VITROS 4600

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Specification for Automation Interface

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IMPORTANT

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

No patent license is granted by the information.

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

VITROS® is a registered trademark of Ortho-Clinical Diagnostics, Inc.

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VITROS®

4600 Chemistry System

Pub. No.: J39931EN Issued: 2011-01-10

Section 1. Introduction ... 1

Overview ...1

References and Definitions ...1

Document Structure ...3

Revision History ...3

Assumptions and Dependencies ...3

Section 2. Software Interfaces ... 5

Operational Overview ...5

Specifications ...6

Lab Automation Protocol ...6

Datalink/Session Layer ...7

Presentation Layer ...10

Query Analyzer Status ...23

Sample Metering Handshaking ...23

Reinitialize Metering ...26

Reinitialize Communications ...28

Query Analyzer Inventory/Resources ...28

Illegal Commands ...29

Internationalization and Language Support ...30

Timing Requirements ...30

Lab Automation Communication Scenarios ...31

Interface Initialization Sequence ...31

Run Two Samples ...32

Remote Sample Startup Interrupted by Local Sample ...33

Non Fatal Error Condition (Insufficient Inventory) ...34

Non Fatal Error Condition (Unknown Sample ID) ...35

Non Fatal Error Condition (Sample In Position Not Received in Time) ...36

Fatal Error Condition ...37

Sample Routed Notification ...38

Query Analyzer Inventory ...39

Section 3. Hardware Interfaces ... 40

Electrical Interfaces ...40

Analyzer Dimensions ...41

Site Specifications ...42

Service Access ...42

Analyzer Heat Rejection and Air Intake Zones ...43

Positional Requirements ...43

Analyzer to Track Positioning/Floor Mounts or Anchors ...44

Floor Mounts/Anchors ...45

Sample Positioning and Adjustments ...46

Sample Center Device Adjustments: Positioning Responsibilities ...46

VITROS® 4600 Metering Proboscis Alignment ...47

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Regulations and Safety Standards ...53

Section 4. Sample Handling ... 54

Supported Containers ...54

Containers that are not Supported ...54

Sample Quality Recommendations ...54

Environmental Issues ...54

Section 5. Guidelines for Laboratory Automation System Protocol Tests ... 55

Introduction ...55 Purpose ...55 Audience ...55 Approach ...55 Material Resources ...55 Skills Required ...56 Protocol Tests ...56

LAS Communication Initialization Test ...56

Analyzer Status Test ...57

Sampling Complete Test ...58

Error Recovery Test ...59

Sample Routed/Host Query Test ...61

Request Inventory Test ...61

Request Resources Level Test ...62

Instrument-Based Testing ...62

Normal Operations Sample Handling ...62

Physical Interfaces ...63

Sample Positioning ...64

Section 6. LAS/LIS Architecture ... 65

Methods to Download Test Orders ...65

Single Instrument Download ...65

Broadcast Download ...65 Host Query ...65 Interface Topology ...65 Case 1 ...65 Case 2 ...66 Case 3 ...67

Section 7. Safety and Precautions ... 69

Patient Safety Considerations ...69

Operator Considerations ...71

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Laboratory Automation Specification

Section 1. Introduction

Overview

The Automation Interface Guide contains interface specifications to assist Lab Automation manufacturers in adapting Lab Automation systems to the Ortho Clinical Diagnostics VITROS® 4600 Chemistry System (VITROS® 4600 System). This document is intended for Lab Automation Vendors and Ortho Clinical Diagnostics personnel who create interfaces between an automated sample delivery system and the VITROS® 4600 System.

Laboratory Automation System (LAS) refers to the subsystems that support the capability to control an automated track and coordinate sample movement to a processing station, for example, a system. The LAS includes the VITROS® 4600 Chemistry System (VITROS® 4600 System), the Lab Automation Computer (LAC), and the hardware that connects them.

This specification provides an explanation of interfaces between the Lab Automation Vendors and Ortho Clinical Diagnostics. Topics include:

• Information to be transmitted between the Lab Automation System and the VITROS® 4600 System

• Format of information to be transmitted between the Lab Information System and the system

• Physical relationships between the system and the sample container • Sample container sizes and aspiration depths

• System footprints and space requirements

• Operator and service access requirements to the system • Environmental specifications for the system

• System sample throughput specifications

• Electrical interconnects between a Lab Automation System and the system • Automation interface guidelines for accurate implementation of the Automation

Interface Specification

• Summary of considerations for Lab Automation System and Lab Information System architecture

• Summary of Lab Automation Interface risk assessment

References and Definitions

Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.

Laboratory Information System (LIS) Guide for the VITROS® 5600 Integrated System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 4600 Chemistry System, J32799EN.

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Unpacking and Installation Instructinos for VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: Split System, J39895

Installation Instructions for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System: Automation (AT) Accessory, J39893

Installation Instructions for the VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: AT Seismic Anchorages, J39896

ISO 8859-1 8-bit single-byte coded graphic character sets -- Part 1: Latin alphabet No. 1 ACK (Acknowledgement Code)

A signal passed between computers to signal a receipt of a message. Analyzer

For the purpose of this specification, the VITROS® 4600 Chemistry System. ASCII: American Standard Code for Information Interchange

A system that is used for character encoding. ASTM: American Society for Testing and Materials

In the context of this document, the communication protocols defined by the 1381 and E-1394 specifications for the communications between clinical laboratory instruments and lab computer systems.

Asynchronous LIS Messages

A feature that enables the system to send unsolicited status updates to the LIS. CRC: Cyclical Redundancy Checking

An error checking algorithm used to verify the integrity of an electronic message. Extended ASCII

A set of codes that extends the basic ASCII set. The basic ASCII set uses 7 bits for each character, giving it a total of 128 unique symbols. The extended ASCII character set uses 8 bits, which gives it an additional 128 characters. Extended ASCII uses the ISO8859-1 implementation to support Western European languages. See ISO 8859-1 8-bit single-byte coded graphic character sets -- Part 1: Latin alphabet No. 1.

GUI: Graphical User Interface

A computer-user interface based on graphics (icons and pictures and menus) instead of text.

HL7: Health Level Seven

A standard message protocol for electronic data exchange in all health care environments including clinical laboratories with automation.

LAC: Lab Automation Computer

A computer used in the LAS to control the track and coordinate sample movement to a processing station.

LAS: Lab Automation System

The subsystems that support the capability to control an automated track and coordinate sample movement to a processing station, for example, an Analyzer.

POR: Point of Reference

A point in space at which the sample tube is placed for external metering. LIS: Lab Information System

The computer system responsible for data management, for example, sample results and patient history.

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Sample Proboscis

Aspiration probe on the system. Sample Carrier

The device that holds the sample container and interfaces with the transport track to facilitate movement from one location to another.

Sample Container

The tube that holds patient samples. UTF-8

Unicode Transformation Format-8 that is an octet (8-bit) lossless encoding of Unicode characters.

Document Structure

The Automation Interface Specification is organized into the following sections: Section 1. Introduction on page 1

Provides general information about the specification Section 2. Software Interfaces on page 5

Describes the software commands and responses exchanged between the system and the lab automation system during sample processing

Section 3. Hardware Interfaces on page 40

Describes the physical interfaces between the lab automation system and VITROS® 4600 Chemistry System

Section 4. Sample Handling on page 54

Describes requirements for containers used in sample processing with lab automation systems

Section 5. Guidelines for Laboratory Automation System Protocol Tests on page 55

Provides guidelines for automation system personnel to use in verifying the correct implementation of an automation interface

Section 6. LAS/LIS Architecture on page 65

Discusses considerations applicable in lab automation interfaces in an LIS environment Section 7. Safety and Precautions on page 69

Explains considerations for minimizing risks

Revision History

Assumptions and Dependencies

• Manual (walk up) samples take priority over samples delivered by the automation system.

• Calibration with fluids delivered by the automation track is not supported. (Controls are Date Page Revision Details

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• Whole blood samples for use on the VITROS® 4600 System require processing from cups not tubes. These samples should be processed on the VITROS® 4600 System directly.

• The system uses two types of interfaces. The LAS interfaces for sample coordination and the LIS interface for prsystemogram, results, etc.

• The automation system handles movement of all samples not placed manually on the system.

• The automation system stops, captures, positions, and steadies the sample for fluid aspiration.

• All required information for processing a sample will be supplied to the system. The Lab Automation System for each sample will supply the two items listed below before it is placed in position for metering but after the “SAMPLING COMPLETE” message for the previous sample.

— Sample ID

— Container type (diameter)

• Sample programming for an individual sample must be downloaded prior to its presentation to the system if host query is not enabled.

• When using host query mode, the SAMPLE ROUTED message should be sent to the system as soon as the decision to route the sample to that system has been made by the automation system. This will maximize the time the system has to complete the host query.

• The automation system ensures the integrity of the sample identification for the sample being aspirated.

• If the LAS has not just received a status message or SAMPLE COMPLETE response, the LAS queries the system for its current status before sending a PREPARE TO RUN SAMPLE command.

• The automation system must complete the following steps within the required time period after the SAMPLING COMPLETE message is sent by the system to guarantee maximum system throughput:

— Send the Sample ID information within a PREPARE TO RUN SAMPLE message for the next sample within 100 milliseconds of SAMPLE COMPLETE.

— Place the next sample into the aspiration position.

— Send the SAMPLE IN POSITION message to the system (no more than 6.4 seconds after the PREPARE TO RUN SAMPLE command). The sample must be in position when this message is sent. Failure to meet this 6.3-second time window will result in the sample not being processed by the system.

• The automation system must supply a “setup” mode used with the system's setup and adjustment mode. In this mode, empty tubes are used to adjust the system's metering system to the location where aspiration will be performed.

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• The automation system must comply with the site specifications in order for system doors and lids to open and for waste containers to be easily emptied. Refer to Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.

• This document does not contain the description of the Graphical User Interface (GUI) but only the functionality of the feature.

• No GUI specifications are detailed in this document.

• The system software is backward compatible with existing VITROS® LAS communications.

• Communication between the System and the LAC requires an RS-232 compatible serial communications port.

Section 2. Software Interfaces

This section contains the detailed specifications that define the software interface between the VITROS® 4600 System and the LAC.

Operational Overview

Query Analyzer Status

1. The LAC sends a QUERY ANALYZER STATUS command to the system. 2. The system sends a ANALYZER STATUS response to the LAC.

Sample Metering Handshaking

3. The sample tube is loaded onto automation track. 4. The LIS downloads test order to the system. 5. The sample tube is carried to system.

6. The LAC sends a PREPARE TO RUN SAMPLE command to the system. The command contains a sample ID and the container type.

7. The system retrieves a sample program and builds a worklist for the sample.

8. The LAC sends a SAMPLE IN POSITION command to the system, handing over control to the system.

9. The system aspirates fluid from the sample tube.

10. The system sends a SAMPLE COMPLETE response to the LAC, releasing the sample back into the control of the LAC.

Reinitialize Metering

11. The LAC sends a REINITIALIZE METERING command to the system. 12. The system reinitializes any reduced subsystems.

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Reinitialize Communications

14. The LAC sends a REINITIALIZE COMMUNICATIONS command to the system. 15. If an error occurs and it is recoverable, the system will respond by issuing the READY

sequence.

16. The initialization sequence is repeated.

Query Analyzer Inventory/Resources

17. The LAC sends a QUERY ANALYZER INVENTORY command to the system. 18. The system retrieves inventory information from the Inventory Manager.

19. The system sends a series of ANALYZER INVENTORY responses to the LAC until all the inventory data has been sent.

20. The LAC sends a QUERY ANALYZER RESOURCES command to the system. 21. The system retrieves resource information from the Inventory Manager. 22. The system sends a QUERY ANALYZER RESOURCES response to the LAC.

Note:

Similar functionality is also available with the LIS interface.

Error Handling

The Lab Automation System handles errors encountered during communication. These errors include physical communication errors, framing errors, and logical state transition errors.

Specifications

Lab Automation Protocol

The functions involved in transferring data from the Lab Automation System (system) to the lab computer and the lab computer to the system are divided into these components:

Physical Layer - This is comprised of the actual hardware and software configuration used to communicate between the two systems.

Datalink Layer - This handles the framing and error detection for the sending and receiving of messages.

Session Layer - This handles to establishment of communication, sequence numbering, and error recovery in the sending and receiving of messages.

Presentation Layer - This specifies the content and format of the records to be implemented in this application.

Physical Layer

The system uses 1 start bit.

The system supports 1 or 2 stop bits.

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The system supports the following baud rates: • 9600

• 19200 • 38400

The system uses 8 data bits.

Datalink/Session Layer

Message Format

The following special control characters are used: STX = 0x02

ETX = 0x03

The following forms of message frames are supported:

Byte 1: STX

Byte 2: Message Length

Byte 3: Message Type

Byte 4: Sequence Number

Byte 5 to N-2: Message Body

Byte N-1: CRC

Byte N: ETX

Message lengths are the total number of bytes in the message excluding the STX and ETX. The following message types are supported:

0x00 Data

0x01 ACK

0x02 NAK

Cyclical Redundancy Checks

The algorithm for computing the Cyclical Redundancy Check (CRC) is the following C code fragment:

unsigned char crc; crc = 0x84;

for (i = 0; i <= (message_len-1); i++) {

crc = ((crc >> 1) | (crc << 7)) ^ message_bytes[i]; }

Where

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Note that this algorithm excludes the STX, ETX and CRC bytes.

Sequence Numbers

The use of sequence numbers in system communications is optional. The LAS selects the use or non-use of sequence numbers.

The system disables the use of sequence numbers if the LAS sets the sequence numbers to 0x00 in the ACK messages that it sends during the initialization sequence.

The system enables the use of sequence numbers if the LAS uses valid, increasing sequence numbers in the ACK messages that it sends during the initialization sequence.

Valid sequence numbers are 0 to 255. The number following 255 is 0.

The system maintains two sets of sequence numbers, one for messages originating from the LAS and another for messages originating from the system.

Interface Initialization Sequence

Communication with the system must be restarted whenever a communication link has been broken because the system was turned off or was reset or because an Interface Communication Failure occurred.

The system starts the initialization sequence after a “power on” or “system reset” as soon as the automation control task has initialized.

The system starts the initialization sequence to recover from an interface communication error after receiving a REINITIALIZE COMMUNICATIONS message from the LAS.

The interface initialization sequence begins when the system sends a READY message to the LAS consisting of an STX followed by an ETX.

The system waits up to 1 second for the LAS to respond with an ACK message. If the LAS does not respond, a second READY message is sent.

The initialization sequence is aborted if the LAS does not respond before a 1 second timeout for the second READY.

Note:

The LAS responds to the READY message by sending ACK messages no more than

500ms apart.

The system waits up to 1 second for the LAS to respond with a second ACK message. If the LAS does not respond before 1 second, the initialization sequence is aborted.

When the system receives two ACK messages to determine if sequence numbers are used, the system responds to the LAS with its own ACK message. This contains the appropriate sequence number immediately followed by an ANALYZER STATUS message.

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Figure 1: Initialization Sequence

Acknowledgements

After a message is sent, the sender stops transmitting until an acknowledgment is received. The receiver sends an ACK message to the sender for every message received with a valid CRC and no communication errors.

The receiver sends a NAK message to the sender for every message received with an invalid CRC or a communication error occurred during transmission (example, parity error).

If sequence numbers are enabled, the receiver sets the sequence number of the ACK or NAK message to the sequence number of the message being acknowledged.

CRC checks are not performed on ACK and NAK messages. Unsolicited ACK and NAK messages are ignored.

Lab Automation System

READY if no response in 1 second

ACK ACK

ACK

Analyzer Status Message ACK

Query Analyzer Status

ACK

READY

Sequence Number = A Sequence Number = A+1 Sequence Number = A+1 Sequence Number = 0 Sequence Number = 0

Sequence Number = A+2 Sequence Number = A+2 Sequence Number = 1 Sequence Number = 1

Initialization Complete

Note:

The Query Analyzer Status message is not part of the initialization

sequence but is provided to demonstrate sequence numbers following initialization.

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Interface Communication Failures

Interface communication errors indicate that the Analyzer-to-LAS interface is unreliable. Since the interface is unreliable, communications between the system and the LAS are disabled.

If any of the following conditions occur, the system goes into an error state and reports a condition code:

• The system reports or receives two consecutive NAK messages as a result of two failed send attempts.

• A message acknowledgment is not received within 250ms.

• The last byte received, based on the message length, was not an ETX. • The interface initialization sequence fails.

• The last byte, based on the message length, was not received within 250ms from the STX.

• The message type field is invalid.

Note:

See the REINITIALIZE COMMUNICATION message for recovering from interface

communication failures.

Presentation Layer

Message Acknowledged

The Message Acknowledged message is sent to the receiver for every message received with a valid CRC.

The following format is used for the Message Acknowledged message:

byte 1: STX

byte 2: Message Length

byte 3: Message Type = 0x01

byte 4: Sequence Number

byte 5: CRC

byte 6: ETX

Message Not Acknowledged

The Message Not Acknowledged message is sent to the receiver for every message received with an invalid CRC or if a communication error occurred during transmission.

The following format is used for the Message Not Acknowledged message:

byte 1: STX

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Illegal Command Received

The Illegal Command Received message is sent to the to LAS when an unrecognized command is received or when a logical error occurs, such as an invalid sequence number or when commands are received out of order.

The following format is used for the Illegal Command Received message:

byte 1: STX

byte 5, 6: Message ID = 0xC009

byte 7: Error Type (see the table below)

byte 8, 9: Error Word (see the table below)

byte 10: CRC

byte 11: ETX

Error Type Error Type Description Error Word Contents 0x00

Invalid command

A non-existent command was received. An invalid command was received. This could be a message with a Message ID that is not defined, or a Message ID that is not supported by the system. For example, the system does not recognize the ANALYZER STATUS message (0xC007).

MSB = high byte of Message ID received LSB = low byte

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0x01

Logical Order Error

A command that violates the logical order of operations was received.A command was sent out of sequence. The system will issue this error under the following conditions:

• A SAMPLE IN POSITION message is sent without a corresponding

PREPARE TO RUN SAMPLE message.

• A second PREPARE TO RUN SAMPLE message is sent before the system sends a SAMPLING

COMPLETE message.

• A second SAMPLE IN POSITION message is sent before the system sends a SAMPLING COMPLETE message.

• A QUERY ANALYZER INVENTORY message is sent during external sampling.

• A QUERY ANALYZER RESOURCES message is sent during external sampling.

MSB = high byte of Message ID received LSB = low byte

0x02 Sequence Number Error

A sequence number error was detected. The system issues this error if the use of sequence numbers was enabled during initialization by the LAS, and the system receives a message with a sequence number that does not match the expected sequence number. See REINITIALIZE COMMUNICATIONS for how to recover from this error.

MSB = sequence number expected LSB = sequence number received Error Type Error Type Description Error Word Contents

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Note:

LAS commands sent to the system should be spaced at least 100ms apart to allow the system to respond with an ILLEGAL COMMAND message if necessary.

Query Analyzer Status

The Query Analyzer Status message is sent by the LAS to request the system report its status. This command is performed before starting a new sample unless a SAMPLING COMPLETE response has just been received.

The following format is used for the Query Analyzer Status message:

byte 1: STX

byte 7: CRC

byte 8: ETX

0x03 Invalid Data

Invalid data was discovered in the message. A data field from the previous message contained unexpected data. The following conditions will cause the system to send this error:

• The Container Type in a PREPARE TO RUN SAMPLE message is invalid. • The Sample ID in a PREPARE TO

RUN SAMPLE or a SAMPLE ROUTED message contains zero or more than 15 characters.

• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message contains invalid UTF-8 characters or insufficient characters (according to the Sample ID Length field).

• The Recovery Type in a REINITIALIZE COMMUNICATIONS message is invalid.

MSB = 0x00 LSB:

0x01 = Invalid container type from PREPARE TO RUN SAMPLE 0x02 = Invalid Sample ID length from

PREPARE TO RUN SAMPLE or SAMPLE ROUTED

0x03 = Invalid Sample ID data from PREPARE TO RUN SAMPLE or SAMPLE ROUTED

0x04 = Invalid recovery type from REINITIALIZE COMMUNICATIONS Error Type Error Type Description Error Word Contents

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Analyzer Status

The Analyzer Status message is sent by the system to indicate its status. This message is sent in response to a QUERY ANALYZER STATUS or as an asynchronous message during the

initialization sequence.

The following format is used for the Analyzer Status message:

byte 1: STX

byte 7: Status Code (see table below)

byte 8: CRC

byte 9: ETX

Analyzer Status Codes

Status Codes Status Code Descriptions 0x00

Analyzer is ready to Sample

The Analyzer is ready to process a sample. The LAS may issue a PREPARE TO RUN SAMPLE message to the Analyzer.

0x01

Analyzer is Busy Performing an External Sample

The Analyzer is processing an external sample (off the automation track). The LAS must wait for a

SAMPLING COMPLETE message to be issued by the Analyzer before presenting any new samples to the Analyzer.

0x02

Analyzer is Busy Performing an Internal Sample

The Analyzer is processing an internal sample (onboard sample tray). This status is necessary since the use of the Analyzer is lab dependent. The LAS should periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the "Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer.

0x03

Analyzer is Equilibrating

The Analyzer is in the process of bringing the thermal conditions into proper range for processing samples. This status occurs normally when the Analyzer is initialized or if a thermally controlled component of the Analyzer is opened. The LAS should periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer. It may require 30 to 40 minutes before the Analyzer is ready to sample.

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0x04

Analyzer has a Fatal Error

The Analyzer is inoperable and is not ready to process samples. One or more subsystems have experienced a mechanical malfunction. The LAS should attempt to restore the Analyzer to an operational state by issuing a REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator and reroute samples to another Analyzer.

0x05

Analyzer is Not Available

This status indicates that the Analyzer is not ready to process samples. It indicates that an operator is performing manual operations such as loading reagents, diagnostics, initializing, or loading an ADD. The LAS should periodically issue a QUERY

ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer.

0x06

Failed in the Sample

The Analyzer's metering proboscis has mechanically failed while inside the sample

container. The LAS should not attempt to move the sample to prevent the possibility of a broken tube and sample spill. The LAS should attempt to restore the Analyzer to an operational state by issuing a

REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the

Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator. The current sample should not be moved by the LAS and other samples may be rerouted to another Analyzer until the Analyzer is ready to sample. Status Codes Status Code Descriptions

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Prepare To Run Sample

The Prepare to Run Sample message is sent by the LAS to indicate that a sample with the given parameters is being placed for aspiration. This command begins the sampling process.

The following format is used for the Prepare to Run Sample message:

byte 1: STX

byte 7: Reserved (always 0x00)

byte 8: Reserved (always 0x00)

byte 9: Container Type (see table below)

byte 10: Sample ID Length (in bytes)

byte 11 to n: Sample ID (15 characters max)

byte n+1: Reserved (always 0x00)

byte n+2: Reserved (always 0x00)

byte n+3: CRC

byte n+4: ETX

Container Types

Note:

The sample tube does not need to be in position at the POR to for the LAS to send the

Prepare to Run Sample message.

Note:

The contents of reserved fields are ignored.

Note:

The Sample ID should be encoded using UTF-8 or Extended ASCII depending on the

configured encoding.

Status Codes Status Code Descriptions

0x00 16mm diameter tube

0x01 13mm diameter tube

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Sample In Position

The Sample in Position message is sent by the LAS to inform the system that the sample it is preparing to run is now in the correct position for sampling to begin.

The following format is used for the Sample In Position message:

byte 1: STX

byte 7: CRC

byte 8: ETX

Sampling Complete

The Sampling Complete message is sent by the system to inform the LAS the metering for the sample is complete.

The following format is used for the Sampling Complete message:

byte 1: STX

byte 7: Metering Status (see table below)

byte n+1: CRC

byte n+2: ETX

Metering Status Codes

In the case of any status that indicates that the sample was not processed, the process of commanding the system to sample should restart by issuing a new PREPARE TO RUN SAMPLE message followed by a SAMPLE IN POSITION message. These commands should be reissued using the same sample ID and parameters as were used for the sample that failed to run.

Note:

These status codes are mutually exclusive.

Status Codes Metering Status Descriptions 0x00

Sample Aspirated With No Error

The sample was aspirated with no errors. No information is known about sample dispense errors, since the SAMPLING COMPLETE message is sent before any sample is dispensed.

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0x01

No Sample Program For Sample ID

The Analyzer could not find a sample program for the Sample ID that was presented by the LAS. The LAS either routes the sample to another Analyzer with the proper sample program, or coordinates with the LIS to download the sample program and then re-presents the sample to the Analyzer. Consult with the laboratory to determine the desired response to this status.

0x02

SAMPLE IN POSITION Not Received In Time

A PREPARE TO RUN SAMPLE message was received but a SAMPLE IN POSITION message was not received in the proper time frame. The SAMPLE IN POSITION message must be issued by the LAS within 6.4 seconds after issuing the PREPARE TO RUN SAMPLE message. The LAS should reissue the PREPARE TO RUN SAMPLE message. This is the only case where a SAMPLING COMPLETE message will be sent prior to a SAMPLE IN POSITION.

0x03

Completed With Error

A problem was encountered while aspirating sample from the container. This status can be due to a clot or bubble detected. If Enhanced LIS plus is enabled the LAS can query the LIS for specific error information to decide what the best corrective action is. Since this status indicates that user attention is required for follow-up, consult the laboratory to determine the desired response to this status.

0x04

Internal Sample Has Priority

An internal sample is being processed. The LAS should periodically issue a QUERY ANALYZER STATUS message until the Analyzer reports a status of “Analyzer Ready To Sample”. The LAS may then proceed to follow the normal procedure for presenting a sample to the Analyzer by first issuing a PREPARE TO RUN SAMPLE message to the Analyzer. The LAS may also reroute the sample to another Analyzer for processing. 0x05

Analyzer Inoperable

The Analyzer is inoperable and is not ready to process samples. One or more subsystems have experience a mechanical malfunction. The LAS should attempt to restore the Analyzer to an operational state by issuing a REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator and reroute samples to another Analyzer.

0x06

Duplicate Sample ID

Tests are in process for the given sample ID. Duplicate sample IDs are not processed.

0x07

Analyzer Not Available

The Analyzer is not ready to process samples. It indicates that an operator is performing manual operations such as loading reagents, diagnostics, initializing, or loading an ADD. The LAS should periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer.

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Note:

The Sample ID should be encoded using UTF-8 or Extended ASCII depending on the configured encoding.

Reinitialize Metering

The Reinitialize Metering message is sent by the LAS to request that the system reinitialize any inoperable subsystems on the system. This message also resets the expected sample command on the system allowing the LAS to remove a sample that is in progress.

The following format is used for the Reinitialize Metering message:

byte 1: STX

byte 5, 6: Message ID = 0xC008 byte 7: CRC byte 8: ETX 0x08 Metering Failed In the Sample

The Analyzer's metering proboscis has mechanically failed while inside the sample container. The LAS should not attempt to move the sample to prevent the possibility of a broken tube and sample spill. The LAS should attempt to restore the Analyzer to an operational state by issuing a REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator. The current sample should not be moved by the LAS and other samples may be rerouted to another Analyzer until the Analyzer is ready to sample.

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Reinitialize Communications

The Reinitialize Communications message is sent by the LAS to the system to attempt to recover from interface communication failures and sequence number errors.

The following format is used for the Reinitialize Communications message:

byte 1: STX

byte 5, 6: Message ID = 0xC00A

byte 7: Recovery Type (see table below)

byte 8: CRC

byte 9: ETX

Recovery Types

Sample Routed

The LAS send the Sample Routed message to the system when a sample has been routed to the system in order to give the system enough time to perform a query for a sample program if needed. The following format is used for the Sample Routed message:

byte 1: STX

byte n+1: CRC

byte n+2: ETX

Status Codes Metering Status Descriptions

0x00 Restart sequence numbers, using the sequence number

byte in the REINITIALIZE COMMUNICATIONS message 0x01 Attempt to recover from an interface communication

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Query Analyzer Inventory

The Query Analyzer Inventory message is sent by the LAS to request the system report its reagent inventory (carts and packs).

The following format is used for the Query Analyzer Inventory message:

byte 1: STX

byte 5, 6: Message ID = 0xC00C

byte 7: CRC

byte 8: ETX

Analyzer Inventory

The system sends a sequence of Analyzer Inventory messages in response to a QUERY ANALYZER INVENTORY request from the LAS.

The following format is used for the Analyzer Inventory message:

byte 1: STX

byte 5, 6: Message ID = 0xC00D

byte 7: Last message; 0x01 indicates last message in response, otherwise 0x00

byte 8: Number of assays in message (max of 10 per message) byte 9 to 6n+8: One repetition per assay

byte 1, 2: Analyte Code

byte 3, 4: Available test count

byte 5: Current Calibration

bit 1: Serum current

bit 2: CSF current

bit 3: Urine current

bit 4: Whole Blood current

bit 5: Plasma current

bit 6: Amnio current

bit 7: Cord Blood current

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byte 6: Calibrated Status

bit 1: Serum calibrated

bit 2: CSF calibrated

bit 3: Urine calibrated

bit 4: Whole Blood calibrated

bit 5: Plasma calibrated

bit 6: Amnio calibrated

bit 7: Cord Blood calibrated

bit 8: Reserved value

byte 6n+9: CRC

byte 6n+10: ETX

Query Analyzer Resources

The Query Analyzer Resources message is sent by the LAS to request the system report its resources (bulk fluids, tips, cuvettes, waste, etc.).

The following format is used for the Query Analyzer Resources message:

byte 1: STX

byte 5, 6: Message ID = 0xC00E

byte 7: CRC

byte 8: ETX

Analyzer Resources

The Analyzer Resources message is sent by the system to the LAS in response to the QUERY ANALYZER RESOURCES command.

Note:

Bytes 13, 14, 15, 16, 25 and 27 are sent by the system but ignored by the LAS.

The following format is used for the Analyzer Resources message:

byte 1: STX

byte 5, 6: Message ID = 0xC00F

byte 7, 8: ERF Level

byte 9, 10: IWF Level

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byte 15, 16: UWR volume in mL byte 17, 18: VersaTip supply count byte 19, 20: MicroTip supply count byte 21, 22: Cuvette supply count

byte 23, 24: Available MicroSlide waste count

byte 25: Available MicroImmunoassay waste percent full byte 26: Available reagent metering tip waste percent full byte 27: Available liquid waste percent full

byte 28: Number of diluents

byte 29 to 4n+28: One repetition per diluent

byte 1, 2: Diluent Code

byte 3, 4: Available count or volume in mL.

byte 4n+29: CRC

byte 4n+30: ETX

Note:

If the VersaTip hopper sensor is blocked, an accurate count of VersaTips cannot be

determined, only that the number of tips available is greater than 300. This condition is encoded with 0xFFFF and the count is considered an infinite supply of tips.

Query Analyzer Status

When the LAS sends a QUERY ANALYZER STATUS, the system responds with an ANALYZER STATUS message containing the appropriate status code based on the current state of the system.

Note:

The LAS may query the system for status at any time, and should do so before any

requests to process samples.

Sample Metering Handshaking

A three-message handshake between the LAS and system to meter a sample consists of the following messages in the order listed:

1. PREPARE TO RUN SAMPLE - passes the control of a sample to the system and provides the sample ID and container type information.

2. SAMPLE IN POSITION - informs the system that the sample is at the POR and ready for metering.

3. SAMPLING COMPLETE - passes the control of the sample back to the LAS and provides metering status.

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Figure 2: Sample Metering Handshake

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Sample Position Not Received In Time” if no SAMPLE IN POSITION message is received within 6.4 seconds of receiving a PREPARE TO RUN SAMPLE.

Note:

In the worst case, the SAMPLE IN POSITION message needs to be received about 6.4

seconds after receiving a PREPARE TO RUN SAMPLE message.

Note:

In addition, the LAS needs to send a PREPARE TO RUN SAMPLE message for the next

sample within 100ms after receiving a SAMPLING COMPLETE message in order to maintain throughput. Failure to meet this timing may result in a skip cycle.

Note:

The only time a SAMPLING COMPLETE message is sent before a SAMPLE IN POSITION

message will be if the SAMPLE IN POSITION is not received in time.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “No Sample Program For Sample ID” if no sample program could be found for the sample ID

ACK

ASM - Ready to Sample ACK

Prepare to Run Sample

ACK ACK Sample in Position

ACK Query Analyzer Status

ASM - External in Progress ACK

Sampling Complete ACK

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The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Completed With Error” if an error occurred that would prevent running one or more tests.

Note:

This situation only applies to aspirate errors, which are any error that occur while the

proboscis is over the sample container.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Internal Sample Has Priority” if an internal sample is being metered when the SAMPLE IN POSITION message is received.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Analyzer Inoperable” if one or more subsystems are in a reduced state when the SAMPLE IN POSITION message is received.

Note:

The LAS may attempt to recover from this status by issuing a REINITIALIZE METERING

command.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Duplicate Sample ID” if there are tests in process for the sample ID in the PREPARE TO RUN SAMPLE message.

Note:

The duplicate sample will not be processed.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Analyzer Not Available” if the system is unable to process samples when the SAMPLE IN POSITION message is received.

Note:

This situation occurs during initialization, equilibration, ADD loading, diagnostics mode or

when some Options & Configuration screens are displayed.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Metering Failed In The Sample” if a mechanical error with the metering system occurred when the proboscis was inside the sample container.

It is assumed that a sample program has been downloaded before the PREPARE TO RUN SAMPLE command. However, if the system is configured for host query, a mechanism needs to be in place to initiate a host query independent of the PREPARE TO RUN SAMPLE. The SAMPLE ROUTED message facilitates this. A SAMPLE ROUTED message is sent to the system as soon as the LAS has routed a sample to it in order to maximize the time available to perform a host query. The system attempts to send a host query when it receives a SAMPLE ROUTED message for the sample ID contained in the message.

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Figure 3: Sample Routed Notification

Reinitialize Metering

The system attempts to reinitialize any inoperable subsystems when it receives a REINITIALIZE METERING message from the LAS.

Note:

The LAS issues a REINITIALIZE METERING message when an ANALYZER STATUS has

an inoperable status or SAMPLING COMPLETE indicates sampling failed due to an inoperable system or metering failed in the sample.

A REINITIALIZE METERING message resets the Sample Metering Handshake so the next expected message is PREPARE TO RUN SAMPLE.

A REINITIALIZES METERING message aborts any further sample aspirations from the interface where the message is received.

Note:

The sample processing acts as if a mechanical sample aspiration error occurred. The

ACK

ACK ACK Sample in Position ACK Sample in Bypass Sample in Bypass ACK Sampling Complete ACK

Note:

Each Sample in Bypass message

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See Figure 4: Reinitialize Metering. Figure 4: Reinitialize Metering

ACK

Analyzer Status Message (ASM) ACK

ACK ACK Sample in Position Reinitialize Metering ACK ACK Query Analyzer Status

ACK

Sampling Complete (Failed in Sample or Analyzer Inoperable)

ASM - Analyzer Initializing ACK

ACK

ASM - Analyzer is Ready ACK

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Reinitialize Communications

If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Reset Sequence Number,” the system restarts the expected sequence numbers using the sequence number in the REINITIALIZE COMMUNICATIONS message.

Note:

The LAS may issue a REINITIALIZE COMMUNICATIONS message after receiving an

ILLEGAL COMMAND RECEIVED message with “Sequence Number Error” error type. If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Recover From Communication Failure,” the system starts the Interface Initialization Sequence.

Query Analyzer Inventory/Resources

If the system receives a QUERY ANALYZER INVENTORY message, the system responds with an ANALYZER INVENTORY message(s) containing the current assay reagent inventory.

Note:

The content of the system inventory matches what is shown on the View by Assay screen.

within Reagent Management. This reports the worst case for each assay across all fluids and reagents. Uncalibrated reagents will not be counted since they cannot be used. If the system receives a QUERY ANALYZER RESOURCES message, the system responds with an ANALYZER RESOURCES message containing the current onboard resource levels.

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Figure 5: Query Analyzer Inventory/Resources

Illegal Commands

The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Invalid Command” if any of the following conditions are met:

• The Message ID is not recognized.

• The Message ID belongs to a message that only the system should send (for example, ANALYZER STATUS).

The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Sequence Number Error” if all the following conditions are met:

• Sequence numbers are enabled.

• The sequence number of an incoming message does not match the expected

Query Analyzer Inventory

ACK Analyzer Inventory (last message = 0x00) ACK ACK ACK Query Analyzer Resources

Analyzer Resources ACK Analyzer Inventory (last message = 0x00) Analyzer Inventory (last message = 0x01) ACK

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The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Logical Order Error” if any of the following conditions are met:

• A SAMPLE IN POSITION message is sent without a corresponding PREPARE TO RUN SAMPLE.

• A second PREPARE TO RUN SAMPLE message is sent before the system sends a SAMPLING COMPLETE message.

• A second SAMPLE IN POSITION message is sent before the system sends a SAMPLING COMPLETE message.

• A QUERY ANALYZER INVENTORY message is sent during external sampling. • A QUERY ANALYZER RESOURCES message is sent during external sampling. The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Invalid Data” if any of the following conditions are met:

• The container type in a PREPARE TO RUN SAMPLE message is invalid.

• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message contains zero or more than 15 characters.

• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message contains invalid UTF-8 characters or insufficient characters (according to the sample id length).

• The recovery type in a REINITIALIZE COMMUNICATIONS message is invalid.

Internationalization and Language Support

The system supports the following configurations for Sample ID character encoding: • UTF-8 (Unicode)

• Extended ASCII (Refer to ISO 8859-1.)

Timing Requirements

The automation system must complete the following steps within the required time period after the SAMPLING COMPLETE message is sent by the system to guarantee system throughput. Failure to meet this timing will result in decreased system throughput.

• Time from SAMPLING COMPLETE to PREPARE TO RUN SAMPLE - 100 milliseconds.

• Time from SAMPLING COMPLETE to SAMPLE IN POSITION- 6.4 seconds (6.5 seconds after PREPARE TO RUN SAMPLE).

All ACK and NAK messages must be sent within 250ms of the received command/response. ACK messages sent by the LAS during the initialization sequence should be separated by no more than 500ms.

LAS commands sent to the system must be spaced at least 100ms apart to allow the illegal command response. This is to allow the system time to respond with an ILLEGAL COMMAND RECEIVED message if required.

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Lab Automation Communication Scenarios

Interface Initialization Sequence

Figure 6: Interface Initialization Sequence

READY if no response in 1 second ACK ACK ACK if no response in 0.5 second

ACK

READY

Sequence Number = A Sequence Number = A+1 Sequence Number = A+2

Sequence Number = 0 Sequence Number = 0 Sequence Number = A+3 Sequence Number = A+3 Sequence Number = 1 Sequence Number = 1

ACK

Sequence Number = A+2

Initialization Complete

Note:

The Query Analyzer Status message is not part of the initialization

sequence but is provided to demonstrate sequence numbers following initialization.

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Run Two Samples

Figure 7: Run Two Samples

ACK

ASM - Ready to Sample ACK ACK ACK Sample in Position ACK ACK ACK ACK Sample in Position ACK Query Analyzer Status

ACK

ASM - Remote in Progress ACK

ASM - Remote in Progress

ASM - Manual Operation

ACK

Sampling Complete Prepare to Run Sample

ACK ACK

Sampling Complete

ACK ACK

ASM - Ready to Sample

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Remote Sample Startup Interrupted by Local Sample

Figure 8: Remote Sample Startup Interrupted by Local Sample

ACK

ASM - Ready to Sample ACK ACK ACK Sample in Position ACK ACK ACK ACK Sample in Position ACK Query Analyzer Status

ACK

ASM - Remote in Progress ACK

ACK

ACK ACK

Sampling Complete (did not sample - Manual had priority

ACK ACK

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Non Fatal Error Condition (Insufficient Inventory)

Note:

In the case of multiple tests per sample and only some of the tests have insufficient

inventory, the tests which have inventory will be posted to the Lab Automation. Figure 9: Non Fatal Error Condition (Insufficient Inventory)

ACK

Analyzer Status Message ACK ACK ACK Sample in Position ACK ACK

Sampling Complete - Completed with Error

ACK

ACK Sample in Position

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Non Fatal Error Condition (Unknown Sample ID)

Figure 10: Non Fatal Error Condition (Unknown Sample ID)

ACK

Analyzer Status Message ACK ACK ACK Sample in Position ACK ACK

Sampling Complete - Unknown Sample ID

ACK

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Non Fatal Error Condition (Sample In Position Not Received in Time)

Figure 11: Non Fatal Error Condition (Sample In Position Not Received In Time)

ACK

Sampling Complete - Sample in Position Not Rec’d in Time Prepare to Run Sample

ACK

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Fatal Error Condition

Note:

If the system still reports a fatal condition after reinitialization, an operator must be called

to check the system. The module and error number reported to the LIS will contain more information about the error.

Figure 12: Fatal Error Condition

ACK

Analyzer Status Message (ASM) ACK

ACK ACK Sample in Position

ACK

Sampling Complete - Failed in Sample or Analyzer Inoperable

ASM - Analyzer Initializing Prepare to Run Sample

ACK Initialize Analyzer

ACK ACK

ASM - Analyzer is Ready ACK

Note:

ASM = Analyzer Status Message

ACK Query Analyzer Status

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Sample Routed Notification

Note:

Each Sample Routed message initiates a host query to the LIS.

Figure 13: Sample Routed Notification

Sample Routed (SID1)

ACK ACK ACK Sample in Position ACK Sampling Complete Sample Routed (SID2)

ACK

ACK Prepare to Run Sample (SID2)

ACK

Sample in Position

ACK

Sampling Complete Prepare to Run Sample (SID1)

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Query Analyzer Inventory

Figure 14: Query Analyzer Inventory

Query Analyzer Inventory

ACK

ACK Query Analyzer Resources

Analyzer Resources ACK ACK Analyzer Inventory (Last message = 0x00) Analyzer Inventory (Last message = 0x00) ACK Analyzer Inventory (Last message = 0x01)

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Section 3. Hardware Interfaces

Note:

In this section, line drawings reflect the VITROS® 5,1 FS Chemistry System; however, the

VITROS® 4600 Chemistry System has the same dimensions and mechanical interface as the VITROS® 5,1 FS Chemistry System.

Electrical Interfaces

Analyzer to Laboratory Information System (LIS)

Refer to the Laboratory Information System (LIS) Guide for VITROS® 5600 Integrated System, the VITROS® 3600 Immunodiagnostic System, and the VITROS® 4600 Chemistry System, J32799.

Analyzer to Lab Automation System

Full RS232 LAS communication interface. The following pins are used (system side): 3 - transmitted data (TxD)

2 - receive data (RxD) 5 - circuit common

The interface has a communication port to the Lab Automation Computer. Communication parameters:

1 start bit 8 data bits 1 or 2 stop bits

EVEN, ODD or no parity

9600, 19200 or 38400 baud rate. The system end is a 9-pin DTE male. No Hardware or Software flow control. Cable Requirements for LAS port

Data Rate (bps) Length meters (ft.)

9,600 15m (50 ft.) max.

Shielded 22AWG wire

Electrical Interface at Sample

The frame section of the Lab Automation System, which supports the sample must be connected to safety ground. The lab automation system and Analyzer must not be physically connected.

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Analyzer Dimensions

This section describes the overall size of the VITROS® 4600 System. Figure 15: Analyzer Dimensions

Reference Description A 233.7 cm (92 in) B 83.8 cm (33 in) C 132.1 cm (52 in) D 205.7 cm (81in) Weight 612.4 kg (1350 lb)

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Site Specifications

The VITROS® 4600 Chemistry System site specifications are described completely in Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897 explain:

• Electrical Power Requirements • System Environmental Specifications • Requirements at the Customer Site

• Specifications for the VITROS® 4600 System and Printer • Specifications for the optional Heat Rejection Plenum

Deviations from site specifications should be reviewed with a Ortho Clinical Diagnostics Field Service Representative.

It is recommended that the floor be level within one inch over 10 feet.

Service Access

The system requires service access from all four sides of the machine. Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897 indicates the appropriate clearances. Access to the machine depends on the track configuration and must be determined by both OCD and the automation vendor. Some general guidelines are:

• Track and supports should be configured to allow access to rear panel quarter-turn fasteners.

• Spacing between the track and system should allow the removal of the rear panel covers by unfastening the quarter-turns, tipping the covers away from the system, lifting the rear panels several inches, and moving the panels to the side of the system. Figure 16: Service Access

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System Heat Rejection and Air Intake Zones

The system contains air intake ports and exhaust ports. The location of these ports are shown in Figure 17. These ports must not be blocked.

The thermal characteristics of the system are explained in Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.

Figure 17: Air Intake and Exhaust Ports

Positional Requirements

This section describes the relative position between system and the sample container. It is assumed that the Lab Automation System will be able to capture and hold the sample container to allow direct aspiration by the system. The following assumptions apply relative to the interface between the two systems.

• The system will be located relative to the automation track through a supplied clamping mechanism mounted to the floor.

• The automation track can be configured to meet the system requirements for sample tube height. See Sample Tube Height: Vertical Dimension for POR on page 51

• The system provides a limited amount of adjustment of the sample metering proboscis in the “X”, “Y”, and “Z” directions of the sample travel path. Refer to

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Figure 18: Positional Requirements - Back of System (With Cabinetry)

System to Track Positioning/Floor Mounts or Anchors

Ortho Clinical Diagnostics provides two methods of locating and positioning the system to the floor in order to maintain alignment relative to the automation system. These floor mounts also allow service personnel to disengage the system for service and reposition the system relative to the automation system.The ability to repeat the exact position of system relative to the original POR depends on the following

The ability to restore the system to the exact position relative to the original POR depends on the following factors:

• The anchors have been installed correctly. Reference the Installation Instructions for the VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: AT Seismic Anchorages, J39896.

• The engagement of the system with the anchors is not so aggressive to cause a shift in anchor positions relative to the floor.

• The automation track is rigidly mounted so there is no relative motion between the system and the track. It is highly recommended to check the alignments of the system to the track position if it has been moved (disengaged from anchors) for some reason. VITROS® 4600 System Metering Proboscis Alignment on page 47

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Floor Mounts/Anchors

Two types of floor mounts can be used to position the system relative to the automation system. Which type of mount to use depends on the site install requirements.

Standard Floor mounts / Anchors

Standard Anchors are included in the AT Accessory and do not need to be ordered separately Figure 19: Standard Floor Mounts.

Seismic Floor Mounts /Anchors Catalog # 6802245

These are intended for use where seismic events are of concern. The design of these floor mounts have been submitted for approval by California Office of Statewide Health Planning and

Development (OSHPD) regulations on earthquake brackets (ref OAS-MIS-PH3001 and OPA-0627). These anchors are ordered in addition to the AT Accessory.

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Sample Positioning and Adjustments

Relative to sample positioning, the following rules apply:

• Maximum fluid aspiration depth is 3.86 inches (98mm) from top of the sample tube. See Supported Containers on page 54 for fill requirements.

• For Aspiration, all sample tubes regardless of size are to be centered about the same vertical axis.

• OCD provides a software adjustment for set-up at the customer site to align proboscis with the track. The range of adjustment will be 50mm (2.0 inch) in “X” direction of metering probe travel. Once this value is set, repeatability of positioning in “X” direction should be +/- .028 inch (0.7 mm).

Sample Center Device Adjustments: Positioning Responsibilities

The following table indicates the alignment adjustment responsibilities for the sample position to the aspiration probe for each degree of freedom in a three-dimensional space.

Adjustment Responsibility

Y Direction Automation Supplier

X and Z Directions OCD Fine position Automation supplier for Coarse position to suggested Point Of Reference (POR) Rotation about X axis Automation Supplier Rotation about Y axis Automation Supplier Rotation about Z axis (Not required)

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Figure 21: Sample Position

VITROS® 4600 System Metering Proboscis Alignment

When the system and the sample tube

grasping/centering device on the track are properly aligned, the proboscis with disposable tip should travel to a depth of 98 mm in a 13mm diameter sample tube, without touching the inside wall. This alignment is primarily supported by the system proboscis adjustment (horizontal and perpendicular to sample travel) and sample position adjustment along the track length.

Figure 22: System Proboscis

The Lab Automation System vendor has complete responsibility for the positioning the sample tube. However, the adjustments indicated in Sample Center Device

Adjustments: Positioning Responsibilities on page 46 facilitates alignment between the system and LAS.

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Point Of Reference (POR)

Point Of Reference//Point in space is the intersection of the XY plane and the axis of the sample tube once positioned for system metering. It is used as the common reference for the system and Automation system. The design of the VITROS® 4600 System accommodates the Clinical and Laboratory Standards Institute (CLSI) standards.

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