Operator Manual
540 Pages
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Operator Manual
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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N/A
First Version of NEO Iris Operating Manual
JUL 2016
NEO Iris_EU-001-101
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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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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Racks
Racks Purpose The NEO Iris uses racks for loading and unloading samples and reagents. You must place reagent vials and sample tubes in a rack and then slide the rack onto the NEO Iris. You can continuously load or unload racks from the NEO Iris during operation according to the consistent color code. NEO Iris racks are equipped with a guide rail underneath to position them correctly in the loading bay, a handle at the back to facilitate handling, and a pin at the front that triggers a sensor to inform the system that the rack is loaded into position. NEO Iris racks use barcodes so the system can identify them. Each rack position has its own positional barcode. On the left of the rack, next to the handle, is the overall rack barcode. The rack barcode encodes the pipetting coordinates to be used when aspirating from tubes loaded in this rack.
Parts of the Rack The photograph below illustrates the parts of the rack.
• A: Guide rail • B: Handle • C: Pin • D: Positional barcodes • E: Rack barcode
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Racks
Chapter 1: Introduction to the NEO Iris
Types of Racks There are two lengths of NEO Iris racks: • Racks for the 14-lane bay • Racks for the 5-lane bay The following table shows every type of NEO Iris rack available in these sizes. Bay Type
# of Positions
Rack Type
Tube or Vial Size
14-lane bay
16
Tube: A
Sample Rack: 16–17X100 mm tube
14-lane bay
16
Tube: B
Sample Rack: 12–13X75–100 mm tube
14-lane bay
16
Tube: C
Sample Rack: Pediatric tube custom rack
14-lane bay
16
Donor: D
Donor Rack: 12 mm diameter tube
14-lane bay
12
Reagent: R
10 ml reagent vial (occupies 2 lanes)
5-lane bay
9
Reagent: S
10 ml reagent vial (occupies 2 lanes). Note: Not for use with controls.
5-lane bay
5
Reagent: T
57 ml (43 mm diameter) vial (occupies 3 lanes)
Limitation: A site visit by an Immucor representative is required to configure the Z position (downward) on the instrument for the C racks and the specific small-volume pediatric tubes in use at your site. C racks cannot be used on the instrument without this configuration. Sample probe crashes will occur without this configuration, when used in conjunction with the C racks. If differently sized small-volume pediatric tubes are subsequently used after the Z position configuration is performed using the originally designated small-volume pediatric tubes, reconfiguration may be required to prevent possible sample probe crashes into the bottom of the new tubes.
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Chapter 1: Introduction to the NEO Iris
Dynamic Scheduler
Dynamic Scheduler The dynamic scheduler is the sequence of events that the instrument must perform to complete the requested assays. The software calculates the schedule based upon the time constraints of the individual assay steps. The system identifies or displays all resources that need to be loaded in order to complete the schedule. The schedule is represented by the software using an axis crossing a time scale and passing through bands of color. The scheduler axis line moves in real time from left to right to demonstrate time passing as the NEO Iris operates. Each plate being run has a sequence of differently color coded bars that represent the sequence of processing steps that the plate is designed to move through for a given assay. The axis line moves through the different color bars as time progresses. The scheduler will adjust to accommodate normal processing delays.
Each band of different color bars represents one plate. The plate identification is prefixed at the left of the color band.
Each given band is spatially placed in the window to represent what the plate’s starting position was in the plate loading tower. Position 1 is designated as the bottom position and position 15 is designated as the top. Therefore, for example, the plate color band for tower position 3 would be lower in the window than that for tower position 8. Refer to Chapter 3 – System Software Navigation for more information regarding the schedule. Limitation: Time stamps for instrument activity may not be accurate around Daylight Saving Time (DST) when a given activity spans a time period falling on both sides of the actual change of time for DST. The following recommendations are published to provide guidance on how to mitigate these time stamp inaccuracies. Allow assays to finish if they are already running during the DST change and remove the racks once processing is complete. Do not interact with the instrument (e.g. loading plates or starting assays) during the DST time change. Initialize the instrument after the DST time change is finished prior to beginning any further assays.
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Miscellaneous Information
Chapter 1: Introduction to the NEO Iris
Miscellaneous Information Continual Access The instrument is designed so that resources can be replenished and new assays started without interrupting the processing of in-progress or scheduled assays. New samples, reagents, system liquid, and plates can be added during test processing. You can also remove completed samples, used reagent containers, plates, and liquid waste during test processing. Instructions for replenishing samples and reagents during instrument operation are included in Chapter 6: Instrument Testing Operation. Instructions for replenishing system liquid during instrument operation and removing liquid waste are included in Chapter 10: Maintaining the NEO Iris.
Expected Results The specific performance characteristics and the expected frequency of the possible assay results are described in the package inserts of each reagent or test well. The expected results are specific to the reagent or test wells in use. Refer to the package inserts for descriptions of expected results for reagents and test wells.
Biological, Electrical, Mechanical and Laser Beam Safety Precautions Warning: Blood samples, liquid waste, used microplates, and consumed liquid reagent containers contain potentially biohazardous material. Warning: Always wear protective gloves and clothing when handling blood samples, liquid waste, used microplates, or consumed liquid reagent containers. All blood samples, liquid waste, used microplates, and consumed liquid reagent containers must be discarded following the standard practice of the laboratory. Warning: All blood products must be treated as potentially infectious. No known test methods can offer assurance that products derived from human blood will not transmit infectious agents. Warning: Follow basic electrical hazard awareness to reduce the risk of injury due to prohibited electricity exposure. Warning: Follow all of the necessary precautions to prevent exposure to and potential injury from instrument mechanical movement. Keep all instrument protective covers in place when operating the instrument to reduce the risk of operator injury due to instrument mechanical movement. Warning: Follow all of the necessary precautions to prevent exposure to and potential injury from barcode laser scanners. Do not look directly into the laser beam of scanners or any reflections of the beam from a mirror-like surface. Exposure to the laser beam light can cause eye damage and permanent injury.
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Chapter 1: Introduction to the NEO Iris
Miscellaneous Information
Markings The label is located next to the power socket on the bottom right side of the instrument. The information on the label includes, but is not limited to, the NEO Iris serial number.
Manufacturer Information
Immucor Medizinische Diagnostik GmbH D-63322 Rödermark Adam-Opel Strasse 26 Post Office Box 20 02 65 Germany
Classification The Neo Iris Instrument is classified as “self-declared” device according to IVD Directive 98/79/EC
Technical Support Please contact your local Technical Support or Immucor Technical Support International or at +49 6074 8420 50 or via e-mail at [email protected]
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Chapter 2: Hardware Components In This Chapter This chapter describes the functions and safety aspects of the NEO Iris hardware. For technical data about the hardware, refer to Appendix C − Hardware Technical Data. 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
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Chapter 2: Hardware Components
The NEO Iris
The NEO Iris NEO Iris Photograph The photograph below shows the NEO Iris as it is viewed from the front. The instrument unit is located on top of the cabinet. The computer monitor and keyboard are attached to the right side of the cabinet.
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Personal Computer (PC)
Chapter 2: Hardware Components
Personal Computer (PC) Purpose The NEO Iris software, installed on a stand-alone PC, controls the NEO Iris. The touch-screen PC monitor is located on the monitor table attached to the right side of the cabinet. The PC tower is located inside the cabinet. For more information about the NEO Iris software, refer to Chapter 3 – System Software Navigation.
How It Works In addition to the standard PC components, the NEO Iris PC is equipped with a touch-screen monitor and a trackball (mouse). This PC is connected to the NEO Iris, and can also be linked to an external Laboratory Information System (LIS). This enables you to download test selections (worklists) to the NEO Iris and export test results from it to the LIS. Attention: Do not install additional software or add-on hardware. This will void your warranty and service contract. Addition of unapproved software may affect the performance of the NEO Iris and provide a means of introducing computer viruses.
Monitor Photograph The photograph below illustrates the touch-screen monitor and its associated parts.
Safety Feature This PC is equipped with the following safety feature: • The computer is attached to an uninterruptible power supply (UPS) with an integral power conditioner to provide a consistent source of electricity, and to provide short periods of backup power.
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Chapter 2: Hardware Components
Cabinet
Cabinet Purpose The cabinet is an integral part of the NEO Iris. It provides a surface on which to safely place the instrument and serves as a compartment in which to store external system components. The section below describes the cabinet parts.
Cabinet Photograph The photograph below shows the cabinet and its parts.
• A: Common waste container • B: System liquid containers
Cabinet Interior The following design features are incorporated into the 20 liter and 10 liter system liquid containers: • The 20 liter system liquid container is connected to the 10 liter refill container so that when the 10 liter refill container is filled with system liquid, the liquid from that container will passively drain into the 20 liter container. • The system is designed such that only the 10 liter refill container is manually filled (using its large cap opening), and not the 20 liter container. The 20 liter container is the direct liquid reservoir for the NEO Iris and is passively filled (indirectly) from the 10 liter refill container, using gravitational equilibration. The equilibration time for the passive draining of a full 10 liter refill container into the 20 liter container is approximately five (5) minutes. • The 10 liter refill container can be detached from the 20 liter container (using the in-line connectors) during operation, so that it can be filled off-line, as long as there is sufficient system liquid in the 20 liter container to process the assays in progress. • As an alternative method of filling, a commercially obtained cube of system liquid can be directly connected (using the supplied in-line connector) to the 20 liter container, instead of using the 10 liter refill container. In this instance, the commercially obtained cube of system liquid must be elevated on the drawer to at least the same level as the 10 liter refill container so that passive gravitational draining equilibration can take place. The cube must be located in the space on the drawer to the left of the common waste container and requires an extended length of tubing to connect the cube to the detachable in-line connector.
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Cabinet
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Limitation: Immucor requires the use of phosphate buffered (approximately 15mM) isotonic saline, pH 6.5-7.5 (PBS), on the NEO Iris system. Reactions between an antibody and its antigen may be weakened if acidic or unbuffered saline is used. Using saline and/or deionized water in PBS preparation from sources with systems in place to control proliferation of microbes helps to reduce the chance for microbial bioburden on the system. Excessive microbial bioburden can cause degradation of system or assay performance.
Safety Features The cabinet is equipped with the following safety features: • The 20 liter container has an integrated sensor to detect low levels of system liquid (cable circled in the photograph below).
• The base of the drawer is a sealed trough that retains any spills from the containers. • The PC tower compartment is separated from the system liquid compartment, protecting the PC tower from splashed liquids. Warning: Inadvertent operator collision with the cabinet doors or the pull out cabinet shelf can cause operator injury.
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Cabinet
Cabinet Exterior The following design features are incorporated into the exterior of the cabinet to ensure the correct positioning of the NEO Iris. • Two welded rings on the top of the cabinet ensure the correct positioning of the instrument and prevent it from moving during operation. • Two rubber-tipped spacers at the back of the cabinet ensure that enough space is left for ventilation, should the cabinet be placed in front of a wall. • Foot mountings positioned close to the wheels ensure stability of the system during operation. Attention: The instrument setup process involves critical positioning and stabilization of the cabinet and centrifuge. Moving the NEO Iris could affect these aspects of instrument setup and cause centrifuge balancing errors to occur. It is recommended that the NEO Iris not be moved once installed.
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Hood
Chapter 2: Hardware Components
Hood Purpose The hood is located on the upper front of the instrument and is used as a protective shield for the operator, to help prevent operator accidents or injuries when the instrument is performing mechanical functions. However, if required, for example in the instances of some maintenance tasks, the hinged hood can be raised to give operator access to perform necessary tasks under controlled circumstances.
How It Works The hood is a physical barrier that prevents operator intervention into the moving mechanical parts area of the main instrument when its components are in motion. If it is necessary to access the inside of the main instrument mechanical area, the hood can be raised up by manually pulling vertically up on the hand bar. The hood can then subsequently be lowered back into the physical barrier position by manually pulling down on the hand bar.
Hood Photographs
Hood in the down protective position
Hood in the up position, for access to the internal parts of the instrument
The photograph below shows the hand bar of the hood in detail.
Hand bar of hood
Safety Features The hood is equipped with the following safety features: • The hood is a physical barrier that prevents operator intervention into the moving mechanical parts area of the main instrument when its components are in motion. • The hood is linked to a sensor so that if the hood is raised under uncontrolled circumstances, such as while the mechanical parts of the main instrument are still in motion, then an audible alarm is sounded and an error message is generated which brings the instrument to an emergency stop. NEO Iris Operator Manual
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Loading Tower
Loading Tower Purpose You load and remove plates through the loading tower, located on the left side of the instrument and accessed from the front. You must load the plates into carrier frames first before placing them in the tower. These frames allow the transport system to move the plates and then load them into the various instrument modules required to complete the assays.
How It Works The loading tower is a self-contained module that enables you to load and unload up to 15 plates. The tower features a translucent door. The plate positions are designed for easy and safe insertion of the plates. The right hand rail of each position corresponds to the guiding groove of the plate carrier, thereby prohibiting incorrect loading of the plate carriers. Ensure also that the plates are fully pushed down into the recess of the plate carrier. When using plate strips, ensure that the strips are properly placed in their white frames and that these frames are in turn fully pushed down into the carrier frame. A mechanical stop at the rear of each position ensures that you cannot insert the plate too far. In addition, each position has an LED indicator that shows the status of that position in accordance with the instrument colorcoding system. Refer to Consistent Color Code in Chapter 1: Introduction to the NEO Iris for more information. Two guidance strips attached to the inside of the door ensure correct placement of the plates in their positions when the loading tower door is being closed. Note: Closing the loading tower door initiates a barcode scan of a new plate after that new plate is loaded and the LED is orange.
Plate Loading Tower Alerts Purpose The purpose of the plate loading tower alerts is to indicate that you should not add or remove plates to or from the tower when the plate transport is accessing the tower. Warning: Do not try to access the loading tower when the transport system is accessing the loading tower . You may cause a plate transport error or crash situation if you ignore the plate loading tower alerts. Visual and Audible Alerts When the plate transport is accessing the loading tower, all of the loading tower LEDs turn to continuous red. Color
State
Meaning
Red
Continuous on all tower slot LEDs simultaneously.
DO NOT add or remove plates to or from the tower.
Additionally, during this time, if you open the loading tower front door, an audible constant tone alarm is generated that can only be silenced by the transport when it leaves the tower, or by you closing the front door before the transport leaves the tower.
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