Las 4600 PDF

J39931EN
Specification for Automation Interface

VITROS® 4600 Chemistry System
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information, even if loss or damage is caused by its negligence or other fault.
VITROS® is a registered trademark of Ortho-Clinical Diagnostics, Inc.
© Ortho-Clinical Diagnostics, Inc., 2011. All rights reserved.

Specification for Automation Interface
Pub. No.: J39931EN
Issued: 2011-01-10
VITROS® 4600 Chemistry System
Section 1. Introduction ........................................................................................................ 1
Overview ......................................................................................................................................... 1
References and Definitions ............................................................................................................ 1
Document Structure ........................................................................................................................ 3
Revision History .............................................................................................................................. 3
Assumptions and Dependencies .................................................................................................... 3
Section 2. Software Interfaces ............................................................................................ 5
Operational Overview ..................................................................................................................... 5
Specifications ................................................................................................................................. 6
Lab Automation Protocol .......................................................................................................... 6
Datalink/Session Layer ............................................................................................................ 7
Presentation Layer ................................................................................................................. 10
Query Analyzer Status .................................................................................................................. 23
Sample Metering Handshaking .................................................................................................... 23
Reinitialize Metering ..................................................................................................................... 26
Reinitialize Communications ........................................................................................................ 28
Query Analyzer Inventory/Resources ........................................................................................... 28
Illegal Commands ......................................................................................................................... 29
Internationalization and Language Support .................................................................................. 30
Timing Requirements ................................................................................................................... 30
Lab Automation Communication Scenarios ................................................................................. 31
Interface Initialization Sequence ............................................................................................ 31
Run Two Samples .................................................................................................................. 32
Remote Sample Startup Interrupted by Local Sample ........................................................... 33
Non Fatal Error Condition (Insufficient Inventory) .................................................................. 34
Non Fatal Error Condition (Unknown Sample ID) .................................................................. 35
Non Fatal Error Condition (Sample In Position Not Received in Time) .................................. 36
Fatal Error Condition .............................................................................................................. 37
Sample Routed Notification ....................................................................................................38
Query Analyzer Inventory ....................................................................................................... 39
Section 3. Hardware Interfaces ......................................................................................... 40
Electrical Interfaces ...................................................................................................................... 40
Analyzer Dimensions .................................................................................................................... 41
Site Specifications ........................................................................................................................ 42
Service Access ............................................................................................................................. 42
Analyzer Heat Rejection and Air Intake Zones ...................................................................... 43
Positional Requirements ............................................................................................................... 43
Analyzer to Track Positioning/Floor Mounts or Anchors ............................................................... 44
Floor Mounts/Anchors ............................................................................................................ 45
Sample Positioning and Adjustments ........................................................................................... 46
Sample Center Device Adjustments: Positioning Responsibilities ......................................... 46
VITROS® 4600 Metering Proboscis Alignment ..................................................................... 47
Point Of Reference (POR) ..................................................................................................... 48
Sample Tube Height: Vertical Dimension for POR ................................................................ 51
Analyzer Dimensions with AT Configuration ................................................................................ 52
Regulations and Safety Standards ............................................................................................... 53
Section 4. Sample Handling .............................................................................................. 54
Supported Containers ................................................................................................................... 54
Containers that are not Supported ............................................................................................... 54
Sample Quality Recommendations ..............................................................................................54
Environmental Issues ................................................................................................................... 54
Section 5. Guidelines for Laboratory Automation System Protocol Tests .................. 55
Introduction ................................................................................................................................... 55
Purpose .................................................................................................................................. 55
Audience ................................................................................................................................ 55
Approach ................................................................................................................................ 55
Material Resources ................................................................................................................ 55
Skills Required ....................................................................................................................... 56
Protocol Tests ............................................................................................................................... 56
LAS Communication Initialization Test ................................................................................... 56
Analyzer Status Test .............................................................................................................. 57
Sampling Complete Test ........................................................................................................58
Error Recovery Test ............................................................................................................... 59
Sample Routed/Host Query Test ........................................................................................... 61
Request Inventory Test .......................................................................................................... 61
Request Resources Level Test ..............................................................................................62
Instrument-Based Testing ............................................................................................................ 62
Normal Operations Sample Handling ..................................................................................... 62
Physical Interfaces ....................................................................................................................... 63
Sample Positioning ................................................................................................................ 64
Section 6. LAS/LIS Architecture ....................................................................................... 65
Methods to Download Test Orders ...............................................................................................65
Single Instrument Download .................................................................................................. 65
Broadcast Download .............................................................................................................. 65
Host Query ............................................................................................................................. 65
Interface Topology ........................................................................................................................ 65
Case 1 .................................................................................................................................... 65
Case 2 .................................................................................................................................... 66
Case 3 .................................................................................................................................... 67
Section 7. Safety and Precautions ................................................................................... 69
Patient Safety Considerations ...................................................................................................... 69
Operator Considerations .............................................................................................................. 71
Environmental Considerations ...................................................................................................... 72
ii Specification for Automation Interface Pub. No.: J39931EN

VITROS® 4600 Chemistry System Issued: 2011-01-10
Overview
Laboratory Automation Specification

Section 1. Introduction
Overview
The Automation Interface Guide contains interface specifications to assist Lab Automation
manufacturers in adapting Lab Automation systems to the Ortho Clinical Diagnostics VITROS®
4600 Chemistry System (VITROS® 4600 System). This document is intended for Lab Automation
Vendors and Ortho Clinical Diagnostics personnel who create interfaces between an automated
sample delivery system and the VITROS® 4600 System.
Laboratory Automation System (LAS) refers to the subsystems that support the capability to control
an automated track and coordinate sample movement to a processing station, for example, a
system. The LAS includes the VITROS® 4600 Chemistry System (VITROS® 4600 System), the
Lab Automation Computer (LAC), and the hardware that connects them.
This specification provides an explanation of interfaces between the Lab Automation Vendors and
Ortho Clinical Diagnostics. Topics include:
• Information to be transmitted between the Lab Automation System and
the VITROS® 4600 System
• Format of information to be transmitted between the Lab Information System and the
system
• Physical relationships between the system and the sample container
• Sample container sizes and aspiration depths
• System footprints and space requirements
• Operator and service access requirements to the system
• Environmental specifications for the system
• System sample throughput specifications
• Electrical interconnects between a Lab Automation System and the system
• Automation interface guidelines for accurate implementation of the Automation
Interface Specification
• Summary of considerations for Lab Automation System and Lab Information System
architecture
• Summary of Lab Automation Interface risk assessment
References and Definitions

Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry
System, J39897.
Laboratory Information System (LIS) Guide for the VITROS® 5600 Integrated System, the
VITROS® 3600 Immunodiagnostic System and the VITROS® 4600 Chemistry System, J32799EN.
Unpacking and Installlation Instructions for VITROS® 5,1 FS Chemistry System and VITROS®
4600 Chemistry System: Intact System, J39894
Pub. No.: J39931EN Specification for Automation Interface 1

Issued: 2011-01-10 VITROS® 4600 Chemistry System
References and Definitions
Unpacking and Installation Instructinos for VITROS® 5,1 FS Chemistry System and VITROS®
4600 Chemistry System: Split System, J39895
Installation Instructions for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600
Chemistry System: Automation (AT) Accessory, J39893
Installation Instructions for the VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry
System: AT Seismic Anchorages, J39896
ISO 8859-1 8-bit single-byte coded graphic character sets -- Part 1: Latin alphabet No. 1
ACK (Acknowledgement Code)
A signal passed between computers to signal a receipt of a message.
Analyzer
For the purpose of this specification, the VITROS® 4600 Chemistry System.
ASCII: American Standard Code for Information Interchange
A system that is used for character encoding.
ASTM: American Society for Testing and Materials
In the context of this document, the communication protocols defined by the E-1381 and E-
1394 specifications for the communications between clinical laboratory instruments and lab
computer systems.
Asynchronous LIS Messages
A feature that enables the system to send unsolicited status updates to the LIS.
CRC: Cyclical Redundancy Checking
An error checking algorithm used to verify the integrity of an electronic message.
Extended ASCII
A set of codes that extends the basic ASCII set. The basic ASCII set uses 7 bits for each
character, giving it a total of 128 unique symbols. The extended ASCII character set uses
8 bits, which gives it an additional 128 characters. Extended ASCII uses the ISO8859-1
implementation to support Western European languages. See ISO 8859-1 8-bit single-byte
coded graphic character sets -- Part 1: Latin alphabet No. 1.
GUI: Graphical User Interface
A computer-user interface based on graphics (icons and pictures and menus) instead of
text.
HL7: Health Level Seven
A standard message protocol for electronic data exchange in all health care environments
including clinical laboratories with automation.
LAC: Lab Automation Computer
A computer used in the LAS to control the track and coordinate sample movement to a
processing station.
LAS: Lab Automation System
The subsystems that support the capability to control an automated track and coordinate
sample movement to a processing station, for example, an Analyzer.
POR: Point of Reference
A point in space at which the sample tube is placed for external metering.
LIS: Lab Information System
The computer system responsible for data management, for example, sample results and
patient history.
2 Specification for Automation Interface Pub. No.: J39931EN

Document Structure
Sample Proboscis
Aspiration probe on the system.
Sample Carrier
The device that holds the sample container and interfaces with the transport track to
facilitate movement from one location to another.
Sample Container
The tube that holds patient samples.
UTF-8
Unicode Transformation Format-8 that is an octet (8-bit) lossless encoding of Unicode
characters.
Document Structure
The Automation Interface Specification is organized into the following sections:
Section 1. Introduction on page 1
Provides general information about the specification
Section 2. Software Interfaces on page 5
Describes the software commands and responses exchanged between the system and the
lab automation system during sample processing
Section 3. Hardware Interfaces on page 40
Describes the physical interfaces between the lab automation system and VITROS® 4600
Chemistry System
Section 4. Sample Handling on page 54
Describes requirements for containers used in sample processing with lab automation
systems
Section 5. Guidelines for Laboratory Automation System Protocol Tests on page 55
Provides guidelines for automation system personnel to use in verifying the correct
implementation of an automation interface
Section 6. LAS/LIS Architecture on page 65
Discusses considerations applicable in lab automation interfaces in an LIS environment
Section 7. Safety and Precautions on page 69
Explains considerations for minimizing risks
Revision History
Date Page Revision Details
2011-01-10 N/A Initial release of the specification
Assumptions and Dependencies

• Manual (walk up) samples take priority over samples delivered by the automation
system.
• Calibration with fluids delivered by the automation track is not supported. (Controls are
not prevented from being delivered by the automation track.)

Assumptions and Dependencies
• Whole blood samples for use on the VITROS® 4600 System require processing from
cups not tubes. These samples should be processed on the VITROS® 4600 System
directly.
• The system uses two types of interfaces. The LAS interfaces for sample coordination
and the LIS interface for prsystemogram, results, etc.
• The automation system handles movement of all samples not placed manually on the
system.
• The automation system stops, captures, positions, and steadies the sample for fluid
aspiration.
• All required information for processing a sample will be supplied to the system. The
Lab Automation System for each sample will supply the two items listed below before it
is placed in position for metering but after the “SAMPLING COMPLETE” message for
the previous sample.
— Sample ID
— Container type (diameter)
• Sample programming for an individual sample must be downloaded prior to its
presentation to the system if host query is not enabled.
• When using host query mode, the SAMPLE ROUTED message should be sent to the
system as soon as the decision to route the sample to that system has been made by
the automation system. This will maximize the time the system has to complete the
host query.
• The automation system ensures the integrity of the sample identification for the sample
being aspirated.
• If the LAS has not just received a status message or SAMPLE COMPLETE response,
the LAS queries the system for its current status before sending a PREPARE TO RUN
SAMPLE command.
• The automation system must complete the following steps within the required time
period after the SAMPLING COMPLETE message is sent by the system to guarantee
maximum system throughput:
— Send the Sample ID information within a PREPARE TO RUN SAMPLE
message for the next sample within 100 milliseconds of SAMPLE
COMPLETE.
— Place the next sample into the aspiration position.
— Send the SAMPLE IN POSITION message to the system (no more than 6.4
seconds after the PREPARE TO RUN SAMPLE command). The sample must
be in position when this message is sent. Failure to meet this 6.3-second time
window will result in the sample not being processed by the system.
• The automation system must supply a “setup” mode used with the system's setup and
adjustment mode. In this mode, empty tubes are used to adjust the system's metering
system to the location where aspiration will be performed.
• The VITROS® 4600 System does not control devices mounted on the automation
track.

Operational Overview
• The automation system must comply with the site specifications in order for system
doors and lids to open and for waste containers to be easily emptied. Refer to Site
Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600
Chemistry System, J39897.
• This document does not contain the description of the Graphical User Interface (GUI)
but only the functionality of the feature.
• No GUI specifications are detailed in this document.
• The system software is backward compatible with existing VITROS® LAS
communications.
• Communication between the System and the LAC requires an RS-232 compatible
serial communications port.
Section 2. Software Interfaces

This section contains the detailed specifications that define the software interface between the
VITROS® 4600 System and the LAC.
Operational Overview
Query Analyzer Status
1. The LAC sends a QUERY ANALYZER STATUS command to the system.
2. The system sends a ANALYZER STATUS response to the LAC.
Sample Metering Handshaking

3. The sample tube is loaded onto automation track.
4. The LIS downloads test order to the system.
5. The sample tube is carried to system.
6. The LAC sends a PREPARE TO RUN SAMPLE command to the system. The command
contains a sample ID and the container type.
7. The system retrieves a sample program and builds a worklist for the sample.
8. The LAC sends a SAMPLE IN POSITION command to the system, handing over control to the
system.
9. The system aspirates fluid from the sample tube.
10. The system sends a SAMPLE COMPLETE response to the LAC, releasing the sample back
into the control of the LAC.
Reinitialize Metering
11. The LAC sends a REINITIALIZE METERING command to the system.
12. The system reinitializes any reduced subsystems.
13. The LAC periodically queries the system status until an “ANALYZER IS READY TO SAMPLE”
code is received.

Specifications
Reinitialize Communications
14. The LAC sends a REINITIALIZE COMMUNICATIONS command to the system.
15. If an error occurs and it is recoverable, the system will respond by issuing the READY
sequence.
16. The initialization sequence is repeated.
Query Analyzer Inventory/Resources

17. The LAC sends a QUERY ANALYZER INVENTORY command to the system.
18. The system retrieves inventory information from the Inventory Manager.
19. The system sends a series of ANALYZER INVENTORY responses to the LAC until all the
inventory data has been sent.
20. The LAC sends a QUERY ANALYZER RESOURCES command to the system.
21. The system retrieves resource information from the Inventory Manager.
22. The system sends a QUERY ANALYZER RESOURCES response to the LAC.
Note: Similar functionality is also available with the LIS interface.

Error Handling
The Lab Automation System handles errors encountered during communication. These errors
include physical communication errors, framing errors, and logical state transition errors.
Specifications
Lab Automation Protocol
The functions involved in transferring data from the Lab Automation System (system) to the lab
computer and the lab computer to the system are divided into these components:
Physical Layer - This is comprised of the actual hardware and software configuration used to
communicate between the two systems.
Datalink Layer - This handles the framing and error detection for the sending and receiving of
messages.
Session Layer - This handles to establishment of communication, sequence numbering, and error
recovery in the sending and receiving of messages.
Presentation Layer - This specifies the content and format of the records to be implemented in this
application.
Physical Layer
The system uses 1 start bit.
The system supports 1 or 2 stop bits.
The system supports EVEN, ODD, and NONE parity.

Specifications
The system supports the following baud rates:

• 9600
• 19200
• 38400
The system uses 8 data bits.
Datalink/Session Layer
Message Format
The following special control characters are used:
STX = 0x02
ETX = 0x03
The following forms of message frames are supported:
Byte 1: STX
Byte 2: Message Length
Byte 3: Message Type
Byte 4: Sequence Number
Byte 5 to N-2: Message Body
Byte N-1: CRC
Byte N: ETX
Message lengths are the total number of bytes in the message excluding the STX and ETX.
The following message types are supported:
0x00 Data
0x01 ACK
0x02 NAK
Cyclical Redundancy Checks

The algorithm for computing the Cyclical Redundancy Check (CRC) is the following C code
fragment:
unsigned char crc;
crc = 0x84;
for (i = 0; i <= (message_len-1); i++)
{
crc = ((crc >> 1) | (crc << 7)) ^ message_bytes[i];
}
Where
message_len is the message length in bytes
message_bytes is the buffer containing the message

Specifications
Note that this algorithm excludes the STX, ETX and CRC bytes.
Sequence Numbers
The use of sequence numbers in system communications is optional. The LAS selects the use or
non-use of sequence numbers.
The system disables the use of sequence numbers if the LAS sets the sequence numbers to 0x00
in the ACK messages that it sends during the initialization sequence.
The system enables the use of sequence numbers if the LAS uses valid, increasing sequence
numbers in the ACK messages that it sends during the initialization sequence.
Valid sequence numbers are 0 to 255. The number following 255 is 0.
The system maintains two sets of sequence numbers, one for messages originating from the LAS
and another for messages originating from the system.
Interface Initialization Sequence

Communication with the system must be restarted whenever a communication link has been broken
because the system was turned off or was reset or because an Interface Communication Failure
occurred.
The system starts the initialization sequence after a “power on” or “system reset” as soon as the
automation control task has initialized.
The system starts the initialization sequence to recover from an interface communication error after
receiving a REINITIALIZE COMMUNICATIONS message from the LAS.
The interface initialization sequence begins when the system sends a READY message to the LAS
consisting of an STX followed by an ETX.
The system waits up to 1 second for the LAS to respond with an ACK message. If the LAS does not
respond, a second READY message is sent.
The initialization sequence is aborted if the LAS does not respond before a 1 second timeout for the
second READY.
Note: The LAS responds to the READY message by sending ACK messages no more than
500ms apart.
The system waits up to 1 second for the LAS to respond with a second ACK message. If the LAS
does not respond before 1 second, the initialization sequence is aborted.
When the system receives two ACK messages to determine if sequence numbers are used, the
system responds to the LAS with its own ACK message. This contains the appropriate sequence
number immediately followed by an ANALYZER STATUS message.
See Figure 1: Initialization Sequence.

Specifications
Figure 1: Initialization Sequence
Lab Automation System
READY
READY if no response in 1
second
Sequence Number = A
ACK
Sequence Number = A+1

ACK
ACK
Sequence Number = 0
Analyzer Status Message
Sequence Number = 0
ACK
Initialization Complete

ACK
Sequence Number = 1
Sequence Number = 1
ACK
Note: The Query Analyzer Status message is not part of the initialization
sequence but is provided to demonstrate sequence numbers
following initialization.
Acknowledgements
After a message is sent, the sender stops transmitting until an acknowledgment is received.
The receiver sends an ACK message to the sender for every message received with a valid CRC
and no communication errors.
The receiver sends a NAK message to the sender for every message received with an invalid CRC
or a communication error occurred during transmission (example, parity error).
If sequence numbers are enabled, the receiver sets the sequence number of the ACK or NAK
message to the sequence number of the message being acknowledged.
CRC checks are not performed on ACK and NAK messages.
Unsolicited ACK and NAK messages are ignored.

Specifications
Interface Communication Failures

Interface communication errors indicate that the Analyzer-to-LAS interface is unreliable. Since the
interface is unreliable, communications between the system and the LAS are disabled.
If any of the following conditions occur, the system goes into an error state and reports a condition
code:
• The system reports or receives two consecutive NAK messages as a result of two
failed send attempts.
• A message acknowledgment is not received within 250ms.
• The last byte received, based on the message length, was not an ETX.
• The interface initialization sequence fails.
• The last byte, based on the message length, was not received within 250ms from the
STX.
• The message type field is invalid.
Note: See the REINITIALIZE COMMUNICATION message for recovering from interface
communication failures.
Presentation Layer
Message Acknowledged
The Message Acknowledged message is sent to the receiver for every message received with a
valid CRC.
The following format is used for the Message Acknowledged message:
byte 1: STX
byte 2: Message Length
byte 3: Message Type = 0x01
byte 4: Sequence Number
byte 5: CRC
byte 6: ETX
Message Not Acknowledged

The Message Not Acknowledged message is sent to the receiver for every message received with
an invalid CRC or if a communication error occurred during transmission.
The following format is used for the Message Not Acknowledged message:
byte 1: STX
byte 5: CRC
byte 6: ETX

Specifications
Illegal Command Received

The Illegal Command Received message is sent to the to LAS when an unrecognized command is
received or when a logical error occurs, such as an invalid sequence number or when commands
are received out of order.
The following format is used for the Illegal Command Received message:
byte 1: STX
byte 5, 6: Message ID = 0xC009
byte 7: Error Type (see the table below)
byte 8, 9: Error Word (see the table below)
byte 10: CRC
byte 11: ETX
Error Type Error Type Description Error Word Contents
0x00 A non-existent command was received. MSB = high byte of Message ID received
Invalid An invalid command was received. This LSB = low byte
command could be a message with a Message ID
that is not defined, or a Message ID that
is not supported by the system. For
example, the system does not recognize
the ANALYZER STATUS message
(0xC007).

Specifications
0x01 A command that violates the logical MSB = high byte of Message ID received
Logical Order order of operations was received.A LSB = low byte
Error command was sent out of sequence.
The system will issue this error under
the following conditions:
• A SAMPLE IN POSITION message is
sent without a corresponding
PREPARE TO RUN SAMPLE
message.
• A second PREPARE TO RUN
SAMPLE message is sent before the
system sends a SAMPLING
COMPLETE message.
• A second SAMPLE IN POSITION
message is sent before the system
sends a SAMPLING COMPLETE
message.
• A QUERY ANALYZER INVENTORY
message is sent during external
sampling.
• A QUERY ANALYZER RESOURCES
message is sent during external
sampling.
0x02 A sequence number error was detected. MSB = sequence number expected
Sequence The system issues this error if the use of LSB = sequence number received
Number sequence numbers was enabled during
Error initialization by the LAS, and the system
receives a message with a sequence
number that does not match the
expected sequence number. See
REINITIALIZE COMMUNICATIONS for
how to recover from this error.

Specifications
0x03 Invalid data was discovered in the MSB = 0x00

Invalid Data message. A data field from the previous LSB:
message contained unexpected data. 0x01 = Invalid container type from
The following conditions will cause the PREPARE TO RUN SAMPLE
system to send this error: 0x02 = Invalid Sample ID length from
• The Container Type in a PREPARE PREPARE TO RUN SAMPLE or
TO RUN SAMPLE message is invalid. SAMPLE ROUTED
• The Sample ID in a PREPARE TO 0x03 = Invalid Sample ID data from
RUN SAMPLE or a SAMPLE ROUTED PREPARE TO RUN SAMPLE or
message contains zero or more than SAMPLE ROUTED
15 characters. 0x04 = Invalid recovery type from
REINITIALIZE COMMUNICATIONS
• 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.
Note: LAS commands sent to the system should be spaced at least 100ms apart to allow the
system to respond with an ILLEGAL COMMAND message if necessary.

The Query Analyzer Status message is sent by the LAS to request the system report its status. This
command is performed before starting a new sample unless a SAMPLING COMPLETE response
has just been received.
The following format is used for the Query Analyzer Status message:
byte 1: STX
byte 7: CRC
byte 8: ETX

Specifications
Analyzer Status
The Analyzer Status message is sent by the system to indicate its status. This message is sent in
response to a QUERY ANALYZER STATUS or as an asynchronous message during the
initialization sequence.
The following format is used for the Analyzer Status message:
byte 1: STX
byte 7: Status Code (see table below)
byte 8: CRC
byte 9: ETX
Analyzer Status Codes
Status Codes Status Code Descriptions
0x00 The Analyzer is ready to process a sample. The LAS

Analyzer is ready to Sample may issue a PREPARE TO RUN SAMPLE message to
the Analyzer.
0x01 The Analyzer is processing an external sample (off the

Analyzer is Busy Performing automation track). The LAS must wait for a
an External Sample SAMPLING COMPLETE message to be issued by the
Analyzer before presenting any new samples to the
Analyzer.
0x02 The Analyzer is processing an internal sample

Analyzer is Busy Performing (onboard sample tray). This status is necessary since
an Internal Sample the use of the Analyzer is lab dependent. The LAS
should periodically issue a QUERY ANALYZER
STATUS message to the Analyzer until the status code
indicates that the "Analyzer Is Ready To Sample”
status before presenting any new samples to the
Analyzer.
0x03 The Analyzer is in the process of bringing the thermal

Analyzer is Equilibrating 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.

Specifications
0x04 The Analyzer is inoperable and is not ready to process

Analyzer has a Fatal Error samples. One or more subsystems have experienced
a mechanical malfunction. The LAS should attempt to
restore the Analyzer to an operational state by issuing
a REINITIALIZE METERING message to the Analyzer.
The LAS should then periodically issue a QUERY
ANALYZER STATUS message to the Analyzer until the
status code indicates that the “Analyzer Is Ready To
Sample” status. For most cases initialization should
take up to two minutes; however there are some
situations that could take up to ten minutes. Therefore,
it is suggested that, if the LAS does not receive an
Analyzer status of “Analyzer Is Ready To Sample”
within ten minutes after issuing the REINITIALIZE
METERING message, the LAS alert the operator and
reroute samples to another Analyzer.
0x05 This status indicates that the Analyzer is not ready to

Analyzer is Not Available process samples. It indicates that an operator is
performing manual operations such as loading
reagents, diagnostics, initializing, or loading an ADD.
The LAS should periodically issue a QUERY
ANALYZER STATUS message to the Analyzer until the
status code indicates that the “Analyzer Is Ready To
Sample” status before presenting any new samples to
the Analyzer.
0x06 The Analyzer's metering proboscis has mechanically

Failed in the Sample 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.

Specifications
Prepare To Run Sample

The Prepare to Run Sample message is sent by the LAS to indicate that a sample with the given
parameters is being placed for aspiration. This command begins the sampling process.
The following format is used for the Prepare to Run Sample message:
byte 1: STX
byte 7: Reserved (always 0x00)
byte 8: Reserved (always 0x00)
byte 9: Container Type (see table below)
byte 10: Sample ID Length (in bytes)
byte 11 to n: Sample ID (15 characters max)
byte n+1: Reserved (always 0x00)
byte n+2: Reserved (always 0x00)
byte n+3: CRC
byte n+4: ETX
Container Types
0x00 16mm diameter tube
0x01 13mm diameter tube
0x02 10mm diameter tube (10.25 mm)
Note: The sample tube does not need to be in position at the POR to for the LAS to send the
Prepare to Run Sample message.
Note: The contents of reserved fields are ignored.
Note: The Sample ID should be encoded using UTF-8 or Extended ASCII depending on the
configured encoding.

Specifications
Sample In Position
The Sample in Position message is sent by the LAS to inform the system that the sample it is
preparing to run is now in the correct position for sampling to begin.
The following format is used for the Sample In Position message:
byte 1: STX
byte 7: CRC
byte 8: ETX
Sampling Complete
The Sampling Complete message is sent by the system to inform the LAS the metering for the
sample is complete.
The following format is used for the Sampling Complete message:
byte 1: STX
byte 7: Metering Status (see table below)
byte n+1: CRC
byte n+2: ETX
Metering Status Codes
In the case of any status that indicates that the sample was not processed, the process of
commanding the system to sample should restart by issuing a new PREPARE TO RUN SAMPLE
message followed by a SAMPLE IN POSITION message. These commands should be reissued
using the same sample ID and parameters as were used for the sample that failed to run.
Note: These status codes are mutually exclusive.
Status Codes Metering Status Descriptions
0x00 The sample was aspirated with no errors. No information is known about
Sample Aspirated sample dispense errors, since the SAMPLING COMPLETE message is
With No Error sent before any sample is dispensed.

Specifications
0x01 The Analyzer could not find a sample program for the Sample ID that was
No Sample Program presented by the LAS. The LAS either routes the sample to another
For Sample ID Analyzer with the proper sample program, or coordinates with the LIS to
download the sample program and then re-presents the sample to the
Analyzer. Consult with the laboratory to determine the desired response to
this status.
0x02 A PREPARE TO RUN SAMPLE message was received but a SAMPLE IN

SAMPLE IN POSITION message was not received in the proper time frame. The
POSITION Not SAMPLE IN POSITION message must be issued by the LAS within 6.4
Received In Time seconds after issuing the PREPARE TO RUN SAMPLE message. The
LAS should reissue the PREPARE TO RUN SAMPLE message. This is
the only case where a SAMPLING COMPLETE message will be sent prior
to a SAMPLE IN POSITION.
0x03 A problem was encountered while aspirating sample from the container.
Completed With This status can be due to a clot or bubble detected. If Enhanced LIS plus
Error is enabled the LAS can query the LIS for specific error information to
decide what the best corrective action is. Since this status indicates that
user attention is required for follow-up, consult the laboratory to determine
the desired response to this status.
0x04 An internal sample is being processed. The LAS should periodically issue
Internal Sample Has a QUERY ANALYZER STATUS message until the Analyzer reports a
Priority status of “Analyzer Ready To Sample”. The LAS may then proceed to
follow the normal procedure for presenting a sample to the Analyzer by
first issuing a PREPARE TO RUN SAMPLE message to the Analyzer. The
LAS may also reroute the sample to another Analyzer for processing.
0x05 The Analyzer is inoperable and is not ready to process samples. One or
Analyzer Inoperable more subsystems have experience a mechanical malfunction. The LAS
should attempt to restore the Analyzer to an operational state by issuing a
REINITIALIZE METERING message to the Analyzer. The LAS should
then periodically issue a QUERY ANALYZER STATUS message to the
Analyzer until the status code indicates that the “Analyzer Is Ready To
Sample” status. For most cases initialization should take up to two
minutes; however there are some situations that could take up to ten
minutes. Therefore, it is suggested that, if the LAS does not receive an
Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after
issuing the REINITIALIZE METERING message, the LAS alert the
operator and reroute samples to another Analyzer.
0x06 Tests are in process for the given sample ID. Duplicate sample IDs are not
Duplicate Sample ID processed.
0x07 The Analyzer is not ready to process samples. It indicates that an operator
Analyzer Not is performing manual operations such as loading reagents, diagnostics,
Available 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.

Specifications
0x08 The Analyzer's metering proboscis has mechanically failed while inside
Metering Failed In the sample container. The LAS should not attempt to move the sample to
the Sample 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.
Note: The Sample ID should be encoded using UTF-8 or Extended ASCII depending on the
configured encoding.
The Reinitialize Metering message is sent by the LAS to request that the system reinitialize any
inoperable subsystems on the system. This message also resets the expected sample command
on the system allowing the LAS to remove a sample that is in progress.
The following format is used for the Reinitialize Metering message:
byte 1: STX
byte 7: CRC
byte 8: ETX

Specifications
The Reinitialize Communications message is sent by the LAS to the system to attempt to recover
from interface communication failures and sequence number errors.
The following format is used for the Reinitialize Communications message:
byte 1: STX
byte 5, 6: Message ID = 0xC00A
byte 7: Recovery Type (see table below)
byte 8: CRC
byte 9: ETX
Recovery Types
0x00 Restart sequence numbers, using the sequence number

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

failure.
Sample Routed
The LAS send the Sample Routed message to the system when a sample has been routed to the
system in order to give the system enough time to perform a query for a sample program if needed.
The following format is used for the Sample Routed message:
byte 1: STX
byte n+1: CRC
byte n+2: ETX

Specifications
Query Analyzer Inventory

The Query Analyzer Inventory message is sent by the LAS to request the system report its reagent
inventory (carts and packs).
The following format is used for the Query Analyzer Inventory message:
byte 1: STX
byte 5, 6: Message ID = 0xC00C
byte 7: CRC
byte 8: ETX
Analyzer Inventory
The system sends a sequence of Analyzer Inventory messages in response to a QUERY
ANALYZER INVENTORY request from the LAS.
The following format is used for the Analyzer Inventory message:
byte 1: STX
byte 5, 6: Message ID = 0xC00D
byte 7: Last message; 0x01 indicates last message in response,
otherwise 0x00
byte 8: Number of assays in message (max of 10 per message)
byte 9 to 6n+8: One repetition per assay
byte 1, 2: Analyte Code
byte 3, 4: Available test count
byte 5: Current Calibration
bit 1: Serum current
bit 2: CSF current
bit 3: Urine current
bit 4: Whole Blood current
bit 5: Plasma current
bit 6: Amnio current
bit 7: Cord Blood current
bit 8: Reserved value

Specifications
byte 6: Calibrated Status

bit 1: Serum calibrated
bit 2: CSF calibrated
bit 3: Urine calibrated
bit 4: Whole Blood calibrated
bit 5: Plasma calibrated
bit 6: Amnio calibrated
bit 7: Cord Blood calibrated
bit 8: Reserved value
byte 6n+9: CRC
byte 6n+10: ETX
Query Analyzer Resources

The Query Analyzer Resources message is sent by the LAS to request the system report its
resources (bulk fluids, tips, cuvettes, waste, etc.).
The following format is used for the Query Analyzer Resources message:
byte 1: STX
byte 5, 6: Message ID = 0xC00E
byte 7: CRC
byte 8: ETX
Analyzer Resources
The Analyzer Resources message is sent by the system to the LAS in response to the QUERY
ANALYZER RESOURCES command.
Note: Bytes 13, 14, 15, 16, 25 and 27 are sent by the system but ignored by the LAS.
The following format is used for the Analyzer Resources message:
byte 1: STX
byte 5, 6: Message ID = 0xC00F
byte 7, 8: ERF Level
byte 9, 10: IWF Level
byte 11, 12: Reserved, set to 0x0000 (possible SWF)
byte 13, 14: Signal Reagent Level

byte 15, 16: UWR volume in mL

byte 17, 18: VersaTip supply count
byte 19, 20: MicroTip supply count
byte 21, 22: Cuvette supply count
byte 23, 24: Available MicroSlide waste count
byte 25: Available MicroImmunoassay waste percent full
byte 26: Available reagent metering tip waste percent full
byte 27: Available liquid waste percent full
byte 28: Number of diluents
byte 29 to 4n+28: One repetition per diluent
byte 1, 2: Diluent Code
byte 3, 4: Available count or volume in mL.
byte 4n+29: CRC
byte 4n+30: ETX
Note: If the VersaTip hopper sensor is blocked, an accurate count of VersaTips cannot be
determined, only that the number of tips available is greater than 300. This condition is
encoded with 0xFFFF and the count is considered an infinite supply of tips.

When the LAS sends a QUERY ANALYZER STATUS, the system responds with an ANALYZER
STATUS message containing the appropriate status code based on the current state of the system.
Note: The LAS may query the system for status at any time, and should do so before any
requests to process samples.

A three-message handshake between the LAS and system to meter a sample consists of the
following messages in the order listed:
1. PREPARE TO RUN SAMPLE - passes the control of a sample to the system and provides the
sample ID and container type information.
2. SAMPLE IN POSITION - informs the system that the sample is at the POR and ready for
metering.
3. SAMPLING COMPLETE - passes the control of the sample back to the LAS and provides
metering status.
See Figure 2: Sample Metering Handshake.

Figure 2: Sample Metering Handshake

ACK
ASM - Ready to Sample
ACK
Prepare to Run Sample

ACK
Sample in Position
ACK

ACK
ASM - External in Progress
ACK
Sampling Complete
ACK
Note: ASM = Analyzer Status Message
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “Sample Position Not Received In Time” if no SAMPLE IN POSITION message is received
within 6.4 seconds of receiving a PREPARE TO RUN SAMPLE.
Note: In the worst case, the SAMPLE IN POSITION message needs to be received about 6.4
seconds after receiving a PREPARE TO RUN SAMPLE message.
Note: In addition, the LAS needs to send a PREPARE TO RUN SAMPLE message for the next
sample within 100ms after receiving a SAMPLING COMPLETE message in order to
maintain throughput. Failure to meet this timing may result in a skip cycle.
Note: The only time a SAMPLING COMPLETE message is sent before a SAMPLE IN POSITION
message will be if the SAMPLE IN POSITION is not received in time.
set to “No Sample Program For Sample ID” if no sample program could be found for the sample ID
in the PREPARE TO RUN SAMPLE message.

set to “Completed With Error” if an error occurred that would prevent running one or more tests.
Note: This situation only applies to aspirate errors, which are any error that occur while the
proboscis is over the sample container.
set to “Internal Sample Has Priority” if an internal sample is being metered when the SAMPLE IN
POSITION message is received.
set to “Analyzer Inoperable” if one or more subsystems are in a reduced state when the SAMPLE
IN POSITION message is received.
Note: The LAS may attempt to recover from this status by issuing a REINITIALIZE METERING
command.
set to “Duplicate Sample ID” if there are tests in process for the sample ID in the PREPARE TO
RUN SAMPLE message.
Note: The duplicate sample will not be processed.
set to “Analyzer Not Available” if the system is unable to process samples when the SAMPLE IN
POSITION message is received.
Note: This situation occurs during initialization, equilibration, ADD loading, diagnostics mode or
when some Options & Configuration screens are displayed.
set to “Metering Failed In The Sample” if a mechanical error with the metering system occurred
when the proboscis was inside the sample container.
It is assumed that a sample program has been downloaded before the PREPARE TO RUN
SAMPLE command. However, if the system is configured for host query, a mechanism needs to be
in place to initiate a host query independent of the PREPARE TO RUN SAMPLE. The SAMPLE
ROUTED message facilitates this. A SAMPLE ROUTED message is sent to the system as soon as
the LAS has routed a sample to it in order to maximize the time available to perform a host query.
The system attempts to send a host query when it receives a SAMPLE ROUTED message for the
sample ID contained in the message.
See Figure 3: Sample Routed Notification.

Figure 3: Sample Routed Notification

ACK
ACK

ACK
Sample in Position
ACK
Sample in Bypass
ACK
Sample in Bypass
ACK
Sampling Complete
ACK
Note: Each Sample in Bypass message

initiates a host query to the LIS.
The system attempts to reinitialize any inoperable subsystems when it receives a REINITIALIZE
METERING message from the LAS.
Note: The LAS issues a REINITIALIZE METERING message when an ANALYZER STATUS has
an inoperable status or SAMPLING COMPLETE indicates sampling failed due to an
inoperable system or metering failed in the sample.
A REINITIALIZE METERING message resets the Sample Metering Handshake so the next
expected message is PREPARE TO RUN SAMPLE.
A REINITIALIZES METERING message aborts any further sample aspirations from the interface
where the message is received.
Note: The sample processing acts as if a mechanical sample aspiration error occurred. The
aborted reps are coded “ME” and reps that have already aspirated will continue to process
normally.

See Figure 4: Reinitialize Metering.

Figure 4: Reinitialize Metering

ACK
Analyzer Status Message (ASM)
ACK

ACK
Sample in Position
ACK
Sampling Complete (Failed in

ACK Sample or Analyzer Inoperable)
ACK
ACK
ASM - Analyzer Initializing
ACK

ACK
ASM - Analyzer is Ready
ACK

If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Reset
Sequence Number,” the system restarts the expected sequence numbers using the sequence
number in the REINITIALIZE COMMUNICATIONS message.
Note: The LAS may issue a REINITIALIZE COMMUNICATIONS message after receiving an
ILLEGAL COMMAND RECEIVED message with “Sequence Number Error” error type.
If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Recover
From Communication Failure,” the system starts the Interface Initialization Sequence.
Query Analyzer Inventory/Resources

If the system receives a QUERY ANALYZER INVENTORY message, the system responds with an
ANALYZER INVENTORY message(s) containing the current assay reagent inventory.
Note: The content of the system inventory matches what is shown on the View by Assay screen.
within Reagent Management. This reports the worst case for each assay across all fluids
and reagents. Uncalibrated reagents will not be counted since they cannot be used.
If the system receives a QUERY ANALYZER RESOURCES message, the system responds with
an ANALYZER RESOURCES message containing the current onboard resource levels.
See Figure 5: Query Analyzer Inventory/Resources.

Illegal Commands
Figure 5: Query Analyzer Inventory/Resources

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

ACK
Analyzer Resources
ACK
Illegal Commands
The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set
to “Invalid Command” if any of the following conditions are met:
• The Message ID is not recognized.
• The Message ID belongs to a message that only the system should send (for example,
ANALYZER STATUS).
to “Sequence Number Error” if all the following conditions are met:
• Sequence numbers are enabled.
• The sequence number of an incoming message does not match the expected
sequence number.

Internationalization and Language Support
to “Logical Order Error” if any of the following conditions are met:
• A SAMPLE IN POSITION message is sent without a corresponding PREPARE TO
RUN SAMPLE.
• A second PREPARE TO RUN SAMPLE message is sent before the system sends a
SAMPLING COMPLETE message.
• A second SAMPLE IN POSITION message is sent before the system sends a
SAMPLING COMPLETE message.
• A QUERY ANALYZER INVENTORY message is sent during external sampling.
• A QUERY ANALYZER RESOURCES message is sent during external sampling.
to “Invalid Data” if any of the following conditions are met:
• The container type in a PREPARE TO RUN SAMPLE message is invalid.
• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message
contains zero or more than 15 characters.
• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message
contains invalid UTF-8 characters or insufficient characters (according to the sample id
length).
• The recovery type in a REINITIALIZE COMMUNICATIONS message is invalid.
Internationalization and Language Support

The system supports the following configurations for Sample ID character encoding:
• UTF-8 (Unicode)
• Extended ASCII (Refer to ISO 8859-1.)
Timing Requirements
The automation system must complete the following steps within the required time period after the
SAMPLING COMPLETE message is sent by the system to guarantee system throughput. Failure
to meet this timing will result in decreased system throughput.
• Time from SAMPLING COMPLETE to PREPARE TO RUN SAMPLE - 100
milliseconds.
• Time from SAMPLING COMPLETE to SAMPLE IN POSITION- 6.4 seconds (6.5
seconds after PREPARE TO RUN SAMPLE).
All ACK and NAK messages must be sent within 250ms of the received command/response.
ACK messages sent by the LAS during the initialization sequence should be separated by no more
than 500ms.
LAS commands sent to the system must be spaced at least 100ms apart to allow the illegal
command response. This is to allow the system time to respond with an ILLEGAL COMMAND
RECEIVED message if required.
The last byte of a message, based on the message length, must be received within 250ms from
receipt of the STX.

Lab Automation Communication Scenarios

Interface Initialization Sequence
Figure 6: Interface Initialization Sequence
READY
READY if no response in 1
second
Sequence Number = A
ACK

ACK
ACK if no response in 0.5
second
ACK
Sequence Number = 0
Sequence Number = 0
ACK
Initialization Complete

ACK
Sequence Number = 1
Sequence Number = 1
ACK
Note: The Query Analyzer Status message is not part of the initialization
sequence but is provided to demonstrate sequence numbers
following initialization.

Run Two Samples

Figure 7: Run Two Samples

ACK
ACK
ACK
Sample in Position
ACK
ACK
ASM - Remote in Progress
ACK
Sampling Complete
ACK

ACK
ASM - Manual Operation
ACK

ACK

ACK
ACK
Sample in Position
ACK

ACK
ACK
Sampling Complete
ACK

Remote Sample Startup Interrupted by Local Sample

Figure 8: Remote Sample Startup Interrupted by Local Sample

ACK
ACK
ACK
Sample in Position
ACK
ACK
ACK
Sampling Complete (did not
ACK sample - Manual had priority

ACK
ACK

ACK
ACK

ACK
Sample in Position
ACK

ACK
ACK
Sampling Complete
ACK

Non Fatal Error Condition (Insufficient Inventory)

Note: In the case of multiple tests per sample and only some of the tests have insufficient
inventory, the tests which have inventory will be posted to the Lab Automation.
Figure 9: Non Fatal Error Condition (Insufficient Inventory)

ACK
ACK

ACK
Sample in Position
ACK
Sampling Complete - Completed
ACK with Error

ACK
Sample in Position
ACK
Sampling Complete
ACK

Non Fatal Error Condition (Unknown Sample ID)

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

ACK
ACK

ACK
Sample in Position
ACK
Sampling Complete - Unknown

Sample ID
ACK

ACK
Sample in Position
ACK
Sampling Complete
ACK

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

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

ACK
ACK

ACK
Sampling Complete - Sample in

Position Not Rec’d in Time
ACK

ACK
Sample in Position
ACK
Sampling Complete
ACK

Fatal Error Condition

Note: If the system still reports a fatal condition after reinitialization, an operator must be called
to check the system. The module and error number reported to the LIS will contain more
information about the error.
Figure 12: Fatal Error Condition

ACK
Analyzer Status Message (ASM)
ACK

ACK
Sample in Position
ACK
Sampling Complete - Failed
in Sample or Analyzer
ACK
Inoperable
Initialize Analyzer
ACK

ACK
ASM - Analyzer Initializing
ACK

ACK
ASM - Analyzer is Ready

ACK

Sample Routed Notification

Note: Each Sample Routed message initiates a host query to the LIS.
Figure 13: Sample Routed Notification
Sample Routed (SID1)

ACK
Prepare to Run Sample (SID1)

ACK
Sample in Position
ACK
Sample Routed (SID2)

ACK
Sampling Complete
ACK
Prepare to Run Sample (SID2)

ACK
Sample in Position
ACK
Sampling Complete
ACK


Figure 14: Query Analyzer Inventory

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

ACK
Analyzer Resources
ACK

Electrical Interfaces
Section 3. Hardware Interfaces

Note: In this section, line drawings reflect the VITROS® 5,1 FS Chemistry System; however, the
VITROS® 4600 Chemistry System has the same dimensions and mechanical interface as
the VITROS® 5,1 FS Chemistry System.
Electrical Interfaces
Analyzer to Laboratory Information System (LIS)
Refer to the Laboratory Information System (LIS) Guide for VITROS® 5600 Integrated System, the
VITROS® 3600 Immunodiagnostic System, and the VITROS® 4600 Chemistry System, J32799.
Analyzer to Lab Automation System

Full RS232 LAS communication interface. The following pins are used (system side):
3 - transmitted data (TxD)
2 - receive data (RxD)
5 - circuit common
The interface has a communication port to the Lab Automation Computer.
Communication parameters:
1 start bit
8 data bits
1 or 2 stop bits
EVEN, ODD or no parity
9600, 19200 or 38400 baud rate.
The system end is a 9-pin DTE male.
No Hardware or Software flow control.
Cable Requirements for LAS port
Data Rate (bps) Length meters (ft.)
9,600 15m (50 ft.) max.
Shielded 22AWG wire
Electrical Interface at Sample

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

Analyzer Dimensions
Analyzer Dimensions
This section describes the overall size of the VITROS® 4600 System.
Figure 15: Analyzer Dimensions
Reference Description
A 233.7 cm (92 in)
B 83.8 cm (33 in)
C 132.1 cm (52 in)
D 205.7 cm (81in)
Weight 612.4 kg (1350 lb)

Site Specifications
Site Specifications
The VITROS® 4600 Chemistry System site specifications are described completely in Site
Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry
System, J39897 explain:
• Electrical Power Requirements
• System Environmental Specifications
• Requirements at the Customer Site
• Specifications for the VITROS® 4600 System and Printer
• Specifications for the optional Heat Rejection Plenum
Deviations from site specifications should be reviewed with a Ortho Clinical Diagnostics Field
Service Representative.
It is recommended that the floor be level within one inch over 10 feet.
Service Access
The system requires service access from all four sides of the machine. Site Specifications for the
VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897 indicates
the appropriate clearances. Access to the machine depends on the track configuration and must be
determined by both OCD and the automation vendor. Some general guidelines are:
• Track and supports should be configured to allow access to rear panel quarter-turn
fasteners.
• Spacing between the track and system should allow the removal of the rear panel
covers by unfastening the quarter-turns, tipping the covers away from the system,
lifting the rear panels several inches, and moving the panels to the side of the system.
Figure 16: Service Access

Positional Requirements
System Heat Rejection and Air Intake Zones

The system contains air intake ports and exhaust ports. The location of these ports are shown in
Figure 17. These ports must not be blocked.
The thermal characteristics of the system are explained in Site Specifications for the VITROS® 5,1
FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.
Figure 17: Air Intake and Exhaust Ports
Positional Requirements
This section describes the relative position between system and the sample container. It is assumed
that the Lab Automation System will be able to capture and hold the sample container to allow direct
aspiration by the system. The following assumptions apply relative to the interface between the two
systems.
• The system will be located relative to the automation track through a supplied clamping
mechanism mounted to the floor.
• The automation track can be configured to meet the system requirements for sample
tube height. See Sample Tube Height: Vertical Dimension for POR on page 51
• The system provides a limited amount of adjustment of the sample metering proboscis
in the “X”, “Y”, and “Z” directions of the sample travel path. Refer to
Figure 18.

System to Track Positioning/Floor Mounts or Anchors
Figure 18: Positional Requirements - Back of System (With Cabinetry)
Ortho Clinical Diagnostics provides two methods of locating and positioning the system to the floor
in order to maintain alignment relative to the automation system. These floor mounts also allow
service personnel to disengage the system for service and reposition the system relative to the
automation system.The ability to repeat the exact position of system relative to the original POR
depends on the following
The ability to restore the system to the exact position relative to the original POR depends on the
following factors:
• The anchors have been installed correctly. Reference the Installation Instructions for
the VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: AT
Seismic Anchorages, J39896.
• The engagement of the system with the anchors is not so aggressive to cause a shift in
anchor positions relative to the floor.
• The automation track is rigidly mounted so there is no relative motion between the
system and the track. It is highly recommended to check the alignments of the system
to the track position if it has been moved (disengaged from anchors) for some reason.
VITROS® 4600 System Metering Proboscis Alignment on page 47

Floor Mounts/Anchors
Two types of floor mounts can be used to position the system relative to the automation system.
Which type of mount to use depends on the site install requirements.
Standard Floor mounts / Anchors
Standard Anchors are included in the AT Accessory and do not need to be ordered separately
Figure 19: Standard Floor Mounts.
Seismic Floor Mounts /Anchors Catalog # 6802245

These are intended for use where seismic events are of concern. The design of these floor mounts
have been submitted for approval by California Office of Statewide Health Planning and
Development (OSHPD) regulations on earthquake brackets (ref OAS-MIS-PH3001 and OPA-
0627). These anchors are ordered in addition to the AT Accessory.
Figure 20: Seismic Mounts

Sample Positioning and Adjustments

Relative to sample positioning, the following rules apply:
• Maximum fluid aspiration depth is 3.86 inches (98mm) from top of the sample tube.
See Supported Containers on page 54 for fill requirements.
• For Aspiration, all sample tubes regardless of size are to be centered about the same
vertical axis.
• OCD provides a software adjustment for set-up at the customer site to align proboscis
with the track. The range of adjustment will be 50mm (2.0 inch) in “X” direction of
metering probe travel. Once this value is set, repeatability of positioning in “X” direction
should be +/- .028 inch (0.7 mm).
Sample Center Device Adjustments: Positioning Responsibilities

The following table indicates the alignment adjustment responsibilities for the sample position to the
aspiration probe for each degree of freedom in a three-dimensional space.
Adjustment Responsibility
Y Direction Automation Supplier
X and Z Directions OCD Fine position

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

Figure 21: Sample Position
VITROS® 4600 System Metering Proboscis Alignment

When the system and the sample tube
grasping/centering device on the track are
properly aligned, the proboscis with
disposable tip should travel to a depth of 98
mm in a 13mm diameter sample tube,
without touching the inside wall. This
alignment is primarily supported by the
system proboscis adjustment (horizontal
and perpendicular to sample travel) and
sample position adjustment along the track
length.
Figure 22: System Proboscis
The Lab Automation System vendor has
complete responsibility for the positioning
the sample tube. However, the adjustments
indicated in Sample Center Device
Adjustments: Positioning Responsibilities
on page 46 facilitates alignment between Dimensions shown are in mm.
the system and LAS.

Point Of Reference (POR)

Point Of Reference//Point in space is the intersection of the XY plane and the axis of the sample
tube once positioned for system metering. It is used as the common reference for the system and
Automation system. The design of the VITROS® 4600 System accommodates the Clinical and
Laboratory Standards Institute (CLSI) standards.
Figure 23: Point of Reference

Figure 24: Point of Reference - Back of System

Figure 25: Point of Reference - Side View

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 CLSI standards. Metering operations assume 100 mm
tube height.
Figure 26: Sample Tube Position

System Dimensions with AT Configuration
System Dimensions with AT Configuration

This section describes the overall size of the VITROS® 4600 Chemistry System with AT
(Automation) Accessories. See Figure 27 and Figure 28.
Figure 27: VITROS® 4600 System with Seismic Anchors - Front View
Figure 28: VITROS® 4600 System with Seismic Anchors - Side View
Figure 29 displays the optional heat rejection plenum that diverts hear from the system directly into
the laboratory’s ventilation system. If a customer requires a heat rejection plenum, OCD and the
automation vendor should review any spatial conflicts. See Site Specifications for the VITROS® 5,1
FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.

Regulations and Safety Standards
Figure 29: VITROS® 4600 System with Heat Rejection Plenum
Regulations and Safety Standards

The VITROS® 4600 Chemistry System is designed to meet Regulatory and Safety requirements
for a worldwide market.

Supported Containers
Section 4. Sample Handling

Supported Containers
All but the 10.25 diameter container measurements assume that the track is set up for the system
to aspirate from 100mm tube lengths.
Minimum Fill Requirement
Tube Size Diameter x

Fluid Volume µL
Length in mm
16 x 100 200 µL plus test volume
16 x 75 200 µL plus test volume
12-13 x 100 200 µL plus test volume
12-13 x 75 200 µL plus test volume
10.25 with varying lengths

• The tube must have a minimum fill of 33 mm below
the rim plus test volume.
• The tube must be supported so the top rim of the
tube is positioned at the same location as a 100
mm tube.
Containers that are not Supported

Cups are not supported by remote sampling but they can be used for local (on-system) sampling.
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 for any volatile assays
• Long term sample degradation
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.

Introduction
Section 5. Guidelines for Laboratory Automation System Protocol Tests

Introduction
Purpose
These guidelines assist automation system personnel in verifying that the Automation Interface
Specification between a Lab Automation System (LAS) and VITROS® 4600 System has been
implemented correctly. The guidelines suggested in this section do not represent a complete
validation tool for the Lab Automation System supplier. Rather, they outline major areas of concern
for basic, fundamental operation. Lab Automation System suppliers should consider using and
reviewing these guidelines at their sites before the first customer delivery.
The objective of these guidelines is make sure that the fluid is aspirated correctly; the guidelines do
not test assay performance.
Audience
These guidelines are primarily designed as a communications tool for both the Lab Automation
Supplier and Ortho Clinical Diagnostics personnel to ensure that the appropriate interfaces have
been tested.
Approach
These guidelines address the actual system to Lab Automation interface by reviewing both the
software and physical interfaces.The software interfaces include the system to LAS connection as
well as the system to LIS connection. The physical interface includes topics such as track height
and system aspirate depth.
Material Resources
The following materials and equipment are required in order to verify implementation of the
Automation Interface Specification:
• VITROS® 4600 System
• Laboratory Automation System to be evaluated with the VITROS® 4600 System
(includes physical hardware, LAS, and LIS)
• Disposables items including:
— Tips
— Tubes
— Reservoirs
— Reagents
— Fluids (water, in most cases)
• V-Docs, the on-system documentation
• Automation interface emulation software

Protocol Tests
Skills Required
The guidelines are designed for personnel who have a basic understanding of theVITROS® 4600
System and the Lab Automation System to be tested. Suggested personnel involved in the
evaluation of the interface between the VITROS® 4600 System 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
Protocol Tests
The LAS protocol tests described in this section require that the automation system's LAS port be
connected to the system, 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 Timing Requirements. Communication sequences should be tested with the VITROS®
4600 System with Automation enabled; however, a simulator tool may be used to verify the
formatting and logical ordering of messages. When these guidelines refer to “Analyzer,” a simulator
tool may be substituted and/or required.
Each step in the protocol test is numbered and the action and expected result are provided. Use
the Actual Result column to record the outcome of the step.
LAS Communication Initialization Test

The LAS Communication Initialization test confirms 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
Refer to Interface Initialization Sequence on page 31.
Item Action Expected Result Actual Result
1 Send the READY The LAS begins the initialization

message from the system sequence.
to the LAS.
2 From the LAS, send the The system responds and sends
REINIT a READY message, beginning
COMMUNICATIONS the initialization sequence.
message.

Protocol Tests
3 • From the LAS, send a The system acknowledges the

QUERY ANALYZER QUERY ANALYZER STATUS
STATUS command. command. The LAS
• Then, from the system, acknowledges the ANALYZER
send an ANALYZER STATUS response.
STATUS response.
4 • From the automation The system acknowledges the

system, send a QUERY QUERY ANALYZER STATUS
ANALYZER STATUS command. The LAS sends a
command. NAK message in response to the
• Then, from the system, incorrect CRC in the ANALYZER
STATUS response with
an incorrect CRC value.
(This step may require a
simulator.)
5 If the LAS uses sequence Control flow and status

numbers, repeat steps 1 messages are the same as in
through 4 using each steps 1 through 4. Ensure that
sequence number. Enable the sequence numbers are
sequence numbers as incrementing in each command/
described in the section response pair.
Sequence Numbers on
page 8. Test sequence
number wrap around
condition.
Analyzer Status Test

The Analyzer Status test verifies compliance with the system/LAS communications protocol,
specifically the system status that is sent by the system to the LAS. The following Analyzer Status
messages are 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 (diagnostics, for example) (
• Analyzer has failed in the sample

Protocol Tests
Refer to Query Analyzer Inventory on page 39.

QUERY ANALYZER QUERY ANALYZER STATUS
STATUS command. command. The LAS
• Then, from the system, acknowledges the ANALYZER
STATUS response.
2 Repeat step 1, sending The LAS accurately interprets

back all possible Analyzer and takes appropriate action for
Status codes to the each ANALYZER STATUS
QUERY ANALYZER response. Refer to Analyzer
STATUS command. (This Status Codes in Analyzer Status
step may need a on page 14.
simulator.)
Sampling Complete Test

The Sampling Complete test verifies the SAMPLING COMPLETE status that is sent by the system
to the LAS for each sample ID. The following SAMPLING COMPLETE metering statuses are
verified:
• Sample aspirated as expected
• No sample program for sample ID
• SAMPLE IN POSITION message not received in time
• Completed with error, check error conditions and Analyzer status
• Internal sample has priority
• Analyzer inoperable, query system status
• Duplicate sample ID
• Analyzer not available
• Metering failed in sample.

Protocol Tests
Refer to Sample Metering Handshaking on page 23.

PREPARE TO RUN PREPARE TO RUN SAMPLE
SAMPLE and a and SAMPLE IN POSITION
SAMPLE IN POSITION messages. Ensure the Sample
command to the system. Complete status is interpreted
• From the system, send correctly by the automation
back a SAMPLE system and that the proper
COMPLETE message action is taken with the sample.
with a status of “Sample Refer to Metering Status Codes
Aspirated As Expected.” in Sampling Complete on
page 17.
2 Repeat step 1, sending The automation system

back all possible SAMPLE accurately interprets and takes
COMPLETE status appropriate action for each
values. (This step may SAMPLE COMPLETE response.
need a simulator.)
Error Recovery Test

The Error Recovery test verifies the ability of the automation interface to recover after an error
occurs. The following error conditions are verified:
• Communications Error
• Loss of Communications
• Incorrect Sample ID
• Invalid Container Type
• Invalid Recovery Type
Refer to Illegal Commands on page 29.
1 • From the LAS, send a • The system does not

command to the system acknowledge the first
containing an invalid command.
CRC value. • The system acknowledges the
• Send the same message second command.
again with a valid CRC
value.

Protocol Tests
2 • From the LAS, send a On receiving the second

command to the system incorrect CRC, the system stops
containing an invalid accepting any new commands
CRC value. until a REINITIALIZE
• Resend the command COMMUNICATIONS command
again with the invalid is sent.
CRC value.
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 The LAS interprets the ILLEGAL

undefined message to the COMMAND RECEIVED
system. The system sends message.
an ILLEGAL COMMAND
RECEIVED message to
the LAS.
5 From the LAS, send a The system sends an ILLEGAL

PREPARE TO RUN COMMAND RECEIVED
SAMPLE command to the message to the LAS. The LAS
system with an invalid interprets the ILLEGAL
container type. COMMAND RECEIVED
message.
6 From the LAS, send a The system sends an ILLEGAL

PREPARE TO RUN COMMAND RECEIVED
SAMPLE command to the message to the LAS. The LAS
system with a non- interprets the ILLEGAL
printable character in the COMMAND RECEIVED
sample ID. message.
7 Reinitialize The system sends an ILLEGAL

communications with the COMMAND RECEIVED
system with sequence message to the LAS. The LAS
numbers enabled. From interprets the ILLEGAL
the LAS, send a command COMMAND RECEIVED
with an invalid sequence message.
number.
8 From the LAS, send a Normal communication

REINITIALIZE resumes.
COMMUNICATIONS
command to the system to
reset the sequence
number.

Protocol Tests
9 From the LAS send a The system sends an ILLEGAL

REINITIALIZE COMMAND RECEIVED
COMMUNICATIONS message to the LAS. The LAS
command to the system interprets the ILLEGAL
with a recovery type of COMMAND RECEIVED
0xFF message.
10 From the LAS, send a The system acknowledges the

SAMPLE and a SAMPLE message and the SAMPLE IN
IN POSITION command to POSITION message. The
the system. From the automation system recognizes
system, send a SAMPLE the different sample ID in the
COMPLETE message SAMPLE COMPLETE message
containing a different as an error.
sample ID than the one in
the PREPARE TO RUN
SAMPLE command.
Sample Routed/Host Query Test

The Sample Routed/Host Query test validates the ability to initiate a host query from the system
through the automation interface. The following condition is tested using the SAMPLE ROUTED
message.
Refer to Sample Metering Handshaking on page 23.
1 Send the SAMPLE The LIS receives a host query

ROUTED message from from the system for the sample
the LAS specifying a ID specified in the SAMPLE
sample ID. ROUTED message.
Request Inventory Test

The Request Inventory test validates the ability to request and receive inventory from the system
through the automation interface.
Refer to Query Analyzer Inventory/Resources on page 28.
1 Send the QUERY The automation system

ANALYZER INVENTORY interprets the ANALYZER
message from the LAS. INVENTORY response(s)
correctly. If multiple data packets
are required to receive the
inventory information, the data
packets are handled correctly.

Instrument-Based Testing
Request Resources Level Test

The Request Resources Level test validates the ability to request and receive resource levels from
the system through the automation interface.
Refer to Query Analyzer Inventory/Resources on page 28.
1 Send the QUERY The automation system

ANALYZER interprets the ANALYZER
RESOURCES message RESOURCES response
from the LAS. correctly.
Instrument-Based Testing
Normal Operations Sample Handling
Normal Operations Sample Handling tests the ability of the LAS to communicate with the system
and process a sample using all sample control commands in sequence.
Refer to Query Analyzer Status on page 23 and Sample Metering Handshaking on page 23.
1 While monitoring the LAS The LAS receives and correctly

communications, send the interprets the ANALYZER
QUERY ANALYZER STATUS message. The
STATUS message from automation system should not
the LAS. present a sample to the system
unless the status is “Analyzer is
Ready to Sample.”
2 While monitoring the LAS The LAS receives the proper

communications, send the responses. If the time between
SAMPLE command to the and SAMPLE IN POSITION
system. exceeds the time specified in
Timing Requirements on
page 30, a status of “Sample In
Position Not Received In Time”
is posted.
3 Wait for the system to The LAS acknowledges the

send the SAMPLE SAMPLE COMPLETE message.
COMPLETE response. The sample ID matches the one
in the PREPARE TO RUN
SAMPLE command.

Physical Interfaces
4 From the LAS, process The system processes the

two consecutive samples samples. The system throughput
with a delay of 1 second is reduced and there is a delay
between the SAMPLE between processing the first and
COMPLETE message second sample.
from the system for the
first sample and the
PREPARE TO RUN
SAMPLE message from
the LAS for the second
sample.
5 From the LAS, process The system processes the

two consecutive samples. samples. The system throughput
Send the PREPARE TO is not reduced; there is no delay
RUN SAMPLE message between processing the first and
for the second sample second sample.
100ms after receiving the
SAMPLE COMPLETE
message for the first
sample.
6 Load a sample in the The system processes the

STAT lane of the system sample from the STAT lane of
and start sampling. Then the system and sends a
attempt to process a SAMPLE COMPLETE message
sample from the LAS. to the LAS with a metering
status of “Internal sample has
priority.”
Physical Interfaces
This section reviews the physical interfaces between the Lab Automation System and the
VITROS® 4600 Chemistry System. Before beginning this evaluation, set up and adjust the system
to track interface following the installation procedure found in the Unpacking and Installlation
Instructions for VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: Intact
System, J39894 or Unpacking and Installation Instructinos for VITROS® 5,1 FS Chemistry System
and VITROS® 4600 Chemistry System: Split System, J39895. Also refer to the Installation
Instructions for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System:
Automation (AT) Accessory, J39893. Use double-sided tape to place the floor mounts temporarily.

Physical Interfaces
Sample Positioning
The Sample Positioning test evaluates the ability of the Lab Automation System to properly position
a sample tube for fluid aspirated by the system. Refer to Sample Positioning and Adjustments on
page 46.
1 Verify that the Lab The automation system sample

Automation System allows positioning device must be
the sample positioning adjustable along the length of
device to be adjusted the track to ensure alignment of
along the length of the the sample with the system
track and fixed into proboscis travel.
position.
2 Measure the height to the When sample metering is

top of the longest sample adjusted to the tallest tube
tube from the floor when height 100mm, aspirate depth is
properly positioned for 98 mm maximum from that point.
sample aspiration by the
sample positioning device.
3 • In normal operating When the system is rigidly

sample handling mode, mounted and properly adjusted,
fill 13mm sample tubes there should be no contact
with just enough fluid for between the sampling probe and
1 test per sample. the sample tube.
• Place sample tubes on
the track and route them
to the system 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.

Methods to Download Test Orders
Section 6. LAS/LIS Architecture

Methods to Download Test Orders
Several methods are used to send test orders to the instrument.
• Single Instrument Download
• Broadcast Download
• Host Query
Single Instrument Download

Single instrument download is one of the simplest ordering schemes; test orders are sent to a single
instrument where the sample is destined to arrive. The major drawback to this approach is that the
destination of a sample must be known in advance. If the sample is routed to a different instrument,
no order for the sample would be available on the alternate instrument.
Broadcast Download
Broadcast downloading sends orders for samples to all instruments in the system, eliminating the
problem with single instrument downloads. With broadcast downloads, orders are always available
wherever a sample may arrive. When results are uploaded from the instrument for a sample that
has run, the orders can be deleted from the remaining instruments. VITROS instruments can be
configured to automatically delete orders after a specified interval if this functionality is not available
in the LIS/LAS. If test orders are not deleted from other systems, tests may be run more than once
if the sample is routed again to another system.
Host Query
In host query mode, the instrument requests test orders when the sample arrives. This eliminates
the need for order cleanup and the risk of running unnecessary tests. It also reduces the bandwidth
load on the network especially in configurations with many instruments. Due to the near-real-time
nature of this approach, the turnaround time from test request to order download is important. If the
order does not arrive before the sample for the system can't process the sample. For the same
reason, this method is less tolerant of network disruption than the other approaches. Depending on
the workflow in the lab (for example a reference lab where most orders are sent down at the
beginning of a shift), with broadcast download you can run the system with no LIS connectivity while
previously downloaded orders are used.
Interface Topology
With a Laboratory Automation System added to the system, the interfaces between the LIS, LAS,
and instruments may have several configurations.
Case 1
The LIS communicates directly to all instruments, both on-track and off-track.
The LAS must notify the LIS of any samples it creates so the orders for those samples can be
available to the instruments on the system. 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-track
instruments. This is an issue if the LAS creates and presents aliquoted tubes to an instrument and
the tubes that have a different sample ID that the one the LIS downloaded.

Interface Topology
Figure 30: Interface Topology - Case 1
Case 2
The LAS intercepts communication between the LIS and on-track instruments. The LIS
communicates directly with off-track instruments.
The LAS has the sole responsibility for the management of samples it creates, for example
aliquoted samples. Additionally the LAS is responsible for providing a recovery/backup mode if the
LIS interface goes down.
This topology allows for a mixture of ordering schemes to be used. For example the LIS-LAS
interface may be broadcast download and the LAS-Instrument may be host query.

Interface Topology
Case 3
The LAS intercepts communication between the LIS and all instruments, both on-track and off-
track.
Similar to Case 2, the LAS has the sole responsibility for the management of samples it creates, for
example aliquoted samples. One advantage to this approach over that of Case 2 is that aliquoted
samples can be run on off-track instruments. Additionally the LAS is responsible for providing a
recovery/backup mode should the LIS interface goes down.
This topology allows for a mixture of ordering schemes to be used. For example the LIS-LAS
interface may be broadcast download and the LAS-Instrument may be host query.

Interface Topology

Patient Safety Considerations
Section 7. Safety and Precautions

Any safety considerations and precautions that can be controlled at the system level are included
in the design of the system. Some potential risks require that the lab automation system follow a
specific protocol when interacting with the system. Other potential risks relate to the lab automation
system itself. The following considerations are vital to enhance the safety and reliability of Ortho
Clinical Diagnostics’s systems and the automation systems to which they connect:
• Patient safety
• Operator safety
• Environmental safety
Automation vendors understand the need for strict compliance with system protocols. Lab
automation system designers are strongly encouraged to consider these possible risks when
designing interfaces between these products. If the system 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 system and that were considered during the system's design are
not shown below.
Potential Risk Potential Result Recommended Preventive Action
Contamination from the Contamination or Refer to the Reference Guide for cleaning
chemical cleaning agent degradation of agents and protocol. See the onboard V-
sample Docs for VITROS® 4600 System or
Reference Guide, J39821 on the CD-ROM.
Particulate Contamination or Remove the stopper from sample tubes as

contamination of sample degradation of close to the system as possible to maintain
on the automation track sample sample quality.
For any volatile assays, Degradation of Remove the stopper from sample tubes as
evaporation or out- sample close to system as possible to maintain
gassing while the sample quality.
sample tube is on the
automation track
Cross contamination Contamination or Set up automation systems to handle

from adjacent sample degradation of samples in a manner that prevents cross
on the automation track sample contamination.
Sample cross- Cross- Make sure that LAS receives a SAMPLE

contamination - contamination of COMPLETE message from the system
Aspirating second fluid sample on track before releasing the sample. Refer to
quantity into same tip Sample Metering Handshaking on page 23.
(“double dip”) when the
sample on track has
been released too early
and next sample is in
position.

Sample too cold after Sample Provide a means of sample temperature

holding in refrigerated temperature equilibration to room temperature after
section of track for reflex outside system refrigeration before the sample is presented
testing. (Automation limits for metering at the system.
track supplier controls
temperature)
Misalignment of Sample aspirate Follow specifications for sample tube

automation track with volume error location specified in Sample Center Device
the system. Adjustments: Positioning Responsibilities on
page 46.
EMI from automation Sample aspirate • Ensure that automation track meets
track to the system via volume error agency specifications.
coupling. • Isolate the mechanical coupling between
the sample automation track and the
system to address potential EMI concerns.
Over-wet sample tip or Sample aspirate • Use error checking communication

aspiration of air volume error protocol (CRC).
because the tube • Follow communications specifications in
diameter information Section 2. Software Interfaces.
from automation system
is incorrect.
Sample tube breaks at System • Refer to acceptable sample tube sizes for
automation track and synchronization the specified in Section 4. Sample
the system interface. or timing error Handling.
• Design the detection of the sample tube
height into the sample track.
• Detect time-out of sample metering
subsystem and communicate error to LAS/
LIS.
Communication error System Follow communications specifications in

between the system and synchronization/ Section 2. Software Interfaces.
the LAS. timing error
Incorrect sample Aspirate from Ensure the integrity of the sample ID

presented to the incorrect sample communicated to the system and
system. positioning of that sample.
Sample ID mis- Aspirate from Verify sample ID in the SAMPLE

communicated from incorrect sample COMPLETE message sent to LAS.
LAS.
Automation track Aspirate from Use barcode verification for labels (i.e.,
system misreads the incorrect sample check digit) and limit the scanner view to
sample tube/carrier one sample.
barcode.

Operator Considerations
Inadequate Test not • Send system resource inventory to LIS

consumables (reagents, completed upon request.
tips, etc.) on the system • Verify adequate supplies by LAS via LIS. If
to complete the test. the supplies are inadequate, have the LAS
reroute the sample to another system.
STAT sample on the A STAT sample Place STAT samples on the system
track is unknown to the on the track may manually and process as locally loaded
system. (All samples on not be processed samples.
the system have priority in a timely
over samples on the fashion
track.)
Sample tube arrives Test not Remove stoppers (caps) from sample tubes
with stopper inserted in executed to allow the system to access the tubes.
tube. Remove caps when the tubes are as close
to the system as possible to ensure sample
quality.
Sample Metering Test not • Use error checking communication

general error report is completed protocol (CRC).
interpreted incorrectly • Use message formats specified in Section
by the LAS. 2. Software Interfaces.
Inactive subsystem(s) Test not Have the LAS verify the system status
on the system. completed before the sample arrives.
Software suppressed Test not • Place STAT samples on the system

results (due to a completed within manually and process as locally loaded
detected error) for a expected time samples.
STAT test. • Verify the system status and condition
reports by LAS/LIS
Operator Considerations
Electric shock at Electrical Make sure that track is properly grounded.

automation track-to- hazards
system coupling.

Environmental Considerations
Environmental Considerations
Metering proboscis Mechanical • Initialize sample metering subsystem by

stuck in sample tube on damage to LAS if it receives a SAMPLE COMPLETE
track when sample is sample track message combined with a sample
released by the area and system metering error message from the system.
automation system • Do not move the sample from metering
position until the LAS receives a SAMPLE
COMPLETE status without an error
message from the system.

IVD
Ortho-Clinical Diagnostics
Johnson & Johnson
50 - 100 Holmers Farm Way
EC REP
High Wycombe
Buckinghamshire HP12 4DP
United Kingdom
Ortho-Clinical Diagnostics, Inc.

100 Indigo Creek Drive
Rochester, NY 14626

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J39931EN

Specification for Automation Interface

No patent license is granted by the information.

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

© Ortho-Clinical Diagnostics, Inc., 2011. All rights reserved.

ii Specification for Automation Interface Pub. No.: J39931EN

Laboratory Automation Specification

References and Definitions

Pub. No.: J39931EN Specification for Automation Interface 1

2 Specification for Automation Interface Pub. No.: J39931EN

Date Page Revision Details

2011-01-10 N/A Initial release of the specification

Assumptions and Dependencies

Pub. No.: J39931EN Specification for Automation Interface 3

4 Specification for Automation Interface Pub. No.: J39931EN

Section 2. Software Interfaces

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

Sample Metering Handshaking

4. The LIS downloads test order to the system.

5. The sample tube is carried to system.

9. The system aspirates fluid from the sample tube.

12. The system reinitializes any reduced subsystems.

Pub. No.: J39931EN Specification for Automation Interface 5

16. The initialization sequence is repeated.

Query Analyzer Inventory/Resources

Note: Similar functionality is also available with the LIS interface.

6 Specification for Automation Interface Pub. No.: J39931EN

The system supports the following baud rates:

Cyclical Redundancy Checks

Pub. No.: J39931EN Specification for Automation Interface 7

Interface Initialization Sequence

8 Specification for Automation Interface Pub. No.: J39931EN

Figure 1: Initialization Sequence

Lab Automation System

Sequence Number = A+1

Sequence Number = A+2

Pub. No.: J39931EN Specification for Automation Interface 9

Interface Communication Failures

Message Not Acknowledged

10 Specification for Automation Interface Pub. No.: J39931EN

Illegal Command Received

Error Type Error Type Description Error Word Contents

Pub. No.: J39931EN Specification for Automation Interface 11

Error Type Error Type Description Error Word Contents

12 Specification for Automation Interface Pub. No.: J39931EN

Error Type Error Type Description Error Word Contents

0x03 Invalid data was discovered in the MSB = 0x00

Query Analyzer Status

Pub. No.: J39931EN Specification for Automation Interface 13

Status Codes Status Code Descriptions

0x00 The Analyzer is ready to process a sample. The LAS

0x01 The Analyzer is processing an external sample (off the

0x02 The Analyzer is processing an internal sample

0x03 The Analyzer is in the process of bringing the thermal

14 Specification for Automation Interface Pub. No.: J39931EN

Status Codes Status Code Descriptions

0x04 The Analyzer is inoperable and is not ready to process

0x05 This status indicates that the Analyzer is not ready to

0x06 The Analyzer's metering proboscis has mechanically

Pub. No.: J39931EN Specification for Automation Interface 15

Prepare To Run Sample

Status Codes Status Code Descriptions

0x00 16mm diameter tube