DxH 560

DxH 560
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DxH 560

Product catalog summary
Introduction
This document serves as a technical manual for the DxH 560, a medical device by Beckman Coulter Ireland Inc., covering safety notices, operational guidelines, and device specifications.
Safety Notices
  • General Precautions: Compliance with health and safety standards is mandatory, including protective gear.
  • Laser and Electronic Precautions: Only authorized personnel should handle maintenance to avoid risks.
  • Biological Hazards: Proper attire and universal precautions are necessary when handling pathogenic materials.
  • Disposal: Follow local regulations for disposing of electrical and biohazardous waste.
System Overview
  • Intended Use: The DxH 560 is for specific diagnostic applications.
  • Hardware Specifications: Details include dimensions, weight, power, and environmental requirements.
  • Consumables: Lists necessary reagents and controls for operation.
Operational Guidelines
  • Installation and Transport: Guidelines for setting up and moving the device.
  • Data Storage and Software: Instructions on managing data and software use.
Warnings and Cautions
  • Warnings: Highlight potentially hazardous situations.
  • Cautions: Indicate situations that could lead to minor injuries.
Regulatory Compliance
  • CE Mark: Compliance with EU safety and environmental standards.
  • RoHS Notice: Compliance with China's pollution control standards.
Operation Principles
The document explains the Coulter Method for cell counting and sizing, specimen preparation, and result calculation.
Startup and Daily Checks
Guidelines for logging in, performing daily checks, and reviewing history are provided.
Quality Control
Details on running quality control materials and participating in interlaboratory programs.
Sample Analysis
Instructions for specimen collection, bar-code labeling, and running analyses.
Data Review
Procedures for reviewing and interpreting sample results, including flagged results.
Shutdown
Procedures for safely shutting down the system.
Troubleshooting
Includes safety precautions, troubleshooting tips, and system messages.
Quality Assurance
Guidelines for calibration, repeatability, and carryover procedures.
Cleaning Procedures
Details on when and how to perform cleaning procedures.
Replacement/Adjustment Procedures
Instructions for replacing and adjusting system components.
Appendices
Additional resources include access levels, bar-code specifications, and training checklists.
Calibration and Quality Assurance
  • Calibration Recommendations: Guidelines for when calibration is necessary.
  • Running Repeatability: Procedures for ensuring consistent results.
  • Running Carryover: Procedures for verifying carryover status.
Cleaning Procedures
  • WBC Bath Filter: Instructions for cleaning and maintaining the filter.
  • Bar-Code Scanner: Cleaning instructions to ensure accurate scanning.
Replacement/Adjustment Procedures
  • Rinsing Head O-Ring: Replacement instructions.
  • Bar-Code Scanner: Replacement instructions.
Access Levels and Reports
  • Security Access Levels: Different access rights for operators and administrators.
  • Reports: Various report formats for patient results and diagnostics.
Bar Codes
  • Specifications: Supported symbologies and character limits.
Printing Parameter Specifications
Specifications for printing parameters, focusing on barcode types and tube lengths.
Training Checklist
A comprehensive checklist for training before operating the instrument.
Implementation Checklist
Checklist for verifying performance during instrument setup.
Abbreviations and Acronyms
List of common abbreviations and acronyms used in the document.
Glossary
Definitions for technical terms used in the manual.
Overview: The document provides detailed instructions and warnings for handling and processing blood samples using the DxH 560 instrument.
Specifications and Procedures: Outlines specifications for bar-code labels and specimen collection, and provides detailed procedures for sample analysis.
Safety and Standards: Emphasizes the importance of adhering to safety standards during operation.
Software and Licensing: Details on software usage and licensing agreements.
Warranty and Liability: Beckman Coulter provides a limited warranty for the software.
Setup and Maintenance: Instructions for setting up the system and performing maintenance procedures.
Quality Control and Troubleshooting: Sections on quality control, troubleshooting, and quality assurance.
Additional Resources: Related documents and further instructions are available on the Beckman Coulter website.
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Catalog excerpts

DxH 560-1

PN C31608AA November 2020 Manufactured for Beckman Coulter Ireland Inc. Lismeehan O’Callaghan’s Mills Co. Clare, Ireland 353-65-683-110

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DxH 560-2

DxH 560 Instructions for Use PN C31608AA (November 2020) Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders. May be covered by one or more pat. - see www.beckmancoulter.com/patents Find us on the World Wide Web at: www.beckmancoulter.com Symbols Glossary is available at www.beckmancoulter.com/techdocs. See Related...

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DxH 560-3

Revision History This document applies to the latest software listed and higher versions. When a subsequent software version affects the information in this document, a new issue will be released to the Beckman Coulter Web site. For labeling updates, go to www.beckmancoulter.com/techdocs and download the latest version of the manual or system help for your instrument. Initial Issue AA, 11/2020 Software version 2.0

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DxH 560-5

Safety Notice Read all product manuals and consult with Beckman Coulter-trained personnel before attempting to operate instrument. Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, contact your Beckman Coulter Representative. Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory...

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DxH 560-6

Safety Notice Safety Precautions Safety Precautions WARNING Risk of operator injury and/or biohazardous contamination if: • All doors, covers, and panels are not closed and secured in place prior to and during instrument operation. • The integrity of safety interlocks and sensors is compromised. • Instrument alarms and error messages are not acknowledged and acted upon. • You contact moving parts. • You mishandle broken parts. • Doors, covers, and panels are not opened, closed, removed, and/or replaced with care. • Improper tools are used for troubleshooting. To avoid injury: • Keep doors, covers,...

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DxH 560-7

Safety Notice General Precautions product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative. General Precautions WARNING Risk of injury. Beckman Coulter urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. Laser Precautions This section contains the following information: • Radiation Statement • Laser Safety • Laser Warning Labels Radiation...

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DxH 560-8

Safety Notice Laser Precautions WARNING Do not attempt to remove the laser or to remove the housing cover. Failure to comply can result in exposure to laser radiation. If removal is required, it must be done by a Beckman Coulter Representative. Laser Warning Labels WARNING Possible harm to operator. This instrument contains components dangerous to the operator. If any attempt has been made to defeat a safety feature, or if this instrument fails to perform as listed in this manual, disconnect power and call your Beckman Coulter Representative. CDRH-approved labels are placed near or on those covers,...

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DxH 560-9

Safety Notice Electronic Precautions Electronic Precautions WARNING Risk of injury from electronic shock. Electronic components can shock and injure you. To prevent possible injury and/or shock, do not tamper with the instrument. Do not remove any components (covers, doors, panels, and so forth) unless otherwise instructed in this document. If conditions that cause static charge exist in your laboratory, be sure to be properly discharged before touching the instrument. Electromagnetic Compatibility (EMC) Information CAUTION This equipment has been designed and tested to CISPR 11 Class A. In a...

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DxH 560-10

Safety Notice Moving Parts Moving Parts WARNING Risk of injury and/or biohazardous contamination. Operating the instrument with open covers and doors can cause injury. When you operate the instrument, ensure that all covers and doors are closed. Operating the instrument with a loose or bent probe can cause injury. If the probe is loose or bent, do not run the instrument. Biohazardous Contamination WARNING Risk of injury and/or biohazardous contamination. The aspiration probe and the associated tubing contain residual biohazardous material. Clean up any blood spill as quickly as possible. Handle...

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DxH 560-11

Safety Notice Disposal of Electrical Instrumentation Warning Condition Pinch Point Potential pinch or pierce point in this area. Be aware of the moving probe and carefully present the test sample to avoid injury. Laser Radiation The laser radiation symbol indicates that there can be laser light radiation in the area. Take precautions to prevent exposure. Disposal of Electrical Instrumentation It is very important that customers understand and follow all laws regarding the safe and proper disposal of electrical instrumentation. The symbol of a crossed-out wheeled bin on the product is required...

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DxH 560-12

Safety Notice CE Mark The maximum waste line length is 1.50 m (5 ft.). The waste drain tube supplied with the system can be connected to either: • An open drain, suitable for biohazardous waste less than 76 cm (30 in.) above the floor • A waste container with a minimum capacity of 2,000 mL (0.53 gal). Discard the old container in accordance with your laboratory's standards for biohazardous material. WARNING Risk of biohazardous contamination. Use caution when draining the waste directly into an open drain. Ensure that the waste line is mechanically secured into the drain so the tubing cannot...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.