ORTHO BioVue® Cassettes

Training and Reference Guide

TRANSFUSION MEDICINE

J66541EN
Export authorized under general license GTDA (General Technical Data Available)

IMPORTANT
The information contained herein is based on the experience and knowledge relating
to the subject matter gained by Ortho-Clinical Diagnostics, Inc. prior to publication.

No patent license is granted by the information.

Ortho-Clinical Diagnostics, Inc. reserves the right to change this information without
notice, and makes no warranty, express or implied, with respect to the information. The
company shall not be liable for any loss or damage, including consequential or special
damages resulting from the use of this information, even if loss or damage is caused
by its negligence or other fault.

ORTHO is a trademark of Ortho-Clinical Diagnostics, Inc.

© Ortho Clinical Diagnostics, 2020. All rights reserved.

ORTHO Optix™ Reader for BioVue® Cassettes Table of Contents
Training and Reference Guide

Table of Contents
Chapter 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Product Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manufacturer’s Contact Information. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Special Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Abbreviations and Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Chapter 2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Materials Required But Not Supplied. . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Instrument Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Environmental Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Non-Operational Environmental Conditions. . . . . . . . . . . . . . . . . . . . . 2-2
Reader Computer Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Hand-held Barcode Scanner Specifications . . . . . . . . . . . . . . . . . . . . 2-2
Printer Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Laboratory Information System Specifications. . . . . . . . . . . . . . . . . . . 2-3
Site Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Safety Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
EMC Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Available Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Chapter 3 Safeguards and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Electrical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Biohazardous Materials Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Instrument Cleaning Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Instrument Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Cybersecurity Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Chapter 4 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Software Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
System Architecture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Laboratory Information System (LIS) . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
System Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Menu Options and Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
e-Connectivity® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
e-Connectivity® Enterprise System . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
e-Connectivity® Agent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Enabling the Remote Access Feature . . . . . . . . . . . . . . . . . . . . . . 4-10
System Security and Architecture. . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Chapter 5 Software Installation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Installing the e-Connectivity® Agent Software . . . . . . . . . . . . . . . . . . . 5-1
Configuring the e-Connectivity® Agent Feature. . . . . . . . . . . . . . . . . . 5-1
Installing the ORTHO Optix™ Reader Software . . . . . . . . . . . . . . . . . 5-1
Chapter 6 Instrument Installation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Installing the Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Setting up the Keyboard and the Hand-Held Barcode Scanner . . . . . 6-1
Completing System Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Pub. No.: J66541EN i

2020-02-01
Table of Contents ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Chapter 7 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Viewing and Editing a Predefined Role . . . . . . . . . . . . . . . . . . . . . . 7-1
Creating a New Role. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Editing a Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Deleting a Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Creating a User. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Editing a User’s Account. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Deleting a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Enabling and Editing a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Creating a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Editing a Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Deleting a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
User-Defined Test Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
User-Defined Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Creating a User-Defined Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Editing a User-Defined Assay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Deleting a User-Defined Assay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
User-Defined Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Creating a User-Defined Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Editing a User-Defined Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Deleting a User-Defined Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
User-Defined Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Creating a User-Defined Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Editing a User-Defined Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Deleting a User-Defined Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Audit Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Viewing and Printing the Audit Log for the
ORTHO Optix™ Reader Software . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Viewing the Audit Log for e-Connectivity® Agent Software . . . . . . . 7-8
Importing an Application Data File . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Chapter 8 Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Reaction Grades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Creating an Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Associating an Order to a Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Imaging the Cassette and Confirming Image Association . . . . . . . . . . 8-3
Reviewing and Editing a Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Setting up the Remote Computer to Allow a Second User
to Access ORTHO Optix™ Reader Software . . . . . . . . . . . . . . . . . . . 8-5
Deleting an Order. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Processing an Order Using the Automatically Accept Results Feature 8-6
Chapter 9 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Quality Control Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Registering a Quality Control Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Creating a Quality Control Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Processing an Order Using a Quality Control Kit . . . . . . . . . . . . . . . 9-2
Editing a Quality Control Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Deleting a Quality Control Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Quality Control Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Status Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Viewing the Status of Quality Control . . . . . . . . . . . . . . . . . . . . . . . . 9-3

ii Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Table of Contents
Training and Reference Guide

Chapter 10 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Viewing Completed Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Printing an Individual Order Report . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Resending a Result to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Chapter 11 Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Generating and Printing a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Chapter 12 Software Backup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Creating a Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Restoring the Database from a Backup . . . . . . . . . . . . . . . . . . . . . . . 12-1
Appendix A Maintenance and Diagnostic Procedures . . . . . . . . . . . . . . . . A-1
Shutdown and Startup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Maintenance and Cleaning Procedures. . . . . . . . . . . . . . . . . . . . . . . . A-1
Routine Cleaning and Disinfection Procedure . . . . . . . . . . . . . . . . . A-2
Cleaning and Inspecting the Lens . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Cleaning the Illumination Chamber. . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Cassette Holder Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Top Cover Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Hand-Held Barcode Scanner Replacement . . . . . . . . . . . . . . . . . . . A-6
Power Supply Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Diagnostic Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
First-Time Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Using the Software to Complete an Adjustment or
Diagnostic Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8
Appendix B Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix C Error Codes, Possible Causes, and Recommended Actions C-1
Appendix D Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
Appendix E Parts Replacement Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Appendix F Key to Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-1
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Pub. No.: J66541EN iii

2020-02-01
Table of Contents ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

iv Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Introduction
Training and Reference Guide

Chapter 1: Introduction

This chapter provides the product information for the ORTHO Optix™ Reader. Read this
guide, particularly the warnings and cautions, before using the ORTHO Optix™ Reader.

Product Overview
The ORTHO Optix™ Reader is a bench-top instrument intended to be used for in vitro
immunohematology reading of tests utilizing the ORTHO BioVue® System Cassette
technology.

Figure 1-1: Components of ORTHO Optix™ Reader

Following the product’s Instructions For Use (IFU), samples are manually pipetted into a
cassette, incubated and centrifuged, using an instrument such as the ORTHO™
Workstation, and then placed into the ORTHO Optix™ Reader to capture an image,
grade the individual columns, and provide an analysis of the results.

The instrument illuminates and images both sides of the cassette. The column grade
results and the interpretation results are displayed on the user interface for review and
approval. The test results are saved by the ORTHO Optix™ Reader.

Manufacturer’s Contact Information

Ortho-Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend
CF35 5PZ
United Kingdom

Ortho provides hardware and software technical support for the ORTHO Optix™
Reader. For field service or technical support, contact Ortho Care™ or your distributor.

Pub. No.: J66541EN 1-1

2020-02-01
Introduction ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Intended Use
The ORTHO Optix™ Reader is a system designed to automate reaction grading, results
interpretation and data management when performing in vitro immunohematology
testing of human blood utilizing ORTHO BioVue® System Cassette technology. The
ORTHO Optix™ Reader can be used as a stand-alone instrument or interfaced with a
Laboratory Information System (LIS).

Trademarks
• ORTHO BioVue® Cassettes
• ORTHO™ Workstation
• ORTHO Optix™ Reader
• AlbaQ-Chek® J (a registered trademark of Alba Bioscience, Inc.)
• Windows 10® (a registered trademark of Microsoft Corporation)

Limitations
• The ORTHO Optix™ Reader is designed to process immunohematology tests only,
and does not support other types of tests commonly performed in clinical
laboratories.
• RhD antigen testing in ORTHO BioVue® Cassettes containing Anti-D is performed by
direct agglutination. Therefore, very weak expressions of D may not be detected and
may be required to use the validated antiglobulin test for detection.
• The ORTHO Optix™ Reader supports remote access through a web browser and
includes 3 Microsoft SQL Client Access Licenses. You are responsible for ensuring
compliance with Microsoft SQL server license agreements. As an example, one user
may access the ORTHO Optix™ Reader software and Microsoft SQL database from
the Reader Computer connected to the ORTHO Optix™ Reader, while another user
reviews and approves results from a different Reader Computer and a third user
remotely logs into the ORTHO Optix™ Reader software to search for historical
results from yet another Reader Computer. This scenario of 3 devices allocated for
use with the ORTHO Optix™ Reader is compatible with the provided SQL Client
Access Licenses. For acquisition of more Client Access Licenses, contact Ortho
Care™ or your distributor for more information, or work with your IT department.

1-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Introduction
Training and Reference Guide

Special Symbols
The following special symbols are used in this document:

The Warning symbol indicates that the system could malfunction if

instructions are not followed.

The Caution symbol indicates that care should be taken to avoid

danger or mistakes.

This Biohazard symbol indicates a biohazard warning.

The Notes symbol indicates additional information is available.

The Book symbol indicates a reference.

Abbreviations and Acronyms

Abbreviation Description
ASTM American Society for Testing and Materials
EMC Electromagnetic Compatibility
ePHI Electronic Protected Health Information
GUI Graphical User Interface
HIPAA Health Insurance Portability and Accountability Act
IAP Information Asset Protection
IFU Instructions For Use
IP Internet Protocol
IVD In Vitro Diagnostics
LAN Local Area Network
LED Light-emitting Diode
LIS Laboratory Information System
MBC Method-Based Control
ORTHO Ortho Clinical Diagnostics
PHI Protected Health Information
PII Personally Identifiable Information
QC Quality Control
SQL Structured Query Language
SSL Secure Sockets Layer
TCP Transmission Control Protocol
USB Universal Serial Bus

Pub. No.: J66541EN 1-3

2020-02-01
Introduction ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Definitions

Term Definition
Analysis Uniquely identifiable test defined on an instrument, made up of
one or more assays.
Assay The complete process or blood analysis which occurs in a
single microtube. It determines the presence or absence of an
agglutination reaction (graded 0 to 4+) between the antibodies
and antigens present in that microtube.
Cybersecurity Measures taken to protect a computer or computer system (as
on the Internet) against unauthorized access or attack.
e-Connectivity® A real-time, secure, two-way connection between the e-
connected systems and Ortho Care™.
LIS A data management system within the laboratory that may
interface to a Hospital Information System, another LIS, or
other various instruments within the lab. It processes test
requests, patient reports, and patient demographics.
e-Connectivity® Part of the e-Connectivity® Enterprise system installation that
Agent manages the client (customer) side.
Profile A group of one or more tests that are ordered concurrently for
a single patient or donor.
Quality Control Policies and procedures that ensure the quality or
effectiveness of a given method or operation upon its
completion.
Reader Computer The computer designated for use with the ORTHO Optix™
Reader.
Tests A predefined combination of one or more assays.
Validation Process used to verify that a system consistently fulfills the
requirements for a specific intended use.

1-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Specifications
Training and Reference Guide

Chapter 2: Specifications

This chapter provides the specifications and requirements of the ORTHO Optix™
Reader.

Materials Required But Not Supplied

• Hand-held Barcode Scanner
• Reader Computer

Instrument Specifications

Weight: 5.4 kg
Dimensions: Approximately 21.5 cm x 43.5 cm x 24.0 cm (Width
x Depth x Height)
Power Requirements: 100 – 240 V~1.7A, 50/60 Hz
Noise Level Generated: Average noise during processing 43 dB
Expected Life: 7 years

Environmental Specifications
Temperature: 18 – 30°C
Relative Humidity: 15 – 85% (non-condensing)
Altitude: 0 to +4,000 meters

The ORTHO Optix™ Reader meets the performance requirements during exposure to
vibration environments as experienced on a lab bench.

Pub. No.: J66541EN 2-1

2020-02-01
Specifications ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Non-Operational Environmental Conditions

The packaged instrument has been tested to withstand normal shipping and storage
conditions without degradation. No special provisions are required for storage and
transport.

Reader Computer Specifications

Operating System: Microsoft Windows 10 Enterprise or

Microsoft Windows 10 Professional

IMPORTANT: The ORTHO Optix™ Reader does not

support Microsoft Windows 10 Home or
Microsoft Windows 10 Education.
Processor: Intel Core i5 (minimum)
Memory: 8GB RAM
USB Ports: 2 minimum (two additional ports may be required for
keyboard and mouse)
Monitor Resolution: 1920 x 1080 (minimum)
Network Connection: For LIS and e-Connectivity®
Hard Disk: 7200 RPM Hard Disk Drive or Solid State Drive
Malware Protection: Customer supplied
Malware must include anti-malware and anti-virus.
Browser: Google Chrome

Hand-held Barcode Scanner Specifications

The Hand-held Barcode Scanner must be configured for use with the ORTHO Optix™
Reader software. The ORTHO Optix™ Reader software supports barcodes with
checksums and barcodes without checksums.

The following barcode symbologies are approved for use:

• Interleaved 2 of 5
• Code 128
• Code 39
• Codabar
• ISBT 128

Printer Specifications
A standard printer can be used with this instrument.

2-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Specifications
Training and Reference Guide

Laboratory Information System Specifications

The ORTHO Optix™ Reader can interface with an LIS using VISION® ASTM.

Refer to Laboratory Information System (LIS) Guide (J66549) for

additional information.

Site Requirements

WARNING:
As with any electrical appliance, place the instrument away from any
source of water, such as a laboratory sink. An electrical hazard may
exist when improperly using the ORTHO Optix™ Reader near water.

The instrument is intended for indoor use, and does not require any special services (for
example, air or cooling liquid).

Select a location for the ORTHO Optix™ Reader that is convenient for laboratory
personnel to perform testing. Place the instrument:

• On a stable and level surface

• Away from direct sunlight
• In an area that is free from dust, solvent and acid vapors
• Near an electrical outlet close enough to the instrument to permit power access
without an extension cord
• Away from extreme heat or cold (close to heating or air-conditioning systems or
vents)
• Where there is no violent shaking or any other type of shock (for example, an
extreme change in temperature)

Safety Requirements
This instrument meets the international standards for safety for in vitro diagnostics (IVD)
electrical equipment.

• IEC 61010-1: Safety requirements for electrical equipment for measurement, control
and laboratory use, Part 1: General requirements
• IEC 61010-2-101: Safety requirements for electrical equipment for measurement,
control and laboratory use, Part 2-101: Particular requirements for IVD medical
equipment
• JIS C 1010-1: Safety requirements for electrical equipment for measurement,
control, and laboratory use, Part 1: General requirements
• JIS C 1010-2-101: Safety requirements for electrical equipment for measurement,
control and laboratory use, Part 2-101: Particular requirements for IVD medical
equipment
• IEC 61010-1: 2001 (Second Edition): Safety requirements for electrical equipment
for measurement, control and laboratory use, Part 1: General requirements
• IEC 61010-2-101: 2002 (Ed 1): Safety requirements for electrical equipment for
measurement, control and laboratory use, Part 2-101: Particular requirements for
IVD medical equipment

Pub. No.: J66541EN 2-3

2020-02-01
Specifications ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

EMC Requirements
It is the manufacturer’s responsibility to provide electromagnetic compatibility
information of the instrument to the user. It is the user’s responsibility to ensure that a
compatible electromagnetic environment for the instrument is maintained to keep the
instrument performing as intended.
• EN/IEC 61326-1: Electrical equipment for measurement, control and laboratory
use - EMC requirements, Part 1: General requirements
• EN/IEC 61326-2-6: Electrical equipment for measurement, control and laboratory
use - EMC requirements, Part 2-6: Particular requirements IVD medical equipment
• JIS C 1806-1 (equivalent to IEC 61326-1 using Japanese Voltage Requirement)
• JIS C 1806-2-6 (equivalent to IEC 61326-2-6 using Japanese Voltage Requirement)

This IVD instrument complies with the emissions and immunity requirements described
in EN/IEC 61326-2-6 for IVD equipment. This instrument has been designed and tested
to CISPR 11 Class A as part of the above requirement. In a domestic environment, it
may cause radio interference, in which user may need to take measures to mitigate the
interference. The electromagnetic environment should be evaluated prior to operation of
the instrument. Do not use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the proper operation.

Available Tests
All regional tests are available on the system, but the tests used for processing of
samples are based on configuration by the lab.

2-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Safeguards and Precautions
Training and Reference Guide

Chapter 3: Safeguards and Precautions

This chapter provides the warning and safety precautions that must be observed in
order to avoid possible harm to personnel and the instrument, and to avoid incorrect test
results.

General Precautions

WARNING:
• Use only BioVue® Cassettes.
• Labs should manage cables to avoid spills.

• Refer to the IFU for each product used with the ORTHO Optix™ Reader for essential
information, including proper handling and storage temperature.
• This instrument must only be operated by trained laboratory personnel with a
knowledge of immunohematology.
• Do not operate the instrument other than as specified in this Training and Reference
Guide or in other documentation this guide references (i.e. IFUs), as it may cause
damage to the instrument and could have an affect on the test results.
• Do not open the top cover during operation of the ORTHO Optix™ Reader.
Interruption to processing may occur.
• Keep the top cover of the ORTHO Optix™ Reader closed when not in use to avoid
dust and foreign objects from entering the instrument.
• Do not remove or adjust the lens.
• Do not shut off or disconnect power during use. This can interrupt processing and
result in loss of work.
• If an error occurs with the ORTHO Optix™ Reader or assistance is needed, or if you
have questions about the safety of the instrument, contact Ortho Care™ or your
distributor.

Electrical Safety Precautions

• A grounded electrical plug is required.
• Procedures must be performed by trained personnel.
• In order to totally disconnect the instrument from the power supply, the grounded
electrical plug must be unplugged (the on / off switch is insufficient).
• Do not position the instrument so that it is difficult to operate the power switch or
disconnect the power supply.
• Without disconnecting the instrument from the power supply, no tool should be used
to remove pieces or to access inaccessible parts.
• The instrument must be connected to an earth-grounded outlet with an Ortho
provided power supply.

Pub. No.: J66541EN 3-1

2020-02-01
Safeguards and Precautions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

• Do not use the power supply if the grounding plug is damaged. Examine the power
supply for damage and discontinue use if there are signs of damage or wear.

Refer to Chapter 2 Specifications for additional information.

• The detachable power supply cord shall only be replaced by a properly-rated cord.
• Although the instrument is grounded, avoid using liquids near the power supply. If
liquid spills occur, immediately disconnect the instrument from the power supply and
remove excess liquid to avoid electrical hazard.
• Several types of electrical interference may be indigenous to the site location and
may require special filtering to prevent malfunctions in the instrument. If interference
is suspected to be a problem, shielding may be required, or filtering of the ac line
power to the site may be necessary. Cellular phones, two-way pagers, and other RF
transmitting devices should not be used within 1 meter of the ORTHO Optix™
Reader. The instrument should be observed to verify normal operation in the
configuration in which it will be used.

Biohazardous Materials Precautions

• Use universal precautions when working with the ORTHO Optix™ Reader. Use only
materials and substances outlined in this Training and Reference Guide or
documented in your laboratory procedures. Follow the laboratory’s Standard
Operating Procedures when working with biohazard materials and substances.
• Universal precautions and good laboratory working practices must be observed, and
laboratory procedures regarding Personal Protective Equipment (lab coats, gloves,
and eye protection, etc.) must be followed.
• All areas of the instrument must be considered potentially biohazardous and handled
with the appropriate care as per your laboratory’s Standard Operating Procedures.

Instrument Cleaning Precautions

• The ORTHO Optix™ Reader is a precision instrument and requires minimal regular
cleaning and maintenance to ensure accurate operation. Follow the procedure in this
guide each time you perform these activities.
• Failure to properly perform the appropriate cleaning or maintenance tasks can result
in damaged parts or compromised sample results.
• Be sure to use 70% Isopropyl alcohol or ethanol, mild detergent, or a quaternary
ammonium-based cleaner.
• When cleaning the ORTHO Optix™ Reader, do not use cleaning solutions past their
expiration date.

3-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Safeguards and Precautions
Training and Reference Guide

Instrument Labels

In compliance with the European Directive 2012/19/EU

on Waste Electrical and Electronic Equipment (WEEE),
this instrument must not be disposed as unsorted
municipal waste. Instead, this instrument must be
collected separately in accordance with local recycling
regulations.

Presence of the symbol indicates that compliance must

be adhered to for this instrument.
The Chinese Regulation, Management Methods for the
restriction of the use of hazardous substances in
electrical and electronic products (“China RoHS”),
requires an electrical or electronic product to be labeled
with the environmentally friendly use period symbol if it
contains restricted substances above specified levels.
The environmentally friendly use period refers to the
period in years (Y) in which the hazardous substances
contained in the electronic and electrical product will not
leak or mutate suddenly under normal operation
conditions and will not result in serious environmental
pollution or cause serious bodily injury to the user or
damage to their assets during normal use by the user of
the electronic and electrical products.
Indicates an alert that unsafe practices can result in
property damage or serious injury.

Indicates a warning about possible exposure to biological

substances that may consist of toxins or medical waste.

Indicates a Universal Serial Bus (USB) port.

Indicates a direct current (DC) power port.

Cybersecurity Precautions

Refer to the Cybersecurity Instructions for Use (J66596) for detailed

information.

Pub. No.: J66541EN 3-3

2020-02-01
Safeguards and Precautions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

3-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes User Interface
Training and Reference Guide

Chapter 4: User Interface

This chapter provides an overview of the components, menu options, and navigation
options used on the ORTHO Optix™ Reader.

Software Overview
The following figure provides a schematic overview of the process and shows the
different interactions.

Figure 4-1: Process Cycle

Pub. No.: J66541EN 4-1

2020-02-01
User Interface ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Software Components
The ORTHO Optix™ Reader is comprised of the following software components.

ORTHO Optix™ Application Software: The application software provides

Reader Software a Graphical User Interface (GUI) and manages the
workflow. The application software interfaces with the LIS
for receiving orders and sending results. The application
software is responsible for sending commands to the
camera software.

Camera Software: The camera software coordinates the

image capture and grading process between components
of the instrument and the image processing software.

Image Processing Software: The image processing

software analyzes the cassette image and provides column
grades. Also, image processing software processes the
images captured for initialization, health checks, and LED
calibration as needed.

Application Data: The data file which contains parameters

used by the application software and image processing
software for processing tests.

e-Connectivity® The e-Connectivity® Agent software is responsible for the

Agent communication between the ORTHO Optix™ Reader and
the Ortho e-Connectivity® Enterprise.

System Architecture
The ORTHO Optix™ Reader software is web browser based and designed to run on a
Local Area Network (LAN). The ORTHO Optix™ Reader software runs with a Structured
Query Language (SQL) server installed locally on the same Reader Computer.

The ORTHO Optix™ Reader software is designed to be used as a standalone

application or can be accessed remotely by a web browser within the same network
(Intranet).

Refer to Chapter 5 Software Installation and Setup for additional

information.

4-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes User Interface
Training and Reference Guide

Laboratory Information System (LIS)

The LIS interface allows the ORTHO Optix™ Reader to communicate with an LIS using
one of four modes:

Upload Mode Also called Unidirectional Mode. This mode allows the
user to order tests manually on the ORTHO Optix™
Reader, and then transfer the results to a connected LIS.
The user cannot release unaccepted results to the LIS,
but they can manually resend accepted results
individually to the LIS.
Download Mode Also called Bidirectional Mode. This mode functions the
same as the Upload Mode, and it allows the LIS to
transmit orders to the ORTHO Optix™ Reader. Once the
order is received by the ORTHO Optix™ Reader, the
order is available for processing on the system.
Host Query Mode This mode functions the same as the Download Mode,
and it allows a user to send a host query message to the
LIS for the order by scanning a sample barcode.
Broadcast Mode This mode functions the same as the Download Mode,
but it sends orders to all instruments on a LIS system.
Use this mode when a LIS system includes multiple
instruments. This mode allows a user to process a
sample on one instrument, and then the instrument
uploads the results to the LIS. When the LIS receives the
results from an instrument, the LIS may cancel the
duplicate orders on all other instruments. The ORTHO
Optix™ Reader may be configured to automatically
cancel orders.

Refer to the Laboratory Information System (LIS) Guide (J66549) and

Configuration Guide (J66581) for additional information.

Ortho Care™ may assist in the connection of the ORTHO Optix™ Reader to the LIS.
However, your Information Technology personnel is responsible for maintaining the
communication after setup. Contact Ortho Care™ or your distributor if additional
assistance is required.

Configuration of the LIS requires use of ports (using TCP / IP port).

Refer to the Cybersecurity Instructions for Use (J66596) for additional

information.

Pub. No.: J66541EN 4-3

2020-02-01
User Interface ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

System Status
The ORTHO Optix™ Reader status is indicated on the front of the instrument by either a
green light (system operational), or a red light (system error).

Example:
During imaging, the status light illuminates:
• Solid green (system operational)
• Solid red (system error)
• Blinking green (system busy)
• Alternative blinking green and red (requires initialization)

The ORTHO Optix™ Reader software displays the Laboratory Information System and
Imaging System software status within the Application Footer located at the bottom of
the application window.

Menu Options and Icons

About
Allows the user to view the software version, product
information, serial number, IP address, and laboratory
information.

Account
Allows the user to:
• Log Off
• Lock Screen
• Change Password

Acknowledge
Allows the user to acknowledge notifications.

Add
Allows the user to create orders, profiles, tests, etc.

Assign
Allows the user to assign available profiles, tests, etc. to
configured or selected profiles, tests, etc.

Audit Log
Allows the user to view activities within the software.

Back
Allows the user to return to the previous screen.

4-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes User Interface
Training and Reference Guide

Back Arrow
Allows the user to go back to the previous screen.

Backup
Allows the user to make a backup copy of all data.
Backups can be used to restore the original data if the
system’s data files are lost or destroyed.

Black and White View

Allows the user to view the image in grayscale.

Column Disabled
Indicates columns are not available for use.

Column Enabled
Indicates columns are available for use.

Cancel
Allows the user to close the software or a dialog box.

Color View
Allows the user to view the image in color.

Connected
Indicates a connection exists between the software and
the LIS or the imaging system.

Date Selector
Allows the user to select the date.

Delete
Allows the user to delete orders, profiles, tests, etc.

Disconnected
Indicates a connection does not exist between the
software and the LIS or the imaging system.

Edit
Allows the user to edit orders, profiles, tests, etc.

Error Notification
Allows the user to view system errors.

Pub. No.: J66541EN 4-5

2020-02-01
User Interface ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Export
Allows the user to export results to an LIS.

Exit
Allows the user to close the software or dialog box.

Forward
Allows the user to advance to the next screen.

Full Screen
Allows the user to expand or minimize the software
window.

Home
Allows the user to return to the Home screen.

Host Query
Allows the user to perform a query on the host LIS.

Image Capture
Allows the user to quickly access the Image Cassette
screen. All order information for “Ready to Image” orders
are automatically sent to the imaging system.

Information
Allows the user to view informational messages.

More
Allows the user to access additional screen options.

Notifications
Allows the user to open the Notifications window and
acknowledge new notifications.

Print
Allows the user to print.

Quality Control
Allows the user to view the status of quality control,
configure the quality control kits, and assign kits to
profiles.

Refresh
Allows the user to refresh the data on the screen.

Remove
Allows the user to remove cassette information or
configured / selected profiles, tests, etc.

4-6 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes User Interface
Training and Reference Guide

Reports
Allows the user to create reports for displaying, printing,
or exporting.

Results
Allows the user to access the results for orders
processed on the system.

Return
Allows the user to return to the previous screen.

Reverse Image
Allows the user to toggle between the front and back
images of the cassette or the columns.

Save
Allows the user to save the information they entered and /
or changed.

Search
Allows the user to conduct a search of the database.

NOTE: Search parameters are screen dependent.

Settings
Allows the user to create and update the following
settings:
• Authorizations
• Barcodes
• Display Settings
• Diagnostics
• LIS
• Notifications
• Restore Menu
• Roles
• Test Setup
• Profiles
• Tests
• Assays
• Analysis
• Import from Application Data
• Users
• Workflow

Show Reagents
Allows the user to view the reagent and cassette
information.

Pub. No.: J66541EN 4-7

2020-02-01
User Interface ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Warning
Allows the user to view warning messages.

Worklist
Allows the user to view, edit, create, or remove orders
and order details.

Home Screen
The Home screen provides an overview of functions and features within the ORTHO
Optix™ Reader software.

Figure 4-2: Home Screen

Main Menu
1
Menu providing access to all features of the software.
Search
Text-entry box for keyword searches. To initiate the search:
• Select Search.
• Enter the search criteria.
2
• Press the Enter key on the keyboard.

Example: If ‘John’ is entered, this may be the first name for a

patient and also the last name of another patient, both patients are
displayed in the results.

4-8 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes User Interface
Training and Reference Guide

Workflow Status
Displays a count of all orders for the following categories:
• Associate to Cassette
3 • Ready to Image
• Ready to Review
NOTE: You may select the numbers in the total row on the Home
Screen to view the list of orders in each category.
Quality Control Status
Displays the following categories:
4 • Profile
• Test
• Status
Notifications
Displays a list of recent notifications and includes a short
5
description and severity level. New messages are indicated with a
number below the triangle button.
Full-Screen
6 Expands the software to full-screen mode. Press ESC to exit the
full screen.
Account
7
Allows the user to log off, lock screen, and change password.
Current Notifications
8 Displays the most recent 5 unacknowledged or unread notification
messages, sorted by priority.
Application Footer
Displays the connectivity status of the LIS and the imaging system.
9
Also, includes the About icon which allows users to view system
and software information.
Interface Status
10
Displays the connectivity status of the LIS.

e-Connectivity®
e-Connectivity® is a real-time, secure, two-way connection between the
user’s e-connected system and Ortho Care™.

e-Connectivity® Enterprise System

The e-Connectivity® Enterprise system manages connectivity, remote access, and data
transfer. The system uses a server architecture consisting of both local (user) and
remote (Ortho) components.

The e-Connectivity® Enterprise system provides functionality for uploading log files and
accessing the Reader Computer remotely. This functionality allows Ortho to
troubleshoot problems, and provide fast, effective assistance.

Pub. No.: J66541EN 4-9

2020-02-01
User Interface ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

e-Connectivity® Agent
The e-Connectivity® Agent implements the communication between the Ortho
instruments and e-Connectivity® Enterprise with the following functions:
• Transferring log files from the instrument to the e-Connectivity® Enterprise
• Allowing remote service access of the instrument to be established
• Allowing product software updates to be downloaded
• Allowing files to be transferred between the e-Connectivity® Enterprise and the
instrument
• Providing a GUI for the e-Connectivity® Agent functionality

Enabling the Remote Access Feature

1. Open the e-Connectivity® Agent application.
2. Click the e-Connectivity® logo to display the options menu.
3. Select Remote access > View only.
4. When the Ortho patient privacy window displays, review the information, sign, and
select I ACCEPT.
5. When the Authorize remote view-only connection? window displays, select Yes.
6. When the View-only connection was authorized window displays, select OK.

System Security and Architecture

The security design of the system meets the Health Insurance Portability and
Accountability Act (HIPAA) standards, Information Asset Protection (IAP) standards,
and Electronic Protected Health Information (ePHI) standards for data and records.
• Data transferred between the ORTHO Optix™ Reader and e-Connectivity®
Enterprise utilizes a communication protocol (TLS Encryption V1.2 or FIPS 140-2) to
encrypt data during transmission.
• No Personally Identifiable Information (PII) or Protected Health Information (PHI)
data is uploaded or accessible through e-Connectivity® access.

The following services are necessary for operation of the ORTHO Optix™ Reader and
e-Connectivity® Agent, and they should not be disabled:
• e-Connectivity® Service
• Questra Service Agent (QSA)
• uvnc_service (UltraVNC)
• Microsoft Message Queuing (MSMQ)

NOTE: These services startup automatically when starting the Reader

Computer.

4-10 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Software Installation and Setup
Training and Reference Guide

Chapter 5: Software Installation and

Setup

This chapter provides instructions for installing and setting up the ORTHO Optix™
Reader and e-Connectivity® software.

IMPORTANT: Administrative privileges for the Reader Computer are required to install
the ORTHO Optix™ Reader and e-Connectivity® software. A Microsoft
Windows administrator username and password is required to complete
the software installation. Contact your IT department to establish
administrator credentials.

Installing the e-Connectivity® Agent Software

1. Save the e-Connectivity® Agent software on the Reader Computer’s C:\ drive.
2. Double-click the OCDAgentInstaller.exe file, and select Run.
3. When the Ortho e-Connectivity®Agent Setup window displays, select Next.
4. Select Install.
5. Select Finish.

Configuring the e-Connectivity® Agent Feature

IMPORTANT: Ortho configures the e-Connectivity® Agent to automatically send log files
to the e-Connectivity® Enterprise. If you need to make additional
configuration changes, use this procedure. For assistance with proxy
setup or other configurations, contact Ortho Care™.
1. Open the e-Connectivity® Agent application.
2. Click the e-Connectivity® logo to display the options menu.
3. Select Tools > Configure e-Connectivity® Features.
4. When the e-Connectivity® Feature Configuration window displays, select OK.
5. Select OK.

Installing the ORTHO Optix™ Reader Software

IMPORTANT: The installation of ORTHO Optix™ Reader software may take up to one
hour.
1. Select a location for the ORTHO Optix™ Reader, the Reader Computer, and the
peripherals.

Refer to Chapter 2 Specifications for additional information.

2. In the Search field on your Reader Computer, enter View PC Name.

Pub. No.: J66541EN 5-1

2020-02-01
Software Installation and Setup ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

3. When the search results display on the screen, select View PC Name. Record the
Reader Computer name (PCName).

NOTE: The Reader Computer name (PCName) is required during the

software installation.

4. Save the ORTHO Optix™ Reader software on the Reader Computer’s C:\ drive.
5. Right-click on the Stratec.Ortho.Reader.Install.exe file, and select Run as
administrator > Run.
6. When Do you want to allow this application from an unknown publisher to
make changes to your device? displays on the screen, select Yes.
7. When the Ortho Windows Settings Setup window displays, select Install.
8. When the ORTHO Optix™ Installer Setup window displays, select I agree to the
license terms and conditions, and select Next > Install.

IMPORTANT: This part of the installation may take approximately 5 to 10 minutes. Do

not close any windows during the installation.
9. Select Finish.
10. When the Microsoft SQL Server window displays, confirm the destination folder,
and select Install.

IMPORTANT: This part of the installation may take approximately 10 to 20 minutes. Do

not close any windows during the installation.
11. When Do you want to continue with this operation displays on the screen, type Y
and press Enter.
12. When the Matlab Runtime window displays, select Install.
13. When the ORTHO Optix™ Setup window displays, select Next.
14. Verify the destination folder, and select Next.
15. Enter the PCName\SQLSERVER2016 in the Database Server field. Use the
PCName for your Reader Computer that was recorded earlier in this procedure.
16. Select TEST/CONFIRM CONNECTION.
17. When the Connection Success window displays, select OK.
18. Select Next.
19. Enter the applicable Configuration Code.

Configuration Code Country

04543 China
05678 France
02876 All countries except China and France

20. Select Next.

21. Enter the required information. Create the administrator username and password
and safeguard them for future use and select Next.

IMPORTANT: Enter the laboratory details exactly as you would like them to appear on
the lab reports. You cannot modify this information once the software
installation is complete.
22. Enter the Laboratory Details, and select Next.

5-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Software Installation and Setup
Training and Reference Guide

23. Select Install.

IMPORTANT: This part of the installation may take approximately 25 to 35 minutes. Do

not close any windows during the installation.
24. Wait until the Language Settings window displays on the screen.
25. Select the desired language, and select Next.
26. Select Install.
27. Select Finish.
28. When the Installation Successfully Completed window displays, select Close.
29. If a USB was used during the installation, remove it from the Reader Computer.
30. Restart the Reader Computer.
31. Launch the ORTHO Optix™ Reader software.
32. Enter the credentials, and select LOGIN.

IMPORTANT: Continuous antivirus software updates will protect the Reader Computer
from viruses and malware.
33. If you are installing the software in Japan, you must import a new application data
file.

Refer to Chapter 7 Importing an Application Data File for additional

information.

34. Consult your IT department to configure the antivirus software to allow access to the
following directories:

e-Connectivity®
• C:\Program Files (x86)\UltraVNC
• C:\Program Files (x86)\Questra\5.2sp2\qsa
• C:\Program Files\OCD\OCD Agent

ORTHO Optix™ Reader Software

• C:\ProgramData\Ortho\
• C:\Program Files\Stratec\Ortho Reader\
35. Run the antivirus software on the Reader Computer.
36. Continue with software configuration. If assistance is needed, contact Ortho Care™
or your distributor.
Refer to the Configuration Guide (J66581).

Pub. No.: J66541EN 5-3

2020-02-01
Software Installation and Setup ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

5-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Instrument Installation and Setup
Training and Reference Guide

Chapter 6: Instrument Installation and

Setup

This chapter provides instructions for installing and setting up the ORTHO Optix™
Reader.

Installing the Instrument

1. Place the ORTHO Optix™ Reader on the designated work surface.

Refer to Chapter 2 Specifications for additional information.

2. Confirm that the following required materials are available:

• ORTHO Optix™ Reader
• Country-specific POWER SUPPLY
• Reader Computer
• USB Cable
• Hand-held Barcode Scanner
• Focus Tool
3. Connect the POWER SUPPLY.

IMPORTANT: You must connect the USB cable directly to the Reader Computer. Do not
connect the USB cable to an external USB hub.
4. Connect the USB cable to the ORTHO Optix™ Reader and an available USB port on
the Reader Computer.
5. Turn on the Reader Computer.
6. Turn on the instrument.
7. Launch the ORTHO Optix™ Reader software.
8. Enter the credentials, and select LOGIN.
9. From the Main Menu, select Settings > Diagnostics > First-Time Setup.
10. Select START and follow the on-screen instructions.
11. If the first-time setup procedure does not complete successfully, see
Appendix C Error Codes, Possible Causes, and Recommended Actions.

Setting up the Keyboard and the Hand-Held Barcode Scanner

1. Configure the keyboard for use with the system.
a. On the Reader computer, go to Start > Settings > Time and Language > Region
and select the appropriate country or region.
b. On the Reader computer, go to Start > Settings > Time and Language >
Language and select the appropriate language.
2. Connect the hand-held barcode scanner to the Reader Computer.

Pub. No.: J66541EN 6-1

2020-02-01
Instrument Installation and Setup ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

3. Follow the instructions provided by the manufacturer to configure the barcode

scanner. Refer to the barcode symbologies shown in the table.

Type Product Name Barcode

Symbology
Reagent BioVue® Blood Grouping Reagents Code 128
Quality ORTHO CONFIDENCE™ WB Code 128
Control AlbaQ-Chek J ®
Code 128
Consumable BioVue® Cassettes Interleaved 2 of 5
Sample ID As determined by lab

NOTE: Configuration of the hand-held barcode scanner is also

dependent on the sample barcode symbologies used by your
lab to identify samples.

Refer to Chapter 2 Specifications for additional information.

4. Do the following to confirm that the barcode scanner and the Reader Computer are
configured correctly.
a. From the Main Menu, select Settings > Barcodes.
b. Select the Entry Value field.
c. Scan a barcode image from the table below, and select SCREEN VALUE.
d. Confirm that the expect result displays in the screen.

Product Name Barcode Barcode Image Expected Result

Symbology
BioVue® Blood Code 128 6400151237
Grouping
Reagents
ORTHO Code 128 QC100114011551
CONFIDENCE™
WB
AlbaQ-Chek® J Code 128 QC1123120426

BioVue® Interleaved 2 17061133123456777772

Cassettes of 5

Samples Check with Sample ID barcodes used in the lab

Completing System Validation

Refer to the Validation Guide (J66546) for additional information.

6-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Getting Started
Training and Reference Guide

Chapter 7: Getting Started

This chapter provides instructions for creating, editing, and deleting users and user
roles, as well as setting up profiles, tests, and user-defined tests

Roles
Roles establish the level of access provided to each user. The role configuration
determines the software features available to a user assigned to a role. (For example, a
role allows a user to accept or reject results).

Viewing and Editing a Predefined Role

The ORTHO Optix™ Reader comes configured with the following predefined roles:
• Administrator
• Senior Lab
• Lab
• Support
1. From the Main Menu, select Settings > Roles.
2. To view or edit the permissions, select the checkbox next to the role and select Edit.
3. Select Save.

Creating a New Role

1. From the Main Menu, select Settings > Roles.
2. Select Add.
3. Enter the Role Name and Role Description.
4. Select the required level of access for each of the permissions.
5. Select Save.

NOTE: When the Reauthentication is Required option is selected,

users are prompted to enter their password to perform the action.

Editing a Role
1. From the Main Menu, select Settings > Roles.
2. Select the checkbox for the desired role.
3. Select Edit to modify the permissions.
4. Make the required updates and select Save.

Pub. No.: J66541EN 7-1

2020-02-01
Getting Started ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Deleting a Role
IMPORTANT: You must remove all users from a role before you can delete the role.
1. From the Main Menu, select Settings > Roles.
2. Select the checkbox for the desired role and select More > Remove.
3. Select CONFIRM.

NOTE:
• Multiple roles may be selected at once.
• Predefined roles cannot be removed.

Users

Creating a User
1. From the Main Menu, select Settings > Users.
2. Select Add.
3. Enter the following information:
• Username (40 character limit. Must be unique.)
• First Name (40 character limit)
• Last Name (40 character limit)
• Email Address (optional field with a 255 character limit)
4. Select Forward.
5. Select the desired Role.
6. Verify that the preset level of access is appropriate for the user. If updates are
required, select CUSTOMIZE USER PERMISSIONS.
7. Select Forward.
8. Enter the following information:
• Password
• Confirm Password
• Password Expiration
NOTE: Password requirements can be configured on the Authorizations
screen.

9. If desired, select Change password on next login.

10.Select Save.

Editing a User’s Account

1. From the Main Menu, select Settings > Users.
2. Select the desired user.
3. Select Edit.
4. Make the required updates on the account details (account lock/unlock and account
deleted), user’s permission, and password screen.
5. Select Save.

7-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Getting Started
Training and Reference Guide

Deleting a User
1. From the Main Menu, select Settings > Users.
2. Select the desired user.
3. Select More > Remove.

NOTE: Multiple users may be selected at once.

4. Select CONFIRM.

Tests

Enabling and Editing a Test

Refer to Chapter 9 Quality Control for additional information.

1. From the Main Menu, select Settings > Test Setup > Tests.
2. Select the checkbox next to the desired Test ID, and select Edit.
3. Make the required updates:
• Enable or Disable Quality Control
• MBC or No Quality Control
○ Expiration Time (Hours)
○ Expiration Notification (Hours)
4. Select Save.

Profiles
A profile is a group of one or more tests that users can order concurrently for a single
patient or donor.

IMPORTANT: The ORTHO Optix™ Reader software prevents the user from editing or
removing a profile while orders for that profile are active on the Worklist.

Creating a Profile
IMPORTANT:
• Tests must be enabled prior to creating a profile.
• When naming profiles or tests, avoid using non-alphanumeric characters such as
“&”, and “+”.
1. From the Main Menu, select Settings > Test Setup > Profiles.
2. Select Add.
3. Enter the Profile Name and Profile Description.
4. Select Forward.
5. Select one or more tests from the Available Tests.

Pub. No.: J66541EN 7-3

2020-02-01
Getting Started ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

6. Select Forward.
7. Select Save.

Editing a Profile
IMPORTANT: You cannot edit a profile when a sample using that profile is active on the
Worklist.
1. From the Main Menu, select Settings > Test Setup > Profiles.
2. Select the desired profile.
3. Select Edit.
4. Make the required updates and select Save.

Deleting a Profile
IMPORTANT: You cannot delete a profile when a sample using that profile is active on
the Worklist.
1. From the Main Menu, select Settings > Test Setup > Profiles.
2. Select the desired profile.
3. Select More > Remove.
4. Select CONFIRM.

User-Defined Test Overview

In some regions, the ORTHO Optix™ Reader allows the use of single column user-
defined tests. These tests allow the system to read and interpret lab-defined tests which
are not available as a part of the test menu.

WARNING:
Each laboratory must establish its own performance characteristics in
compliance with applicable laws and regulations before performing
user-defined tests and reporting patient results. Users are responsible
for following all local or regional regulatory requirements for user-
defined protocols and user-defined reagents.

The system accepts orders for profiles. Profiles contain orders for one or more tests. A
test contains one or more analysis or interpreted result. An analysis or interpreted result
is determined using one or more assays or columns. To create an order for a user-
defined test, create an order for a profile which contains the required test. A user-
defined test contains an analysis or interpreted result which produces results of positive
or negative. An analysis is the result of an assay consisting of one column.

Create user-define tests in the following order:

• Select or define the assay.
• Create the analysis using the selected assay.
• Create the user-define test with the analysis.
• Enable the user-defined test.
• Create a profile with the test.

7-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Getting Started
Training and Reference Guide

User-Defined Assays
IMPORTANT: User-defined tests can use a predefined assay or a user-defined assay. If
using a user-defined assay, you must create that assay before creating
the user-defined test.

Creating a User-Defined Assay

1. From the Main Menu, select Settings > Test Setup > Assays.
2. Select Add.
3. Enter the Assay Name, and select the following:
• Positive Threshold
• Column Type
4. If mixed field detections are desired, select the checkbox next to Enable mixed field
detection.
5. Select a Sample Type.
6. Select Forward.
7. If a reagent is required, select Assign to add it to the Configured Reagents list.
8. Select Forward.
9. Select Save.

Editing a User-Defined Assay

1. From the Main Menu, select Settings > Test Setup > Assays.
2. Select the desired assay.
3. Select Edit.

NOTE: Assays imported from the application data file are predefined, but
the threshold may be modified.

4. Make the required updates and select Save.

Deleting a User-Defined Assay

1. From the Main Menu, select Settings > Test Setup > Assays.
2. Select the desired assay.
3. Select More > Remove.
4. Select CONFIRM.

NOTE: Assays imported from the application data file cannot be removed.

Pub. No.: J66541EN 7-5

2020-02-01
Getting Started ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

User-Defined Analysis

Creating a User-Defined Analysis

1. From the Main Menu, select Settings > Test Setup > Analysis.
2. Select Add.
3. Enter the Analysis Name. The system automatically assigns a PosNeg Analysis
Result.
4. Select Save.

Editing a User-Defined Analysis

1. From the Main Menu, select Settings > Test Setup > Analysis.
2. Select the desired analysis.
3. Select Edit.

NOTE: Analysis imported from the application data file are not editable.

4. Make the required updates and select Save.

Deleting a User-Defined Analysis

1. From the Main Menu, select Settings > Test Setup > Analysis.
2. Select the desired analysis.
3. Select More > Remove.
4. Select CONFIRM.

NOTE: Analysis imported from the application data file cannot be deleted.

User-Defined Tests

Creating a User-Defined Test

CAUTION:
You must validate all new and updated user-defined tests prior to use.

IMPORTANT:
• User-defined analysis must be created prior to creating user-defined tests.
• When naming profiles or tests, avoid using non-alphanumeric characters such as
“&”, and “+”.
1. From the Main Menu, select Settings > Test Setup > Tests.
2. Select Add.
3. Enter the Test Name.
4. Select Forward.

7-6 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Getting Started
Training and Reference Guide

WARNING:
Use only BioVue® Cassettes.

5. Locate the desired cassette, and select Assign.

6. Select Forward.
7. Select the following information:
• Column Type
• Assay (predefined or user defined)
• Analysis
8. Select Forward.
9. Select a Quality Control Mode.
10.Select Forward.
11. Select Save.

Editing a User-Defined Test

CAUTION:
You must validate all new and updated user-defined tests prior to use.

1. From the Main Menu, select Settings > Test Setup > Tests.
2. Select the checkbox next to the desired test.
3. Select Edit.
4. Make the required updates and select Save.

Deleting a User-Defined Test

1. From the Main Menu, select Settings > Test Setup > Tests.
2. Select the checkbox next to the desired test.
3. Select More > Remove.
4. Select CONFIRM.

NOTE: Tests imported from the application data file cannot be removed.

Audit Log

Viewing and Printing the Audit Log for the ORTHO Optix™
Reader Software
NOTE: The ORTHO Optix™ Reader audit log captures activity within the
software.

1. From the Main Menu, select Audit Log.

2. Select More > Print.
3. Select all applicable options, and then select Print.

Pub. No.: J66541EN 7-7

2020-02-01
Getting Started ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Viewing the Audit Log for e-Connectivity® Agent Software

IMPORTANT: The e-Connectivity® audit log is for e-Connectivity® troubleshooting only.
1. Open the e-Connectivity® Agent application.
2. Click the e-Connectivity® logo to display the options menu.
3. Select Tools > View audit log.
4. When the Audit log viewer window displays, select Done.

Importing an Application Data File

IMPORTANT: You should only perform this procedure when instructed by Ortho Care™
or install instructions.
1. From the Main Menu, select Settings > Test Setup > Import from Application
Data.
2. Select CHOOSE FILE and import the Application Data file.
3. Select SUBMIT.

7-8 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Worklist
Training and Reference Guide

Chapter 8: Worklist

This chapter provides instructions for processing orders using the ORTHO Optix™
Reader.

Overview
The Worklist screen displays all orders that are in process.

Orders display on the Worklist after being manually created by a user or imported into
the software through the LIS.

The following statuses display in the Test Status column:

• Ready to Associate
• Ready to Image
• Ready to Review
NOTE: Use the hyperlink in the Test Status column to open a screen
and advance the order to the next step in the workflow.

Reaction Grades
The following table provides reaction grades and corresponding interpretation
descriptions:

Reaction Grades Interpretation Description

4+ Agglutinated cells form a band at the top of the column.
3+ Most agglutinated cells remain in the upper half of the column.
2+ Agglutinated cells observed throughout the length of the
column. A small button of cells may also be visible at the
bottom of the column.
1+ Most agglutinated cells remain in the lower half of the column.
A button of cells will also be visible at the bottom of the
column.
0.5+ Most agglutinated red blood cells pass through and form a
disrupted (not smooth) button at the bottom of the column.
Small agglutinates are visible above the button.
0 (Negative) All red blood cells pass through and form a smooth button at
the bottom of the column.

Refer to the Visual Reference Guide (J39791) for additional

information.

Pub. No.: J66541EN 8-1

2020-02-01
Worklist ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Creating an Order
1. From the Main Menu, select Worklist.
2. Select Add.
3. Select New Patient or Existing Patient, and choose an LIS from the drop-down list.
4. Select Forward.
5. Select the patient from the search results or enter the following information as
applicable to your facility policies and procedures:
• Patient ID
• First Name
• Middle Name
• Last Name
• Date of Birth
• Gender
• Medical Record
• National ID
• Other ID
• Birth Name
• Mother’s Birth Name
• Order Comments
NOTE: The Patient ID must be unique.

6. Select Forward.
7. Enter the Sample ID and select Sample Type, Priority, and Sample Source.
8. Select a profile from the Available Profiles.

NOTE: Profiles are set up on the Settings > Test Setup > Profiles
screen.

9. Select Forward.
10.Review the Summary screen to confirm all the order information is correct.
11. Select Save.

Associating an Order to a Cassette

1. From the Main Menu, select Worklist.
2. Select the Ready to Associate hyperlink for the desired order.
3. Manually enter or scan the Sample ID to validate the sample that is associated with
the order.
4. If you need to choose a specific panel cell or a dilution series, select Edit in the
Association in Progress table.

IMPORTANT: To assure the software reads the cassette barcode correctly, observe that
the barcode on the label is not obstructed or damaged.
5. Select the Cassette Barcode field, scan the cassette barcode with a hand-held
barcode scanner, and then press the Tab or Enter key on the keyboard.

8-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Worklist
Training and Reference Guide

WARNING:
A cassette may contain associations for a different order. To assure the
results are associated with the correct sample, use care when
selecting columns for all associations.

6. Verify that the selected tests are associated with the intended columns of the
cassette. The software defaults the selection on the screen to the first available
column. You may change the selections, so the associations match the test location
on the cassette.

Cassette Software

7. Select Save. The software automatically returns you to the Worklist and displays a
message confirming the association is complete.

Imaging the Cassette and Confirming Image Association

IMPORTANT:
• Refer to the IFU for additional information about proper sample preparation.
• When processing a cassette on the ORTHO Optix™ Reader, follow the product’s IFU
and the Standard Operating Procedures (SOPs) within your facility.
• For best results, capture images of the cassette on the ORTHO Optix™ Reader
immediately after centrifuging the cassette.
• Do not open the top cover of the ORTHO Optix™ Reader during image capture. To
stop the operation of the ORTHO Optix™ Reader, select CANCEL.
• During image capture do not turn off or disconnect the power supply to the ORTHO
Optix™ Reader.
1. From the Main Menu, select Image.
2. Place the cassette into the instrument, and select Image Capture.

IMPORTANT: After you accept the column images, you cannot change the order or the
associations.
3. Carefully review the image quality and the order associations, and select Accept or
Reject.

Pub. No.: J66541EN 8-3

2020-02-01
Worklist ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Reviewing and Editing a Result

IMPORTANT: If the system is configured to automatically accept results and a flag was
not generated for the result, the order is moved from the Worklist to the
Results screen after the image association is confirmed.
1. From the Main Menu, select Worklist.
2. Identify the order.
3. Select Ready to Review hyperlink.

NOTE: Software settings configured by the System Administrator may

add additional requirements during results review, including:
• Requiring a comment when rejecting a result
• Requiring a comment when modifying column grades
• Requiring a different user to accept a result than the user
who imaged the cassette.
4. As applicable, verify the following information is correct for each order before
reviewing the results on the screen:
• Patient ID
• Last Name
• First Name
• Birth Date
• Gender
• Order ID
• Sample ID
• Donor ID
• Priority
5. Review the flag field.

Flag Description
M Results edited by a user
Q QC invalid
X Errors from imaging system
I Indeterminate result
F User-defined test
C Discrepant result
P Below or equal to positive reaction threshold
6. Verify the following information is correct for each test before reviewing the results
on the screen:
• Test
• State
• Analysis
• Result
• Quality Control Status
• Instrument ID
• Processed Date
• Cassette Information such as Name, Barcode, Lot and Expiration
• Column Images
• Assays

8-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Worklist
Training and Reference Guide

• Grade
• Original Grade
• Threshold
• Analysis
• Current Result
• Original Result
• Donor ID (if applicable)
• Reagent Lot Information (if applicable)
NOTE: Multiple tests may exist within the profile. Be sure to review
each test.

7. To modify a grade or a result interpretation, select Edit.

NOTE: A result can no longer be edited once a result has been

accepted with the Accept Result button.

8. If required, enter a comment.

9. Select Accept or Reject.
10. Select CONFIRM.

NOTE: If the result is edited, a second confirmation message displays

on the screen.

Setting up the Remote Computer to Allow a Second User to

Access ORTHO Optix™ Reader Software
1. In the Search field of the Remote Computer, enter Windows Defender Firewall.
2. When the search results display on the screen, select Windows Defender Firewall.
3. When the Windows Defender Firewall window displays, select Advanced
Settings.
4. When the Windows Defender Firewall with Advanced Security window displays,
select Inbound Rules.
5. Select New Rule.
6. When the New Inbound Rule Wizard window displays, choose Port as the rule
type.
7. Choose TCP as the protocol.
8. Choose Specific local ports, and enter 3000.
9. Select Next.
10.Choose Allow the Connection, and select Next.
11. Select Next.
12.Enter the name for the new profile.
13.Select Finish.

NOTE: The Inbound Rules list displays the rules.

14.In the Search field of the Reader Computer, enter IIS.

Pub. No.: J66541EN 8-5

2020-02-01
Worklist ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

15.When the search results displays on the screen, select Internet Information
Services (IIS) Manager > Run as Administrator > Run.
16.When the Internet Information Services (IIS) Manager window displays, expand
the Reader Computer name located in the left pane, and then expand Sites.
17.Select Stratec.Ortho.Reader.Web.Portal, and then select Bindings… located in
the right pane.
18.When the Site Bindings window displays, select the site which has 3000 in the Port
column, and select Edit.
19.When the Edit Site Binding window displays, select the SSL Certificate that
matches the Reader computer name.
20.Select Select... > OK.
21.Select Close.
22.On the Remote Computer, enter the main server address (for example https://us-
593xvp2.ad.orthoclinical.com:3000) either in Chrome browser, and confirm the site
appears as secured.
23.On the Reader Computer, double-click on Powered by STRATEC.
24.When the Version Information window displays, record the URL on the URL for
Remote Users field.
25.On the Remote Computer, open the Chrome browser and enter the URL recorded
from the Reader Computer.

Deleting an Order
1. From the Main Menu, select Worklist.
2. Select the checkbox of the desired order.

NOTE: Multiple orders may be selected at once.

3. Select More > Remove.

4. Select CONFIRM.

NOTE: Orders may be cancelled by the LIS.

Refer to the Laboratory Information System (LIS) Guide (J66549) for

additional information.

Processing an Order Using the Automatically Accept Results

Feature
IMPORTANT: If the system is configured to automatically accept results and a flag was
not generated for the result, the order is moved from the Worklist to the
Results screen after the image association is confirmed.

If the automatically accept results feature is enabled, the test is held when any of the
following circumstances exist:
• Additional results are pending
• User action is required due to a flag or discrepancy with a result
• Quality control is not valid

8-6 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Quality Control
Training and Reference Guide

Chapter 9: Quality Control

This chapter provides the instructions to register, create, edit, and delete quality control
kits.

Overview
The Quality Control screen allows users to configure quality control kits and expected
results, assign quality control kits to tests, and manage the status of quality control. The
software maintains information about Ortho Clinical Diagnostics quality control kits,
which allows users to scan the barcode and the software automatically retrieves the
details. If you add third-party quality control kits to the system, you are responsible for
the kit validation.

To place an order for a test on any sample, including a quality control sample, the test
must be in a profile. The system tracks quality control for each test. If you use a test
requiring quality control in more than one profile, you only need to run quality control for
that test once. The system applies the results of quality control to that test in all profiles,
independent of the ordered profile.

Quality Control Kits

Registering a Quality Control Kit

IMPORTANT: To register a quality control kit and link it to a test, the Quality Control
Mode within each test configuration must be set to MBC.
1. From the Main Menu, select Settings > Test Setup > Tests.
2. Select the desired test.
3. Select Edit.
4. Select MBC, set Expiration Time (Hours) and Expiration Notification (Hours).
5. Select Save.

Creating a Quality Control Kit

IMPORTANT: You must complete this procedure each time a quality control kit expires.
1. From the Main Menu, select Quality Control > Quality Control Kits.
2. Select Add.
3. Enter or scan the barcode for each vial in the kit.
4. Select Forward.
5. Make selections to match tests to QC samples or SELECT ALL.
6. Select Save.

Pub. No.: J66541EN 9-1

2020-02-01
Quality Control ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Processing an Order Using a Quality Control Kit

1. From the Main Menu, select Worklist.
2. Select Add.
3. Select Quality Control Sample, and choose an LIS from the drop-down list.
4. Select Forward.
5. Select a Quality Control Kit.
6. Select one or more Quality Control Sample IDs.
7. Select a Profile.
NOTE: All tests with quality control enabled in the selected profile
display under Applicable Test. If you do not want to run the quality
control sample on a test, use the toggle to disable the test.

8. Select Forward.
9. Review the Summary screen to confirm all the information is correct.
10.Select Save.

Editing a Quality Control Kit

1. From the Main Menu, select Quality Control > Quality Control Kits.
2. Select the desired quality control kit.
3. Select Edit.
4. Make the required updates, and select Save.

Deleting a Quality Control Kit

1. From the Main Menu, select Quality Control > Quality Control Kits.
2. Select the desired quality control kit using the checkbox.
3. Select More > Remove.
4. Select CONFIRM.

Quality Control Status

Status Overview
The status of quality control kits for each of the related profiles can be viewed on the
Quality Control Status screen. The available statuses are:
• Expired
• Failed
• Incomplete
• Not Applicable
• Not Run
• Partial
• Passed

9-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Quality Control
Training and Reference Guide

The Quality Control Status screen provides the status information for each of the profiles
with colored indicators.

The profile is considered passed when the following conditions are met:
• All tests within the profile requiring QC have a QC Status of Passed
The profile is considered partial when the following conditions are met:
• One or more tests within the profile has a QC Status of partial
• No test within the profile have a QC Status of failed
• All tests within the profile are valid and have not expired
The profile is considered failed when the following conditions are met:
• One or more tests within the profile has a QC Status of failed
• One or more test within the profile has a QC status of not run
• One or more tests within the profile are valid and have not expired

NOTE: The Valid Until Date field displays the validity date and time for
a profile. The time between the result date and the valid until
date is referred to as the valid period for the profile.

Viewing the Status of Quality Control

1. From the Main Menu, select Quality Control > Quality Control Status.
2. If desired, select Show Expired Quality Control Kits.

Pub. No.: J66541EN 9-3

2020-02-01
Quality Control ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

9-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Results
Training and Reference Guide

Chapter 10: Results

This chapter provides instructions for viewing results of orders obtained with the
ORTHO Optix™ Reader.

Overview
The Results screen displays the column reaction grades and the interpretation for all
orders processed on the system. Once the results of an order are completed, the order
is removed from the Worklist and added to the Results screen. If the ORTHO Optix™
Reader is interfaced with an LIS, the result is automatically sent to the LIS after being
accepted.

Viewing Completed Results

1. From the Main Menu, select Results.
2. Identify the order.
3. Select the Sample ID or the View Comment hyperlink to open the Result Details
screen.

You cannot approve, reject, reorder or edit results from the Result
Details screen.

Printing an Individual Order Report

You may view the result and then generate an order report.
1. From the Main Menu, select Results.
2. Select the Sample ID and review the completed result.
3. Select Order Report.
4. When the Order Report displays on the screen, select Print.
5. Select the pages and layout.
6. Select Print.

You may generate an order report from the Results screen without viewing the
result.
1. From the Main Menu, select Results.
2. If the Order Number is not visible, enable the Order Number column from
More > Columns.
3. Select the Order Number.
4. When the Order Report displays on the screen, select Print.
5. Select the pages and layout.
6. Select Print.

Pub. No.: J66541EN 10-1

2020-02-01
Results ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Resending a Result to the LIS

IMPORTANT: When the automatically accept results feature is enabled, the software
sends results to the LIS automatically.
1. From the Main Menu, select Results.
2. Identify the sample to be exported.
3. Select More > Export to LIS.

10-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Reports
Training and Reference Guide

Chapter 11: Reports

This chapter provides instructions for generating, viewing, and printing the reports.

Overview
Within the Reports screen, users can create reports for display, print, or export. The
reports include information such as laboratory details, patient data, order details, and
report creation details.

Generating and Printing a Report

1. From the Main Menu, select Reports.
2. Select a Report from the drop-down list.
3. Enter the required information.
4. Select VIEW REPORT.
5. Select Print.
6. Select a page size and page orientation from the drop-down list, and select Print.

NOTE: Reports can also be saved to PDF by selecting PDF from the
export drop-down list when a report is in view state.

Pub. No.: J66541EN 11-1

2020-02-01
Reports ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

11-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Software Backup
Training and Reference Guide

Chapter 12: Software Backup

This chapter provides the instructions for backing up and restoring the database.

Overview
To avoid data loss, regular backups are recommended. Follow your laboratories IT
policies for backing up and maintaining system data.

Creating a Backup
1. From the Main Menu, select Backup.
2. Select the following type of backup as applicable:
• All data backup
• Configuration backup
3. Enter the location in the Database Backup Location field, and select START
BACKUP.

Restoring the Database from a Backup

This feature allows the user to return the system to the point of the backup that is being
restored.
1. From the Main Menu, select Settings > Restore Menu.
2. Select the following type of restore as applicable:
• Backup of Configuration Only
• Backup of Complete Database
3. Enter the location in the Back-up File Path field, and select LOAD DETAILS.
4. Select the following databases as applicable:
• Working
• Metadata
• Security
5. Select RESTORE.
6. Select CONFIRM.

Pub. No.: J66541EN 12-1

2020-02-01
Software Backup ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

12-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Maintenance and Diagnostic Procedures
Training and Reference Guide

Appendix A: Maintenance and

Diagnostic Procedures

This appendix provides the instructions on how to execute maintenance, cleaning,

replacement, and diagnostic activities in the ORTHO Optix™ Reader.

Shutdown and Startup Procedure

1. Log out of the ORTHO Optix™ Reader software and close the browser.
2. Turn off the ORTHO Optix™ Reader.
3. Restart the Reader computer.
4. Log into the Reader computer.
5. Wait until the Windows start-up screen displays, and then turn on the ORTHO
Optix™ Reader.

NOTE: The status indicator on the instrument blinks green and red.

6. Log into the ORTHO Optix™ Reader software.

7. From the Main Menu, select Settings > Diagnostics > Initialize Imaging System.
8. Select START.

NOTE: When the instrument is initialized, the status indicator is green.

If the status indicator is red or flashing red, view the
Notifications for an associated error message.

Maintenance and Cleaning Procedures

In normal use, the ORTHO Optix™ Reader requires minimal maintenance. Maintenance
procedures are recommended periodically to ensure that the instrument remains in
optimum working condition. The maintenance log provided in Appendix B should be
used to document the maintenance procedures executed for the system.

BIOHAZARD WARNING:
The instrument processes results of a cassette that may contain
potentially biohazardous materials. Operate the instrument in
compliance with your laboratory procedures for handling biohazardous
materials, and in accordance with the procedures defined by the
appropriate national biohazard safety guidelines or regulations. Users
should wear Personal Protective Equipment, and follow applicable
regulatory agency safety guidelines.

WARNING:
Log out of the ORTHO Optix™ Reader software and close the browser,
turn off the instrument, and disconnect the power supply and USB
cable, then shut down the computer before cleaning the instrument.

Pub. No.: J66541EN A-1

2020-02-01
Maintenance and Diagnostic Procedures ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

IMPORTANT:
• Keep the TOP COVER of the ORTHO Optix™ Reader closed when not in use.
• Perform the Routine Cleaning and Disinfection Procedure prior to moving the
system within your laboratory.
• Perform the Routine Cleaning and Disinfection Procedure and Cleaning the
Illumination Chamber procedure before returning the instrument to Ortho Clinical
Diagnostics, Inc. or your distributor.
• T10 Torx® screwdriver and a T20 Torx® screwdriver are required to perform some
nonroutine aspects of system cleaning and some part replacement procedures.

• Refer to Chapter 1 Introduction for the instrument overview.

• Refer to the Ready for Recycling Instructions (J66622) and EU
WEEE Treatment Instructions (J67182) for additional information.
• Refer to Appendix D Parts List for parts identification.

Routine Cleaning and Disinfection Procedure

Use the following procedure for routine cleaning and disinfection of the ORTHO Optix™
Reader, to address error conditions and as when determined by your lab’s practices.
1. Log out of the ORTHO Optix™ Reader software and close the browser.

WARNING:
To prevent personal injury from moving parts and damage to the
equipment, use care while accessing the instrument.

2. Turn off the instrument, disconnect the power cable, power supply, and USB cable
from the instrument, and shut down the computer.
3. Open the TOP COVER, unscrew the THUMB NUT from under the instrument and
slide the CASSETTE HOLDER ASSEMBLY out of the top of the instrument.
4. Using a cloth moistened with mild detergent, clean both sides of the TOP COVER,
and the entire exterior of the main HOUSING and REAR PLATE. Remove any
remaining detergent residue with a cloth moistened with clean water. Disinfect with a
lint-free cloth moistened with 70% Isopropyl alcohol.
5. Identify the DIFFUSER and ILLUMINATION COVER.
6. Using a cloth moistened with mild detergent, clean the DIFFUSER and the
ILLUMINATION COVER. Remove any remaining detergent residue with a cloth
moistened with clean water. Disinfect with a lint-free cloth moistened with 70%
Isopropyl alcohol.
7. Close the TOP COVER and turn the instrument upside down making sure to avoid
damaging the top of the instrument.
8. Using a cloth moistened with mild detergent, clean the exterior of the BOTTOM
PLATE and feet. Remove any remaining detergent residue with a cloth moistened
with clean water. Disinfect with a lint-free cloth moistened with 70% Isopropyl
alcohol.
9. Using a cloth moistened with mild detergent, clean the CASSETTE HOLDER
ASSEMBLY and THUMB NUT. Remove any remaining detergent residue with a cloth
moistened with clean water. Disinfect with a lint-free cloth moistened with 70%
Isopropyl alcohol.

A-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Maintenance and Diagnostic Procedures
Training and Reference Guide

10. Open the TOP COVER by holding the CASSETTE HOLDER ASSEMBLY in place
while fastening the THUMB NUT from underneath. Ensure that the CASSETTE
HOLDER ASSEMBLY is flush with the HOUSING and that the THUMB NUT is
secure.
11. Confirm that the USB cable and the power cable are disconnected from the wall
outlet and the instrument. Using a cloth moistened with mild detergent, clean the
USB cable, POWER SUPPLY, and power cable. Remove any remaining detergent
residue with a cloth moistened with clean water. Disinfect with a lint-free cloth
moistened with 70% Isopropyl alcohol.
12. Allow the surfaces to air-dry completely.

Cleaning and Inspecting the Lens

WARNING:
Do not remove or adjust the lens.

IMPORTANT:
• Cleaning and inspecting the lens is not part of routine maintenance. You should only
perform this procedure when instructed by Ortho Care ™.
• T10 Torx® screwdriver and a T20 Torx® screwdriver are required to perform this
procedure.

1. Log out of the ORTHO Optix™ Reader software and close the browser.

WARNING:
To prevent personal injury from moving parts and damage to the
equipment, use care while accessing the instrument.

2. Turn off the instrument, disconnect the POWER SUPPLY and USB cable, and shut
down the computer.
3. Close the TOP COVER and turn the instrument upside down onto a protective
padded surface.
4. Remove the THUMB NUT.
5. Using a T10 Torx® screwdriver, remove the T10 ground screw.
6. Using a T20 Torx® screwdriver, loosen the 5 remaining T20 screws located on the
BOTTOM COVER of the instrument.
7. Remove the BOTTOM COVER.
8. Clean the lens with a lint-free microfiber cloth.
9. Install the BOTTOM COVER and secure it with the screws.
10. Install the THUMB NUT.
11. Turn the instrument upright.
12. Restart the computer.
13. Turn on the I/O power switch on the ORTHO Optix™ Reader.
14. Open the ORTHO Optix™ Reader software and log-in.

Pub. No.: J66541EN A-3

2020-02-01
Maintenance and Diagnostic Procedures ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

15. From the Main Menu in the software, select Settings > Diagnostics and complete
the following tasks:
• Initialize Imaging System
• Check Focus
• Check Field of View

Cleaning the Illumination Chamber

IMPORTANT:
• Cleaning the Illumination Chamber is not part of routine maintenance. You should
only perform this procedure when instructed by Ortho Care ™.
• T10 Torx® screwdriver and a T20 Torx® screwdriver are required to perform this
procedure.

1. Log out of the ORTHO Optix™ Reader software and close the browser.

WARNING:
To prevent personal injury from moving parts and damage to the
equipment, use care while accessing the instrument.

2. Turn off the instrument, disconnect the POWER SUPPLY and USB cable, and shut
down the computer.
3. Close the TOP COVER and turn the instrument upside down onto a protective
padded surface.
4. Remove the THUMB NUT.
5. Using a T10 Torx® screwdriver, remove the T10 ground screw.
6. Using a T20 Torx® screwdriver, loosen the 5 remaining T20 screws located on the
BOTTOM COVER of the instrument.
7. Remove the BOTTOM COVER.
8. Using a cloth moistened with mild detergent, clean the DIFFUSER and
ILLUMINATION COVER. Remove any remaining detergent residue with a cloth
moistened with clean water. Wipe the instrument with a lint-free cloth moistened with
70% Isopropyl alcohol.
9. Allow the surfaces to air-dry completely.
10. Install the BOTTOM COVER and secure it with the screws.
11. Install the THUMB NUT.
12. Turn the instrument upright.
13. Restart the computer.
14. Turn on the I/O power switch on the ORTHO Optix™ Reader.
15. Open the ORTHO Optix™ Reader software and log-in.

A-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Maintenance and Diagnostic Procedures
Training and Reference Guide

16. From the Main Menu in the software, select Settings > Diagnostics and complete
the following tasks:
• Initialize Imaging System
• Check Focus
• Check Light Leak
• Check Field of View
• Check Illumination
• Check Empty Chamber

Replacement Procedures

BIOHAZARD WARNING:
The instrument processes results of a cassette that may contain
potentially biohazardous materials. Operate the instrument in
compliance with your laboratory procedures for handling biohazardous
materials, and in accordance with the procedures defined by the
appropriate national biohazard safety guidelines or regulations.
Instrument users should wear Personal Protective Equipment, and
follow applicable regulatory agency safety guidelines.

Cassette Holder Replacement

1. Log out of the ORTHO Optix™ Reader software and close the browser.

WARNING:
To prevent personal injury from moving parts and damage to the
equipment, use care while accessing the instrument.

2. Turn off the instrument, disconnect the POWER SUPPLY and USB cable, and shut
down the computer.
3. Turn the instrument on its side onto a protective padded surface and open the TOP
COVER.
4. Remove the THUMB NUT.
5. Remove the CASSETTE HOLDER through the opening in the TOP COVER.

WARNING:
Discard the CASSETTE HOLDER in compliance with your laboratory
procedures for handling biohazardous materials.

6. Discard the old CASSETTE HOLDER.

7. Install the new CASSETTE HOLDER.
8. Install the THUMB NUT.
9. Turn the instrument upright.
10. Restart the computer.
11. Turn on the I/O power switch on the ORTHO Optix™ Reader.
12. Open the ORTHO Optix™ Reader software and log-in.

Pub. No.: J66541EN A-5

2020-02-01
Maintenance and Diagnostic Procedures ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

13. From the Main Menu in the software, select Settings > Diagnostics and complete
the following tasks:
• Initialize Imaging System
• Initialize Motor
• Check Field of View

Top Cover Replacement

1. Log out of the ORTHO Optix™ Reader software and close the browser.

WARNING:
To prevent personal injury from moving parts and damage to the
equipment, use care while accessing the instrument.

2. Turn off the instrument, disconnect the POWER SUPPLY and USB cable, and shut
down the computer.
3. Open the TOP COVER.
4. Using a T10 Torx® screwdriver, remove the 8 T10 screws from the hinges and place
them in a safe location.

WARNING:
Discard the TOP COVER in compliance with your laboratory
procedures for handling biohazardous materials.

5. Discard the old TOP COVER.

6. Install the new TOP COVER using the screws you removed from the old TOP
COVER.
7. Restart the computer.
8. Turn on the I/O power switch on the ORTHO Optix™ Reader.
9. Open the ORTHO Optix™ Reader software and log-in.
10. From the Main Menu in the software, select Settings > Diagnostics and complete
the following task:
• Initialize Imaging System
• Check Light Leak

A-6 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Maintenance and Diagnostic Procedures
Training and Reference Guide

Hand-Held Barcode Scanner Replacement

Refer to Chapter 6 Instrument Installation and Setup for Setting up the

Keyboard and the Hand-Held Barcode Scanner.

Power Supply Replacement

1. Log out of the ORTHO Optix™ Reader software and close the browser.

WARNING:
To prevent personal injury from moving parts and damage to the
equipment, use care while accessing the instrument.

2. Turn off the instrument, disconnect the POWER SUPPLY and USB cable, and shut
down the computer.
3. Replace the power supply.
4. Restart the computer.
5. Turn on the I/O power switch on the ORTHO Optix™ Reader.
6. Open the ORTHO Optix™ Reader software and log-in.
7. From the Main Menu in the software, select Settings > Diagnostics and complete
the following task:
• Initialize Imaging System

Diagnostic Procedures

First-Time Setup
Performs all required diagnostics actions when setting up a new or installing a
replacement of ORTHO Optix™ Reader.

Adjustments

Function Description
Initialize Imaging System Initializes the instrument.
Calibrate Lighting Adjusts the lighting inside of the instrument.
Check Focus Determines if the camera lens is focused.

Pub. No.: J66541EN A-7

2020-02-01
Maintenance and Diagnostic Procedures ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Diagnostics

Function Description
Analyze Cassette Used to troubleshoot the workflow process. This
procedure simulates all events, including imaging
and grading a cassette.
Obtain Serial Number Provides the serial number of the instrument.
Obtain Calibration Results Provides the most recent illumination calibration
results.
Obtain Camera Firmware Provides the firmware version for the camera.
Information
Obtain Microcontroller Provides the firmware version for the
Firmware Information microcontroller board.
Obtain Imaging System Provides a status of the imaging system.
Status
Capture Grayscale Image Captures and saves a monochrome image.
Check Light Leak Checks the illumination chamber for proper lighting.
Check Field of View Determines the camera has the correct field of
view.
Check Illumination Checks the uniformity of the lighting from the front
and back LEDs.
Check Empty Chamber Checks that the illumination chamber is empty.
Capture Color Image Captures and saves a color image.
Initialize Motor Initializes the rotor and the diffuser motors.
Test Diffuser Motor Checks that the diffuser motor is operating
correctly.
Test Rotor Motor Checks that the rotor motor is operating correctly.
Check Pixels Checks that the pixels in the image are not over or
under responsive.

Using the Software to Complete an Adjustment or

Diagnostic Procedure
1. From the Main Menu, select Settings > Diagnostics.
2. Select the desired adjustment or diagnostic task, and then select START.

NOTE: Multiple procedures may be selected at once.

3. Wait for the status to display on the screen.

A-8 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Maintenance Log
Training and Reference Guide

Appendix B: Maintenance Log

Use this Maintenance Log to document all cleaning activities.

Hospital / Facility: ______________________________________________________________

Instrument Serial Number: _______________________________________________________

Procedure Date Performed Initials

Reviewed by: ___________________________________ Date: _________________________

Pub. No.: J66541EN B-1

2020-02-01
Maintenance Log ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

B-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Appendix C: Error Codes,

Possible Causes, and
Recommended Actions

This appendix provides an overview of the error messages that may occur while using
the ORTHO Optix™ Reader, and provides recommended actions for resolving the error.
If additional assistance is needed to resolve an error condition, contact Ortho Care™ or
your distributor.

The messages are categorized into three severity levels (from high to low).
• Error - Is the most severe notification, and requires an immediate response from the
user. The notification displays as red and takes precedence over Warning and
Information severity messages.
• Warning - Used to notify the user about important issues that require some level of
action. The notification displays as amber and takes precedence over Information
severity messages.
• Information - Used to notify the user about issues requiring no further action. The
notification displays as green.

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM001 Error Error identifying the barcode. The cassette being scanned 1. Check that the cassette
{Message} does not match the being imaged or
order on the worklist. scanned matches the
cassette barcode
associated with the order
on the worklist. If the
barcode does not match,
check that the proper
cassette is being imaged
or scanned, or edit the
association.
2. Check the barcode on
the cassette for any
imperfections that would
prevent the barcode from
being scanned.
CAMM002 Error Error identifying the barcode. The camera identified 1. Check that no additional
Multiple barcodes were multiple barcodes on the barcodes are attached to
found. {Message} cassette. the cassette.
2. Check the barcode on
the cassette for any
imperfections that would
prevent the barcode from
being scanned.
CAMM003 Error Error identifying the barcode. The camera is unable to Check the cassette to make
Barcode was not found. locate the barcode when sure the barcode is not
{Message} scanning the cassette. obstructed from the camera,
damaged, or missing. Scan
the cassette again.

Pub. No.: J66541EN C-1

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM004 Error Error identifying the barcode. The camera located an 1. Check no additional
{Message} unexpected barcode when barcodes are attached to
scanning the cassette. the cassette.
2. Check that the barcode
is available on the
cassette.
CAMM005 Error Error calibrating the An error occurred during 1. Inspect the diffuser for
instrument. {Message} LED calibration. debris or damage.
2. From the Main Menu in
The illumination LEDs are
the software, select
not functioning properly or
Settings > Diagnostics
the diffuser is obstructed.
and complete the Check
Illumination task to check
the uniformity of the
lighting.
3. Investigate images in the
calibration folder to
determine sequence of
calibration images that
continuously increase in
brightness.
CAMM006 Error Error calibrating the Software detected a serial From the Main Menu in the
instrument. Calibration is number change. software, select Settings >
required. {Message} Diagnostics and complete
the First-Time Setup task.
CAMM007 Error Error verifying the operation Communication with the 1. Check the cable
of the camera. {Message} camera failed. connections.
2. Check that the
instrument is turned on.
3. Log out of the software
and close the browser.
4. Turn off the instrument
and the Reader
computer.
5. Restart the Reader
computer and turn on the
instrument.
6. Log into the ORTHO
Optix™ Reader
software.

C-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM008 Error Error imaging the cassette. The cassette holder is not 1. Log out of the software
Cassette was not rotated. seated properly. and close the browser.
{Message}
2. Turn off the instrument.
The shaft or bushing on the
cassette holder is dirty. 3. Shut off the power and
shutdown the Reader
Obstructed motion of the computer.
cassette.
4. Disconnect the power
supply and USB cable.
Dirty or defective sensor.
5. Check for an obstruction
in the gear motor that
Damaged or defective would prevent the
cassette holder gears. rotation of the cassette.
6. Check the cassette
Damaged or defective motor.
holder is properly
installed with thumb nut
and moves freely when
rotated manually.
7. Check for the bushing in
the main housing or
shaft on the cassettes
holder for debris and
clean if necessary.
8. Inspect the sensor for
debris and clean as
necessary.
9. Remove the cassette or
debris from the imaging
system.
10. Properly seat the
cassette holder.
11. Connect the power
supply and USB cable.
12. Restart the Reader
computer and turn on the
instrument.
13. Log into the ORTHO
Optix™ Reader
software.
14. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Initialize Imaging
System
CAMM009 Error Error imaging the cassette. Unexpected error. Software If error persists, contact
Cassette is inserted in the resolves backwards Ortho Care™.
instrument backwards. cassettes automatically.
{Message}
CAMM010 Error Error calibrating the Physical machine change 1. Retry calibration setup in
instrument. {Message} has been detected during diagnostics.
calibration.
2. If that fails to a first time
set up.
3. Inspect optical path,
clean if necessary and
retry calibration.

Pub. No.: J66541EN C-3

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM011 Error Error communicating with the The top cover is open when 1. Close the top cover.
instrument. Close the cover. it was expected to be closed.
2. Check that the magnet is
{Message}
clear of debris or
The magnet or reed switch
obstructions.
is disconnected, damaged or
missing.
CAMM012 Error Error communicating with the The diffuser did not move as 1. Log out of the software
instrument. Diffuser is not in expected. and close the browser.
the expected position.
2. Turn off the instrument.
{Message} The linear actuator or sensor
failed. 3. Shut off the power and
shutdown the Reader
computer.
4. Disconnect the power
supply and USB cable.
5. Check for an obstruction
that would prevent the
diffuser from moving
correctly.
6. Properly seat the
cassette holder.
7. Connect the power
supply and USB cable.
8. Restart the Reader
computer and turn on the
instrument.
9. Log into the ORTHO
Optix™ Reader
software.
10. From the Main Menu in
the software, select
Settings > Diagnostics
and perform the
following tasks:
- Initialize Motor
- Initialize Imaging
System

C-4 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM013 Error Error verifying the field of The image processing 1. Log out of the software
view. {Message} system detected the top and close the browser.
corners of the cassette
2. Turn off the instrument.
holder are in a different
position than previously 3. Disconnect the power
detected. supply and the USB
cable from the Reader.
4. Reseat the cassette
holder.
5. Check that the thumb nut
is tight.
6. Connect the power
supply and the USB
cable.
7. Restart the Reader
computer.
8. Turn on the instrument.
9. Log into the ORTHO
Optix™ Reader
software.
10. From the Main Menu in
the software, select
Settings > Diagnostics
and perform the
following tasks:
- Check Field of View
- Calibrate Lighting
11. Repeat the Check Field
of View task.
CAMM014 Error Error communicating with the The camera detected an 1. Log out of the software
imaging system. {Message} illumination failure. and close the browser.
2. Turn off the instrument.
Illumination (front or back
LEDs) at the diffuser has 3. Shut off the power and
changed since calibration. shutdown the Reader
Illumination LEDs not computer.
connected.
4. Disconnect the power
supply and USB cable.
5. Inspect / clean the
diffuser.
6. Connect the power
supply and USB cable.
7. Restart the Reader
computer and turn on the
instrument.
8. Log into the ORTHO
Optix™ Reader
software.
9. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Calibrate Lighting
CAMM015 Error Error communicating with the The camera detected a light Check the top and bottom
instrument. Light leak leak. covers are closed.
detected. {Message}

Pub. No.: J66541EN C-5

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM016 Error Error communicating with the The camera had an I/O 1. Check the cable
instrument. {Message} exception. connections.
2. Check power.
3. Restart the software.
4. Check the available disk
space.
CAMM017 Error Error verifying focus. Unexpected error. Focus is If error persists, contact
{Message} fixed. Ortho Care™.

CAMM018 Error Error communicating with the The software could not 1. Log out of the software
imaging system. {Message} communicate with the and close the browser.
imaging system.
2. Turn off the instrument.
3. Disconnect the power
supply and the USB
cable from the Reader.
4. Connect the power
supply and the USB
cable.
5. Restart the Reader
computer.
6. Turn on the instrument.
7. Log into the ORTHO
Optix™ Reader
software.
8. From the Main Menu in
the software, select
Settings > Diagnostics
and perform the
following tasks:
- Initialize Imaging
System
CAMM019 Error Error communicating with the Firmware reports an error From the Main Menu in the
instrument. Motor issue while the imaging system software, select Settings >
detected. {Message} could not move the motor. Diagnostics and complete
the following tasks:
- Initialize Motor
- Initialize Imaging
System

C-6 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM020 Error Error communicating with the Communication with the 1. Log out of the software
instrument. Microcontroller MicroController has failed. and close the browser.
issue detected. {Message}
2. Turn off the instrument.
The software could not
communicate with the 3. Shut off the power and
imaging system. shutdown the Reader
computer.
4. Disconnect the power
supply and USB cable.
5. Connect the power
supply and USB cable.
6. Restart the Reader
computer and turn on the
instrument.
7. Log into the ORTHO
Optix™ Reader
software.
8. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Initialize Imaging
System
CAMM021 Error Error communicating with the The diffuser did not move 1. Log out of the software
instrument. {Message} into position within the time and close the browser.
allowed.
2. Turn off the instrument.
3. Disconnect the power
supply and the USB
cable from the Reader.
4. Remove the cassette or
debris from the imaging
system.
5. Remove the cassette
holder.
6. Check for an obstruction
that would prevent the
diffuser from moving
correctly.
7. Seat the cassette holder
in the instrument.
8. Connect the power
supply and USB cable.
9. Restart the Reader
computer and turn on the
instrument.
10. Log into the ORTHO
Optix™ Reader
software.
11. From the Main Menu in
the software, select
Settings > Diagnostics
and perform the
following tasks:
- Initialize Motor
- Initialize Imaging
System

Pub. No.: J66541EN C-7

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM022 Error Error communicating with the The diffuser did not move 1. Log out of the software
instrument. {Message} into the expected position. and close the browser.
2. Turn off the instrument.
3. Shut off the power and
shutdown the Reader
computer.
4. Disconnect the power
supply and USB cable.
5. Remove and inspect the
cassette holder.
6. Check for an obstruction
that would prevent the
diffuser from moving
correctly.
7. Connect the power
supply and USB cable.
8. Restart the Reader
computer and turn on the
instrument.
9. Log into the ORTHO
Optix™ Reader
software.
10. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Initialize Imaging
System

C-8 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM023 Error Error communicating with the Rotor did not move into the 1. Log out of the software
instrument. Rotor issue expected position. and close the browser.
detected. {Message}
2. Turn off the instrument.
3. Shut off the power and
shutdown the Reader
computer.
4. Disconnect the power
supply and USB cable.
5. Remove the cassette or
debris from the imaging
system.
6. Remove the cassette
holder.
7. Inspect the cassette
holder shaft and bushing
and clean if necessary.
8. Check for an obstruction
that would prevent the
diffuser from moving
correctly.
9. Connect the power
supply and USB cable.
10. Restart the Reader
computer and turn on the
instrument.
11. Log into the ORTHO
Optix™ Reader
software.
12. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Initialize Imaging
System
CAMM024 Error Error communicating with the Some features of the Use a different cassette.
instrument. Non-Ortho cassette were not as
cassette detected. expected. Cassette may not
{Message} have been manufactured by
Ortho.

Pub. No.: J66541EN C-9

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM025 Error Error communicating with the The software cannot 1. Log out of the software
imaging system. {Message} communicate with the and close the browser.
imaging system.
2. Turn off the instrument.
Cable disconnected.
3. Shut off the power and
shutdown the Reader
computer.
Imaging system powered off.
4. Disconnect the power
supply and USB cable.
Imaging system not in ready
5. Remove the cassette or
state.
debris from the imaging
system.
Imaging system software or
firmware has stopped. 6. Connect the power
supply and USB cable.
7. Restart the Reader
computer and turn on the
instrument.
8. Log into the ORTHO
Optix™ Reader
software.
9. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Initialize Imaging
System
CAMM026 Error Error communicating with the Developer condition code not No action is required.
instrument. Previous move utilized by the software.
not complete. {Message}
CAMM027 Error Error communicating with the Developer condition code 1. From the Main Menu in
instrument. Previous Sequence 1 or 2 did not the software, select
sequence not complete. complete in proper Settings > Diagnostics
{Message} sequence. and perform:
- Initialize Imaging
System
2. Restart the software.
CAMM028 Error Error communicating with the Firmware reported an error 1. From the Main Menu in
instrument. Motor issue while the imaging system the software, select
detected. {Message} could not move the rotor Settings > Diagnostics
motor. and perform:
- Initialize Imaging
System
CAMM029 Error Error communicating with the Software detected a serial 1. From the Main Menu in
instrument. Serial number number change. the software, select
mismatch detected. Settings > Diagnostics
{Message} and perform:
- First-Time Setup
2. If the error persists,
verify that the
RegistrationInterface.sol
dat file is not set as read
only.

C-10 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CAMM030 Error Error communicating with the The software cannot 1. Log out of the software
imaging system. {Message} communicate with the and close the browser.
imaging system.
2. Turn off the instrument.
Cable disconnected.
3. Shut off the power and
shutdown the Reader
computer.
Imaging system powered off.
4. Disconnect the power
supply and USB cable.
Imaging system not in ready
5. Remove the cassette or
state.
debris from the imaging
system.
Imaging system software or
firmware has stopped. 6. Connect the power
supply and USB cable.
7. Restart the Reader
computer and turn on the
instrument.
8. Log into the ORTHO
Optix™ Reader
software.
9. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Initialize Imaging
System
CAMM031 Error Error communicating with the The software cannot 1. Log out of the software
imaging system. {Message} communicate with the and close the browser.
imaging system.
2. Turn off the instrument.
Cable disconnected.
3. Shut off the power and
shutdown the Reader
computer.
Imaging system powered off.
4. Disconnect the power
supply and USB cable.
Imaging system not in ready
5. Remove the cassette or
state.
debris from the imaging
system.
Imaging system software or
firmware has stopped. 6. Connect the power
supply and USB cable.
7. Restart the Reader
computer and turn on the
instrument.
8. Log into the ORTHO
Optix™ Reader
software.
9. From the Main Menu in
the software, select
Settings > Diagnostics
and perform:
- Initialize Imaging
System
CMEXP01 Error Error exporting image. User deleted LIS device In the software, check that
Export of {orderIdentifier} to configuration. the LIS is available.
{deviceType} {deviceName}
was not successful. {path}
does not exist.

Pub. No.: J66541EN C-11

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CMEXP02 Error Error exporting image. LIS has been deactivated. In the software, check that
Export of {orderIdentifier} to the LIS is available.
{deviceType} {deviceName}
was not successful. An error
occurred when writing to
{path}.
CMEXP03 Error Error exporting LIS host query could not be In the software, check that
{orderIdentifier} to sent. the LIS is available.
{deviceType} {deviceName}.
The device configuration was
deleted.
CMEXP04 Error Error exporting LIS has been deactivated. Check the LIS configuration.
{orderIdentifier} to
{deviceType}
{deviceName}. The device is
disabled.
CMLIS01 Error Error processing order. Order not found. Check download shared
Cancellation message was folder to determine if orders
ignored. An order from are being transferred by LIS.
{category} {deviceName} for
{patientIdentifier},
{sampleIdentifier}, and
{profileName} does not
exists.
CMLIS02 Error Error processing order. Order cancellation request Check download shared
Cancellation message was was already received from a folder to determine if orders
ignored. Message from different LIS. are being transferred by LIS.
{category} {deviceName} for
{patientIdentifier},
{sampleIdentifier}, and
{profileName} were created
on a different {category}.
CMLIS03 Error Error processing order. One Generic error with order. 1. Refer to the notification
or more validation errors for detailed information.
contained in
2. Check download shared
OC_COM_LIS_U003.
folder to determine if
Message received from
orders are being
{category} {device} for
transferred by LIS.
{patientIdentifier},
{sampleIdentifier}, and 3. Check the LIS
{profileName} included configuration (LIS side).
{errors}.
4. Check the LIS
configuration (Reader
side).
CMLIS04 Error Error processing an order Generic error with order. 1. Refer to the notification
received from {deviceType} for detailed information.
{deviceName}.
2. Check download shared
folder to determine if
orders are being
transferred by LIS.
3. Check the LIS
configuration (LIS side).
4. Check the LIS
configuration (Reader
side).

C-12 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CMLIS05 Error Error processing order. Generic error with order. 1. Refer to the notification
Message received from for detailed information.
{category} {device} was not
2. Check download shared
processed because the
folder to determine if
value translations are not
orders are being
available for
transferred by LIS.
{deviceTranslationsNotCon-
figured}. 3. Check the LIS
configuration (LIS side).
4. Check the LIS
configuration (Reader
side).
CMLIS06 Error Error processing order. Generic error with order. 1. Refer to the notification
Message received from for detailed information.
{category} {device} was not
2. Check download shared
processed because the
folder to determine if
value translations are not
orders are being
available for
transferred by LIS.
{deviceTranslationsNotCon-
figured}. 3. Check the LIS
configuration (LIS side).
4. Check the LIS
configuration (Reader
side).
CMLIS07 Error Error processing order. Generic error with order. 1. Refer to the notification
Message received from for detailed information.
{category} {device} was not
2. Check download shared
processed because the
folder to determine if
value translations are not
orders are being
available for
transferred by LIS.
{deviceTranslationsNotCon-
figured}. 3. Check the LIS
configuration (LIS side).
4. Check the LIS
configuration (Reader
side).
CMLIS08 Error Error processing order. Profile not configured. Error 1. Check the LIS profile
Message received from with profile name. mapping.
{deviceType} {deviceName}
2. Check the profile
could not be processed. One
configuration.
or more order records
contains an invalid universal 3. Check order sent by LIS.
test ID (O@5) record.
4. Check download shared
folder to determine if
orders are being
transferred by LIS.
5. Enable additional test
profile.
CMLIS09 Error Error processing message. Invalid data sent from the Check download shared
Message from {deviceType} LIS. folder to determine if orders
{deviceName} could not be are being transferred by LIS.
processed. One or more
records do not contain a
patient identifier (P@3)
record.

Pub. No.: J66541EN C-13

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CMLIS10 Error Error processing order. User attempted to cancel the 1. Check cancellation was
Cancellation message was order after it was processed. for correct order.
ignored. Message received This could occur when:
2. Check the LIS to verify
from {category} - LIS order is sent into
the intended order was
{deviceName} Reader
selected.
for {patientIdentifier}, - Result is then received from
{sampleIdentifier} and the instrument and the
{profileName}, but the order status of the order changes
has a result. - A cancellation message for
the order is subsequently
sent from the LIS
The software do not cancel
the order once a result is
generated. The user should
check that they have
cancelled the correct order in
the LIS. If they have
cancelled the correct one,
they will need to reject/
accept the result in the
software.
CMLIS11 Error Error processing order. Order cancellation message Check cancellation was for
Cancellation message was was not received. the correct order.
ignored. Message received
from {category}
{deviceName} for
{patientIdentifier},
{sampleIdentifier} and
{profileName}, but the order
is not on the worklist.
CMLIS12 Error Error processing message. Invalid data sent from the LIS 1. Check download shared
Message for {profileName} folder to determine if
received from {category} orders are being
{deviceName} could not be transferred by LIS.
processed. {profileName}
2. Check the LIS
contains crossmatch tests,
configuration (LIS side).
but the universal test
identifier for
{sampleIdentifier} does not
contain donor sample
information.
CMLIS13 Error Error processing an order The LIS previous results 1. Check download shared
received from {deviceType} display option could not be folder to determine if
{deviceName}. The previous found. orders are being
result of transferred by LIS.
{previousResultValue} does
2. Check the LIS
not match any display option
configuration (LIS side).
alias defined by the current
application data.
CMLIS14 Error Error processing an order The LIS previous results 1. Check download shared
received from {deviceType} display option could not be folder to determine if
{deviceName}. Unable to found. orders are being
resolve a display option for a transferred by LIS.
previous result. Incorrect
2. Check the LIS
nomenclature may be
configuration (LIS side).
configured in the result
mappings for the LIS.
Display options are resolved
for {displayOptionNames}.

C-14 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
CMLIS15 Error Error processing an order The LIS previous results 1. Check download shared
received from {deviceType} possible result could not be folder to determine if
{deviceName}. Unable to found. orders are being
resolve a possible result for a transferred by LIS.
previous result. The
2. Check the LIS
{possibleResultNames} may
configuration (LIS side).
be resolved.
CMLIS16 Error Error processing an order The LIS previous results test 1. Check download shared
received from {deviceType} analysis specification could folder to determine if
{deviceName}. The previous not be found. orders are being
result analysis of transferred by LIS.
{previousResultInterpreta-
2. Check the LIS
tion} does not match any test
configuration (LIS side).
analysis defined by the
current application data.
CMLIS17 Warning Error processing message. Image directory does not 1. Check the directory of
Message for exist. LIS configuration.
{sampleIdentifier} and
2. Check directory exists.
{profileNames} was
received, but was already 3. Check permissions on
processed. directory.
4. Check the LIS
connection (physical or
permissions).
5. Check the LIS
configuration (LIS side).
6. Check download shared
folder to determine if
orders are being
transferred by LIS.
CMLIS18 Information An order for Image write error. 1. Check the directory of
{sampleIdentifier} and LIS configuration.
{profileNames} was
2. Check directory exists.
received and is pending
review. 3. Check permissions on
directory.
4. Check the disk space.
5. Check the LIS
connection (physical or
permissions).
6. Check LIS configuration
(LIS side).
7. Check download shared
folder to determine if
orders are being
transferred by LIS.
COM1001 Error Error receiving message. An The instrument is not 1. Check the instrument
incoming connection from configured. configuration.
{IpAddress} was rejected by
2. Check the LIS
the application because an
configuration (LIS side).
active host or instrument is
not configured.
COM1002 Error Error receiving message. An An incoming connection to Check the instrument
incoming connection from the software was rejected configuration.
{IpAddress} was rejected by because the instrument was
the application. The host or not enabled.
instrument is not configured
correctly.

Pub. No.: J66541EN C-15

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM1003 Error Error receiving message. An An incoming connection to Review the configuration to
incoming connection from the software was rejected verify the required device
{IpAddress} was rejected by because the instrument was interface is enabled.
the application because not enabled.
{DeviceCategory}
{DeviceName} is not
enabled.
COM1004 Error Error receiving message. An An incoming connection to 1. Review the configuration
incoming connection from the application was rejected to make sure that device
{IpAddress} was rejected by because the device is has the identified IP
the application because configured to use a different address.
{DeviceCategory} listener.
2. Check the LIS
{DeviceName} is configured
configuration (LIS side).
to use a different listener.
3. Check the LIS
configuration (Reader
side).
COM1009 Error Error creating listener The listener service failed to 1. Review the IP address
service. {IpAddress} is start due to an invalid IP assigned to the identified
invalid. address. device interface. If this is
reconfigured, restart the
Reader Computer.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM1010 Error Error creating listener The listener service failed to 1. Review the IP address
service. {IpAddress} is start due to an invalid IP assigned to the identified
invalid. address. device interface. If this is
reconfigured, restart the
Reader Computer.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM1011 Error Error connecting A connection between the 1. Review the IP address
{DeviceCategory} software and the identified assigned to the identified
{DeviceName} because the LIS or instrument has not device interface.
{IpAddress} is not valid. been established due to an
2. Check the LIS
invalid IP address.
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM1012 Error Error connecting A connection between the 1. Review the IP address
{DeviceCategory} software and the identified assigned to the identified
{DeviceName} because LIS or instrument has not device interface.
the {IpAddress} is not valid. been established due to an
2. Check the LIS
invalid IP address.
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).

C-16 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM1013 Error Error sending message to The identified device not 1. Review the identified
the {DeviceCategory} configured correctly while device configuration.
{DeviceName}. sending a message.
2. Check the LIS
{DeviceCategory} is not
configuration (LIS side).
configured correctly.
3. Check the LIS
configuration (Reader
side).
COM1014 Error Error sending message to Connection to the LIS/ 1. Disable then re-enable
the {DeviceCategory} instrument has been lost. the LIS / instrument
{DeviceName}. The setting to see if the
application is not connected Reader can be
to the {DeviceCategory}. re-established.
2. Check the cable
connections.
3. Check the LIS
connection (physical or
permissions).
4. Check the LIS
configuration (LIS side).
COM1015 Error Error sending message to A connection between the 1. Review the configuration
{DeviceCategory} software and the identified for the identified device
{DeviceName}. No inbound LIS or instrument has not interface.
connection from the host to been established.
2. Check the cable
the application was found.
connections.
3. Check the LIS
connection (physical or
permissions).
4. Check the LIS
configuration (LIS side).
COM1016 Error Error sending message to An error occurred when 1. Restart the Reader. If
{DeviceCategory} sending a message through error persists, reinstall of
{DeviceName}. An error the identified device resulting Reader may be required.
occurred while the message in the failure to compose the
2. Restart the software.
was being composed. message.
3. Reinstall the software.
COM1017 Error Error connecting device. A required DLL is missing Reinstall the software.
{ContractName} was not from the system.
found.
COM1018 Error Error starting TCP listener for The listener service failed to 1. Review the IP address
{IpAddress} at {PortNumber} start due to an invalid IP assigned to the identified
and {ListenerId}. Configure address: Port. device interface. If this is
the listener again and then configured again, restart
restart the application the Reader Computer.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).

Pub. No.: J66541EN C-17

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM1019 Error Error starting TCP listener for The listener service failed to 1. Review the IP address
{IpAddress} at {PortNumber} start due to an invalid IP assigned to the identified
and {ListenerId}. address: Port. device interface. If this is
configured again, restart
the Reader Computer.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM1021 Information The connection for LIS or Instrument interface No action is required.
{DeviceCategory} enabled.
{DeviceName} is enabled.
COM1022 Information The connection for LIS or Instrument interface No action is required.
{DeviceCategory} disabled.
{DeviceName} is disabled.
COM1025 Information The connection for Established a connection No action is required.
{DeviceCategory} between the software and
{DeviceName} is online. the identified LIS or
instrument.
COM1026 Error Error communicating with LIS or Instrument interface No action is required.
device. The connection for enabled.
{DeviceCategory}
{DeviceName} is offline.
COM1027 Error Error sending message to The identified instrument 1. Review the identified
{DeviceCategory} connection disabled while device configuration and
{DeviceName}. Connection sending a message. make sure that the
is disabled. device is enabled.
2. Check the cable
connections.
3. Check the LIS
connection (physical or
permissions).
4. Check the LIS
configuration (LIS side).
COM1028 Error Error sending message to Sending a message through 1. Review the configuration
{DeviceCategory} the identified device failed. for the identified device.
{DeviceName}. Check the
2. Check the cable
log for details.
connections.
3. Check the LIS
connection (physical or
permissions).
4. Check the LIS
configuration (LIS side).
COM1029 Warning Error sending message to Sending a message through 1. Restart the software.
{DeviceCategory} the identified device failed
2. Restart the Reader
{DeviceName}. An error was when running the identified
Computer.
reported while attempting to exception.
run the {Exception}. 3. If error persists, reinstall
of software may be
required.
COM1101 Information {Path} does not exist on this The system created the file No action is required.
system. The application path automatically for an
created the path interface shared folder since
automatically. the identified file path did not
exist.

C-18 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM1102 Error Error communicating with The system could not create 1. Review the file path
device. {Path} does not exist the file path automatically for defined in the interface
on this system. The an interface shared folder and make sure that the
application could not create since the identified file path system has permission
the path automatically. did not exist. to access this file
location.
2. Check the LIS
connection (physical or
permissions).
3. Check the LIS
configuration (LIS side).
COM1103 Error Error communicating with Invalid file extension 1. Review the file extension
device. {FileExtension} is not assigned to the identified file. configuration for the
valid. identified device.
2. Check the LIS
connection (physical or
permissions).
3. Check the LIS
configuration (LIS side).
COM1104 Error Error communicating with The software is not able to 1. Review the windows
device. A file watcher could import files from the permissions to read /
not be started for {Path}. identified folder path. write to the identified
folder. Review the
configuration for the
identified file path.
2. Check the LIS
connection (physical or
permissions).
3. Check the LIS
configuration (LIS side).
COM1105 Error Error completing The identified file could not 1. Review the windows
transaction. {FileName} was be moved from the identified permissions on the file
not moved to location. exchange folders
{DestinationPath} and will assigned to the device
remain at {SourcePath}. interface.
2. Check the LIS
connection (physical or
permissions).
3. Check the LIS
configuration (LIS side).
COM1106 Error Error completing The identified file could not 1. Review the windows
transaction. {FileName} be saved to disk. permissions to write to
could not be written to disk. the identified folder.
The file was not sent. Review the configuration
for the identified file path.
2. Check the LIS
connection (physical or
permissions).
3. Check the LIS
configuration (LIS side).

Pub. No.: J66541EN C-19

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM1107 Error Error completing The identified file cannot be 1. Review the windows
transaction. {FileName} saved to the identified permissions on the
could not be saved to {Path}. location. folder where the system
is trying to save the file.
2. Check the LIS
connection (physical or
permissions).
3. Check the LIS
configuration (LIS side).
COM1108 Error Error importing {FileName} A flat file interface share Check the file extension
received by folder has received a file with configuration for the
{DeviceCategory} an unsupported file identified instrument.
{DeviceName}. The file extension.
contains an unsupported
extension.
COM1109 Error Error completing Contents of the file is Check the file content of
transaction. {FileName} incomplete or corrupt. result file in Error folder.
contains invalid contents.
The message was moved to
the errors folder.
COM2001 Error Error processing message Processing the identified 1. Make sure that
from {DeviceCategory} message failed because messages being sent to
{DeviceName} because no there is no data. the identified device
data is available. The contains the data as
message was not imported. expected by the device
configuration.
2. Check the LIS
configuration (LIS side).
3. Check download shared
folder to determine if
orders are being
transferred by LIS.
COM2002 Error Error processing message Presence of illegal 1. Make sure that
from {DeviceCategory} characters within the messages being sent to
{DeviceName} because of identified message. the identified instrument
illegal characters. The do not contain illegal
message was not imported. characters.
2. Check the LIS
configuration (LIS side).
3. Check download shared
folder to determine if
orders are being
transferred by LIS.
COM2003 Error Error processing message Lack of a header record in 1. Make sure that
from {DeviceCategory} the identified message. messages being sent to
{DeviceName} because the the identified instrument
header in the message is have a header record in
invalid. The message was the message.
not imported.
2. Check the LIS
configuration (LIS side).
3. Check download shared
folder to determine if
orders are being
transferred by LIS.

C-20 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM2004 Error Error processing message Insufficient number of 1. Make sure that
from {DeviceCategory} delimiters in the header messages being sent to
{DeviceName} because it record the identified the identified instrument
has an incorrect terminator message. have the correct number
record. The message was of delimiters in the H
not imported. record of the message.
2. Check the LIS
configuration (LIS side).
3. Check download shared
folder to determine if
orders are being
transferred by LIS.
COM2005 Error Error processing message A message does not contain 1. Make sure that
from {DeviceCategory} a distinct set of delimiters. messages being sent to
{DeviceName} because the identified device and
trailing delimiters are not the devices delimiter
supported. configuration match.
2. Check the LIS
configuration (LIS side).
3. Check download shared
folder to determine if
orders are being
transferred by LIS.
COM2006 Error Error processing message Invalid message structure or 1. Review the identified
from {DeviceCategory} unsupported data within the device configuration for
{DeviceName} because one message. the relevant
or more mapping errors components.
exist. Observed errors are
2. Check the LIS
{MappingsWhereVal-
configuration (LIS side).
ueIsNullOrEmpty},
{MappingWhereValueIsIn- 3. Check download shared
valid}, folder to determine if
{MappingsWhereFieldNot- orders are being
Found}, transferred by LIS.
{MappingsWhereRepeating-
BlockNotFound},
{MappingsWhereRepeating-
BlockNotDefined},
{MappingsWhereRepeating-
FieldIsUnsupported},
{MappingsWhereCompo-
nentNotFound},
{MappingsWhereSubCom-
ponentNotFound},
{MappingsWhereFieldStruc-
tureIsInvalid},
{MappingsWhereDataType-
ConversionFailed},
{MappingsWhereDataTy-
peIsUnsupported}, and
{MappingsWhereEnterprise-
PropertyCouldNotBeRe-
solved}.
COM2101 Error Error processing message Misconfiguration of device Review the device mapping
from {DeviceCategory} mappings. configuration for the
{DeviceName} because the identified device.
record structure does not
match any defined
transaction. The message
was not imported.

Pub. No.: J66541EN C-21

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM2102 Error Error processing message Application matching the 1. Review the identified
from {DeviceCategory} message with more than one device configuration and
{DeviceName} because configured transaction type. make sure that the
more than one record configured record
matches the defined transactions are unique.
transaction. The message
2. Check the LIS
was not imported.
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM2103 Error Error processing message A required DLL is missing Reinstall the software.
from {DeviceCategory} from the system.
{DeviceName} because a
required service was not
found to determine the
transaction for
{CommunicationType}.
The message is rejected.
COM2104 Error Error sending message to The application database Reinstall the software.
{DeviceCategory} has been misconfigured by
{DeviceName}. A the installer process.
transaction was not defined
for {TransactionCode}.
COM2105 Error Error sending message to Application matching the 1. Review the identified
{DeviceCategory} message with more than one device configuration and
{DeviceName}. More than configured transaction type. make sure that the
one transaction was defined configured record
for {TransactionCode}. transactions are unique.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM2106 Error Error sending message to A required DLL is missing Reinstall the software.
{DeviceCategory} from the system.
{DeviceName}. A required
service for the
{CommunicationType} was
not found.
COM2107 Error Error sending message to Invalid or duplicate set of 1. Review the identified
{DeviceCategory} mappings while processing device configuration and
DeviceName}. An invalid or the identified message. verify the required
duplicate set of mappings mappings exist and are
are configured. unique.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM2108 Error Error sending message to A required DLL is missing Reinstall the software.
{DeviceCategory} from the system.
{DeviceName}. An
executable for the action
defined for
{TransactionCode} was not
found.

C-22 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM2109 Error Error sending message to A possible duplicate DLL Reinstall the software.
{DeviceCategory} exists.
{DeviceName}. Multiple
executables for the action
defined for
{TransactionCode} were
found.
COM2110 Error Error sending message to An error while running the 1. Restart the software.
{DeviceCategory} identified transaction.
2. Restart the Reader
{DeviceName}. An error was
Computer.
reported while
{TransactionCode} was 3. If error persists, reinstall
being run. of software may be
required.
COM2111 Error Error sending message to An error while running the 1. Restart the software.
{DeviceCategory} identified transaction.
2. Restart the Reader
{DeviceName}. An error was
Computer.
reported while
{TransactionCode} was 3. If error persists, reinstall
being run. of software may be
required.
COM2112 Error Error processing message A required DLL is missing Reinstall the software.
from {DeviceCategory} from the system.
{DeviceName} because
executable for
{TransactionCode} was not
found.
COM2113 Error Error processing message A possible duplicate DLL Reinstall the software.
from {DeviceCategory} exists.
{DeviceName} because of
multiple executables for the
action defined for
{TransactionCode}.
COM2114 Error Error processing message An error while running the 1. Restart the software.
from {DeviceCategory} identified transaction.
2. Restart the Reader
{DeviceName} because an
Computer.
executable for
{TransactionCode} was 3. If error persists, reinstall
running and an error of software may be
message was generated. required.
COM2115 Error Error processing message A required DLL is missing Reinstall the software.
from {DeviceCategory} from the system.
{DeviceName} because an
executable for
{TransactionCode} was
running.
COM2116 Error Error processing message Misconfiguration of Reinstall the software.
from {DeviceCategory} application database by the
{DeviceName} because the installer process.
domain for {EnterpriseType}
does not exist.

Pub. No.: J66541EN C-23

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM2118 Error Error processing message A mismatch in the message 1. Review the identified
from {DeviceCategory} encoding and expected device configuration and
{DeviceName} because the encoding by the instrument check the field exists in
header record does not while processing the the message being sent
contain the encoding message. to this device or disable
method. Ensure the field the character encoding
exists or disable the validation in the device
character encoding configuration.
validation. The message
2. Check the LIS
was not imported.
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM2119 Error Error processing message A mismatch in the message 1. Review the identified
from {DeviceCategory} encoding and expected device configuration and
{DeviceName} because an encoding by the instrument check the encoding
encoding method in the while processing the assigned to the device is
header record does not message. matching the encoding of
match the configured the message.
{DeviceCategory} encoding.
2. Check the LIS
The message was not
configuration (LIS side).
imported.
3. Check the LIS
configuration (Reader
side).
COM2120 Error Error processing message A mismatch in the message 1. Review the identified
from {DeviceCategory} delimiter information and device configuration and
{DeviceName} because an defined delimiter information check the delimiter
insufficient number of for the instrument. confguration for the
delimiters exist in the header device that correlates in
record. The message was the message.
not imported.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM2121 Error Error processing message A mismatch in the message 1. Review the identified
from {DeviceCategory} delimiter information and that device configuration and
{DeviceName} because of defined for the instrument. check the delimiter
incorrect delimiters in the confguration for the
header record. The message device that in the
was not imported. message correlate.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM2122 Error Error processing message A mismatch in the message 1. Review the identified
from {DeviceCategory} delimiter information and that device configuration and
{DeviceName} because the defined for the instrument. check the delimiter
message does not contain a confguration for the
distinct set of delimiters. The device that in the
message was not imported. message correlate.
2. Check the LIS
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).

C-24 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
COM2123 Error Error processing message A mismatch in the end of line 1. Review the identified
from {DeviceCategory} information of the message device configuration and
{DeviceName} because it and that defined for the check the delimiter
contains end-of-line instrument. confguration for the
characters that do not match device that in the
the {DeviceCategory} message correlate.
configuration. The message
2. Check the LIS
was not imported.
configuration (LIS side).
3. Check the LIS
configuration (Reader
side).
COM2124 Error Error sending message to A mismatch in message data 1. Review the identified
{DeviceCategory} and the data mapping device configuration and
{DeviceName}. Invalid defined for the instrument. check the delimiter
mapping property confguration for the
configuration exception device that in the
raised by the outgoing message correlate.
message mapper service
2. Check the LIS
{PathToValue}=null and
configuration (LIS side).
optional flag={IsOptional}.
3. Check the LIS
configuration (Reader
side).
COM2125 Error Error processing message Possible software error Refer to the notification for
from {DeviceCategory} detailed information.
{DeviceName} because a
required service used to
analyze the message for the
{CommunicationType} was
not found.
DBB1001 Error Error backing up The database back up failed Re-run the backup
{DatabaseName} after after final attempt. procedure again.
{Retries} attempts because
of {Error}.
DBB1003 Information Backup for {DatabaseName} The database back up has No action is required.
to {BackupPath} completed. been completed
successfully.
DBB1004 Warning Error backing up The database that is being 1. Check the instrument
{DatabaseName} after backed up failed after last configuration.
{Retries} attempts because attempt due to an error
2. Check that the backup
of {Error}.
location is available and
try the backup again.
DBB1005 Warning Error backing up The database that is being No action is required unless
{DatabaseName} because of backed up failed after first it is followed by DBB1004
{Error}. attempt due to an error. error message code.
DBB1006 Warning Error manually backing up Manual database backup Re-run the manual backup
{DatabaseName} because of failed. again.
{Error}.
DBB1007 Information {UserAction} could not be The user failed 1. Enter valid user
authenticated. re-authentication during the credentials.
manual backup process.
2. Attempt to complete
action again.
DVCH001 Warning Error creating {imageFolder} File/share permission issue. Check LIS and instrument
for {deviceType} Incorrect folder/file configuration.
{deviceName}. configuration.
DVCH002 Error Error creating {imageFolder} File/share permission issue. Check LIS and instrument
for {deviceType} Incorrect folder/file configuration.
{deviceName}. configuration.

Pub. No.: J66541EN C-25

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
EAGT001 The instrument e-Connectivity® Agent 1. Restart the software.
e-Connectivity® feature is software internal error while
2. Restart the Reader
not functional. starting e-Connectivity®
computer.
Agent, starting file upload, or
initializing internal 3. If error persists, reinstall
e-Connectivity® Agent the software may be
software module. required.
Possible corrupted
e-Connectivity® Agent
software or Windows error
that prevents Windows
service from running.
EAGT002 Failure during Cable connection. Investigate e-Connectivity®
e-Connectivity® upload/ file Agent log file to determine
download. specific reason.
Internet instability /
disconnection.

Firewall setting.

EAGT003 e-Connectivity® Agent not Error while retrieving a 1. Reinstall the software.
functional after 3 retries. setting from the registries.
2. Utilize repair feature
within e-Connectivity®
Incomplete installation of
Agent installer.
registry.

Corrupted or incorrect
update of registry.

EAGT004 Remote service access not Corrupt or incomplete 1. Reinstall the software.
established. installation of
2. Utilize repair feature
e-Connectivity® Agent
within e-Connectivity®
software.
Agent installer.
VNC not compatible with
3. Refer to customer IT
anti-virus software or IT
requirements.
administration policy.
EAGT005 Remote service access not Termination process timeout 1. Close other applications
terminated. (not completed with to decrease usage of
30 seconds) due to Reader system resources.
Computer performance.
2. Shut down and restart
the Reader Computer.
3. Restart the software.
4. Reinstall the software.
EAGT006 Requested action not User update setting using 1. Close the software, If
completed. GUI was not completed as problem persists.
reported by the service to the
2. Shutdown and restart the
GUI.
Reader Computer.
Service cannot access
3. Restart the software.
registry due to permissions,
corruption or missing registry 4. Reinstall the software.
setting.
EAGT007 Network connection not Failure when using test 1. Check the Ethernet
available. connection button. cable connection.
2. Check permissions for
Internet connection failed.
the network access.
3. Check the Internet
connection.
4. Enter the valid user
credentials.

C-26 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
EAGT008 Instrument is currently not Failure when using test 1. Attempt to test
connected to the predictive connection button. connection again.
technology center.
2. Check the Internet
Connection to back office or
connection / speed.
Ortho homepage not
possible after 10 seconds
due to Internet connection.
Connection refused or
redirected.

EAGT009 Connection is not available Failure when using test 1. Attempt to test
to the e-Connectivity® connection button could not connection again.
server. reach Axeda network but
2. Check the Internet
system can establish
connection / speed.
connection to Ortho
homepage due to potential 3. Check the customer
firewall setting or firewall settings.
e-Connectivity® server
unavailable.
EAGT010 Connection failed, undefined Failure when using test Contact Ortho Care™.
exception. connection button.

Undetermined cause
preventing connection.

ECONN01 Error Error connecting to the Invalid output folder. 1. Restart the software.
instrument. Output directory
2. Restart the Reader
is not configured for logging
Computer.
XML for e-Connectivity®.
3. If error persists, reinstall
of software may be
required.
EO10005 Error Error processing order The LIS import message 1. Review the system
received from {HostName}. contains identified orders for configuration to check
{AssaysNotConfigured} was assays which are not the required assays exist
not configured and configured within the system. within the system.
{RequestedTests} were
2. Enable additional test
included in the order.
profile.
LI41002 Error Error sending message. The The import folder location for 1. Check the Windows
system cannot access the the identified device could access permissions for
{hostname} {folderlist}. not be accessed and it is the identified folder.
Orders and results will not be preventing export file
2. Check the cable
processed until the folders creation.
connections.
are available.
3. Check the LIS
connection (physical or
permissions).
4. Check the LIS
configuration (LIS side).
LI43002 Error Error accessing the export at The export folder location for 1. Check the Windows
{foldername} for the identified device could access permissions for
{hostname}. File was not not be accessed and it is the identified folder.
exported. preventing export file
2. Check the cable
creation.
connections.
3. Check the LIS
connection (physical or
permissions).
4. Check the LIS
configuration (LIS side).

Pub. No.: J66541EN C-27

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
LI46002 Warning Error processing cancellation The system is not configured Review the system
message from to process cancellation configuration and enable
{DeviceCategory} messages for the identified cancellation message
{DeviceName}. Cancellation order. support if required.
messages from the LIS is
disabled.
LI46003 Warning Error sending message. The identified order cannot Check the worklist and
Cannot cancel order with be cancelled. manually delete any orders
{SampleIdentifier} and not needed as the automatic
{RequestedTest}. cancellation failed.
LM10001 Information {UserAction} could not be Authentication of Laboratory 1. If error persists, a
authenticated. Management details failed. reinstall of Reader may
be required.
2. Reinstall the software.
QC01 Warning Error processing order. QC expired. 1. Run Quality Control.
Expired quality control for
2. Attempt to complete the
{sampleNumber},
action again.
{testIdentifier},
{instrumentName},
{resultDate}. Test this
sample again as soon as
possible.
QC02 Warning Error processing order. QC about to expire. 1. Run Quality Control.
Quality control for
2. Attempt to complete the
{sampleNumber},
action again.
{testIdentifier},
{instrumentName},
{resultDate} is expiring soon.
Test this sample again as
soon as possible.
RE10002 Error Error executing {Name} An error executing the 1. Restart the software.
{Version} for identified action occurred
2. Restart the Reader
{SampleIdentifier}. when executing the identified
Computer.
{CalledActions} was not rule.
completed because 3. If error persists, reinstall
{FailedAction} generated of software may be
{Error}. required.
SIG10001 Error Error saving data. The server Error with master installation 1. Restart the software.
URL was not loaded communication server.
2. Restart the Reader
because of {UrlIssues}. The
Computer.
server will not be started and
communication between 3. If error persists, reinstall
client terminals and the of software may be
master installation will not required.
occur.
SIG10002 Error Error saving data. The URL Error with master installation 1. Restart the software.
for the communication server communication server.
2. Restart the Reader
could not be loaded because
Computer.
of an unexpected problem.
Check the log for details. The 3. If error persists, reinstall
server was not started and of software may be
no communication between required.
client terminals and the
master installation is
possible.
SIG10003 Error Error starting the Error with master installation 1. Restart the software.
communication server communication server.
2. Restart the Reader
because of an unexpected
Computer.
problem. Check the log for
details. 3. If error persists, reinstall
of software may be
required.

C-28 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Error Codes, Possible Causes, and Recommended Actions
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
WFC0001 Error Error processing request. Error with the workflow 1. Restart the software.
{Device} encountered an configuration.
2. Restart the Reader
error while attempting to start
Computer.
a workflow.
3. If error persists, reinstall
of software may be
required.
WFC0002 Error Error processing request. Error with the workflow 1. Restart the software.
First step of workflow was configuration.
2. Restart the Reader
not defined for
Computer.
{WorkflowName}.
3. If error persists, reinstall
of software may be
required.
WFC0003 Error Error processing request. Error with the workflow 1. Restart the software.
{StepName} cannot process configuration.
2. Restart the computer.
the data of {DataType}.
3. If error persists, reinstall
of software may be
required.
WFC0004 Error Error saving data. Workflow Error with the workflow 1. Restart the software.
controller configuration is configuration.
2. Restart the Reader
invalid.
Computer.
3. If error persists, reinstall
of software may be
required.
WFC0005 Error Error configuring workflow. A Error with the workflow 1. Restart the software.
step with {EntryStatus} was configuration.
2. Restart the Reader
not found in
Computer.
{WorkflowName}.
3. If error persists, reinstall
of software may be
required.
WFC0006 Error Error processing request. Error with the workflow 1. Restart the software.
Workflow configuration is configuration.
2. Restart the Reader
missing for
Computer.
{WorkflowConfigurationId}.
3. If error persists, reinstall
of software may be
required.
WFC0007 Error Error processing request. Error with the workflow 1. Restart the software.
Workflow configuration configuration.
2. Restart the Reader
missing for {EntityType}.
Computer.
3. If error persists, reinstall
of software may be
required.
WFC0008 Error Error saving data. A distinct Error with the workflow 1. Restart the software.
workflow was not found for configuration.
2. Restart the Reader
{EntityType}.
Computer.
3. If error persists, reinstall
of software may be
required.
WFC0009 Error Error saving data. The Error with the workflow 1. Restart the software.
workflow controller could not configuration.
2. Restart the Reader
be started because the
Computer.
workflow was not configured.
3. If error persists, reinstall
of software may be
required.

Pub. No.: J66541EN C-29

2020-02-01
Error Codes, Possible Causes, and Recommended Actions ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Message Severity Error Message Possible Cause Recommended

Code Action
WFOP001 Error Error processing workflow. Possible workflow software 1. Refer to the notification
Order ID {entityId} was error. for detailed information.
halted because of an
2. Check worklist for
{reason} error.
missing/incorrect
information.
WFRP001 Error Error processing workflow. Possible workflow software 1. Refer to the notification
Result ID {entityId} was error. for detailed information.
halted because of an
2. Check worklist for
{reason} error.
missing/incorrect
information.

C-30 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Parts List
Training and Reference Guide

Appendix D: Parts List

Pub. No.: J66541EN D-1

2020-02-01
Parts List ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Part
Callout Part Name Quantity
Number

1 COVER ASSEMBLY J66759 1

2 CASSETTE HOLDER ASSY, BV J67322 1

3 BUMPER, TOP 3B7280 2

4 COVER, ILLUMINATION J66488 1

5 BUMPER, FEET J55546 4

6 NUT, THUMB J66808 1

NOT POWER SUPPLY J66872 1

SHOWN

NOT FOCUS TOOL 6902217 1

SHOWN

D-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Parts Replacement Log
Training and Reference Guide

Appendix E: Parts Replacement Log

Hospital / Facility: ______________________________________________________________

Instrument Serial Number: _______________________________________________________

Procedure Date Performed Initials

Cassette Holder Replacement

Top Cover Replacement

Hand-held Barcode Scanner Replacement

Power Supply Replacement

Reviewed by: ___________________________________ Date: _________________________

Pub. No.: J66541EN E-1

2020-02-01
Parts Replacement Log ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

This page intentionally left blank.

E-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Key to Symbols
Training and Reference Guide

Appendix F: Key to Symbols

Symbols Description
Biohazard

Electrical Hazard

General Warning (Direct or indirect danger to personal

safety or instrument). Refer to Reference Guide.

Important or Caution

Lot Number

Manufacturer’s Serial Number

Catalog Number or Product Code

CE Mark

Manufacturer

Date of Manufacture

For In Vitro Diagnostic Use

Fragile, Handle with Care

Keep Dry

This End Up
▲▲

Pub. No.: J66541EN F-1

2020-02-01
Key to Symbols ORTHO Optix™ Reader for BioVue® Cassettes
Training and Reference Guide

Fuse Label

Handle with Care

In compliance with European Directive 2012/19/EU on

Waste Electrical and Electronic Equipment (WEEE), this
instrument must not be disposed of as unsorted
municipal waste. Separate disposal collection is required
at the end of the product’s life cycle. [Applies to
customers within the European Union only.]
Der Grüne Punkt [the Green Dot]. Manufacturer follows
certain packaging material waste disposal management
regulations.
The Chinese Regulation, Management Methods for the
restriction of the use of hazardous substances in
electrical and electronic products (“China RoHS”),
requires an electrical or electronic product to be labeled
with the environmentally friendly use period symbol if it
contains restricted substances above specified levels.
The environmentally friendly use period refers to the
period in years (Y) during which the hazardous
substances contained in the electronic and electrical
product will not leak or mutate suddenly under normal
operation conditions and will not result in serious
environmental pollution or cause serious bodily injury to
the user or damage to their assets during normal use by
the user of the electronic and electrical products.

F-2 Pub. No.: J66541EN

2020-02-01
ORTHO Optix™ Reader for BioVue® Cassettes Revision History
Training and Reference Guide

Revision History

Software Version Lot Date Section Description

1.0.0 2020-02-01 Initial Release

Pub. No.: J66541EN i

2020-02-01
Ortho-Clinical Diagnostics
1500 Boulevard Sébastien Brant
B.P. 30335
67411 lllkrich
CEDEX, France

Ortho-Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend
CF35 5PZ
United Kingdom