FSE Training Book

F ield ield S erv er vice ic e Tr Tr aining ini ng 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 samples (printouts, (printouts, graphics, graphics, displays displays or or screens, screens, etc.) are are for information information and and illustration purposes only and shall not be used for clinical or maintenance evaluations. Any product product information information in this document document should should be used used in conjunction 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 Abbott Laboratories Laboratories product product names names and trademarks trademarks are owned owned by or licensed to Abbott Laboratori Laboratories, es, its subsidiaries subsidiaries or affiliates. affiliates. No use of of any Abbott Abbott trademark, trademark, trade 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 trademarks brands, brands, product product names, and trade names are the property property of their 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)

i ii

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: •

Syste System m compo compone nent nts, s, hard hardwa ware re,, and and soft softwa ware re

•

Key Key norm normal al and and abn abnor orma mall indi indica cato tors rs

•

Troubl Troublesho eshootin oting, g, installa installation tion,, and preven preventive tive mainte maintenan nance ce procedu procedures res

•

Concret Concrete e actions actions they they can can take take to ensure ensure custo customer mer servic service e and busin business ess objec 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 Diagnostics Division, Division, itit establishes establishes a set of consistent consistent processes processes and procedures 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

iv

•

A lapto laptop p compu computer ter with with acce access ss to to the the GSS GSS websi website te

•

A basic basic unders understan tanding ding of of the materi materials als provid provided ed in the the Hematolo Hematology gy Basics Basics prepretraining computer based training

•

Familiar Familiarizat ization ion with the Effecti Effective ve Troub Troublesh leshooti ooting ng mode modell

•

Underst Understand anding ing of basic basic FSR FSR busine business ss and and technica technicall procedur procedures, es, tools tools and and concontacts


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 maintenance, 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 troubleshooting process

•

Reinforce Effective Troubleshooting and Fort through the use of case studies and in class exercises


v

vi


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


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

Troublesho Troubleshooting oting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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


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 yo ur 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: •

Electron Electronic ic Resourc Resources: es: Operat Operator’s or’s Manual Manual,, e-Soluti e-Solutions ons,, block diagr diagrams, ams, Opera Opera-tor’s Manual, FRUD

•

Instrume Instrument: nt: FS FS Logon, Logon, Reports Reports,, Result Result Details Details,, and and Gains Gains Report Report

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


1- 1

Objectives

Objectives After completing completing this module, module, you should should be able to: •

Access Access inform informatio ation n necessa necessary ry to identif identify y and resolv resolve e operatio operational nal and and hardwar hardware e errors.

•

Identif Identify y the the STEPs STEPs utilized utilized for effecti effective ve trou troubles bleshoot hooting. ing.

•

Identif Identify y the various various sourc sources es of servic service e document documentatio ation n and descri describe be the types types of information contained in each.

•

Locate Locate and and describe describe the Impleme Implementa ntation tion Classi Classifica fication tions s of a Tech Technica nicall Service Service Bulletin (TSB).

•

Define Define TSB and ISA and how these these document documents s are are used. 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 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, overview, information on manual usage, accident accident prevention symbols and functional description • Includes block and functional diagrams, mechanism and motor listings, and LED operating conditions

Troubleshooting

• Contains Contains drawings drawings and schematics schematics

Parts Lists

• Lists of Supplemental Supplemental Tools Tools and Supplies Supplies • Links to the Field Replaceable Replaceable Unit Database Database (FRUD) and a list of Customer and Field Service Replaceable parts • Removal & Replacement procedures indexed by number to the linked Parts list

Removal & Replacement Verification Procedures Maintenance

Pre-Site Specification & Checklist

• Provides Provides detailed procedures procedures used to verify correct instrument instrument operation • Planned Planned Maintenance Maintenance (PM) recommended recommended checklist checklist • Recommendations may be subject to change due to local business or regulatory needs • Site specifications and a checklist that outlines the activities of Field Personnel • An action item item summary is included included in 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 INTERNAL USE ONLY. No information in this database may be given out (electronic or hard copy) to any NON-Abbott Personnel without the prior writ ten permission from Abbott Laboratories. TSBs:

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

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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


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.


1-5

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:

1-6

•

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?


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


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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:

1-8

•

Curve instability

•

Control shifts

•

Imprecision

•

Failed calibration attempts


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


1-9

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.


1-11

Module Summary

1-12


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.


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:

2-2

•

An electrical current

•

A particle free isotonic solution to conduct the current

•

An opening between the electrodes

•

A known quantity of blood.


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 aperture. 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


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).

2-4


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.


2-5

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:

2-6

•

Lymphocytes

•

Mids (monocytes, basophils, eosinophils)

•

Granulocytes


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 Methemoglobin Chromagen

Hemoglobin is measured using a methemoglobin chromagen formed using the cyanide-free lytic 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 Methhemoglobin

The hemoglobin concentration is measured 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 participates to form a chromagen for hemoglobin measurement.


2-7

Background

CELL-DYN Emerald Measurands •

White blood cell (WBC)

•

Red blood cell (RBC)

•

Platelets (PLT)

•

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:

HC T MC V = ------------ × 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: HG B × 10 MC H = ------------------------ 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 MC HC = --------------------------- HC T

2-8


Activity — Component Identif ication

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


2-9


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

Component

Name

Function

1

2

3

2-10



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

Component

Name

Function

1

2


2-11


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

Component

Name

Function

1 2 3 4 5 6

2-12



Syringe Module Identify each syringe in the Syringe Module.

Component

Name

Function

1

2

3

4

5


2-13


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

Component

Name

Function

1 2 3 4 5 6

2-14



Rear Panel Identify the rear panel connections.

Component

Name

Function

1 2 3 4 5 6 7 8 9 10


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


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.


2-17

Module Summary

2-18


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.


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


Activity — Installation

Task

Training Content

Page Number

Reagent Overview

Cleaner Reagent Lyse Reagent Diluent Reagent

Page 1-10 to 1-11

Sample Types and Handling

Specimen requirements Control mixing and handling handout Patient specimen mixing and handling handout

Page 1-12, 5-5 to 5-6, 11-3

System Startup Startup •Operator Login •Run Startup cycle

Pages 2-14, 2-31, 5-9

Power On and Power Off

Power analyzer off and on

Page 5-16

Running a Background

Normal Background Auto-background as part of Start-up Manual Normal background

Page 5-9, 2-31Appendix H

Running control Sample

Running Controls (Read only. Controls will be run later in training)

Page 11-11

Running patient sample

Running Specimens Probe availability Idle for 1 hour

Page 5-11 to 5-12


3-3

Module Summary

Module Summary In this module you have learned about the installation of the CELL-DYN Emeral d 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


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


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 installation

•

Use diagnostic and service procedures for troubleshooting purposes

•

Install software and software updates.


4-1

Activity — Software Navi gation

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


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?


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


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.


Perform normal specimen testing

•

Identify key operations in the sampling, processing and reporting of results

•

Locate resources related to result interpretation and flag codes


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 Sample Specifications

Task Basic Run

Task Daily Shut Down

5-2

Content

Page Number

Specimen collection and handling

Page 5-5

Specimen stability

Page 5-6

Interfering substances

Page 5-6; Appendix B

Specimen identification

Page 5-6

Content

Page Number

Daily Start Up •Auto-Background •Background (not “auto”)

Page 5-9;

Run Quality Control •When to run QC •QC Guidelines •Running Controls

Page 11-3

Run Sample – Specimen ID

Pages 5-6 to 5-7

Running Specimens

Pages 5-11 to 5-13

Content

Page 2-32

Page 11-9 to 11-10 Page 11-10 to 11-11

Page Number

Manual Shut Down

Page 5-16

Auto Shut Down

Page 2-29


Activity — Normal Observat ions

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


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


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.


5-5

Module Summary

5-6


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)


6-1

Objectives

Objectives After completing this module you will be able to:

6-2

•

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


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.


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


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.


6-5

Module Summary

6-6


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.


Identify circumstances that require instrument calibration

•

Perform instrument calibration

•

Verify instrument calibration

•

Perform an instrument precision check


7-1

Activity — Calibrati on

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


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.


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


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.


Adjust the WBC gains

•

Adjust the RBC/PLT gains


8-1

Activity — Electronic Gain Adjustment

Activity — Electronic Gain Adjustment Time to complete: 30 minutes 1. Perform VP-03: Electronic Gains Adjustment

8-2


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?


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


Module 9: Troubleshooting

Activity — Troubleshooting System Components 60 minutes Customer attempted to resolve an issue with counting chambers overfill ing 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.


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


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.


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


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.


9-5

Activity — System Troubleshooting

9-6


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.


A-1

Software Overview

Main Menu

A-2

CELL-DYN Emerald Field Ser vice 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


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


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


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 interferences inside the analyzer or check for an interference source outside the analyzer.

Note: An open door will cause higher values

A-6


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.


A-7

Software Overview

Printers/Drivers Printers validated by C2:

A-8

•

EPSON LX 300+ II (dot matrix)

•

HP 6980 (ink jet)


Software Overview

Software Map


A-9

FSE Training Book

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