Luminex 100E User Manual

Luminex 100E
User Manual
© LUMINEX® CORPORATION, 2004. All rights reserved. No part of this publication may be r eproduced, 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
U.S.A.
V oice: (512) 219-8020
Fax: (512) 219-5195
Luminex 100ETM User Manual
CN-M028-01
PN 89-00002-00-013 Rev. D
July 2004
Luminex Corporation (Luminex) reserves the right to modify its product s 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 HTS, Luminex 100, Luminex 100 IS, LabMAP, xMAP, LumAvidin, Luminex SD, Luminex XYP, Luminex FlexMAP. All other trademarks, including Windows,
Cheminert, Pentium, and Dell The contents of this manual and the associated Luminex software are the proper ty of L uminex and are
copyrighted. Except as specified in the End User License Agreement, any reproduction in whole or in part is strictly prohibited.
are trademarks of their respective companies.
Contents
Introduction 1-1
Safety 2-1
Instrument Components 3-1
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Safety Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Laser, Luminex 100E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Biological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Decontamination of the Luminex 100E for Return Shipment . . . .2-6
Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
xMAP Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Laboratory Reagents Required . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 -2
Other Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Luminex Real-time (LXR) Library. . . . . . . . . . . . . . . . . . . . . . . . .3-3
Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
General, Luminex 100E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
User-Accessible Components. . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Power Input Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
P1 Communications Port (DB9-PIN). . . . . . . . . . . . . . . . .3-7
P2 Synchronization Port (DB15-PIN) . . . . . . . . . . . . . . . .3-8
Air Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
Regulated Flow Sheath Supply . . . . . . . . . . . . . . . . . . . .3-10
Sample Input Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
Optical. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
Installing the Luminex 100E into the Host System. . . . . . . . . . . .3-12
PN 89-00002-00-013 Rev. D i
Luminex® 100E™ User Manual Version 1.0 xMAP Technology
Maintenance and Cleaning 4-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Before Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
After Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Instrument Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Calibrate the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Semi-Annually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Remove or Replace the Syringe Seal. . . . . . . . . . . . . . . . . . . . 4-3
As Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Instrument Front Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Remove the Instrument Front Panel . . . . . . . . . . . . . . . . . 4-4
Reinstall the Instrument Front Panel. . . . . . . . . . . . . . . . . 4-4
Air Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Remove the Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Clean the Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Reinstall the Air Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Remove the Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Replace the Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Verify Syringe Operation . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Product Numbers 5-1
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
xMAP Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Index Index-1
ii PN 89-00002-00-013 Rev. D
Introduction
1
About This Manual This manual introduces you to the Luminex
explains the features of the Luminex 100E analyzer and provides instructions on installation and use of the analyzer.
®
100E analyzer. It
Intended Use The Luminex 100E analyzer is designed as a component in a host
system. This component is designed for a wide range of laboratory testing applications measuring biomolecular reactions on the surfaces
of xMAP indoor use only.
Systems analysts, software designers, and programmers who need an overall perspective of the capabilities and functions of the Luminex Runtime (LXR) should refer to the LXR Programmer’s Reference provided by the LXR Software Development Kit (LXR SDK) version 2.0 or greater for more information. The Luminex 100E analyzer responds to applications developed using the LXR SDK version 2.0. LXR SDK version 2.0 supplies the runtime software and several utility applications needed to develop new applications and maintain the Luminex 100E analyzer.
®
and customer-specific microspheres. It is intended for
LXR is packaged as a collection of Windows The interfaces of the various components are written as Component
Object Model (COM) objects that conform to the Microsoft automation standards. This COM Automation support allows access to the Luminex 100E analyzer via programming and scripting software.
PN 89-00002-00-013 Rev. D 1 - 1
®
binary and data files.
®
Luminex 100E User Manual xMAP Technology
Technical Support You can contact Luminex Technical Support for questions or
concerns regarding the Luminex 100E analyzer.
Users in the U.S. and Canada may call 1-877-785-BEAD (-2323) between the hours of 7:00 a.m. and 7:00 p.m. Central Time, Monday through Friday for assistance. Users outside of the U.S. and Canada can contact us at + 1 512-381-4397 between the hours of 7:00 a.m. to 7:00 p.m. Central Time, Monday through Friday.
Inquiries may also be sent by email to support@luminexcorp.com.
1 - 2 PN 89-00002-00-013 Rev. D
Safety
2
Symbols These symbols describe warnings, cautions, and general information
used in the operation of this Luminex 100E analyzer. These symbols are further defined under “Safety Precautions.”
Number Symbol Description
1 Protective ground
2 Warning (refer to manual)
3 Warning (refer to manual)
4 Warning (refer to manual)
Safety Precautions Read the following safety information before setting up or using the
Luminex 100E analyzer. The user should be present during operation. The Luminex 100E analyzer 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 Luminex 100E analyzer 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 Luminex Corporation.
PN 89-00002-00-013 Rev. D 2 - 1
Luminex 100E User Manual xMAP Technology
The following labels appear on the back panel of the Luminex 100E analyzer.
Figure 1. Voltage Label
Figure 2. FCC Label
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
2 - 2 PN 89-00002-00-013 Rev. D
xMAP Technology Safety
Do not perform any maintenance or cleaning of the electrical
.
components of this system.
The Luminex 100E analyzer complies with European Union (EU) safety requirements.
This analyzer contains fluidic components. In the event of a fluidic leak, disconnect the power. Contact Luminex Corporation for further information.
Laser, Luminex 100E United States and international regulations require the following
warnings to appear on the analyzer during operation and maintenance. The labels in this section are representative.
Figure 3. Laser Class Label
The following label appears on the back panel of the Luminex 100E analyzer.
Figure 4. Laser Caution Label
Under NO circumstances should you remove the Luminex 100E analyzer cover or this label! When performing routine
maintenance, disconnect power to the analyzer.
PN 89-00002-00-013 Rev. D 2 - 3
Luminex 100E User Manual xMAP Technology
All Luminex 100E analyzer laser apertures are contained inside a protective housing within the analyzer. This label appears on the optics cover within the Luminex 100E analyzer.
Mechanical
Figure 5. Laser Caution Label on Optics Cover
CAUTION — Use of controls or adjustments or performance of
procedures other than those specified herein may result in hazardous radiation exposure.
Attention — L’utilisation des commandes ou réglages ou l’exéction
des procédures autres que celles spécifiées dans les présentes prescriptions peuvent être cause d’une exposition à un rayonnement dangereux.
This label appears above the laser apertures located inside the optics enclosure inside the Luminex 100E analyzer.
Figure 6. Avoid Exposure Label
Warning: During operation, this analyzer contains moving parts.
Risk of personal injury is present. Observe all warnings and cautions.
2 - 4 PN 89-00002-00-013 Rev. D
xMAP Technology Safety
Warning: During operation, this analyzer contains moving parts that
result in a pinch point hazard. Risk of personal injury is present. Keep hands and fingers away from the syringe arm.
Biological Warning: All human/animal samples may contain hazardous
infection agents.Where exposure (including aerosol) to potentially biohazardous materials exists, operators should follow appropriate biosafety procedures and use personal protective equipment, such as gloves, gowns, laboratory coats, face shields (or mask and eye protections), and ventilation devices.
Observe all local, state, and federal biohazard handling regulations when disposing of biohazardous waste material.
PN 89-00002-00-013 Rev. D 2 - 5
Luminex 100E User Manual xMAP Technology
Decontaminating the Luminex 100E Analyzer for Return Shipment
Note: You are responsible for decontaminating the unit prior to shipment.
Luminex Technical Support will provide a Return Material Authorization (RMA) number if they direct you to return the analyzer to Luminex; they will also instruct you in returning the analyzer according to Luminex procedures.
Before returning the Luminex 100E analyzer, sanitize and decontaminate the accessible surfaces and internal fluidics system. This is particularly important if you have analyzed biohazardous samples. Make a copy of this page to complete and return with the analyzer. Submit the completed checklist, both signed and dated, with the Luminex 100E analyzer.
1. Replace the fluid in the sheath system with a freshly prepared solution of 10% - 20% household bleach and water.
2. Using a solution of 10% - 20% household bleach and water, sanitize the analyzer using maintenance tools in the LXR library. Follow this by washing twice with distilled water.
3. Disconnect the power plug from the analyzer
4. Disconnect the fluidic lines.
5. Disconnect the sample probe from the host’s sample mount sample probe line.
6. Wash all exterior surfaces with a mild detergent, followed by a 10%-20% bleach solution.
7. Remove the air filter from the analyzer and clean all accessible surfaces with detergent followed by a 10%-20% bleach solution.
8. Pack the analyzer using a biohazard bag, place it in an approved shipment box, and then insert it into a shipping crate. 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:______________________________________________
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