Beckman Coulter Cell Lab Quanta SC User manual

Cell Lab Quanta SC
Instructions for Use
PN 721742AD (October 2011)
Manufactured for
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821

WARNINGS AND PRECAUTIONS
READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING
TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL
INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS
TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE.
BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY
STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO,
PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR
ANY OTHER AUTOMATED LABORATORY ANALYZER.
HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS
WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:
WARNING - Can cause injury.
CAUTION - Can cause damage to the instrument.
IMPORTANT - Can cause misleading results.
WARNING Risk of operator injury if:
r All doors, covers and panels are not closed and secured in place prior to and during instrument operation.
r The integrity of safety interlocks and sensors is compromised.
r Instrument alarms and error messages are not acknowledged and acted upon.
r You contact moving parts.
r You mishandle broken parts.
r Doors, covers and panels are not opened, closed, removed and/or replaced with care.
r Improper tools are used for troubleshooting.
To avoid injury:
r Keep doors, covers and panels closed and secured in place while the instrument is in use.
r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors.
r Acknowledge and act upon instrument alarms and error messages.
r Keep away from moving parts.
r Report any broken parts to your Beckman Coulter Representative.
r Open/remove and close/replace doors, covers and panels with care.
r Use the proper tools when troubleshooting.
CAUTION System integrity might be compromised and operational failures might occur if:
r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals.
r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s
computer with software authorized by Beckman Coulter.
r You install software that is not an original copyrighted version. Only use software that is an original copyrighted
version to prevent virus contamination.
IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter
distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot
guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most
current information bulletins concerning the product. If you purchased this product from a third party and would like
further information concerning this topic, call your Beckman Coulter Representative.

iii
PN 721742AD
REVISION STATUS
Initial Issue A, 10/05
Software Version 1.0
Issue AA, 11/08
Software Version 1.0
Revision AA contains updates or new information in the following chapters:
r Chapter 1:
t Updates to the laser warning labels instructions, and graphic depicting location of all of
these labels. See Heading 1.6, WARNING LABELS AND PRECAUTIONS section.
t Updates to Table 1.1, List of Approved Reagents, under Heading 1.8, REAGENTS.
t Indicates the BCI website to access reagent information and search by Reagent Name or
Part Number, under Heading 1.8, REAGENTS.
t Indicates the BCI website to access Cell Lab Quanta System Application Notes, under
Heading 1.8, REAGENTS.
t Added instructions for three new warning labels:
t Heading 1.6, WARNING LABELS AND PRECAUTIONS
r Chapter 4:
t Updates to Table 4.7, Cups Approved for Use , under Heading 4.2, CUPS
Issue AB, 07/09
Software Version 1.0
Revision AB contains an update to the new corporate address.
Issue AC, 03/10
Software Version 1.0
Revision AC contains updates or new information in the following chapters:
r Cover page:
t Replaced the manufacturer’s symbol to show the Brea, California address.
r Chapter 1:
t Replaced the label on the rear of the instrument to show the Brea, CA address.
r Chapter 4:
t Updated Table 4.1, Absolute Count Performance Specifications under Heading 4.1,
PERFORMANCE SPECIFICATIONS.
r Chapter 7:
t Added an important notice under the Playing Back Files section.
t Updated the following sections: Create/Delete Protocol Groups, Assign a User to a
Protocol Group and Remove a User Assigned to a Protocol Group.
Issue AD, 10/11
Software Version 1.0.
Changes were made to pages 2-3.
Note: Changes that are part of the most recent revision are indicated in text by a bar in the
margin of the amended page.
This document applies to the latest software listed and higher versions. When a subsequent software version
affects the information in this document, a new issue will be released to the Beckman Coulter website. For
labeling updates, go to www.beckmancoulter.com and download the latest version of the manual or system
help for your instrument

PN 721742AD
iv
REVISION STATUS

PN 721742AD v
CONTENTS
REVISION STATUS, iii
CONTENTS, v
Illustrations, xi
Tables, xiii
INTRODUCTION, xv
Text Conventions, xvi
Graphic Conventions, xvi
Safety Symbols, xvii
1 USE AND FUNCTION,1-1
1.1 SYSTEM OVERVIEW,1-1
1.2 INTENDED USE,1-1
1.3 QUANTA SC SYSTEM OVERVIEW,1-2
1.4 SYSTEM COMPONENTS,1-3
1.5 PRINCIPLES OF OPERATION,1-4
1.6 WARNING LABELS AND PRECAUTIONS,1-5
Mercury Arc Lamp,1-5
Laser,1-6
Laser Interlocks,1-8
Handling Precautions,1-9
1.7 OPTIONS,1-9
Hardware Options,1-9
Flow Cell Configurations,1-10
Jumper Positions for Different Size Particles µm,1-11
Light Source Configuration,1-11
Printer,1-11
1.8 REAGENTS,1-11
1.9 CONTROLS AND INDICATORS,1-12
Waste Bottle and Vacuum Bottle,1-13
PC,1-14
1.10 MATERIAL SAFETY DATA SHEETS (MSDS),1-15
2INSTALLATION,2-1
2.1 DELIVERY INSPECTION,2-1
2.2 SPECIAL REQUIREMENTS,2-1
Space and Accessibility,2-1
Installation Category,2-2

PN 721742AD
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CONTENTS
Electrical Input,2-3
Ambient Temperature and Humidity,2-3
Heat Dissipation,2-3
Drainage,2-4
2.3 INSTALLATION PROCEDURES,2-4
Interunit Connections,2-4
Lifting and Carrying,2-4
3 OPERATION PRINCIPLES,3-1
3.1 OVERVIEW,3-1
3.2 SAMPLE FLOW,3-1
4 SPECIFICATIONS,4-1
4.1 PERFORMANCE SPECIFICATIONS,4-1
Absolute Count,4-1
Fluorescence,4-1
Sizing,4-1
Optics,4-1
Parameters,4-2
Calculated Parameters,4-2
FC and FSD Relevance,4-2
Mathematical Definitions,4-2
Numeric Range of FSD and FC,4-2
FSD and FC Calibration,4-3
Possible FSD and FC Calculation Errors,4-3
Software,4-3
Fluidics,4-3
Installation Requirements,4-4
4.2 CUPS,4-4
4.3 FLOW CELL,4-4
5 GETTING STARTED,5-1
5.1 POWERING UP THE SYSTEM,5-1
Turn On the Instrument and the Computer,5-1
5.2 INTRODUCTION TO THE QUANTA SC SOFTWARE,5-1
Overview,5-1
Microsoft Windows Basics,5-2
Desktop,5-2
Windows Password,5-2
Launching the Software,5-3
To Launch from the Start Menu,5-3
To Launch from the Desktop,5-3
Main Screen,5-4
Main Menu,5-4

PN 721742AD vii
CONTENTS
Menu Options,5-4
File Menu,5-5
Instrument Menu,5-5
Gain Menu,5-6
Volume Menu,5-6
Analysis Menu,5-6
Regions Screen,5-7
Compensation Screen,5-7
Protocols Screen,5-8
Current Settings Screen,5-8
File Information Screen,5-9
Security Menu,5-9
Help Menu,5-10
Closing a Window or Closing the Software,5-10
Closing a Window,5-10
Closing the Software,5-10
5.3 POWERING DOWN THE SYSTEM,5-11
Turn Instrument and Workstation OFF,5-11
5.4 PLACING A CUP ON THE INSTRUMENT,5-12
6DAILYROUTINE,6-1
6.1 PERFORM STARTUP,6-1
6.2 RUN QC (QUALITY CONTROL) SAMPLES,6-4
6.3 PERFORM SHUTDOWN,6-4
7SOFTWARE,7-1
7.1 UNDERSTANDING THE MAIN SCREEN,7-1
Parameter Information,7-3
Calibrate FSD or FC,7-4
Region Statistics,7-5
7.2 WORKING WITH THE FILE MENU,7-5
Saving Listmode (.LMD) Files,7-6
Auto Save Option,7-6
Playing Back Files,7-7
Defining Playback Options,7-8
Generating a Microsoft Excel Report,7-9
Exporting Data to Excel,7-9
Printing,7-9
Exiting (Closing) the Application,7-11
7.3 WORKING WITH THE INSTRUMENT MENU,7-11
Start Up,7-12
Shut Down,7-13
Defining the Power Setting,7-14
Running the Cleaning Cycle,7-16

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CONTENTS
Flushing,7-17
Fill Cup,7-18
Resetting Fluid Count,7-18
Setting Up the Instrument,7-19
Understanding the Instrument Setup Screen,7-20
Understanding the Diagnostic Functions Screen,7-22
Laser Control,7-23
Understanding the Laser Control Options,7-23
Importing Settings,7-24
Understanding the Import Settings Screen,7-25
Automatically Aligning the Optics,7-25
Understanding the Auto Optical Alignment Screen,7-26
7.4 WORKING WITH THE GAIN MENU,7-27
Show Gain Settings,7-27
Defining Tracking Settings,7-28
Understanding the Tracking Settings Screen,7-29
Tracking Start,7-30
Reset Tracking,7-31
7.5 WORKING WITH THE VOLUME MENU,7-31
Calibrating the Volume,7-31
Calibration Beads,7-32
Understanding the Volume Calibration Screen,7-35
Displaying Channels,7-35
7.6 WORKING WITH THE ANALYSIS MENU,7-36
Parameter Ratio Analysis,7-36
Data Flag Settings,7-37
7.7 WORKING WITH THE REGIONS MENU,7-39
Managing Regions,7-39
Understanding the Manage Regions Screen,7-42
Showing Region Statistics,7-45
Understanding the Region Statistics Screen,7-46
7.8 WORKING WITH THE COMPENSATION MENU,7-47
Defining Compensation Settings,7-47
Understanding the Compensation Settings Screen,7-50
7.9 WORKING WITH THE MANAGE PROTOCOLS SCREEN,7-52
Understanding the Protocol Management Screen,7-53
Loading Protocols,7-54
Creating New Protocols,7-55
Saving Current Settings to a Protocol,7-57
Deleting Protocols,7-58
Save Description Changes (Editing a Protocol),7-60
Create/Delete Protocol Groups,7-61
Assign a User to a Protocol Group,7-62
Remove a User Assigned to a Protocol Group,7-63

PN 721742AD ix
CONTENTS
7.10 WORKING WITH THE CURRENT SETTINGS SCREEN,7-64
Defining Stop Sample Criteria,7-64
Defining the Concentration (Use, # of Seconds, and Start Time),7-65
Enabling/Disabling Checkboxes,7-65
Defining Auto Save Options,7-66
Customizing an Excel Report,7-68
Pre-defined Excel Templates,7-68
Creating/Modifying Text in Excel Report,7-68
Defining Filter Configurations,7-70
Understanding the Current Instrument Settings Screen,7-71
7.11 WORKING WITH THE FILE INFORMATION SCREEN,7-73
Entering Sample Information,7-74
Understanding the File Information Screen,7-75
7.12 WORKING WITH THE SECURITY MENU,7-76
Change Password,7-76
Manage Users,7-77
Understanding the Security Menu Screen,7-78
Password Options,7-79
Modify Database Path,7-79
7.13 WORKING WITH THE HELP MENU,7-80
Launching Help,7-80
Viewing Software Information,7-80
8 QUALITY CONTROL,8-1
8.1 OVERVIEW,8-1
8.2 QC MATERIALS,8-1
8.3 DAILY QC,8-1
Before Running Flow-Check Fluorospheres,8-1
Running Flow-Check Fluorospheres,8-2
Running the Arc Lamp Alignment Beads,8-3
8.4 QC METHOD,8-4
Prepare QC Material,8-4
Flow-Check Fluorospheres,8-4
8.5 AUTOMATICALLY ALIGNING THE OPTICS,8-4
Arc Lamp Alignment Beads,8-4
9 SAMPLE ANALYSIS,9-1
9.1 BEFORE RUNNING SAMPLES,9-1
9.2 PREPARING SAMPLES,9-1
9.3 RUNNING SAMPLES,9-2
9.4 AFTER RUNNING SAMPLES,9-4

PN 721742AD
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CONTENTS
9.5 SETTING INITIAL GAIN, VOLTAGE AND DISCRIMINATOR VALUES,9-5
9.6 WORKING WITH REGIONS,9-5
10 CLEANING/REPLACEMENT,10-1
10.1 INSTRUMENT CLEANING AND HANDLING REQUIREMENTS, 10-1
10.2 INSTRUMENT QUICK DISCONNECT, 10-1
10.3 OPENING/CLOSING THE COVER, 10-2
10.4 EMPTYING THE WASTE BOTTLE, 10-4
10.5 CHANGING A FILTER, 10-5
10.6 CHANGING AN ARC LAMP EXCITATION FILTER, 10-12
10.7 REPLACING THE FUSE, 10-15
10.8 ADJUSTING FUSE VOLTAGE, 10-17
11 TROUBLESHOOTING,11-1
11.1 SYSTEM CONNECTIONS, 11-1
11.2 MONITOR VACUUM READINGS, 11-3
11.3 ERROR MESSAGES, 11-4
11.4 TROUBLESHOOTING GUIDE, 11-5
REFERENCES, REFERENCES-1
GLOSSARY,GLOSSARY-1
INDEX,INDEX-1
BECKMAN COULTER, INC. CUSTOMER END USER LICENSE AGREEMENT,1

PN 721742AD xi
CONTENTS
Illustrations
1.1 Quanta SC System,1-1
1.2 Schematic Overview of Quanta Instrument,1-2
1.3 System Components,1-3
1.4 Triangular Flow Cell: Overview,1-4
1.5 Mercury Arc Lamp Warning Labels,1-5
1.6 Laser Warning Labels,1-7
1.7 Laser Warning Labels,1-7
1.8 Laser Interlocks,1-8
1.9 Optical Filter Configuration -- Laser 488 nm,1-9
1.10 Optical Filter Configuration -- Lamp 365 nm,1-10
1.11 Inside the Instrument: Controls and Indicators,1-12
1.12 Vacuum Regulator: Controls and Indicators,1-12
1.13 Jumper Positions: Controls and Indicators,1-13
1.14 Reservoirs: Controls and Indicators,1-13
1.15 Waste System and Reagents,1-14
1.16 Workstation PC: Controls and Indicators,1-14
5.1 Desktop,5-2
5.2 Main Screen,5-4
5.3 Main Menu,5-4
5.4 File Menu,5-5
5.5 Instrument Menu,5-5
5.6 Gain Menu,5-6
5.7 Volume Menu,5-6
5.8 Analysis Menu,5-6
5.9 Regions Screen,5-7
5.10 Compensation Screen,5-7
5.11 Protocols Screen,5-8
5.12 Current Instrument Settings Window,5-8
5.13 File Information Screen,5-9
5.14 Security Menu,5-9
5.15 Help Menu,5-10
7.1 Main Screen: Defined,7-1
7.2 Main Screen: Parameter Information,7-3
7.3 Main Screen: Calibrate,7-4
7.4 Main Screen: Region Statistics,7-5
7.5 Instrument Setup Screen: Defined,7-20
7.6 Diagnostic Functions Screen: Defined,7-22
7.7 Laser Control Options: Defined,7-23
7.8 Import Setting Screen: Defined,7-25
7.9 Auto Optical Alignment Screen: Defined,7-26
7.10 Tracking Settings Screen: Defined,7-29
7.11 Volume Calibration Screen: Defined,7-35
7.12 Manage Regions Screen: Defined,7-42
7.13 Single Parameter Region Definition Screen: Defined,7-43
7.14 Region Definition Screen for And/Or Regions: Defined,7-44
7.15 Region Statistics Screen: Defined,7-46
7.16 Compensation Settings Screen: Defined,7-50
7.17 Set Compensation using the FLn Control Screen: Defined,7-51

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CONTENTS
7.18 Protocol Management Screen: Defined,7-53
7.19 Current Instrument Settings Screen: Defined,7-71
7.20 File Information Screen: Defined,7-75
7.21 Security Menu: Manage Users,7-78
10.1 Disconnect Analyzer Power, 10-1
11.1 Cable Connections: Back of Instrument, 11-1
11.2 Cable Connections: Back of PC, 11-2
11.3 Cable Connections: Monitor, 11-2
11.4 Tubing Connections: Waste Bottle and Vacuum Bottle, 11-3

PN 721742AD xiii
CONTENTS
Tables
1.1 List of Approved Reagents,1-11
2.1 System Dimensions and Accessibility,2-2
4.1 Absolute Count Performance Specifications,4-1
4.2 Fluorescence Performance Specifications,4-1
4.3 Sizing Performance,4-1
4.4 Optics Performance,4-1
4.5 Fluidics Specifications,4-3
4.6 Installation Requirements,4-4
4.7 Cups Approved for Use,4-4
11.1 Error Messages, 11-4
11.2 Troubleshooting Guide, 11-5

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CONTENTS

PN 721742AD xv
INTRODUCTION
OVERVIEW
This introductory section contains the following topics:
r ABOUT THIS MANUAL
r CONVENTIONS, and
r GRAPHICS.
ABOUT THIS MANUAL
The manual covers the description, installation, operation and maintenance of the Cell Lab
QuantaTM SC system.
The information in your Quanta SC Instructions For Use manual is organized as follows:
s Chapter 1, USE AND FUNCTION
Contains a short description of the major instrument components and options, and the
reagents and quality control materials used.
s Chapter 2, INSTALLATION
Contains instrument requirements, and diagrams of the interunit cable connections.
s Chapter 3, OPERATION PRINCIPLES
Contains a brief description of how the system uses light scatter analysis to perform
cellular enumeration.
s Chapter 4, SPECIFICATIONS
Details the instrument and performance specifications.
r Chapter 5, GETTING STARTED
Provides information needed to get started, including Powering Up and Powering Down.
r Chapter 6, DAILY ROUTINE
Provides instructions for procedures that need to be done daily, including Start Up and
Shut Down.
r Chapter 7, SOFTWARE
Provides details on how to use the software.
r Chapter 8, QUALITY CONTROL
Provides information on how to run quality control material to verify instrument setup.
r Chapter 9, SAMPLE ANALYSIS
Provides information on how to run patient samples.
r Chapter 10, CLEANING/REPLACEMENT
Provides information on cleaning and replacement procedures.
r Chapter 11, TROUBLESHOOTING
Provides information on error messaging and instrument troubleshooting guide.
r INDEX
Provides page numbers for indexed information.

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INTRODUCTION
CONVENTIONS
CONVENTIONS
Text Conventions
r Bold font indicates a software option, such as Startup.
r Italics font indicates screen text displayed on the instrument, such as
Run Shutdown.
r A Note contains supplemental information.
r An ATTENTION contains information that is important to remember or helpful when
performing a procedure.
r The terms “screen” and “window’ are used interchangeably.
r Quanta is used interchangeably with Quanta SC System and instrument.
r Bold, italics font indicates a procedure heading.
Graphic Conventions
r indicates “select” with or “click” the left mouse button.
r indicates double-click with the left mouse button.
r indicates “click” the right mouse button.

PN 721742AD xvii
INTRODUCTION
SYMBOLS
SYMBOLS
Safety Symbols
Safety symbols alert you to potentially dangerous conditions. These symbols, together with
text, apply to specific procedures and appear as needed throughout this manual.
GRAPHICS
All graphics, including screens and printouts, are for illustration purposes only and must not
be used for any other purpose.
Symbol Warning Condition Action
Biohazard. Consider all materials (specimens,
reagents, controls, and calibrators, and so forth)
and areas these materials come into contact with as
being potentially infectious.
Wear standard laboratory attire
and follow safe laboratory
procedures when handling any
material in the laboratory.
Electrical shock hazard.Possibility of electrical
shock when instrument is plugged in to the power
source.
Before continuing, unplug the
instrument from the electrical
outlet.
Hot Surface hazard. Possibility of injury from a hot
surface.
Before continuing, use caution
when touching a surface that may
be hot.
Light hazard. Consider all light sources and light
emissions as being potentially hazardous to your
eyes.
Before continuing, verify that you
are wearing the proper protective
eye wear to avoid damage to your
eyes from beams of light. Never
look directly into a beam of light.
Laser hazard. Consider all laser sources as being
potentially hazardous to your eyes.
Before continuing, verify that you
are wearing the proper protective
eye wear to avoid damage to your
eyes from beams of light. Never
look directly into a beam of light.
International warning. Whenever this symbol is
present, refer to the product labeling for detailed
description of the warning.
Before continuing, verify that you
have read and understood the
warning described in the product
labeling.
WEEE International warning. Whenever this symbol
is present, refer to local disposal requirements in
the event that the labeled parts need replacement or
disposal.
Before continuing, please contact
your dealer or local Beckman
Coulter office for proper
decontamination information and
take back program to facilitate the
proper collection, treatment,
recovery, recycling, and safe
disposal of device.
A28219-AA

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INTRODUCTION
GRAPHICS

PN 721742AD 1-1
1
1USE AND FUNCTION
1.1 SYSTEM OVERVIEW
Figure 1.1 shows the Cell Lab Quanta SC system. The Quanta SC system is a three-color flow
cytometer, which provides the additional sizing parameter of Electronic Volume (EV) and the
granularity differentiating parameter of Side Scatter. Two light sources are provided; the
mercury arc lamp and the 488 nm solid state laser.
Figure 1.1 Quanta SC System
1.2 INTENDED USE
The Cell Lab Quanta SC instrument is intended for General Laboratory Use. The instrument
simultaneously measures the fluorescence and electronic volume (EV) based on the Coulter
Principle.1

PN 721742AD
1-2
USE AND FUNCTION
QUANTA SC SYSTEM OVERVIEW
1.3 QUANTA SC SYSTEM OVERVIEW
Figure 1.2 shows the major components of the Quanta instrument.
Figure 1.2 Schematic Overview of Quanta Instrument
M
M
M
M
Vacuum System
Valve
Assembly
Syringe Pump
Power
Supply
Pre-Amp ECV
Vacuum
Pump
Vacuum
Regulator
10 " Hg
Controller
Power
Supply
Flow Cell
Microscope
Filter Plate
Laser 488 nm
Mercury Arc
Lamp 100 W
Dichroic
450 dcxr
Micro-objective
(100x) 1.25µm Sample cup
Flow Cell
channel
Electrodes
Mirror Diode
PMTPMT
Y Axis X Axis
Y Axis
X Axis
Transducer’s
position (T)
Focus (F)
UG1 Filter
Z Axis
(Focus)
Motors Motors (PC)
(Lamp’s motors & Microsc’s motors)
Syringe Pump
SIU Board (PC) Data
PMT
Power
Supply
Syringe
Pump COM 1
(PC)
Sheath fluid
bottle
Beam Shaper
Drip
Chamber
Fiber
Optics
Waste
Bottle
Vacuum
Bottle
COM2 (PC) Laser Control
SC
550 DLP 600 DLP
670 LP
575 BP
z 488 rdc
FL3
FL2FL1
525 BP (Laser)
460 BP (Lamp)
2380057
Log Amplifiers
Motherboard
Card
Cage A/D
SC
A/D
FL1
A/D
FL3
A/D
EV
A/D
FL2