VITROS 5,1 FS S F A I -...

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VITROS® 5,1 FS SPECIFICATION FOR AUTOMATION INTERFACE

02 May 2018

DOCUMENT NUMBER: J26605

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REVISIONHISTORY

Date Description of change Page

02 May 2018 Updated logo and date on title page.

Added a revision history.

Wording, spelling, punctuation throughout the document has been edited for consistency and clarity.

Changes noted with change bars:

Section 2.1.7 – removed statement "A new message is received prior to an acknowledgment for a previously sent message."

Section 2.1.8.8.1 – updated description

- Changed from “This status indicates that 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” to:

“This status indicates that a PREPARE TO RUN SAMPLE message was received but a SAMPLE IN POSITION message was not issued by the LAS within 6.4 seconds of issuing the PREPARE TO RUN SAMPLE message. The LAS should reissue the PREPARE TO RUN SAMPLE message within 100 milliseconds after receiving a SAMPLING COMPLETE message in order to maintain throughput. Failure to meet this timing may result in a skip cycle.”

- Changed from “This is the only case where a SAMPLING COMPLETE message will be sent prior to a SAMPLE IN POSITION.” to:

“A SAMPLING COMPLETE message will be sent prior to a SAMPLE IN POSITION message if the SAMPLE IN POSITION is not received in time, or other error conditions occur including no sample program is specified for the sample ID (in PREPARE TO RUN), or the analyzer becomes inoperable.”

Section 4.1 - updated description

- Added details in Table for 12-13 mm tube size fill requirement with Greiner MiniCollect® Complete Z series details and added minimum fill details for tube.

- Removed 13 x 100 and 13 x 75 tube size from Table.

- Added IMPORTANT below the Minimum Fill Requirement Table.

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Date Description of change Page

Section 10.2 – Updated description

- Changed from "Refer to the Operator’s Manual for cleaning agents and protocol . NEED 5,1 DOC # or ref to the V-Docs" to:

Refer to the Quick Reference Guide (J33140) for cleaning agents and protocol.

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25 May 2005 Initial version

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TABLEOFCONTENTS

TableofContentsREVISION HISTORY ...................................................................................................................................... 2

TABLE OF CONTENTS .................................................................................................................................. 4

1 Introduction ........................................................................................................................................... 7

1.1 Purpose ........................................................................................................................................... 7

1.2 Scope ............................................................................................................................................... 7

1.3 References ..................................................................................................................................... 7

1.4 Definitions ...................................................................................................................................... 8

1.5 Audience ......................................................................................................................................... 9

1.6 General Description ..................................................................................................................... 9

1.6.1 Document Structure .............................................................................................................. 9

1.6.2 Assumptions and Dependencies ...................................................................................... 9

2 Software Interfaces ............................................................................................................................ 11

2.1 Analyzer to Lab Automation System .................................................................................... 12

2.1.1 Message Format ................................................................................................................. 12

2.1.2 Cyclical Redundancy Checks ............................................................................................. 13

2.1.3 Sample ID Encoding ............................................................................................................ 13

2.1.4 Sequence Numbers ............................................................................................................. 13

2.1.5 Interface Initialization Sequence ........................................................................................ 14

2.1.6 Acknowledgments ................................................................................................................ 14

2.1.7 Interface Communication Failures ..................................................................................... 14

2.1.8 Messages............................................................................................................................... 15

2.1.9 Timing Requirements ........................................................................................................ 30

2.2 Lab Automation Communication Scenarios .................................................................................. 31

3 Hardware Interfaces .......................................................................................................................... 40

3.1 Electrical Interface ...................................................................................................................... 40

3.1.1 Analyzer to Lab Information System .................................................................................. 40

3.1.2 Analyzer to Lab Automation System ................................................................................. 40

3.1.3 Electrical Interface at Sample ............................................................................................. 40

3.2 Positional Requirements .......................................................................................................... 41

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3.2.1 Assumptions .......................................................................................................................... 41

3.3 Analyzer to Track positioning / Floor mounts or Anchors ................................................ 42

3.3.1 Types of floor mounts/ Anchors ........................................................................................ 42

3.4 Sample Positioning and Adjustments ................................................................................... 43

3.4.1 Sample Center Device Adjustments: Positioning Responsibilities ............................... 43

3.4.2 VITROS® 5,1 FS Metering Proboscis alignment ............................................................. 44

3.4.3 Point Of Reference (POR) .................................................................................................. 44

3.4.4 Sample tube height: Vertical dimension for POR ........................................................... 46

3.5 Analyzer Dimensions ................................................................................................................. 47

3.6 Site Specifications ...................................................................................................................... 49

3.6.1 Analyzer ................................................................................................................................. 49

3.7 Service Access ............................................................................................................................ 49

3.8 Analyzer Heat Rejection and Air Intake Zones ................................................................. 50

3.9 Regulations and Safety Standards ........................................................................................ 50

4 Sample Handling .................................................................................................................................. 51

4.1 Supported Containers ............................................................................................................... 51

4.2 Containers that WILL NOT be Supported ............................................................................ 51

4.3 Sample Quality Recommendations ....................................................................................... 51

4.4 Environmental Issues ................................................................................................................ 52

5 Automation Interface Guidelines ........................................................................................................ 53

5.1 Introduction .................................................................................................................................. 53

5.1.1 Purpose / Objective .............................................................................................................. 53

5.2 Audience ....................................................................................................................................... 53

5.3 Approach ...................................................................................................................................... 53

5.4 Material Resources .................................................................................................................... 53

5.5 Skills Required ............................................................................................................................ 54

6 Laboratory Automation Controller (LAS) Protocol Tests ................................................................ 55

6.1 LAS Communications Initialization Test ............................................................................... 55

6.2 Analyzer Status ........................................................................................................................... 56

6.3 Sampling Complete ................................................................................................................... 56

6.4 Error Recovery ............................................................................................................................ 57

6.5 Sample Routed/Host Query ..................................................................................................... 59

6.6 Request Inventory ...................................................................................................................... 59

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6.7 Request Resources Levels ...................................................................................................... 59

7 Instrument-Based Testing ................................................................................................................... 61

7.1 Normal Operations Sample Handling ................................................................................... 61

8 Physical Interfaces ............................................................................................................................... 62

8.1 Sample Positioning .................................................................................................................... 62

9 LAS/LIS Architecture ............................................................................................................................ 63

9.1 Summary of considerations for LIS/LAS architecture ....................................................... 63

9.2 LIS/LAS architecture considerations ..................................................................................... 63

9.2.1 Case 1 .................................................................................................................................... 63

9.2.2 Case 2 .................................................................................................................................... 64

9.2.3 Case 3 .................................................................................................................................... 64

10 Safety and Precautions ................................................................................................................... 65

10.1 Risk Avoidance ....................................................................................................................... 65

10.2 Patient Considerations .......................................................................................................... 65

10.3 Operator Considerations ....................................................................................................... 67

10.4 Environmental Considerations ............................................................................................ 67

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1 Introduction

1.1 Purpose

This document contains interface specifications to assist Lab Automation manufacturers in adapting Lab

Automation systems to the Ortho Clinical Diagnostics VITROS® 5,1 FS Chemistry System with AT Accessory.

1.2 Scope

This specification provides an understanding of interfaces between the Lab Automation Vendors and Ortho Clinical Diagnostics.

Topics covered include:

Information to be transmitted between the Lab Automation System and the VITROS® 5,1 FS Chemistry System with AT Accessory

Format of information to be transmitted between the Lab Information System and the analyzer.

Physical relationships between the analyzer and the sample container

Sample container sizes and aspiration depths

Analyzer footprints and space envelopes

Operator and service access requirements to the analyzer

Analyzer environmental specifications

Analyzer sample throughput specifications

Electrical interconnects between the Lab Automation System and analyzer

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

1.3 References

Site Specification for the VITROS® 5,1 FS Chemistry System, Publication No. J22961

Specification for Laboratory Computer Interface, Publication No. J23306

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1.4 Definitions

Term Definition

CRC Cyclical Redundancy Checking. An error checking algorithm used to verify the integrity of an electronic message

Asynchronous LIS Messages

A feature that enables the analyzer to send unsolicited status updates to the LIS.

LAS Lab Automation System. The transport system and controller that manages the movement of samples from position to position within the lab.

LIS Lab Information System. Responsible for data management, i.e., sample results, patient history.

Sample Proboscis Analyzer aspiration probe.

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.

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1.5 Audience 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® 5,1 FS Chemistry System with AT Accessory.

1.6 General Description

1.6.1 Document Structure

The Automation Interface Specification is organized as follows:

Section Title Description

1 Introduction Provides general information about the specification

2 Software Interfaces Describes the software commands and responses used during

sample processing with a lab automation system

3 Hardware Interfaces Describes the physical interfaces between the lab automation

system and VITROS® 5,1 FS Chemistry System with AT Accessory

4 Sample Handling Describes requirements for containers used in sample

processing with lab automation systems

5 Automation Interface Guidelines Provides checklists for automation system personnel to use in

verifying the correct implementation of an automation interface

6 LAS/LIS Architecture Discusses considerations applicable in lab automation

interfaces in an LIS environment

1.6.2 Assumptions and Dependencies

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

2.) Calibration with fluids delivered by the automation track is not supported.

3.) The analyzer uses a “two port” system to communicate and coordinate with lab automation. The LAS port communication interface coordinates sample handling at the physical interface. Communication requiring transfer of large amounts of data (sample programs, test results, etc.) occurs by means of the existing LIS port on the analyzer.

4.) The automation system handles movement of all samples not placed manually on the analyzer.

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

6.) All required information for processing a sample will be supplied to the analyzer. The Lab Automation System for each sample will supply items listed below before it is placed in position for metering but after the “Sampling Complete” message for the previous sample.

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o Sample ID

o Container type (diameter)

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

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

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

10.) If the LAS has not received a status message or SAMPLE COMPLETE response fairly recently, the LAS will query the analyzer for its current status before sending a PREPARE TO RUN SAMPLE command.

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

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

b) Place the next sample into the aspiration position

c) Send the SAMPLE IN POSITION message to the analyzer 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 analyzer.

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

13.) The AT Analyzer does not control devices mounted on the automation track.

14.) The automation system must comply with the site specifications in order for analyzer doors and lids to open and for waste containers to be easily emptied.

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2 Software Interfaces This section describes how to process a sample on an analyzer in conjunction with a Lab Automation System (LAS).

Sample programs describing the tests to be performed on specific samples must be downloaded to the analyzer through its Lab Information Port or manually programmed using the analyzer GUI. The analyzer stores these sample programs internally while waiting for a sample with a Sample ID matching one of the sample programs to be placed on the analyzer.

Standard VITROS® analyzers scan the tubes in the tray (once the “Start Sampling” target is touched) attempting to match the bar coded sample ID to one of the sample programs already downloaded. The sample program that is found for that ID is then performed on the sample.

Placing the sample, reading the sample ID, and making the “Start Sampling” switch must be performed by the Lab Automation System. To accomplish this, the Lab Automation System moves a sample to the analyzer on which it is to be run. The LAS must then coordinate with the analyzer to determine when the sample can be placed into the correct position for aspiration. While the sample is being placed into position, the LAS sends the analyzer a PREPARE TO RUN SAMPLE message. The sample ID (read by the automation system from the sample bar code) and the container type must be included in these messages to permit the analyzer to begin processing the sample.

The analyzer uses the supplied sample ID to find the program to be run on the sample, then starts aspirating fluid from the sample container in order to run the requested tests. Once the analyzer has aspirated all the fluid required to run the tests, the analyzer sends a SAMPLING COMPLETE message to the LAS. This message tells the LAS that the sample may be removed from the sampling position and that it can replace that sample with another. At this point, the LAS can move the samples and start a new sample. To guarantee maximum system throughput, sample movement and transmission of commands must be completed within the minimum times defined. Otherwise, delays can occur because the analyzer will need to wait for its next cycle to process the request.

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Lab Information Data

Lab Information Port

Analyzer

Lab Automation Port

Lab Automation Coordination Messages

2.1 Analyzer to Lab Automation System

Communications between the analyzer and the Lab Automation System (LAS) will be performed using a three wire RS-232 interface. This interface communicates time critical information between the LAS and the analyzer, which is needed to maintain coordination of the automation system.

2.1.1 Message Format

The format for commands and status information numbers in this document uses hexadecimal notation for software written in the “C” language. A number such as 0x03 equates to 3 Hex.

The following special control characters shall be used:

STX = 0x02

ETX = 0x03

Message frames shall be of the form:

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 shall be the total number of bytes in the message excluding the STX and ETX.

Lab Information

System

Lab Automation

System

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Message types shall be the following:

0x00 Data

0x01 ACK

0x02 NAK

Reserved bytes of messages should be set to 0x00 but will be ignored by the analyzer.

2.1.2 Cyclical Redundancy Checks

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

unsigned char crc;

crc = 0x84;

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

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

}

Where message length is the message length in bytes, and message bytes is the buffer containing the message (excluding the STX, ETX and CRC bytes).

The CRC calculation excludes the STX, ETX, and the CRC sum byte.

Example in hex: 02 04 01 00 11 03. Where 02 is the STX and 03 is the ETX. The length is 04 and the calculated CRC is 11.

2.1.3 Sample ID Encoding

The following character encodings for Sample IDs shall be supported:

UTF-8 (Unicode) Extended ASCII (ISO 8859-1)

2.1.4 Sequence Numbers

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

To disable the use of sequence numbers, the LAS shall set the sequence numbers to 0 in the ACK

messages it sends during the initialization sequence.

To enable the use of sequence numbers, the LAS shall use valid increasing sequence numbers in the ACK messages it sends during the initialization sequence.

Valid sequence numbers shall be 0 to 255. The number following 255 is 0.

Messages originating from the LAS shall use one set of sequence numbers while messages originating from the analyzer shall use another set of sequence numbers.

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2.1.5 Interface Initialization Sequence

Whenever a communication link has been broken because the analyzer was turned off, reset, or an Interface Communication Failure occurred, communication between the analyzer and the LAS must be restarted. Refer to Lab Automation Communication Scenarios: Interface Initialization Sequence, for a diagram of this process.

The analyzer will start the initialization sequence after a “power up” or “automation task reset.”

The LAS may initiate the initialization sequence by issuing a REINITIALIZE COMMUNICATIONS message with the appropriate parameters to the analyzer.

The initialization sequence shall begin when the analyzer sends a READY message to the LAS consisting of an STX followed by an ETX. After issuing the READY message the analyzer waits up to 1 second for the LAS to respond. If the LAS does not respond within 1 second, the analyzer issues a second READY message and waits one more second. If the LAS still has not responded after the second time-out period, the initialization sequence is aborted.

When the LAS receives a READY message from the analyzer, the LAS begins sending ACK messages (with sequence numbers, if desired). When the analyzer has received a maximum of three ACK

messages (to determine if it must use sequence numbers), it responds by issuing its own ACK message with appropriate sequence number immediately followed by an analyzer status message.

ACK messages sent by the LAS during the initialization sequence should be separated by no more than 500ms.

The Interface Initialization Sequence may be retried an unlimited number of times.

2.1.6 Acknowledgments

After a message is sent, the sender stops transmitting until an acknowledgment is received.

The receiver shall send an ACK message to the sender for every message with a valid CRC and no

communications error.

The receiver shall send a NAK message to the sender for every message received with an invalid CRC or a communications error occurring during transmission (ex. parity error).

If sequence numbers are enabled, the receiver shall set the sequence number of the ACK or NAK

message to the sequence number of the message being acknowledged.

CRC checks shall not be performed on ACK and NAK messages.

Unsolicited ACK and NAK messages should be ignored.

2.1.7 Interface Communication Failures

Interface communication errors indicate that the analyzer to LAS interface is unreliable. Since the automation interface is unreliable at this point, these errors are presented on the screen to the operator and the interface is no longer used. If asynchronous messages are enabled on the analyzer LIS interface, an Error Message is transmitted to the LIS.

Any of the follow conditions shall cause an interface communication error on the analyzer.

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The analyzer reports or receives two consecutive NAK messages.

A message acknowledgment is not received within 250ms.

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

The last byte of a message, based on the message length, was not an ETX.

The message type field of the message is invalid.

The interface initialization sequence fails.

See REINITIALIZE COMMUNICATIONS message for recovering from interface communication failures.

2.1.8 Messages

2.1.8.1 Message Acknowledged

:

Description: This message will be sent by a receiver for every message received with a valid CRC and no communications error occurred. The sequence number returned with this message (if sequence numbers have been enabled) will be the sequence number for the command that this message is acknowledging.

Direction: Bidirectional

Format:

byte 1: STX

byte 2: Message Length:

byte 3: Message Type = 0x01

byte 4: Sequence number

byte 5: CRC

byte 6: ETX

2.1.8.2 Message Not Acknowledged

Description This message will be sent by a receiver for every message that has a CRC error or a

communications error (ex. parity error). The sequence number returned with this message (if sequence numbers have been enabled) will be the sequence number for the command that this message is acknowledging.

Direction Bidirectional

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Format:

byte 1: STX

byte 2: Message Length



byte 5: CRC

byte 6: ETX

2.1.8.3 Illegal Command Received

Description: This message will be sent by the analyzer when an unrecognized command is

received. It will also be sent when logical errors such as a sequence number error occurs or a command received out of order for the current set of operations being performed is received.

Direction: Analyzer to LAS

Format:

byte 1: STX




byte 5, 6: Message ID = 0xC009

byte 7: Error Type

byte 8, 9: Error word

byte 10: CRC

byte 11: ETX

Error Type Descriptions:

0x00: An invalid command was received.

0x01: A command that violates the logical order of operations was received.

0x02: A sequence number error was detected.

0x03: Invalid data was discovered in the message.

Error word contents by Error Type

0x00: MSB = high byte of Message ID received, LSB = low byte.

0x01: MSB = high byte of Message ID received, LSB = low byte.

0x02: MSB = sequence number expected, LSB = sequence number received.

0x03: MSB = 0

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LSB:

0x01 = Invalid container type

0x02 = Invalid sample id length

0x03 = Invalid sample id data

0x04 = Invalid recovery type

2.1.8.3.1 Error Types

Invalid Command (0x00)

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 analyzer. For example, the analyzer does not recognize the ANALYZER STATUS message (0xC007).

Logical Order Error (0x01)

A command was sent out of sequence. The analyzer 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 analyzer sends a SAMPLING COMPLETE message.

A second SAMPLE IN POSITION message is sent before the analyzer 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.

Sequence Number Error (0x02)

The analyzer will issue this error if the use of sequence numbers was enabled during initialization by the LAS, and the analyzer 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.

Invalid Data (0x03)

A data field from the previous message contained unexpected data. The following conditions will cause the analyzer 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).

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The Recovery Type in a REINITIALIZE COMMUNICATIONS message is invalid.

2.1.8.4 Query Analyzer Status

Description: This message will be sent by the LAS to request the analyzer report on status.

Direction: LAS to Analyzer

Format:

byte 1: STX





byte 7: CRC

byte 8: ETX

NOTE: This command should be performed before starting a new sample unless a Sampling Complete response has just been received.

2.1.8.5 Analyzer Status

Description: This message will be sent by the analyzer in response to the QUERY ANALYZER

STATUS command or as an asynchronous message when the analyzer has completed initialization. A status code of 0x00 indicates that the analyzer is ready to sample. All other status codes indicate that the analyzer is not available.


Format:

byte 1: STX




byte 5, 6:Message ID = 0xC007

byte 7: Status Code

byte 8: CRC

byte 9: ETX

Status Codes:

0x00: Analyzer is ready to sample

0x01: Analyzer is busy performing an external sample

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0x02: Analyzer is busy performing an internal sample

0x03: Analyzer is equilibrating

0x04: Analyzer has a fatal error, check LIS error messages (Inoperable)

0x05: Analyzer is not available (ex. cartridge loading, diagnostics)

0x06: Analyzer has failed in the sample.

2.1.8.5.1 Analyzer Status Codes

Analyzer Is Ready To Sample (Code 0x00)

This status indicates that the analyzer is ready to process a sample. The LAS may issue a PREPARE TO RUN SAMPLE message to the analyzer.

Analyzer Is Busy Performing An External Sample (Code 0x01)

This status indicates that 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.

Analyzer Is Busy Performing An Internal Sample (0x02)

This status indicates that 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.

Analyzer Is Equilibrating (Code 0x03)

This status indicates that 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 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.

Analyzer Has A Fatal Error (Code 0x04)

This status indicates that 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 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

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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.

Analyzer Is Not Available (Code 0x05)

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 the “Analyzer Is Ready To Sample” status before presenting any new samples to the analyzer.

Failed In The Sample (Code 0x06)

This status indicates that the analyzer 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 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.

2.1.8.6 Prepare To Run Sample

Description: This message will be sent by the LAS to the Analyzer to indicate that a sample, with the given parameters, is being placed for aspiration. This command is the start of the sampling process. For this command to be successful, the analyzer must have a sample program available (downloaded by the LIS or manually programmed). This is also the restart point for errors. If sampling is unsuccessful due to reasons such as no sample ID or tip failure, the interface state machine requires that retrying start with this command once the error condition is fixed. This command should be preceded by a request for analyzer status unless a SAMPLING COMPLETE response has just been received.

Once this command has been issued to the analyzer, the analyzer is considered to have control of the sample. The sample may not be moved until the analyzer sends a SAMPLING COMPLETE message to the LAS. A SAMPLING COMPLETE

message will always be sent unless an Interface Communication Failure occurs.


Format:

byte 1: STX

byte 2: Message length


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byte 7: Reserved (always set to “0”)

byte 8: Reserved (always set to “0”)

byte 9: Container Type

byte 10: Sample ID length in bytes

byte 11 thru n: Sample ID (15 characters maximum)

byte n + 1: Reserved (always set to ”0”)

byte n + 2: Reserved (always set to ”0”) byte n + 3: CRC

byte n + 4: ETX

Container Types:

0x00: 16mm diameter tube

0x01: 13mm diameter tube

NOTE: Refer to Interface Communication Failures and Sampling Errors sections.

2.1.8.7 Sample In Position

Description: This message confirms to the analyzer that the sample it is preparing to run is now

placed in the correct position for sampling to commence. This message may be sent immediately upon receipt of the ACK for the Prepare to Run Sample command.


Format:

byte 1: STX





byte 7: CRC

byte 8: ETX

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2.1.8.8 Sampling Complete

Description: This message will be sent to the LAS by the Analyzer to indicate that the sample at the metering station is complete. The automation system controls the sample once this message is successfully sent by the analyzer. A metering status of 0x00 indicates that sampling completed as expected. All other metering status indicate that there was a problem sampling and that operator intervention may be required.


Format:

byte 1: STX





byte 7: Metering Status



byte n + 2: CRC

byte n + 3: ETX

Metering Status:

0x00: As expected

0x01: No sample program for ID

0x02: ”Sample In Position” not received in time

0x03: Completed with error, check error conditions and analyzer status

0x04: Manual (internal) sample has priority

0x05: Analyzer inoperable, query analyzer status

0x06: Duplicate sample id

0x07: Analyzer not available

0x08: Metering failed in the sample (don’t move the sample)

2.1.8.8.1 Metering Status Codes

In the case of any status that indicates that the sample was not processed, the process of commanding the analyzer 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.

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Sample Aspirated With No Error (Code 0x00)

This status means that 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.

No Sample Program For Sample ID (Code 0x01)

This status indicates that 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.

Sample Position Not Received In Time (Code 0x02)

This status indicates that a PREPARE TO RUN SAMPLE message was received but a SAMPLE IN POSITION message was not issued by the LAS within 6.4 seconds of issuing the PREPARE TO RUN SAMPLE message. The LAS should reissue the PREPARE TO RUN SAMPLE message within 100 milliseconds after receiving a SAMPLING COMPLETE message in order to maintain throughput. Failure to meet this timing may result in a skip cycle.

A SAMPLING COMPLETE message will be sent prior to a SAMPLE IN POSITION message if the SAMPLE IN POSITION is not received in time, or other error conditions occur including no sample program is specified for the sample ID (in PREPARE TO RUN), or the analyzer becomes inoperable.

Completed With Error (Code 0x03)

This status indicates that a problem was encountered while aspirating the 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.

Internal Sample Has Priority (Code 0x04)

This status indicates that 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.

Analyzer Inoperable (Code 0x05)

This status indicates that 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 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

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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.

Duplicate Sample ID (Code 0x06)

This status indicates that tests are in process for the given sample ID. However, the analyzer does process the sample. The automation system should not reuse a sample ID until all results are reported for the current instance of that sample ID. Consult with the laboratory to determine he desired response to this status.

Analyzer Not Available (Code 0x07)

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 the “Analyzer Is Ready To Sample” status before presenting any new samples to the analyzer.

Metering Failed In The Sample (Code 0x08)

This status indicates that the analyzer 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 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.

2.1.8.9 Reinitialize Communications

Description: This command may be used by the LAS in an attempt to recover from communication and sequence number errors. The type of error recovery desired must be specified as a parameter to this message.

The first type of error that may be recovered is a sequence number error. Sequence number errors will be reported by the analyzer whenever an unexpected sequence number is received from the LAS. The LAS may use the REINITIALIZE COMMUNICATIONS message to re-synchronize the analyzer to the LAS. Refer to the ILLEGAL COMMAND message.

The second type of error that may be recovered is an interface communication failure (refer to Section 3.5.1.3 Interface Communication Failures). If this type of recovery is possible, the analyzer will ACK this message then issue a READY sequence. If the analyzer does not ACK the message and issue the READY sequence, the error cannot be recovered without operator intervention. This recovery type does not reset the expected response at the analyzer.


Format:

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byte 1: STX




byte 5, 6: Message ID = 0xC00A

byte 7: Recovery type

byte 8: CRC

byte 9: ETX

Recovery types:

0x00: Restart sequence numbers using the Sequence Number byte in the REINITIALIZE COMMUNICATIONS message.

0x01: Attempt recovery from an Interface Communication Failure.

2.1.8.10 Reinitialize Metering

Description: This message will be sent by the LAS to request the analyzer reinitialize the Sample Metering subsystem. All subsystems that are “INOP” will be reinitialized.

This command will also reset the expected sample command on the analyzer back to PREPARE TO RUN SAMPLE. The REINITIALIZE METERING message may be used to recover from logical order errors or if an error has caused the operator to remove a sample that was in progress.


Format:

byte 1: STX





byte 7: CRC

byte 8: ETX

2.1.8.11 Sample Routed

Description: It is assumed that a sample program has been downloaded prior to the PREPARE TO RUN SAMPLE command. However, if the analyzer is configured for host query, there needs to be some mechanism to initiate a host query independent of the PREPARE TO RUN SAMPLE. A SAMPLE ROUTED message

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should be sent to the analyzer as soon as the LAS has routed a sample to the analyzer in order to maximize the time available to perform a host query.


Format:

byte 1: STX







byte n + 1: CRC

byte n + 2: ETX

2.1.8.12 Query Analyzer Inventory

Description: This message will be sent by the LAS to request that the analyzer report inventory.

Because of the time to process and transmit a response, this query will not be accepted while actively processing external samples.


Format:

byte 1: STX




byte 5, 6: Message ID = 0xC00C

byte 7: CRC

byte 8: ETX

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2.1.8.13 Analyzer Inventory

Description: A sequence of these messages will be sent by the analyzer in response to the QUERY ANALYZER INVENTORY command.

To keep the size of the messages small a maximum of 10 assays will be allowed per message. To send an inventory response for 30 assays would take 3 messages; the first two would have a 0x00 in the 7th byte and the third would have a 0x01.


Format:

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 this message (n)

byte 9 to 6n+8: One block for each assay

o byte 1, 2: Analyte Code

o byte 3, 4: Available test count

o byte 5: Current status

bit 1: Serum/Plasma current

bit 2: CSF current

bit 3: Urine current

bit 4: Whole Blood current bit 5-8: Reserved (set to 0)

o byte 6: Calibrated status

bit 1: Serum/Plasma calibrated

bit 2: CSF calibrated

bit 3: Urine calibrated

bit 4: Whole Blood calibrated

bit 5-8: Reserved (set to 0)

o byte 6n-9: CRC

o byte 6n-10: ETX

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2.1.8.14 Query Analyzer Resources

Description: This message will be sent by the LAS to request that the analyzer report resources.

This includes diluents, bulk fluids, tips, cuvettes and waste space. Because of the time to process and transmit a response, this query will not be accepted while actively processing external samples.


Format:

byte 1: STX




byte 5, 6: Message ID = 0xC00E

byte 7: CRC

byte 8: ETX

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2.1.8.15 Analyzer Resources

Description: This message will be sent by the analyzer in response to the QUERY ANALYZER RESOURCES command.


Format:

byte 1: STX




byte 5, 6: Message ID = 0xC00F

byte 7, 8: ERF Level

byte 9, 10: IWF Level

byte 11, 12: Reserved = 0x0000



byte 17, 18: VersaTip supply count�

byte 19, 20: MicroTip supply count

byte 21, 22: Cuvette supply count

byte 23, 24: Available slide waste count

byte 25: Cuvette waste percent full�


byte 28: Number of diluents (n)

byte 29 to 4n+28: One block for each diluent.

byte 1, 2: Diluent Code

byte 3, 4: Available volume in mL

byte 4n+29: CRC

byte 4n+30: ETX

� If the VersaTip hopper sensor is blocked there is no way to get an accurate count. Only that

the number of tips available is greater than 300. In this case we consider there to be an infinite supply of tips, this condition will be encoded with 0xFFFF.

� Cuvette waste volume accounts for cuvettes, tips, and MicroTip trays.

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2.1.9 Timing Requirements

• The automation system must complete the following steps within the required time period after the SAMPLING COMPLETE message is sent by the analyzer to guarantee system throughput. Failure to meet this timing will result in decreased analyzer 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 analyzer must be spaced at least 100ms apart to allow the illegal command response. This is to allow the analyzer time to respond with an ILLEGAL COMMAND RECEIVED message if required.

• The last byte of a message, based on the message length, must be received within 250ms from receipt of the STX.

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2.2 Lab Automation Communication Scenarios

INTERFACE INITIALIZATION SEQUENCE

Lab Automation Analyzer

READY

READY (if no response in 1 sec.)

ACK

ACK

ACK (if no response in 0.5 sec.)

ACK

Query Analyzer Status

ACK

Sequence Number = A

Sequence Number = A+1

Sequence Number = A+2 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

Analyzer Status Message

ACK


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RUN TWO SAMPLES



ACK

ACK

Analyzer Status Message Ready to sample

Prepare to Run Sample

Sample In Position

ACK ACK


ACK

ACK

ACK Analyzer Status Message

Remote in Progress Sampling Complete


ACK

ACK

Analyzer Status Message Manual operation


ACK

ACK



Sample In Position

ACK ACK


ACK

ACK



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REMOTE SAMPLE STARTUP INTERRUPTED BY LOCAL SAMPLE



ACK

ACK



Sample In Position

ACK ACK


ACK

ACK


ACK


Manual operation Sampling Complete

Did not sample Manual sample had priority

ACK

Analyzer Status Message Manual operation


ACK

ACK



Sample In Position

ACK ACK


ACK

ACK



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NON FATAL ERROR CONDITION

Insufficient Inventory



ACK



Sample In Position

ACK ACK

ACK

Sampling Complete (Completed with error)


Sample In Position

ACK ACK

ACK

Sampling Complete

NOTE: In the case of multiple tests per sample, and only has insufficient inventory, the tests which have inventory will be posted to the Lab Automation

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NON FATAL ERROR CONDITION Unknown Sample ID



ACK

ACK


Prepare to Run Sample ACK

Sample In Position ACK

ACK

Sampling Complete (Unknown Sample ID)


ACK


ACK

Sampling Complete

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NON FATAL ERROR CONDITION Sample In Position Not Received In Time



ACK

ACK

Analyzer Status


ACK

Sampling Complete (Sample In Position Not Received In Time)


Sample In Position

ACK

ACK

ACK

Sampling Complete

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FATAL ERROR CONDITION



ACK

ACK




ACK

Sampling Complete (Failed in Sample or Analyzer Inop)

Initialize Analyzer

ACK


ACK

ACK

Analyzer Status Message (Analyzer Initializing)

Query Analyzer Status ACK

ACK

Analyzer Status Message (Analyzer is Ready)

NOTE: If the analyzer still reports a fatal condition after reinit an operator must be called to check the analyzer. The module and error number reported to the LIS will contain more information about the error.

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SAMPLE ROUTED NOTIFICATION


Sample Routed (SID1)

ACK

Prepare to Run Sample (SID1) ACK


Sample Routed

(SID2)

ACK

ACK Sampling Complete


(SID2) ACK


ACK Sampling Complete

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

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QUERY ANALYZER INVENTORY

Lab Automation Analyzer Query Analyzer Inventory

ACK

ACK Analyzer Inventory (last message = 0x00)

ACK

ACK

Analyzer Inventory (last message = 0x00)

Analyzer Inventory (last message = 0x01)

Query Analyzer Resources

ACK

ACK

Analyzer Resources

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3 Hardware Interfaces

3.1 Electrical Interface

3.1.1 Analyzer to Lab Information System

Refer to for Laboratory Computer Interface, Publication No. J23306

3.1.2 Analyzer to Lab Automation System

• Full RS232 LAS communication interface. The following pins are used (analyzer side): 3 - transmitted data (TxD) 2 - receive data (RxD)

5 - circuit common

• One 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.

• Analyzer end is a 9-pin DTE female.

• 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

3.1.3 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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3.2 Positional Requirements

This section describes the relative position between analyzer 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 analyzer. The following assumptions apply relative to the interface between the two systems.

3.2.1 Assumptions

• The analyzer 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 analyzer requirements for sample tube height.

Reference section 3.4.4.

• The analyzer will provide a limited amount of adjustment of the sample metering proboscis in the

direction (“X” direction) perpendicular sample travel path. The analyzer will also provide a limited amount of adjustment of the sample metering proboscis in the vertical “Z” direction. Refer to Figure

3.1

• The automation system must provide adjustability of the sample position along the track (“Y”

direction) in order to align the sample with the analyzer proboscis travel. Refer to Figure 3.1

Metering Probe line of travel

Metering Probe vertical

Z line of travel

X

Direction of

Y Sample travel

Figure 3.1

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3.3 Analyzer to Track positioning / Floor mounts or Anchors

Ortho Clinical Diagnostics provides two methods of locating and positioning the analyzer 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 analyzer relative to the automation system. The ability to repeat the exact position of analyzer relative to the original POR depends on the following factors:

a. Anchors have been installed correctly. Reference Install Instructions J26396 b. Analyzer engagement with anchors is not so aggressive to cause a shift in anchors position

relative to floor. c. Automation track is rigidly mounted so there is no relative motion between analyzer and track.

It is highly recommended to check alignments of analyzer to track position, if it has been moved (disengaged from anchors) for some reason. Reference section 3.4.2

3.3.1 Types of floor mounts/ Anchors

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

3.3.1.1.1 Standard Floor mounts / Anchors

Standard Anchors are included in the AT Accessory and do not need to be ordered separately.

3.3.1.1.2 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). These anchors are ordered in addition to the AT Accessory.

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3.4 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. Reference

section 4.1 for fill requirements.

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

• Ortho 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. Refer to Figure 3.6 section 3.4.3. Once this value is set, repeatability of positioning in “X” direction should be +/- .028 inch (0.7 mm).

3.4.1 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.

Z

Y

X

Figure 3.2

Adjustment Responsibility Y Direction Automation Supplier X & Z Directions Ortho 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 Not Required

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3.4.2 VITROS® 5,1 FS Metering Proboscis alignment

When the analyzer 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 analyzer proboscis adjustment (horizontal and

perpendicular to sample travel) and sample position adjustment along the track length.

The Lab Automation System vendor has complete responsibility

for the positioning the sample tube. However, the adjustments

indicated in section 3.4.1 should facilitate alignment between the

analyzer and LAS.

Maximum Top of Tube Position

Figure 3.4 (Dimensions shown are in mm)

3.4.3 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 analyzer metering. It is used as the common reference for the analyzer and Automation system. The design of the VITROS® 5,1 FS accommodates the NCCLS standards. Refer to Figure 3.5.

Z

X

Y

Bottom of Sample Tube

Floor Reference

Figure 3.5

NCCLS Standard 850 +/- 10mm

100mm Distance from Analyzer Side panel to POR

260mm Distance from back surface of Analyzer to POR

POR

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100mm 4.0in

50mm 2.0in Range of Analyzer adjustment in “X” direction

Figure 3.6 Back View of Analyzer

Back Cabinetry Panel of Analyzer

Figure 3.7

260 mm 10.25 in

POR in “Y” direction

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3.4.4 Sample tube height: Vertical dimension for POR

Position of sample tube shown below is based on 100mm tube lengths. Dimensions are given to the bottom of the tube in alignment with the NCCLS standards. Metering operations assume 100 mm tube height.

Front View of Analyzer

100mm Tube

100mm Tube

830mm Minimum Distance to Bottom of 100mm Tube

880mm Maximum Distance to Bottom of 100mm Tube

Floor Reference

Figure 3.8

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3.5 Analyzer Dimensions

This section describes the overall size of the VITROS® 5,1 FS with AT (Automation) Accessory. Refer to

Figure 3.9-3.11.

2647mm 104.2in

300mm 11.8 in

1084mm 42.68in

Floor

Figure 3.9 shown with Seismic anchors

850mm 33.5 inch

8 inch 200mm

Figure 3.10 Figure 3.11

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The figure shown below displays the optional heat rejection plenum that diverts heat from the analyzer directly into the customer ventilation system

Figure 3.12

383mm 15 inch

Figure 3.13

If a customer requires the heat rejection plenum, Ortho and the automation vendor should review any possible spatial conflicts. For additional information, refer to Site Specification for the VIRTROS 5,1 FS Chemistry System Publication No. J22961.

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3.6 Site Specifications

3.6.1 Analyzer

VITROS® 5,1 FS site specifications are outlined in Publication No. J22961. Specification covers:

• Electrical Power Requirements

• System Environmental Specifications

• Requirements at the Customer Site

• Specifications for the VITROS® 5,1 FS Chemistry 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.

3.7 Service Access

The analyzer requires service access from all four sides of the machine. Site Specification Publication No.

J22961 indicates the appropriate clearances. Access to the machine will depend on the track configuration and is to be worked out between Ortho 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 analyzer should allow removal of the rear panel covers by unfastening the quarter-turns,

tipping the covers away from the analyzer, lifting the rear panels several inches, and

moving the panels out to the side of the analyzer.

Figure 3.14

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3.8 Analyzer Heat Rejection and Air Intake Zones

The analyzer contains air intake ports and exhaust ports. The location of these ports are shown in the figure

below. These ports must not be blocked.

Analyzer thermal characteristics are found in Site Specification Publication No. J22961

Bottom front and Right side of analyzer are air Intake ports

Exhaust ports

Figure 3.15

3.9 Regulations and Safety Standards

The VITROS® 5,1 FS Chemistry Systems is designed to meet Regulatory and Safety requirements for a

worldwide market.

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4 Sample Handling

4.1 Supported Containers

All but the 10.25 diameter container measurements assume that the track is set up for the system to aspirate from 100 mm tube lengths.

Minimum Fill Requirement

Tube Size Diameter x Length mm

Fluid Volume µL

16 x 100 200 µL plus test 16 x 75 200 µL plus test 12-13 x 100* 200 µL plus test 12-13 x 75* 200 µL plus test

*Greiner MiniCollect® Complete Z series tubes (representative geometry, Greiner Item #450549, Sample Handling shall identify this geometry as a 12-13 mm tube) 10.25 with varying lengths • The tube must have a minimum fill of 30

mm below the rim plus test volume. • The tube must be supported so the top rim

of the tube is positioned at the same location as a 100 mm tube.

IMPORTANT: The use of micro collection sample tubes (also commonly referred to as pediatric tubes or capillary tubes) on Laboratory Automation systems can only occur if those sample tubes meet both the specifications for use of the Laboratory Automation System and the analyzers intended to process them.

4.2 Containers that WILL NOT be Supported

• Cups will NOT be accommodated by remote sampling but can be used for local (on-

analyzer) sampling.

• Pediatric capillary draw tubes will NOT be accommodated by remote sampling but can be used for local (on-analyzer) sampling.

4.3 Sample Quality Recommendations

• The sample automation system should allow for primary tube sampling. • If secondary aliquot tubes are used, they should minimize:

- Sample contamination with microorganisms

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- Out-gassing of volatile sample constituents - Long term sample degradation

4.4 Environmental Issues

• Sample tubes should remain uncapped for the minimum amount of time to maintain sample quality.

• Sample caps should be replaced on the sample container shortly after testing has been completed. This will help to ensure sample quality for any follow-up testing that may be required.

• For installations in brightly lighted areas, opaque or amber shielding of the tubes or opaque or amber tubes will help maintain sample quality.

• Installations with high particulate counts should have dust baffles positioned to protect open sample containers.

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5 Automation Interface Guidelines

5.1 Introduction

5.1.1 Purpose / Objective

These guidelines are designed to assist automation system personnel in verifying the correct implementation of the Automation Interface Specification between a Lab Automation System (LAS) and VITROS® 5,1 FS Chemistry System with AT Accessory. These procedures do not represent a complete validation tool for the Lab Automation Supplier. Rather, they are provided to ensure that certain major areas of concern are addressed for basic, fundamental operation. The guidelines should be used and reviewed at the Lab Automation Supplier site before the first customer delivery.

5.2 Audience

These guidelines are primarily designed as a communications tool for both the Lab Automation Supplier and Ortho Clinical Diagnostics, Inc. personnel to ensure that the appropriate interfaces have been addressed.

5.3 Approach

These guidelines address the actual Analyzer to Lab Automation interface by reviewing both the software and physical interfaces. The software interfaces include the Analyzer to LAS connection as well as the Analyzer to LIS connection. The physical interface includes topics such as track height and analyzer aspirate depth, as well as maintenance and serviceability issues.

5.4 Material Resources

The following materials and equipment are required in order to verify implementation of the Automation Interface Specification:

• VITROS® 5,1 FS Chemistry System (s) • AT Accessory(s) • Automation System to be evaluated with the VITROS® 5,1 FS Chemistry System (includes physical hardware, LAS, and LIS) • Disposables items including:

- tips - cups - reservoirs - scrap cartridges - fluids (water, in most cases)

• V-DOCS

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• Automation interface emulation software

5.5 Skills Required

This checklist is designed for personnel who have a basic understanding of the VITROS® AT Chemistry System and the Lab Automation System to be tested. Suggested personnel involved in the evaluation of the interface between the VITROS® 5,1 FS Chemistry System with AT Accessory and the automation system should include:

• Customer Technical Service Lab Automation Representative (Ortho) • Technical Specialist(s) representing the Lab Automation System supplier • Technical Specialist(s) representing the Lab Information System supplier

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6 Laboratory Automation Controller (LAS) Protocol Tests

The LAS test cases described in this section require that the automation system’s LAS port be connected to the analyzer, including a passive line-monitoring device. Message time stamping should be less than 100ms resolution. All message sequences should follow the timing constraints defined in Section 2.1.9, LAS Communication Timing Requirements. Communication sequences should be tested with the VITROS® 5,1 FS Chemistry System with Automation enabled; however, a simulator tool may be used to verify the formatting and logical ordering of messages. Where these guidelines refer to “analyzer,” a simulator tool may be substituted and/or required.

6.1 LAS Communications Initialization Test

This section tests for compliance with the analyzer LAS communications protocol, including:

• Initialize communications sequence • Message acknowledged • Message not acknowledged • Sequence numbers • Query analyzer status • Analyzer status • Reinitialize communications

Item Action Expected Result Actual Result 1 Send the READY message from

the analyzer to the LAS The LAS begins the initialization sequence as defined in the Interface Initialization Sequence section of this interface specification. Refer to Section 2, Software Interfaces.

2 From the LAS, send the REINIT COMMUNICATIONS message.

The analyzer responds and sends a READY message, beginning the initialization sequence.

3 From the LAS, send a QUERY ANALYZER STATUS command. Then, from the analyzer, send an ANALYZER STATUS response.

The analyzer acknowledges the QUERY ANALYZER STATUS command. The LAS acknowledges the ANALYZER STATUS response.

4 From the automation system, send a QUERY ANALYZER STATUS command. Then, from the analyzer, send an ANALYZER STATUS response with an incorrect CRC value. (may need a simulator)

The analyzer acknowledges the QUERY ANALYZER STATUS command. The LAS sends a NAK message in response to the incorrect CRC in the ANALYZER STATUS response.

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Item Action Expected Result Actual Result 5 If the LAS uses sequence

numbers, repeat steps 1 through 4 using each sequence number. Enable sequence numbers as described in the Sequence Numbers section of the Automation Interface Specification. Test sequence number wrap around condition.

Control flow and status messages are the same as in steps 1 through 4. Ensure that the sequence numbers are incrementing in each command/ response pair.

6.2 Analyzer Status

This section verifies the analyzer status that is sent by the analyzer to the LAS. The following Analyzer Status messages will be verified:

• Analyzer is ready to sample • Analyzer is busy processing an external sample • Analyzer is busy processing an internal sample • Analyzer is equilibrating • Analyzer has a fatal error, check LIS error messages (inoperable) • Analyzer is not available (cartridge loading, diagnostics, etc.) • Analyzer has failed in the sample.

This section tests for compliance with the analyzer/LAS communications protocol described in the following section of the automation interface specification:

• Section 2.1.8.5, Analyzer Status

Item Action Expected Result Actual Result 1 From the LAS, send a QUERY

ANALYZER STATUS command. Then, from the analyzer, send an ANALYZER STATUS response.

The analyzer acknowledges the QUERY ANALYZER STATUS command. The LAS acknowledges the ANALYZER STATUS response.

2 Repeat step 1, sending back all possible Analyzer Status codes. (may need a simulator)

The LAS accurately interprets and takes appropriate action for each ANALYZER STATUS response.

6.3 Sampling Complete

This section verifies the SAMPLING COMPLETE status that is sent by the analyzer to the LAS for each sample ID. The following SAMPLING COMPLETE metering statuses will be verified:

• Sample aspirated as expected • No sample program for sample ID • SAMPLE IN POSITION not received in time

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• Completed with error, check error conditions and analyzer status • Internal sample has priority • Analyzer inoperable, query analyzer status • Duplicate sample ID • Analyzer not available • Metering failed in sample

This section tests functionality and commands described in the following sections of the automation interface specification:

• Section 2.1.8.8, Sampling Complete

Item Action Expected Result Actual Result 1 From the LAS, send a PREPARE TO

RUN SAMPLE and a SAMPLE IN

POSITION command to the analyzer. From the analyzer, send back a SAMPLE COMPLETE message with a status of “Sample Aspirated As Expected.”

The analyzer acknowledges the PREPARE TO RUN SAMPLE and SAMPLE

IN POSITION messages. Ensure the Sample Complete status is interpreted correctly by the automation system and that the proper action is taken with the sample.

2 Repeat step 1, sending back all possible Sample Complete status values. (may need a simulator)

The automation system accurately interprets and takes appropriate action for each Sample Complete response.

6.4 Error Recovery

This section tests the ability of the automation interface to recover after introduction of an error condition. The following error conditions will be verified:

• Communications Error • Loss of Communications • Incorrect Sample ID • Invalid Container Type • Invalid Recovery Type

This section tests for compliance with the analyzer/LAS communications protocol described in the following sections of the Automation Interface Specification:

• Section 2.1.8.1, Message Acknowledged • Section 2.1.8.2, Message Not Acknowledged • Section 2.1.8.3, Illegal Command Received • Section 2.1.8.9, Reinitialize Communications

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Item Action Expected Result Actual Result1 From the LAS, send a command to

the analyzer containing an invalid CRC value.

Send the same message again with a valid CRC value.

The analyzer does not acknowledge the first command.

The analyzer acknowledges the second command.

2 From the LAS, send a command to the analyzer containing an invalid CRC value. Resend the command again with the invalid CRC value.

On receiving the second incorrect CRC, the analyzer stops accepting any new commands until a REINITIALIZE COMMUNICATIONS command is sent.

3 Send a REINITIALIZE COMMUNICATION message to recover from the interface communications error generated in step 2.

Normal operation resumes.

4 From the LAS, send an undefined message to the analyzer. The analyzer sends an ILLEGAL COMMAND RECEIVED message to the LAS.

The LAS interprets the ILLEGAL COMMAND RECEIVED message.

5 From the LAS, send a PREPARE TO RUN SAMPLE command to the analyzer, with an invalid container type.

The analyzer sends an ILLEGAL COMMAND RECEIVED message to the LAS. The LAS interprets the ILLEGAL COMMAND RECEIVED message.

6 From the LAS, send a PREPARE TO RUN SAMPLE command to the analyzer, with a non-printable character in the sample ID.


7 Reinitialize communications with the analyzer with sequence numbers enabled. From the LAS, send a command with an invalid sequence number.


8 From the LAS, send a REINITIALIZE COMMUNICATIONS command to the analyzer to reset the sequence number.

Normal communication resumes.

9 From the LAS send a REINITIALIZE COMMUNICATIONS command to the analyzer with a recovery type of 0xFF


10 From the LAS, send a PREPARE TO RUN SAMPLE and a SAMPLE IN POSITION command to the analyzer. From the analyzer, send a SAMPLE COMPLETE message containing a different sample ID than the one in the PREPARE TO RUN SAMPLE command.

The analyzer acknowledges the PREPARE TO RUN SAMPLE message and the SAMPLE IN POSITION message. The automation system recognizes the different sample ID in the SAMPLE COMPLETE message as an error.

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6.5 Sample Routed/Host Query

This section tests the ability to initiate a host query from the analyzer through the automation interface. The following condition will be tested:

• Ability to initiate a host query from the analyzer using the SAMPLE ROUTED message


• Section 2.1.8.11, Sample Routed

Item Action Expected Result Actual Result 1 Send the SAMPLE ROUTED

message from the LAS specifying a sample ID.

The LIS receives a host query from the analyzer for the sample ID specified in the SAMPLE ROUTED message.

6.6 Request Inventory

This section tests the ability to request and receive inventory from the analyzer through the automation interface. The following condition will be tested:

• Ability to obtain the inventory from the analyzer


• Section 2.1.8.12, Query Analyzer Inventory • Section 2.1.8.13, Analyzer Inventory

Item Action Expected Result Actual Result 1 Send the QUERY ANALYZER

INVENTORY message from the LAS.

The automation system interprets the ANALYZER INVENTORY response(s) correctly. If multiple data packets are required to receive the inventory information, the data packets are handled correctly.

6.7 Request Resources Levels

This section tests the ability to request and receive resource levels from the analyzer through the automation interface. The following condition will be tested:

• Ability to obtain resource levels from the analyzer

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• Section 2.1.8.14, Query Analyzer Resources • Section 2.1.8.15, Analyzer Resources

Item Action Expected Result Actual Result 1 Send the QUERY ANALYZER

RESOURCES message from the LAS.

The automation system interprets the ANALYZER RESOURCES response correctly.

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7 Instrument-Based Testing

7.1 Normal Operations Sample Handling

This section tests the ability of the LAS to communicate with the analyzer and process a sample using all sample control commands in sequence. This section tests for compliance with the analyzer/LAS communications protocol described in the following sections of the Automation Interface Specification:

• Section 2.1.8.5, Analyzer Status • Section 2.1.8.6, Prepare to Run Sample • Section 2.1.8.7, Sample In Position • Section 2.1.8.8, Sampling Complete • Section 2.9, Timing Requirements

Item Action Expected Result Actual Result1 While monitoring the LAS

communications, send the QUERY ANALYZER STATUS message from the LAS.

The LAS receives and correctly interprets the ANALYZER STATUS message. The automation system should not present a sample to the analyzer unless the status is “Analyzer is Ready to Sample.”

2 While monitoring the LAS communications, send the PREPARE TO RUN SAMPLE command to the analyzer.

The LAS receives the proper responses. If the time between PREPARE TO RUN SAMPLE and SAMPLE IN POSITION exceeds the time specified in section 2.1.9. A status of “Sample In Position Not Received In Time” is posted.

3 Wait for the analyzer to send the SAMPLE COMPLETE response.

The LAS acknowledges the SAMPLE COMPLETE message. The sample ID matches the one in the PREPARE TO RUN SAMPLE command.

4 From the LAS process two consecutive samples with a delay of 1 second between the SAMPLE COMPLETE message from the analyzer for the first sample and the PREPARE TO RUN SAMPLE message from the LAS for the second sample.

The analyzer processes the samples. The analyzer throughput is reduced and there is a delay between processing the first and second sample.

5 From the LAS process two consecutive samples. Send the PREPARE TO RUN SAMPLE message for the second sample 100ms after receiving the SAMPLE COMPLETE message for the first sample.

The analyzer processes the samples. The Analyzer throughput is not reduced, there is no delay between processing the first and second sample.

6 Load a sample in the STAT lane of the analyzer and start sampling, then attempt to process a sample from the LAS.

The analyzer processes the sample from the STAT lane of the analyzer and sends a SAMPLE COMPLETE message to the LAS with a metering status of “Internal sample has priority”

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8 Physical Interfaces

This section reviews the physical interfaces between the Lab Automation System and the VITROS® 5,1 FS Chemistry System with AT Accessory. Prior to the start of this evaluation, set up and adjust the analyzer to track interface following the installation procedure found in the Installation Instructions, J26396. Temporary placement of floor mounts can be accomplished using double-sided tape.

8.1 Sample Positioning

This section evaluates the ability of the Lab Automation System to properly position a sample tube for fluid aspirated by the analyzer. This section tests for compliance with the Sample Positioning and Adjustment section of the Automation Interface Specification.

Item Action Expected Result Actual Result1 Verify that the Lab Automation System

allows the sample positioning device to be adjusted along the length of the track and fixed into position.

The automation system sample positioning device must be adjustable along the length of the track to ensure alignment of the sample with the analyzer proboscis travel. Ref to section 3.2.1

2 Measure the height to the top of the longest sample tube from the floor when properly positioned for sample aspiration by the sample positioning device.

See Section 3.4.4 When sample metering is adjusted to the tallest tube height 100mm, aspirate depth is 98 mm maximum from that point.

3 In normal operating sample handling mode, fill 13mm sample tubes with just enough fluid for 1 test per sample. Place sample tubes on the track and route them to the analyzer for processing. Watch the sampling probe as it drops into the tube to aspirate fluid. Record any observations of the proboscis or tip contacting the side of the sample tube.

When system is rigidly mounted and properly adjusted, there should be no contact between the sampling probe and the sample tube. Reference section 3.4.2

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9 LAS/LIS Architecture

9.1 Summary of considerations for LIS/LAS architecture

With the advent of today’s computer systems, implementation of Dynamic-Broadcast downloading is becoming the norm for a state of the art LIS. In fact, a properly configured Dynamic-Broadcast system capable of auto-deletion results inconsiderable savings in time and in increased productivity. This type of scenario is well suited for cases where the LIS is the central repository of all samples being managed in a laboratory. To insure proper management of samples, there should be sufficient unique Sample IDs to manage all samples in the labor storage for a period of 2 months. If Sample IDs are reused, they should be periodically deleted from the instruments. If the laboratory anticipates a high volume of sample downloads, were command that STAT samples be prioritized and downloaded first.

LIS LAS

AT 1

5,1 FS

AT 2

9.2 LIS/LAS architecture considerations

When a Laboratory Automation System is introduced, the architecture may look like the following:

9.2.1 Case 1

The LAS does not intercept LIS to instrument communication. Automation samples can be run on any instrument. All instruments do not need to be on the Automation system. Caution: The LAS must notify the LIS of any samples it creates. The LIS will then broadcast download that sample ID to all instruments capable of running that sample. The LIS will need to create an entry in its database to receive the results of this newly created sample. If the LIS downloads both the primary sample ID and the aliquoted sample ID, the LIS must make sure to auto-delete both periodically.

Figure B-1. Case 1 scenario Note: If the link between the LIS and LAS is not present, then only samples downloaded from the LIS can be run, without manual programming, on the AT. This is an issue if the LAS creates and presents aliquoted tubes to the analyzer that have a different sample ID than the one the LIS downloaded.

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9.2.2 Case 2

The LAS intercepts LIS to instrument communication. Automation Samples can only run on track. Caution: The LAS should coordinate forwarding of LIS information, including deletions, sent to it, to insure that sample programming is present at the instrument prior to a sample being presented. This can be done if the LAS implements a broadcast download methodology and automatically deletes any residual information. The LAS is solely responsible for the management of samples it creates. Additionally, the LAS must provide a recovery/backup mode in case the LAS intercepted LIS communication link goes down.

9.2.3 Case 3

The LAS intercepts LIS to instrument communications. Automation sample required to run on any instruments in the lab. Approach 1: Similar in concept to case 2, with the addition of the LAS being required to transmit a sample created message to the LIS. The LIS is then responsible for broadcasting this information to instruments that are not on the LAS. In this case the LIS sends broadcasts and deletions to the LAS and other instrumentation. The LAS decides to forward the information as it chooses. Additionally, the LAS must provide a recovery/backup mode in case the LAS intercepted LIS communication link goes down. Approach 2: This is similar to case 1, with the only change being that the LAS is responsible for all instrument “LIS” communication, even if the instrument is not attached to the track. Therefore the LAS may also broadcast and delete sample ID’s it created. Additionally, the LAS must provide a recovery/backup mode in case the LAS intercepted LIS communication link goes down.

LIS LIS

5,1 FS

5,1 FS

LAS LAS

AT 2

LAS LIS

LAS

AT 1

LIS

AT 2

LAS LIS

LAS

AT 1

LIS

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10 Safety and Precautions

10.1 Risk Avoidance

Any safety considerations and precautions that can be controlled at the analyzer level are included in the AT system design. Some potential risks require that the lab automation system follow a specific protocol when interacting with the analyzer. Other potential risks relate to the lab automation system itself. To enhance the safety and reliability of our analyzers and the automation systems to which they connect, the following considerations are listed:

• Considerations for patient safety • Considerations for operator safety • Considerations for environmental safety

These considerations are listed so that automation vendors will understand the need for strict compliance with analyzer protocols. Lab automation system designers are strongly encouraged to consider these possible risks when designing interfaces between these products. If the analyzer is used in a manner not specified by Ortho Clinical Diagnostics, the protection provided by the equipment may be impaired. Risks that are strictly controlled within the AT analyzer and that were considered during the analyzer’s design are not shown below.

10.2 Patient Considerations

Potential Risk Potential Result Recommended Preventive Action Chemical cleaning agent contamination.

Contamination or degradation of sample

• Refer to the Quick Reference Guide (J33140) for cleaning agents and protocol.

Particulate contamination of sample on automation track.


• Remove stopper from sample tubes as close to the analyzer as possible to maintain sample quality.

Evaporation or out-gassing while sample tube is on automation track.

Degradation of sample • Remove stopper from sample tubes as close to analyzer as possible to maintain sample quality.

Cross contamination from adjacent sample on automation track.


• Set up automation systems to handle samples in a manner that prevents cross-contamination.

Sample cross-contamination - Aspirating second fluid quantity into same tip (“double dip”) when sample on track has been released too early and next sample is in position.

Cross-contamination of sample on track

• Ensure that LAS receives “sample complete” message from the AT analyzer before releasing the sample. Refer to Section 2.

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Potential Risk Potential Result Recommended Preventive Action Sample too cold after holding in refrigerated section of track for reflex testing. (Automation track supplier controls temperature.)

Sample temperature outside VITROS® 5,1 FS Chemistry System limits

• Provide a means of sample temperature equilibration to room temperature after refrigeration, before presentation at the AT analyzer.

Misalignment of automation track with AT analyzer.

Sample aspirate volume error

• Follow specifications for sample tube location specified in Section 4.

EMI from automation track to AT analyzer via coupling.


• Ensure that automation track meets agency specifications. • Isolate the mechanical coupling between the sample automation track and the analyzer to address potential EMI concerns.

Over-wet sample tip or aspiration of air because tube diameter information from automation system is incorrect.


• Utilize error checking communication protocol (CRC). • Follow communications specifications in Section 2.

Sample tube breaks at automation track and AT analyzer interface.

System synchronization or timing error

• Refer to acceptable sample tube sizes for the specified in Section 4. • Design sample tube height detection as a feature of the sample track. • Detect time-out of sample metering subsystem and communicate error to LAS/LIS.

Communication error between the AT analyzer and the LAS.

System synchronization/ timing error

• Follow communications specifications in Section 2.

Incorrect sample presented to AT analyzer.

Aspirate from incorrect sample

Ensure integrity of the sample ID communicated to the analyzer and positioning of that sample.

Sample ID mis-communicated from LAS.


• Verify sample ID in the “sample complete” message sent to LAS.

Automation track system misreads sample tube/carrier barcode.


• Use barcode verification for labels (i.e. check digit) and limit scanner view to one sample.

Inadequate consumables (reagents, tips, etc.) on analyzer to complete the test.

Test not completed • Send analyzer resource inventory to LIS upon request • Verify adequate supplies by LAS via LIS. If supplies are inadequate, we recommend that the LAS reroute the sample to another analyzer in this event.

STAT sample on the track is unknown to the analyzer. (All samples on the analyzer have priority over samples on the track.)

A STAT sample on the track may not be processed in a timely fashion

• Place STAT samples on the analyzer manually and process as local locate-loaded samples.

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Potential Risk Potential Result Recommended Preventive Action Sample tube arrives with stopper inserted in tube.

Test not executed • Remove caps from sample tubes to allow the analyzer to access the tubes. Remove caps as close to the analyzer as possible to ensure sample quality.

Sample Metering general error report is interpreted incorrectly by the LAS.

Test not completed • Utilize error checking communication protocol (CRC). • Use message formats specified in Section 2 of this document.

Inactive subsystem(s) on the AT analyzer.

Test not completed • Verify analyzer status by LAS prior to sample arrival.

Software suppressed results (due to a detected error) for a STAT test.

Test not completed within expected time

• Place STAT samples on the analyzer manually and process as local locate-loaded samples. • Verify analyzer status and condition reports by LAS/LIS

10.3 Operator Considerations

Potential Risk Potential Result Recommended Preventive Action Electric shock at automation track-to - analyzer coupling.

Electrical hazards • Ensure that track is properly grounded.

10.4 Environmental Considerations

Potential Risk Potential Result Recommended Preventive Action Metering proboscis stuck in sample tube on track when sample is released by the automation system. .

Mechanical damage to sample track area and AT analyzer

• Initialize sample metering subsystem by LAS if it receives a “Sample Complete” message combined with a sample metering error message from the AT analyzer. • Do not move sample from metering position until LAS receives a “Sample Complete” status without error message from AT analyzer.

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