Galileo NEO Operator Manual Sept 2014

Document Revision History Date

Version

Chapters

Description

DEC 2009

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N/A

First Version of Operating Manual Galileo NEO

APR 2010

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Chapter 2

Updating to hardware / software changes

Chapter 3 Chapter 8 Chapter 10 Appendix A

Update for cutoffs / adding assay descriptions to Attachment 1

Attachment 1 JUL 2011

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All previous ones

New Attachment 3

JAN 2012

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New Attachment 4

Table of Content (toc)

Update to various minor changes (like trademark); Complete harmonization as far as possible to US version NEO001-101/102 New Attachment 3 integrated reflecting changes with software version 1.5.10 New Attachment 4 for TPHA information New Attachment 4 for TPHA information is added TPHA assays description listed

Glossary of terms Index

TPHA information listed

Chapter 10 MAY 2012 NEO Decontamination detailed instructions

SEPT 2014

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About this manual

Updating of revised standards in Use of Icons table

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Chapter 12: Limitations of Use and Warnings

Clarification of user's responsibility for manupulation of results.

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About this Manual ... 1 In this section ... 1 How this Manual is Organized ...2 Chapter 1 : Introduction to the NEO ... 1-1 In this chapter ... 1-1 About the NEO ... 1-2 Consistent Color Code ... 1-3 Barcodes ... 1-5 Reagents ... 1-7 Racks ... 1-8 Dynamic Schedule ... 1-10 Miscellaneous Information ... 1-11 Chapter 2: Hardware Components ... 2-1 In this chapter ... 2-1 The NEO ... 2-2 Personal Computer (PC) ... 2-3 Cabinet ... 2-5 Hood ... 2-8 Loading Tower ... 2-10 Transport System ... 2-12 Plate Carrier ... 2-14 14-lane and 5-lane Bays... 2-15 Pipetting System ... 2-17 Incubator ... 2-22 Washer ... 2-24 Centrifuge ... 2-26 Camera Reader ... 2-28 Disposal Information ... 2-29 Chapter 3: System Software Navigation ... 3-1 In this chapter ... 3-1 Screen Layout ... 3-2 Navigation Options ... 3-5 About the Main Menu Bar ... 3-6 Logging In... 3-7 Initializing the Instrument ... 3-8 Start Run Assistant ... 3-9 Work List Editor ... 3-12 Plate List... 3-16 Test Results ... 3-24 Maintenance ... 3-25 Utilities ... 3-26 Instrument Settings ... 3-33 Help ... 3-37 Shutdown ... 3-41 About the Machine Monitor... 3-42 Incubator ... 3-43 Wash Buffers ... 3-44 Reader... 3-45 Plate Loading ... 3-46 14-lane Bay ... 3-55 5-lane Bay ... 3-58 Using the Status Bar ... 3-60 Chapter 4: Security ... 4-1 In this chapter ... 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 Neo Operator Manual

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Changing a Password ... 4-11 Archive Configuration ... 4-12 Chapter 5: Instrument Start-Up ... 5-1 In this chapter ... 5-1 Starting Up ... 5-2 Logging In and Initialization ... 5-3 Chapter 6: Instrument Testing Operation ... 6-1 In this chapter ... 6-1 Using the Start Run Assistant... 6-2 Loading Samples... 6-3 Downloading Requests from LIS ... 6-12 Completing the Sample Loading Process... 6-13 Loading Reagents and Controls ... 6-16 Loading Plates... 6-20 Starting Processing ... 6-25 Continuous Loading during Operation ... 6-26 Chapter 7: Test Results ... 7-1 In this chapter ... 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 ... 7-14 Exporting Test Results ... 7-15 Viewing Archives ... 7-17 Chapter 8: NEO Reports ... 8-1 In this chapter ... 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 In this chapter ... 9-1 Logging Out ... 9-2 Shutting Down the NEO after Operation... 9-3 Extended Shutdown of the NEO ... 9-7 Chapter 10: Maintaining the NEO ... 10-1 In this chapter ... 10-1 Maintenance and Verification Action Status Screen ... 10-2 Daily Tasks ... 10-5 PC and NEO Module Shutdown ... 10-6 Filling the System Liquid... 10-7 Emptying the Common Waste Container ... 10-10 Cleaning the Instrument ... 10-12 Checking Pipettor Reference... 10-13 Verifying the Reader ... 10-15 Completing Reagent Quality Control (QC) ... 10-18 Completing QC3_Cell Quality Control (QC) ... 10-19 Deleting Historic Sample Plate Entries ... 10-20 Performing the Pipettor Self Check ... 10-22 Weekly Maintenance Tasks... 10-25 Weekly Tasks ... 10-25 Verifying the Washer ... 10-26 ii

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Checking the Reader Performance ... 10-30 Creating Archives ... 10-34 Cleaning the Pipettor Wash Towers ... 10-41 Cleaning the Common Waste Container ... 10-43 Inspecting the Syringes ... 10-44 Monthly Tasks ... 10-46 Clearing Test Data ... 10-47 Deleting Historic Maintenance Plate Entries... 10-49 Checking the RVP Calibration Date ... 10-50 Decontaminate Tubings... 10-51 As Needed Tasks ... 10-57 Flushing the System Liquid ... 10-58 Emptying the 20 Liter System Liquid Container... 10-59 Performing the Pipettor Verification Test (PipTest) ... 10-60 Performing the Positions Check (PosCheck)... 10-62 Performing the Syringe Change ... 10-63 Checking the Residual Volume ... 10-64 Removing and Reinserting the Manifold ... 10-67 Using the Washer Teach Tool ... 10-72 Checking the Manifold Probes... 10-74 Adjusting the Manifold Grub Screws ... 10-76 Cleaning the Liquid Level Sensor and Trough... 10-80 Cleaning the Liquid Overflow Detection Mat... 10-87 Removing and Replacing a Syringe ... 10-88 Removing and Replacing a Probe ... 10-93 Cleaning the Reader Mirror and Light Diffuser ... 10-100 Changing the Camera Lamp ... 10-103 Replacing the Y-pusher ... 10-108 Chapter 11: Troubleshooting the NEO ... 11-1 In this chapter ... 11-1 The Troubleshooting Process Steps ... 11-2 Using Error Codes to Troubleshoot ... 11-4 Troubleshooting Software Failure ... 11-8 Pipettor Self Check Failures ... 11-11 Clot Detection Recovery Process ... 11-14 Troubleshooting Plate Transport Errors ... 11-15 Troubleshooting Pipettor Errors ... 11-22 Troubleshooting Centrifuge Errors ... 11-25 Troubleshooting Incubator Errors ... 11-36 Troubleshooting Washer Errors ... 11-41 Troubleshooting Camera Reader Errors... 11-48 Troubleshooting 14-lane and 5-lane Bay Errors ... 11-50 Troubleshooting Plate Tower Errors ... 11-52 Chapter 12: Limitations of Use and Warnings ... 12-1 In this chapter ... 12-1 Limitations of Use ... 12-2 Warnings ... 12-10 Appendix A: Preparing the NEO for First Use ... A-1 In this appendix ... 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-9 Setting up the Instrument ... A-10 Completing the Post-Installation Check ... A-11 Verifying the Installation ... A-12 Removal of the Instrument ... A-13 Appendix B: Maintenance Records ... B-1 In this appendix ... B-1 Maintenance Forms ... B-2 Neo Operator Manual

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Appendix C: Hardware Technical Data ... C-1 In this appendix ... C-1 Hardware Technical Data ... C-2 Glossary Glossary-1 Index Index-1 Attachment 1 for Neo Operator Manual ATT1-1 Attachment 2 for Neo Operator Manual ATT2-2 Attachment 3 for Neo Operator Manual ATT3-3 Attachment 4 for Neo Operator Manual ATT4-4

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About this Manual In this section The Galileo Neo Operator Manual is designed to guide the Galileo Neo operator through all procedures required to use and maintain the NEO, including operating procedures, maintenance, and troubleshooting. This chapter provides high-level information about how this manual is organized. About this Manual ... 1 In this section ... 1 How this Manual is Organized ...2

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About this Manual-1

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 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 12 character hyphenated format. The first six characters (NEO_EU) identify the instrument and manufacturer. 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 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

Related to…

Type of Warning 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

Warning

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 Consult instructions for use

In Vitro Diagnostic medical device (IVD)

Biological risks

Manufacturer

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

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Potential hazard resulting in possible injury EN ISO 18113:2011 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use EN ISO 15223:2012 – Medical devices symbols to be used with medical devices labels, labeling and information to be supplied. EN ISO 15223:2012 – Medical devices symbols to be used with medical devices labels, labeling and information to be supplied. EN ISO 15223:2012 – Medical devices symbols to be used with medical devices labels, labeling and information to be supplied. Directive 2012/19/EC - Waste Electrical and Electronic Equipment Directive 98/79/EC - on in vitro diagnostic medical devices EN ISO 15223:2012 – Medical devices symbols to be used with medical devices labels, labeling and information to be supplied About this Manual-3

About this Manual

How this Manual is Organized

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 In this chapter This chapter provides an introduction to the NEO. Chapter 1 : Introduction to the NEO ... 1-1 In this chapter... 1-1 About the NEO ... 1-2 Consistent Color Code ... 1-3 Barcodes ... 1-5 Reagents ... 1-7 Racks ... 1-8 Dynamic Schedule ... 1-10 Miscellaneous Information ... 1-11

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Chapter 1: Introduction to the NEO

About the NEO

About the NEO Intended Use The Galileo Neo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO 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 and antigen screening. The NEO is intended for use only with the reagents described in Attachment 1 for Galileo Neo Operator Manual.

Limitation: The NEO is for in vitro diagnostic use.

Principles of Operation The NEO is designed to automate standard immunohematology assays and operate as a walk-away system, meaning you can leave the NEO 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 system to support and to simplify the overall system operation. The NEO is a closed system and can only be used with specified Immucor products. The NEO is an ergonomically friendly and easy-to-use system. Features of the NEO system have been designed to maximize operator efficiency and thereby minimize result errors. The NEO 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 plate reader uses CCD cameras to capture an image of the microplate from underneath. The NEO software calculates a reaction value for each well based on a multi feature image analysis. The NEO 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 uses software to drive its mechanics and data processing. The operator uses hardware in combination with the software to operate and maintain the NEO.

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Consistent Color Code

Chapter 1: Introduction to the NEO

Consistent Color Code Purpose In order to improve process control when loading or unloading the NEO, many safeguards have been incorporated into the system. To indicate when it is safe to use a component, the NEO 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 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 Green Continuous Green Flashing

Meaning You can place a suitable item into this position.

Orange Continuous Orange Flashing

The system has not been requested to use this component and there are no errors. A warning has been issued for this component, an error occurred or you can remove a rack.

Red Continuous Red Flashing

DO NOT place anything in this position.

You should remove an item from this position.

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)

Insert Plate (Slot unused)

Start Test (Slot in access)

Strips remaining?

Yes

Plate removed (Slot empty)

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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

Barcodes Purpose The NEO 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 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.

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.

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

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Barcodes

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 st year (YY). For example, February 1 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 st th an expiration date of February 1 2010 and it was the thirteenth (13 ) 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.

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 from the bottom of the tube.

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Reagents

Chapter 1: Introduction to the NEO

Reagents The NEO 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 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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Chapter 1: Introduction to the NEO

Racks

Racks Purpose The NEO 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. You can continuously load or unload racks from the NEO during operation according to the consistent color code. NEO 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 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.

B

E

D

C A

 A: Guide rail  B: Handle  C: Pin  D: Positional barcodes  E: Rack barcode

Types of Racks There are two lengths of NEO racks:  Racks for the 14-lane bay  Racks for the 5-lane bay

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Racks

Chapter 1: Introduction to the NEO The following table shows every type of NEO rack available in these sizes. Bay Type 14-lane bay

# of Positions 16

Rack Type

14-lane bay

16

Tube: B

14-lane bay

16

Tube: C

14-lane bay

16

14-lane bay

12

5-lane bay

9

Reagent: S

5-lane bay

5

Reagent: T

Tube: A

Donor: D Reagent: R

Tube or Vial Size Sample Rack: 16–17X100 mm tube Sample Rack: 12–13X75–100 mm tube Sample Rack: Pediatric tube custom rack Donor Rack: 12 mm diameter tube 10 ml reagent vial (occupies 2 lanes) 10 ml reagent vial (occupies 2 lanes). Note: Not for use with controls. 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

Dynamic Schedule

Dynamic Schedule 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 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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