Beckman Coulter A97260AD IDC and DxI Connection Modules For In Vitro Diagnostic Use Instructions For Use

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Instructions For Use

Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 U.S.A.

Power Processor Generic/IDC and DxI Connection Modules

For In Vitro Diagnostic Use

A97260AD June 2019

Power Processor

Beckman Coulter Eurocenter S.A. 22, rue Juste-Olivier Case Postale 1044 CH - 1260 Nyon 1, Switzerland Tel: +41 (0) 22 365 36 11

Rx Only

Generic/IDC and DxI Connection Modules Instructions For Use

PN A97260AD (June 2019)

Trademarks

Beckman Coulter and the Beckman Coulter symbol are trademarks of Beckman Coulter, Inc.

All other trademarks are the property of their respective owners.

Find us on the World Wide Web at:

www.beckmancoulter.com

Original Instructions

What’s New in this Release

These instructions apply to Power Processor systems with the latest software version listed in this document, as well as previous software versions. When a subsequent software version changes the information in this document, a new issue will be released.

A97260AD, June 2019

This Instructions For Use manual is for Power Processor used with PrepLink software Version 5.0.

Changes

• Safety Notice:

A97260AC, March 2018

This Instructions For Use manual is for Power Processor used with PrepLink software Version 5.0.

Changes

• Safety Notice:

Initial Issue A97260, June 2011

This is the initial release of the Power Processor Generic/IDC and DxI Connection Modules Instructions for Use, PN A97260 (June 2011).

Removed Moving Parts Label from the Hardware Labels section. Moved it to “Legacy Hardware Labels” table.

Replaced the Moving Parts symbol to Crushing of hands symbol in the Symbols Glossary table Added the California Proposition 65 symbol to the Symbols Glossary table Removed the Country of Origin symbol from the Symbols Glossary table

Added a symbols glossary to address changes to global labeling requirements and identify the symbols that relate to product identification, classification, cautions, and warnings.

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This document was created as part of the reorganization of the current Power Processor Instructions for Use manual, PN 968232, to improve the content and usability of these instructions, and the

method by which this information is delivered to our customers.

Information that was previously contained in the Power Processor Instructions for Use manual, PN 968232, is now available as a Document Set of separate Power Processor IFU manuals, each specific to the individual Power Processor modules.

Material that is generic to the entire Power Processor system is contained in the Power Processor General System Operation IFU manual, PN B01683.

The new Document Set of Power Processor Instructions for Use manuals includes the following:

• General System Operation IFU, PN B01683

• Inlets, Outlets, Hematology, and Barcode Verification Modules IFU, PN B01519

• Centrifuge Module IFU, PN A97119

• Decapper and Recapper Modules IFU, PN A97252

• Aliquot Module IFU, PN A97103

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What’s New in this Release

• LX and DxC Connection Modules IFU, PN A97111

• AU Connection Modules IFU, PN B01540

• Generic/IDC and DxI Connection Modules IFU, PN A97260

• Stockyard Modules IFU, PN A97244

Documentation Changes for Generic/IDC and DxI Connection Modules

Significant new, or changed, Generic/IDC and DxI Connection Module information that was not in the Power Processor IFU, PN 968232, include the following:

• New Rack Assignment information.

• Improvements to the “Stop Button Recovery with Instrument Connections” procedure.

• Improvements to the “Stop Button Recovery without Instrument Connections” procedure.

• Centaur Connection module hardware description and error code information added.

• WARNING note added to the Safety Notice section noting that each sample tube must have a

unique sample ID.

• C-Tick label added to Safety section.

• Caution regarding when the Generic/IDC and DxI Connection Modules are in

system is still active.

• Updated table 3.1 Module Function Codes.

PAUSE, the air

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Read all product manuals and consult with Beckman Coulter-trained personnel before attempting to operate instrument. Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, contact your Beckman Coulter Representative.

Alerts for Warning, Caution, Important, and Note

WARNING

Warning indicates a potentially hazardous situation which, if not avoided, could cause death or serious injury. Warning can indicate the possibility of erroneous data that could cause an incorrect diagnosis.

CAUTION

Caution indicates a potentially hazardous situation which, if not avoided, can cause minor or moderate injury. Caution can also alert against unsafe practices, or indicate the possibility of erroneous data that could cause an incorrect diagnosis.

Safety Notice

IMPORTANT

NOTE Note indicates notable information to follow.

TIP Tip indicates information to consider.

Important indicates important information to follow.

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Safety Notice

General Warnings and Cautions

WARNING

Do not use the equipment in a manner not specified by Beckman Coulter, Inc., as the protection provided by the equipment can be impaired.

WARNING

Each sample tube processed by the system must have a unique sample ID and readable bar code label. The system sends sample tubes with duplicate sample IDs to the Error Lane. Damaged or unreadable bar code labels cause errors.

If you load multiple sample tubes with the same sample ID on the automation system and on a connected analyzer at the same time, the system can send duplicate results to the LIS. Contact your Beckman Coulter Representative for suggestions to implement unique sample ID labeling.

CAUTION

To reduce risk of personal injury, operate the system only with all covers in place.

CAUTION

Do not load or view the Instructions for Use PDF files onto any computer connected to the automation system. Failure to follow this caution can reduce computer processing speed and system performance.

CAUTION

Use only the approved Power Processor parts and supplies as listed in the Power Processor General System Operation IFU, Appendix B. Use only the approved sample tubes as noted in the Power Processor General System Operation IFU, Operational Overview.

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Electromagnetic Wave and Noise Precautions

This In Vitro diagnostic (IVD) equipment complies with the emission and immunity requirement described in IEC 61326-2-6.

CAUTION

This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment, it could cause radio interference, in which case, you might need to take measures to mitigate the interference.

It is advised that before operation of the device, the electromagnetic environment be evaluated. Do not use this device near sources of strong electromagnetic radiation (for example, unshielded intentional RF sources), as they could interfere with the correct operation.

Hardware Labels

Safety Notice

Hardware Labels

Biohazard Label

This label indicates a caution to operate only with all covers in position to decrease risk of personal injury or biohazard.

Pneumatic Label

This label indicates a caution that the Inlet module works under a pressure of 0.7 mpa (100 PSI).

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Safety Notice

Compliance and Certification Markings

These labels and materials declaration table (the Table of Hazardous Substance's Name and Concentration) meet People's Republic of China Electronic Industry Standard SJ/ T11364-2006 "Marking for Control of Pollution Caused by Electronic Information Products" requirements.

Recycling Label

This label is required in accordance with the Waste Electrical and Electronic Equipment (WEEE) Directive of the European Union. The presence of this label indicates that:

1. the device was put on the European Market after August 13, 2005 and

2. the device is not to be disposed of via the municipal waste collection system of any member

state of the European Union

Customers must understand and follow all laws regarding the correct decontamination and safe disposal of electrical equipment. For Beckman Coulter products bearing this label, contact your dealer or local Beckman Coulter office for details on the take-back program that facilitates the correct collection, treatment, recovery, recycling and safe disposal of these products.

For the Japan Market: This system is considered an industrial waste, subject to special controls for infectious waste. Prior

to disposal of the system, refer to the "Waste Disposal and Public Cleaning Law" for compliance procedures.

cNRTLus Certification Mark

This symbol indicates recognition by a Nationally Recognized Testing Laboratory (NRTL) that the instrument has met the relevant product safety standards for the United States and Canada.

OSHA, CEC

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CE Marking

The CE marking indicates that a product has been assessed before being placed on the market, and has been found to meet the applicable directives relating to the European Union safety, health, and environmental protection requirements.

RoHS Caution Symbol

This symbol indicates that this electronic information product contains certain toxic or hazardous elements, and can be used safely during its environmental protection use period. The number in the middle of the logo indicates the environmental protection use period (in years) for the product. The outer circle indicates that the product can be recycled. The logo also signifies that the product should be recycled immediately after its environmental protection use period has expired. The date on the label indicates the date of manufacture.

Safety Notice

Compliance and Certification Markings

These labels and materials declaration table (the Table of Hazardous Substance's Name and Concentration) meet People's Republic of China Electronic Industry Standard SJ/T11364-2006 Marking for Control of Pollution Caused by Electronic Information Products requirements.

RCM Symbol

This symbol indicates compliance with the Australian Communications Media Authority (ACMA) requirements (safety and EMC) for Australia and New Zealand.

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Safety Notice

Symbols Glossary

Symbol Symbol Title, Symbol Meaning, and Symbol Reference

Title of Symbol: Caution

Meaning of Symbol: Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, the presented on the medical device itself.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements. #5.4.4

Title of Symbol: In vitro diagnostic medical device

Meaning of Symbol: Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1: Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements, clause 5.5.1

Title of Symbol: Dangerous voltage

Meaning of Symbol: To indicate hazards arising from dangerous voltages.

IEC 60417: Graphical symbols for use on equipment - Overview and application, #5036

Supplemental Product-Specific Manufacturer Information

This symbol can also indicate an area of the system to not access under any circumstances, due to possibility of high voltages and the risk of electrical shock.

Title of Symbol: Warning; Biological hazard

Meaning of Symbol: To warn of a biological hazard.

Standard Number, Title of Standard, and Symbol Reference Number:

IEC 60878. Graphical Symbols for electrical equipment in medical practices. #7010-W009

Supplemental Product-Specific Manufacturer Information

This label indicates a caution to operate only with all covers in position to decrease risk of personal injury or biohazard.

This label indicates the use of biohazardous materials in the area. Use caution when working with possible infectious samples.

Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats. Handle and dispose of biohazardous materials according to your laboratory procedures.

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Symbols Glossary (Continued)

Symbol Symbol Title, Symbol Meaning, and Symbol Reference

Safety Notice

Symbols Glossary

Title of Symbol: Warning; Crushing of hands

Meaning of Symbol: To warn of a closing motion of mechanical parts of equipment

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 7010. Graphical Symbols for electrical equipment in medical practices. #W024

Supplemental Product-Specific Manufacturer Information

Use caution to avoid injury to hands when close to equipment with moving mechanical parts.

Title of Symbol: Consult instructions for use

Meaning of Symbol: Indicates the need for the user to consult the instructions for use.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements. #5.4.3

Title of Symbol: Date of Manufacture

Meaning of Symbol: To indicate the date when the medical device was manufactured.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements. #5.1.3

Title of Symbol: Authorised representative in the European Community

Meaning of Symbol: Indicates the authorized representative in the European community.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements. #5.1.2

Title of Symbol: Manufacturer

Meaning of Symbol: Indicates the medical device manufacturer as defined in EU Directives 90/385/ EEC, 93/42/EEC and 98/79/EC.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements. #5.1.1

Supplemental Product-Specific Manufacturer Information

This symbol identifies who the legal manufacturer of the product is.

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Safety Notice

Symbols Glossary

Symbols Glossary (Continued)

Symbol Symbol Title, Symbol Meaning, and Symbol Reference

Title of Symbol: Catalogue Number

Meaning of Symbol: Indicates the manufacturer's catalogue number so that the medical device can be identified.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements. #5.1.4

Title of Symbol: Serial number

Meaning of Symbol: Indicates the manufacturer's serial number so that a specific medical device can be identified.

Standard Number, Title of Standard, and Symbol Reference Number:

ISO 15223-1. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements. #5.1.7

Title of Symbol: Stop

Meaning of Symbol: To identify the control or the indicator to stop the active function.

Standard Number, Title of Standard, and Symbol Reference Number:

IEC 60417: Graphical symbols for use on equipment - Overview and application, #5110A

Supplemental Product-Specific Manufacturer Information

This symbol indicates a stop button.

Title of Symbol: Cooling Unit

Meaning of Symbol: Denotes the cooling unit.

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Title of Symbol: Driver Box

Meaning of Symbol: Denotes the driver box.

Title of Symbol: Made in Japan

Meaning of Symbol: Indicates the country where the device hardware was manufactured.

Title of Symbol: RxOnly Symbol

Meaning of Symbol: Caution: U.S. Federal Law restricts this device to sale by or on the order of a licensed practitioner.

Title of Symbol: California Proposition 65

Meaning of Symbol: This product may contain chemicals known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to

https://www.P65Warnings.ca.gov.

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Historical Power Processor systems may contain the following additional labels.

456161-B

TO REDUCE RISK OF PERSONAL INJURY,

OPERATE ONLY WITH ALL COVERS IN PLACE.

CAUTION

A011459L.EPS

CAUTION

SHARP OBJECTS

A16558-AA

A016351L.EPS

Legacy Hardware Labels

Symbol Description

Safety Notice

Symbols Glossary

Please Hold This Portion

This symbol, located on the drawer in the Dynamic Inlet and Outlet modules and the top cover of the centrifuge, indicates the most stable position to hold the drawer or cover.

Stop Button

This symbol indicates a stop button that you can use to halt any hazardous condition.

Power On

This symbol indicates the location of the Power On button in the Centrifuge module.

RoHS Environmental

This symbol indicates that the product does not contain any toxic or hazardous substances or elements. The "e" stands for electrical, electronic, and environmental electronic information products. This logo indicates that this electronic information product does not contain any toxic or hazardous substances or elements, and is green and is environmental. The outer circle indicates that the product can be recycled. The logo also signifies that the product can be recycled after being discarded, and should not be casually discarded.

C-Tick Mark

The C-Tick mark is intended for use on products that comply with the applicable Electromagnetic Compatibility (EMC) standards in the Australian or New Zealand market.

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Caution

To reduce the risk of electrical shock, disconnect the power supply cord before servicing.

Caution, Biohazard Label

This caution symbol indicates a caution to operate only with all covers in position to decrease risk of personal injury or biohazard.

Sharp Object Label

A label reading “CAUTION SHARP OBJECTS” is found on the Decapper device in the Decapper/Serum Level Detection (SLD) module.

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Safety Notice

CAUTION PARTS MOVE AUTOMATICALLY

A015081L.EPS

Symbols Glossary

Legacy Hardware Labels (Continued)

Symbol Description

Caution, Moving Parts

This caution symbol warns the operator of moving parts that can pinch or crush. This label is found in several locations.

Moving Parts Label

This label indicates moving parts that can pinch or crush. This label is found in several locations.

Caution parts move automatically

While the system is in operation, do not touch or go close to any moving parts. Close protective guards and covers during operation. Failure to close covers correctly can cause injury or incorrect results.

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What’s New in this Release,iii

Safety Notice,v

General Information,xix

CHAPTER 1: Module Description,1-1

Generic (CLSI) Connection Modules,1-1

Multiple Generic Connections,1-1

Generic Connection Modules Description,1-2

Power Processor with Generic Connections,1-2 Key Features,1-2 Hardware,1-2

Additional Hardware Information,1-3 Centaur Generic Connection Module,1-3

Software,1-3

PrepLink,1-3 Line Control Computer,1-3 Tube Routing,1-4 Sample Location with Generic Connections,1-5

Instrument Dynamic (CLSI) Connection Modules,1-6

Multiple IDC and Generic Connections,1-6

Instrument Dynamic Connection Modules Description,1-7

Power Processor with IDC Connections,1-7 Key Features,1-7 Hardware,1-8 Additional Hardware Information,1-9

Printer,1-9 H-Lane Module,1-9

Software,1-10

Tube Routing,1-10 PrepLink,1-10 Line Control Computer,1-11 Sample Location with IDC and Generic Connections,1-12

CHAPTER 2: Module Procedures,2-1

Generic Connection Module Procedures,2-1

Rack Assignment,2-1 Test Configuration,2-1

How to Configure a Test for Generic Connections,2-2

Contents

How to Remove a Test from Generic Connections,2-3

Test Assignment for Generic Connection Instruments,2-3

Generic Connection Test Assignment,2-4

Setting the Rerun Mode,2-5

Rerun Mode with Dilutions,2-5

Pausing the Generic Connection Module,2-6

How to Pause the Generic Connection Module,2-7

Clustering Generic Connections,2-8

How to Assign a Generic Connection Cluster,2-9

How to Delete a Generic Connection Cluster,2-9 Aliquot Priority,2-10 Always Create an Aliquot Tube Feature with Generic and IDC

Connections,2-11

Share Primary,2-11

Instrument Dynamic (CLSI) Connection Modules Procedures,2-12

Sample Type/Material Type Logic,2-12 Test Assignment Procedure,2-12 Outlet Configuration,2-12

Stockyard,2-13

Pending Rack,2-14

How to Configure the Pending Rack,2-15 IDC Instrument Setup,2-16

Instrument Mode,2-16 Setting the Rerun Mode,2-17

How to Set the Rerun Mode,2-18

Rerun Mode with Dilutions,2-18 Reflex and Add-On Tests,2-19

Aliquot Module,2-19 Operation,2-20

STAT Sample Processing,2-20 Pause the IDC Module,2-20

How to Pause the Connection Module,2-21 Print Pending Rack Maps,2-22

How to Print the Pending Rack,2-22 Basic Tube Routing,2-23

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CHAPTER 3: Error Recovery Procedures,3-1

Error Recovery General Information,3-2

Power Processor Module Function Codes,3-2 General Error Recovery Procedure,3-2

System Error Recovery Procedures,3-3

Gripper Finger Error Recovery,3-3

Error Recovery,3-3 Jammed Sample Tube Carrier Recovery,3-4

Error Recovery,3-4 Bypassing a Module,3-5

How to Bypass a Module,3-5 Flashing AUTO/MANUAL Button on keypad(s),3-6

Error Recovery,3-6

Stop Button Recovery with Instrument Connections,3-7

Stop Button Recovery,3-7

CHAPTER 4: Troubleshooting,4-1

Error Code Tables,4-1

Error Code Explanation,4-1

Nomenclature,4-1

Unit Error Code Categories,4-2

Generic/IDC and DxI Modules Error Codes,4-4

Centaur Module Error Codes,4-7

Generic/IDC (CLSI) Connection Track Module Error Codes,4-8

L and H-Lane Error Codes,4-11

Smart H-Lane Error Codes,4-14

Sensor Diagrams,4-16

Background Information,4-16

Generic/IDC (CLSI) Connection Module,4-17

L and H Lane,4-19

Contents

Intended Use

The basic Power Processor is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Processor can be configured with optional software and hardware to allow processing of sample tubes on Generic Connection Instruments.

The Power Processor performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.

General Information

Scope of this Manual

This Instructions For Use manual is for Power Processor Generic/IDC and DxI Connection Modules used with PrepLink software Version 5.0. This manual contains information and instructions that will assist you in performing Power Processor Generic/IDC and DxI Connection Module operations and troubleshooting functions.

NOTE

Th is d ocu men t is par t of the Power Processor Instructions for Use Document Set and, o nly cov ers the Power Processor Generic/IDC and DxI Connection Modules. For information and instructions for other Power Processor modules, refer to the appropriate Power Processor manual from the list below.

Power Processor Instructions for Use Document Set

• General System Operation IFU, PN B01683

• Inlets, Outlets, Hematology, and Barcode Verification Modules IFU, PN B01519

• Centrifuge Module IFU, PN A97119

• Decapper and Recapper Modules IFU, PN A97252

• Aliquot Module IFU, PN A97103

• LX and DxC Connection Modules IFU, PN A97111

• AU Connection Modules IFU, PN B01540

• Generic/IDC and DxI Connection Modules IFU, PN A97260

Be sure to follow all safety cautions and warnings noted in this document.

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• Stockyard Modules IFU, PN A97244

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General Information

Document Conventions

Safety Information

For more information, refer to the Safety Notice section, in this document.

Alerts for Warning, Caution, Important, and Note

WARNING

WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. May be used to indicate the possibility of erroneous data that could result in an incorrect diagnosis (does not apply to all products).

CAUTION

CAUTION indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. May be used to indicate the possibility of erroneous data that could result in an incorrect diagnosis (does not apply to all products).

IMPORTANT

Following the advice in the IMPORTANT notice adds benefit to the performance of a piece of equipment or to a process.

NOTE NOTE is used to call attention to notable information that should be followed during installation, use,

or servicing of this equipment.

IMPORTANT is used for comments that add value to the step or procedure being performed.

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Trademarks and Product Names

Associated registered trademark and trademark symbols will only be used in the first instance where they apply.

The product family names, Synchron and UniCel, will only appear associated with members of products in those families the first time the product name is mentioned. Thereafter the product name will be used alone. One exception to this rule is the use of names of instrument racks, since the name of the rack includes the product family and is associated with a specific Beckman Coulter part number.

General Information

Document Conventions

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General Information

Document Conventions

xxii

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This chapter provides a brief description of the Power Processor Generic/IDC and DxI Connection Modules.

Generic (CLSI) Connection Modules

Power Processor can be configured with optional software and hardware to allow processing of sample tubes on Generic Connection Instruments (non-LX/DxC and IDC). The Power Processor performs all pre-analytical sample tube preparation, then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.

CHAPTER 1 Module Description

IMPORTANT

and related software functions. Refer to Chapters 1 through 3 in the General System Operation IFU for information about standard Power Processor hardware and features.

This chapter contains information specific only to the optional Generic Connection hardware

Multiple Generic Connections

At installation, the Beckman Coulter Service Representative configures the Power Processor for up to 12 Generic Connection Modules.

CAUTION

Do not operate the system without the Generic Connection LAS sample pipette cover located on the back of the instrument in place. Make sure that the PAUSE button on the Generic Connection Module is lighted before lifting the instrument pipette cover.

CAUTION

Even when the Generic Connection Module is in PAUSE mode, the air system is still active and applying a constant air pressure to the sample pipette arm. This may cause unexpected movement of the sample pipette arm when resolving a jammed object error creating a possible moving part or pinch hazard. Use caution when resolving jammed object errors at the LAS sample pipette.

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1-1

Module Description

Generic Connection Modules Description

Power Processor with Generic Connections

The Power Processor with Generic Connections allows the operator to assign tests and route sample tubes to Generic Connection Modules (non-LX/DxC and IDC). The Power Processor performs all preanalytical sample tube preparation and automatically routes sample tubes to Generic Connection instruments or instrument Clusters. Once samples are pipetted for analysis by the Generic Connection instrument, the system can route sample tubes for testing on other instruments or to Outlet Racks. Primary sample tube and aliquot tube routing and sorting decisions are based on parameters set by the operator.

Key Features

The optional hardware and software add the following features to the Power Processor:

Hardware

• Automatic loading of tubes to Generic Connection Modules.

• Clustering (grouping) of Generic Connection instruments for enhanced tube routing and

testing.

• Routing of the tubes to the Pending Rack for Rerun/Add-on testing determined by operator.

• Tube routing for Primary and aliquot tubes.

• Ability to pause each Generic Connection Module.

Hardware required to connect Generic Connections to the system includes:

• Generic Connection Module

• Generic Connection Instruments (for example, DxI, Centaur, AU2700/5400)

As sample tubes route on the system, they move through the Generic Connection Module. At the TLane intersection of the main track and Generic Connection Module, the sample tubes are read by a bar code reader. Once the sample IDs are scanned, the sample tubes either route to the Generic Connection Module for testing by the Generic Connection instrument or pass the Generic Connection Module to continue routing on the system.

For sample tubes that route to the Generic Connection Module, another bar code reader scans the sample ID and sends the Sample ID to the connected instrument. The instrument queries the LIS for programming, if needed. When the instrument is ready to process the sample, the tube is released to the aspiration point, and the instrument aspirates the sample from the tube on the track. Then the sample tubes route to the main track again for processing on other instruments or routing to the Stockyard/Outlet Racks.

1-2

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Module Description

Generic Connection Modules Description

Additional Hardware Information

When a system is configured with a Generic (CLSI) Connection Module before an LX or DxC Connection Module, the H-lane can have a keypad. The H-lane with a keypad uses the error codes and sensor diagram located in CHAPTER 4, Troubleshooting.

Software

NOTE

Clinical and Laboratory Standards Institute is referred to as CLSI in this manual.

Centaur Generic Connection Module

When a Bayer Advia® Centaur™ instrument is connected to the Power Processor system, it is configured as a Generic Connection Module.

Information regarding setup, operation, maintenance and troubleshooting the Centaur Generic Connection can be found in this document. For information regarding the Centaur instrument, refer to the manufacturer’s manuals or contact the manufacturer’s representative.

The PrepLink and Line Control Computer show changes to some screens when they are configured for Generic Connection Modules.

PrepLink

The following PrepLink screens contain changes or added features when the Power Processor is configured for Generic Connections:

• Locations

• Rack Assignment

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• Test Configuration

• Instrument Loading

• Aliquot Screen

• GC Cluster Screen

Line Control Computer

When the Line Control Computer is configured to manage the Power Processor with Generic Connections, the Main screen shows a default graphical representation of the automation line, including all additional hardware modules connected to the system. This default Main screen display cannot be the same as the module placement of the system in your laboratory. The default representation always shows four instruments before the twelve Generic Connection instruments. Outlet 1A always shows after Outlet 2A, 2B, and/or 2C (Stockyard). Connected instruments not configured for the system will show as gray on the Main screen. All other information shown on the Main screen is correct, such as number of sample tubes sorted to Outlets, racks or the Generic Connection instruments. Refer to Figure 1.1.

1-3

Module Description

Generic Connection Modules Description

Figure 1.1 Line Control Computer Showing Power Processor Track Diagram with instruments and Generic Connections

Tube Routing

When the Power Processor is configured with Generic Connections, the PrepLink makes sample tube routing decisions using the following information:

• Sample programming

• Availability of Generic Connection instruments

• Configuration parameters set by the operator which include tests assigned to Generic

Connection instrument(s) or Cluster(s) created for systems configured with an Aliquot Module

Once a sample tube is routed to the Generic Connection Module, PrepLink considers tests programmed for the sample tube that is assigned to the Generic Connection as complete and routes the sample tube for additional testing or to the Stockyard.

1-4

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Module Description

Generic Connection Modules Description

Sample Location with Generic Connections

When the operator searches for samples by Status on the Locations tab, Generic Connections are

shown when you select in the #12 dependent on the number connected to the system. Refer to Figure 1.2. To search for samples by Sample ID, or Status on a Generic Connection, refer to the procedure “How to Search for Samples” in CHAPTER 3 of the General System Operation IFU.

Figure 1.2 Locations Tab Showing List of Generic Connections

For text box. The Generic Connections are numbered from #1–

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1-5

Module Description

Instrument Dynamic (CLSI) Connection Modules

Clinical and Laboratory Standards Institute is referred to as CLSI in this manual.

The Power Processor V3.5 or later can be configured with optional software and hardware to allow processing of centrifuged and decapped sample tubes to Dynamic Connection Instruments (with CLSI connections, such as the DxI). Generic instruments with dynamic connections to the system are referred to as IDC instruments. This section contains information specific to the hardware and related software functions of the Power Processor with DxI as an Instrument Dynamic Connection (IDC).

The IDC connection to PrepLink:

• Tracks sample status,

• Monitors chemistry reagents,

• Makes optimal decisions based upon the tests requested,

• Makes optimal decisions based upon tests available,

• Makes optimal decisions based upon instruments available.

In this chapter, IDC instruments are referred to as "instruments." DxI will be used as an example of an IDC instrument throughout this chapter.

IMPORTANT

the Power Processor with DxI connection hardware and software. For detailed information about the DxI system, refer to the UniCel DxI Instructions For Use.

This section only provides procedures and information that directly relate to the operation of

Multiple IDC and Generic Connections

At installation, the Beckman Coulter Service Representative configures the Power Processor for up to 12 CLSI connected IDC and/or Generic Connection instruments.

CAUTION

1-6

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Instrument Dynamic Connection Modules Description

Power Processor with IDC Connections

The Power Processor with IDC connections performs all pre-analytical sample tube preparation steps, then aspirates the sample from the sample tubes to connected IDC instruments for testing. The system routes sample tubes that have been analyzed by the IDC instruments, and sample tubes that require testing on other instruments, to specific racks in the Outlet Modules for storage or additional testing.