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REVISION STATUS
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
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dress, or product name may be made without the prior written authorization of Abbott
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trademarks brands, product names, and trade names are the property of their respective
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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.
This guide was developed and produced by U.S. Commercial Operations in Irving, TX. it is
intended for training of Abbott Field Service personnel.
Note
The note signal word appears adjacent to an important point of
information that is relevant to the current subject matter. The note
is preceded by an envelope icon.
Reference Materials
The laptop icon signals a location recommending the use of
Reference Materials (i.e. Service and Support Manual, TSB, ISA,
Operations Manual, etc.) during training. Alternate media can be
substituted at the instructor’s discretion.
Diagnostic Information
The tool icon signals an important point of diagnostic information
that is relevant to the current subject matter.
Training Objectives
The magnifying glass icon appears next to a module header to
identify the training objectives for the subject matter that follows.
Activity
The clock icon appears along with an activity header to identify a
student activity.
Notes
Course Objectives
Course Agenda
NOTE:The information below provides a suggested training agenda.
Days and topics may vary.
The class is designed to provide instrument hardware and assay troubleshooting training.
Training includes hands-on troubleshooting activities.
Day One:
COURSE INTRODUCTION and TRAINING OVERVIEW
SERVICE TOOLS
COMPONENT and SOFTWARE OVERVIEW
Day Two:
REVIEW
BASIC OPERATION
VACUUM/PRESSURE and FLUIDIC SYSTEM
OPTIC SYSTEM and DATA INTERPRETATION
Day Three:
HEMOGLOBIN SYSTEM
ELECTRONIC and POWER and ELECTRONIC SYSTEMS
SAMPLE LOADER
Hazards
The CELL-DYN Ruby and CELL-DYN 3200 Systems have been designed for optimal
operator safety. However, this does not reduce the importance of safety awareness
where hazards exist. Standard warning conventions, including hazard signal words and
symbols are described below:
Safety icons in this manual and on the CELL-DYN System identify potentially dangerous
conditions. Service Personnel must recognize the icons and understand the type and
degree of potential hazard. If text accompanies the icon, it describes the nature of the
hazard and is labeled with WARNING or CAUTION.
Review the Hazard and Safety Information contained in the CELL-DYN RUBY Service and Support
Manual Section: General Data, CELL-DYN Ruby Operator’s Manual, Section; 8 Hazards, CELL-DYN
3200 Service and Support Manual Section: General Data, CELL-DYN 3200 Operator’s Manual, Sec-
tion; 8 Hazards for complete information.
Wear appropriate personal protective equipment such as gloves, lab coat, and protective
eyewear when working in the Lab Environment.
Dispose of all biohazardous materials in accordance with local, state, and federal
regulations governing the treatment of regulated medical waste. Dispose of sharps (e.g.
probes, needles, broken glass, and slides) that are contaminated with potentially
infections materials in an appropriately labeled, puncture-resistant, and leak proof
container.
CAUTION: Class 3B laser light when Warns against direct viewing of the beam or reflections from the
open. Avoid exposure to beam. beam.
Identifies an activity that may present a safety related hazard, and advises the Operator to consult caution/
warning instructions. Examples Include:
CAUTION: Lifting Hazard Identifies an activity where one may be required to lift or move a
heavy object. Obtain assistance when moving and/or use appropriate
lifting devices.
CAUTION: Moving Parts Identifies an activity or area where moving parts are present.
CAUTION: Chemical Hazard Identifies an activity or area where hazardous chemicals are present.
Refer to the Material Safety Data Sheet (MSDS) or package insert for
specific safety information.
WARNING: Splash/Spray Hazard Identifies an area where fluids may be under pressure. Safety glasses
with side shields must be worn when handling or working near
potentially infectious materials.
Some general safety icons not directly related to the CELL-DYN System but identify
potentially dangerous conditions:
Safety Icon Hazard Description
CAUTION: Hot Surface Identifies an area where a hot surface is present or may be present in
case of an instrument malfunction.
WARNING: Probe Stick Hazard Identifies an activity or area where probes may be present.
Avoid placing your hand in the range of a moving probe in order to
minimize the risk of skin puncture.
Electrostatic sensitive devices Identifies an area where electrostatic sensitive devices may be
present. A ground strap must be worn while servicing the system.
Note: Card Cage Ground A protective grounding symbol appears on the System at any electrical
terminal that must be connected to earth ground before any other
connections can be safely made to the equipment.
Icon Description
The alternating current symbol appears on the System at a
terminal to which or from which an alternative (sine wave)
current or voltage can be applied or supplied.
Other hazard symbols not directly related to the CELL-DYN System but notify the user
that precautions should be taken when handling material.
Do not look directly into the laser beam, aperture, or any reflection
of the beam from a mirror-like surface. Do not place any objects
into the beam, or remove the protective covers, or bypass the
interlocks. Do not use controls or adjustments, or perform
procedures other than those specified. Do not remove, damage, or
obliterate the laser warning labels. If any label becomes illegible,
replace it. When the access door, or inner protective cover are
removed, helium-neon laser power up to 10 mW continuous wave
at 632.8 nm in a beam with a 1 mR divergence could be accessible
in the interior of the optics bench. This amount of energy, with
insignificant attenuation with distance, is sufficient to cause eye
damage.
Caution
Use of controls or adjustments or performance of procedures other than those specified
in the CELL-DYN Ruby Service and Support Manual, Advisories and/or Bulletins may
result in hazardous laser light exposure. If the instrument is used or modified in a
manner not specified by the manufacturer, the protection provided by the instrument
may be impaired.
End of Module
STOP
THINK
EVALUATE
PROCEED
Notes
Objectives
Web based resources contain digital copies of books, procedures, illustrations. Most of
these resources will be found through the Global Service and Support (GSS) website.
Your instructor will guide you to each of these resources on you laptop.
Instrument Service GSS Web Home Page and The TSB and ISA all Product
Advisory (ISA)/Technical GSS Product Page Database is used for the
Service Bulletin (TSB) distribution of Technical
Database Service Bulletins (TSB) and
Instrument Service Advisories
(ISA) to Abbott Personnel
only.
Classroom Materials
You will also have access to tangible resources that you will be able to use in the
classroom and on the work site. These materials are generally found on the GSS Web.
Some of these resources have been provided for you. Your instructor will distribute the
various diagrams, password Log-in cards and Quick Reference Guides. The STEP
process worksheets will be included with each module where needed.
Instructor Provided
11x17 Cable GSS Web/Hematology/ Troubleshooting Tool
Connection Service and Support Manual/
Diagrams Troubleshooting/Block
Diagrams
Instructor Provided
Password Log-in Instructor Provided Log-in codes for accessing
Card non-customer software
menus
Code is entered backwards
Notes
Activity 1
Activity Instructions
In this activity, the instructor will direct a class review of the ASE
and Effective Troubleshooting (S.T.E.P.) process. An overview of
these process are provided on the Field Service AH-HA pad that
the instructor has provided for you.
Notes
Instructions:
Additions to the tables within the Ah_Ha note pad will occur
throughout the class as you explore these failures in more detail.
END OF ACTIVITY
Notes
Module Summary
Now that you’ve completed the Service Tools Module, you should
be able to identify the service resources utilized during service of
the CELL-DYN Ruby System and the type of information contained
or provided by each resource. You should also be able to locate
these reference resources within the various databases, websites
and handouts.
Notes
Review
2. What is the current TSB revision level of the CELL-DYN Ruby Systems
in the Classroom?
End of Module
This module provides an overview of the CELL-DYN Ruby System hardware and software.
This module introduces the principles, and procedures associated with:
• Component Identification
• Software Menu
• Software Navigation
Notes
Objectives
Notes
Activity - Components
Activity Instructions
In this activity, the class will be divided into three groups.
Resources Needed
Utilize the Diagrams, you have been provided with, to identify and
locate key components.
Two 28 VDC • Generates Vacuum and Pressure • Pumps cycle ON/OFF every 5
Pumps seconds
RBC/PLT Mixing • Area for mixing red blood cells and platelets
Chamber to be counted
• Position of input ports create swirling mixing
action when syringe injects fluid in
WBC Mixing Chamber/ • Mixing and heating of WBC Lyse and sample • A out of range monitoring
Heater Assembly • Swirling mixing action created when syringe occurs if temperature does
not fall between 20°C and
injects fluid in
40°C
Hemoglobin Heater • Heats Diluent/Sheath for HGB Dilution (for • A out of range monitoring
use prior to Shear Valve) and HGB/NOC occurs if temperature does
Lyse prior to transfer to HGB Flow Cell not fall between 40°C and
51°C
High Speed Serial • High Speed Serial Link between analyzer and
Link (HSSL) Data Module
Motor Processing • Sends power, speed and direction to stepper • Stepper Motors run on
Module (MPM) drivers +28VDC
Top View
Temperature Control • Control and drive WBC and HGB Heaters • Enabled during instrument
Module (TCM) prime; disabled during standby
• Takes approx. 6 minutes to
stabilize
• Five LEDs & three potentiome-
ters
• Four Channels:
• 0o - Cellular Size.
• 10o - Cellular Complexity.
• 90o - Cellular Lobularity.
• 90oD - Cell Granularity.
Laser Power Supply • Powers Laser Tube • Located beneath the Optical
Bench
• Receives +28V from APS
• Typical Laser Power Reading
>5.0 mw.
Main Power Switch • Turn OFF/ON power to entire instru- • It is not necessary to turn the Sys-
ment tem main power switch OFF under
normal operating conditions.
• For periods of inactivity, there is a
standby mode.
• If the system is idle for four hours, it
automatically goes into Standby
mode.
USB Ports
AbbottLink Plug in
Bar Code
Reader
Locate Analyzer Status Indicator Lights. Note status indication listed below.
LED Color Status Indication
READY Green The Analyzer is ready to run specimens.
END OF ACTIVITY
Notes
Activity - Software 1
Activity Instructions
In this activity you will:
• Explore the CELL-DYN Ruby software as your
instructor directs you to perform various tasks.
• This will include identifying key areas of the screen,
their function, and how to navigate to various screens.
Finally, you will perform case study #1 found after the end of this
activity.
Display Screen
• Refer to the Software Map on the following page and the figure
below during instructor review of Display Screen primary areas
Primary Sections:
Title Bar Example Only
Menu Bar
Tool Bar
Operating State
Sampling Mode
QC Status
Status Bar
VIEW
System (Controlled by Tool Bar buttons)
Messages
Function Keys
Title Bar
Identifies the View displayed. Displays the last run sequence number and the current date and time.
Menu Bar (Example of Menu structure, available options may vary based on software version.)
File: Access Basic System Commands: Diagnostics: Access diagnostic functions such as:
• Backup and Restore • Diagnostic Views:
• Shutdown and Exit • Check to display 4th tab
Setup: Customize System Operating Conditions such as: • Raw Data & Count Rate Summary
• Patient Sample Setup • HSSL Log
• Units Set Selection • Mechanical Operations
• Customizing Run and Data Views • Digital/Voltages Readings
• Customizing Moving Average View • Auto-Gain Wizard
• Customize Print Report • Setpoints
• QCID Setup • Bar Code Alignment
• Administrative Setup Window • Extended WBC Diag
Calibration: Access Calibration Procedures such as: • SRP/Blood Comparison
• Last Auto-Calibration Date • Electronic Cells Diag
• Quick Precision Check • Reset Admin Password
• Calibration Log Help: • Operator’s Manual
• Auto-Calibration Wizard • About CELL-DYN Ruby (software ver)
• Manual Calibration (FSE login Only) Sign Off: Allows Operator to update OPID
Tool Bar
The Tool bar buttons control the display of the Main View and the associated function keys.
Run View: Display specimen view of the last run sequence number
Orders: Display Pending Orders
Data Log: Display system data log
QC View: Display QC Log
Groups: Displays samples based on groups of criteria
Groups are: FWBC, NRBC/RRBC, Exceptions, and Not Transmitted
• Group criteria cannot be edited and groups cannot be added
Reagent: Display selected tab: Current Reagent, Reagent Log
• Note: the Current Reagent display is a calculated Software indication of reagent status
Maintenance: Display selected tab: Scheduled, As-Needed, Special Protocols, Maintenance Log
• Maintenance Log is a record of maintenance performance dates
Access Help Videos
System: Display selected tab:
• Calibration Log - Record of last calibration date and Record of Precision results
• Event Log - Record of Faults
• Set Point Log - Record of changes to set points
Advanced tab
contains various
Search Criteria
F3 - Find/Filter
Opens the Find/Filter dialog box, which has two tabs: Find/Filter and Advanced Find/Filter.
Find – locates the earliest matching entry. The number of matches is displayed, along with a Find Next key
that is used to move to the next matching entry.
Filter – displays a new screen with all matching entries. The filtered entries screen is exited by selecting the
Unfilter function key.
Steps:
1. Select Setup from the menu bar and QCID Setup from the pull-
down menu. The QCID Setup: View dialog box appears (the
default view displays QCID: Background).
2. Select the Create button and the QCID Setup: Basics dialog box
opens (The default view displays Control Type: Commercial).
3. Select Whole Blood from the drop down menu in the Control
Type field.
5. Select Continue.
7. Click on the QC Limits tab and enter the control means and limits.
END OF ACTIVITY
Notes
Case Study 1
After replacing the HDD you now need to reinstall the software.
The customer has a back up copy that they have made during
weekly backups.
Use the Instrument Service and Support Manual and ISA database
to identify the procedures that would be necessary for you to
restore the instrument back to proper operation. List the
procedures below:
Notes
Notes
Activity - Software 2
Activity Instructions
Resources Needed
END OF ACTIVITY
Notes
Module Summary
Notes
Review
1. List the two (2) heaters that have been added to the CELL-DYN Ruby
System?
End of Module
Notes
This module provides an overview of the CELL-DYN Ruby System operation. This module
introduces the principles, and procedures associated with:
• Sample Analysis
• Maintenance
• Normal Operating conditions
• Precision and Calibration
Ultrasonic
RBC/PLT Mixing Sensor (S1)
Diluent/Sheath Chamber Short Sample
Reservoir 1 HGB
Diluent/Sheath Heater Assembly Sensor (S2)
Reservoir 2 HGB Flow Cell
Solenoid
WBC Lyse
Reservoir
Waste
Vent Chambers
Chamber Waste Normally HGB Lyse Diluent/Sheath
Chambers Closed Solenoid Syringe Syringe
Sample Transfer WBC Lyse
WBC Mixing
Peristaltic Chamber/WOC Syringe
Pump (staging) Bubble Trap Heater Sample Injection
Syringe
Notes
Objectives
Basic Operation
The term Basic Operation is often used to refer to processes and procedures required for
performing the day-to-day operation of the CELL-DYN Ruby. However, it does not refer to only
those procedures performed on a daily basis. As presented in this module, Basic Operation
process and procedures include:
• System Priming and Standby
• Instrument Maintenance
• Instrument Configuration
• Calibration
• Quality Control
• Reagent Handling
• Specimen Processing
The overall operation of the CELL-DYN Ruby System is to analyze EDTA-anticoagulated blood
and report hematological parameters. The EDTA-anticoagulated blood specimen consists of both
a liquid and a cellular portion.
• The liquid portion, called Plasma,
consists of various nutrients, proteins,
enzymes, hormones and water.
• The cellular portion consists of three WBC
cellular types:
• White Blood Cells (WBC)
• Red Blood Cells (RBC)
PLT
• Platelets (PLT) RBC
Proper mixing of specimens prior to sample aspiration is essential for obtaining accurate results
on the CELL-DYN Ruby System. Specimens stored at refrigerator temperatures must be brought
to room temperature prior to mixing.
For control or calibrator mixing instructions, refer to the manufacturer’s product insert.
• WBC Lyse
• Acts as the diluting fluid for WOC (WBC Optical
Count).
• Osmotically lyses RBC.
• Maintains the light scattering properties of the
WBCs for the duration of the measurement period.
• Provides sufficient wetting action to prevent accu-
mulation of air bubbles in the Optical Flow Cell
system.
• Provides an acceptable background count.
Notes
Notes
Calibration Overview
When to perform
Scheduled calibration of the CELL-DYN Ruby System should
conform to the guidelines established by regulatory agencies.
Calibration Materials
Two types of calibration materials can be used to calibrate the
CELL-DYN Ruby System:
• Commercial Calibrator or Assayed Fresh Whole Blood
Calibration Procedures
Calibration consists of three groups of procedures
• Pre-Calibration Procedures - to verify proper instrument
performance to ensure a successful calibration.
• Calibration Procedures
Two methods of calibration are available on the
CELL-DYN Ruby System:
• Auto-Calibration Wizard
• Manual Calibration
Notes
Instructor Debrief/Review:
At the conclusion of the activity, your instructor will lead a group
review of “normal” function, calling on students randomly for
their observations.
Resources Needed
In this session utilize the Diagrams you have been provided in
class to identify and locate key components.
The instructor will provide fresh whole blood and calibrator for
use during this activity. Disposable Pipettes and Red Top
Tubes are also needed.
Observe Instrument Operation and record requested data within the Tables contained on
the following pages. Complete all tables.
Knowing how the instrument sounds and looks during routine operation is a critical key
to troubleshooting.
Rotation of Shear Valve Describe Speed of rotation (fast, slow, quantify timing, etc.):
Draining and filling of the How full does the chamber fill?
RBC/PLT Mix Chamber
Does the RBC/PLT Mix Chamber completely empty during the drain
cycle?
HGB Heater and WBC Touch each Heater Assembly and quantify the level of heat present.
Heater Assembly HGB Heater (Temp between 40°C and 50°C):
(C
(Continued on next page)
WOC Segment
Rotation of Peristaltic Describe Speed of rotation (fast, slow, quantify timing, etc.):
Pump for Staging
List solenoids involved in staging blood through ports 1 and out port 2
through valve 52:
Syringe Movement All Syringe movement (smooth, jerky, rapid, slow, stop/start):
Injection Syringe move during count cycle (smooth, jerky, rapid, slow,
stop/start):
Opening/Closing of Once a solenoid has been closed, press on it with your finger. Was
Solenoids there movement or a clicking sound?
Peri-pump rotation:
Observe Instrument Operation and record information in the table below while precision
analysis is running:
CLOSE MODE OBSERVATION
Component/Function Observation
In closed mode, observe rack Do the racks move smoothly or jerkily?
movement, sample mixing, tube
spin and aspiration
How many times are specimen tubes mixed?
Note length of blood sample extension going into and out from
the Shear Valve prior to rotation:
END OF ACTIVITY
Notes
Module Summary
Notes
Review
2. During normal operation, while the instrument is idle and in the Ready
state, the vacuum and pressure pumps cycle on/off every _________
seconds.
3. Where is bubble mix used on the CELL-DYN Ruby Flow Panel AND
what does normal bubble-mix look like?
6. Describe the process for preparing whole blood for a closed mode
precision.
7. Complete the Table by recording either a Calculated (C), Measured (M) or Derived (D) next
to each parameter.
White Blood Cell Parameters Red Blood Cell Parameters
WBC: White Blood Cell Count (WOC) RBC: Red Blood Cell Count
NEU: Neutrophil Absolute Count MCH: Mean Cell Hemoglobin
LYM: Lymphocyte Absolute Count MCHC: Mean Cell Hemoglobin Concentration
MONO: Monocyte Absolute Count HCT: Hematocrit
EOS: Eosinophil Absolute Count MCV: Mean Cell Volume
BASO: Basophil Absolute Count RDW: Red Cell Distribution Width
%N: Neutrophil Percentage of WBCs HGB: Hemoglobin Concentration
%L: Lymphocyte Percentage of WBCs Reticulocyte Package
%M: Monocyte Percentage of WBCs %R: Percentage of Reticulocytes
%E: Eosinophil Percentage of WBCs RETC: Reticulocyte absolute concentration
%B: Basophil Percentage of WBCs Platelet Parameters
PLT: Platelet Count
MPV: Mean Platelet Volume
PCT*: Plateletcrit
PDW*: Platelet Distribution Width
*Clinical significance has not been established for PCT or PDW. Therefore, they are not reportable in the US.
End of Module
This module provides an overview of two of the CELL-DYN Ruby System Subsystems. This
module introduces the principles, and procedures associated with:
• Vacuum and Pressure SubSystem
• Fluidics SubSystem
• Normal Operation
• Service Procedures
Pressure
Pump
Shear Valve Assembly
Vacuum
Pump
Y-Valve
Open Mode
Probe
Solenoid
Closed Mode
Probe
Notes
Objectives
The main purpose of the CELL-DYN Ruby’s Vacuum/Pressure Subsystem is to move the fluids
throughout the analyzer.
When troubleshooting Accumulator Wet errors, verify whether or not the accumulator contains
any fluid. If fluid is present, consider the following:
• Vac accumulator #1 wet: inspect WC #3 & #4, exercise valves 32 & 98, inspect tubings.
• Vac accumulator #2 wet: inspect WC #2,exercise valve 18 inspect associated tubing.
• Inspect Reagent Reservoirs for cracks. Inspect associated tubing and valves.
• Verify readings in Digital Voltage Readings screen.
• Use Hemostats to isolate problem.
Electronics
VPM • Controls Vacuum/Pressure Levels PRM • Pumps ON/OFF
If you suspect a defective VPM Pressure Sensor, check the ohm reading using a digital voltmeter.
• Attach the DVM leads between pins 2 and 4 on the pressure sensor (the pins are located just below the
sensor). A reading of greater then 4.8 kOhms may indicate a bad sensor. If you suspect a bad sensor
replace the board. Most sensors will read in the 4.0 to 4.5 kOhm range.
Activity - Vac/Pres
Activity Instructions
In this activity you will:
• remove Vacuum Pressure Assembly RR E 1.01 and locate components
• perform Vacuum and Pressure VP-15, VP-4 and VP-16
Resources Needed
The instructor will provide hemostats for you to use during this activity.
In this session you will be performing service procedures. Refer to the CELL-DYN
Ruby System Service and Support Manual Removal and Replacement, and
Verification Procedure Sections for instructions.
Locate the components listed below and present a review of the Assemblies Compo-
nents and functions to the instructor:
3 Pressure Accumulators
2 Vacuum Accumulators
Vacuum and Pressure pumps
VPM
PRM
Multi-Port Coupler and Manual Drain Lines
• Answer the review questions at the end of this module while awaiting your groups
turn with the instructor
END OF ACTIVITY
Fluidics
Your instructor will discuss the Fluidics Subsystem using the flow diagram and flow panel
diagrams previously distributed. It is important to correlate the Flow Panel components to the
aspiration, dilution, staging, measurement and waste pathway for RBC/PLT, WBC and HGB.
The CELL-DYN Ruby’s Fluidic Subsystem components control the flow, pathway, quantity and
type of fluids in use. Key fluidic processes include, specimen aspiration, sample dilution and
mixing, waste management, and flushing.
Analysis
Measurement Results
of Data
The status sensor subsystem provides the main computer with the status of the system
mechanical, electronic and fluidic functions. The subsystem uses optical sensors, and ultrasonic
sensor and fluid sensors to detect various system conditions.
STEPS EVENT
The sample is aspirated. Blood is aspirated through the Shear Valve using variable vacuum. The variable
vacuum uses two levels of vacuum, one for the Open Mode and one for the
Closed Mode.
• Open Mode is used to aspirate the blood from a collection tube that has
been opened and is held under the open mode probe.
• Closed Mode is used to mix and then aspirate the blood directly from a
closed collection tube by piercing the tube stopper.
Sensors check the integrity of To detect a short sample condition during sample aspiration two ultrasonic
the aspirated sample sensors (S1, S3) and one blood sample detector (S2) are employed in the
sample aspiration flow system.
• S1 controls the leading edge (open & closed mode) during aspiration.
• S3 controls the leading edge (open mode) during transfer. These sen-
sors detect the presence or absence of liquid in the aspiration line, and
they are not adversely affected by the density or viscosity of the sample.
• Blood sample detector (S2) controls the leading edge (closed mode) dur-
ing transfer.
Separation The Shear Valve rotates to isolate three segments of the blood sample:
RBC/PLT = 1.67µL WBC = 20µL HGB = 12µL
Dilution and Mixing To begin the dilution process, the blood segments are picked up at the Shear
Valve by reagents delivered through syringes, the segments are then directed to
their respective dilution/mixing chambers where the final dilution is prepared:
• RBC/PLT is diluted with Diluent/Sheath
• HGB is diluted with Diluent/Sheath and HGB Lyse
• WBC is diluted with WBC Lyse
The input ports in the dilution cups are oriented so that the whole blood and
reagent swirl when injected by the syringes. This swirling action along with
Bubble mix is used to mix the reagent and whole blood, resulting in a
homogeneous final dilution.
Staged for Optical After dilution and mixing, the RBC/PLT, WBC and NOC samples must be staged
Measurement before processing through the Optical Flow Cell. The staging is performed by a
peristaltic pump through valve 5-2:
• RBC/PLT is staged first through valve 5-4
• NOC is second through valve 4-1
• WBC is third through valve 5-5
After staging, the sample dilution is injected into the Optical Flow Cell by the
Sample Injection Syringe.
Laminar Flow and Optical Laminar flow describes the flow properties of two liquids moving at different rates
Measurement of speed in the same direction without intermingling.
Diluent/sheath (Reservoir 2 through valve 6-5) is forced into the outer area of the
flow cell by 9 psi. The pressure hydrodynamically focuses the sample stream
aligning the blood cells in single file through the sensing region.
Flushing and Waste At the end of the measurement cycle, the CELL-DYN Ruby System flushes and
drains the system components. There are four waste chambers that perform the
draining and collection of waste from various components.
• 12” Hg (#1) vacuum level is used to pull fluids into the reagent reservoir
and waste chambers
• 12 psi pressure used to empty chambers
Activity Instructions
In this activity you will:
• use dye to trace RBC/PLT, WBC and HGB pathways
• perform Temperature Control Module Adjustment VP-36
• complete Case Study 2
Instructor Debrief/Review:
At the conclusion of the activity, your instructor will lead a group review calling on stu-
dents randomly for their observations.
Resources Needed
In this session utilize the Flow Diagrams you have been provided in class.
The instructor will provide blue dye for you to use during this activity.
Refer to the CELL-DYN Ruby System Service and Support Manual, Verification Pro-
cedure Section for information on performing the procedures listed on the following
page.
RBC/PLT
HGB
WBC
NOTE: The TCM controls and drives the WBC and HGB
Heaters.
END OF ACTIVITY
Notes
Case Study 2
Notes
Module Summary
Notes
Review
3. True or False
The PRM PCB receives +28 VDC from the PDM J20 to operate
the pumps.
Notes
8. There are five (5) ports on the HGB Flow Cell, which port is used to
deliver sample into the flow cell?
End of Module
This module provides an overview of the CELL-DYN Ruby System Optics Bench and Optical
Measurement Subsystem. This module introduces the principles, and procedures associated
with:
• Optics Bench
• Service Procedures
• Data Interpretation and Flagging
• Moving Average Program
90o Scatter
0o Scatter (Cell Lobularity)
(Cell Size)
Notes
Objectives
Optics
The purpose of the CELL-DYN Ruby’s Optical Measurement Subsystem is to count, classify and
size blood cells.
Staging
The measurement process begins with the Sample Dilution being “staged” by the Sample
Aspiration Pump through valve 5-2 to an Optical Flow Cell within the Optics Bench.
Analysis
Next, the cells within the sample dilution are injected into the Optics Bench where they are
quantitatively analyzed through the process of Flow Cytometry. In Flow cytometry individual
cells in a single file are passed through a beam of light. A sensor or sensors measure the loss of,
or scattering of, light created by the physical or chemical characteristics of the cells.
The precision of the fluid flow through the Optical Flow Cell is critical to proper cell identification,
as well as proper alignment of the flow cell and bench components with the laser beam.
Laminar Flow • Diluent/Sheath enters near the base of the Flow Cell Assembly under a pressure of 9 psi.
• Since the Sample and Diluent/Sheath liquid streams are traveling at different speeds, they
flow alongside one another but do not mix.
Sample Injection • Sample Injection Syringe injects the staged diluted sample into the flow cell.
Hydrodynamic • A cone-shaped flow cell directs the fluid flow through a narrow internal quartz chamber.
Focusing
• The shape of flow cell and flow rate of Diluent/Sheath forces the cells to flow in single file.
Light Beam • A laser beam is positioned by optical bench components to intersect the cells as they pass in
single file through the Optical Flow Cell.
• A helium neon laser is used to generate the beam of light.
• Typically the laser’s power output is >5.0 milliwatts.
• The beam of laser light is vertically polarized.
Light Scatter • As the light strikes the cells it scatters yielding information about the cells characteristics:
• 0o scatter relates to Cellular Size.
• 10o scatter relates to Cellular Complexity.
• 90o scatter relates to Cellular Lobularity.
• 90oD scatter relates to Cell Granularity.
Light Detection • Four Light Detectors collect the light scatter.
• Each of the four light detectors identify light scatter in measures of 0 to 256 light channels
• The more light detected, the higher the channel number recorded, and the more pronounced the
particular cell characteristic.
• Light scatter information is graphically presented in the form of scatterplots and histograms.
• Microspheres (known size) are used to set the detectors (channel sensitivity).
• FL-Cal is used to set gains for RBC Linear MCV Measurement.
Measurement • MAM processes signals between pre-amplifiers (PAM), photodiodes and SPM.
(Circuitry)
• SPM detects valid cell pulses, counts valid cell pulses, and captures the peak voltages of
valid cell pulses. Sends data to CPU/DCM.
• CPU/DCM digitizes signals, sorts the pulse signals into one of 256 size channels as list mode
data, and converts the data into a reportable result.
Note: The Y are the top adjustment screws and the X are the side adjustment screws located on the mirrors.
Note: PMT Dynode Verification and Adjustment (CD3200 Service and Support Manual VP-22)
Post
Mirror
Laser Alignment Tools Laser Power Meter Polarizer Alignment Post Hanging Mount
NEUTROPHILS
MONOCYTES
EOSINOPHILS
LYMPHOCYTES
BASOPHILS
N1 REGION
Notes
Activity - Optics
Activity Instructions
In this activity each of you will be:
• performing an Optics Bench alignment on a demonstra-
tion bench
• performing validation procedures on the analyzers
Optics Bench
Resources Needed
In this session you will be performing service procedures.
Refer to the CELL-DYN Ruby System Service and Support
Manual for instruction.
3. Proper eye shielding to prevent eye damage from the laser as refer-
enced in the Optics Bench Alignment Procedure (VP-18)
END OF ACTIVITY
Data Interpretation
Your instructor will conduct a review of the how the optics counts, classifies and sizes cells. This
will include a review of scatterplots, histograms, test parameters, and flagging.
As previously stated, the CELL-DYN Ruby System uses flow cytometric techniques to analyze
the RBC, PLT, WBC, and NOC populations. It also uses MAPSS™ (Multi-Angle Polarized
Scatter Separation) technology.
MAPSS technology uses various combinations of measurements from four light detectors (0°,
10°, 90°, and 90°D) to classify WBC subpopulations and to provide morphological flagging.
• 0°= size and 10°= complexity
• 90°= lobularity and 90°D= granularity
During the measurement cycle light signals collected by each detector are converted into
electrical signals or pulses. If a pulse falls above the hardware threshold in the 0° and 10°
detectors, the cell counter counts the pulse and stores it for further evaluation. Pulses that fall
below this threshold are not included in the count.
The pulses are then sorted into light channels ranging from 0 to 256: the more light detected, the
higher the channel number recorded, and the more pronounced the particular cell characteristic.
This data is called list mode data.
For WBC cell subpopulations the system uses all four angles of scatter to distinguish cell types
and classify WBCs into the five subpopulations as shown in the graphic on the proceeding page:
1. First, the data is used to discriminate between Mononuclear and Polymorphonuclear
cells (90°/10°).
2. Then between Polymorphonuclear cells: Eosinophils and Neutrophils (90°D/90°).
3. And lastly between Mononuclear cells: Monocytes and Lymphocytes (0°/10°) and
Basophils.*
4. Optical light scatter is plotted as a scatterplot graph. A scatterplot displays each cell
as a single dot plotted where X and Y axes intersect. The dots are generally color
coded to represent a specific cell population or sub-population.
* Basophils appear among Mononuclear rather than Polymorphonuclear cells because their granules dissolve
in the WBC Lyse reagent; on Scatterplots they appear as degranulated cells.
NOTE:The Red Blood Cell parameters, including Reticulocytes, are determined using three
angles (0°,10° and 90°) of light scatter. Reticulocytes 10° scatter is similar to the
scatter for a mature RBC, but Retics exhibit greater 90° scatter. Platelet parameters
are determined using two angles of light scatter (0°and 10°).
Algorithms, programmed within the software, then determine the WBC count and the percent of
cells in each subpopulation. Once the WBC count is determined, the absolute number of cells in
each subpopulation is calculated by multiplying that WBC count by the percentage.
• RBC Count
• PLT Count
• An algorithm analyzes the Histogram to eliminate interference and determine the lower and upper
thresholds for the count. Once thresholds have been determined, the PLT count is derived from 10° data.
Histogram
The CELL-DYN Ruby System generates Histograms from the channel data stored in List Mode.
Histograms represent the frequency and size of cells. The X axis is the size (volume) and the Y
axis is the frequency (count). The CELL-DYN Ruby generates Histograms for WBC, RBC, and
PLT data.
For additional information refer to the CELL-DYN Ruby System Operator’s Manual,
Section 3: Principles of Operation, Subsection: Messages and Data Flagging.
Results that fall outside the range of the selected limit set are
displayed in color.
• Yellow indicates that the result exceeded the lower limit.
• Purple indicates that the result exceeded the upper
limit.
• Purple and Yellow results are underlined on the graphic
printouts.
• Results that exceed a parameter’s linear range are indi-
cated by >>>> in place of the result.
• Results that have been determined to require laboratory
validation are indicated by an asterisk [*] next to the
result.
• Results that do not have sufficient data to calculate
values are represented by -------.
There are several programs are available for monitoring system performance during routine
analysis of patient specimens such as:
• Quality Control File Statistics
• Moving Average Programs including X-B
NOTE:The Moving Average programs on the CELL-DYN Ruby automatically and
continuously monitor instrument performance. This allows identification of
potential problems and more efficient troubleshooting. The programs track the
results of various parameters in the patient population analyzed on the System.
For additional information refer to the CELL-DYN Ruby Operator’s Manual
Section 11 Quality Control.
Verify Optics Bench %CV readings and Mean Channels. Clean and Align as indicated.
Note the following:
4095 is the maximum DAC setting on any one angle of scatter
Laser Power must not be less than 3.5mw
Offset values should all be < 1.0
Notes
Case Study 3
A CELL-DYN Ruby has elevated Band/IG Flagging. The Customer has verified that the
flagging is NOT correlating with Manual Blood Smears or an alternate analyzer. The
following troubleshooting steps were performed or observed, and the issues remain
unresolved:
• Customer has cycled power
• Auto Clean was performed
• 7.0 Latex CVs are reporting as follows:
• 0° = 6.2%
• 10° = 5.5%
• 90D° = 14.0%
• 90° = 13.0%
Using your knowledge of the STEP Process, of normal instrument operation, and your
troubleshooting resources (Troubleshooting Information Database [eSolutions], TSBs/
ISAs, etc.); What procedures, checks, measurements, etc. would use to isolate the root
cause of this error?
Indices
Indices are a group of tests that provide clinically relevant information about the size,
shape and content of Red Blood Cells. They are used for diagnosing anemia.
FL CAL is a stabilized RBC preparation that is used to standardize and check the optics
bench of Ruby and 3200. FL CAL is run with known target channels for a known size to
set-up the gains for the RBC Linear MCV measurement. Unless the appropriate gains
are used, the MCV signal will not be linear.
NOTE:FL CAL target channels are subject to change. Always refer to the GSS
website for the latest information.
NOTE: MCVs use Sphere Technology on the CELL-DYN Ruby System. Traditionally
the MCV results form Sphere Technology run higher than those determined
from traditional Impedance Technology.The degree of difference is generally
higher on abnormal samples than normal samples.
The CELL-DYN Ruby’s X-B Program monitors MCV, MCH, MCHC Indice results. When
the X-B results are out of control, data should be reviewed for shifts and trends in the
results.
If two or more X-B batches are “OUT” that is indicative of systematic error. Systematic
errors require a stepwise troubleshooting approach to isolate the source of the problem.
Since two of the RBC indices included in the X-B program are calculated parameters,
their inter-relationships can be used to assist in troubleshooting. The table below
correlates the X-B Pattern to the relationship of the measured and derived parameters:
If the
If the HGB is: If the MCV is:
RBC Count is:
Calculation
MCH will be: Low High High Low N/A N/A HGB ÷ RBC x 10
MCHC will be: Low High High Low Low High HGB ÷ HCT x 100
or
(HGB x 1000)÷ (RBC x MCV)
MCV will be: N/A N/A N/A N/A High Low Derived from RBC optical data
Notes
Module Summary
Now that you’ve completed the Optics Module, you should be able
to identify the operating conditions of the Optics Bench and
measurement subsystems on the CELL-DYN Ruby System. You
should also be able to:
• perform key Service and Support procedures
• use diagrams to relate subsystem function
• identify the measured parameter used within RBC
indice calculations
• recognize parameters included in Moving Average Pro-
gram and locate Moving Average program data within
the software for the purpose of evaluating instrument
performance
Review
1. Name the four angles of scatter that are measured on the CELL-DYN Ruby System and
what cell characteristic they are looking at.
a. ______________________________________________________
b. ______________________________________________________
c. ______________________________________________________
d. _______________________________________________________
2. If the RBC Count is increased, the MCH will be ___________ and the MCV will
be____________.
3. If the HGB measurement is low, the MCH will be ___________ and the MCHC will
be____________.
4. If a customer reports that the CELL-DYN Ruby System is reporting numerous Band flags
that are not confirmed by a blood smear. Where would you begin your troubleshooting?
5. What order are samples staged into the Optical Flow Cell?
7. List the software steps required to view the Moving Average Program results.
End of Module
This module provides an overview of the CELL-DYN Ruby System Hemoglobin (HGB)
Subsystem. This module introduces the principles, and procedures associated with:
• Theory of Operation
• Hemoglobin Components
• Service Procedures
Notes
Objectives
Hemoglobin
The CELL-DYN Ruby System uses a Colorimetric process for analyzing HGB Concentration.
STEPS EVENT
Heater A Hemoglobin Heater (set to 45°C ±0.5°C) Heats the Diluent/Sheath that is used in
preparing the HGB dilution.
Measurement The HGB Flow Cell is a light tight enclosure. It uses an LED (Light Emitting Diode)
monochromatic light at 555nm to pass through the solution.
A photo detector collects the light that passes through.
The Higher the concentration of solution, the more light absorbed, so the lower the
reading.
Readings Five separate readings are made on each sample. The lowest and highest readings
are eliminated, and the three remaining readings are averaged to give a final result.
• The sample enters through the top front port of the HGB Flow Cell
Five readings are taken on a Diluent/Sheath blank. The lowest and highest readings
are eliminated, and the three remaining readings are averaged to give a final result.
• Diluent/Sheath is supplied through valves 9-4 and 9-5.
The system compares the two readings (reference and sample) to determine the
HGB concentration of the sample.
Raw Data The sample and hemoglobin reference readings are displayed on the RAW DATA
SUMMARY screen. When viewing those readings, note the following:
• Bubbles in the flow cell can yield a very low, or very high reading.
• Average Sample Raw Data reading is ~700.
• The Reference Reading is 2050 + 200.
• On a background count, both the sample and reference readings should be
similar numbers.
Be sure to press STOP before exiting RAW DATA SUMMARY Screen.
Electronics The FCM (Flow Control Module) supplies the 5V drive voltage for the LED located in
the HGB Flow Cell. The output signal from the HGB Flow Cell photo detector is
amplified by the FCM and sent to the CPU/DCM.
Hemoglobin Circuitry
Notes
Activity - Hemoglobin
Activity Instructions
In this activity you will:
• perform Hemoglobin Current Verification/Adjustment
Finally, you will complete a case study that will test your knowledge
of hemoglobin measurement on the CELL-DYN Ruby System.
Resources Needed
In this session you will be performing service procedures.
Refer to the CELL-DYN Ruby System Service and Support
Manual Verification Procedures for instructions.
END OF ACTIVITY
Notes
Case Study 4
1.
2.
3.
Notes
Module Summary
Notes
Review
1. Where are the HGB Reference Readings located and what is a normal
reading?
5. The sample enters the HGB Flow Cell through which line (top or side)?
6. Where are the voltage readings for the Hemoglobin Flow Cell located?
End of Module
Notes
This module provides an overview of two of the CELL-DYN Ruby System SubSystems. This
module introduces the principles, and procedures associated with:
• Electronics SubSystem
• Power SubSystem
• Maintenance
• Service Procedures
Notes
Objectives
Notes
Activity - Electronics
Activity Instructions
During the module debrief, your instructor will call upon you to
demonstrate the location of an assigned board and it’s function.
Resources Needed
In this session you will be locating components. Refer to the
CELL-DYN Ruby Service and Support Manual, General Data
Section for additional information.
Signal Processor • Detects and counts valid cell pulses Failure often represents as a loss of
Module (SPM) • Sends optical data to CPU/DCM for signal and/or unable to adjust gain.
processing
Sample Handler • Performs the same functions as the MPM SHM boards are
Module (SHM1 and and stepper drivers for the aspiration probe interchangeable. Ensure jumper
SHM2) up/down motor is set properly per board
• Drives the DC barcode spin motor location.
• Controls the Aspiration Tower
• Sample Loader Controller
Miscellaneous Boards
Cable Distribution • Two CDMs
Module (CDM) • Distribute +28vdc and +15.5vdc voltages to
solenoids
• Collects reagent and waste sensor informa-
tion for distribution to FCM
Sample Handler • Provides the LED drive and reads the out-
Module2 (SHM2) puts of the photo-detectors of the optical
sensors in the Sample Loader
• Controls five three-way valves
END OF ACTIVITY
Notes
Case Study 5
Power Distribution
Your instructor will discuss the Power Distribution Subsystem using the diagram located below.
The Power Distribution subsystem supplies the Analyzer voltages used for measurement, fluidic
control and mechanical motion control. It consists of:
• Analyzer Power Supply (APS)
• ATX Computer Power Supply (CPS)
• Laser Power Supply (LPS)
• Power Distribution Module (PDM)
Activity - Power
Activity Instructions
In this activity you will:
• locate the Power Supply Assemblies and Power Distribution Module
• perform System Voltage Verification (VP-1)
• trace power from the power supply to primary components using the power
block and record information in provided tables
During the module debrief, your instructor will call upon you to identify the function of
various generated power voltages and to relate these to normal vs. abnormal function.
Resources Needed
In this session you will be locating components. Refer to the CELL-DYN Ruby
Service and Support Manual, General Data Section and Verification Procedure
section for additional information and instruction.
Use the Power Block diagram to trace the power distribution to primary instrument com-
ponents. Then record that component and/or function in the table below underneath the
proper voltage and power supply. Two have been provided as an example.
Power Supply Voltages and Distribution Service Notes
Analyzer Power +15.5 VDC
Supply (APS) • Solenoid Activate
+28 VDC
• Solenoid Hold (regulated)
+/- 15VRAW
+/- 15VDC
+/- 12VDC
+/- 12VDC
END OF ACTIVITY
Notes
Case Study 6
The Instrument will not power ON, there are no fans running and
the monitor has the dialog box, “check video cable connection”.
Notes
Case Study 7
Notes
Module Summary
Now that you’ve completed the Electronic and Power Module, you
should be able to locate key components and identify Normal
operating conditions on the CELL-DYN Ruby System. You should
also be able to perform routine service procedures and system
repairs.
Review
1. If the +5vdc signal were missing on the ATX CPS what type of errors or symptoms would be
seen on the analyzer?
3. Temperature Control Module receives ________ from the PDM via connector J15.
5. The _________ PCBs are used to distribute the +28vdc and +15.5vdc from the PDM PCB
that are used to drive the solenoids in the system.
6. The purpose of the______________ PCB is to turn the vacuum and pressure pumps ON/
OFF.
7. Which SHM PCB provides the LED drive and reads the outputs of the photo-detectors of the
optical sensors in the Sample Loader?
End of Module
This module provides an overview of the CELL-DYN Ruby Sample Loader. This module
introduces the principles, and procedures associated with:
• Maintenance
• Service Procedures
• Normal Operation
Notes
Objectives
Sample Loader
The CELL-DYN Ruby Sample Loader works in conjunction with the Aspiration Tower, which is
physically mounted to the Sample Loader’s base plate.
The Aspiration Tower is intended to detect tube type, spin tube to read bar code label, pierce
tube to vent/aspirate and wash needle after aspiration. The unit works in conjunction with the
sample aspiration subsystem and aspirates the blood sample.
The Sample Loader will maneuver the rack(s) laterally and longitudinally in order to process the
sample tube(s). Additionally, the Sample Loader will detect tube(s) in the rack, mix the sample,
and read rack/tube bar code labels.
The Sample Loader electronics provide communications with, and control of, the various
electronic and mechanical components in the Sample Loader.
The Pneumatics Control Subsystem provides electronic control of the valves supplying pressure
and vacuum to the air cylinders controlling the cross transfer assemblies (sweep arms), rack
advance pawls, and mixer bladders.
Analyzer
Unload Side
Sample Loader
Load Side
Rack Advance
5th Aspiration Position
4th
Mixing Position
3rd Mixing Position
TOP VIEW
Component Description
Guide System There are two guide systems: GS1 and GS2 that perform the functions of piercing,
Assemblies tube spinning, and cleaning.
• GS1 guide system controls the vent/aspirate needle
• GS2 guide system controls the bar code spinner, wash block, and tube
height flag.
Both guide systems move vertically along two shafts, and are connected together
by a sliding shaft.
Rack Movement • Racks have an orientation groove to prevent them from being incorrectly
placed in the Sample Loader
• The rack at the processing station is mechanically locked in position after each
index step by a spring-loaded detent pin on the Sample Loader wall that
engages a detent in each tube position in the rack. This ensures correct posi-
tioning and avoids the possibility of accidental movement.
• An air cylinder drives a rod with spring-loaded pawls (fingers) mounted along
the length. These fingers engage grooves in the side of the rack through slots
in the rear wall.
• Cross transfer assemblies provide lateral (Y-axis) movement of the racks. The
movement caused by these cross transfer assemblies occurs on the load
(right) side and the unload (left) side of the Sample Loader. An air cylinder is
used to drive the sweep arms together in an equal arc simultaneously.
• Sensors:
• Load Side Empty Sensor
• Unload Side Fourth Rack Sensor
• Unload Side Fifth Rack Sensor
Tube Sensors • Two (2) optical sensors mounted on a PCB to detect the presence of tubes in
the rack.
• The sensors are numbered 4 and 3 (left to right) and indicate the number of
steps that it takes the index pawl to advance to reach each sensor.
• Tube sensors are adjustable.
• The detection of sample tube(s) by these sensors will determine if the mixer
head is lowered to pick up the tubes for mixing. They are also used to deter-
mine an alarm status.
Lateral Indexing
Unload Side Cross Transfer Arms Load Side Cross Transfer Arms
EVENT
3. The motor:
• rotates the mixer head through at least 15 inversions.
• returns the mixer head to the vertical position.
4. The molded flag on the mixer head body trips an optical sensor, verifying the vertical
position.
When the mixing sequence is completed, the rack indexes one step and the process repeats.
Assuming the sequence starts with the first tube in the rack, each tube receives at least 30
inversions (15 inversions times two mixing positions).
EVENT
Aspiration Tower • During Sample aspiration GS2 solenoid stop (plunger) and GS1 sensors:
• move down for a pre-determined period of time
• stop moving when the spin cone makes contact with the top of the tube
• GS1 moves the vent/aspirate needle into the tube to a distance dictated by the
type of tube being processed. This pierces the cap and vents the tube to atmo-
spheric pressure and allows sample aspiration to take place.
• after sample aspiration concludes, GS1 moves the vent/aspirate needle up and
the outside of the needle is washed. GS1 continues upward to home position,
while the GS2 solenoid stop (plunger) engages the bottom of GS2 preventing it
from moving down.
• GS1 moves the vent/aspirate needle into the wash block and the vent needle is
rinsed.
• Vacuum #2 (Closed) is applied to aspirate the sample.
• Spin Cone rotates specimen for barcode read to occur.
• Tube height sensors (S1 and S2) are checked to determine the type of tube being pro-
cessed (Standard BD or Sarstedt).
• Diluent/Sheath is used to back flush through the end of the needle, and the wash block
vacuum port collects the waste.
Notes
Activity Instructions
In this activity you will:
• observe the function of the Sample Loader
• locate and identify components
• perform key R&R and VP procedures
During the module debrief, your instructor will call upon you to
demonstrate the location of an assigned board and it’s function.
Resources Needed
In this session you will be locating components. Refer to the
CELL-DYN Ruby Operator’s Manual, Section 1 Use or
Function and/or the CELL-DYN Ruby Service and Support
Manual, General Data Section for additional information.
Tube Spinner
• Jams and creates bar code read errors
END OF ACTIVITY
Notes
Case Study 8
Notes
Module Summary
Now that you’ve completed the Sample Loader Module, you should
be able to locate key components and identify Normal operating
conditions on the CELL-DYN Ruby System. You should also be
able to perform routine service procedures and system repairs.
Notes
Review
1. The Sample Loader uses both vacuum and pressure to fill and empty
the bladders. TRUE FALSE
3. The GS2 guide system controls what systems on the Sample Loader?
4. Where should you measure the pressure for the Bladder Assembly?
6. What valve on the Sampler Loader is used to raise the mixer head
assembly?
7. The Sample Loader employs five 3-way valves to drive the air
cylinders and mixer bladders. What PCB controls these valves?
End of Module
This module provides an opportunity to practice all that you have learned in troubleshooting
situations:
STOP
THINK
EVALUATE
PROCEED
This exercise will be focused upon practicing your skills in determining the root cause of
an instrument error and in using the troubleshooting process.
You will complete two errors that will be related to the fluidics subsystem.
Upon encountering an error state you will follow the Effective Troubleshooting S.T.E.P.
process. Both you and your partner will work through the S.T.E.P. worksheet to isolate
and identify the most likely cause. After you have done this, you will perform any
necessary procedures to return the instrument to a fully functional state.
WARNING: Biohazard. Potential Biohazard, follow biosafety practices.
1. Upon detection of an error state, stop. Document the error on the top of the S.T.E.P. work-
sheet.
2. Complete a S.T.E.P. worksheet for each error (A and B) following the Effective Troubleshoot-
ing guidelines throughout your repair.
3. After identifying the root cause of the error, perform the repair, then perform the required ver-
ification procedures and return the instrument to a “Ready” state.
4. Be prepared to share your process with the class. Each group will have a different system
error and will discuss how they arrived at the solution and their process as documented on
the S.T.E.P. worksheet.
STOP Identify the PROBLEM. (List error code or describe problem situation)
THINK List Meaningful DATA such as Abnormal Observations, Test Results, Voltage Readings, LEDs,
Lot numbers, 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
Categorize probable area of failure based on gathered data. Is the Problem related to:
OPERATOR REAGENT ENVIRONMENT ANALYZER (Circle One)
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 the data or it is not the root cause of the problem.
P ROCEED List the step(s) used to verify the failure had been resolved?
(List Procedures, Diagnostic tests, etc.)
Notes
STOP Identify the PROBLEM. (List error code or describe problem situation)
THINK List Meaningful DATA such as Abnormal Observations, Test Results, Voltage Readings, LEDs,
Lot numbers, 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
Categorize probable area of failure based on gathered data. Is the Problem related to:
OPERATOR REAGENT ENVIRONMENT ANALYZER (Circle One)
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 the data or it is not the root cause of the problem.
P ROCEED List the step(s) used to verify the failure had been resolved?
(List Procedures, Diagnostic tests, etc.)
Notes
This exercise will be focused upon practicing your skills in determining the root cause of
an instrument error and in using the troubleshooting process.
The error in this activity will be related to the optics subsystem. Upon encountering an
error state you will follow the Effective Troubleshooting S.T.E.P. process. Both you and
your partner will work through the S.T.E.P. worksheet to isolate and identify the most likely
cause. After you have done this, you will perform any necessary procedures to return the
instrument to a fully functional state.
WARNING: Biohazard. Potential Biohazard, follow biosafety practices.
1. Upon detection of an error state, stop. Document the error on the top of the S.T.E.P. work-
sheet.
2. Complete the S.T.E.P. worksheet following the Effective Troubleshooting guidelines through-
out your repair.
3. After identifying the root cause of the error, perform the repair, then perform the required ver-
ification procedures and return the instrument to a “Ready” state.
4. Be prepared to share your process with the class. Each group will have a different system
error and will discuss how they arrived at the solution and their process as documented on
the S.T.E.P. worksheet.
Notes
STOP Identify the PROBLEM. (List error code or describe problem situation)
THINK List Meaningful DATA such as Abnormal Observations, Test Results, Voltage Readings, LEDs,
Lot numbers, 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
Categorize probable area of failure based on gathered data. Is the Problem related to:
OPERATOR REAGENT ENVIRONMENT ANALYZER (Circle One)
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 the data or it is not the root cause of the problem.
P ROCEED List the step(s) used to verify the failure had been resolved?
(List Procedures, Diagnostic tests, etc.)
Notes
This exercise will be focused upon practicing your skills in determining the root cause of
an instrument error and in using the troubleshooting process.
The error in this activity will be related to the temperature, power and/or electronic
subsystems. Upon encountering an error state you will follow the Effective
Troubleshooting S.T.E.P. process. Both you and your partner will work through the
S.T.E.P. worksheet to isolate and identify the most likely cause. After you have done this,
you will perform any necessary procedures to return the instrument to a fully functional
state.
WARNING: Biohazard. Potential Biohazard, follow biosafety practices.
1. Upon detection of an error state, stop. Document the error on the top of the S.T.E.P. work-
sheet.
2. Complete the S.T.E.P. worksheet following the Effective Troubleshooting guidelines through-
out your repair.
3. After identifying the root cause of the error, perform the repair, then perform the required ver-
ification procedures and return the instrument to a “Ready” state.
4. Be prepared to share your process with the class. Each group will have a different system
error and will discuss how they arrived at the solution and their process as documented on
the S.T.E.P. worksheet.
Notes
STOP Identify the PROBLEM. (List error code or describe problem situation)
THINK List Meaningful DATA such as Abnormal Observations, Test Results, Voltage Readings, LEDs,
Lot numbers, 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
Categorize probable area of failure based on gathered data. Is the Problem related to:
OPERATOR REAGENT ENVIRONMENT ANALYZER (Circle One)
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 the data or it is not the root cause of the problem.
P ROCEED List the step(s) used to verify the failure had been resolved?
(List Procedures, Diagnostic tests, etc.)
Notes
Troubleshooting Run
Sample Loader and Tower
This exercise will be focused upon practicing your skills in determining the root cause of
an instrument error and in using the troubleshooting process.
The error in this activity will be related to the Sample Loader and tower subsystem. Upon
encountering an error state you will follow the Effective Troubleshooting S.T.E.P. process.
Both you and your partner will work through the S.T.E.P. worksheet to isolate and identify
the most likely cause. After you have done this, you will perform any necessary
procedures to return the instrument to a fully functional state.
WARNING: Biohazard. Potential Biohazard, follow biosafety practices.
CAUTION: Moving Parts.
1. Upon detection of an error state, stop. Document the error on the top of the S.T.E.P. work-
sheet.
2. Complete the S.T.E.P. worksheet following the Effective Troubleshooting guidelines through-
out your repair.
3. After identifying the root cause of the error, perform the repair, then perform the required ver-
ification procedures and return the instrument to a “Ready” state.
4. Be prepared to share your process with the class. Each group will have a different system
error and will discuss how they arrived at the solution and their process as documented on
the S.T.E.P. worksheet.
Notes
STOP Identify the PROBLEM. (List error code or describe problem situation)
THINK List Meaningful DATA such as Abnormal Observations, Test Results, Voltage Readings, LEDs,
Lot numbers, 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
Categorize probable area of failure based on gathered data. Is the Problem related to:
OPERATOR REAGENT ENVIRONMENT ANALYZER (Circle One)
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 the data or it is not the root cause of the problem.
P ROCEED List the step(s) used to verify the failure had been resolved?
(List Procedures, Diagnostic tests, etc.)
Notes
Troubleshooting
The following tables contain general tips for troubleshooting failures on a
CELL-DYN Ruby System.
NOTE: When troubleshooting refer to the CELL-DYN Ruby Service and Support
Manual, Technical Service Bulletins, Instrument Service Advisories,
Troubleshooting Information database, and/or the CELL-DYN Operator’s
Manual
PROBLEM Areas of Investigation and possible causes
Sample Loader Faults • Clean sensors, racks, plate, sweep arms and cover.
• Verify that the racks can move right to left without binding:
• Perform adjustments.
• Verify function of Detent pin; remove and clean as needed.
• Use Mechanical Operations to exercise suspect components.
• Verify Sweep arms operation; Clean and adjust as needed:
• Perform VP-30.
• Inspect tubing connections on Manifold Assembly.
• Possible SHM2 failure - replace (Swap with SHM1, set jumpers).
Sample Loader Mixing • Verify Mixhead Home Sensor clean; adjust as needed.
Errors
• Ensure Mixhead Lifter Shaft is clean & dry (NO lubrication).
• Check SL Valves and tubing for obstructions; flush as needed.
Aspiration or Short Sample • Verify Vacuum 2 reading in open, closed and retic modes.
Errors
• Verify VP-4; VPM Reference Voltage in Specification.
• Verify Sample pathway Integrity:
• Check for possible obstruction in Y Valve (unscrew and flush as needed).
• Verify Tubing Integrity (not flared or loose) and all connections tight.
• Check Valve Operation.
• Inspect Ultrasonic Sensor for chipped or broken connectors; replace.
Reagent Detection Errors • Inspect connectors on top of reservoir; clean and adjust as needed.
• Clean Reagent Reservoir - electrodes may be dirty or have build-up.
• Verify Vacuum 1 level within specification.
Blue screen on display and • Possible Hard Drive Failure; Verify voltage on PDM in specification.
unresponsive commands.
• Possible Software Corruption; Reinstall Software.
• Loss of +5 volts:
• Verify voltage at ATX PS.
• Perform VP-01 and verify incoming (wall) power within specification.
HSSL Com errors, Loss of • HSSL Cable loose or not secure.
communication,
• Possible PDM failure:
unresponsive
• +5 Volts low or lacking.
• +15 volts low on test points E1 and E2.
• Perform VP-01 and verify incoming (wall) power within specification.
(Continued)
(Continued)
Module Summary
Now that you’ve completed the Troubleshooting Module, you should be able to perform
routine service procedures and system repairs.
End of Module
This module provides an overview of the CELL-DYN Ruby System Preventative Maintenance
and Installation Procedures. It also provides an overview of AbbottLink and its uses on the
CELL-DYN Ruby System. The module includes the following topics:
• Preventative Maintenance
• Installation
• AbbottLink
• Reticulocyte Package
Notes
Objectives
Activity Instructions
In this activity the instructor will debrief the procedures associated with CELL-DYN Ruby
System Installation and Preventative Maintenance.
Resources Needed
In this session you will be performing service procedures.
Refer to the CELL-DYN Ruby ISA Database for the Installation and Preventative
Maintenance checklists.
Instructor Review - PM
END OF ACTIVITY
Notes
Case Study 9
The customer states the system locked-up while running and upon
reboot the system will not initialize. Error code HSSL Time-out
2100 on CELL-DYN Ruby System is being generated and system
appears to be locked up.
Upon speaking with the customer you learn that the customer has
a 2nd CELL-DYN Ruby System that is hooked up to emergency
power and a UPS/Line Conditioner. This CELL-DYN Ruby is not
experiencing any issues.
Notes
Activity - AbbottLink
Activity Instructions
Resources Needed
Internet: https://abbottlinkuser.abbott.com
Intranet: http://abbottlinkuser.web.abbott.com
• Login using your AbbottLink ID (or one provided by the
instructor)
Select the Model drop down box and select CELL-DYN Ruby
then click the Filter Button
Action Window: Displays a short list of logs and files that are
available for retrieval from the instrument. The complete list of
logs and files is listed by clicking the View All link in the bottom
right corner of the window.
Jump To: Displays a drop down list of items that you can
quickly move to by clicking the desired selection.
Note: Historical Data is stored on the server for 120 days
In the Data Item menu, scroll down and select Instrument Notifi-
cation Text
Select >=
Pick one (1) instrument issue and use for classroom discussion
You have the option to save it to your computer or CD. You can
either click on the Open button to view the file or click on the Save
button to store it onto a CD
END OF ACTIVITY
Notes
Reticulocyte Package
The Reticulocyte Package software is designed to configure the
instrument to process stained, diluted specimens. This enables the
operator of the CELL-DYN Ruby System to analyze a whole blood
specimen for reticulocytes.
Reticulocytes
Reticulocytes are defined by the Clinical Laboratory and Standards
Institute (CLSI) as transitional red cells, between nucleated red
cells and the so-called mature erythrocytes. Unlike a mature RBC,
reticulocytes contain ribosomal RNA.
Instrument
The Reticulocyte Package is enabled by selecting the Retic test
selection in the Next Open Tube Entry (NOTE) region and
acknowledging the message to run the reticulocyte method startup
script.
Reticulocyte Reagent
• Contains New Methylene Blue stain.
• Stains reticular RNA and stabilizes the RBCs while
decreasing the interference from WBCs and PLTs.
• Stored at room temperature and in the dark.
Quality Assurance
Notes
Notes
(OPTIONAL)
Activity - Reticulocyte
Activity Instructions
Resources Needed
Run a RETC_Background
In the NOTE region of the Run View screen, select the
QCID lookup icon. From the pull-down menu, select
RETC_background.
Remove the cap from fresh tube of reticulocyte reagent.
Place the tube under the aspiration probe, immerse the
probe in the reagent, and press the touch plate.
Listen for an audible beep and remove the tube from
under the aspiration probe, and replace the cap on the
reagent tube.
Review the results for the background count.
Notes
Module Summary
Notes
Review
2. Which AbbottLink log would you review to monitor how many times a
system has seen incomplete aspiration errors?
Practical Exam
This exercise will be focused upon accessing your skills in determining the root cause of
an instrument error and in using the troubleshooting process.
Upon encountering an error state follow the Effective Troubleshooting S.T.E.P. process.
Work through the S.T.E.P. worksheet to isolate and identify the most likely cause. After
you have done this, you will perform any necessary procedures to return the instrument
to a fully functional state.
WARNING: Biohazard. Potential Biohazard, follow biosafety practices.
CAUTION: Moving Parts.
1. Upon detection of an error state, stop. Document the error on the top of the S.T.E.P. work-
sheet.
2. Complete the S.T.E.P. worksheet following the Effective Troubleshooting guidelines through-
out your repair.
3. After identifying the root cause of the error, perform the repair, then perform the required ver-
ification procedures and return the instrument to a “Ready” state.
Remove Peri-Pump tubing from pump, and Tubing from the 6 NC valves
Notes
STOP Identify the PROBLEM. (List error code or describe problem situation)
THINK List Meaningful DATA such as Abnormal Observations, Test Results, Voltage Readings, LEDs,
Lot numbers, 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
Categorize probable area of failure based on gathered data. Is the Problem related to:
OPERATOR REAGENT ENVIRONMENT ANALYZER (Circle One)
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 the data or it is not the root cause of the problem.
P ROCEED List the step(s) used to verify the failure had been resolved?
(List Procedures, Diagnostic tests, etc.)
Notes
End of Module
This module provides an overview of the different components, systems, and subsystems that
comprise the CELL-DYN® 3200 System when it is compared to the CELL-DYN Ruby System.
This module introduces the principles, and procedures associated with the CELL-DYN 3200:
• Software
• Basic Operation, Setup and Maintenance
• Service Procedures
• Preventative Maintenance and Installation
Notes
Objectives
Notes
Activity Instructions
Resources Needed
Reported Errors
Part Usage
Notes
Activity Instructions
In this activity you will:
• Explore the CELL-DYN® 3200 software as your
instructor directs you to perform various tasks.
• This will include identifying key areas of the screen,
their function, and how to navigate to various screens.
• locate logs and perform functions within the software
• perform service verification procedures
• run controls and observe Instrument “normal” Operation
Resources Needed
In this session utilize the Quick Reference Diagram you have been
provided in class to aid in Software Navigation.
DIAGNOSTICS MENU
Diagnostic Menu (partial list) Ready
END OF ACTIVITY
Notes
In this section, your instructor will discuss the similarities and differences in the Electronics and
Power Distribution Subsystems between the CELL-DYN® 3200 and CELL-DYN Ruby Systems.
The electronic subsystem devices control, monitor, and drive many of the instrument compo-
nents. There are many individual printed circuit boards (PCBs) and electronic assemblies
located throughout the analyzer. Many of the PCBs are the same as those on the CELL-DYN
Ruby System and are interchangeable between the two systems. The table below provides a
quick comparison between the electronics of the two systems.
• Same = Interchangeable between CELL-DYN Ruby and CELL-DYN 3200
• New, Different, or “name”= System specific
• None = Not present on that system
CELL-DYN CELL-DYN
Ruby 3200
Component Notes
CPU/DCM Same Same
Signal Processor Module (SPM) Same Same
Main Amplifier Module (MAM) Same Same
Solenoid Driver Module (SDM) Same Same
Cable Distribution Module (CDM) Same Same
Vacuum Pressure Module (VPM) New Different
Flow Control Module (FCM) Same Same
Motor Processor Module (MPM) Same Same
Temperature Control Module (TCM) New None
Pump Relay Module (PRM) New Different
Y-Valve Driver (MDM) Same Same
Shear Valve Driver Module Same Same
Pre-Amplifier Boards Same Same
(0, 10, 90 and 90D)
Sampler Handler Module Same Same
(SHM1 and SHM2)
Power Distribution Module (PDM) New Different
Power Supply Switching Linear
PC Power Supply New None
The Power Distribution subsystem supplies the Analyzer voltages used for measurement, fluidic
control and mechanical motion control. It consists of:
• Linear Power Supply Module
• DC power to analyzer components including Fans, motors, pumps and solenoids
• Splits out AC power
Power Diagram
AC Line
Pow er Sw itch
Transformer
J4 115VAC + 2400VDC
LASER P/S LASER
(Top)
115VAC, Rear Fan
J7
115VAC, Side Fan
J8
115 VAC, PRM
J2
Notes
Activity - Power
Activity Instructions
Resources Needed
You should also utilize the Diagrams, you have been provided with,
to identify and locate key components.
Notes
Case Study 10
Notify your instructor that you are ready to perform Case Study 10
on a CELL-DYN 3200 analyzer
The following has been performed on the system but has not
resolved the error:
END OF ACTIVITY
Notes
Review 1
5. What is the function and location of the MAM Board on the CELL-DYN
3200 System?
Notes
In this section, your instructor will discuss the similarities and differences in the Vacuum/Pressure
and Fluidic Subsystems when comparing a CELL-DYN® 3200 and CELL-DYN Ruby System.
The CELL-DYN 3200 System Fluidic and Vacuum/Pressure Subsystems function the same as
the CELL-DYN Ruby System. However, slight differences in components can be observed.
CELL-DYN CELL-DYN
Ruby 3200
Component Notes
Vacuum and Pressure Pumps DC AC
Separation of HGB Sample and Lyse Lines into New (two One line
lines)
HGB Mixing Chamber/Flow Cell
Mixing Chambers Heaters New None
Sample Aspiration
• A mechanical Y-Valve sets the pathway for either Open or Closed Mode sampling.
• The whole blood sample is pulled from the open or closed pathway through the shear
valve by the vacuum in WC2 (Waste Chamber 2).
• Due to the differences in tubing length, the vacuum level is approximately 3.3"
Hg in the Open Mode and approximately 4.5" Hg in the Closed Mode.
• In Closed Mode, the 2nd sensor detects the leading edge of the sample before the
shear valve makes the cut.
• The sensor is an optical sensor and is only used in CLOSED mode.
NOTE:The Closed Aspiration probe is different than the CELL-DYN Ruby probe although
it looks the same and appears to be the same length. There are two major
differences:
• The sample port is smaller on the CELL-DYN® 3200 Probe.
• The inner diameter and wall is slightly smaller on the CELL-DYN 3200
Probe.
• In OPEN mode, the ultrasonic sensor senses the leading and trailing edge of the
sample, and the 2nd sensor is not used.
• The Ultrasonic Sensor monitors the whole blood sample entering the shear
valve.
• The sensor detects the presence or absence of liquid in the aspiration line,
and is not adversely affected by the density or viscosity of the sample.
• The Ultrasonic Sensor monitors aspiration and is used to detect a short sam-
ple situation.
Activity - Fluidics
Activity Instructions
Resources Needed
Refer to the CELL-DYN® 3200 System Service and Support Manual, General Data
Section and Verification Procedures for additional information on the operation of
these subsystems and performance of the service procedures.
You should also utilize the Diagrams, you have been provided with, to identify fluidic
pathways.
Slide out Pneumatic Assembly (R&R E1.01) to allow for viewing of subsystem compo-
nents:
AC Pump
AC Pump Relay
Tubing Connections
END OF ACTIVITY
This exercise will be focused upon practicing your skills in determining the root cause of
an instrument error and in using the troubleshooting process.
The error in this activity will be related to the fluidics subsystem. Upon encountering an
error state you will follow the Effective Troubleshooting S.T.E.P. process. Both you and
your partner will work through the S.T.E.P. worksheet to isolate and identify the most likely
cause. After you have done this, you will perform any necessary procedures to return the
instrument to a fully functional state.
WARNING: Biohazard. Potential Biohazard, follow biosafety practices.
WARNING: Splash/Spray Hazard.
1. Upon detection of an error state, stop. Document the error on the top of the S.T.E.P.
worksheet.
2. Complete the S.T.E.P. worksheet following the Effective Troubleshooting guidelines through-
out your repair.
3. After identifying the root cause of the error, perform the repair, then perform the required ver-
ification procedures and return the instrument to a “Ready” state.
4. Be prepared to share your process with the class. Each group will have a different system
error and will discuss how they arrived at the solution and their process as documented on
the S.T.E.P. worksheet.
Notes
STOP Identify the PROBLEM. (List error code or describe problem situation)
THINK List Meaningful DATA such as Abnormal Observations, Test Results, Voltage Readings, LEDs,
Lot numbers, 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
Categorize probable area of failure based on gathered data. Is the Problem related to:
OPERATOR REAGENT ENVIRONMENT ANALYZER (Circle One)
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 the data or it is not the root cause of the problem.
P ROCEED List the step(s) used to verify the failure had been resolved?
(List Procedures, Diagnostic tests, etc.)
Notes
Sample Loader
In this section, your instructor will discuss the similarities and differences in the Sample Loader
Subsystem when comparing a CELL-DYN® 3200 and CELL-DYN Ruby System. Some of these
Differences are highlighted in the table below:
• Same = Interchangeable between CELL-DYN Ruby and CELL-DYN 3200
• New, Different, or “name”= System specific
• None = Not present on that system
CELL-DYN CELL-DYN
Ruby 3200
Component Notes
Interlocking Sample Loader Side Yes Not Present
Rails
Sample Loader Pneumatic Line Quick Individual
connection Disconnect Connections
Tube Sensor PCB Adjustable/ Adjustable/
Facing Rear Facing Front
Open/Closed Aspiration Tubing Equal length Longer Open
Lengths Tubing
Serviceability Access Panels 2 Panels None
Major S/L Assemblies Attached to Yes N/A
Platen from Underneath
Straight Rack Advance Arm and Yes N/A
Pawl Assembly Movement (w/Delrin
guide for stabilization)
Flat Contoured Sweep Arms with Yes N/A
Integrated Gears and Sensor Flags
Replaceable Sweep Arm Bearing Yes N/A
Blocks
Mix Head Home Sensor Optical Reed
Integrated Home Sensor Flag on Yes N/A
Mix Head
Mix Head Tube Inversion Inward Outward
Tube Capture Chute Yes None
Mix Head Release Mechanism for Yes None
Rotating Unit Outward and Cleaning
Mix Motor 0.9 Degree per Step (less Yes N/A
noise)
Location of SHM PCBs Left side of Front Panel
Instrument
The Pneumatics Control Subsystem provides electronic control of the valves supplying pressure
and vacuum to the air cylinders controlling the cross transfer assemblies (sweep arms), rack
advance pawls, and mixer bladders.
Notes
Activity Instructions
In this activity the instructor will assist the class in locating the
Sample Loader components on a CELL-DYN® 3200 System.
Resources Needed
Run 5 samples through the Sample Loader and observe it’s operation. Record observa-
tions in table below:
Rack Movement Location of sensor that detects when load side empty:
Aspiration
Notes
Case Study 11
• Power cycled
What clues can you identify from the data provided or procedures
you would perform?
Notes
Activity - Optics
Activity Instructions
In this activity you will perform the listed service procedures related to Optics Bench
performance and Data Interpretation/Flagging troubleshooting on a CELL-DYN® 3200
System.
Resources Needed
In this session you will be performing service procedures. Refer to the CELL-DYN
3200 System Service and Support Manual Removal and Replacement and
Verification Procedure Sections for instructions.
END OF ACTIVITY
Case Study 12
During the performance of a service call on a CELL-DYN® 3200 System, the Optical Flow
Cell was adjusted to specification. A WOC gain adjustment was performed and the 90D
DAC setting is reporting at 4095 and the 90° is reporting at 1032. The CV’s for the four
channels are reporting: 0°=4.1%, 10°=3.4%, 90°=12.1%, 90°D=10.8%.
NEU:.010 %N:.222
EOS: 2.49 %E: 53.8
Using your knowledge of the STEP Process, of normal instrument operation, and your
troubleshooting resources (Troubleshooting Information Database [eSolutions],
TSBs/ISAs, etc.), list whatever procedure(s) you would perform next?
Notes
Notes
Activity Instructions
Resources Needed
END OF ACTIVITY
Notes
Reticulocyte Package
The Reticulocyte Package software is designed to configure the
instrument to process stained, diluted specimens. This enables the
operator of the CELL-DYN® 3200 System to analyze a whole blood
specimen for reticulocytes.
Instrument
The Reticulocyte Package must be enabled in order to process
reticulocyte specimens. To enable the analyzer perform the
following steps:
• From the MAIN MENU, press the [SET UP] key followed by
the [OPERATION SET UP] key.
• From the OPERATION SET UP MENU screen, press the
[TURN ON RETIC PKG] key to enable the Reticulocyte Pack-
age.
• The RETIC MAIN menu screen displays and the software to
analyze reticulocytes is now enabled on the CELL-DYN 3200
System.
Notes
Module Summary
Notes
Review 2
Open Mode?
Open Mode?
End of Module
Notes
Module 1 Review
2. What is the current TSB revision level of the CELL-DYN Ruby Systems
in the Classroom?
Student should record TSB revision from TSB Sticker located on
Training Instruments.
Notes
Notes
After replacing the HDD you now need to reinstall the software.
The customer has a back up copy that they have made during
weekly backups.
1. Use the Instrument Service and Support Manual and ISA database to
identify the procedures that would be necessary for you to restore the
instrument back to proper operation. List the procedures below:
Backup Procedure (VP-48).
Operating System (OS) Install and Hard Drive Format (VP-47).
Application Software Install (VP-41).
Restore from Backup (VP-49).
Operations Manual Install (VP-46).
Touchscreen Calibration (VP-6).
Notes
Notes
Module 2 Review
1. List the two (2) heaters that have been added to the CELL-DYN Ruby
System?
HGB and WOC Heaters.
Notes 5. Describe the difference between the two power switches on the
instrument and how each is properly used.
The System main power switch, located on the back of the Analyzer,
should be left ON during normal operating conditions.
With the System main power switch in the ON position, the Data Mod-
ule Power button (spring-loaded momentary type) is used to power the
Analyzer and Display ON.
The Display and Printer have their own power switches and should be
left ON as long as the main power switch to the System is ON. Power
to the Display and printer should be turned OFF when the System
main power switch is turned OFF.
The Application Programs “shutdown” menu option should be used to
turn the Analyzer OFF.
It is not necessary to turn the System main power switch OFF under
normal operating conditions. The System main power switch (rear
panel) should be turned OFF when a malfunction is suspected, when
when the system will be moved, or when the system will be inactive
for an extended period of time (greater than 2 weeks), or as deemed
necessary by an Abbott representative.
Notes
Module 3 Review
WBC Lyse
• Act as the diluent for the WBC.
• Osmotically lyse the red cells.
• Maintain the right scattering properties of the WBC for the
duration of the measurement period.
• Provide sufficient wetting action to prevent accumulation of
air bubbles in the WBC flow system.
• Serve as a rinsing agent for the WBC Mixing Chamber.
• Act as a diluent for Reticulocytes.
2. During normal operation, while the instrument is idle and in the Ready
state, the vacuum and pressure pumps cycle on/off every 5 seconds.
(unless Sample Loader lines are clamped).
3. Where is bubble mix used on the CELL-DYN Ruby Flow Panel AND what does normal
bubble-mix look like?
RBC/PLT, HGB/NOC and WOC Mixing Chambers.
4.25 psi.
6. Describe the process for preparing whole blood for a closed mode precision.
To prepare specimens for use follow the guidelines stated below:
• Obtain 15 ml of normal whole blood within four (4) hours of draw.
• All specimens must have been properly collected in tubes containing EDTA
anticoagulant.
• Pool, mix, and aliquot into five (5) unused, red top (non anticoagulant) tubes.
• Be certain that all specimens used are brought to room temperature and mixed well
before aspiration.
7. Complete the Table by recording either a Calculated (C), Measured (M) or Derived (D) next
to each parameter.
White Blood Cell Parameters Red Blood Cell Parameters
M WBC: White Blood Cell Count (WOC) M RBC: Red Blood Cell Count
C NEU: Neutrophil Absolute Count C MCH: Mean Cell Hemoglobin
C LYM: Lymphocyte Absolute Count C MCHC: Mean Cell Hemoglobin Concentration
C MONO: Monocyte Absolute Count C HCT: Hematocrit
C EOS: Eosinophil Absolute Count D MCV: Mean Cell Volume
C BASO: Basophil Absolute Count D RDW: Red Cell Distribution Width
M %N: Neutrophil Percentage of WBCs M HGB: Hemoglobin Concentration
M %L: Lymphocyte Percentage of WBCs Reticulocyte Package
M %M: Monocyte Percentage of WBCs M %R: Percentage of Reticulocytes
M %E: Eosinophil Percentage of WBCs C RETC: Reticulocyte absolute concentration
M %B: Basophil Percentage of WBCs Platelet Parameters
**M PLT: Platelet Count
D MPV: Mean Platelet Volume
C PCT*: Plateletcrit
C PDW*: Platelet Distribution Width
*Clinical significance has not been established for PCT or PDW. Therefore, they are not reportable in the US
**The Platelet count is directly derived from measured optical data.
Notes
Have class list checks and measurements. This may include VP-36
TCM Adjustment, Running Background, Checking Heater Tempera-
ture.
Review Cable Connection Diagram.
Notes
Notes
Module 4 Review
3. True or False----The PRM PCB receives +28 VDC from the PDM J20
to operate the pumps.
True.
Notes 8. There are five (5) ports on the HGB Flow Cell, which port is used to
deliver sample into the flow cell?
Top front port.
Notes
Notes
Notes
Module 5 Review
1. Name the four angles of scatter that are measured on the CELL-DYN
Ruby System and what cell characteristic they are looking at.
a. 0° scatter is mainly representative of particle SIZE
2. If the RBC Count is increased, the MCH will be Low and the MCV
will be not affected.
3. If the HGB measurement is low, the MCH will be Low and the
MCHC will be Low.
5. What order are samples staged into the Optical Flow Cell?
RBC/PLT, NOC and WOC.
The RBC/PLT is staged first through 54, if applicable, the NOC is
staged second through 41 and the WBC (WOC) is staged last
through 55.
Notes 7. List the software steps required to view the Moving Average Program
results.
QC View, F5- Moving Average.
Use the F8 - Closed Batch Data view to examine the batch means.
View the Levey-Jennings graphs of the batches and determine
whether the results are acceptable.
Notes
Notes
Notes
Module 6 Review
1. Where are the HGB Reference Readings located and what is a normal
reading?
Select Diagnostics, Diagnostic Views, click on Raw Data Summary.
Verify that HGB reference and sample readings are within 2050 ±200.
The difference between the HGB sample and reference readings
must be <20 counts after a background cycle.
5. The sample enters the HGB Flow Cell through which line (top or side)?
Top front port.
6. Where are the voltage readings for the Hemoglobin Flow Cell located?
From the Diagnostics menu, select:
• Digital / Voltage Readings.
• HGB output (click on box to left).
• Stream.
The Password for Operator ID: FSE is required to gain access to the
Digital /Voltage Readings screen.
Notes
Notes
Notes
Notes
Instrument will not power on, there are no fans running and the
monitor has the dialog box, “check video cable connection”.
Press the Data Module power button and check to see if the unit
boots up.
Verify outlet voltage is between 100 – 240 VAC and 47 – 63 Hz.
Perform VP-1 System Voltage Verification.
Verify that +5VDC is present on the ATX CPS.
Notes
Notes
Module 7 Review
1. If the +5vdc signal were missing on the ATX CPS what type of errors or
symptoms would be seen on the analyzer?
Failure to receive this +5vdc signal will render the analyzer inoperable
(no voltages).
3. Temperature Control Module receives +28 VDC from the PDM via
connector J15.
5. The CDM PCBs are used to distribute the +28vdc and +15.5vdc from
the PDM PCB that are used to drive the solenoids in the system.
6. The purpose of the Pump Relay Module (PRM) PCB is to turn the
vacuum and pressure pumps ON/OFF.
7. Which SHM PCB provides the LED drive and reads the outputs of the
photo-detectors of the optical sensors in the Sample Loader?
SHM2.
Notes
Notes
Notes
Notes
Module 8 Review
1. The Sample Loader uses both vacuum and pressure to fill and empty
the bladders. TRUE FALSE
Vacuum is applied and the mixer head is lowered over the sample
tubes by the mixer lift air cylinder. Vacuum is applied to the bladders
to release the sample tube(s).
Pressure is applied to bladders to inflate and capture the sample
tube(s). Pressure is applied to the mixer lift air cylinder and the mixer
head and tubes are raised to clear the rack.
2. How much pressure is used to inflate the mixer bladders? 6.5 psi.
3. The GS2 guide system controls what systems on the Sample Loader?
The bar code spinner, wash block, and tube height flag.
4. Where should you measure the pressure for the Bladder Assembly?
Remove the plug to the pneumatic line verification port just behind
the tower assembly and attach the vacuum/pressure meter to the tub-
ing.
6. What valve on the Sampler Loader is used to raise the mixer head
assembly?
Valve 3.
7. The Sample Loader employs five 3-way valves to drive the air
cylinders and mixer bladders. What PCB controls these valves?
SHM2.
Notes
Notes
The customer states the system locked-up while running and upon
reboot the system will not initialize. Error code HSSL Time-out
2100 on CELL-DYN Ruby System is being generated and system
appears to be locked up.
Upon speaking with the customer you learn the customer had a
2nd CELL-DYN Ruby System hooked up to emergency power and
has UPS/Line Conditioner installed not experiencing the issue.
Notes
Notes
Module 10 Review
1. In the Dashboard screen which window displays a short list of logs and
files that are available for retrieval from the instrument?
Action Window.
2. Which log would you review to monitor how many times a system has
seen incomplete aspiration errors?
Event Log.
Notes
Notes
Module 11 Review 1
Notes 5. What is the function and location of the MAM Board on the CELL-DYN
3200 System?
The MAM boards on the CELL-DYN® 3200 and CELL-DYN Ruby
System perform the same function. This consists of:
• Processing optical channel signals between pre-amplifiers
and SPM PCB.
• Sending optical data to the CPU/DCM for processing.
Notes
• Power cycled
What clues can you identify from the data provided or procedures
you would perform?
Pusher arms are not retracting/extending properly.
Use Service Manual general data to determine which valve controls
sweep arms V2 load side and V5 unload side.
Notes
Notes
NEU:.010 %N:.222
EOS: 2.49 %E: 53.8
Notes
Notes
Module 11 Review 2
Open Mode?
Only the Ultrasonic Sensor is used to detect presence or absence of
blood in the aspiration line.
Open Mode?
3.3” Hg Acceptable Range of (3.1-3.5).
Notes 6. List a couple of instrument symptoms that could indicate that the
Optics Bench is out of alignment?
The appearance of “George” is compressed meaning the lympho-
cytes populations are not falling at approximately 1 x 1 and Neutro-
phils at 2.5 x 2.5.
Also Poor CV’s with 0º>8%, 10º>5%, 90º>18%, and 90ºD>18%.
End of Module