MU - Analizadores Química Clínica Automáticos VITROS 5,1 FS (INGLES)

Part # J26605
VITROS 5,1 FS
SPECIFICATION FOR AUTOMATION INTERFACE
25 MAY 2005
DOCUMENT NUMBER: J26605
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Part # J26605
TABLE OF CONTENTS
1. INTRODUCTION.................................................................................................... 4
1.1. Purpose .........................................................................................................................................................4
1.2. Scope .............................................................................................................................................................4
1.3. References.....................................................................................................................................................4
1.4. Definitions.....................................................................................................................................................4
1.5. Audience .......................................................................................................................................................5
1.6. General Description.....................................................................................................................................5
1.6.1. Document Structure ...............................................................................................................................5
1.6.2. Assumptions and Dependencies.............................................................................................................5
2. SOFTWARE INTERFACES ................................................................................... 7
2.1. Analyzer to Lab Automation System .........................................................................................................8
2.1.1. Message Format .....................................................................................................................................8
2.1.2. Cyclical Redundancy Checks.................................................................................................................8
2.1.3. Sample ID Encoding ..............................................................................................................................9
2.1.4. Sequence Numbers.................................................................................................................................9
2.1.5. Interface Initialization Sequence............................................................................................................9
2.1.6. Acknowledgments................................................................................................................................10
2.1.7. Interface Communication Failures .......................................................................................................10
2.1.8. Messages..............................................................................................................................................10
2.1.8.1. Message Acknowledged...............................................................................................................10
2.1.8.2. Message Not Acknowledged........................................................................................................11
2.1.8.3. Illegal Command Received ..........................................................................................................11
2.1.8.3.1. Error Types ...........................................................................................................................12
2.1.8.4. Query Analyzer Status .................................................................................................................12
2.1.8.5. Analyzer Status ............................................................................................................................13
2.1.8.5.1. Analyzer Status Codes .............................................................................................................13
2.1.8.6. Prepare To Run Sample ...............................................................................................................14
2.1.8.7. Sample In Position .......................................................................................................................15
2.1.8.8. Sampling Complete......................................................................................................................15
2.1.8.8.1. Metering Status Codes .............................................................................................................16
2.1.8.9. Reinitialize Communications .......................................................................................................17
2.1.8.10. Reinitialize Metering....................................................................................................................18
2.1.8.11. Sample Routed .............................................................................................................................18
2.1.8.12. Query Analyzer Inventory............................................................................................................19
2.1.8.13. Analyzer Inventory.......................................................................................................................19
2.1.8.14. Query Analyzer Resources...........................................................................................................20
2.1.8.15. Analyzer Resources......................................................................................................................20
2.1.9. Timing Requirements...........................................................................................................................21
2.2. Lab Automation Communication Scenarios............................................................................................22
3. HARDWARE INTERFACES ................................................................................ 31
3.1. Electrical Interface ....................................................................................................................................31
3.1.1. Analyzer to Lab Information System ...................................................................................................31
3.1.2. Analyzer to Lab Automation System ...................................................................................................31
3.1.3. Electrical Interface at Sample ..............................................................................................................31
3.2. Positional Requirements............................................................................................................................32
3.2.1. Assumptions.........................................................................................................................................32
3.3. Analyzer to Track positioning / Floor mounts or Anchors ....................................................................33
3.3.1. Types of floor mounts/ Anchors...........................................................................................................33
3.3.1.1. Standard Floor mounts / Anchors.................................................................................................33
3.3.1.2. Seismic Floor mounts /Anchors Catalog # 6802245 ....................................................................33
3.4. Sample Positioning and Adjustments.......................................................................................................34
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3.4.1. Sample Center Device Adjustments: Positioning Responsibilities ......................................................34

3.4.2. VITROS 5,1 FS Metering Proboscis alignment...................................................................................35
3.4.3. Point Of Reference (POR) ...................................................................................................................35
3.4.4. Sample tube height: Vertical dimension for POR ................................................................................37
3.5. Analyzer Dimensions .................................................................................................................................38
3.6. Site Specifications ......................................................................................................................................40
3.6.1. Analyzer...............................................................................................................................................40
3.7. Service Access.............................................................................................................................................40
3.8. Analyzer Heat Rejection and Air Intake Zones ......................................................................................41
3.9. Regulations and Safety Standards............................................................................................................41
4. SAMPLE HANDLING........................................................................................... 42
4.1. Supported Containers................................................................................................................................42
4.2. Containers that WILL NOT be Supported .............................................................................................42
4.3. Sample Quality Recommendations...........................................................................................................42
4.4. Environmental Issues.................................................................................................................................42
5. AUTOMATION INTERFACE GUIDELINES ......................................................... 43
5.1. Introduction................................................................................................................................................43
5.1.1. Purpose / Objective..............................................................................................................................43
5.2. Audience .....................................................................................................................................................43
5.3. Approach ....................................................................................................................................................43
5.4. Material Resources ....................................................................................................................................43
5.5. Skills Required ...........................................................................................................................................44
6. LABORATORY AUTOMATION CONTROLLER (LAS) PROTOCOL TESTS ..... 45
6.1. LAS Communications Initialization Test.................................................................................................45
6.2. Analyzer Status ..........................................................................................................................................46
6.3. Sampling Complete ....................................................................................................................................46
6.4. Error Recovery ..........................................................................................................................................47
6.5. Sample Routed/Host Query.......................................................................................................................49
6.6. Request Inventory......................................................................................................................................49
6.7. Request Resources Levels..........................................................................................................................49
7. INSTRUMENT-BASED TESTING........................................................................ 51
7.1. Normal Operations Sample Handling ......................................................................................................51
8. PHYSICAL INTERFACES.................................................................................... 52
8.1. Sample Positioning.....................................................................................................................................52
9. LAS/LIS ARCHITECTURE................................................................................... 53
9.1. Summary of considerations for LIS/LAS architecture...........................................................................53
9.2. LIS/LAS architecture considerations.......................................................................................................53
9.2.1. Case 1 ..................................................................................................................................................53
9.2.2. Case 2 ..................................................................................................................................................54
9.2.3. Case 3 ..................................................................................................................................................54
10. SAFETY AND PRECAUTIONS............................................................................ 55

10.1. Risk Avoidance.......................................................................................................................................55
10.2. Patient Considerations ..........................................................................................................................55
10.3. Operator Considerations.......................................................................................................................57
10.4. Environmental Considerations .............................................................................................................57
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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 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
1.4. Definitions
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.
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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.
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:

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
Manual (walk up) samples take priority over samples delivered by the automation system.
Calibration with fluids delivered by the automation track is not supported.
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 via the analyzers existing LIS
port.
The automation system handles movement of all samples not placed manually on the analyzer.
The automation system stops, captures, positions, and steadies the sample for fluid aspiration.
All required information for processing a sample will be supplied to the 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.
- Sample ID
- Container type (diameter)
Sample programming for an individual sample must be downloaded prior to its presentation to the analyzer
if host query is not enabled.
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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.
The automation system ensures the integrity of the sample identification for the sample being aspirated.
If the LAS has not just received a status message or SAMPLE COMPLETE response, the LAS queries the
analyzer for its current status before sending a PREPARE TO RUN SAMPLE command.
The automation system must complete the following steps within the required time period after the
SAMPLING COMPLETE message is sent by the analyzer to guarantee maximum system throughput:
- Send the Sample ID information within a PREPARE TO RUN SAMPLE message for the next
sample within 100 milliseconds of SAMPLE COMPLETE.
- Place the next sample into the aspiration position
- Send the SAMPLE IN POSITION message to the 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.
The automation system must supply a setup mode used with the analyzers setup and adjustment mode. In
this mode, empty tubes are used to adjust the analyzers metering system to the location where aspiration will
be performed.
The AT Analyzer does not control devices mounted on the automation track.
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.
Lab Lab Information Data

Information
System
Lab Information Port
Analyzer
Lab Automation Port
Lab
Automation
System Lab Automation Coordination Messages
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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.
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.
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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.
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 has still not responded after the second timeout 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.
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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 analyzers LIS interface an Error Message is transmitted to
the LIS. Refer to <TBD> for details.
Any of the follow conditions shall cause an interface communication error on the analyzer.
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.
A new message is received prior to an acknowledgment for a previously sent message.
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
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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
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.
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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
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 shall 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 COMMUNICAITONS 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).
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 its status.
Direction: LAS to Analyzer
Format:
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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 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
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 (cartridge loading, diagnostics, etc.)
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 and 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.
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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 that the Analyzer Is Ready To Sample status before presenting any new
samples to the analyzer. It may require 30 to 40 minutes before the analyzer is ready to sample.
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 that the Analyzer Is Ready To Sample
status. For most cases initialization should take up to two minutes; however there are some situations that could take
up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an analyzer status of Analyzer Is
Ready To Sample within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the
operator and reroute samples to another analyzer.
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 that 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 analyzers metering proboscis has mechanically failed while inside the sample
container. The LAS should not attempt to move the sample to prevent the possibility of a broken tube and sample
spill. The LAS should attempt to restore the analyzer to an operational state by issuing a REINITIALIZE METERING
message to the analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the
analyzer until the status code indicates that the Analyzer Is Ready To Sample status. For most cases initialization
should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is
suggested that, if the LAS does not receive an analyzer status of Analyzer Is Ready To Sample within ten minutes
after issuing the REINITIALIZE METERING message, the LAS alert the operator. The current sample should not
be moved by the LAS and other samples may be rerouted to another analyzer until the analyzer is ready to sample.
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, tip failure, etc., 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.
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Format:
byte 1: STX
byte 2: Message length
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
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.
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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 (dont 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.
Sample Aspirated With No Error (Code 0x00)

This status means that 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 In Position No 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 received in the proper time frame. The SAMPLE IN POSITION message must be issued by the LAS within 6.4
seconds after issuing the PREPARE TO RUN SAMPLE message. The LAS should reissue the PREPARE TO RUN
SAMPLE message. This is the only case where a SAMPLING COMPLETE message will be sent prior to a SAMPLE IN
POSITION.
Completed With Error (0x03)

This status indicates that a problem was encountered while aspirating sample from the container. This status can be
due to a clot or bubble detected. If Enhanced LIS plus is enabled the LAS can query the LIS for specific error
information to decide what the best corrective action is. Since this status indicates that user attention is required for
follow-up, consult the laboratory to determine the desired response to this status.
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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 that the Analyzer Is Ready To Sample
status. For most cases initialization should take up to two minutes; however there are some situations that could take
up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an analyzer status of Analyzer Is
Ready To Sample within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the
operator and reroute samples to another analyzer.
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 that 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 analyzers metering proboscis has mechanically failed while inside the sample
container. The LAS should not attempt to move the sample to prevent the possibility of a broken tube and sample
spill. The LAS should attempt to restore the analyzer to an operational state by issuing a REINITIALIZE METERING
message to the analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the
analyzer until the status code indicates that the Analyzer Is Ready To Sample status. For most cases initialization
should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is
suggested that, if the LAS does not receive an analyzer status of Analyzer Is Ready To Sample within ten minutes
after issuing the REINITIALIZE METERING message, the LAS alert the operator. The current sample should not
be moved by the LAS and other samples may be rerouted to another analyzer until the analyzer is ready to sample.
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 are interface communication failures
(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
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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:
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 which 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 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
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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 the analyzer report its inventory.
Because of the time to process and transmit a response, this query will not accepted
while actively processing external samples.
Format:
byte 1: STX
byte 5, 6: Message ID = 0xC00C
byte 7: CRC
byte 8: ETX
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. So 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
byte 1, 2: Analyte Code
byte 3, 4: Available test count
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)
byte 6: Calibrated status
bit 1: Serum/Plasma calibrated
bit 2: CSF calibrated
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bit 3: Urine calibrated

bit 4: Whole Blood calibrated
bit 5-8: Reserved (set to 0)
byte 6n+9: CRC
byte 6n+10: ETX
2.1.8.14. Query Analyzer Resources

Description: This message will be sent by the LAS to request the analyzer report its 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 accepted while actively
processing external samples.
Format:
byte 1: STX
byte 5, 6: Message ID = 0xC00E
byte 7: CRC
byte 8: ETX
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
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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.
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.)
Sequence Number = A
ACK
Sequence Number = A+1
ACK
ACK Sequence Number = A+2
(if no response in 0.5 sec.)
ACK
Sequence Number = 0
Analyzer Status Message
Sequence Number = 0
ACK

Query Analyzer Status
ACK
Sequence Number = 1
Sequence Number = 1
ACK
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RUN TWO SAMPLES

ACK
ACK Ready to sample
Prepare to Run Sample

ACK
Sample In Position
ACK

ACK
ACK Remote in Progress
Sampling Complete
ACK

ACK
ACK Manual operation

ACK
ACK Ready to sample

ACK
Sample In Position
ACK

ACK
Sampling Complete
ACK
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Part # J26605
REMOTE SAMPLE STARTUP INTERRUPTED BY LOCAL SAMPLE

ACK
ACK Ready to sample

ACK
Sample In Position
ACK

ACK
Sampling Complete
ACK Did not sample
Manual sample had priority
ACK

ACK
ACK Ready to sample

ACK
Sample In Position
ACK

ACK
Sampling Complete
ACK
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Part # J26605
NON FATAL ERROR CONDITION

Insufficient Inventory

ACK
ACK

ACK
Sample In Position
ACK
Sampling Complete
ACK (Completed with error)

ACK
Sample In Position
ACK
Sampling Complete
ACK
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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Part # J26605

Unknown Sample ID

ACK
ACK

ACK
Sample In Position
ACK
Sampling Complete
(Unknown Sample ID)
ACK

ACK
Sample In Position
ACK
Sampling Complete
ACK
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Part # J26605

Sample In Position Not Received In Time

ACK
Analyzer Status
ACK

ACK
Sampling Complete
(Sample In Position Not Received In Time)
ACK

ACK
Sample In Position
ACK
Sampling Complete
ACK
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FATAL ERROR CONDITION

ACK
ACK

ACK
Sample In Position
ACK
Sampling Complete
(Failed in Sample or
ACK Analyzer Inop)
Initialize Analyzer
ACK

ACK
(Analyzer Initializing)
ACK

ACK

(Analyzer is Ready)
ACK
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

(SID1) ACK
Sample In Position
ACK
Sample Routed
(SID2) ACK
Sampling Complete
ACK

(SID2) ACK
Sample In Position
ACK
Sampling Complete
ACK
NOTE: Each Sample Routed message initiates a host

query to the LIS.
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Part # J26605
QUERY ANALYZER INVENTORY
Query Analyzer Inventory
ACK
Analyzer Inventory
ACK (last message = 0x00)
Analyzer Inventory
Analyzer Inventory
Query Analyzer Resources

ACK
Analyzer Resources
ACK
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Part # J26605
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 vertical
Z line of travel
Metering
Probe line of
travel
X
Direction of
Y
Sample travel
Figure 3.1
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Part # J26605
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. Standard Floor mounts / Anchors

Standard Anchors are included in the AT Accessory
and do not need to be ordered separately.
3.3.1.2. 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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Part # J26605
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.
OCD provides a software adjustment for set-up at the customer site to align proboscis with the track.
The range of adjustment will be 50mm (2.0 inch) in X direction of metering probe travel. 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.
Adjustment Responsibility
Y Y Direction Automation Supplier
X X & Z Directions OCD Fine position Automation

supplier for Coarse position to
suggested Point Of Reference (POR)
Rotation about X axis Automation Supplier

Rotation about Y axis Automation Supplier
Rotation about Z Not Required
Figure 3.2
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3.4.2. VITROS 5,1 FS Metering Proboscis alignment
When the analyzer and the sample tube grasping/centering device Maximum Top of Tube Position
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.
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.
Bottom of
Sample Tube
NCCLS
POR
Standard
850 +/- 10mm
Floor
Reference
100mm Distance
from Analyzer 260mm
Side panel to POR Distance from
back surface
of Analyzer to
Figure 3.5 POR
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Part # J26605
100mm 4.0in
50mm 2.0in
Range of Analyzer adjustment in X direction
Figure 3.6 Back View of Analyzer
Back
Cabinetry
Panel of Figure 3.7
Analyzer
260 mm
10.25 in
POR in Y direction
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Part # J26605
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
880mm
Maximum
830mm Distance to
Minimum Bottom of
Distance to 100mm Tube
Bottom of
100mm Tube
Floor Reference
Figure 3.8
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Part # J26605
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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Part # J26605
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, OCD 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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Part # J26605
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 OCD and the automation vendor. Some general guidelines are:
Track and supports should be configured to

allow access to rear panel quarter-turn
fasteners.
Spacing between the track and 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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Part # J26605
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 Exhaust ports
are air Intake 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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Part # J26605
4. Sample Handling
4.1. Supported Containers

All container measurements assume that the track is set-up for analyzer to aspirate from 100mm tube
lengths.
Minimum Fill Requirement

Tube Size Fluid Volume L
Diameter x
Length mm
16 x 100
13 x 100 200L plus test
16 x 75 volume
13 x 75
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
- 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 (OCD)
Technical Specialist(s) representing the Lab Automation System supplier
Technical Specialist(s) representing the Lab Information System supplier
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Part # J26605
6. Laboratory Automation Controller (LAS) Protocol Tests

The LAS test cases described in this section require that the automation systems 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 LAS begins the initialization
the analyzer to the LAS 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 The analyzer responds and sends
COMMUNICATIONS message. a READY message, beginning the
initialization sequence.
3 From the LAS, send a QUERY The analyzer acknowledges the
ANALYZER STATUS command. QUERY ANALYZER STATUS
Then, from the analyzer, send an command. The LAS
ANALYZER STATUS response. acknowledges the ANALYZER
STATUS response.
4 From the automation system, send The analyzer acknowledges the
a QUERY ANALYZER STATUS QUERY ANALYZER STATUS
command. Then, from the command. The LAS sends a NAK
analyzer, send an ANALYZER message in response to the
STATUS response with an incorrect CRC in the ANALYZER
incorrect CRC value. STATUS response.
(may need a simulator)
Page 45 of 57
Part # J26605

5 If the LAS uses sequence Control flow and status messages
numbers, repeat steps 1 through 4 are the same as in steps 1 through
using each sequence number. 4. Ensure that the sequence
Enable sequence numbers as numbers are incrementing in each
described in the Sequence command/ response pair.
Numbers section of the
Automation Interface
Specification. Test sequence
number wrap around condition.
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
1 From the LAS, send a QUERY The analyzer acknowledges
ANALYZER STATUS the QUERY ANALYZER
command. Then, from the STATUS command. The LAS
analyzer, send an ANALYZER acknowledges the ANALYZER
STATUS response. STATUS response.
2 Repeat step 1, sending back all The LAS accurately interprets
possible Analyzer Status and takes appropriate action
codes. for each ANALYZER STATUS
(may need a simulator) 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
Page 46 of 57
Part # J26605
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

1 From the LAS, send a PREPARE TO The analyzer acknowledges the
RUN SAMPLE and a SAMPLE IN PREPARE TO RUN SAMPLE and SAMPLE
POSITION command to the analyzer. IN POSITION messages. Ensure the
From the analyzer, send back a Sample Complete status is
SAMPLE COMPLETE message with a interpreted correctly by the
status of Sample Aspirated As automation system and that the
Expected. proper action is taken with the
sample.
2 Repeat step 1, sending back all The automation system accurately
possible Sample Complete status interprets and takes appropriate
values. action for each Sample Complete
(may need a simulator) 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
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
Page 47 of 57
Part # J26605

1 From the LAS, send a command to The analyzer does not acknowledge the
the analyzer containing an invalid first command.
CRC value.
The analyzer acknowledges the second
Send the same message again with a command.
valid CRC value.
2 From the LAS, send a command to On receiving the second incorrect CRC,
the analyzer containing an invalid the analyzer stops accepting any new
CRC value. Resend the command commands until a REINITIALIZE
again with the invalid CRC value. COMMUNICATIONS command is sent.
3 Send a REINITIALIZE Normal operation resumes.
COMMUNICATION message to
recover from the interface
communications error generated in
step 2.
4 From the LAS, send an undefined The LAS interprets the ILLEGAL
message to the analyzer. The COMMAND RECEIVED message.
analyzer sends an ILLEGAL
COMMAND RECEIVED message to
the LAS.
5 From the LAS, send a PREPARE TO The analyzer sends an ILLEGAL
RUN SAMPLE command to the COMMAND RECEIVED message to the
analyzer, with an invalid container LAS. The LAS interprets the ILLEGAL
type. COMMAND RECEIVED message.
6 From the LAS, send a PREPARE TO The analyzer sends an ILLEGAL
RUN SAMPLE command to the COMMAND RECEIVED message to the
analyzer, with a non-printable LAS. The LAS interprets the ILLEGAL
character in the sample ID. COMMAND RECEIVED message.
7 Reinitialize communications with The analyzer sends an ILLEGAL
the analyzer with sequence numbers COMMAND RECEIVED message to the
enabled. From the LAS, send a LAS. The LAS interprets the ILLEGAL
command with an invalid sequence COMMAND RECEIVED message.
number.
8 From the LAS, send a Normal communication resumes.
REINITIALIZE COMMUNICATIONS
command to the analyzer to reset the
sequence number.
9 From the LAS send a REINITIALIZE The analyzer sends an ILLEGAL
COMMUNICATIONS command to COMMAND RECEIVED message to the
the analyzer with a recovery type of LAS. The LAS interprets the ILLEGAL
0xFF COMMAND RECEIVED message.
10 From the LAS, send a PREPARE TO The analyzer acknowledges the
RUN SAMPLE and a SAMPLE IN PREPARE TO RUN SAMPLE message
POSITION command to the analyzer. and the SAMPLE IN POSITION
From the analyzer, send a SAMPLE message. The automation system
COMPLETE message containing a recognizes the different sample ID in
different sample ID than the one in the SAMPLE COMPLETE message as an
the PREPARE TO RUN SAMPLE error.
command.
Page 48 of 57
Part # J26605
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

1 Send the SAMPLE ROUTED The LIS receives a host query
message from the LAS from the analyzer for the
specifying a sample ID. 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

1 Send the QUERY ANALYZER The automation system
INVENTORY message from interprets the ANALYZER
the LAS. 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
Page 49 of 57
Part # J26605
Section 2.1.8.14, Query Analyzer Resources
Section 2.1.8.15, Analyzer Resources

1 Send the QUERY ANALYZER The automation system
RESOURCES message from interprets the ANALYZER
the LAS. RESOURCES response
correctly.
Page 50 of 57
Part # J26605
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

1 While monitoring the LAS The LAS receives and correctly interprets
communications, send the QUERY the ANALYZER STATUS message. The
ANALYZER STATUS message from automation system should not present a
the LAS. sample to the analyzer unless the status is
Analyzer is Ready to Sample.
2 While monitoring the LAS The LAS receives the proper responses. If
communications, send the PREPARE the time between PREPARE TO RUN
TO RUN SAMPLE command to the SAMPLE and SAMPLE IN POSITION
analyzer. 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 The LAS acknowledges the SAMPLE
SAMPLE COMPLETE response. COMPLETE message. The sample ID
matches the one in the PREPARE TO RUN
SAMPLE command.
4 From the LAS process two The analyzer processes the samples. The
consecutive samples with a delay of 1 analyzer throughput is reduced and there
second between the SAMPLE is a delay between processing the first and
COMPLETE message from the second sample.
analyzer for the first sample and the
PREPARE TO RUN SAMPLE message
from the LAS for the second sample.
5 From the LAS process two The analyzer processes the samples. The
consecutive samples. Send the analyzer throughput is not reduced, there
PREPARE TO RUN SAMPLE message is no delay between processing the first
for the second sample 100ms after and second sample.
receiving the SAMPLE COMPLETE
message for the first sample.
6 Load a sample in the STAT lane of the The analyzer processes the sample from
analyzer and start sampling, then the STAT lane of the analyzer and sends a
attempt to process a sample from the SAMPLE COMPLETE message to the LAS
LAS. with a metering status of Internal sample
has priority
Page 51 of 57
Part # J26605
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.

1 Verify that the Lab Automation System The automation system sample
allows the sample positioning device to positioning device must be adjustable
be adjusted along the length of the along the length of the track to ensure
track and fixed into position. alignment of the sample with the
analyzer proboscis travel. Ref to section 3.2.1
2 Measure the height to the top of the See Section 3.4.4
longest sample tube from the floor When sample metering is adjusted to the
when properly positioned for sample tallest tube height 100mm, aspirate depth is
aspiration by the sample positioning 98 mm maximum from that point.
device.
3 In normal operating sample handling When system is rigidly mounted and

mode, fill 13mm sample properly adjusted, there should be no
tubes with just enough fluid for 1 test contact between the sampling probe
per sample. Place sample tubes on and the sample tube. Reference section 3.4.2
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.
Page 52 of 57
Part # J26605
9. LAS/LIS Architecture
9.1. Summary of considerations for LIS/LAS architecture

With the advent of todays 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.
Page 53 of 57
Part # J26605
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
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 IDs it created. Additionally, the LAS must provide a recovery/backup mode in case the LAS intercepted LIS
LIS LIS
5,1 5,1
FS FS
LAS LAS
LAS LAS
LAS LAS
LIS LIS
LIS LIS
AT 2 AT 2
AT 1 AT 1
Page 54 of 57
Part # J26605
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 analyzers design are not shown below.
10.2. Patient Considerations
Potential Risk Potential Result Recommended Preventive Action

Chemical cleaning agent Contamination or Refer to the Operators Manual for cleaning
contamination. degradation of sample agents and protocol . NEED 5,1 DOC # or ref to
the V-Docs
Particulate contamination of sample Contamination or Remove stopper from sample tubes as close to
on automation track. degradation of sample the analyzer as possible to maintain sample
quality.
Evaporation or out-gassing while Degradation of sample Remove stopper from sample tubes as close to
sample tube is on automation track. analyzer as possible to maintain sample quality.
Cross contamination from adjacent Contamination or Set up automation systems to handle samples in
sample on automation track. degradation of sample a manner that prevents cross-contamination.
Sample cross-contamination - Cross-contamination of Ensure that LAS receives sample complete

Aspirating second fluid quantity into sample on track message from the AT analyzer before releasing
same tip (double dip) when the sample. Refer to Section 2.
sample on track has been released
too early and next sample is in
position.
Page 55 of 57
Part # J26605

Sample too cold after holding in Sample temperature Provide a means of sample temperature
refrigerated section of track for outside VITROS 5,1 FS equilibration to room temperature after
reflex testing. Chemistry System limits refrigeration, before presentation at the AT
(Automation track supplier controls analyzer.
temperature.)
Misalignment of automation track Sample aspirate volume Follow specifications for sample tube location
with AT analyzer. error specified in Section 4.
EMI from automation track to AT Sample aspirate volume Ensure that automation track meets agency
analyzer via coupling. error 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 Sample aspirate volume Utilize error checking communication protocol
air because tube diameter error (CRC).
information from automation system Follow communications specifications in
is incorrect. Section 2.
Sample tube breaks at automation System synchronization Refer to acceptable sample tube sizes for the
track and AT analyzer interface. or timing error 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 System synchronization/ Follow communications specifications in
AT analyzer and the LAS. timing error Section 2.
Incorrect sample presented to AT Aspirate from incorrect Ensure integrity of the sample ID communicated
analyzer. sample to the analyzer and positioning of that sample.
Sample ID mis-communicated from Aspirate from incorrect Verify sample ID in the sample complete
LAS. sample message sent to LAS.
Automation track system misreads Aspirate from incorrect Use barcode verification for labels (i.e. check
sample tube/carrier barcode. sample digit) and limit scanner view to one sample.
Inadequate consumables (reagents, Test not completed Send analyzer resource inventory to LIS upon
tips, etc.) on analyzer to complete request
the test. 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 A STAT sample on the
unknown to the analyzer. (All track may not be Place STAT samples on the analyzer manually
samples on the analyzer have processed in a timely and process as local locate-loaded samples.
priority over samples on the track.) fashion
Page 56 of 57
Part # J26605

Sample tube arrives with stopper Test not executed Remove caps from sample tubes to allow the
inserted in tube. analyzer to access the tubes. Remove caps as
close to the analyzer as possible to ensure sample
quality.
Sample Metering general error Test not completed Utilize error checking communication protocol
report is interpreted incorrectly by (CRC).
the LAS. Use message formats specified in Section 2 of
this document.
Inactive subsystem(s) on the AT Test not completed Verify analyzer status by LAS prior to sample
analyzer. arrival.
Software suppressed results (due to a Test not completed within Place STAT samples on the analyzer manually
detected error) for a STAT test. expected time and process as local locate-loaded samples.
Verify analyzer status and condition reports by
LAS/LIS
10.3. Operator Considerations

Electric shock at automation track-to Electrical hazards Ensure that track is properly grounded.
- analyzer coupling.
10.4. Environmental Considerations

Metering proboscis stuck in sample Mechanical Initialize sample metering subsystem by LAS if it
tube on track when sample is damage to sample receives a Sample Complete message combined with
released by the automation system. track area and AT a sample metering error message from the AT
. analyzer analyzer.
Do not move sample from metering position until
LAS receives a Sample Complete status without
error message from AT analyzer.
Page 57 of 57

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Part # J26605

DOCUMENT NUMBER: J26605

3.4.1. Sample Center Device Adjustments: Positioning Responsibilities ......................................................34

10. SAFETY AND PRECAUTIONS............................................................................ 55

Topics covered include:

Specification for Laboratory Computer Interface, Publication No. J23306

Sample Proboscis: Analyzer aspiration probe.

Sample Container: The tube that holds patient samples.

1.6. General Description

1.6.1. Document Structure

The Automation Interface Specification is organized as follows:

1.6.2. Assumptions and Dependencies

Lab Lab Information Data

Lab Information Port

Lab Automation Port

2.1. Analyzer to Lab Automation System

2.1.1. Message Format

The following special control characters shall be used:

Message frames shall be of the form:

Message types shall be the following:

2.1.2. Cyclical Redundancy Checks

2.1.3. Sample ID Encoding

2.1.4. Sequence Numbers

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

2.1.5. Interface Initialization Sequence

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

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

The analyzer reports or receives two consecutive NAK messages.

A message acknowledgment is not received within 250ms.

A new message is received prior to an acknowledgment for a previously sent message.

The message type field of the message is invalid.

The interface initialization sequence fails.

2.1.8.1. Message Acknowledged

2.1.8.2. Message Not Acknowledged

2.1.8.3. Illegal Command Received

Error Type Descriptions

Error word contents by Error Type

Invalid Command (0x00)

Logical Order Error (0x01)

Sequence Number Error (0x02)

Invalid Data (0x03)

2.1.8.4. Query Analyzer Status

2.1.8.5.1.Analyzer Status Codes

Analyzer Is Ready To Sample (Code 0x00)

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

Analyzer Is Busy Performing An Internal Sample (0x02)

Analyzer Is Equilibrating (Code 0x03)

Analyzer Has A Fatal Error (Code 0x04)

Analyzer Is Not Available (Code 0x05)

Failed In The Sample (Code 0x06)

2.1.8.6.Prepare To Run Sample

Direction: LAS to Analyzer

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

2.1.8.7. Sample In Position

2.1.8.8. Sampling Complete

Direction: Analyzer to LAS

2.1.8.8.1. Metering Status Codes

NOTE: These status codes are mutually exclusive.

Sample Aspirated With No Error (Code 0x00)

No Sample Program For Sample ID (Code 0x01)

Sample In Position No Received In Time (Code 0x02)