VITROS EQUIPOS AUTOMATIZADO

J39931EN
Specification for Automation Interface
VITROS® 4600 Chemistry System
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IMPORTANT
The information contained herein is based on the experience and knowledge relating to the subject
matter gained by Ortho-Clinical Diagnostics, Inc. prior to publication.
No patent license is granted by the information.
Ortho-Clinical Diagnostics, Inc. reserves the right to change this information without notice, and
makes no warranty, express or implied, with respect to the information. The company shall not be liable for any loss or damage, including consequential or special damages resulting from the use of this
information, even if loss or damage is caused by its negligence or other fault.
VITROS® is a registered trademark of Ortho-Clinical Diagnostics, Inc.
© Ortho-Clinical Diagnostics, Inc., 2011. All rights reserved.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Section 1. Introduction ........................................................................................................ 1
Overview ......................................................................................................................................... 1
References and Definitions ............................................................................................................ 1
Document Structure ........................................................................................................................ 3
Revision History .............................................................................................................................. 3
Assumptions and Dependencies .................................................................................................... 3
Section 2. Software Interfaces ............................................................................................ 5
Operational Overview ..................................................................................................................... 5
Specifications ................................................................................................................................. 6
Lab Automation Protocol .......................................................................................................... 6
Datalink/Session Layer ............................................................................................................ 7
Presentation Layer ................................................................................................................. 10
Query Analyzer Status .................................................................................................................. 23
Sample Metering Handshaking .................................................................................................... 23
Reinitialize Metering ..................................................................................................................... 26
Reinitialize Communications ........................................................................................................ 28
Query Analyzer Inventory/Resources ........................................................................................... 28
Illegal Commands ......................................................................................................................... 29
Internationalization and Language Support .................................................................................. 30
Timing Requirements ................................................................................................................... 30
Lab Automation Communication Scenarios ................................................................................. 31
Interface Initialization Sequence ............................................................................................ 31
Run Two Samples .................................................................................................................. 32
Remote Sample Startup Interrupted by Local Sample ........................................................... 33
Non Fatal Error Condition (Insufficient Inventory) .................................................................. 34
Non Fatal Error Condition (Unknown Sample ID) .................................................................. 35
Non Fatal Error Condition (Sample In Position Not Received in Time) .................................. 36
Fatal Error Condition .............................................................................................................. 37
Sample Routed Notification ....................................................................................................38
Query Analyzer Inventory ....................................................................................................... 39
Section 3. Hardware Interfaces ......................................................................................... 40
Electrical Interfaces ...................................................................................................................... 40
Analyzer Dimensions .................................................................................................................... 41
Site Specifications ........................................................................................................................ 42
Service Access ............................................................................................................................. 42
Analyzer Heat Rejection and Air Intake Zones ...................................................................... 43
Positional Requirements ............................................................................................................... 43
Analyzer to Track Positioning/Floor Mounts or Anchors ............................................................... 44
Floor Mounts/Anchors ............................................................................................................ 45
Sample Positioning and Adjustments ........................................................................................... 46
Sample Center Device Adjustments: Positioning Responsibilities ......................................... 46
VITROS® 4600 Metering Proboscis Alignment ..................................................................... 47
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
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Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
1
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 E1394 specifications for the communications between clinical laboratory instruments and lab
computer systems.
Asynchronous LIS Messages
A feature that enables the system to send unsolicited status updates to the LIS.
CRC: Cyclical Redundancy Checking
An error checking algorithm used to verify the integrity of an electronic message.
Extended ASCII
A set of codes that extends the basic ASCII set. The basic ASCII set uses 7 bits for each
character, giving it a total of 128 unique symbols. The extended ASCII character set uses
8 bits, which gives it an additional 128 characters. Extended ASCII uses the ISO8859-1
implementation to support Western European languages. See ISO 8859-1 8-bit single-byte
coded graphic character sets -- Part 1: Latin alphabet No. 1.
GUI: Graphical User Interface
A computer-user interface based on graphics (icons and pictures and menus) instead of
text.
HL7: Health Level Seven
A standard message protocol for electronic data exchange in all health care environments
including clinical laboratories with automation.
LAC: Lab Automation Computer
A computer used in the LAS to control the track and coordinate sample movement to a
processing station.
LAS: Lab Automation System
The subsystems that support the capability to control an automated track and coordinate
sample movement to a processing station, for example, an Analyzer.
POR: Point of Reference
A point in space at which the sample tube is placed for external metering.
LIS: Lab Information System
The computer system responsible for data management, for example, sample results and
patient history.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
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
Pub. No.: J39931EN
Issued: 2011-01-10
•
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.)
Specification for Automation Interface
VITROS® 4600 Chemistry System
3
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.
4
•
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.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
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.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
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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.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
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
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Specification for Automation Interface
VITROS® 4600 Chemistry System
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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.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Specifications
Figure 1: Initialization Sequence
Lab Automation
System
READY
ACK
ACK
Sequence Number = A
Sequence Number = A+1
Sequence Number = A+1
Sequence Number = 0
ACK
READY if no response in 1
second
ACK
Analyzer Status Message
Sequence Number = 0
Initialization Complete
Query Analyzer Status
Sequence Number = A+2
Sequence Number = A+2
Sequence Number = 1
ACK
ACK
Analyzer Status Message
Sequence Number = 1
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.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
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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:
10
byte 1:
STX
byte 2:
Message Length
byte 3:
Message Type = 0x02
byte 4:
Sequence Number
byte 5:
CRC
byte 6:
ETX
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
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 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC009
byte 7:
Error Type (see the table below)
byte 8, 9:
Error Word (see the table below)
byte 10:
CRC
byte 11:
ETX
Error Type
Error Type Description
Error Word Contents
0x00
Invalid
command
A non-existent command was received.
An invalid command was received. This
could be a message with a Message ID
that is not defined, or a Message ID that
is not supported by the system. For
example, the system does not recognize
the ANALYZER STATUS message
(0xC007).
MSB = high byte of Message ID received
LSB = low byte
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Specification for Automation Interface
VITROS® 4600 Chemistry System
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Specifications
12
Error Type
Error Type Description
Error Word Contents
0x01
Logical Order
Error
A command that violates the logical
order of operations was received.A
command was sent out of sequence.
The system will issue this error under
the following conditions:
• A SAMPLE IN POSITION message is
sent without a corresponding
PREPARE TO RUN SAMPLE
message.
• A second PREPARE TO RUN
SAMPLE message is sent before the
system sends a SAMPLING
COMPLETE message.
• A second SAMPLE IN POSITION
message is sent before the system
sends a SAMPLING COMPLETE
message.
• A QUERY ANALYZER INVENTORY
message is sent during external
sampling.
• A QUERY ANALYZER RESOURCES
message is sent during external
sampling.
MSB = high byte of Message ID received
LSB = low byte
0x02
Sequence
Number
Error
A sequence number error was detected.
The system issues this error if the use of
sequence numbers was enabled during
initialization by the LAS, and the system
receives a message with a sequence
number that does not match the
expected sequence number. See
REINITIALIZE COMMUNICATIONS for
how to recover from this error.
MSB = sequence number expected
LSB = sequence number received
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Specifications
Error Type
Error Type Description
Error Word Contents
0x03
Invalid Data
Invalid data was discovered in the
message. A data field from the previous
message contained unexpected data.
The following conditions will cause the
system to send this error:
• The Container Type in a PREPARE
TO RUN SAMPLE message is invalid.
• The Sample ID in a PREPARE TO
RUN SAMPLE or a SAMPLE ROUTED
message contains zero or more than
15 characters.
• The Sample ID in a PREPARE TO
RUN SAMPLE or a SAMPLE ROUTED
message contains invalid UTF-8
characters or insufficient characters
(according to the Sample ID Length
field).
• The Recovery Type in a REINITIALIZE
COMMUNICATIONS message is
invalid.
MSB = 0x00
LSB:
0x01 = Invalid container type from
PREPARE TO RUN SAMPLE
0x02 = Invalid Sample ID length from
PREPARE TO RUN SAMPLE or
SAMPLE ROUTED
0x03 = Invalid Sample ID data from
PREPARE TO RUN SAMPLE or
SAMPLE ROUTED
0x04 = Invalid recovery type from
REINITIALIZE COMMUNICATIONS
Note: LAS commands sent to the system should be spaced at least 100ms apart to allow the
system to respond with an ILLEGAL COMMAND message if necessary.
Query Analyzer Status
The Query Analyzer Status message is sent by the LAS to request the system report its status. This
command is performed before starting a new sample unless a SAMPLING COMPLETE response
has just been received.
The following format is used for the Query Analyzer Status message:
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byte 1:
STX
byte 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC006
byte 7:
CRC
byte 8:
ETX
Specification for Automation Interface
VITROS® 4600 Chemistry System
13
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 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC007
byte 7:
Status Code (see table below)
byte 8:
CRC
byte 9:
ETX
Analyzer Status Codes
14
Status Codes
Status Code Descriptions
0x00
Analyzer is ready to Sample
The Analyzer is ready to process a sample. The LAS
may issue a PREPARE TO RUN SAMPLE message to
the Analyzer.
0x01
Analyzer is Busy Performing
an External Sample
The Analyzer is processing an external sample (off the
automation track). The LAS must wait for a
SAMPLING COMPLETE message to be issued by the
Analyzer before presenting any new samples to the
Analyzer.
0x02
Analyzer is Busy Performing
an Internal Sample
The Analyzer is processing an internal sample
(onboard sample tray). This status is necessary since
the use of the Analyzer is lab dependent. The LAS
should periodically issue a QUERY ANALYZER
STATUS message to the Analyzer until the status code
indicates that the "Analyzer Is Ready To Sample”
status before presenting any new samples to the
Analyzer.
0x03
Analyzer is Equilibrating
The Analyzer is in the process of bringing the thermal
conditions into proper range for processing samples.
This status occurs normally when the Analyzer is
initialized or if a thermally controlled component of the
Analyzer is opened. The LAS should periodically issue
a QUERY ANALYZER STATUS message to the
Analyzer until the status code indicates that the
“Analyzer Is Ready To Sample” status before
presenting any new samples to the Analyzer. It may
require 30 to 40 minutes before the Analyzer is ready
to sample.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Specifications
Status Codes
Status Code Descriptions
0x04
Analyzer has a Fatal Error
The Analyzer is inoperable and is not ready to process
samples. One or more subsystems have experienced
a mechanical malfunction. The LAS should attempt to
restore the Analyzer to an operational state by issuing
a REINITIALIZE METERING message to the Analyzer.
The LAS should then periodically issue a QUERY
ANALYZER STATUS message to the Analyzer until the
status code indicates that the “Analyzer Is Ready To
Sample” status. For most cases initialization should
take up to two minutes; however there are some
situations that could take up to ten minutes. Therefore,
it is suggested that, if the LAS does not receive an
Analyzer status of “Analyzer Is Ready To Sample”
within ten minutes after issuing the REINITIALIZE
METERING message, the LAS alert the operator and
reroute samples to another Analyzer.
0x05
Analyzer is Not Available
This status indicates that the Analyzer is not ready to
process samples. It indicates that an operator is
performing manual operations such as loading
reagents, diagnostics, initializing, or loading an ADD.
The LAS should periodically issue a QUERY
ANALYZER STATUS message to the Analyzer until the
status code indicates that the “Analyzer Is Ready To
Sample” status before presenting any new samples to
the Analyzer.
0x06
Failed in the Sample
The Analyzer's metering proboscis has mechanically
failed while inside the sample
container. The LAS should not attempt to move the
sample to prevent the possibility of a broken tube and
sample spill. The LAS should attempt to restore the
Analyzer to an operational state by issuing a
REINITIALIZE METERING message to the Analyzer.
The LAS should then periodically issue a QUERY
ANALYZER STATUS message to the
Analyzer until the status code indicates that the
“Analyzer Is Ready To Sample” status. For most cases
initialization should take up to two minutes; however
there are some situations that could take up to ten
minutes. Therefore, it is suggested that, if the LAS
does not receive an Analyzer status of “Analyzer Is
Ready To Sample” within ten minutes after issuing the
REINITIALIZE METERING message, the LAS alert the
operator. The current sample should not be moved by
the LAS and other samples may be rerouted to another
Analyzer until the Analyzer is ready to sample.
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
15
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 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC002
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
Status Codes
Status Code Descriptions
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.
16
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
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 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC004
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 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC005
byte 7:
Metering Status (see table below)
byte 8:
Sample ID Length (in bytes)
byte 9 to n:
Sample ID (15 characters max)
byte n+1:
CRC
byte n+2:
ETX
Metering Status Codes
In the case of any status that indicates that the sample was not processed, the process of
commanding the system to sample should restart by issuing a new PREPARE TO RUN SAMPLE
message followed by a SAMPLE IN POSITION message. These commands should be reissued
using the same sample ID and parameters as were used for the sample that failed to run.
Note: These status codes are mutually exclusive.
Status Codes
Metering Status Descriptions
0x00
Sample Aspirated
With No Error
The sample was aspirated with no errors. No information is known about
sample dispense errors, since the SAMPLING COMPLETE message is
sent before any sample is dispensed.
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
17
Specifications
18
Status Codes
Metering Status Descriptions
0x01
No Sample Program
For Sample ID
The Analyzer could not find a sample program for the Sample ID that was
presented by the LAS. The LAS either routes the sample to another
Analyzer with the proper sample program, or coordinates with the LIS to
download the sample program and then re-presents the sample to the
Analyzer. Consult with the laboratory to determine the desired response to
this status.
0x02
SAMPLE IN
POSITION Not
Received In Time
A PREPARE TO RUN SAMPLE message was received but a SAMPLE IN
POSITION message was not received in the proper time frame. The
SAMPLE IN POSITION message must be issued by the LAS within 6.4
seconds after issuing the PREPARE TO RUN SAMPLE message. The
LAS should reissue the PREPARE TO RUN SAMPLE message. This is
the only case where a SAMPLING COMPLETE message will be sent prior
to a SAMPLE IN POSITION.
0x03
Completed With
Error
A problem was encountered while aspirating sample from the container.
This status can be due to a clot or bubble detected. If Enhanced LIS plus
is enabled the LAS can query the LIS for specific error information to
decide what the best corrective action is. Since this status indicates that
user attention is required for follow-up, consult the laboratory to determine
the desired response to this status.
0x04
Internal Sample Has
Priority
An internal sample is being processed. The LAS should periodically issue
a QUERY ANALYZER STATUS message until the Analyzer reports a
status of “Analyzer Ready To Sample”. The LAS may then proceed to
follow the normal procedure for presenting a sample to the Analyzer by
first issuing a PREPARE TO RUN SAMPLE message to the Analyzer. The
LAS may also reroute the sample to another Analyzer for processing.
0x05
Analyzer Inoperable
The Analyzer is inoperable and is not ready to process samples. One or
more subsystems have experience a mechanical malfunction. The LAS
should attempt to restore the Analyzer to an operational state by issuing a
REINITIALIZE METERING message to the Analyzer. The LAS should
then periodically issue a QUERY ANALYZER STATUS message to the
Analyzer until the status code indicates that the “Analyzer Is Ready To
Sample” status. For most cases initialization should take up to two
minutes; however there are some situations that could take up to ten
minutes. Therefore, it is suggested that, if the LAS does not receive an
Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after
issuing the REINITIALIZE METERING message, the LAS alert the
operator and reroute samples to another Analyzer.
0x06
Duplicate Sample ID
Tests are in process for the given sample ID. Duplicate sample IDs are not
processed.
0x07
Analyzer Not
Available
The Analyzer is not ready to process samples. It indicates that an operator
is performing manual operations such as loading reagents, diagnostics,
initializing, or loading an ADD. The LAS should periodically issue a
QUERY ANALYZER STATUS message to the Analyzer until the status
code indicates that the “Analyzer Is Ready To Sample” status before
presenting any new samples to the Analyzer.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Specifications
Status Codes
Metering Status Descriptions
0x08
Metering Failed In
the Sample
The Analyzer's metering proboscis has mechanically failed while inside
the sample container. The LAS should not attempt to move the sample to
prevent the possibility of a broken tube and sample spill. The LAS should
attempt to restore the Analyzer to an operational state by issuing a
REINITIALIZE METERING message to the Analyzer. The LAS should
then periodically issue a QUERY ANALYZER STATUS message to the
Analyzer until the status code indicates that the “Analyzer Is Ready To
Sample” status. For most cases initialization should take up to two
minutes; however there are some situations that could take up to ten
minutes. Therefore, it is suggested that, if the LAS does not receive an
Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after
issuing the REINITIALIZE METERING message, the LAS alert the
operator. The current sample should not be moved by the LAS and other
samples may be rerouted to another Analyzer until the Analyzer is ready
to sample.
Note: The Sample ID should be encoded using UTF-8 or Extended ASCII depending on the
configured encoding.
Reinitialize Metering
The Reinitialize Metering message is sent by the LAS to request that the system reinitialize any
inoperable subsystems on the system. This message also resets the expected sample command
on the system allowing the LAS to remove a sample that is in progress.
The following format is used for the Reinitialize Metering message:
Pub. No.: J39931EN
Issued: 2011-01-10
byte 1:
STX
byte 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC008
byte 7:
CRC
byte 8:
ETX
Specification for Automation Interface
VITROS® 4600 Chemistry System
19
Specifications
Reinitialize Communications
The Reinitialize Communications message is sent by the LAS to the system to attempt to recover
from interface communication failures and sequence number errors.
The following format is used for the Reinitialize Communications message:
byte 1:
STX
byte 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC00A
byte 7:
Recovery Type (see table below)
byte 8:
CRC
byte 9:
ETX
Recovery Types
Status Codes
Metering Status Descriptions
0x00
Restart sequence numbers, using the sequence number
byte in the REINITIALIZE COMMUNICATIONS message
0x01
Attempt to recover from an interface communication
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:
20
byte 1:
STX
byte 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
byte 5, 6:
Message ID = 0xC010
byte 7:
Sample ID Length (in bytes)
byte 8 to n:
Sample ID (15 characters max)
byte n+1:
CRC
byte n+2:
ETX
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
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 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
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:
Pub. No.: J39931EN
Issued: 2011-01-10
byte 1:
STX
byte 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
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
Specification for Automation Interface
VITROS® 4600 Chemistry System
21
Specifications
byte 6:
byte 6n+9:
CRC
byte 6n+10:
ETX
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
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 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
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:
22
byte 1:
STX
byte 2:
Message Length
byte 3:
Message Type = 0x00
byte 4:
Sequence Number
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
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Query Analyzer Status
byte 15, 16:
UWR volume in mL
byte 17, 18:
VersaTip supply count
byte 19, 20:
MicroTip supply count
byte 21, 22:
Cuvette supply count
byte 23, 24:
Available MicroSlide waste count
byte 25:
Available MicroImmunoassay waste percent full
byte 26:
Available reagent metering tip waste percent full
byte 27:
Available liquid waste percent full
byte 28:
Number of diluents
byte 29 to 4n+28:
One repetition per diluent
byte 1,
2:
Diluent Code
byte 3,
4:
Available count or volume in mL.
byte 4n+29:
CRC
byte 4n+30:
ETX
Note: If the VersaTip hopper sensor is blocked, an accurate count of VersaTips cannot be
determined, only that the number of tips available is greater than 300. This condition is
encoded with 0xFFFF and the count is considered an infinite supply of tips.
Query Analyzer Status
When the LAS sends a QUERY ANALYZER STATUS, the system responds with an ANALYZER
STATUS message containing the appropriate status code based on the current state of the system.
Note: The LAS may query the system for status at any time, and should do so before any
requests to process samples.
Sample Metering Handshaking
A three-message handshake between the LAS and system to meter a sample consists of the
following messages in the order listed:
1. PREPARE TO RUN SAMPLE - passes the control of a sample to the system and provides the
sample ID and container type information.
2. SAMPLE IN POSITION - informs the system that the sample is at the POR and ready for
metering.
3. SAMPLING COMPLETE - passes the control of the sample back to the LAS and provides
metering status.
See Figure 2: Sample Metering Handshake.
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
23
Sample Metering Handshaking
Figure 2: Sample Metering Handshake
Lab Automation
System
Query Analyzer Status
ACK
ASM - Ready to Sample
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Query Analyzer Status
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.
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “No Sample Program For Sample ID” if no sample program could be found for the sample ID
in the PREPARE TO RUN SAMPLE message.
24
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Sample Metering Handshaking
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “Completed With Error” if an error occurred that would prevent running one or more tests.
Note: This situation only applies to aspirate errors, which are any error that occur while the
proboscis is over the sample container.
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “Internal Sample Has Priority” if an internal sample is being metered when the SAMPLE IN
POSITION message is received.
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “Analyzer Inoperable” if one or more subsystems are in a reduced state when the SAMPLE
IN POSITION message is received.
Note: The LAS may attempt to recover from this status by issuing a REINITIALIZE METERING
command.
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “Duplicate Sample ID” if there are tests in process for the sample ID in the PREPARE TO
RUN SAMPLE message.
Note: The duplicate sample will not be processed.
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “Analyzer Not Available” if the system is unable to process samples when the SAMPLE IN
POSITION message is received.
Note: This situation occurs during initialization, equilibration, ADD loading, diagnostics mode or
when some Options & Configuration screens are displayed.
The system sends a SAMPLING COMPLETE message to the LAS with the metering status code
set to “Metering Failed In The Sample” if a mechanical error with the metering system occurred
when the proboscis was inside the sample container.
It is assumed that a sample program has been downloaded before the PREPARE TO RUN
SAMPLE command. However, if the system is configured for host query, a mechanism needs to be
in place to initiate a host query independent of the PREPARE TO RUN SAMPLE. The SAMPLE
ROUTED message facilitates this. A SAMPLE ROUTED message is sent to the system as soon as
the LAS has routed a sample to it in order to maximize the time available to perform a host query.
The system attempts to send a host query when it receives a SAMPLE ROUTED message for the
sample ID contained in the message.
See Figure 3: Sample Routed Notification.
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
25
Reinitialize Metering
Figure 3: Sample Routed Notification
Lab Automation
System
Query Analyzer Status
ACK
Analyzer Status Message
ACK
Prepare to Run Sample
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.
Reinitialize Metering
The system attempts to reinitialize any inoperable subsystems when it receives a REINITIALIZE
METERING message from the LAS.
Note: The LAS issues a REINITIALIZE METERING message when an ANALYZER STATUS has
an inoperable status or SAMPLING COMPLETE indicates sampling failed due to an
inoperable system or metering failed in the sample.
A REINITIALIZE METERING message resets the Sample Metering Handshake so the next
expected message is PREPARE TO RUN SAMPLE.
A REINITIALIZES METERING message aborts any further sample aspirations from the interface
where the message is received.
Note: The sample processing acts as if a mechanical sample aspiration error occurred. The
aborted reps are coded “ME” and reps that have already aspirated will continue to process
normally.
26
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Reinitialize Metering
See Figure 4: Reinitialize Metering.
Figure 4: Reinitialize Metering
Lab Automation
System
Query Analyzer Status
ACK
Analyzer Status Message (ASM)
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Sampling Complete (Failed in
Sample or Analyzer Inoperable)
ACK
Reinitialize Metering
ACK
Query Analyzer Status
ACK
ASM - Analyzer Initializing
ACK
Query Analyzer Status
ACK
ASM - Analyzer is Ready
ACK
Note: ASM = Analyzer Status Message
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
27
Reinitialize Communications
Reinitialize Communications
If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Reset
Sequence Number,” the system restarts the expected sequence numbers using the sequence
number in the REINITIALIZE COMMUNICATIONS message.
Note: The LAS may issue a REINITIALIZE COMMUNICATIONS message after receiving an
ILLEGAL COMMAND RECEIVED message with “Sequence Number Error” error type.
If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Recover
From Communication Failure,” the system starts the Interface Initialization Sequence.
Query Analyzer Inventory/Resources
If the system receives a QUERY ANALYZER INVENTORY message, the system responds with an
ANALYZER INVENTORY message(s) containing the current assay reagent inventory.
Note: The content of the system inventory matches what is shown on the View by Assay screen.
within Reagent Management. This reports the worst case for each assay across all fluids
and reagents. Uncalibrated reagents will not be counted since they cannot be used.
If the system receives a QUERY ANALYZER RESOURCES message, the system responds with
an ANALYZER RESOURCES message containing the current onboard resource levels.
See Figure 5: Query Analyzer Inventory/Resources.
28
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Illegal Commands
Figure 5: Query Analyzer Inventory/Resources
Lab Automation
System
Query Analyzer Inventory
ACK
Analyzer Inventory
(last message = 0x00)
ACK
Analyzer Inventory
(last message = 0x00)
ACK
Analyzer Inventory
(last message = 0x01)
ACK
Query Analyzer Resources
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).
The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set
to “Sequence Number Error” if all the following conditions are met:
Pub. No.: J39931EN
Issued: 2011-01-10
•
Sequence numbers are enabled.
•
The sequence number of an incoming message does not match the expected
sequence number.
Specification for Automation Interface
VITROS® 4600 Chemistry System
29
Internationalization and Language Support
The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set
to “Logical Order Error” if any of the following conditions are met:
•
A SAMPLE IN POSITION message is sent without a corresponding PREPARE TO
RUN SAMPLE.
•
A second PREPARE TO RUN SAMPLE message is sent before the system sends a
SAMPLING COMPLETE message.
•
A second SAMPLE IN POSITION message is sent before the system sends a
SAMPLING COMPLETE message.
•
A QUERY ANALYZER INVENTORY message is sent during external sampling.
•
A QUERY ANALYZER RESOURCES message is sent during external sampling.
The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set
to “Invalid Data” if any of the following conditions are met:
•
The container type in a PREPARE TO RUN SAMPLE message is invalid.
•
The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message
contains zero or more than 15 characters.
•
The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message
contains invalid UTF-8 characters or insufficient characters (according to the sample id
length).
•
The recovery type in a REINITIALIZE COMMUNICATIONS message is invalid.
Internationalization and Language Support
The system supports the following configurations for Sample ID character encoding:
•
UTF-8 (Unicode)
•
Extended ASCII (Refer to ISO 8859-1.)
Timing Requirements
The automation system must complete the following steps within the required time period after the
SAMPLING COMPLETE message is sent by the system to guarantee system throughput. Failure
to meet this timing will result in decreased system throughput.
•
Time from SAMPLING COMPLETE to PREPARE TO RUN SAMPLE - 100
milliseconds.
•
Time from SAMPLING COMPLETE to SAMPLE IN POSITION- 6.4 seconds (6.5
seconds after PREPARE TO RUN SAMPLE).
All ACK and NAK messages must be sent within 250ms of the received command/response.
ACK messages sent by the LAS during the initialization sequence should be separated by no more
than 500ms.
LAS commands sent to the system must be spaced at least 100ms apart to allow the illegal
command response. This is to allow the system time to respond with an ILLEGAL COMMAND
RECEIVED message if required.
The last byte of a message, based on the message length, must be received within 250ms from
receipt of the STX.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Lab Automation Communication Scenarios
Lab Automation Communication Scenarios
Interface Initialization Sequence
Figure 6: Interface Initialization Sequence
Lab Automation
System
READY
ACK
ACK
ACK if no response in 0.5
second
Sequence Number = A
Sequence Number = A+1
Sequence Number = A+2
Sequence Number = A+2
Sequence Number = 0
ACK
Query Analyzer Status
ACK
Analyzer Status Message
Sequence Number = 0
Initialization Complete
Sequence Number = A+3
Sequence Number = A+3
Sequence Number = 1
ACK
READY if no response in 1
second
ACK
Analyzer Status Message
Sequence Number = 1
Note: The Query Analyzer Status message is not part of the initialization
sequence but is provided to demonstrate sequence numbers
following initialization.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
31
Lab Automation Communication Scenarios
Run Two Samples
Figure 7: Run Two Samples
Lab Automation
System
Query Analyzer Status
ACK
ASM - Ready to Sample
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Query Analyzer Status
ACK
ASM - Remote in Progress
ACK
Sampling Complete
ACK
Query Analyzer Status
ACK
ASM - Manual Operation
ACK
Query Analyzer Status
ACK
ASM - Ready to Sample
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Query Analyzer Status
ACK
ASM - Remote in Progress
ACK
Sampling Complete
ACK
Note: ASM = Analyzer Status Message
32
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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Lab Automation Communication Scenarios
Remote Sample Startup Interrupted by Local Sample
Figure 8: Remote Sample Startup Interrupted by Local Sample
Lab Automation
System
Query Analyzer Status
ACK
ASM - Ready to Sample
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Query Analyzer Status
ACK
ASM - Manual Operation
ACK
Sampling Complete (did not
sample - Manual had priority
ACK
Query Analyzer Status
ACK
ASM - Manual Operation
ACK
Query Analyzer Status
ACK
ASM - Ready to Sample
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Query Analyzer Status
ACK
ASM - Remote in Progress
ACK
Sampling Complete
ACK
Note: ASM = Analyzer Status Message
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Specification for Automation Interface
VITROS® 4600 Chemistry System
33
Lab Automation Communication Scenarios
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)
Lab Automation
System
Query Analyzer Status
ACK
Analyzer Status Message
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Sampling Complete - Completed
with Error
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Sampling Complete
ACK
34
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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Lab Automation Communication Scenarios
Non Fatal Error Condition (Unknown Sample ID)
Figure 10: Non Fatal Error Condition (Unknown Sample ID)
Lab Automation
System
Query Analyzer Status
ACK
Analyzer Status Message
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Sampling Complete - Unknown
Sample ID
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Sampling Complete
ACK
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Specification for Automation Interface
VITROS® 4600 Chemistry System
35
Lab Automation Communication Scenarios
Non Fatal Error Condition (Sample In Position Not Received in Time)
Figure 11: Non Fatal Error Condition (Sample In Position Not Received In Time)
Lab Automation
System
Query Analyzer Status
ACK
Analyzer Status Message
ACK
Prepare to Run Sample
ACK
Sampling Complete - Sample in
Position Not Rec’d in Time
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Sampling Complete
ACK
36
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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Lab Automation Communication Scenarios
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
Lab Automation
System
Query Analyzer Status
ACK
Analyzer Status Message (ASM)
ACK
Prepare to Run Sample
ACK
Sample in Position
ACK
Sampling Complete - Failed
in Sample or Analyzer
Inoperable
ACK
Initialize Analyzer
ACK
Query Analyzer Status
ACK
ASM - Analyzer Initializing
ACK
Query Analyzer Status
ACK
ASM - Analyzer is Ready
ACK
Note: ASM = Analyzer Status Message
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Specification for Automation Interface
VITROS® 4600 Chemistry System
37
Lab Automation Communication Scenarios
Sample Routed Notification
Note: Each Sample Routed message initiates a host query to the LIS.
Figure 13: Sample Routed Notification
Lab Automation
System
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
38
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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Lab Automation Communication Scenarios
Query Analyzer Inventory
Figure 14: Query Analyzer Inventory
Lab Automation
System
Query Analyzer Inventory
ACK
Analyzer Inventory
(Last message = 0x00)
ACK
Analyzer Inventory
(Last message = 0x00)
ACK
Analyzer Inventory
(Last message = 0x01)
ACK
Query Analyzer Resources
ACK
Analyzer Resources
ACK
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Specification for Automation Interface
VITROS® 4600 Chemistry System
39
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)
9,600
Length meters (ft.)
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.
40
Specification for Automation Interface
VITROS® 4600 Chemistry System
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Analyzer Dimensions
Analyzer Dimensions
This section describes the overall size of the VITROS® 4600 System.
Figure 15: Analyzer Dimensions
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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)
Specification for Automation Interface
VITROS® 4600 Chemistry System
41
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
42
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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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.
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•
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.
Specification for Automation Interface
VITROS® 4600 Chemistry System
43
System to Track Positioning/Floor Mounts or Anchors
Figure 18: Positional Requirements - Back of System (With Cabinetry)
System to Track Positioning/Floor Mounts or Anchors
Ortho Clinical Diagnostics provides two methods of locating and positioning the system to the floor
in order to maintain alignment relative to the automation system. These floor mounts also allow
service personnel to disengage the system for service and reposition the system relative to the
automation system.The ability to repeat the exact position of system relative to the original POR
depends on the following
The ability to restore the system to the exact position relative to the original POR depends on the
following factors:
44
•
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
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
System to Track Positioning/Floor Mounts or Anchors
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 OPA0627). These anchors are ordered in addition to the AT Accessory.
Figure 20: Seismic Mounts
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Specification for Automation Interface
VITROS® 4600 Chemistry System
45
Sample Positioning and Adjustments
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.
46
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)
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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Sample Positioning and Adjustments
Figure 21: Sample Position
VITROS® 4600 System Metering Proboscis Alignment
When the system and the sample tube
grasping/centering device on the track are
properly aligned, the proboscis with
disposable tip should travel to a depth of 98
mm in a 13mm diameter sample tube,
without touching the inside wall. This
alignment is primarily supported by the
system proboscis adjustment (horizontal
and perpendicular to sample travel) and
sample position adjustment along the track
length.
Figure 22: System Proboscis
The Lab Automation System vendor has
complete responsibility for the positioning
the sample tube. However, the adjustments
indicated in Sample Center Device
Adjustments: Positioning Responsibilities
on page 46 facilitates alignment between
the system and LAS.
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Dimensions shown are in mm.
Specification for Automation Interface
VITROS® 4600 Chemistry System
47
Sample Positioning and Adjustments
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
48
Specification for Automation Interface
VITROS® 4600 Chemistry System
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Sample Positioning and Adjustments
Figure 24: Point of Reference - Back of System
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Specification for Automation Interface
VITROS® 4600 Chemistry System
49
Sample Positioning and Adjustments
Figure 25: Point of Reference - Side View
50
Specification for Automation Interface
VITROS® 4600 Chemistry System
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Sample Positioning and Adjustments
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
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Specification for Automation Interface
VITROS® 4600 Chemistry System
51
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.
52
Specification for Automation Interface
VITROS® 4600 Chemistry System
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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.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
53
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
Length in mm
Fluid Volume µL
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
54
•
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.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
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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)
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•
V-Docs, the on-system documentation
•
Automation interface emulation software
Specification for Automation Interface
VITROS® 4600 Chemistry System
55
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.
56
Item
Action
Expected Result
1
Send the READY
message from the system
to the LAS.
The LAS begins the initialization
sequence.
2
From the LAS, send the
REINIT
COMMUNICATIONS
message.
The system responds and sends
a READY message, beginning
the initialization sequence.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Actual Result
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Protocol Tests
Item
Action
Expected Result
3
• From the LAS, send a
QUERY ANALYZER
STATUS command.
• Then, from the system,
send an ANALYZER
STATUS response.
The system acknowledges the
QUERY ANALYZER STATUS
command. The LAS
acknowledges the ANALYZER
STATUS response.
4
• From the automation
system, send a QUERY
ANALYZER STATUS
command.
• Then, from the system,
send an ANALYZER
STATUS response with
an incorrect CRC value.
(This step may require a
simulator.)
The system acknowledges the
QUERY ANALYZER STATUS
command. The LAS sends a
NAK message in response to the
incorrect CRC in the ANALYZER
STATUS response.
5
If the LAS uses sequence
numbers, repeat steps 1
through 4 using each
sequence number. Enable
sequence numbers as
described in the section
Sequence Numbers on
page 8. Test sequence
number wrap around
condition.
Control flow and status
messages are the same as in
steps 1 through 4. Ensure that
the sequence numbers are
incrementing in each command/
response pair.
Actual Result
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:
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•
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
Specification for Automation Interface
VITROS® 4600 Chemistry System
57
Protocol Tests
Refer to Query Analyzer Inventory on page 39.
Item
Action
Expected Result
1
• From the LAS, send a
QUERY ANALYZER
STATUS command.
• Then, from the system,
send an ANALYZER
STATUS response.
The system acknowledges the
QUERY ANALYZER STATUS
command. The LAS
acknowledges the ANALYZER
STATUS response.
2
Repeat step 1, sending
back all possible Analyzer
Status codes to the
QUERY ANALYZER
STATUS command. (This
step may need a
simulator.)
The LAS accurately interprets
and takes appropriate action for
each ANALYZER STATUS
response. Refer to Analyzer
Status Codes in Analyzer Status
on page 14.
Actual Result
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:
58
•
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.
Specification for Automation Interface
VITROS® 4600 Chemistry System
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Protocol Tests
Refer to Sample Metering Handshaking on page 23.
Item
Action
Expected Result
1
• From the LAS, send a
PREPARE TO RUN
SAMPLE and a
SAMPLE IN POSITION
command to the system.
• From the system, send
back a SAMPLE
COMPLETE message
with a status of “Sample
Aspirated As Expected.”
The system acknowledges the
PREPARE TO RUN SAMPLE
and SAMPLE IN POSITION
messages. Ensure the Sample
Complete status is interpreted
correctly by the automation
system and that the proper
action is taken with the sample.
Refer to Metering Status Codes
in Sampling Complete on
page 17.
2
Repeat step 1, sending
back all possible SAMPLE
COMPLETE status
values. (This step may
need a simulator.)
The automation system
accurately interprets and takes
appropriate action for each
SAMPLE COMPLETE response.
Actual Result
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.
Item
Action
Expected Result
1
• From the LAS, send a
command to the system
containing an invalid
CRC value.
• Send the same message
again with a valid CRC
value.
• The system does not
acknowledge the first
command.
• The system acknowledges the
second command.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
Actual Result
59
Protocol Tests
60
Item
Action
Expected Result
2
• From the LAS, send a
command to the system
containing an invalid
CRC value.
• Resend the command
again with the invalid
CRC value.
On receiving the second
incorrect CRC, the system stops
accepting any new commands
until a REINITIALIZE
COMMUNICATIONS command
is sent.
3
Send a REINITIALIZE
COMMUNICATION
message to recover from
the interface
communications error
generated in step 2.
Normal operation resumes.
4
From the LAS, send an
undefined message to the
system. The system sends
an ILLEGAL COMMAND
RECEIVED message to
the LAS.
The LAS interprets the ILLEGAL
COMMAND RECEIVED
message.
5
From the LAS, send a
PREPARE TO RUN
SAMPLE command to the
system with an invalid
container type.
The system sends an ILLEGAL
COMMAND RECEIVED
message to the LAS. The LAS
interprets the ILLEGAL
COMMAND RECEIVED
message.
6
From the LAS, send a
PREPARE TO RUN
SAMPLE command to the
system with a nonprintable character in the
sample ID.
The system sends an ILLEGAL
COMMAND RECEIVED
message to the LAS. The LAS
interprets the ILLEGAL
COMMAND RECEIVED
message.
7
Reinitialize
communications with the
system with sequence
numbers enabled. From
the LAS, send a command
with an invalid sequence
number.
The system sends an ILLEGAL
COMMAND RECEIVED
message to the LAS. The LAS
interprets the ILLEGAL
COMMAND RECEIVED
message.
8
From the LAS, send a
REINITIALIZE
COMMUNICATIONS
command to the system to
reset the sequence
number.
Normal communication
resumes.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Actual Result
Pub. No.: J39931EN
Issued: 2011-01-10
Protocol Tests
Item
Action
Expected Result
9
From the LAS send a
REINITIALIZE
COMMUNICATIONS
command to the system
with a recovery type of
0xFF
The system sends an ILLEGAL
COMMAND RECEIVED
message to the LAS. The LAS
interprets the ILLEGAL
COMMAND RECEIVED
message.
10
From the LAS, send a
PREPARE TO RUN
SAMPLE and a SAMPLE
IN POSITION command to
the system. From the
system, send a SAMPLE
COMPLETE message
containing a different
sample ID than the one in
the PREPARE TO RUN
SAMPLE command.
The system acknowledges the
PREPARE TO RUN SAMPLE
message and the SAMPLE IN
POSITION message. The
automation system recognizes
the different sample ID in the
SAMPLE COMPLETE message
as an error.
Actual Result
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.
Item
Action
Expected Result
1
Send the SAMPLE
ROUTED message from
the LAS specifying a
sample ID.
The LIS receives a host query
from the system for the sample
ID specified in the SAMPLE
ROUTED message.
Actual Result
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.
Item
Action
Expected Result
1
Send the QUERY
ANALYZER INVENTORY
message from the LAS.
The automation system
interprets the ANALYZER
INVENTORY response(s)
correctly. If multiple data packets
are required to receive the
inventory information, the data
packets are handled correctly.
Pub. No.: J39931EN
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Specification for Automation Interface
VITROS® 4600 Chemistry System
Actual Result
61
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.
Item
Action
Expected Result
1
Send the QUERY
ANALYZER
RESOURCES message
from the LAS.
The automation system
interprets the ANALYZER
RESOURCES response
correctly.
Actual Result
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.
62
Item
Action
Expected Result
1
While monitoring the LAS
communications, send the
QUERY ANALYZER
STATUS message from
the LAS.
The LAS receives and correctly
interprets the ANALYZER
STATUS message. The
automation system should not
present a sample to the system
unless the status is “Analyzer is
Ready to Sample.”
2
While monitoring the LAS
communications, send the
PREPARE TO RUN
SAMPLE command to the
system.
The LAS receives the proper
responses. If the time between
PREPARE TO RUN SAMPLE
and SAMPLE IN POSITION
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
send the SAMPLE
COMPLETE response.
The LAS acknowledges the
SAMPLE COMPLETE message.
The sample ID matches the one
in the PREPARE TO RUN
SAMPLE command.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Actual Result
Pub. No.: J39931EN
Issued: 2011-01-10
Physical Interfaces
Item
Action
Expected Result
4
From the LAS, process
two consecutive samples
with a delay of 1 second
between the SAMPLE
COMPLETE message
from the system for the
first sample and the
PREPARE TO RUN
SAMPLE message from
the LAS for the second
sample.
The system processes the
samples. The system throughput
is reduced and there is a delay
between processing the first and
second sample.
5
From the LAS, process
two consecutive samples.
Send the PREPARE TO
RUN SAMPLE message
for the second sample
100ms after receiving the
SAMPLE COMPLETE
message for the first
sample.
The system processes the
samples. The system throughput
is not reduced; there is no delay
between processing the first and
second sample.
6
Load a sample in the
STAT lane of the system
and start sampling. Then
attempt to process a
sample from the LAS.
The system processes the
sample from the STAT lane of
the system and sends a
SAMPLE COMPLETE message
to the LAS with a metering
status of “Internal sample has
priority.”
Actual Result
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.
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
63
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.
64
Item
Action
Expected Result
1
Verify that the Lab
Automation System allows
the sample positioning
device to be adjusted
along the length of the
track and fixed into
position.
The automation system sample
positioning device must be
adjustable along the length of
the track to ensure alignment of
the sample with the system
proboscis travel.
2
Measure the height to the
top of the longest sample
tube from the floor when
properly positioned for
sample aspiration by the
sample positioning device.
When sample metering is
adjusted to the tallest tube
height 100mm, aspirate depth is
98 mm maximum from that point.
3
• In normal operating
sample handling mode,
fill 13mm sample tubes
with just enough fluid for
1 test per sample.
• Place sample tubes on
the track and route them
to the 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.
When the system is rigidly
mounted and properly adjusted,
there should be no contact
between the sampling probe and
the sample tube.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Actual Result
Pub. No.: J39931EN
Issued: 2011-01-10
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.
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
65
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.
66
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Interface Topology
Figure 31: Interface Topology - Case 2
Case 3
The LAS intercepts communication between the LIS and all instruments, both on-track and offtrack.
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.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
67
Interface Topology
Figure 32: Interface Topology - Case 3
68
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
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.
Patient Safety Considerations
Potential Risk
Potential Result
Recommended Preventive Action
Contamination from the
chemical cleaning agent
Contamination or
degradation of
sample
Refer to the Reference Guide for cleaning
agents and protocol. See the onboard VDocs for VITROS® 4600 System or
Reference Guide, J39821 on the CD-ROM.
Particulate
contamination of sample
on the automation track
Contamination or
degradation of
sample
Remove the stopper from sample tubes as
close to the system as possible to maintain
sample quality.
For any volatile assays,
evaporation or outgassing while the
sample tube is on the
automation track
Degradation of
sample
Remove the stopper from sample tubes as
close to system as possible to maintain
sample quality.
Cross contamination
from adjacent sample
on the automation track
Contamination or
degradation of
sample
Set up automation systems to handle
samples in a manner that prevents cross
contamination.
Sample crosscontamination Aspirating second fluid
quantity into same tip
(“double dip”) when the
sample on track has
been released too early
and next sample is in
position.
Crosscontamination of
sample on track
Make sure that LAS receives a SAMPLE
COMPLETE message from the system
before releasing the sample. Refer to
Sample Metering Handshaking on page 23.
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Specification for Automation Interface
VITROS® 4600 Chemistry System
69
Patient Safety Considerations
70
Potential Risk
Potential Result
Recommended Preventive Action
Sample too cold after
holding in refrigerated
section of track for reflex
testing. (Automation
track supplier controls
temperature)
Sample
temperature
outside system
limits
Provide a means of sample temperature
equilibration to room temperature after
refrigeration before the sample is presented
for metering at the system.
Misalignment of
automation track with
the system.
Sample aspirate
volume error
Follow specifications for sample tube
location specified in Sample Center Device
Adjustments: Positioning Responsibilities on
page 46.
EMI from automation
track to the system via
coupling.
Sample aspirate
volume error
• Ensure that automation track meets
agency specifications.
• Isolate the mechanical coupling between
the sample automation track and the
system to address potential EMI concerns.
Over-wet sample tip or
aspiration of air
because the tube
diameter information
from automation system
is incorrect.
Sample aspirate
volume error
• Use error checking communication
protocol (CRC).
• Follow communications specifications in
Section 2. Software Interfaces.
Sample tube breaks at
automation track and
the system interface.
System
synchronization
or timing error
• Refer to acceptable sample tube sizes for
the specified in Section 4. Sample
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
between the system and
the LAS.
System
synchronization/
timing error
Follow communications specifications in
Section 2. Software Interfaces.
Incorrect sample
presented to the
system.
Aspirate from
incorrect sample
Ensure the integrity of the sample ID
communicated to the system and
positioning of that sample.
Sample ID miscommunicated from
LAS.
Aspirate from
incorrect sample
Verify sample ID in the SAMPLE
COMPLETE message sent to LAS.
Automation track
system misreads the
sample tube/carrier
barcode.
Aspirate from
incorrect sample
Use barcode verification for labels (i.e.,
check digit) and limit the scanner view to
one sample.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
Operator Considerations
Potential Risk
Potential Result
Recommended Preventive Action
Inadequate
consumables (reagents,
tips, etc.) on the system
to complete the test.
Test not
completed
• Send system resource inventory to LIS
upon request.
• Verify adequate supplies by LAS via LIS. If
the supplies are inadequate, have the LAS
reroute the sample to another system.
STAT sample on the
track is unknown to the
system. (All samples on
the system have priority
over samples on the
track.)
A STAT sample
on the track may
not be processed
in a timely
fashion
Place STAT samples on the system
manually and process as locally loaded
samples.
Sample tube arrives
with stopper inserted in
tube.
Test not
executed
Remove stoppers (caps) from sample tubes
to allow the system to access the tubes.
Remove caps when the tubes are as close
to the system as possible to ensure sample
quality.
Sample Metering
general error report is
interpreted incorrectly
by the LAS.
Test not
completed
• Use error checking communication
protocol (CRC).
• Use message formats specified in Section
2. Software Interfaces.
Inactive subsystem(s)
on the system.
Test not
completed
Have the LAS verify the system status
before the sample arrives.
Software suppressed
results (due to a
detected error) for a
STAT test.
Test not
completed within
expected time
• Place STAT samples on the system
manually and process as locally loaded
samples.
• Verify the system status and condition
reports by LAS/LIS
Potential Risk
Potential Result
Recommended Preventive Action
Electric shock at
automation track-tosystem coupling.
Electrical
hazards
Make sure that track is properly grounded.
Operator Considerations
Pub. No.: J39931EN
Issued: 2011-01-10
Specification for Automation Interface
VITROS® 4600 Chemistry System
71
Environmental Considerations
Environmental Considerations
72
Potential Risk
Potential Result
Recommended Preventive Action
Metering proboscis
stuck in sample tube on
track when sample is
released by the
automation system
Mechanical
damage to
sample track
area and system
• Initialize sample metering subsystem by
LAS if it receives a SAMPLE COMPLETE
message combined with a sample
metering error message from the system.
• Do not move the sample from metering
position until the LAS receives a SAMPLE
COMPLETE status without an error
message from the system.
Specification for Automation Interface
VITROS® 4600 Chemistry System
Pub. No.: J39931EN
Issued: 2011-01-10
IVD
EC
REP
Ortho-Clinical Diagnostics
Johnson & Johnson
50 - 100 Holmers Farm Way
High Wycombe
Buckinghamshire HP12 4DP
United Kingdom
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626