrocyte Red blood cell.
Flow cytometry A process for measuring the characteristics of cells or other biological particles as they pass

through a measuring apparatus in a fluid stream.

g Gram, a unit of weight.
Gravimetric Of or relating to measurement by weight.
Histogram, light-scatter A two-dimensional graphic presentation of multidimensional accumulated data. Usually the

X-axis is set to Side Scatter and the Y-axis is set to Forward Scatter.

Hz Hertz, a unit of frequency.
Icon Touch screen graphic that displays processing or troubleshooting information to the user or

as a button requests a function.

IEC International Electrical Commission.
Immunofluorescence Fluorescence as the result of, or identifying, an immune response.
Immunophenotyping Process of identifying/categorizing cells through the use of cell surface antigen marking.
in. Inch, a unit of measure.
Instrument cycle Number of sample processing cycles (prime and gravimetric validation cycles are not

included).

In vitro Latin phrase meaning outside of a living system, as in a laboratory or in an artificial

container such as a test tube.

K

EDTA (tripotassium ethlyenediaminetetraacetic acid) A salt solution that prevents clotting of blood

3

kg Kilogram, a unit of weight equal to 1,000 g.

PN 4237395AA

specimens placed in purple-stoppered blood collection tubes.

-1

GLOSSARY

LALS OPTION This option is for use on flow cytometers that measure a low angle of forward scatter (FALS)

light.
Laminar flow hood Also called: safety cabinet.
lb Pound, a unit of weight.
Leukocyte White blood cell.
Lot number A manufacturer’s code that identifies when a reagent was manufactured.
Lysing/Lysis Disruption of the cellular membrane.
Mean Arithmetic average of a group of data.
mg

Microcontroller An integrated circuit that can organize the functions of multiple components.
Microprocessor The integrated circuitry for electronically controlled devices.
mL

mm Millimeter, a unit of linear measurement, equal to one-thousandth of a meter.
Monoclonal antibodies Antibodies produced by a single cell or its identical progeny, specific fo r a given antigen.

Milligram, a unit of weight, equal to 10

Milliliter, a unit of volumetric measurement, equal to 10

-3

gram.

-3

liter.

MSDS Material Safety Data Sheets.

2

-6

liter.

µL
Optical flag switch A switch that moves to the ON position when its optical sensor detects the presence of an

Positive-displacement
pipet

Precision A measure of the ability of the instrument to reproduce similar results when a sample is run

Preincubation Maintaining a chemical mixture at a specified temperature for a specific time period.
Quality Control (QC) A comprehensive set of procedures your laboratory sets up to ensure that an instrument is

Reproducibility A procedure to check that the system gives similar results (within established limits) every

rpm Revolutions per minute.
Safety cabinet Also called: laminar flow hood.
SD (Standard Deviation) A measure of deviation from the mean.

Microliter, a unit of volumetric measurement, equal to 10

object, such as the test tube.

A pipet that entraps a measured quantity of liquid, increases its pressure and then delivers

the liquid.

repeatedly. Also called: reproducibility.

working accurately and precisely.

time it measures the same sample. Also called: precision.

xx–()

∑

SD

-------------------------- -=
N1–

Tare weight A deduction from the gross weight made to allow for the weight of a container.
T ube loading position The position where the carousel starts processing; tube position 1 is at the dispensing head

position (3 o’clock position).

Transient A temporary phenomenon such as a pulse, that occurs before a system’s power reaches the

steady state condition.

-2

PN 4237395AA

V Volt, a unit of electrical potential difference measurement.
Vac Volts of alternating current.
Vortex A whirling motion of liquid.
W Watt, a unit of power.

GLOSSARY

PN 4237395AA

-3

GLOSSARY

-4

PN 4237395AA

INDEX

Symbols

µL

definition, GLOSSARY-2

A

A

definition, GLOSSARY-1

accessibility, instrument

installation requirements, 2-1

accuracy

definition, GLOSSARY-1
performance specifications, 4-3

specifications, 4-3
action log sheet, A-7
adjustment procedures

touch screen contrast, 2-18
AG

definition, GLOSSARY-1
air-displacement pipet

calibration, B-2

definition, GLOSSARY-1
alignment

checking carousel, 2-19
ambient temperature

definition, GLOSSARY-1

instrument, 2-1, 4-1
anticoagulant recommended, 4-2

B

buttons

convention used, x

definition, GLOSSARY-1

tube loading position, definition,

GLOSSARY-2
tube loading position, description, 3-2
tube loading position, figure, 3-1

CD4

definition, GLOSSARY-1

centrifugation

definition, GLOSSARY-1

characteristics, performance, 4-3
checking

alignment, at installation, 2-19

cm

definition, GLOSSARY-1

coefficient of variation (CV)

definition, GLOSSARY-1

components, system

description, 1-2
dimensions, 4-1
location, 1-2
reagent storage and dispense area, 1-3
sample processing area, 1-2

connections, tubing

WASTE container, 2-14

connectors, level sense

location, 2-12

conventions used, x
COULTER CLONE monoclonal antibody

used with sample, 4-2

cover

reagent, location on system, 2-16

CV

definition, GLOSSARY-1

CYTO-STAT monoclonal antibody

used with sample, 4-2

PN 4237395AA

C

cable connections

at installation, 2-17

calibration

of air-displacement pipet, B-2
of positive-displacement pipet, B-6
specification, 4-3

carousel

checking alignment, 2-19
description, 1-2
home position, definition, GLOSSARY -1
home position, description, 3-1
home position, figure, 3-1

D

Data Sheets, Material Safety

ordering, 1-5

dc

definition, GLOSSARY-1

definitions, GLOSSARY-1
deionized water

definition, GLOSSARY-1
for use as OPTION reagent, 1-5

delivery inspection, instrument

if installed by Coulter representative, 2-2
if installed by customer, 2-2

delivery volume, 4-3

-1

density

definition, GLOSSARY-1
reagents, 4-3

water, 4-3
dimensions, 4-1
direct current

definition, GLOSSARY-1
dispensing head

description, 1-2

location on system, 1-2
distilled water

definition, GLOSSARY-1

for use as OPTION reagent, 1-5
documentation for your instrument

about your reference manual, x

conventions used, x

introduction to your manuals, ix

H

hardware

options, 1-4
special requirements, 2-1

histogram, light-scatter

definition, GLOSSARY-1
history of methods, 1-1
home position, carousel

definition, GLOSSARY-1

description, 3-1

figure, 3-1
hub key

description, 1-2

location on system, 1-2
humidity, allowance, 2-1, 4-1
Hz

definition, GLOSSARY-1

E

EDTA

definition as K
recommended, 4-2

electrical input

special requirements, 2-1

electronics

description, 1-3

erythrocyte

definition, GLOSSARY-1

extension cord

Caution, 2-1

EDTA, GLOSSARY-1

3

F

fixing reagent, 1-5
flow cytometry

definition, GLOSSARY-1

G

g

definition, GLOSSARY-1

gravimetric

definition, GLOSSARY-1

Gravimetric Validation

at installation, 2-22

ground path requirement, 2-1

I

icons

convention used, x

definition, GLOSSARY-1
IEC

definition, GLOSSARY-1
immunofluorescence

definition, GLOSSARY-1
immunophenotyping

definition, GLOSSARY-1
ImmunoPrep A, B, and C, See reagents
in vitro

definition, GLOSSARY-1
in., GLOSSARY-1
indexing base

description, 1-2

location on system, 1-2
inspection

at delivery, 2-2
installation

by Coulter representative, 2-2

by customer, 2-2

category, 4-1

hardware, 2-1

operator certification, 2-2, 2-22

requirements, 2-1

who installs, 2-1
instrument

accessibility, 2-1

characteristics, 4-3

-2

PN 4237395AA

components, description, 1-2
components, location on system, 1-2
delivery inspection, 2-2
dimensions, 4-1
electrical input requirements, 4-1
installation special requirements, 2-1
intended use, 1-1
layout, 2-1
location, 2-1
performance specifications, 4-3
physical specifications, 4-1
purpose, 1-1
unpacking, 2-2, 2-3
view, 1-1

instrument cycle

definition, GLOSSARY-1

intended use of instrument, 1-1

K

K3EDTA

definition, GLOSSARY-1
used for performance characteristics, 4-2

key

carousel, description, 1-2
carousel, location on system, 1-2
hub, description, 1-2
hub, location on system, 1- 2

kg

definition, GLOSSARY-1

L

LALS OPTION

definition, GLOSSARY-2
description, 1-4

laminar flow hood

accessibility requirements, 2-1
definition, GLOSSARY-2
reagent cover not needed, 2-1

space requirements, 2-1
layout of instrument, 2-1
lb

definition, GLOSSARY-2
leukocyte

definition, GLOSSARY-2
level sense connector

colors, 2-12

how to connect, 2-12

location on instrument, 2-12

location, reagents, 2-12
location, WASTE, 2-12

lid

See sample processing area lid
See also reagent cover

log sheets

action, A-7
maintenance and operational checks, A-5
reagent, A-3

lot number

definition, GLOSSARY-2

lysing

definition, GLOSSARY-2
lysing reagent, 1-4
lysis

definition, GLOSSARY-2

M

maintenance and operational checks l o g

sheet, A-5

manuals for your instrument

about your reference manual, x

conventions used, x

how to use, ix

introduction to your manuals, ix

using the manuals, ix
Material Safety Data Sheets (MSDS)

ordering, 1-5
mean

definition, GLOSSARY-2
method history, 1-1
mg

definition, GLOSSARY-2
microcontroller

definition, GLOSSARY-2
microprocessor

definition, GLOSSARY-2
mixing speed, specifications, 4-2
mL

definition, GLOSSARY-2
mm

definition, GLOSSARY-2
monoclonal antibodies

definition, GLOSSARY-2

used with sample, 4-2
MSDS (Material Safety Data Sheets)

definition, GLOSSARY-2

how to order, 1-5

PN 4237395AA

-3

N

noise, specifications, 4-1
normal sample flow, 3-1

O

operation principles, 3-1
operational checks, and maintenance, log

sheet, A-5

operator certification

at installation, 2-2, 2-22
form, B-15
procedure, B-1

optical flag switch

definition, GLOSSARY-2
OPTION reagent, See reagents
options, 1-4

P

performance characteristics

instrument, 4-3

precision, 4-3

reproducibility, 4-3
performance specifications

accuracy, 4-3

precision, 4-3

reproducibility, 4-3
physical specifications, instrument, 4-1
pipet

air-displacement, definition,

GLOSSARY-1
calibration procedure, B-1
positive-displacement, definition,

GLOSSARY-2

positive-displacement pipet

calibration, B-6
definition, GLOSSARY-2

power

cable connection, 2-17
consumption, 4-1
electrical input, 4-1
installation category, 4-1
specifications, 4-1

power cable

connection, 2-17

Power Up screen, 2-18
precision (reproducibility)

characteristics, 4-3
definition, GLOSSARY-2

operator certification procedure, B-10
specifications, 4-3

preincubation

definition, GLOSSARY-2

preventive maintenance and operational

checks log sheet, A-5

priming

amount of reagent used, 4-2
at installation, 2-21
automatic, 3-3
new reagent, 3-3
types, 3-2, 4-2
user-requested, 3-2

principles, operation, 3-1

Q

QC (quality control)

definition, GLOSSARY-2

quality control (QC)

definition, GLOSSARY-2

R

Reagent A, See reagents
Reagent B, See reagents
Reagent C, See reagents
reagent cover

location on system, 2-16
not needed in safety cabinet/laminar flow

hood, 2-1

reagent delivery system

description, 1-3
reagent log sheet, A-3
reagent storage and dispense area

description, 1-3
reagents

deionized water, 1-5

distilled water, 1-5

empty containers, 2-13

fixing reagent, 1-5

ImmunoPrep, 1-4

location in system, 2-8, 2-11

lysing reagent, 1-4

monoclonal antibodies, used with sample,

4-2
OPTION reagent, 1-5
priming amounts, 4-2
Reagent A, 1-4
Reagent B, 1-4

-4

PN 4237395AA

Reagent C, 1-5
recommended, 4-1
stabilizing reagent, 1-4
types used, 1-4
usage, 4-2

reference manual

about your reference manual, x
conventions used, x
introduction to your manuals, ix

using the manuals, ix
references, REFERENCES-1
reproducibility (precision)

definition, GLOSSARY-2

performance characteristics, 4-3

performance specifications, 4-3
requirements, installation

hardware, 2-1

instrument accessibility, 2-1

power input, 2-1

room temperature, 2-1

space needed, 2-1
room temperature

ambient operating, 4-1

special requirements, 2-1

specifications, 4-1
rpm

definition, GLOSSARY-2

S

safety cabinet

accessibility requirements, 2-1

definition, GLOSSARY-2

reagent cover not needed, 2-1

space requirements, 2-1
sample

processing time specifications, 4-2

size, 4-2

tube size, 4-2

type, 4-2
sample flow, 3-1
sample processing area

description, 1-2

location on system, 1-2
sample processing area lid

location on system, 1-2
sample tube

material made of, 4-2

size, 4-2

See also tube

SD (standard deviation)

definition, GLOSSARY-2

software screens

Power Up screen, 2-18
space needed, instrument, 2-1
special requirements, installation, 2-1
specifications

instrument, 4-1

performance, 4-3
specimen

processing time specifications, 4-2

type, 4-2

See also sample
stabilizing reagent, 1-4
standard deviation(SD)

definition, GLOSSARY-2
syringe

delivery volume, 4-3
system components

description, 1-2

T

tare weight

definition, GLOSSARY-2
temperature, ambient operating, 2-1, 4-1
throughput, 4-2
touch screen

adjust contrast, 2-18

description, 1-4
TQ-Prep Workstation

components, description, 1-2

installation requirements, 2-1

intended use, 1-1

performance specifications, 4-3

physical specifications, 4-1

purpose, 1-1

view of instrument, 1-1
transient

definition, GLOSSARY-2
troubleshooting icons

convention used, x
tube

loading position, definition, GLOSSARY-2

loading position, description, 3-2

loading position, figure, 3-1

See also sample tube
tube detector

description, 1-3

location on system, 1-2

PN 4237395AA

-5

tube lifter

description, 1-3
location on system, 1-2

U

unpacking of instrument, 2-3
use and function, instrument, 1-1

V

V

definition, GLOSSARY-3

Vac

definition, GLOSSARY-3
ventilation requirements, 2-1
vortex

definition, GLOSSARY-3
vortex mixer

description, 1-3

location on system, 1-2

W

W

definition, GLOSSARY-3
WASTE container

location in system, 2-15
water, deionized

definition, GLOSSARY-1

for use as OPTION reagent, 1-5
water, distilled

definition, GLOSSARY-1

for use as OPTION reagent, 1-5
worksheet

See log sheets

-6

PN 4237395AA

BECKMAN COULTER, INC. CUSTOMER END USER LICENSE AGREEMENT

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COULTER, COULTER CLONE, the "CC" logo, CYTO-STAT, ImmunoPrep, Multi-Q-Prep,
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Teflon is a registered trademark of E. I. duPont de Nemours & Co.

PN 4237395AA

All other trademarks, service marks, products, or services are trademarks or registered
trademarks of their respective holders.

Documentation

S Reference

PN 4237395

S Operator’s Guide

PN 4237396

S Operating Summary (In English)

PN 4237389

Use and Function • Installation • Operation Principles •
Specifications/Characteristics • Log Sheets • Operator Certification • References •
Glossary • Index

Controls and Indicators • Startup • Sample Processing • Shutdown • Calibration •
Cleaning Procedures • Replace/Adjust Procedures • Troubleshooting • Master Index

Overview of daily procedures and description of screen buttons and icons.

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