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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.
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.
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.
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
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.
Objectives
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.
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
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:
• Instrument features
• Mandatory
ISAs:
• 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.
Adjustable Torque Driver (part # 8701693201) and Torx Bits T6, T10, and T20
sizes:
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?
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.
• Power
• Fluidics
• Optics
• Robotics
• Temperature
Reagent Errors refer to problems with Reagent, Calibrators and/or Controls such as:
• Curve instability
• Control shifts
• Imprecision
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
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?
4. Name the section of STEP where you identify what is and what is not working.
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.
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
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
• An electrical current
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.
• As each cell passes through the aperture, a transitory change in the resistance
between the electrodes is produced.
• 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.
1. Cell Type
2. Cell Count
3. WBC Differential
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.
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).
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.
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
• Granulocytes
* 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
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.
Fluidics Modules
Identify the three Fluidics Modules and list their function.
Sampling Module
Identify the components that make up the Sampling Module.
Counting Module
Identify each of the components in the Counting Module.
Syringe Module
Identify each syringe in the Syringe Module.
Reagents
Identify the reagents and associated components, and list the function of each.
Rear Panel
Identify the rear panel connections.
8
9
10
Review
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?
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.
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.
Activity — Installation
Time to complete: 30 minutes
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)
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.
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
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).
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).
Review
3. List the Keystrokes Needed to access the following screens from the main menu:
Running precision
Viewing a QC File
5. What waste capacity should be entered into the capacity field if the instrument waste
empties into a drain?
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.
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
Required Resources
This information is required for running the instrument. All information referenced is
located in the Operator’s Manual.
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).
Review
3. If the aspiration probe is not visible, what must the operator do to run a sample?
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.
This module will cover both types of maintenance. You will review and perform the
following procedures:
Monthly Maintenance
• Bleach Cleaning
Semi-Annual Maintenance
As Needed Maintenance
• Emergency Stop
• External Cleaning
• Decontamination
• Back flush
Objectives
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).
Annual Maintenance
1. Perform Syringe Module: Pistons, Seal Plate, O-rings (R&R C1.01).
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.
Review
4. When replacing an electro valve, what three things should you take note of?
1.
2.
3.
Module Summary
In this module you have practiced performing maintenance on the CELL-DYN Emerald,
including.
Customer Maintenance:
• Monthly
• Semi-annual
• As needed
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
Activity — Calibration
Time to complete: 45 minutes
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.
7. Run QC in QC Files.
Review
Module Summary
In this module you performed a calibration on the CELL-DYN Emerald, including pre- and
post-calibration procedures.
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
Review
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.
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
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.
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:
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
PROCEED List the step(s) used to verify the failure has been resolved:
(List Procedures, Precision Run, Diagnostic Tests, Boards swapped, etc.)
Customer has reported Error MECH: Home Syringe Not Found along with an abnormal
grinding sound noting syringe pistons are not moving as expected.
Instructions
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.
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:
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
PROCEED List the step(s) used to verify the failure has been resolved:
(List Procedures, Precision Run, Diagnostic Tests, Boards swapped, etc.)
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.
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:Remember to log
out as AFSE or
analyzer will not
go into automatic
shutdown.
Main Menu
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
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
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
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.
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.
Abbott Service
Printers/Drivers
Printers validated by C2:
• EPSON LX 300+ II (dot matrix)
• HP 6980 (ink jet)
Software Map