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Field Service Training

Workbook
The CELL-DYN Emerald is manufactured and/or distributed by Abbott Laboratories,
U.S.A., Abbott Park, IL 60064.
REVISION STATUS
Document Control Number Date Content Revised
204979-101 October 2008 New Release

All samples (printouts, graphics, displays or screens, etc.) are for information and
illustration purposes only and shall not be used for clinical or maintenance evaluations.

Any product information in this document should be used in conjunction with the latest
version of the Operator’s and Service Manuals. If any discrepancies in information exist
within this document or any other, the latest version of the Operator’s and/or Service
Manual takes precedence.

All Abbott Laboratories product names and trademarks are owned by or licensed to
Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade
name, trade dress, or product name may be made without the prior written authorization
of Abbott Laboratories, except to identify the product or services of Abbott Laboratories.
All other trademarks brands, product names, and trade names are the property of their
respective companies. All rights reserved.

Except as permitted above, no license or right, expressed or implied, is granted to any


person under any patent, trademark, or other proprietary right of Abbott Laboratories.

Each person assumes full responsibility and all risks arising from use of the information.
The information is presented “AS IS” and may include technical inaccuracies or
typographical errors. Abbott Laboratories reserves the right to make additions, deletions,
or modifications to the information at any time without any prior notification.
Trademark Statement
CELL-DYN and Emerald are trademarks of Abbott Laboratories.

This guide was developed and produced by ADD Commercial Training in Irving, TX.
Copyright 2008, Abbott Laboratories, Abbott Park, Illinois.

CELL-DYN Emerald Field Service Training Workbook (204979-101) iii


Training Overview
CELL-DYN Emerald Field Service Training is an intensive 2 1/2-day course of
presentations and activities designed to provide the Field Service Organization with the
opportunity to orient Field personnel to:
• System components, hardware, and software
• Key normal and abnormal indicators
• Troubleshooting, installation, and preventive maintenance procedures
• Concrete actions they can take to ensure customer service and business objec-
tives are achieved.

The purpose of CELL-DYN Emerald Field Service Training Workbook is to prepare Field
Personnel for their role as crucial drivers of customer service excellence.

The benefits of CELL-DYN Emerald Field Service Training Workbook are twofold: for
Abbott Diagnostics Division, it establishes a set of consistent processes and procedures
for improved customer service; for Field personnel, it provides an essential map through
the often competing demands of day-to-day decision-making.

Materials Needed for Class


• A laptop computer with access to the GSS website
• A basic understanding of the materials provided in the Hematology Basics pre-
training computer based training
• Familiarization with the Effective Troubleshooting model
• Understanding of basic FSR business and technical procedures, tools and con-
tacts

iv CELL-DYN Emerald Field Service Training Workbook (204979-101)


Training Objectives
After completing the CELL-DYN EMERALD Field Service Training Workbook Program,
students should able to:
• Perform basic operations on the CELL-DYN Emerald including:
• Navigation of the software interface and use functions specific to the mainte-
nance, diagnostic and configuration of the instrument
• Performance of Calibration, Quality Control and Troubleshooting
• Perform a basic specimen run
• Perform troubleshooting and repair procedures including:
• Location of instrument components
• Perform component diagnostic procedures
• Remove and replace components based upon information derived from root
cause analysis
• Repair instrument components when removal or replacement is unnecessary
• Perform installation procedures
• Identify job aids, references and resources available to FSRs
• Apply understanding of basic Hematology concepts and CELL-DYN Emerald
technologies to interpret results and enhance troubleshooting capability
• Identify the cause of result flagging and correlate those findings to the trouble-
shooting process
• Reinforce Effective Troubleshooting and Fort through the use of case studies and
in class exercises

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vi CELL-DYN Emerald Field Service Training Workbook (204979-101)
Contents

Training Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Materials Needed for Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Training Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Service Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Module Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Overview and Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Activity — Component Identification . . . . . . . . . . . . . . . . . . . . . . . .2-9
Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Activity — Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Activity — Software Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Normal Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Required Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Activity — Normal Observations . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5

CELL-DYN Emerald Field Service Training Workbook (204979-101) vii


Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Activity — Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . .6-3
Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Activity — Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
Gains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Activity — Electronic Gain Adjustment . . . . . . . . . . . . . . . . . . . . . .8-2
Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3
Module Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Activity — Troubleshooting System Components . . . . . . . . . . . . . .9-1
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
Activity — Troubleshooting System Components Part 2 . . . . . . . . .9-3
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Activity — System Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Supplemental Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

viii CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 1: Service Tools

The CELL-DYN Emerald Service tools module is to familiarize you with the tools and
resources available to you to perform your role as a FSR effectively and efficiently. In this
module you will be introduced to various manuals, documents, diagnostic tools and
troubleshooting principles. Topics include:
• Electronic Resources: Operator’s Manual, e-Solutions, block diagrams, Opera-
tor’s Manual, FRUD
• Instrument: FS Logon, Reports, Result Details, and Gains Report

You will also receive a brief introduction to the Effective Troubleshooting process and the
forms used to document your findings.

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Objectives

Objectives

After completing this module, you should be able to:


• Access information necessary to identify and resolve operational and hardware
errors.
• Identify the STEPs utilized for effective troubleshooting.
• Identify the various sources of service documentation and describe the types of
information contained in each.
• Locate and describe the Implementation Classifications of a Technical Service
Bulletin (TSB).
• Define TSB and ISA and how these documents are used.

The CELL-DYN Emerald System Service and Support Manual, CELL-DYN Emerald
System Operator’s Manual, and CELL-DYN Emerald System Assay Information can be
accessed through the Abbott Global Service and Support (GSS) intranet site unless
otherwise noted.

Service Personnel should keep their laptop documents at the current revision levels
through timely installation of CD-ROM updates and/or replication.

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Objectives

CELL-DYN Emerald Service and Support Manual


The CELL-DYN Emerald Service and Support Manual is the primary reference for
repairing the CELL-DYN Emerald System. It contains instrument-specific
information, including the following sections:

SECTION TOPIC
Proprietary Info • Liability disclaimer, trademarks listing and the service manual revision log

General Data • Product overview, information on manual usage, accident prevention symbols and
functional description
• Includes block and functional diagrams, mechanism and motor listings, and LED
operating conditions
Troubleshooting • Contains drawings and schematics

Parts Lists • Lists of Supplemental Tools and Supplies


• Links to the Field Replaceable Unit Database (FRUD) and a list of Customer and
Field Service Replaceable parts
Removal & • Removal & Replacement procedures indexed by number to the linked Parts list
Replacement
Verification • Provides detailed procedures used to verify correct instrument operation
Procedures
Maintenance • Planned Maintenance (PM) recommended checklist
• Recommendations may be subject to change due to local business or regulatory
needs
Pre-Site • Site specifications and a checklist that outlines the activities of Field Personnel
Specification & • An action item summary is included in the checklist
Checklist

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Objectives

CELL-DYN Emerald System Operator’s Manual


The CELL-DYN Emerald System Operator’s Manual is the reference for operating
the CELL-DYN Emerald System. It describes the Systems and their components,
installation procedures, theory of operations, and operating procedures. The
manual also provides a description of the various diagnostic checks, routine
maintenance procedures, and a troubleshooting guide.

CELL-DYN Emerald System Assay Information


CELL-DYN Emerald System Assay Information contains information that includes
control values, specimen requirements, cross reactivity, assay parameters, and
more. This is the reference source for assay information on the CELL-DYN
Emerald System.

TSB and ISA Database


The TSB and ISA all Product Database is used for the distribution of Technical
Service Bulletins (TSB) and Instrument Service Advisories (ISA) to Abbott
Personnel only. Local users can access the database directly from the Abbott
server, while field users can access a locally replicated version. The TSB and ISA
databases are also contained in the online manual. Once you are within the
database choose CELL-DYN Emerald System to view the relevant TSBs or ISAs.

Note: The information in these databases are CONFIDENTAL and for INTER-
NAL USE ONLY. No information in this database may be given out (electronic
or hard copy) to any NON-Abbott Personnel without the prior written permission
from Abbott Laboratories.

TSBs:

Technical Service Bulletins are used to notify Service Personnel of the following:

• Physical change or modification to instrument requiring on-site implementation


by Areas of the World. Examples of TSBs include:

• Instrument Safety improvements

• Enhanced Result generation

• Instrument features

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Objectives

• Implementation Classification and other guidelines for identifying affected


instruments.

• Mandatory

• Optional TSB completion on each instrument through a TSB sticker. When a


TSB is performed, the TSB number should be crossed off on the sticker.

• TSB completion is tracked within the Complaint Handling System.

ISAs:

Instrument Service Advisories are used to notify Service Personnel of the


following:

• Field Service communication of information on a particular product or product


group that does not require implementation by Areas of the World.

Examples of ISAs include:

• Changes to parts

• Troubleshooting assistance

• Software Changes

ISAs can be used as a supplement to the service manual until a revision of the
manual containing the information is available.

Performance of an ISA is usually not tracked on the instrument.

Emerald Software Simulator

The Emerald Software Simulator is a stand-alone simulation of the Emerald


Operating System and is used to aide in learning how to navigate and use the
instrument software.

Adjustable Torque Driver (part # 8701693201) and Torx Bits T6, T10, and T20
sizes:

The Emerald requires specialized torque drivers to prevent damaging screws


used in instrument component assemblies.

USB Flash Drive:

The USB Flash drive is used to Install, Backup, Restore data.

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Troubleshooting

Troubleshooting
General Troubleshooting
Effective troubleshooting and problem resolution requires four logical STEPs:
• STOP - Identify the Problem
• THINK - Gather Information/Data
• Look for Comparison (What IS working vs. What IS Not)
• Gather Clues
• Categorize Failure
• EVALUATE - Identify potential Causes
• Verify problem
• Check Causes against data
• PROCEED - Resolution/Corrective action
• Isolate and correct Root cause of failure - Perform Repair
• Verify Problem Resolution
• Complete all checklists and verifications

Information Gathering
Gather pertinent system information. This includes asking questions surrounding What,
Where, When, and How Often or How Many. Questions such as:
• When was the recommended preventative maintenance last performed?
• What Reagent kit, Calibrator, Control, Bulk Solutions, lot numbers are in use and
what are the expiration dates?
• What tests are affected? Not affected?
• When did the problem first occur (Date/Time)?
• When was the last time the problem was not occurring?
• What troubleshooting steps have been taken?
• Is the problem observed or is an instrument error displayed/printed?

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Troubleshooting

Categorizing Failure
Errors or observed problems can generally be traced to one of four categories of
variables affecting the generation of a result
• Analyzer
• Operator
• Reagent
• Environment

Analyzer Errors refer to instrument hardware and software problems which can
interfere or influence generation of correct results. These will be discussed further in later
modules.

Analyzer components can be classified into one of the following categories:

• Power

• Fluidics

• Optics

• Robotics

• Temperature

CELL-DYN Emerald Field Service Training Workbook (204979-101) 1-7


Troubleshooting

Operator Errors refer to human-associated interventions which can interfere with


correct result generation such as:

• Improper sample type for analysis

• Improper sample loading and/or handling

• Incorrect sample vessel and/or consumable

• Bubbles present in reagent and/or sample

Failure Symptoms include:

• Level Sense Errors caused by bubbles or foam

• Failed calibration attempts

• Failed run attempts

Reagent Errors refer to problems with Reagent, Calibrators and/or Controls such as:

• Improperly stored products

• Expired Reagent, Calibrators and/or Controls

• Control ranges established incorrectly

• Caps not sealed

Failure Symptoms include:

• Curve instability

• Control shifts

• Imprecision

• Failed calibration attempts

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Troubleshooting

Environment Errors refer to laboratory and surrounding conditions that can influence
the generation of a correct result. These will be discussed further in later modules and
include:

• Electrical Specification

• Physical Specifications (Spatial Layout)

• Computer and Interface Specifications

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Module Review

Module Review

1. Which section of the Service and Support Manual has error code troubleshooting?

2. Where can you find power and fluidics diagrams in the Service and Support Manual?

3. Where is parameter-specific precision data located in the Operator’s Manual?

4. Name the section of STEP where you identify what is and what is not working.

5. Name the 4 categories of a failure.

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Module Summary

Module Summary

Now that you’ve completed the Service Tools module, you should be familiar with
accessing on-line tools and resources. In the upcoming modules, you will have several
opportunities to practice using the STEP process and the Effective Troubleshooting
model to analyze and resolve errors on the CELL-DYN Emerald system.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 1-11


Module Summary

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Module 2: Overview and Operations

The CELL-DYN Instrument Overview module is where you will obtain your first look at
the instrument. You will be shown key components of the system, their function, location
and any additional information that may be of use when troubleshooting the instrument.

During the Activity in this module, you should document the information that is presented
to you. This information will be used in this module and in additional activities later in this
course. You may not be able to fill out every item on the worksheet now, but you will
come back to it during later modules.

Objectives

After completing this module you will be able to:


• Locate major components on the CELL-DYN Emerald system
• Describe the functions and location of major components
• Note any key features or concerns for the component as your instructor shows it
to you.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-1


Background

Background
Technology Introduction
The CELL-DYN Emerald uses the following technology and methods:
• Electronic impedance
• Electronic valves
• Counting chambers / Counting heads (apertures)
• Lysate modified differential
• LED hemoglobin analysis
• Cyanide-free lytic reagent forms methemoglobin chromagen

Counting Module

The Counting Module includes WBC/HGB counting chamber with the WBC
aperture and the hemoglobin LED in the left bath, the RBC/PLT counting chamber
with the RBC/PLT aperture in the right bath, and the liquid valve manifold
assembly with its associated tubing below the baths.

Electronic Impedance

Electrical Impedance is based on one principal: Electrical Resistance. It measures


the changes in resistance between two electrodes as a blood cell is passed
between them. The cell acts as a resistor and impedes the flow of the current.
This is possible because blood cells are poor conductors of electric current. To
measure the resistance requires:

• An electrical current

• A particle free isotonic solution to con-


duct the current

• An opening between the electrodes

• A known quantity of blood.

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Background

Electrical Impedance Counting

Electrical Impedance counting is use to count and size WBCs, RBCs and
Platelets. This method is based on the measurement changes in an electrical
current produced by particles (cells), suspended in a conductive liquid, as they
pass through an aperture of known dimensions.

• An electrode is submerged in the liquid on either side of the aperture to create


an electrical pathway through it.

• As each cell passes through the aperture, a transitory change in the resistance
between the electrodes is produced.

• This change produces a measurable electrical pulse.

• The number of pulses indicates the number of cells that traversed the aper-
ture. The amplitude of each pulse is essentially proportional to the volume of
the cell that produced it.

Electrical Impedance provides key information on three components of cell


populations:

1. Cell Type

2. Cell Count

3. WBC Differential

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-3


Background

Cell Type

Identifies cells based on their size. As a cell moves through the aperture, one at
a time, it impedes the flow of current producing a voltage pulse. The magnitude of
the pulse is essentially proportional to the size of the cell.

Thresholds set within the


analyzer:

• Discriminate between the


voltage pulses

• Categorize the pulses


into one of three blood
cell types

• Use thresholds based on


the volume of the cell
measured in femtoliters.

The diluted blood sample is split into two parts, one for counting Red Blood Cells
(RBC) and platelets (PLT) and the other for counting white blood cells (WBC).

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Background

The number of cell pulses


for each cell type are
counted and reported as the
total number of cells
presented in the volume of
blood being tested.

After counting the WBCs,


the dilution remains in the
WBC bath and is measured
for hemoglobin
concentration. This is
accomplished by using
reagents to lyse or destroy,
the RBCs leaving the WBC
population intact.

The resulting WBC population is sorted by size into three key populations. The
smallest cells are identified as lymphocytes. Neutrophils make up the “Gran”
population. The other white blood cells including the Monocytes, Basophils and
Eosinopils are generally included in the mid-size population.

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Background

Lysate Modified Differential

The lyse alters the WBC membrane to allow the cytoplasm to slowly diffuse and
shrink the membrane around the nucleus and any granules that may be present.
The cells are counted and sized as they travel through the aperture plate of the
Counting Module. The analyzer produces a three part differential:

• Lymphocytes

• Mids (monocytes, basophils, eosinophils)

• Granulocytes

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Background

Absorption Spectrophotometry and Hemoglobin Measurement

A methemoglobin chromagen complex is used for the colorimetric determination


of Hemoglobin (HGB). A portion of the lysed, diluted sample from the WBC Mixing
Chamber is used for HGB measurement. A low-energy Light-Emitting Diode
(LED) is used as the light source and the complex is measurable at 555 nm. (The
quaternary ammonium lysate participates to form a chromagen for hemoglobin
measurement.)
Instrument Hemoglobin Method Measurement
CD Emerald Cyanide Free Hemoglobin is measured using a methemoglobin
Methemoglobin chromagen formed using the cyanide-free lytic
Chromagen reagent. The methemoglobin is measured by
means of absorption spectrophotometry using a
555 nm LED as the light source. The LED shines
through the WBC counting chamber after the
WBC count is completed. The Hemoglobin
concentration is directly proportional to the
absorbency of the sample. A blank reading is
made during the rinse cycle and an automatic
offset circuit for the LED maintains the blank
range. The blank and sample readings are
compared to determine the hemoglobin
concentration of the sample. Three measurands
are obtained: HGB, MCH and MCHC.
CD1800 Cyanide Free Modified The hemoglobin concentration is measured
Methhemoglobin optically using the solution from the WBC bath.
The cyanide free diff lyse converts hemoglobin to
a modified hemoglobin complex that is
measurable at 540 nm
• The quaternary ammonium lysate partici-
pates to form a chromagen for hemoglo-
bin measurement.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-7


Background

CELL-DYN Emerald Measurands


• White blood cell • Red blood cell (RBC) • Platelets (PLT)
(WBC) • HGB • MPV
• LYM # • **HCT
• LYM % • ***MCV
• *MID# • MCH
• *MID% • MCHC
• GRAN# • RDW
• GRAN%

* MID cells may include less frequently occurring and rare cells correlating to
monocytes, eosinophils, basophils, blasts and other precursor white cells.

**HCT is the ratio of red blood cells to plasma and is expressed as a percentage
of the whole blood volume. It is derived from the volume of the RBCs that are
counted during the measurement cycle.

Calculated Measurands

***The mean cell volume (MCV) is the average volume of individual RBCs:

HCT
MCV = ------------ × 10
RBC

The Hemoglobin value is used to calculate the MCH and MCHC as follows:

The MCH is the average amount of HGB contained in the RBC. It is calculated as
follows:

HGB × 10
MCH = -------------------------
RBC

The MCHC is the ratio of the weight of HGB to the volume of the average RBC. It
is calculated as follows:

HGB × 100
MCHC = ----------------------------
HCT

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Activity — Component Identification

Activity — Component
Identification
Time to complete: 45 minutes

Complete the following tables with the correct component identification and where
applicable the function of the component/module.

Front Panel
Identify the eight Front Panel Components and list their function.

Component Name Function


1
2
3
4
5
6
7
8

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-9


Activity — Component Identification

Fluidics Modules
Identify the three Fluidics Modules and list their function.

Component Name Function

2-10 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — Component Identification

Sampling Module
Identify the components that make up the Sampling Module.

Component Name Function

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-11


Activity — Component Identification

Counting Module
Identify each of the components in the Counting Module.

Component Name Function

2-12 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — Component Identification

Syringe Module
Identify each syringe in the Syringe Module.

Component Name Function

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-13


Activity — Component Identification

Reagents
Identify the reagents and associated components, and list the function of each.

Component Name Function

2-14 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — Component Identification

Rear Panel
Identify the rear panel connections.

Component Name Function

8
9

10

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-15


Review

Review

1. How many syringes are located in the syringe block?

2. How many motors control syringe movement?

3. How many electrovalves are involved in the operation of the CELL-DYN Emerald?

4. Should the diluent reagent be above, below or at the same level as the instrument?

5. Name the reagents used on the CELL-DYN Emerald.

2-16 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module Summary

Module Summary

In this module you have learned about the major components and functions of the
Emerald. In addition you have been introduced to the technologies employed by the
system to test patient samples and generate results.

In the next module you will learn about installation of the CELL-DYN Emerald system.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 2-17


Module Summary

2-18 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 3: Installation

The installation process for the CELL-DYN Emerald is a simple procedure. As a FSR you
may be called upon to replace an instrument under certain circumstances. It is important
to understand the procedure and requirements that are used when installing the system
and bringing it to an operational state.

Objectives

Objectives:
After completing this module you will be able to:
• Install the CELL-DYN Emerald instrument
• Install system reagents
• Perform Screen calibration procedure.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 3-1


Activity — Installation

Activity — Installation
Time to complete: 30 minutes

1. Review ISA 175-001

2. Review the list of required tools and supplies located on Pages 2-5 and 2-6 of the
Emerald Operator’s Manual.

3. Upon completion of the installation procedures, you will perform VP-05 Touch
screen Calibration located on the GSS Website

4. Install Reagents by using the procedure located on page 2-10 of the Operator’s
Manual. Pay close attention to Figures 2.9 and 2.10 on pages 2-15 and 2-16
respectively.

5. Review each task and read the associated pages in the Operator’s Manual.
Follow the directions in the Operator’s Manual and run each of the following:

a. Perform Start-Up
b. Run a patient specimen (use normal control if whole blood samples are not
available)

3-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — Installation

Task Training Content Page Number


Reagent Cleaner Reagent Page 1-10 to 1-11
Overview Lyse Reagent
Diluent Reagent
Sample Types Specimen requirements Page 1-12, 5-5 to
and Handling Control mixing and handling handout 5-6, 11-3
Patient specimen mixing and handling handout
System Startup Startup Pages 2-14,
•Operator Login 2-31, 5-9
•Run Startup cycle
Power On and Power analyzer off and on Page 5-16
Power Off
Running a Normal Background Page 5-9,
Background Auto-background as part of Start-up 2-31Appendix H
Manual Normal background
Running Running Controls (Read only. Controls will be run later Page 11-11
control Sample in training)
Running Running Specimens Page 5-11 to 5-12
patient sample Probe availability
Idle for 1 hour

CELL-DYN Emerald Field Service Training Workbook (204979-101) 3-3


Module Summary

Module Summary

In this module you have learned about the installation of the CELL-DYN Emerald system.
You have performed installation procedures and have learned about the criteria used to
determine suitability for installation into a customer site.

In the next module you will learn about the software of the CELL-DYN Emerald system.

3-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 4: Software Overview

The operating system for the CELL-DYN Emerald is substantially different from other
Abbott Hematology products. The instrument interface uses a touch screen to navigate
the software interface.

In this module you will perform the following software based procedures:
• Instrument Set Up
• Barcoding
• Instrument Reagent Prime
• Quality Control
• Maintenance
• Service procedures
• Mechanical Operation/Actuation
• Software installation and updates

Objectives

After completing this module you will be able to:


• Perform basic Operations including instrument priming, loading reagents within
the software, and performing quality control and patient testing
• Set up the instrument and configure instrument settings after performing an instal-
lation
• Use diagnostic and service procedures for troubleshooting purposes
• Install software and software updates.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 4-1


Activity — Software Navigation

Activity — Software Navigation


Time to complete: 45 minutes

Note: You may use supplemental reference materials located in Appendix A of this
workbook.

1. Perform the instrument startup on Page 2-12 thorough 2-14 in the Operator’s
Manual.

2. Manually load reagents onto the system (Operator’s Manual, Page 2-16).

3. Prime the newly loaded reagents.

4. Set up a new Quality Control file (Pages 11-3, 11-4). This procedure will be used
in the next step as well as when you will run precisions check in a later module.

5. Using provided Quality Control Material, Perform the Quality Control procedure
located on Page 11-11.

6. Review the Event Log to locate when control and procedures were last performed
(Page 9-2, 9-3).

Perform all mechanical checks in software Main Screen - Maintenance - Mechanical


Checks.

4-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Review

Review

1. What is the fastest way to check in your login status?

2. What happens if service forgets to log out?

3. List the Keystrokes Needed to access the following screens from the main menu:
Running precision

Viewing a QC File

Setting the Date and Time

4. What are the three logins/password for the Emerald?

5. What waste capacity should be entered into the capacity field if the instrument waste
empties into a drain?

CELL-DYN Emerald Field Service Training Workbook (204979-101) 4-3


Module Summary

Module Summary

In this module you have learned about the software interface of the CELL-DYN Emerald
system. You have learned how to navigate the interface, perform basic operations
configure instrument settings. You have also used diagnostic procedures and functions
within the software interface to perform Field Service operations.

In the next module you will observe the CELL-DYN Emerald system during operations.

4-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 5: Normal Operations

In this module you will be performing normal patient testing. While you are running the
patient specimens you will observe the instrument in action, documenting the sounds,
visually tracking the flow of blood through the system. This will be continued in the next
module.

The second task in this section will be the review of provided case studies to identify
result flags. Result flagging indicates that an unusual condition exists and that special
attention should be paid to the result. Interpretation of flags is a broad subject that goes
beyond the scope of the classroom training. You should read the provided resources
related to instrument flagging to improve your troubleshooting and FSR capabilities.

Objectives

After completing this module you will be able to:


• Perform normal specimen testing
• Identify key operations in the sampling, processing and reporting of results
• Locate resources related to result interpretation and flag codes

CELL-DYN Emerald Field Service Training Workbook (204979-101) 5-1


Required Resources

Required Resources

This information is required for running the instrument. All information referenced is
located in the Operator’s Manual.

Task Content Page Number


Sample Specifications Specimen collection and Page 5-5
handling
Specimen stability Page 5-6
Interfering substances Page 5-6; Appendix B
Specimen identification Page 5-6
Task Content Page Number
Basic Run Daily Start Up Page 5-9;
•Auto-Background
•Background (not “auto”) Page 2-32
Run Quality Control Page 11-3
•When to run QC
•QC Guidelines Page 11-9 to 11-10
•Running Controls Page 11-10 to 11-11
Run Sample – Specimen ID Pages 5-6 to 5-7
Running Specimens Pages 5-11 to 5-13
Task Content Page Number
Daily Shut Down Manual Shut Down Page 5-16
Auto Shut Down Page 2-29

5-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — Normal Observations

Activity — Normal Observations


Time to complete: 30 minutes

Note: One will need to trip door sensor in order to run instrument and observe normal
movements/fluidics (HGB results will be invalid while the door is open).

1. Obtain a tube control material from your instructor

2. Run the specimen as many times as needed to observe each component


identified during Module 2. Note any special movements, indicators, bubbling,
sounds, etc. that indicate proper operations. Document your findings on in your
workbook. Pay particular attention to:
• Observe HGB LED (green beam of light in WBC counting chamber
• Note bubble mixing to ensure homogenous mixture before counting
• Note the syringe and probe movements
• Note normal operational sounds of the analyzer

CELL-DYN Emerald Field Service Training Workbook (204979-101) 5-3


Review

Review

1. If logged in as AFSE, what is printed on each report if the Start Up background


checks fail?

2. If logged in as operator, what happens if the start up cycle fails?

3. If the aspiration probe is not visible, what must the operator do to run a sample?

4. How often should Shutdown be performed?

5-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module Summary

Module Summary

In this module you have observed the normal operations of the CELL-DYN Emerald. You
have performed basic operations including instrument start-up and shut-down and have
directly observed the normal function of components.

In the next module you will perform routine maintenance procedures.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 5-5


Module Summary

5-6 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 6: Maintenance

Maintenance is key to preserving proper instrument operations. The operator can


perform most maintenance procedures but some are performed during scheduled FSR
visits.

This module will cover both types of maintenance. You will review and perform the
following procedures:

Monthly Maintenance

• Bleach Cleaning

Semi-Annual Maintenance

• Lubrication of Syringe Pistons

As Needed Maintenance

• Emergency Stop

• External Cleaning

• Decontamination

• Back flush

Annual Maintenance (Field Service Only)

• Piston greasing and O-ring replacement (syringe module)

• Sampling Probe O-ring replacement

• Motor screw greasing (sample and syringe modules)

CELL-DYN Emerald Field Service Training Workbook (204979-101) 6-1


Objectives

Objectives

After completing this module you will be able to:


• Perform monthly, semi-annual, annual and as needed maintenance
• Document maintenance procedures that are complete
• Review records to determine which procedures need to be performed

6-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — Preventive Maintenance

Activity — Preventive Maintenance


Time to complete: 90 minutes

Monthly Maintenance
1. Perform the Bleach Cleaning Procedure located in the Operator’s Manual, (Page
9-5, 6).

Semi-Annual Maintenance
1. Review the Lubrication of Syringe Pistons Procedure located in the Operator’s
Manual, (Pages 9-7, 8).

As Needed Maintenance
1. Review the Emergency Stop Procedure, Operator’s Manual (Page 9-8).

2. Review the External Cleaning Procedure, Operator’s Manual (Page 9-9).

3. Review the system Decontamination Procedure (9-9, 9-10) DO NOT PERFORM,


REVIEW ONLY.

4. Review the Backflush Procedure, Operator’s Manual (Page 9-11).

Annual Maintenance
1. Perform Syringe Module: Pistons, Seal Plate, O-rings (R&R C1.01).

2. Perform Counting Module: Electrovalves (R&R B1.04).

Note: R & R procedures are located in the CELL-DYN Emerald System Service and
Support Manual, Section 4 - Removal and Replacement.

Note: You should perform prime all 3x with all reagent lines out [Reagents – Prime
ALL] and drain all 3x [Maintenance-Fluidics-Drain All] to remove as much liquid out of the
system prior to removal of components.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 6-3


Review

Review

1. Name the customer maintenance procedure that needs to be performed on a monthly


and semi-annual basis.

2. Where can you find the backflush procedure?

3. What type of grease should be used on the syringe module O-rings?

4. When replacing an electro valve, what three things should you take note of?
1.

2.

3.

6-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module Summary

Module Summary

In this module you have practiced performing maintenance on the CELL-DYN Emerald,
including.

Customer Maintenance:
• Monthly
• Semi-annual
• As needed

FSR Annual Maintenance


• Syringe module O-ring replacement
• Lubrication
• Silicon
• Lubriplate
• Plastic grease

In the next module you will perform calibration.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 6-5


Module Summary

6-6 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 7: Calibration

Calibration is a procedure that helps assure that the Emerald accuracy is within expected
limits. There are a number of circumstances where it may be necessary to perform
calibration. These include:
• When Indicated by QC
• After major service calls
• Every six months
• As directed by the regulatory agencies governing the laboratory

In this module you will review the pre-calibration procedures, using the software to
perform calibration.

Objectives

After completing this module you will be able to:


• Identify circumstances that require instrument calibration
• Perform instrument calibration
• Verify instrument calibration
• Perform an instrument precision check

CELL-DYN Emerald Field Service Training Workbook (204979-101) 7-1


Activity — Calibration

Activity — Calibration
Time to complete: 45 minutes

1. From Main Menu, Go to Maintenance, Select Precision

2. Using Fresh Normal Blood or Normal Control, perform 10 runs within Precision
File.

3. Refer to the acceptable CV limits in the performance table on page 4-10 of the
Operator’s manual to determine if precision is acceptable.

4. Review calibration Overview, Operator’s Manual Pages 6-1 to 6-3

5. Perform Automatic Instrument calibration using the procedure located in the


Operator’s Manual beginning on page 6-7

6. Perform instrument calibration verification located on Page 6-10.

7. Run QC in QC Files.

7-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Review

Review

1. When is it necessary to calibrate the Emerald?

2. What are the specifications for precision?

3. Name the parameters that can be calibrated.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 7-3


Module Summary

Module Summary

In this module you performed a calibration on the CELL-DYN Emerald, including pre- and
post-calibration procedures.

In the next module you will perform electronic gains.

7-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 8: Gains

Performing Gain adjustment is an electronic process to verify a particle of known size is


being properly placed into a channel of known size. The CELL-DYN Emerald employs an
auto gain adjustment procedure that is quick and simple.

Please Note: The CELL-DYN Emerald uses a different set of Standard Reference
Particles (SRP) than any other CELL-DYN products. Only use the SRP bottles with
“GREEN” caps.

Objectives

After completing this module you will be able to:


• Adjust the WBC gains
• Adjust the RBC/PLT gains

CELL-DYN Emerald Field Service Training Workbook (204979-101) 8-1


Activity — Electronic Gain Adjustment

Activity — Electronic Gain


Adjustment
Time to complete: 30 minutes

1. Perform VP-03: Electronic Gains Adjustment

8-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Review

Review

1. Which latex particles are run undiluted?

2. How do I make-up RBC and PLT beads?

3. What log-on level will allow you to perform a Gain Adjustment?

4. How do I navigate to perform Gain Adjustment?

CELL-DYN Emerald Field Service Training Workbook (204979-101) 8-3


Module Summary

Module Summary

In this module you have performed the Gains adjustment procedure for the CELL-DYN
Emerald. You have learned when it is appropriate to perform the Gains adjustment
procedure as well as the materials that are needed and where to locate procedures to
accomplish this task.

In the next module you will begin to apply your troubleshooting skills.

8-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Module 9: Troubleshooting

Activity — Troubleshooting System


Components
60 minutes

Customer attempted to resolve an issue with counting chambers overfilling by turning the
instrument over on its side. After removing clog from counting chamber, the instrument
will not boot up?

Instructions

1. Discuss possible causes of the instrument not booting up

2. How would you begin to approach this using the Effective Troubleshooting Model?

3. Use the Effective Troubleshooting form on the next page to resolve the error. You
will hand this troubleshooting form in to your instructor upon completion of the
module.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 9-1


Instructions

STOP Identify the PROBLEM (What is wrong with what?) Describe problem situation

THINK Ask questions (What, When, Where, How Big). List Meaningful DATA such as Abnormal
Observations, Test Results, Voltage Readings, LEDs, Reagent Lot Numbers, etc.:

Look for COMPARISONs (Compare to another system, component, assay, analyzer, etc.).
Identify assay(s),system(s) and/or similar component(s) where the problem IS and IS NOT:
Problem IS occurring here: Problem IS NOT occurring here:

List CLUES. (What is unique about the Problem [IS data]?)


Look for patterns, differences, symptoms, procedure/check results, etc.

Categorize probable area of failure: OPERATOR REAGENT ENVIRONMENT ANALYZER


Which instrument system is the most likely area of failure? (check all that apply)
†Fluidics †Optics †Robotics †Temperature Control †Power †Other

EVALUATE Identify possible CAUSES and TEST the cause against the Meaningful Data and Clues.
The cause must explain ALL of the data or it is not the root cause of the problem

List the step(s) used to isolate the cause of the failure:


(List Procedures, Precision Run, Diagnostic Tests, Boards Swapped, etc.)

PROCEED List the step(s) used to verify the failure has been resolved:
(List Procedures, Precision Run, Diagnostic Tests, Boards swapped, etc.)

9-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — Troubleshooting System Components Part 2

Activity — Troubleshooting System


Components Part 2
60 minutes

Customer has reported Error MECH: Home Syringe Not Found along with an abnormal
grinding sound noting syringe pistons are not moving as expected.

Instructions

1. Discuss possible causes of the reported error?

2. How would you begin to approach this using the Effective Troubleshooting Model?

3. Use the Effective Troubleshooting form on the next page to resolve the error. You
will hand this troubleshooting form in to your instructor upon completion of the
module.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 9-3


Instructions

STOP Identify the PROBLEM (What is wrong with what?) Describe problem situation

THINK Ask questions (What, When, Where, How Big). List Meaningful DATA such as Abnormal
Observations, Test Results, Voltage Readings, LEDs, Reagent Lot Numbers, etc.:

Look for COMPARISONs (Compare to another system, component, assay, analyzer, etc.).
Identify assay(s),system(s) and/or similar component(s) where the problem IS and IS NOT:
Problem IS occurring here: Problem IS NOT occurring here:

List CLUES. (What is unique about the Problem [IS data]?)


Look for patterns, differences, symptoms, procedure/check results, etc.

Categorize probable area of failure: OPERATOR REAGENT ENVIRONMENT ANALYZER


Which instrument system is the most likely area of failure? (check all that apply)
†Fluidics †Optics †Robotics †Temperature Control †Power †Other

EVALUATE Identify possible CAUSES and TEST the cause against the Meaningful Data and Clues.
The cause must explain ALL of the data or it is not the root cause of the problem

List the step(s) used to isolate the cause of the failure:


(List Procedures, Precision Run, Diagnostic Tests, Boards Swapped, etc.)

PROCEED List the step(s) used to verify the failure has been resolved:
(List Procedures, Precision Run, Diagnostic Tests, Boards swapped, etc.)

9-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Activity — System Troubleshooting

Activity — System Troubleshooting


60 minutes

In the remaining time you have in this class you will be performing troubleshooting
activities on unknown errors. In each case you should attempt to bring the instrument to
a ready state. You should pay particular attention to any unusual instrument activity,
errors, or data flags produced by the instrument.

You will be using the Effective Troubleshooting Module that was discussed in the
previous troubleshooting activities. Fill out each Effective Troubleshooting worksheet
fully and hand them in at the end of bug runs.

CELL-DYN Emerald Field Service Training Workbook (204979-101) 9-5


Activity — System Troubleshooting

9-6 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Appendix A: Supplemental Materials

Software Overview
Signing On
The Login Screen allows you to login
as different users. If no password is
entered, you will be logged in as
“User/Lab Technician,” the lowest
level. The service password is
AFSE.

Note:Do not disclose


the password to
the customer.

Note:Remember to log
out as AFSE or
analyzer will not
go into automatic
shutdown.

CELL-DYN Emerald Field Service Training Workbook (204979-101) A-1


Software Overview

Main Menu

A-2 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Software Overview

Maintenance

Button Function
Initialize system Used after an emergency stop
Motor Init To reinitialize the 3 steppers motors
Fluidics To clean the system in case of clogging
Mechanical Checks To check the mechanical components of the instrument
Precision To test the repeatability of the instrument (up to 33 replicates)
Sys Clean To clean the entire instrument before packing
Error Log Logs the errors from the instrument
Abbott Service Only available with FSR password

CELL-DYN Emerald Field Service Training Workbook (204979-101) A-3


Software Overview

Fluidics

Button Function
Drain All Drains the counting chambers and the Waste/Vacuum Syringes.
Refill Refills the counting chambers
Clean Cleans the apertures and counting chambers with cleaner.
Backflush Applies backpressure to the apertures.
Bleach Initiates a bleach cleaning cycle.
Init Press Cycle to adjust the « 0 » of the pressure

A-4 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Software Overview

Mechanical Checks

Button Function
Check Valves Changes valve state
Check Probe Probe moves
Check Rocker Rocker moves
Check Syringe Syringes move
Check Sensors Displays sensor state
HGB LED Off/On Turns LED off/on
Remove Probe For probe maintenance
Lubrication Pos. For syringe maintenance

CELL-DYN Emerald Field Service Training Workbook (204979-101) A-5


Software Overview

Check Sensors Screen

Pressure:
• In the stand by mode, the pressure is 0.
• To check a pressure leak:
• Run a cycle (Run Analysis)
• Stop the cycle by pressing the ON/OFF button, when pistons are in
medium position.
• Select Check Sensors.
• Check the value for Pressure.

Note:This value must be unchanged over time. If the pressure decreases,


check the tubing and the syringe block.

HGB sensor:
• If the LED is OFF, the value will be around 0.
• If the LED is ON (turn ON in the previous menu), the value will be
between 800 - 900.

WBC and RBC sensors:


• In Stand by mode, the values are less than 30.
• If one or both values are higher (higher than 100), check for interfer-
ences inside the analyzer or check for an interference source outside
the analyzer.

Note: An open door will cause higher values

A-6 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Software Overview

Abbott Service

For Factory Use Only

To check the current inside the counting bath:


1. Turn ON by pressing the button.
2. Access the counting chambers.
3. Put a pin of the voltometer inside the counting
bath, a pin to the ground.
4. Measure the voltage.
For WBC chamber, the value should be a minimum
of 8V.
For RBC/PLT chamber, the value should be a
minimum of 12V.

Note: If the values are significantly different, the


counting chamber or the CPU board are suspect.
To adjust the electronic gains for WBC, RBC and
PLT.
To adjust the HGB blank.

To park the pistons before transportation.

Allows service to add an entryin the maintenance log


to note that a service operaton has been done.

CELL-DYN Emerald Field Service Training Workbook (204979-101) A-7


Software Overview

Printers/Drivers
Printers validated by C2:
• EPSON LX 300+ II (dot matrix)
• HP 6980 (ink jet)

A-8 CELL-DYN Emerald Field Service Training Workbook (204979-101)


Software Overview

Software Map

CELL-DYN Emerald Field Service Training Workbook (204979-101) A-9


Software Overview

A-10 CELL-DYN Emerald Field Service Training Workbook (204979-101)

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