System User Manual.book

System User Manual.book
Lum/nex
®
Luminex 200™ System User Manual
© LUMINEX CORPORATION, 2001-2005. All rights reserved. No part of this publication may be reproduced,
transmitted, transcribed, or translated into any language or computer language, in any form or by any means
without prior express, written consent of:
LUMINEX CORPORATION
12212 Technology Boulevard
Austin, Texas 78727-6115
U.S.A.
Voice: (512) 219-8020
Fax: (512) 219-5195
Luminex® 200™ System User Manual
REF
CN-M064-01
PN 89-00002-00-109 Rev. A
July 2005
Luminex Corporation (Luminex) reserves the right to modify its products and services at any time. This guide
is subject to change without notice. Although prepared to ensure accuracy, Luminex assumes no liability for
errors or omissions, or for any damages resulting from the application or use of this information.
The following are trademarks of Luminex: Luminex, Luminex 100, Luminex 100 IS, Luminex 200, LabMAP,
xMAP, LumAvidin, Luminex XYP, Luminex SeroMAP, Luminex FlexMAP, and Luminex SD. All other trademarks, including Windows, Cheminert, Pentium, and Dell are trademarks of their respective companies.
The Luminex 100 IS software uses the VideoSoft® VsFlexGrid Pro 7.0, VsPrinter 7.0, and VsView 3.0
ActiveX controls, which are copyrighted by VideoSoft, 2001.
The contents of this manual and the associated Luminex software are the property of Luminex and are
copyrighted. Except as specified in the End User License Agreement, any reproduction in whole or in part is
strictly prohibited.
Contents
Safety
1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Warnings and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Luminex 200 Analyzer Laser . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Barcode Reader Laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Biological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Heat. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Blue Indicator Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Decontaminating the Luminex 200 Analyzer for Return
Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
The System
2-1
Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
xMAP Technology Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Required Laboratory Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Luminex IS 2.3 Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Luminex 200 Performance Specifications . . . . . . . . . . . . . . . . . . . 2-3
Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Accuracy and Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Luminex 200 Analyzer General . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Luminex XYP Instrument General . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Luminex SD System General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
PC Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Recommended Additional Equipment . . . . . . . . . . . . . . . . . . . 2-6
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
PN 89-00002-00-109 Rev. A
Luminex 200 System User Manual
xMAP Technology
Fluidics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Optical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
xMAP Technology Reagents . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Maintenance and Cleaning
3-1
Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Before Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
After Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Routine Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sheath and Waste Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Weekly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Run Self-Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Clean the Sample Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Flush the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Clean Exterior Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Calibrate the system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Every Six Months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Luminex 200 Analyzer Air Intake Filter . . . . . . . . . . . . . . . . . 3-6
Luminex XYP Instrument Air Intake Filter. . . . . . . . . . . . . . . 3-7
Syringe Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Luminex 200 Analyzer Ventilation Filter . . . . . . . . . . . . . . . 3-10
Annually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Sheath Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
As required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Replacing the SD System with a Sheath Bottle . . . . . . . . . . . 3-13
Storing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Taking the System out of Storage . . . . . . . . . . . . . . . . . . . . . 3-13
Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Troubleshooting
4-1
Troubleshooting the Luminex 200 System. . . . . . . . . . . . . . . . . . . 4-1
Power Supply Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Pressurization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Fluid Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Sample Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Calibration and Control Problems . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Acquisition Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Bead Detail Irregularities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Error States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
System Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
ii
PN 89-00002-00-109 Rev. A
xMAP Technology
Contents
Sample Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Luminex SD Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Malfunction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Draining the Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Product Numbers
5-1
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
xMAP Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
PN 89-00002-00-109 Rev. A
iii
Luminex 200 System User Manual
iv
xMAP Technology
PN 89-00002-00-109 Rev. A
1
Safety
Please become familiar with the information in this chapter before
using the equipment. Do not perform procedures on your Luminex®
200TM system that are not specifically contained in this manual,
unless you are directed to do so by Luminex Technical Support.
Intended Use
Warnings and Notes
The Luminex software is designed to use xMAP® technology with
assay kits available through kit manufacturers. The Luminex 200
system performs a wide range of xMAP technology-based laboratory
tests, measuring biomolecular reactions on the surface of xMAP
microspheres.
Informational notes and warnings appear in this manual.
Note: A note provides general helpful information. No safety or
performance issues are involved.
Caution: This message is used in cases where the hazard is minor or
only potential hazard is present. Failure to comply with the caution
may result in potentially hazardous conditions.
Warning: This message is used in cases where danger to the
operator or to the performance of the instrument is present. Failure to
comply with the warning may result in incorrect performance,
instrument failure, invalid results, or hazard to the operator.
Danger: This message is used in cases where significant risk of
serious injury or death is present.
PN 89-00002-00-109 Rev. A
1-1
xMAP Technology
Luminex 200 System User Manual
Symbols
Symbol
These symbols describe warnings, cautions, and general information
used in the operation of this instrument. Some of these symbols are
further defined under “Safety Precautions.”
Description
Symbol
Description
Protective ground
Warning
(refer to manual)
Warning
(refer to manual)
On
Warning
(refer to manual)
Warning (refer to
manual)
Catalog Number
Consult instructions
for use
In vitro Diagnostic
Medical Device
Batch Code
Serial Number
Temperature
Limitation
Expiration Date
Date of Manufacture
Manufacturer
Underwriter’s
Laboratory
Canadian
Underwriter’s
Laboratory
European Union
Conformity
WEEE - Do not
throw in trash
Off
Safety Precautions
1-2
Description
Warning
(refer to manual)
Alternating current
(ac)
Fluidics
Symbol
Warning
(refer to manual)
Read the following safety information before setting up or using the
Luminex 200 analyzer. A user should be present during operation.
This system contains electrical, mechanical, and laser components
which, if handled improperly, are potentially harmful. In addition,
biological hazards may be present during system operation.
Therefore, we recommend that all system users become familiar with
the specific safety advisories below, in addition to adhering to
standard laboratory safety practices. The protection provided by the
equipment may be impaired or the warranty voided if the system is
used in a manner not specified by the instructions or by Luminex
Corporation.
This system contains fluidics. In the event of a fluid leak, turn off all
power to the system and disconnect all power cords. The on/off
PN 89-00002-00-109 Rev. A
xMAP Technology
Safety
switch is not a disconnect means; power cords must be removed
from the outlet. Contact Luminex Corporation for further
information.
You must monitor waste levels manually. Do not allow the waste
container to overflow! Empty the waste container each time the
sheath fluid container is filled. Do not place the waste container on
top of the instrument. Contact Luminex Technical Support before
relocating the waste container or rerouting the waste line.
Warning: If biological samples have been tested with the system,
use your standard laboratory safety practices when handling
system waste.
Luminex 200 Analyzer
Laser
The Luminex 200 system classifies per FDA 21 CFR 1040.10 and
1040.11 as a Class II laser product consisting of a Class I laser
product (Luminex 200 analyzer) and a Class II laser product
(barcode reader).
Under NO circumstances should you remove the Luminex 200
analyzer cover! When performing routine maintenance, turn power
to the Luminex 200 analyzer OFF and disconnect the power cord.
All laser apertures are located within the Luminex 200 analyzer and
are contained within a protective housing.
Warning — Use of controls or adjustments or performance of
procedures other than those specified herein may result in
hazardous radiation exposure.
Barcode Reader Laser
Do not stare into the beam or shine it into other people’s eyes.
Mechanical
Warning: During operation, this system contains exposed,
moving parts. Risk of personal injury is present. Observe all
warnings and cautions.
Warning: During operation, this system contains exposed,
moving parts which could result in puncture hazard. Risk of
personal injury is present. Keep hands and fingers away from the
Luminex XYP instrument slot during operation.
Warning: During operation, this system contains exposed,
moving parts which could result in pinch point hazard. Risk of
personal injury is present. Keep hands and fingers away from the
Luminex XYP instrument slot during operation.
PN 89-00002-00-109 Rev. A
1-3
Luminex 200 System User Manual
xMAP Technology
Access doors must be closed while operating the Luminex 200
analyzer; the operator must be present during operation.
Biological
Warning: Human and animal samples may contain biohazardous
infectious agents.
Where exposure (including aerosol) to potentially biohazardous
material exists, follow appropriate biosafety procedures and use
personal protective equipment, such as gloves, gowns, laboratory
coats, face shields, or mask and eye protection, and ventilation
devices.
Observe all local, state, and federal biohazard handling
regulations when disposing of biohazardous waste material.
Heat
Warning: The heater plate of the Luminex XYP instrument may
be hot and could cause personal injury if touched. Do not touch
the heater plate.
Blue Indicator Light
1-4
The blue light above the Luminex 200 analyzer sample arm indicates
the on/off status of the Luminex 200 analyzer, and is harmless. The
blue light-emitting diode (LED) does not emit light in the UV
spectrum.
PN 89-00002-00-109 Rev. A
xMAP Technology
Decontaminating
the Luminex 200
Analyzer for Return
Shipment
Safety
Luminex Technical Support will give you a Return Material
Authorization (RMA) number if they direct you to return the system.
They will explain how to return the system according to Luminex
procedures.
The accessible surfaces and the internal fluidics system must be
sanitized and decontaminated before returning the analyzer. This is
particularly important when biohazardous samples have been run.
Make a copy of this page to fill out and return with the system.
Complete the following checklist, signed and dated, and return it
with the Luminex 200 analyzer.
Note: It is the user’s
responsibility to
decontaminate the
analyzer before
shipment.
1.
Remove all specimens, disposables, and reagents from the system.
2.
Disconnect the sheath line going from the SD system to the analyzer.
3.
Connect a sheath bottle filled with a solution of 10% to 20% household
bleach solution to the analyzer.
4.
Sanitize the system using the Sanitize command on the main screen of
the system. Follow this by washing twice with distilled water.
5.
Disconnect the system from AC power by turning off the power switch
on the rear of the system, then unplugging the analyzer power cord
from the wall source.
6.
Disconnect the SD system and waste and sheath containers.
7.
Rinse the waste container with 10% to 20% household bleach solution
and drain.
8.
Wash all exterior surfaces with a mild detergent, followed by a 10% to
20% household bleach solution.
9.
Open the front doors of the analyzer. Clean all accessible surfaces with
mild detergent followed by a 10% to 20% household bleach solution.
10. Pack the system within a biohazard bag, place it in the corrugated box,
then insert it in its original packaging or an approved shipping
container. Attach this checklist to the top of the corrugated box prior to
packaging in the crate.
Was there an internal leak in the system?
Yes
No
Print Name:
Signature:
Date:
PN 89-00002-00-109 Rev. A
Instrument Serial No.
1-5
xMAP Technology
PN 89-00002-00-109 Rev. A
Safety
1-6
2
The System
Theory of Operation
Luminex 200 technology is based on flow cell fluorometry with
Luminex-developed innovations. The fluidics, optics, robotics,
temperature control, software, and xMAP® microspheres work
together to enable simultaneous analysis of up to 100 analytes in a
single test sample. Assay analysis requiring temperature control is
provided through the Luminex XYP instrument heater block.
There are two fluidics paths in the Luminex 200 analyzer. The first
path involves a syringe-driven mechanism that controls the sample
uptake. This mechanism permits small sample uptake volumes from
small reaction volumes. The syringe-driven system transports a
specified volume of sample from a sample container to the cuvette.
The sample is injected into the cuvette at a steady rate for analysis.
Following analysis, the sample path is automatically purged with
Luminex xMAP Sheath Fluid by the second fluidics path. This
process removes residual sample within the tubing, valves, and
probe. The second fluidics path is driven by positive air pressure and
supplies sheath fluid to the cuvette and sample path.
Luminex xMAP Sheath Fluid is the delivery medium of the sample
to the optics component. The analysis sample is acquired using a
sample probe from a 96-well microtiter plate via the Luminex XYP
instrument and injected into the base of the cuvette. The sample then
passes through with sheath fluid at a reduced rate resulting in a
narrow sample core to ensure that each microsphere is illuminated
individually. The sample injection rate is such that the xMAP
microspheres are introduced to the optics path as a series of single
events. The Luminex SD system lets you run samples continuously
without refilling sheath bottles. It automatically draws sheath from a
non pressurized bulk sheath container to constantly maintain a
reservoir of pressurized sheath fluid. A single 20 liter sheath
container provides enough fluid for 48 hours or more of normal
operation.
PN 89-00002-00-109 Rev. A
2-1
xMAP Technology
Luminex 200 System User Manual
The optics assembly consists of two lasers. One laser excites the dye
mixture inside the xMAP microspheres and the second laser excites
the fluorophore bound to the surface of the xMAP microspheres.
Avalanche photo diode detectors measure the excitation emission
intensities of the color coding classification dye mixtures inside the
xMAP microspheres and a photomultiplier tube detects the excitation
emission intensity of the reporter molecule bound to the surface of
the xMAP microspheres. High speed digital signal processors and
advanced computer algorithms provide analysis of the xMAP
microspheres as they are processed through the Luminex 200
analyzer. Results of the analyses are processed and provided in a
report format.
Hardware
xMAP Technology
Reagents
2-2
The Luminex 200 system includes the following hardware:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Luminex 200 analyzer
Computer (PC), monitor, and accessories
Luminex XYP instrument
Luminex Sheath Delivery System (Luminex SD™)
Power cables
Alignment guide
Two long sample probes
Reservoir
Shield
Heater block
Sheath fluid container
Waste container
Sheath fluid line
Air line
Sheath fluid intake line
Communications: 1 serial communication cable
Communications: 1 USB communication cable
Communications: 1 CANBUS cable (short cable)
Barcode reader
Sample probe height alignment kit
3/32 Hexdrive, Balldriver wrench
•
•
•
•
•
Classification calibration microspheres (CAL1)
Reporter calibration microspheres (CAL2)
Classification control microspheres (CON1)
Reporter control microspheres (CON2)
Luminex xMAP Sheath Fluid
PN 89-00002-00-109 Rev. A
xMAP Technology
Required
Laboratory
Reagents
Luminex IS 2.3
Software
The System
•
•
•
•
Household bleach
70% isopropanol or 70% ethanol
Mild detergent
Distilled water
Luminex IS 2.3 software provides complete control of the system
and performs data analysis. Your Luminex 200 system is preloaded
with the Luminex software. However, we supply a software CD
should you need to reinstall the software.
This software requires a dedicated system. Unauthorized additional
software is prohibited and may result in improper operation of the
system.
Luminex 200
Performance
Specifications
Speed
•
•
•
•
•
•
•
•
•
•
•
•
•
Accuracy and Precision
PN 89-00002-00-109 Rev. A
•
•
Speed: greater than or equal to1.7 GHz Intel® Pentium® IV
processor with 256 MB RAM
USB communications link for fast data transfer
Automatic transfer of assay templates and new reagent
information into the system via a 3½” diskette or large capacity
read/write CD
Installation: < 4 hours
System calibration: < 10 minutes
System controls: < 10 minutes
Barcode reader entry of sample IDs
Automatic post-analysis
Analyze one 96-well plate/hour depending on manufacturer’s kit
Up to 100 xMAP microsphere sets per sample
Sheath flowrate: 90 µL/sec ± 5 µL
Sample injection rate into detector area: 1 µL/sec ± 0.05 µL
System warmup: 30 minutes. Systems that remain inactive for at
least four hours will require a warm-up to restart the lasers. After
acquiring sample, running system calibrators, running system
controls, and warming up the instrument, the system resets the
four-hour internal clock.
Sample uptake volume: ± 5%
Classification of xMAP microspheres: > 80%
2-3
xMAP Technology
Luminex 200 System User Manual
•
•
•
•
Sensitivity
•
•
Capacity
•
•
•
•
•
•
•
•
2-4
Detect 1000 fluorochromes phycoerythrin (PE) per xMAP
microsphere
Reporter channel dynamic range: 3.5 decades of detection
The specifications below reflect minimum capacity values:
•
•
•
•
•
•
•
Luminex 200
Analyzer General
Misclassification of xMAP microspheres: ≤ 2 - may vary by
xMAP microsphere product lines. Refer to the specific product
information sheet for further details.
Temperature control: 0°C to + 2°C of target
Internal sample carry over: < 0.9%
Soluble background fluorescence emission at 575 nm
automatically subtracted from fluorescence intensity values
•
•
•
10 GB hard drive
Store data for up to 240,000 test results
1.4 MB 3½” diskette
100 MB read/write CD ROM
Analyze multiple 96-well plates per batch
Analyze multiple assay templates per plate
Distinguish a minimum of 1 to a maximum of 100 unique xMAP
microsphere sets in a single sample
Detect and distinguish surface reporter fluorescence emissions at
575 nm on the surface of 1-100 unique xMAP microspheres sets
in a single sample
Sample core: 15-20 µm core at 1 µL/sec. sample inject rate
Maintain samples at a constant temperature from 35°C to 55°C
(95°F to 131°F)
Automatic sampling from a 96-well plate
Start sampling from any well position
Sheath container and waste container hold enough volume to run
up to two 96-well plates between refills
Microtiter plates with 96 wells must be compatible with the
Luminex XYP instrument plate holder. The following microtiter
plate types are compatible with the Luminex XYP instrument
plate holder: flatbottom, conical, round, filter bottom, half plates
[overall height no more than 0.75” (19 mm)], any color.
Microtiter plates with 96 wells must be compatible with
Luminex XYP instrument heater block temperature from 35°C to
55°C (95°F to 131°F) when performing heated assays and using
the heater block.
Indoor use only
Operating temperature: 15°C to 30°C (59°F to 86°F)
Humidity: 20% to 80%, noncondensing
PN 89-00002-00-109 Rev. A
xMAP Technology
The System
•
•
•
•
•
•
•
•
Optics
•
•
•
•
•
Fluidics
Electronics
Luminex XYP
Instrument General
Reporter laser: 532 nm, nominal output 10-16.5 mW, maximum
500 mW, frequency-doubled diode; mode of operation,
continuous wave (CW)
Classification laser: 635 nm, 9.1 mW ± 6%, maximum output 25
mW, diode; mode of operation, continuous wave (CW)
Reporter detector: Photomultiplier tube, detection bandwidth of
565-585 nm
Classification detector: Avalanche photo diodes with temperature
compensation
Doublet discrimination detector: Avalanche photo diodes with
temperature compensation
•
•
•
•
Sheath flow rate 90 µL ± 5 µL/second
Cuvette: 200 micron square flow channel
Sample injection rate: 1 µL/second
Sample uptake volume: 20-200 µL
•
•
•
Reporter channel detection: A/D resolution 14 bits
Communications interface: USB
Luminex XYP instrument, communications interface: RS 232
•
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•
Ambient temperature: 15°C to 30°C (59°F to 86°F)
Humidity: 20% to 80%, noncondensing
Altitude: operation up to 2400 m (7874 ft) above mean sea level
Physical dimensions: 44 cm (17.25 inches) W x 60 cm (23.5
inches) D x 8 cm (3 inches) H
Weight: 15 kg (33 lbs.)
UL installation category: UL Installation Category II, as defined
in Annex J of UL 61010A-1
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•
PN 89-00002-00-109 Rev. A
Altitude: Operation up to 2400 m (7874 ft.) above mean sea level
Physical dimensions: 43 cm (17 inches) W x 50.5 cm (20 inches)
D x 24.5 cm (9.5 inches) H
Weight: maximum of 25 kg (60 lbs.)
UL installation category: UL Installation Category II, as defined
in Annex J of UL 61010A-1
Pollution degree: UL Pollution Degree 2, as defined in Section
3.7.3.2 of UL 61010A-1
Shipping and storage: The allowable shipping and storage
temperature and humidity ranges are 0°C to + 50°C and 20-80%
noncondensing, respectively
Input voltage range: 100 - 120 V~ ± 10%, 1.4 Amp, and 200-240
V~ ± 10%, 0.8 Amp, 47-63 Hz.
AC inlet fuse: 3 Amp, 250 V~, fast acting
2-5
xMAP Technology
Luminex 200 System User Manual
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Luminex SD System
General
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PC Specifications
Pollution degree: UL Pollution Degree 2, as defined in Section
3.7.3.2 of UL 61010A-1
Heater operating range: 35°C to 55°C (95°F to 131°F) with
tolerance 0°C to +2°C
Input voltage range: 100-240 V~ ± 10%, 1.8 Amps, 47-63 Hz
AC inlet fuse: 3 A, 250 V~, fast acting
Ambient temperature: 15°C to 30°C (59° to 86°F)
Humidity: 20% to 80%, noncondensing
Altitude: designed to operate at up to 2400m (7874 feet) above
mean sea level
Physical dimensions: 20 cm (8 inches) W x 30 cm (11.75 inches)
D x 24.75 cm (9.75 inches) H
Weight: 9 kg (20 lbs)
UL installation category: UL Installation Category II, as defined
in Annex J of UL 61010A-1
Pollution degree: UL Pollution Degree 2, as defined in Section
3.7.3.2 of UL 61010A-1
Input voltage range: 100-240 V~ ± 10%, 0.4 Amps, 47-63 Hz
AC inlet fuse: 2 Amp, 250 V~, time lag
For systems using a PC, A Dell OptiPlex GX280 or Dell Optiplex
GX520 (or newer PC) is shipped with the Luminex 200 system. For
systems using a laptop, a Dell D610 Notebook is shipped with the
system. Microsoft® Windows® XP is pre-installed on the computers.
The power requirements are 115-230 V~, 6 Amps, 50-60 Hz
For updated information regarding the PC, notebook, or operating
system, go to http://www.luminexcorp.com, then click on the
Support link to open the FAQ list.
Recommended Additional
Equipment
2-6
Uninterruptible
Power Supply
(UPS)
Luminex highly recommends using an uninterruptible power supply
(UPS) to protect your system from power outages. Choose one that
can provide 1050 Watts for at least 45 minutes. The UPS should be
UL listed, CSA certified, and CE marked when used internationally.
Surge Protector
If you do not use a UPS, use a surge protector. Choose a protector
that meets your needs. Factors to consider include electrical
environment, endurance, suppressed voltage rating, and method of
protection. It should have six outlets, rated at least 1500 Watts, and
PN 89-00002-00-109 Rev. A
xMAP Technology
The System
be UL listed, CSA certified, CE marked for nondomestic use when
used internationally.
Printer
Barcode Labels
Vortex
Bath Sonicator
System Overview
Printer, HP LaserJet 2300 or available equivalent
Use the Code 128 barcode label type when scanning barcode labels
into the system as patient identities.
VWR product number 58816-121: Speed range 0-3200 rpm or
equivalent
Cole-Parmer® product number 08849-00: Operating frequency 55
kHz or equivalent
The system consists of three subsystems: electronic, fluidic, and
optical. The following section describes the user-accessible
components of each subsystem.
Electronics
Power Input
Module
The power input modules contain the on/off switch and fuses.
Communications
Ports (SB9-PIN)
The communications port connects the Luminex 200 analyzer or the
Luminex XYP instrument to the computer, and the Luminex SD
system to the Luminex 200 analyzer.
Luminex 200
Analyzer
Ventilation Filter
Located on the bottom of the Luminex 200 analyzer, the filter must
be checked and cleaned as necessary. For proper ventilation, do not
obstruct the area below and allow at least two inches (5 cm) of
clearance around the Luminex 200 analyzer.
Luminex XYP
Instrument
Ventilation Filter
The XYP instrument ventilation filter cleans the air that cools the
internal parts of the Luminex XYP instrument. See Figure 2-1.
PN 89-00002-00-109 Rev. A
2-7
xMAP Technology
Luminex 200 System User Manual
1
2
3
4
5
6
7
1
1. Air intake filter access door
5. Communication Ports (DB9)
2. Power Switch
6. XYP Communication Port (DB9)
3. Power Input Module
7. Analyzer ventilation filter
(on bottom of analyzer)
4. XYP Ventilation Filter
Figure 2-1 Back of the Luminex 200 Analyzer and Luminex XYP
Instrument
Fluidics
2-8
Luminex XYP
Instrument Sample
Probe
A stainless steel sample probe acquires the sample.
Cheminert® Fitting
This fitting attaches the sample probe to the sample tubing.
Disconnect this fitting when you remove the sample probe. See
Figure 2-2.
Warning: During operation, this system contains exposed moving
parts that can result in a puncture hazard. Risk of personal injury
is present. Keep hands and fingers away from the sample probe.
The shield should be in place.
PN 89-00002-00-109 Rev. A
xMAP Technology
The System
1
2
3
4
1. Cheminert Fitting
2. Probe Holder
3. Probe Adjustment Screw 4. Luminex XYP Instrument Sample Probe
Figure 2-2 Fluidics Components
Access Doors
The Luminex 200 analyzer has three access doors. Two of the access
doors are on the front, and the third is on the back. The front left
access door supplies access to the sheath filter. The front center
access door supplies access to the syringe. The rear access door
supplies access to the air intake filter. See Figure 2-3.
1
2
1. Left door, access to service panel
2. Center door, access to syringe
Figure 2-3 Luminex 200 Analyzer Access Doors
PN 89-00002-00-109 Rev. A
2-9
Luminex 200 System User Manual
xMAP Technology
Air Intake Filter
A replaceable air intake filter cleans the air used to pressurize sheath
fluid. This filter is enclosed behind an access door located on the
back of the Luminex 200 analyzer.
Syringe
The syringe delivers a sample from the 96-well microtiter plate to the
cuvette.
Sheath Filter
The sheath filter removes particles greater than ten microns in
diameter from the sheath fluid.
Air, Waste, and
Sheath Fluid
Connectors
The air, waste, and sheath connectors, located on the left side of the
analyzer, connect to the SD system and waste fluid containers using
clear tubing. The air connector is green, the sheath fluid connector is
blue, and the waste fluid connector is orange.
Luminex Sheath
Delivery System
For proper operation, place the Luminex SD system at the same level
as the base of the Luminex XYP instrument. Do not put it on top of
the Luminex 200 analyzer. If you are not using the SD system, sheath
fluid levels must be monitored manually. Check the sheath fluid level
before starting a run or procedure.
Warning: If biological samples have been tested with the
system, use your standard laboratory safety practices.
Waste Fluid
Container
The waste fluid container receives waste from the system. The waste
container should not be placed on top of the instrument. Ensure that
the waste tubing is not elevated above the level of the Luminex 200
analyzer at any point. Contact Luminex Technical Support before
you relocate the waste fluid container. To maintain a stable flow rate,
do not move the waste line or container during system operation.
Caution: Waste levels must be manually monitored. Do not
allow the waste container to overflow.
Optical
xMAP Technology
Reagents
2 - 10
The optical system consists of the optical assembly and the excitation
lasers. The optical assemblies do not require manual adjustment by
the user.
The xMAP technology reagent system consists of classification
calibration microspheres, reporter calibration microspheres,
classification control microspheres, and reporter control
microspheres.
PN 89-00002-00-109 Rev. A
3
Maintenance and Cleaning
To ensure accurate test results, properly clean and maintain the
Luminex 200 system. Read and follow all instructions in this section.
For your convenience, a maintenance log form is included at the end
of this chapter.
It is important to use only xMAP Sheath Fluid or other Luminexapproved sheath fluid. USE OF NON-LUMINEX APPROVED SHEATH
FLUID SHALL CONSTITUTE “IMPROPER USE” AND MAY VOID
WARRANTY RIGHTS PROVIDED BY LUMINEX AND/OR ITS
AUTHORIZED PARTNER.
Warning: When analyzing potentially infectious biological
samples on the Luminex 200 analyzer, follow standard
laboratory safety practices. These safety precautions should also
be taken when cleaning or maintaining the analyzer.
Do not remove the analyzer cover under any circumstances!
Daily Maintenance
Before Running Samples
If the system is powered on, but idle for more than four hours, click
the Maintenance tab. Click Warmup. Wait 30 minutes for the
Luminex 200 analyzer and the optics system to warm up.
‹ Before you run samples:
1. Turn the Luminex 200 analyzer on. The system begins warming
automatically.
2. Verify the levels of sheath fluid and waste fluid.
3. Click Prime to prime the analyzer, then click OK.
PN 89-00002-00-109 Rev. A
3-1
xMAP Technology
Luminex 200 System User Manual
4. Click Alcohol Flush. A confirmation dialog box opens. Click
Eject/Retract to eject the Luminex XYP instrument tray. Place
at least 1.2 mL of 70% isopropanol or 70% ethanol in the
reservoir. Click OK.
5. Click Wash. In the confirmation dialog box, click on the dropdown arrow located to the right of the Eject/Retract button to
choose the desired location. Click Eject/Retract. The Luminex
XYP instrument tray ejects. Place distilled water in the selected
well or reservoir on the plate. Click OK. Perform this step twice.
6. Check that the Luminex XYP instrument sample probe has been
vertically aligned for the plate used in the kit.
Adjust the sample
probe vertical
height
Note: Verify that the microtiter
plate is not warped. Warped
plates can lead to incorrect
probe height adjustment.
Note: Alignment discs can be
placed in any well as long as the
well is designated in the software.
‹ To adjust the sample probe vertical height:
1. Remove the clear plastic shield that covers the sample probe
area.
2. In a 96-well microtiter plate where overall height is no more than
0.75 inches (19 mm), place the appropriate alignment tool in the
plate:
For a standard plate with flat-bottom wells—stack two of the
larger (5.08 mm diameter) alignment discs together and place
them into the selected well.
For a filter bottom plate—stack three of the larger (5.08 mm
diameter) alignment discs together and place them into the
selected well.
For a half-volume plate with flat-bottom wells—stack two of
the smaller (3.35 mm diameter) alignment discs together and
place them into the selected well.
For a round-bottom (U-bottom) plate—stack two of the
smaller (3.35 mm diameter) alignment discs in the selected well.
For a plate with conical wells—place one alignment sphere into
the selected well.
3. Select the Maintenance tab, then click Eject/Retract to eject
the plate holder. Place the 96-well microtiter plate on the
Luminex XYP instrument plate holder with position A1 in the
top left corner.
4. Verify that the correct location is selected in the Luminex IS 2.3
Software, and that you are using the appropriate number of
alignment discs. Click Eject/Retract to retract the plate.
3-2
PN 89-00002-00-109 Rev. A
xMAP Technology
Maintenance and Cleaning
5. Loosen the probe adjustment screw on the probe holder one-third
to one-half turn. Pull it upward until it touches the top of the
adjustment slide. Tighten the thumbscrew.
6. Click Sample Probe Down to lower the sample probe.
7. Gently push the probe down until it just touches the top of the
alignment discs or sphere.
8. Tighten the probe adjustment screw.
9. Click Sample Probe Up to raise the sample probe.
10. Replace the plastic shield that covers the sample probe area.
After Running Samples
‹ After running samples:
1. Sanitize with a 10% to 20% household bleach solution.
2. Run two Wash cycles with distilled water.
3. Soak with distilled water. Wait until the soak completes.
4. If desired, turn off the Luminex 200 analyzer.
Routine Tasks
Sheath and Waste Fluids
Replace the sheath fluid and empty the waste container as required.
Be careful not to touch the seal in the waste bottle cap or allow it to
become wet or dirty. This could cause the bottle to become
pressurized, causing pressure errors in the system. If the seal gets
wet, let it air-dry. Touching the seal can contaminate it. If it gets
dirty, you should replace the waste bottle cap.
If you are using the waste line, do not move it while the system is
running. While you can move the line along a horizontal surface, do
not permanently reroute the waste line elevation without first
contacting Technical Support. You can move the line temporarily for
cleaning and maintenance purposes.
You must manually monitor waste container levels. The Run Batch
tab displays a warning when you need to refill (or replace) the sheath
fluid container. See Figure 3-4.
PN 89-00002-00-109 Rev. A
3-3
xMAP Technology
Luminex 200 System User Manual
Figure 3-4 Refill Sheath Fluid Warning (Circled in Photo)
Refill the Sheath
Fluid Container
‹ To refill the sheath fluid container:
1. Release system pressure by removing the lid from the sheath
fluid container.
2. Refill the sheath fluid container.
If the sheath container ever runs dry, prime the system at least twice
until the air is removed from the system.
Empty the Waste
Container
‹ To empty the waste container:
1. Disconnect the waste container from the Luminex 200 analyzer.
2. Unscrew the waste container lid, being careful not to touch the
Gore-TexTM seal. If the seal becomes wet or soiled, it may impair
venting.
Note: There is NO warning of
a high waste volume. Empty
the waste container each time
you fill the sheath container.
3. Discard the waste from the waste container by appropriate
means.
4. Reconnect the waste container to the Luminex 200 analyzer and
replace the cap.
Any time the sheath container is disconnected from the Luminex
200 analyzer, you must remove air from the sample lines by
priming.
3-4
PN 89-00002-00-109 Rev. A
xMAP Technology
Maintenance and Cleaning
Weekly
Visual Inspection
Run Self-Diagnostics
Open all of the Luminex 200 analyzer doors and visually inspect for
leaks, corrosion, and other signs of improper function. Check all
visible tubing connections. Check the Luminex XYP instrument air
intake filter for buildup of dust. Check the SD system and its
connection for leaks. If you see a leak, turn off the power to the
Luminex SD system and contact Luminex Corporation.
Run Self-Diagnostics on a weekly basis to check system integrity. On
the Maintenance tab, click Self Diag. The system performs selfdiagnostic tests. The results display on the Diagnostics tab. The
lasers shut off during Self-Diagnostics, and must warm up again for
30 minutes after Self-Diagnostics completes.
Clean the Sample Probe
Danger: Be sure that the system is not performing an operation
when you remove the sample probe.
Caution: The Luminex XYP instrument sample probe should slide
up easily while removing it from the sample arm. If you feel
resistance, do not force the probe up. Contact Luminex Technical
Support.
‹ To clean the sample probe:
1. Remove the sample probe as follows: Unsnap the light housing
located above the probe. Then, unscrew the Cheminert fitting on
top of the probe completely. Next, gently grasp the probe and
push up. Remove the probe out of the top of the sample arm.
2. Clean the sample probe using a bath sonicator or using a 10 mL
syringe. If you are using a bath sonicator, place the bottom of the
sample probe in the bath sonicator for 2 to 5 minutes. If you are
using a syringe, force distilled water through the bottom of the
sample probe.
3. Replace the sample probe and adjust the vertical height. You
should adjust the vertical height anytime the probe is removed.
4. Alcohol Flush the system with 70% isopropanol or 70% ethanol.
Flush the System
PN 89-00002-00-109 Rev. A
Run 3 backflushes, 3 drains, 2 alcohol flushes and 3 washes with
distilled water.
3-5
xMAP Technology
Luminex 200 System User Manual
Monthly
Clean Exterior Surfaces
‹ To clean exterior surfaces, follow these steps:
1. Disconnect the system from ac power by turning off the power
switches and unplugging the Luminex 200 analyzer, the Luminex
XYP instrument, and the Luminex SD system.
2. Wipe all exterior surfaces with mild detergent, then a 10% to
20% household bleach solution, and finally with plain distilled
water.
3. Open both doors of the analyzer. Clean all accessible surfaces
with detergent followed by a 10% to 20% household bleach
solution and then plain distilled water.
4. Dry the sheet metal surfaces to prevent corrosion.
5. Plug in and power on the Luminex 200 analyzer, the Luminex
XYP instrument, and the Luminex SD system.
Calibrate the system
You should calibrate the system on a monthly basis as part of
regularly scheduled maintenance. For instructions on calibrating the
system and verifying calibration, see the Luminex online help or the
Luminex IS Software Manual For Version 2.3.
Every Six Months
Luminex 200 Analyzer Air
Intake Filter
Note: Hold on to the tubing!
Do not allow the tubing to fall
inside the the analyzer.
‹ To replace the analyzer air intake filter:
1. Disconnect the Luminex 200 analyzer from ac power by turning
off the power switch on the rear of the analyzer, then unplugging
the power cord from the wall source.
2. On the back of the Luminex 200 analyzer, in the upper left
corner, remove the screw at the top of the panel and open the
panel door.
3. Grasp the tubing and pull the filter 3 to 4 inches from the unit.
See Figure 3-5.
3-6
PN 89-00002-00-109 Rev. A
xMAP Technology
Maintenance and Cleaning
Figure 3-5 Grasping the Tubing
4. Remove the filter with one hand, and hold the tubing with the
other hand.
5. Connect a new filter to the tubing and position the filter inside
the panel.
6. Reattach the panel door to the unit.
7. Plug in and power on the Luminex 200 analyzer.
Luminex XYP Instrument
Air Intake Filter
‹ To replace the XYP instrument air intake filter:
1. Disconnect the Luminex XYP instrument from ac power by
turning off the power switch on the rear of the Luminex XYP
instrument, then unplugging the Luminex XYP instrument power
cord from the wall source.
2. On the back of the Luminex XYP instrument, to the left side,
gently remove the screen from the Luminex XYP instrument
filter. Do not remove the screws. See Figure 3-6.
PN 89-00002-00-109 Rev. A
3-7
Luminex 200 System User Manual
xMAP Technology
Figure 3-6 Removing the Screen
3. Replace the filter and replace the screen. See Figure 3-7.
Figure 3-7 Removing and Replacing the Filter
4. Plug in and turn on Luminex XYP instrument power.
3-8
PN 89-00002-00-109 Rev. A
xMAP Technology
Syringe Seal
Maintenance and Cleaning
‹ To replace the syringe plunger seal:
Danger: The syringe arm does not deactivate when changing the
plunger; injury could result if the system is not unplugged.
1. Disconnect the Luminex 200 analyzer from ac power by turning
off the power switch on the rear of the analyzer, then unplugging
the power cord from the wall source.
2. Open the center-most door on the front of the Luminex 200
analyzer.
3. Locate the syringe (a glass cylinder with a metal rod). See
Figure 3-8.
1
2
1. Syringe Seal
2. Syringe
Figure 3-8 Syringe and Syringe Seal
4. Unscrew the knob on the syringe arm (at the bottom of the
syringe), and forcefully push the syringe arm down.
5. Unscrew the syringe from the top of its housing.
6. Pull the plunger out of the syringe.
7. Remove and replace the plunger seal and the black “O” ring.
8. Return the plunger to the syringe.
9. Screw the syringe back into its housing.
10. Return the syringe arm to its original position.
PN 89-00002-00-109 Rev. A
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xMAP Technology
Luminex 200 System User Manual
11. Hand-tighten the screw on the syringe arm.
12. Plug in the power cord and turn the Luminex 200 analyzer power
on.
13. Prime the system twice, watching for any leaks in the syringe
area.
14. When the prime finishes, close the center door.
Luminex 200 Analyzer
Ventilation Filter
‹ To clean the Luminex 200 analyzer ventilation filter:
1. Disconnect the Luminex 200 analyzer from ac power by turning
off the power switch on the rear of the analyzer, then unplug the
analyzer power cord from the wall source.
2. While facing the Luminex 200 analyzer, place your index finger
up under the right side of the analyzer (in the space between the
Luminex 200 analyzer and the Luminex XYP instrument). When
you feel the filter, push the filter toward the left of the analyzer.
See Figure 3-9.
3. Remove the filter from the left side of the Luminex 200 analyzer.
Figure 3-9 Luminex 200 Analyzer Ventilation Filter
4. Clean the filter with a vacuum or with distilled water. Stand the
filter upright to air dry.
5. Re-install it with the arrows facing up. The filter should click
into place.
6. Plug in and turn on the Luminex 200 analyzer power.
3 - 10
PN 89-00002-00-109 Rev. A
xMAP Technology
Maintenance and Cleaning
Annually
Sheath Filter
‹ To change the Luminex 200 analyzer sheath filter:
1. Disconnect the Luminex 200 analyzer from ac power by turning
off the power switch on the rear of the analyzer, then unplugging
the analyzer power cord from the wall source.
2. Disconnect the sheath fluid tubing before changing the filter.
3. Open the left door on the Luminex 200 analyzer. Disconnect the
filter by pushing down on the metal clamps on each connection.
See Figure 3-10.
Figure 3-10 Sheath Filter
4. Connect the new sheath filter, matching up the color-coded
fittings. The arrow on the sheath filter should be pointing up.
5. Reconnect the sheath fluid tubing.
6. Plug in and power on the Luminex 200 analyzer.
7. Close the left analyzer door.
8. Prime twice.
PN 89-00002-00-109 Rev. A
3 - 11
xMAP Technology
Luminex 200 System User Manual
As required
Fuses
Danger: To avoid serious injury or death by electric shock,
you must turn off the system and unplug it from the wall
outlet.
‹ To replace the fuses in either the Luminex 200 analyzer or the
Luminex XYP instrument:
1. Turn off the power switch on the rear of the analyzer or
instrument, then unplug the instrument power cord from the wall
source. Remove the power cord from the analyzer or instrument.
2. With a small, flathead screwdriver, open the module door on the
lower left corner of the back of the analyzer or instrument. See
Figure 3-11.
Figure 3-11 Opening the Module Door
3. Remove the red cartridge (use a flathead screwdriver).
4. Check both fuses for damage.
5. Replace damaged fuses with the type specified on the sticker to
the right of the power input module.
6. Replace the module door.
7. Plug in and power on the analyzer or instrument.
3 - 12
PN 89-00002-00-109 Rev. A
xMAP Technology
Replacing the SD System
with a Sheath Bottle
Maintenance and Cleaning
1. Turn off the SD and disconnect the tubing from the Luminex 200
analyzer.
2. Turn the black regulator screw inside the center door of the
Luminex 200 one full turn counter-clockwise.
3. Attach the sheath bottle. Make sure there is sheath fluid in the
bottle (to the fill line) and the cap is tightened.
4. Prime the system.
5. As the system is priming, adjust the black regulator screw inside
the center door of the Luminex 200. Turn clockwise to increase
or counterclockwise to decrease, until the sheath pressure value
is within +/- 0.1 psi of the normal level of your instrument.
Visually monitor the pressure gauge on the Run Batch tab. Make
sure pressure is centered within the green tolerance range.
6. When the prime function is complete, loosen the sheath bottle
cap to release pressure.
7. Tighten sheath cap and prime the system once again.
8. Make sure that the sheath and air pressure values increase to the
normal level once again.
Storing the System
This procedure explains the steps you should take before placing the
system into long-term storage.
‹ Before storing the system:
1. Run a sanitize with 10% to 20% household bleach solution.
2. Run a sanitize with distilled water.
3. Run four washes with distilled water.
4. Remove the sample probe from the instrument, flush with
distilled water from the narrow end out through the larger end,
replace it in the sample arm, and wrap the end with Parafilm.
Taking the System out of
Storage
Follow this procedure before you begin using the system after it has
been stored long-term.
‹ Before using the system:
1. Turn on the Luminex 200 and XY Platform and watch for the
following indications that the instruments are responding
correctly:
PN 89-00002-00-109 Rev. A
3 - 13
xMAP Technology
Maintenance and Cleaning
• The light above the sample probe on the Luminex 200 and the
light next to the door of the XY platform are lit
• The compressor starts in the Luminex 200. It is a low
rumbling sound.
• Place your hand behind the Luminex 200 to feel air coming
out of the rear fan.
• Observe movement of the syringe inside the front middle door
of the Luminex 200 shortly after the instrument is powered on.
2. Turn on the PC and start up the IS software.
3. Complete a Warmup command, which will take 30 minutes.
4. Remove the Parafilm from the end of the sample probe.
5. After Warmup is complete, run three Backflush commands, three
Drain commands, two Alcohol Flush commands, and three
Washes with distilled water. Make sure that the sheath bottle or
Luminex SD has a sufficient amount of sheath fluid and that the
waste container is empty. Verify that the pressure during each of
the maintenance commands reads between 6 and 9 psi in the
System Monitor.
PN 89-00002-00-109 Rev. A
3 - 14
Luminex 200 Maintenance Log
Month(s): ________________________________________Year:_______________
Maintenance Log
Procedure: Use this form to record information over a four-week period. Fill in the month(s) and year above. Fill in the dates in the first line of the table. For each item listed at the left, enter
your initials under each date that you perform the item.
Note: Follow your standard laboratory safety practices when cleaning or maintaining the system. Do not remove the instrument cover under any circumstances.
Dates
Daily maintenance
Startup
Initials: (for each item listed at the left, fill in your initials under each date that you perform the item)
Laser warmup
Check sheath fluid
Check waste level
Tighten sheath cap
Alcohol Flush (70% isopropanol or 70%
ethanol)
Wash twice with distilled water
Shut down
Initials: (for each item listed at the left, fill in your initials under each date that you perform the item)
Sanitize (10% to 20% household
bleach solution)
Wash twice (distilled water)
Soak (distilled water)
Loosen sheath cap
Turn system off (optional)
Weekly
Visual inspection
Date/Initials:
Date/Initials:
Date/Initials:
Date/Initials:
Monthly
Clean sample probe
Date/Initials:
Wipe exterior surfaces
Date/Initials:
Calibrate and verify
Date/Initials:
Every six months
Replace air intake filter,
analyzer
Date/Initials:
Replace air intake filter, XYP
Date/Initials:
Replace syringe plunger seal, or
syringe
Date/Initials:
Check analyzer ventilation filter
Date/Initials:
Yearly
Replace sheath filter
Date/Initials:
As required
Replace fuses
Date/Initials:
Comments:
PN 89-00002-00-109 Rev. A
4
Troubleshooting
Troubleshooting the
Luminex 200
System
Troubleshooting procedures help users isolate, identify, and remedy
problems with the Luminex 200 analyzer and Luminex XYP. This
chapter does not troubleshoot problems with the PC. For help with
PC problems, please call Dell Technical Support at 800-624-9896.
To troubleshoot a problem, select a general symptom. Next, identify
the possible problem and remedy it with one of the solutions listed.
This chapter supplies information for the following topics:
•
•
•
•
•
•
•
•
•
•
•
Power Supply Problems
Communication
Pressurization
Fluid Leaks
Sample Probe
Calibration Problems
Acquisition Problems
Bead Detail Irregularities
Error Messages
Printing Errors
Verification
You can find answers to frequently asked questions (FAQs) on our
website: http://luminexcorp.custhelp.com.
Luminex Technical Support is available to users in the U.S. and
Canada by calling 1-877-785-BEAD (-2323) between 7:00 a.m. and
7:00 p.m. Central Time, Monday through Friday. Users outside of the
U.S., Canada and Europe can call us at +1-512-381-4397 between
7:00 a.m. and 7:00 p.m. Central Time, Monday through Friday.
Inquiries may also be sent by email to [email protected]
PN 89-00002-00-109 Rev. A
4-1
xMAP Technology
Luminex 200 System User Manual
Users in Europe can call us at +31-162408333 between 8:30 and
5:30, Central European Time, Monday through Friday. Email
inquiries in Europe can be sent to [email protected]
Power Supply
Problems
Power supply problems often involve a blown fuse, faulty electronic
component, or even something as simple as a disconnected cable.
Use extreme care when you replace a fuse.
Symptom
Analyzer will not turn on, or
XYP will not turn on.
Fuses continue to open (blow).
Communication
Possible problem
Solution
The power cord is disconnected.
Verify that the power cord is
plugged in.
No voltage is coming from the
electrical outlet.
Verify that the electrical outlet is
operational.
The power supply is faulty.
Contact Technical Support.
A fuse has burned out.
See page 3-12 for instructions
on changing fuses.
A component has a short circuit.
Contact Technical Support.
Communication problems described in this section involve the links
between the data system (PC and IS 2.3 software) and the Luminex
200 analyzer and XYP instrument. This section does not address
communication issues with other peripheral devices.
The term “Communication” refers to:
•
•
•
•
Symptom
PC cannot initialize
communication with analyzer.
4-2
The transfer of data between the PC and the analyzer.
The current status of the analyzer and XYP instrument.
Instrument readbacks.
Instrument control, sample acquisition, session uploading, and
start, stop and pause features.
Possible problem
Solution
The communication cable is
unplugged, or plugged into the
wrong port.
Check the communications
cable connections.
The XYP or the analyzer power
is not turned on.
Turn off the PC and then turn on
the analyzer, XYP, and then the
PC.
PN 89-00002-00-109 Rev. A
xMAP Technology
Pressurization
Symptom
Pressurization fails or
pressure is too low.
Pressure too high.
PN 89-00002-00-109 Rev. A
Troubleshooting
Normal air and sheath pressure readings vary between 6-9 psi while
the compressor runs. If the system pressure is out of range, your
sample acquisition will fail or return poor results.
Possible problem
Solution
The sheath and waste lines are
not fully connected.
Make sure the lines between the
sheath and waste bottles and the
analyzer are fully connected.
The sheath or waste bottle
fittings are cracked.
Inspect the fittings to be sure
they form a tight seal.
There is a leak in the system.
Check for system leaks. A leak
will be obvious if there is fluid
on the surface on which the
system sits.
The compressor does not
engage.
Run a Prime command. If you
do not hear the compressor turn
on, contact Technical Support.
The Cheminert fitting is loose.
Ensure that the fitting connects
tightly above the sample probe,
below the blue light.
Fluid leaks in the system.
See Fluid Leak on page 4-4.
The sheath bottle has an air
leak.
Disconnect the sheath and waste
bottle connections from the
analyzer. Run a Prime
command. If pressure builds,
remove and retighten the sheath
fluid bottle cap, then reconnect
fluid lines to the analyzer. If
pressurization fails again,
replace the sheath bottle.
The sheath bottle is overfilled.
Ensure that the sheath bottle is
not filled above the fill line.
The Sheath Delivery System is
overfilled.
Drain the SD reservoir and refill
it. See page 4-17.
Regulator not adjusted properly.
If using bottles, open the center
door on the Luminex analyzer.
Use a screwdriver to adjust the
regulator to fit in the center of
the green region on the Run
Batch tab.
4-3
xMAP Technology
Luminex 200 System User Manual
Fluid Leaks
Symptom
Pressure too low.
Fluid leaks can result in poor pressurization and failed sample
acquisition.
Possible problem
Solution
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
The syringe seal leaks.
Replace the syringe seal. See
page 3-9.
The syringe valve leaks.
Hand-tighten the syringe
connection (silver knob) on the
syringe valve. Run a Prime
command. If leaks continue,
contact Technical Support.
Large amount of fluid pooled
around instrument.
Fittings or fluid lines are
damaged.
Contact Technical Support.
Fluid dripping from the
sample probe.
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
The sample three-way valve is
faulty.
Contact Technical Support.
The syringe seal leaks.
Replace the syringe seal. See
page 3-9.
The syringe valve leaks.
Hand-tighten the syringe
connection (silver knob) on the
syringe valve. Run a Prime. If
leaks continue, contact
Technical Support.
Fluid is leaking from the front
of the analyzer.
Sample Probe
Symptom
Problems with the sample probe can lead to fluid leaks and
pressurization problems, as well as inhibit sample acquisition.
Possible problem
Solution
Sample probe leak.
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
Sample arm is stuck in the up
position
The system isn’t properly
pressurized.
Check pressure settings. Ensure
that the sample probe is not
clogged and there are no leaks
in the syringe seal or syringe
valve.
4-4
PN 89-00002-00-109 Rev. A
xMAP Technology
Sample arm is stuck in the
down position
Troubleshooting
The sample probe height is too
low, or the path to the well is
blocked.
DO NOT turn off the Luminex
XYP instrument.
1. Remove the blue light
housing from the analyzer.
2. Unscrew the Cheminert
fitting. The system monitor
changes from “Busy” to
“Running” and sample
acquisition continues. Click
Cancel to make adjustments
before continuing with the
rest of the samples.
3. If the sample arm does not
raise, save the data that has
been collected. Turn off the
analyzer, but keep the XYP
instrument on.
4. Exit the Luminex IS
Software.
5. Turn the analyzer back on
and restart the software.
6. Run a Wash with distilled
water to remove air from
the system.
7. Verify probe height.
Sample arm does not go down
smoothly.
PN 89-00002-00-109 Rev. A
The 96-well plate is incorrectly
seated in the XYP instrument.
Adjust the 96-well plate.
The 96-well plate is warped.
Inspect the 96-well plate.
Replace it if it is warped.
The sample arm is misaligned.
Readjust the sample arm
horizontal alignment.
The sample probe is bent.
Remove the sample probe from
the Luminex 200 analyzer. Roll
it on a flat surface. If it does not
roll smoothly, replace it with a
new sample probe. Adjust the
sample probe height (see
page 3-2).
4-5
xMAP Technology
Luminex 200 System User Manual
Calibration and
Control Problems
Symptom
Calibration is slow or fails.
4-6
Possible problem
Solution
The calibration microspheres
are not fully suspended.
Vortex the calibration vials to
resuspend the microspheres.
Wrong lot number or target
values are entered in Update
CAL Targets dialog box.
Verify that correct lot number
and target values are used.
The system calibrators are in the
wrong well on the plate.
Verify that calibrators are in the
correct well.
Not enough calibrator
microspheres added to the well.
Add at least five drops of
calibrator microspheres to the
well. Hold the vial upside down
at a 90 degree angle to the plate
while dispensing them.
Calibrator lot is expired.
Use a fresh bottle of calibrator
microspheres.
The sample probe height is
incorrect.
Adjust the sample probe height.
See page 3-2.
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
There is a partial clog in the
system.
Clean the sample probe, then
flush the system. See page 3-5.
There is air in the system.
Verify sample probe height. Run
three Prime commands, two
Alcohol Flush commands, then
three Washes with water.
The waste container is not
vented.
Check that the seal in the waste
container cap is dry and that the
waste container cap is vented.
The waste line was moved
during system operation,
resulting in unstable flow rate.
Verify that the waste line is not
moved during system operation.
Possible problem with the laser.
View the calibration trend
report. Check for dramatic
changes in temperature, sheath
pressure, or voltages. If any of
these are evident on the report,
contact Technical Support.
PN 89-00002-00-109 Rev. A
xMAP Technology
Zero events collected during
calibration.
Analyzer fails Controls.
PN 89-00002-00-109 Rev. A
Troubleshooting
There is a problem with fluid
levels.
Check the sheath and waste
fluid levels. Verify that tubing
for both bottles is tightly
connected to the instrument.
Check that the waste bottle cap
is vented.
Laser-related issue.
Verify fluid is moving through
the system by performing a
Wash, which causes fluid to go
out to waste. If no fluid is going
to waste, clean the sample
probe, then flush the system
(see page 3-5). If the issue does
not resolve, contact Technical
Support.
The waste container is not
vented.
Check that the seal in the waste
container cap is dry and that the
waste container cap is vented.
The Cheminert fitting is loose.
Make sure that the Cheminert
fitting is tightened.
The control microspheres are
not fully suspended.
Vortex the control vials to
resuspend the microspheres.
Wrong control lot number or
target values are entered in
Update CON Targets box.
Verify that the correct lot
number and target values are
used.
The system controls are in the
wrong well on the plate.
Verify that control microspheres
are in the correct well.
Not enough control
microspheres added to the well.
Add at least five drops of control
microspheres to the well. For
accurate drop volume, hold the
vial upside down at a 90 degree
angle to the plate while
dispensing them.
Control lot is expired.
Use a fresh bottle of control
microspheres.
Control microspheres have been
diluted.
Do not dilute the control
microspheres.
The sample probe height is
incorrect.
Adjust the sample probe height.
See page 3-2.
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
4-7
xMAP Technology
Luminex 200 System User Manual
There is air in the system.
Verify sample probe height. Run
three Prime commands, two
Alcohol Flush commands, then
three Washes with water
The waste container is not
properly vented.
Verify that the waste container is
properly vented and that the seal
is not wet or soiled.
The waste line was moved
during system operation,
resulting in unstable flow rate.
Verify that the waste line is not
moved during system operation.
Possible problem with the
lasers.
Check the system control trend
report for consistent failures. If
any are evident on the report,
contact Technical Support.
Acquisition
Problems
Symptom
Acquisition fails or slows.
Slow or unsuccessful sample
acquisition.
4-8
Possible problem
Solution
The air pressure is out of range.
See Pressurization on page 4-3.
The sample probe height is
incorrect.
Adjust the sample probe height.
See page 3-2.
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
The sheath bottle has a leaky
seal.
Make sure that the sheath bottle
lid is tightened. Remove and
replace the sheath bottle lid.
The sheath or waste lines are
not fully connected.
Disconnect and reconnect the
lines; you should hear them
click.
The calibration microspheres
have expired.
Replace old microspheres with a
fresh lot.
The wrong wells are selected for
the calibration microspheres.
Ensure that the correct wells are
selected in the Maintenance tab.
The calibration lot number or
target values selected in setup is
incorrect.
Enter the correct calibration lot
number and target values in the
Update CAL Targets box.
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
PN 89-00002-00-109 Rev. A
xMAP Technology
Bead Detail
Irregularities
Troubleshooting
The air pressure is out of range.
See Pressurization on page 4-3.
The sample probe is not
vertically aligned.
Adjust the sample probe height.
See page 3-2.
Air is present in the system.
Verify sample probe height. Run
three Prime commands, two
Alcohol Flush commands, then
three Washes with water
The acquisition volume is set
too high.
Set the acquisition volume to at
least 25 µL less than the actual
volume in your wells. This
setting lets the analyzer acquire
sample more efficiently with
less chance of acquiring air.
The xMAP microspheres are not
fully suspended.
Gently vortex the plate or
resuspend beads with a
multichannel pipettor to ensure
that the microspheres are
present in the solution.
You are using photobleached
microspheres.
Replace the microspheres with a
fresh batch.
There is an insufficient number
of beads in the sample.
Ensure that there are 2000-5000
beads per beadset per well.
The sample is too concentrated.
Dilute concentrated biological
fluids, such as serum or plasma,
at least 1:5.
Use these tools to assist in diagnosing system and kit-related
problems:
•
•
•
•
•
system calibrators
system controls
assay standards
assay controls
error messages
Review calibration/control trend reports routinely to detect trends.
Use system xMAP control microspheres to check the success of the
system calibration and for troubleshooting purposes. If there is a
problem with your kit results, xMAP controls can help determine if
the problem is analyzer related. If Calibration and Controls are
successful, contact the kit manufacturer.
PN 89-00002-00-109 Rev. A
4-9
xMAP Technology
Luminex 200 System User Manual
A normal bead detail display is shown below. It depicts a tight bead
population within a white region.
Figure 4-1 Normal Bead Detail
The histogram for the bead detail above looks like this:
Figure 4-2 Normal Histogram
Symptom
xMAP microspheres classify
too high.
4 - 10
Possible problem
You may be using
photobleached calibration
microspheres.
Solution
Replace the calibration
microspheres with a fresh batch.
To avoid photobleaching,
protect your microspheres from
light.
PN 89-00002-00-109 Rev. A
xMAP Technology
Troubleshooting
xMAP microspheres hit the
lower right of the region.
You may be using
photobleached xMAP
microspheres.
Replace microspheres with a
fresh batch. To avoid
photobleaching, protect your
microspheres from light.
Beads appear scattered.
There is air in the system.
Verify sample probe height. Run
three Prime commands, two
Alcohol Flush commands, and
then three washes with distilled
water.
The sheath fluid is empty.
Make sure there is sheath fluid
in the sheath container. Prime
the system until all air is out of
the system.
The xMAP microspheres have
agglutinated.
Add additional detergent to the
assay buffer. For example, add
.02% to 0.1% Tween-20,
Triton® X100, or SDS.
The solvent is incompatible.
View a list of incompatible
solvents at the Luminex
Technical Support website http://luminexcorp.custhelp.com.
If the solvent you are using is
listed, switch solvents.
You are using incompatible
sheath fluid.
Use only Luminex sheath fluid
in the Luminex 200 analyzer.
Other fluids may damage your
analyzer and may void your
warranty.
Microspheres appear as a long
diagonal line.
PN 89-00002-00-109 Rev. A
4 - 11
xMAP Technology
Luminex 200 System User Manual
Error States
Error Message
Disconnected
The following error states display on the Status Bar on the Run Batch
tab when an error occurs during system operation.
Possible problem
Solution
The software has not made
initial connection.
On the toolbar, click Connect;
wait for the status to change.
The communication cables are
not connected.
Remove and reconnect the cable
connections.
Close the software application
and reopen it.
Close the software application,
then turn off the Luminex
system. Power on the system
and check the status.
Refill Sheath
Sheath fluid is low.
Refill the sheath container, then
click Resume.
Running: Sheath Empty
Sheath fluid is empty.
Replace or fill the sheath fluid
container with sheath fluid. Run
two Prime commands.
System Error
Messages
There are two types of error messages: system error messages, and
sample error messages.
System error messages are displayed in three places:
• the Message Log on the Diagnostics Tab
• the message log located in the Windows message log folder
• the Errors tab on the Analysis window
Error Message
Possible problem
Solution
Unknown Diagnostic Error
Unknown/varied
Record the error code number
and message. Contact Luminex
Technical Support.
XYP Instrument Heater
Stability Range Exceeded
The heater block temperature is
not hitting the target value.
Verify the heater temperature is
set correctly in the software.
4 - 12
PN 89-00002-00-109 Rev. A
xMAP Technology
Troubleshooting
Low Voltage Detected
Possible laser failure.
Turn off the analyzer, XYP, and
PC, then turn them back on.
Make sure system is completely
warmed up. Calibrate and verify
the system. If the error message
occurs again, contact Luminex
Technical Support.
Runtime Sheath Pressure out
of Limits (Too High)
The sheath fluid pressure is too
high.
Ensure that the sheath fluid
container is at the same level as
the analyzer. On systems with a
Luminex Sheath Delivery
system, ensure that the sheath
fluid pressure reading is equal to
the original reading. If it is not,
contact Technical Support for
instructions to adjust the
regulator. Calibrate and verify
the system.
Runtime Sheath Pressure Out
of Limits (Too Low)
There is a pressurization
problem with the sheath fluid.
See Pressurization on page 4-3.
Low Laser Power Detected
The system is not sufficiently
warmed up.
Warm up the system. This takes
approximately 30 minutes.
Calibrate and verify the system.
Possible Laser Failure
Open the calibration trend
report for CAL2 and record the
last three reporter voltages.
Contact Luminex Technical
Support with this information.
Command Encountered Time
Out Error
The current command failed.
Check the system to verify that
it is warmed up and that there
are no pressurization problems.
Repeat the command. If the
command continues to time out,
contact Technical Support.
Instrument Not Calibrated
The instrument is out of
calibration.
Calibrate the instrument.
PN 89-00002-00-109 Rev. A
4 - 13
xMAP Technology
Luminex 200 System User Manual
Sample Error
Messages
Message
Sample error messages occur when there is a problem with sample
acquisition. These errors can display on the Diagnostics tab in the
Message Log, in Reports, or on the Errors tab in a batch analysis.
Possible problem
Solution
Insufficient Bead Count
There are not enough beads seen
to meet the minimum requested.
Ensure there are 2000-5000
beads per set per well.
Ensure proper beads are
selected.
Adjust sample probe height. See
page 3-2.
Resuspend beads in the wells.
Check for clogs.
Temperature Divergence from
Calibration Temperature
You are running the system at
an ambient temperature that is
out of range of the temperature
at which the system was initially
calibrated.
Calibrate and verify the system.
If this message still appears
after calibration, contact
Technical Support.
Failed Control in Batch
One or more of the assay
controls are not within the
expected range.
Verify that you selected the
correct template.
Verify that the correct assay lot
number and concentration
values were selected and entered
correctly.
Verify that the system is
functioning properly by running
system calibration and controls.
If the system controls pass,
contact the kit manufacturer.
Failed Curve Fit
The calculation could not occur
for the assay standards for data
interpretation.
Verify that you selected the
correct template.
Verify that the correct control
lot number and target values
were selected and entered
correctly.
Verify that the system is
functioning properly by running
system calibration and controls.
If the system controls pass,
contact the kit manufacturer.
4 - 14
PN 89-00002-00-109 Rev. A
xMAP Technology
Sample High or Low
Troubleshooting
The results do not fall within the
highest and lowest standards.
Verify that you selected the
correct template.
The wrong control lot number
or target values are selected.
Verify that the correct control
lot number and target values
were selected and entered
correctly.
Verify that the system is
functioning properly by running
system calibrators and controls.
If the sample is noted as High,
dilute the sample following the
kit manufacturer’s suggestions.
If the sample is noted as Low,
vortex the sample to ensure
homogeneity.
Sample Timed Out
The samples are concentrated.
Verify that the samples are
properly mixed.
Not enough sample loaded into
the well.
Verify that you loaded the
correct sample volume to the
well.
The sample probe is clogged.
Clean the sample probe. See
page 3-5.
Sample probe height is
incorrect.
Adjust the sample probe height.
See page 3-2.
There is a clog in the sample
line.
Clean the sample probe, then
flush the system. See page 3-5.
Verify that the delta cal
temperature is within ± 3.0. If
the system is not within these
limits, recalibrate, then run the
sample again.
Sample Empty Detected
The system completely acquired
the entire sample volume.
Verify that you properly mixed
the samples before dispensing
into the wells.
There is no sample in the
designated well.
Verify that you loaded the
sample to the correct well on the
plate.
Verify that the sample volume
added to the well is correct.
The probe is clogged.
PN 89-00002-00-109 Rev. A
Clean the sample probe. See
page 3-5.
4 - 15
xMAP Technology
Luminex 200 System User Manual
Cannot calculate inverse
function
Luminex SD
Problems
Filter
4 - 16
The sample probe is not
properly aligned.
Align the sample probe. See
page 3-2.
There is a clog in the fluid line.
Clean the sample probe, then
flush the system. See page 3-5.
Delta Cal temp out of range.
Verify that the delta cal
temperature is within ± 3.0
degrees. Recalibrate if outside
these limits and run the sample
again.
There is a problem with the kit.
Verify that the system is
functioning properly by running
system calibration and controls.
If they pass, contact the kit
manufacturer.
This error message encompasses a range of mathematical errors
often indicating the sample result was negative or invalid. This is
according to the parameters defined by the formula used to analyze
the sample results. Standards, assay controls, and unknowns may be
flagged with Unknown Formula Failure. A standard curve is plotted
using the MFI and expected concentration value. An Unknown
Formula Failure message may occur when the system is unable to
calculate a standard concentration from the standard curve.
You are using the wrong
template.
Verify that you are using the
correct template. Consult the
online help.
You are using incorrect lot
information.
Verify that you have entered the
correct lot information.
There is a problem with the kit.
Run system calibration and
controls. If they pass, contact
the kit manufacturer.
If the empty sheath fluid container is not replaced and the system
continues to operate, the Luminex SD system eventually vents
pressure to prevent air from being introduced into the Luminex 200
analyzer. This may interrupt a sample and prevent further samples
from being collected.
If the filter attached to the sheath intake line becomes clogged from
extended use, an alarm will sound even though the bulk sheath
container is not empty. If this happens, replace the filter, part number
CN-0037-01.
PN 89-00002-00-109 Rev. A
xMAP Technology
Malfunction
Draining the Reservoir
Troubleshooting
If the alarm sounds even though the bulk sheath container has fluid
and the sheath filter is in good condition, the system is reporting a
malfunction. If this happens, contact Luminex Technical Support.
If you need to ship the Luminex SD system back to Luminex
Corporation, drain the reservoir before you pack the system.
1. In the IS 2.3 software, click Prime or Warmup to pressurize the
system.
2. Leave the green air tubing connected between the Luminex 200
analyzer and the SD system.
3. On the SD front panel, disconnect the blue tubing from the
intake labeled Sheath Out and disconnect the white tubing from
the intake labeled Sheath In.
4. Insert the white tubing into the intake labeled Sheath Out and
insert the blue tubing into the intake labeled Sheath In.
5. Turn the unit off and then on again.
6. Press the Prime button on the front panel of the SD system.
7. Sheath fluid will pump from the Sheath Delivery System
reservoir into the 20L Sheath Box.
To refill the Sheath Delivery System, reconnect the tubing according
to color coding and press the Prime button on the SD.
Contact Technical Support for additional information.
PN 89-00002-00-109 Rev. A
4 - 17
Luminex 200 System User Manual
4 - 18
xMAP Technology
PN 89-00002-00-109 Rev. A
5
Product Numbers
Hardware
Note: These part
numbers are subject to
change without notice.
Note: Common
description of product is
enclosed in brackets.
PN 89-00002-00-109 Rev. A
Product Description
Customer
Number
Rear Air Filter
CN-0001-01
Bottom Air Filter
CN-0002-01
Air Filter, Intake
CN-0027-01
Alignment guide, XYP instrument
CN-0016-01
Bar Code Scanner
CN-PC03-01
Serial Cable, 5 feet
CN-0005-01
PC, Luminex 100 IS
CN-PC04-01
2 Amp, 250 Volts, Fast Acting Fuse (Qty 10)
CN-0019-01
3 Amp, 250 Volts, Fast Acting Fuse
CN-0051-01
Heater Block, XYP
CN-0017-01
Wrench, Hexdrive, Ball Driver
3/32”
CN-0025-01
Luminex 100 IS, Version 2.3 [complete
system]
CN-L005-01
Luminex 100 IS, Version 2.3 [complete
system] with laptop
CN-L007-01
5-1
xMAP Technology
Luminex 200 System User Manual
5-2
Luminex 100 IS Documentation Version 2.3
(Manuals on CD)
Luminex 100 IS User Manual, Version 2.3
(North American)
Luminex 100 IS User Manual, Version 2.3
(International English)
Luminex 100 IS User Manual, Version 2.3
(Danish)
Luminex 100 IS User Manual, Version 2.3
(French)
Luminex 100 IS User Manual, Version 2.3
(German)
Luminex 100 IS User Manual, Version 2.3
(Greek)
Luminex 100 IS User Manual, Version 2.3
(Italian)
Luminex 100 IS User Manual, Version 2.3
(Spanish)
CN-M032-01
Luminex 100 IS Developer Guide to xMAP
Technology Version 2.3
CN-M029-01
Power Cord, USA
Power Cord, Australia
Power Cord, Brazil
Power Cord, Denmark
Power Cord, Germany, Sweden, France,
Belgium, and Spain
Power Cord, Switzerland
Power Cord, Israel
Power Cord, UK
Power Cord, Italy
Power Cord, Japan
Power Cord, China
CN-P001-01
CN-P002-01
CN-P003-01
CN-P004-01
CN-P005-01
Reservoir, XYP
CN-0022-01
Sample Needle Height Alignment Kit
[Sample Probe Alignment Kit]
CN-0015-01
Short Sample Needle
CN-0006-01
Long Sample Needle
CN-0007-01
Sample Holder, Large, 1.5 mL
CN-0008-01
Sample Holder, Small, 1.2 mL
CN-0009-01
Sheath Filter with Quick Disconnect
CN-0010-01
Sheath Bottle
CN-0011-01
Syringe Cylinder with Seal
CN-0013-01
CN-M017-01
CN-M018-01
CN-M031-01
CN-M019-01
CN-M020-01
CN-M030-01
CN-M022-01
CN-M021-01
CN-P006-01
CN-P007-01
CN-P008-01
CN-P009-01
CN-P010-01
CN-P012-01
PN 89-00002-00-109 Rev. A
xMAP Technology
Product Numbers
Syringe Seal (Qty 4)
CN-0014-01
Cable, USB
CN-0018-01
Waste Bottle
CN-0012-01
Luminex SD [Luminex Sheath
Delivery System]
CN-S001-01
Product Description
Customer
Number
Luminex 100 IS Version 2.3 [Software CD]
CN-SW08-01
Product Description
Customer
Number
Microspheres, LX100, CL1 CL2 Calibration
(xMAP Classification Calibrator)
L100-CAL1
Microspheres, LX100, RP1 Calibration
(xMAP Reporter Calibrator)
L100-CAL2
Microspheres, LX100, CL1 CL2 Control
(xMAP Classification Control)
L100-CON1
Microspheres, LX100, RP1 Control (xMAP
Reporter Control)
L100-CON2
xMAP Sheath Fluid, LX100
40-50000
Product Description
Customer
Number
Basic Training Course
CN-0070-01
Software
xMAP Reagents
Training
PN 89-00002-00-109 Rev. A
5-3
Luminex 200 System User Manual
5-4
xMAP Technology
PN 89-00002-00-109 Rev. A
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