Early Sepsis Indicator (ESId) Application Addendum
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Early Sepsis Indicator (ESId) Application Addendum UniCel DxH 900 Series with System Manager Software Coulter Cellular Analysis System Published Version: DxH 900 and DxH 690T - v1 PN C21894AC April 2020 Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 U.S.A.

UniCel DxH 900 Series with System Manager Software Coulter Cellular Analysis System Early Sepsis Indicator (ESId) Application Addendum PN C21894AC (April 2020) The Early Sepsis Indicator (ESId) application is intended for use on the following instrument as an individual or workcell (connected) system: • UniCel DxH 900 Coulter Cellular Analysis System and the following instrument as an individual system: • UniCel DxH 690T Coulter Cellular Analysis System Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered...

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, 3/2018 DxH 900 Software Version 1.0.0 Issue AB, 5/2019 DxH 900/DxH 690T Software Version 1.2 The following sections were modified: • UniCel DxH 900 Series with System Manager Software Coulter Cellular...

Revision History • Limitations in CHAPTER 1, System Overview and Operation Principles • Method/VCS 360 Analysis in CHAPTER 1, System Overview and Operation Principles • Parameter Measurement and Derivation in CHAPTER 1, System Overview and Operation Principles • COULTER LATRON CP-X Control in CHAPTER 2, Quality Control • Commercial Control - COULTER 6C Plus Cell Control in CHAPTER 2, Quality Control • Extended QC in CHAPTER 2, Quality Control • XM Analysis in CHAPTER 2, Quality Control • Running Samples in CHAPTER 3, Sample Analysis and Data Review • Test Orders in CHAPTER 3, Sample...

Revision History The following sections were modified: • About This Manual in the Introduction • Intended Use in CHAPTER 1, System Overview and Operation Principles • Specimen Tubes in CHAPTER 1, System Overview and Operation Principles • Added Automated VCSn Optimization to CHAPTER 2, Quality Control • Processing Results in CHAPTER 3, Sample Analysis and Data Review • Activating ESId in CHAPTER 4, Setup • Decision Rules/Flagging Limits/Locations in CHAPTER 4, Setup • Added Manually Add MDW Rule 11 in CHAPTER 4, Setup • Added Edit MDW Value in Decision Rules (K3EDTA) in CHAPTER 4, Setup •...

Revision History

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...

Safety Notice Safety Precautions Safety Precautions WARNING Risk of operator injury 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, and panels closed and...

Revision History, iii Safety Notice, vii Alerts for Warning and Caution, vii Safety Precautions, viii Introduction, xv How to Use Your Manuals, xv About This Manual, xv Conventions, xv Graphics, xvi Symbols, xvi System Overview and Operation Principles, 1-1 Intended Use, 1-1 System Parameters, 1-1 Supplies, 1-2 Reagents, 1-2 Required Controls, 1-2 Specimen Tubes, 1-2 System Manager, 1-2 Operation Principles, 1-3 Method/VCS 360 Analysis, 1-3 Parameter Measurement and Derivation, 1-5 Quality Control, 2-1 Quality Control, 2-1 COULTER LATRON CP-X Control, 2-1 Automated VCSn Optimization, 2-1...

Data Review, 3-1 Processing Results, 3-1 Editing Patient Demographics and Active Test Orders, 3-3 Partial Release, 3-4 MDW Masking, 3-4 Setup, 4-1 Activating ESId, 4-1 Deactivating ESId, 4-2 Print and Save Configuration, 4-3 Setting Up an Operator and Roles, 4-3 Access Levels (Operator and Roles), 4-3 Decision Rules/Flagging Limits/Locations, 4-4 Restore Default MDW Rules, 4-4 Manually Add MDW Rule 11, 4-5 Edit Default ED Location, 4-6 Edit MDW Value in Decision Rules (K3EDTA), 4-7 Activate Decision Rules, 4-8 Enable MDW Decision Rules, 4-9 Set Up Flagging Limits, 4-10 Multi-Location Setup...

K3EDTA Performance, 6-1 Testing Temperature, 6-1 Accuracy - MDW, 6-1 Clinical Study, 6-1 Clinical Performance, 6-3 Added Value Analyses, 6-6 Clinical Performance Differentiating Between Sepsis versus Non-Sepsis Per Sepsis-3 Criteria, 6-7 Clinical Performance Differentiating Between SIRS versus Sepsis, 6-10 Open-Vial to Closed-Vial Comparison, 6-11 Operating Range, 6-11 Throughput, 6-11 Repeatability, 6-11 Limitations, 6-12 Flagging and Messages Available with Decision Rules, A-1 Flagging and Messages Available with Decision Rules, A-1 Glossary References Beckman Coulter, Inc. Customer End...

Distribution of MDW Values for Various Sub-populations, 5-4 Capacity of MDW to Differentiate between Sepsis (ROC Curve) and All Other Conditions, 5-5 Capacity of MDW to Differentiate between SIRS and Sepsis (ROC Curve), 5-9 Distribution of MDW Values for Various Sub-populations, 6-4 Distribution of MDW Values for Various Sub-populations, 6-8 Monocyte Volume Distribution Width, 1-4 Capacity of MDW to Differentiate between SIRS and Sepsis (ROC Curve), 6-10