NEO IRIS Operator Manual July 2016

Copyrights and Disclaimers 2016, Immucor, Inc. NEO Iris™ is a trademark of Immucor, Inc. (hereinafter “Immucor”). The contents of this manual are protected by copyright. The Immucor name, logos, related trademarks, and service mark are owned and used in commerce by Immucor and are protected by U.S. and international trademark laws. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form by any means without written permission from the copyright holder. Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Immucor to provide accurate and up-to-date information to customers. No warranties of any nature are extended by this document. You should be very careful to ensure that the use of this information and/or hardware and software material complies with the laws, rules, and regulations of the jurisdictions with respect to which it is used. All operating instructions must be followed. In no event shall Immucor be held responsible for failures, errors, or other liabilities resulting from a customer’s noncompliance with the procedures and precautions outlined in this manual. The sample screen displays and sample printouts in this NEO Iris Operator Manual are for information and illustration purposes only. Immucor makes no representations or warranties about the accuracy or reliability of the information presented on the screen displays, and this information is not to be used for clinical or maintenance evaluation. Immucor reserves the right to make changes to the product to improve reliability, function or design, or to discontinue any product at any time without notice or obligation. The material contained in this manual is subject to change without notice. Immucor will not be liable for any consequences resulting from the use of this publication. Any comments or suggestions regarding this publication should be forwarded to Immucor Medizinische Diagnostik GmbH, Adam-Opel Strasse 26 A, Post Office Box 20 02 65, D-63322 Rödermark, Germany ([email protected]). Microsoft, Windows, and the Windows logo are registered trademarks or trademarks of Microsoft Corporation in the United States and other countries. All third-party trademarks, service marks, and trade names are the property of their respective owners and are hereby acknowledged.

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No responsibility is assumed by Immucor for the use or reliability of software or equipment that is not supplied by Immucor or its affiliated dealers. All warnings and cautions must be reviewed by the Operator prior to using the NEO Iris for the first time.

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Document Revision History Date

Version

Chapters

MAY 2016

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First Version of NEO Iris Operating Manual

JUL 2016

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Chapter 12:

Update of the limitations on interfering substances

Limitations

for Lipemia and Icterus (Levels defined)

of Use and Warnings

Attachment 1

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Description

Table of Contents About This Manual ... v How This Manual Is Organized ... vi Chapter 1: Introduction to the NEO Iris ...1-1 About the NEO Iris ...1-2 Consistent Color Code ...1-3 Barcodes ...1-5 Reagents ...1-9 Racks ... 1-10 Dynamic Scheduler ... 1-12 Miscellaneous Information ... 1-13 Chapter 2: Hardware Components ...2-1 The NEO Iris ...2-2 Personal Computer (PC) ...2-3 Cabinet ...2-4 Hood ...2-7 Loading Tower ...2-8 Transport System ... 2-10 Plate Carrier ... 2-12 14-lane and 5-lane Bays ... 2-13 Pipetting System ... 2-15 Incubator ... 2-20 Washer ... 2-22 Centrifuge ... 2-24 Camera Reader ... 2-27 Disposal Information ... 2-28 Chapter 3: System Software Navigation ...3-1 Navigation ...3-2 Main Menu Bar ...3-6 Machine Monitor ... 3-46 Status Bar ... 3-64 Chapter 4: Security ...4-1 Assigning Passwords and User Access Rights ...4-2 Adding a User ...4-3 Editing a User ...4-8 Deleting a User ...4-9 Default Access Rights... 4-10 Changing a Password ... 4-12 Archive Configuration ... 4-14 Chapter 5: Instrument Start-Up ...5-1 Starting Up ...5-2 Logging In and Initialization ...5-3 Chapter 6: Instrument Testing Operation ...6-1 Using the Start Run Assistant ...6-2 Loading Samples...6-3 Downloading Requests from LIS... 6-11 Completing the Sample Loading Process ... 6-12 Loading Reagents and Controls ... 6-15 Loading Plates ... 6-19 Starting Processing ... 6-24 Continuous Loading during Operation ... 6-25

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Table of Contents Chapter 7: Test Results... 7-1 Accessing the Results Screen ... 7-2 Sample View and Plate View Icons and Symbols ... 7-5 Using Tool Tips ... 7-7 Viewing Test Details ... 7-8 Approving Test Results ... 7-13 Exporting Test Results ... 7-14 Viewing Archives ... 7-16 Chapter 8: NEO Iris Reports ... 8-1 Reports Overview ... 8-2 Parts of the Report ... 8-3 Plate Based Reports ... 8-8 Sample Based Reports ... 8-10 Current Reports ... 8-12 Quality Control Reports ... 8-17 Reagent Reports ... 8-20 Accessing Plate Based Reports ... 8-22 Accessing Sample Based Reports ... 8-23 Printing Reports ... 8-25 Printing Reagents Report from Test Details ... 8-30 Test Results and Interpretation... 8-32 Chapter 9: System Shutdown ... 9-1 Logging Out ... 9-2 Shutting Down the NEO Iris After Operation ... 9-3 Extended Shutdown of the NEO Iris ... 9-7 Chapter 10: Maintaining the NEO Iris ... 10-1 Maintenance Overview ... 10-2 Daily Maintenance Tasks ... 10-5 Weekly Maintenance Tasks ... 10-23 Monthly Maintenance Tasks ... 10-37 As Needed Maintenance Tasks... 10-47 Chapter 11: Troubleshooting the NEO Iris ... 11-1 The Troubleshooting Process Steps... 11-3 Using Error Codes to Troubleshoot ... 11-5 Troubleshooting Software Failure ... 11-9 Pipettor Self Check Failures ... 11-13 Clot Detection Recovery Process ... 11-16 Troubleshooting Plate Transport Errors ... 11-17 Troubleshooting Pipettor Errors ... 11-25 Troubleshooting Centrifuge Errors ... 11-28 Troubleshooting Incubator Errors ... 11-39 Troubleshooting Washer Errors ... 11-44 Troubleshooting Camera Reader Errors ... 11-52 Troubleshooting 14-lane and 5-lane Bay Errors ... 11-54 Troubleshooting Plate Tower Errors ... 11-56 Chapter 12: Limitations of Use and Warnings ... 12-1 Limitations of Use ... 12-2 Warnings... 12-13 Appendix A: Preparing the NEO Iris for First Use ... A-1 Verifying all Parts Are Present... A-2 Environmental Conditions and General Safety Features ... A-3 User Safety ... A-5 Making the Connections ... A-7 Software Installation ... A-10 ii

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Table of Contents Setting Up the Instrument ... A-11 Completing the Post-Installation Check ... A-12 Verifying the Installation ... A-13 Removal of the Instrument ... A-14 Appendix B: Maintenance Records ... B-1 Maintenance Forms ... B-2 Appendix C: Hardware Technical Data ... C-1 Hardware Technical Data ... C-2 Glossary of Terms ... 1 Glossary ... 2 Attachment I: NEO Iris Operator Manual... I-1 Copyrights and Disclaimers ... I-2 Sample Requirements ... I-4 Assay Descriptions ... I-6 Assay Cutoffs ... I-16 Assay Reagent Component Grid ... I-38 Assay Procedural Steps ... I-41 Test Results and Interpretation ... I-58 Attachment II: NEO Iris Operator Manual ... II-1 Copyrights and Disclaimers ... II-2 Scope ... II-3 Essential Information for Communication ... II-4 Result Message Structure ... II-7 Host Query Message Structure ... II-16 Order Message Structure... II-18 Message Examples ... II-21 Index ... 1

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About This Manual In This Section The NEO Iris Operator Manual is designed to guide the NEO Iris™ operator through all procedures required to use and maintain the NEO Iris, including operating procedures, maintenance, and troubleshooting. This chapter provides high-level information about how this manual is organized. About This Manual ... v How This Manual Is Organized ... vi

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About This Manual

How This Manual Is Organized

How This Manual Is Organized In This Section This section describes the organization of this manual, including: • Format • Notational Conventions • Limitations of Use and Warnings • Use of Icons • Front Pages • Chapters

Format This manual is divided into chapters that describe specific aspects of the NEO IRIS structure or functionality.

Notational Conventions This manual uses a page numbering system that includes a prefix of the chapter number hyphenated with the page number. Sequential lists that describe step-by-step procedures are included as numbered lists. The footer of each page contains the current manual version identified using a nine character hyphenated format. The first three characters (NEO) identify the instrument. The second set of three characters identifies this document as the operator manual (001). The final set of three characters identifies the version of the operator manual. 100 designates version 1; 200 designates a full version 2 update; and so on. If changes are made to individual chapters in between full manual version updates, then chapter version numbers are incremented by single digits. For example, 101 is the first update of a chapter falling between a full manual update from version 1 to version 2.

Limitations of Use and Warnings Limitations of use and warnings are located throughout this manual, specifically in the body of the text where they are most relevant to the information. An icon draws your attention to limitations of use and warnings. Chapter 12 – Limitations of Use and Warnings contains a complete list of all of the limitations of use and warnings in this manual.

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How This Manual Is Organized

About This Manual

Use of Icons Some of the following safety symbols may be displayed on the NEO Iris or may appear in the manual to alert you of warnings or limitations of use, or to direct you to information. Examples are shown below. Symbol

Type of Warning

Related to…

Laser beam safety warning

Laser beam safety issues

Alternating current

Power supply

Direct current

Power supply

Protective conductor terminal

Power supply

Fuse

Power supply

On (supply)

Power supply

Off (supply)

Power supply

Limitations and Warnings

Potentially damaging or dangerous outcomes if certain critical procedural steps are ignored or incorrectly executed

Warning, risk of electric shock

Potential hazard related to power supply

Warning, risk of crushing or pinching

Potential hazard resulting in possible injury

Consult instructions for use

In Vitro Diagnostic medical device (IVD) Biological risks

Manufacturer

Manufacturing date

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About This Manual

How This Manual Is Organized

Separate collection for electrical and electronic equipment Authorized Representative in the European Community Serial number Catalog number

Front Pages The front pages of this manual include the Copyrights and Disclaimers page and the Table of Contents.

Chapters The Table of Contents sequentially lists all chapter contents. The first page of each chapter lists the contents of that chapter.

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Chapter 1: Introduction to the NEO Iris In This Chapter This chapter provides an introduction to the NEO Iris. CHAPTER 1: INTRODUCTION TO THE NEO IRIS ...1-1 About the NEO Iris ...1-2 Consistent Color Code ...1-3 Barcodes ...1-5 Reagents ...1-9 Racks ... 1-10 Dynamic Scheduler ... 1-12 Miscellaneous Information ... 1-13

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Chapter 1: Introduction to the NEO Iris

About the NEO Iris

About the NEO Iris Intended Use The Neo Iris (NEO Iris) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation and data management functions. The NEO Iris is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as Syphilis. The NEO Iris is part of the Galileo Family of instruments and is intended for use only with the reagents described in Attachment 1 for Neo Iris Operator Manual. Limitation: The Neo Iris is for in vitro diagnostic use.

Principles of Operation The NEO Iris is designed to automate standard immunohematology assays and operate as a walk-away system, meaning you can leave the NEO Iris to operate independently for periods of time. This leaves you free to carry out other tasks in the laboratory. Several unified principles have been integrated into the NEO Iris system to support and to simplify the overall system operation. The NEO Iris is a closed system and can only be used with specified Immucor products. The NEO Iris is an ergonomically friendly and easy-to-use system. Features of the NEO Iris system have been designed to maximize operator efficiency and thereby minimize result errors. The NEO Iris is a robotic instrument programmed to move microplates, liquid reagent fluids, and blood sample fluids to different bays and processing areas for a given assay in the correct sequence. Such bays and areas include incubator bays, the microplate washing station, the centrifuge, and the reader. The NEO Iris plate reader uses CCD cameras to capture an image of the microplate from underneath. The NEO Iris software calculates a reaction value for each well based on a multi feature image analysis. The NEO Iris then assigns a result and interpretation to the wells based on predefined criteria associated with the calculated reaction value. Some assay protocols require multiple test wells for a given blood sample interpretation, such as ABO and Rh (D) typing. The NEO Iris uses software to drive its mechanics and data processing. The operator uses hardware in combination with the software to operate and maintain the NEO Iris.

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Consistent Color Code

Chapter 1: Introduction to the NEO Iris

Consistent Color Code Purpose In order to improve process control when loading or unloading the NEO Iris, many safeguards have been incorporated into the system. To indicate when it is safe to use a component, the NEO Iris uses Light Emitting Diodes (LEDs) with a consistent color code to indicate the status of specific components. By following the consistent color code, you can continuously load and unload samples, microplates, and reagents onto the NEO Iris during operation. Continuous loading enables a high sample throughput while increasing the flexibility of the system. This table describes each of the LED colors within the consistent color code. Color

State

Meaning

Green Continuous

You can place a suitable item into this position.

Green Flashing

You should remove an item from this position.

Orange Continuous

The system has not been requested to use this component and there are no errors.

Orange Flashing

A warning has been issued for this component, an error occurred or you can remove a rack.

Red Continuous

DO NOT place anything in this position.

Red Flashing

DO NOT remove anything from this position.

Color Scheme In the Plate Loading Tower Implementation of the color scheme in the Plate Loading Tower produces the following states in the tower LEDs:

Start (Slot empty)

Start Test (Slot in access)

Insert Plate (Slot unused)

Strips remaining?

Yes

Plate removed (Slot empty)

NEO Iris Operator Manual

Tests Finished (Slot “finished”)

Machine takes plate (Slot in progress)

No

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Consistent Color Code

Color Scheme In the 14-lane and 5-lane Bays Implementation of the color scheme in the 14-lane and 5-lane bays produces the following states in the lane LEDs:

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Barcodes

Chapter 1: Introduction to the NEO Iris

Barcodes Purpose The NEO Iris uses barcodes to identify reagents, microplates, and samples in the loading bays. Using barcode technology increases the number of steps that can be automated, thus decreasing handling errors. The NEO Iris supports the use of the following barcode symbologies: • Codabar • Code 128 • ISBT 128 (Concatenated barcodes are not supported) • Code 39 • Interleaved 2 of 5 Note: To increase data security, Immucor recommends that you use a check digit in conjunction with sample barcodes. Limitation: Barcodes can be no longer than 18 characters in length.

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Barcodes

Limitation: Barcodes must have a module size larger than 0.2mm and a bar width ratio between 2.25:1 to 3:1. Decodability grade (grading system of A to F; A being best, F is failing) of C or better is required for consistent reading of barcodes on the instrument. This grade measures the bar width consistency throughout the barcode label. It is usually an indication of print quality of the barcode label. The minimum number of characters in the barcode is 3. The length of the barcode is variable but must be completely visible with a quiet zone (white space on each end of the label) of 3 mm when placed in the sample or donor rack. The minimum height of the barcode must be 10 mm. If barcodes have parameters outside of these specifications, barcode misreads can occur on the instrument. Pipe characters (|) are not permitted as part of a sample identification. Limitation: If samples have barcode identification information that is eighteen (18) characters in length and the first three (3) characters are identical to the first three (3) characters of the assay control material in assays which include plate or run controls, then the sample will be interpreted as a replicate of the control material. In this case, either the plate will fail unnecessarily (if the sample reacts differently than expected for the corresponding control), or the plate will pass but no results for that sample will be produced (if the sample reacts as expected for the corresponding control). Such a condition can also be exhibited when an assay such as crossmatch or antigen screening assay generates a set of circumstances such that the combination of donor and primary sample barcode identification information adds up to eighteen (18) characters and the primary sample identification begins with the same first three (3) characters as one of the control material barcode identifications.

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Barcodes

Chapter 1: Introduction to the NEO Iris

Reagent Barcodes Reagent barcodes are used to identify reagents, controls and diluents. The following information is encoded in the reagent barcode: • Reagent ID – The type of reagent • Lot number – Batch identifier • Expiration Date – The last date that the reagent may be used • Serial Number – Unique identifier for each vial

Microplate Barcodes Microplate barcodes are located on the short side of the plate frame. The instrument has an internal plate barcode scanner that scans the plate frame to verify the plate ID when the instrument processes the samples. For more information about the internal barcode scanner, refer to Chapter 2 –Hardware Components. There are two (2) different barcode schemes used on the sides of plates, of which only one is used on a given plate frame. The barcode scheme used on a given plate frame is dependent on when a given lot of a given product is manufactured. The schemes are named Scheme 1 and Scheme 2.

Scheme 1 The following information is sequentially encoded in the plate frame barcode for Scheme 1: • Plate code (indicating the type of plate) linked with the lot number (batch identifier). • Plate serial number – the unique plate identifier. Scheme 1 does not have encoded information for the plate expiration date. The plate expiration date must be entered into the software manually. Refer to Chapter 3 – System Software Navigation for information regarding the manual entry of plate expiration dates using the Expiry Date tab of the Plate Loading Tower dialog.

Scheme 2 The following information is sequentially encoded in the plate frame barcode for Scheme 2: • Three (3) digit product identifier. For example, 008 identifies Capture-R® Select plates. • Five (5) character expiration date (DDDYY). The DDD portion is the numeric day within the year (YY). For example, February 1st 2010 would be represented as 03210. • Three (3) digit lot number (batch identifier). • Five (5) digit plate serial number – the unique plate identifier. The instrument software combines the three (3) digit product identifier with the three (3) digit lot number to create the alpha-numeric lot number of the plate. The software uses a truth table to convert the product identifier to either one or two alpha character(s) that can be prefixed onto the three (3) digit lot number, the combination of which can be printed on reports. For example, SC represents Capture-R® Select plates. The printed alpha-numeric lot number of SC123 would actually be composed of 008 and 123. If a particular plate of this lot number had an expiration date of February 1st 2010 and it was the thirteenth (13th) plate manufactured, then the overall plate frame barcode would be 0080321012300013. Scheme 2 has encoded information for the plate expiration date. The plate expiration date does not need to be entered into the software manually. The Expiry Date tab of the Plate Loading Tower dialog will automatically populate with date information when Scheme 2 plate frame barcodes are scanned by the instrument. Refer to Chapter 3 – System Software Navigation for information regarding the Expiry Date tab of the Plate Loading Tower dialog.

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Barcodes

Sample Barcodes Sample barcodes are located on sample tubes and encode the sample ID. The sample ID can be mapped to information downloaded from the host Laboratory Information System (LIS). Note: For correct reading of sample barcodes in the loading bay, the sample barcodes must be positioned between 20 mm and 105 mm (0.8 and 4.1 inches) from the bottom of the tube.

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Reagents

Chapter 1: Introduction to the NEO Iris

Reagents The NEO Iris accesses all reagents, such as antisera and reagent red cells, through vials with lot numbered barcodes. The operator loads these vials into reagent racks which are slotted into the loading bay. For more information, refer to Racks. The barcodes identify each vial individually so that the system can electronically monitor the fill level when the reagents are removed from the NEO Iris and then reused at a later time. When a reagent vial is empty, the software automatically moves to another bottle of the same reagent type if it is present on the instrument. When using barcoded reagents, the system automatically registers the position of the reagent so the reagent can be placed in any accessible position. Note: For more information about loading reagents, refer to Chapter 6 – Instrument Testing Operation.

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