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LIS - Abbott Architect-90937-105
LIS - Abbott Architect-90937-105
LIS - Abbott Architect-90937-105
ARCHITECT System
Laboratory Automation System
Standard Interface Manual
90937-105
© 1998, 2014 Abbott Laboratories
Table of contents
Read me first ..............................................................................Read me first-1 Customer service
................................................................................................. Read me first-2 Proprietary statement
...........................................................................................Read me first-3 Disclaimers
........................................................................................................... Read me first-4 ARCHITECT System
warranty statement for USA customers only ...................Read me first-5 ARCHITECT System Agency
approvals ..............................................................Read me first-6 Trademark statement
...........................................................................................Read me first-7 System labeling
.................................................................................................... Read me first-8 LAS configuration
........................................................................................ 1-1 Configure LAS settings
.............................................................................................................1-2 Configure LAS serial port
settings ...........................................................................................1-3 View the LAS timeout setting
...................................................................................................1-4 View the LAS serial port settings
.............................................................................................1-5 Verify LAS communications
..................................................................................................... 1-6 LAS requirements
........................................................................................ 2-1 Processing module-specific requirements
.............................................................................. 2-2 Standard components
.............................................................................................................. 2-4 Port connections
.......................................................................................................................2-5 System LAS skins kits
.............................................................................................................. 2-6 Third-party vendor LAS
guidelines .......................................................................................... 2-7 General responsibilities
..................................................................................................... 2-7 Safety provisions
................................................................................................................2-8 Sample pipettor safety guard
............................................................................................2-9 Mechanical interface
......................................................................................................... 2-9 Emergency stop
............................................................................................................... 2-10 Physical requirements
..................................................................................................... 2-15 Processing module drawings
.......................................................................................... 2-17 ARCHITECT standard interface
specification ................................................... 3-1 Assumptions and dependencies
.............................................................................................. 3-2 Communications overview
........................................................................................................3-3 Message format
........................................................................................................................3-5 Cyclical redundancy
checks .................................................................................................... 3-6 Sequence numbers
...................................................................................................................3-7 Interface initialization
sequence .............................................................................................. 3-9 Messages
................................................................................................................................3-10 ACK (message
acknowledged) .......................................................................................3-10 NAK (message not
acknowledged) ................................................................................ 3-11 LAS to processing module
messages ............................................................................ 3-11 Processing module to LAS messages
............................................................................3-17 LAS/processing module interaction diagrams
...................................................................... 3-27 Establishing communication
............................................................................................3-27
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Table of contents-i
Table of contents
Running samples ..............................................................................................................3-28 LAS sample
startup interrupted by sample on the i 2000 processing module sample
carousel .....................................................................................................................3-31 LAS sample
startup interrupted by sample on the c System processing module
sample carousel ........................................................................................................3-32 Using
sequence numbers ................................................................................................3-33 Running samples
with Pipettor bypass enabled ............................................................ 3-36 Error scenario 1 - Double sample
in position ................................................................ 3-37 Error scenario 2 - Probe failure in tube
......................................................................... 3-39 Error scenario 3 - Failure of sample to remain at
aspiration point until processing
module completes sampling .....................................................................................3-40 Error scenario 4 -
Using virtual messaging with Pipettor bypass disabled .................. 3-41 Processing module/LAS/LIS
configurations ..................................................... 4-1
Foreword
This manual has been designed to help you familiarize yourself with all aspects of the LAS (laboratory
automation system) standard interface with the ARCHITECT System.
Read me first topics include:
• Customer service, page Read me first-2
• Proprietary statement, page Read me first-3
• Disclaimers, page Read me first-4
• ARCHITECT System warranty statement for USA customers only, page Read me first-5
• ARCHITECT System Agency approvals, page Read me first-6
• Trademark statement, page Read me first-7
• System labeling, page Read me first-8
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Read me first-1
Customer service Read me first
Customer service
For questions about the ARCHITECT System, contact your local representative or find country-specific
contact information at www.abbottdiagnostics.com.
Read me first-2 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Read me first Proprietary statement
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Proprietary statement
The ARCHITECT System software programs and system documentation are protected by copyright
(©1998, 2014 Abbott Laboratories, Abbott Park, Illinois). All rights are reserved.
The software and manual were developed solely for use with the ARCHITECT System and for In Vitro
diagnostic applications as specified in the operating instructions.
The information, documents and related graphics published herein (the "Information") are the sole
property of Abbott Laboratories. Permission to use the Information is granted, provided that
• the copyright notice appears on all copies;
• use of the Information is for operation of ABBOTT products by Abbott trained personnel or
informational use only;
• the Information is not modified in any way; and
• no graphics are used separate from accompanying text.
Each person assumes full responsibility and all risks arising from use of the Information. The Information
is presented "AS IS" and may include technical inaccuracies or typographical errors. Abbott Laboratories
reserves the right to make additions, deletions, or modifications to the Information at any time without
any prior notification.
Read me first-3
Disclaimers Read me first
Disclaimers
All samples (printouts, graphics, displays, screens, etc.) are for information and illustration purposes only
and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens
do not reflect actual patient names or test results.
The Information was developed to be used by Abbott Laboratories trained personnel, by other persons
knowledgeable or experienced with the operation and service of the product identified, or under the direct
supervision and with cooperation from Abbott Laboratories technical sales or service representatives.
In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in
connection with or arising from the use of the Information by persons not fully trained by Abbott
Laboratories. This limitation shall not apply to those persons knowledgeable or experienced with the
operation and service of the product identified, or under the direct supervision and with cooperation from
Abbott Laboratories technical sales or service representatives.
No confidential relationship shall be established in the event that any user of the Information should make
any oral, written or electronic response to Abbott Laboratories (such as feedback, questions, comments,
suggestions, ideas, etc.). Such response and any information submitted therewith shall be considered non-
confidential, and Abbott shall be free to reproduce, publish or otherwise use such information for any
purposes whatsoever including, without limitation, the research, development, manufacture, service, use,
or sale of products incorporating such information. The sender of any information to Abbott is fully
responsible for its content, including its truthfulness and accuracy and its non- infringement of any other
person's proprietary rights.
Abbott Laboratories is not engaged in rendering medical advice or services.
Updates to the Information may be provided in either paper or electronic format. Always refer to the latest
documents for the most current information.
Incremental manual updates may cause the master Table of contents or master Index page numbering to
change.
No part of this media may be reproduced, stored, retrieved, or transmitted in any form or by any means
without the prior written permission of Abbott Laboratories.
Read me first-4 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Read me first ARCHITECT System warranty statement for USA customers only
Trademark statement
AbbottLink, ARCHITECT, i1000
SR
, i4000
SR
Read me first-7
System labeling Read me first
System labeling
The symbols in the following table are used on ARCHITECT System labeling.
Key to symbols used on labeling
Label Description
Read me first-8 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Authorized Representative in the European Community
Legal manufacturer
In Vitro Diagnostic Medical Device
Manufacturer
Date of manufacture
Serial number
Alternating current
Laser
Caution, risk of electrical shock
Electrical and electronic equipment waste
NOTE: Indicates the item should go to a separate waste collection for electrical and electronic equipment and should
not go into the general waste or trash.
Read me first System labeling
Label Description
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Read me first-9
Temperature limitation
Use by/Expiration date
Consult operating instructions
Caution, consult accompanying documents
Batch code/Lot number
Quantity
Unit
Biological risks
Biohazard
Caution, hot surface
Caution, probe stick hazard
Assay disk
Version
Conventional units
Standard international unit
Sample cups
ICT Cleaning Fluid
ICT Lyophilized Cleaning Solution
Water Bath Additive
Pre-Trigger Solution
System labeling Read me first
Label Description
Utilizing approved procedures, the instrument is restored to original specifications. In addition, any approved
mandatory upgrades are performed.
Key to symbols used only on ARCHITECT iARM labeling
Label Description
Read me first-10 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Trigger Solution
Concentrated Wash Buffer
Wash buffer
Reaction vessels
Septum
Replacement caps
Multi-Assay Manual Diluent
Catalog number/List number
Acid Wash
Alkaline Wash
ICT Reference Solution
Detergent A
Detergent B
For use with
Product of USA
Caution, water inlet pressure is not to exceed 30 psig.
Caution, surface is unsuitable for stepping onto
Caution, surface is unsuitable for sitting on
Read me first System labeling
Label Description
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Read me first-11
Flush outlet
Gravity waste outlet
Water inlet
Caution, protective earth ground required
System labeling Read me first
NOTES
Read me first-12 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Section 1 LAS configuration Introduction
Configuration involves supplying the ARCHITECT System with information it needs to meet your site's
specific LAS requirements. You perform system configuration at the time of installation and may
reconfigure the system at any time if necessary.
NOTE: Refer to the ARCHITECT System Operations Manual for a description of screens and windows
used for LAS configuration.
LAS configuration topics include:
• Configure LAS settings, page 1-2
• Configure LAS serial port settings, page 1-3
• View the LAS timeout setting, page 1-4
• View the LAS serial port settings, page 1-5
• Verify LAS communications, page 1-6
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 1-1
LAS configuration Configure LAS settings Section 1
processing module:
• The LAS vendor must provide a means for local sample handling for patient samples, calibrators, and
controls. This solution must also support a stand- alone mode (continued sample processing when the
LAS system is down), a separate power supply, control hardware, and a local user interface.
• For samples that require STAT and Routine tests, samples must be presented to the STAT LAS position
(right side of the processing module) first and the Routine LAS position (left side of the processing
module) second, regardless of the tests ordered on the sample. If samples are presented to the Routine
LAS position first, the processing module sends a SAMPLING COMPLETE message with the 0x01 field
indicating "No test ordered for SID" and not process any routine tests.
For samples that only have routine tests ordered:
– If the LAS has the physical capability to bypass the STAT LAS position, Virtual Messaging (SAMPLE
IN STAT POSITION / STAT SAMPLING COMPLETE) allows the LAS to position the sample at the
Routine pipettor. These messages do not require the sample to be physically positioned at the STAT LAS
position when they are sent.
– If the LAS does not have the physical capability to bypass the STAT
LAS position, the LAS must still position the sample at the STAT LAS position, send the SAMPLE IN
STAT POSITION message, and wait for the STAT SAMPLING COMPLETE message before
positioning the sample at the Routine LAS position.
For samples that only have STAT tests ordered:
– If the LAS has the physical capability to bypass the routine LAS
position, Virtual Messaging (SAMPLE IN POSITION / SAMPLING COMPLETE) allows the LAS to
position the sample at the STAT pipettor. These messages do not require the sample to be physically
positioned at the routine LAS position when they are sent.
– If the LAS does not have the physical capability to bypass the routine
LAS position, the LAS must still position the sample at the routine LAS position, send the SAMPLE IN
POSITION message, and wait for the SAMPLING COMPLETE message before moving the sample away
from the processing module.
Section 2-2 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
LAS
requirements Section 2
Processing module-specific requirements
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
NOTE: To use virtual messages, the LAS must have knowledge of orders on samples and be able to
determine the difference between STAT and routine assays. Additionally, the LAS must provide the
hardware necessary to bypass the STAT and routine sampling position. If a sample bypasses a pipettor
with orders for that pipettor, those orders for that pipettor will be sent to exception.
• The processing module can be mounted on the left or right side of the LAS, however the LAS must not
block service access to the processing module and the sample presentation described above must be
maintained.
Section 2-3
LAS requirements Standard components Section 2
Standard components
The following table describes components supplied by Abbott Laboratories.
Table 2.1: Standard components supplied by Abbott Laboratories
Component Description LAS interface Communicates with the LAS via RS-232 LIS interface Communicates with
the LIS via RS-232 or TCP-IP Sample carousel (c System) Provides local sample handling and can also be
used as a backup to the track LAS carousel (i2000), LN8C96-07 Provides a
backup to the track LAS skins kit Includes sample covers and track support assembly LLS antenna with cabling (i
System)
Section 2-4 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Provides liquid level sense capability to the track
LAS
requirements Section 2
Port connections
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Port connections
The LAS port is a RS-232 serial cable with a 25-pin connector. Only pins 1, 2, 3, and 7 of the connector
are used. Refer to the following table and figure for pin assignment information.
Table 2.2: PIN assignments for the 25-pin connector
Pin No. EIA Circuit Description Direction - Abbott
instrument
Direction - Computer 1 – Shield – No Connection 2 BA Transmitted Data Output Input 3 BB Received Data Input
Output 7 AB Signal Ground – –
Figure 2.1: Pin-to-pin connections (wiring diagram)
Section 2-5
See Configure LAS serial port settings, page 1-3.
LAS requirements System LAS skins kits Section 2
General responsibilities
The table below describes general responsibilities of a third-party vendor.
Table 2.3: LAS vendor responsibilities
Component Description LAS track Provides tube positioning control and/or adjustments
in X, Y, and Z axes Bar code reading capability Guarantees positive identification of patient sample
identification Physical connection and guarding Connects LAS track to the ARCHITECT processing
module where applicable Communication cable Connects LAS track to the ARCHITECT processing
module Positive sample identification Ensures accurate sample identification throughout
sample aspiration Emergency stop facility (if required by area-specific
regulations)
Provides emergency stop capability for each processing module
Pipettor safety guard Prevents contact with the pipettor probe during
operation LAS track to processing module level sense interface (i System)
LAS track must provide unshielded access to the sampling position to ensure proper level sense capability by the
processing module LAS track to processing module level sense interface (c System)
LAS track must ensure proper level sense capability by the processing module
Section 2-7
LAS requirements Third-party vendor LAS guidelines Section 2
Safety provisions
Before LAS operation begins, vendors are responsible for ensuring compliance to area-specific
regulations which may include installing an emergency stop capacity for the ARCHITECT processing
module.
The LAS is responsible for ensuring the sample at the aspiration position is held in place until the
processing module returns a sampling complete message (0xC005 and 0xC00B) for Physical messaging
only (Message type: 0x00). The LAS must detect any condition whereby the sample is moved prior to
receiving this message and an incorrect sample is presented for sample aspiration. If this condition is
detected:
• the LAS must immediately stop presenting additional samples to the processing module.
• results from the first and subsequent impacted samples must be suppressed (see Risk mitigation, page
5-1). One method of suppressing results is by stopping the processing module by sending the
REINITIALIZE COMMUNICATIONS (recovery 0x03).
• the subsequently impacted sample(s) must be discarded (c System only).
• the sample probe must be replaced and calibrated before proceeding (c System only).
NOTE: If Pipettor Bypass (Virtual Messaging) is enabled and the LAS determines that a sample only has
tests ordered for one pipettor, virtual messages must be used to skip the appropriate pipettor position.
Installation, design, and configuration of the interface between the ARCHITECT processing module and
LAS track must meet applicable safety standards. These standards are listed in the following table.
Table 2.4: Safety standards
Identifier Title UL 61010A-1 Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1 General Requirements IEC 61010-1 Safety Requirements for
Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1 General Requirements CAN/CSA-C22.2 No. 1010-1 Safety
Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1 IEC/EN 61010-1 Safety
Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1 IEC 61010-2-081 Safety Requirements for Electrical Equipment
for Measurement, Control, and Laboratory Use - Part
Section 2-8 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
LAS
requirements Section 2
Third-party vendor LAS guidelines
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
CAUTION: Prior to operation of the new equipment the vendor must perform a risk assessment to
anticipate all possible operator hazards, including potential operator misuse.
Mechanical interface
Because individual installations can vary, expertise in mechanical design and fabrication is required to
customize the installation to fulfill applicable safety requirements.
NOTE: All stated dimensions are nominal and are for reference only. Systems designed to interface to the
ARCHITECT processing module must account for
Section 2-9
Identifier Title
2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other
purposes IEC 61010-2-101 Safety Requirements for Electrical Equipment for Measurement, Control, and
Laboratory Use - Part 2-101: Particular requirements for In Vitro (IVD) medical equipment ISO 3864:1984 Safety
colors and safety signs 98/79/EC In Vitro Diagnostic Directive
LAS requirements Third-party vendor LAS guidelines Section 2
hardware manufacturing tolerances and installation environment anomalies (variances). Contact Abbott
Laboratories for detailed mechanical drawings of the ARCHITECT processing modules.
Mechanical interface requirements include:
• The height of the tube carrier (for example the bottom of the tube) shall be approximately 34 inches
(868 mm) from the floor.
• For c Systems and i2000
SR
, the LAS connection may use the mounting interface designed for the RSH
(Retest Sample Handler), with adjustable hooks or similar mechanical mountings, on the LAS processing
module interface module.
• For the i2000, the left side of the processing module has a bolt hole pattern available for physical
connection between the processing module and the LAS.
• The physical connection is important to maintain the relative positions of both units (determined at
installation), and to prevent sampling errors caused by movement of either the ARCHITECT processing
module or the LAS. An electrically insulated mechanical connection is recommended between the LAS
mechanical mountings and LAS to maintain alignment of the processing module probe to the sample tube
position.
• The LAS shall be electrically insulated from the mounting brackets attached to the ARCHITECT
processing module.
IMPORTANT: The c System LAS requires the sample to be capacitively coupled to the c System ground
to ensure proper function of the c System liquid level sense (LLS). This capacitive path includes the LAS
track. It is the LAS vendors' responsibility to ensure the c System LLS performance has not been
compromised.
The i System sample LLS (liquid level sense) is based on a principle similar to AM radio transmission.
The sample probe transmits a fixed frequency signal over the air. This signal is received by the antenna
PCBs (printed circuit boards) mounted on the front of the processing module at each aspiration location.
To ensure proper function, the LAS must provide a clear electrically unshielded path between the entire
sample tube and the antenna. It is the LAS vendor's responsibility to ensure the i System LLS
performance has not been compromised.
Emergency stop
An emergency stop facility shall be installed in the sample pipettor vicinity if required by area-specific
regulations. This allows an operator to quickly stop the processing module to avoid any potentially
hazardous situation.
Emergency stop topics include:
• Electrical hookup, page 2-11
Section 2-10 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
LAS
requirements Section 2
Third-party vendor LAS guidelines
• Accessibility, page 2-12
• Restrictions, page 2-12
• Reliability, page 2-13
• Easily identifiable controls, page 2-13
• Control types, page 2-13
• Legible markings, page 2-14
• Irreversible engagement, page 2-14
• Integration with other emergency stop controls, page 2-15
Electrical hookup
The activation of an emergency stop control must halt all potentially hazardous movement immediately.
If the processing module is to be installed in a laboratory where emergency stop systems already exist,
then the new emergency stop control shall be integrated into the functionality of the previously installed
system allowing the emergency stop controls to activate for the entire system at once.
Since the emergency stop facility involves interruption of hazardous voltages the installation must be
performed only by a qualified electrician. Components of the emergency stop facility must account for
analyzer ratings.
For the processing module the effect of the control is the immediate removal of the main electrical input
power to the module. This halts all movement immediately.
Figure 2.2: Emergency stop operation
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 2-11
LAS requirements Third-party vendor LAS guidelines Section 2
NOTE: It is necessary (or desirable) to remove power to the SCC (system control center) to meet this
requirement.
Accessibility
The emergency stop engagement control shall be located:
• for quick accessibility and for safe operation without hesitation.
• within easy reach of the sample pipettor safety guards.
• within visual range of the sample pipettor movement.
For more information, see Restrictions, page 2-12.
Restrictions
The emergency stop engagement control:
• shall not be more than 63 inches (1.6 m) from the sample pipettor.
• shall be between 24 inches (0.6 m) and 63 inches (1.6 m) above the floor level.
• mounting, location, and activation method shall be such that engagement occurs only when intended.
Figure 2.3: Emergency stop shall be located near the sample pipettor area
Section 2-12 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
LAS
requirements Section 2
Third-party vendor LAS guidelines
Reliability
Components that comprise the emergency stop facility and their installation must operate reliably in the
environment in which they reside. Reliability considerations include:
• vibration
• shock
• temperature
• dust
• foreign bodies
• moisture
• corrosive materials
• likelihood of infrequent operation
The control must be able to withstand significant stresses that could result from foreseeable abuse during
activation in emergency situations.
The design of the control shall be constructed so that it is not easily bypassed or defeated.
The components and installation shall conform to local electrical codes and standards.
Easily identifiable controls
The emergency stop control shall be:
• clearly identifiable.
• adequately illuminated.
• colored red.
The background should be colored yellow (as far as practical).
Figure 2.4: Emergency stop control
Control types
Acceptable actuators include:
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 2-13
LAS requirements Third-party vendor LAS guidelines Section 2
• mushroom-type push buttons
• wires, ropes, bars
• handles
When wires, ropes, bars, or handles are used to activate the electrical switch that removes power from the
system, ensure the LAS is brought to an immediate halt in the event of a failure of the mechanical
operating mechanism.
Legible markings
Requirements for markings include the following:
• Switch markings shall be designed to remain legible for as long as the equipment is installed.
• Informational signs, if used, shall be unambiguous and written in the language of the country in which
the system is installed.
• General warning signs, such as showing only the words Danger or Hazard, shall not be used.
Irreversible engagement
Once the emergency stop is engaged, re-activation of the equipment shall only be possible when intended.
Resetting the control device shall not, by itself, restore operation to the potential hazard.
Some commercially available controls are designed to meet the requirements of European Standard
EN418.
Figure 2.5: Emergency stop switch examples
Section 2-14 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
The emergency stop switch on the left in the figure above is designed to be readily engaged but it can
only be reset using a key.
Temporary removal of the main electrical input power to the processing module is sufficient to prevent
re-activation of the sample pipettor. This is because power loss to the module resets all of its electrical
devices, including the sample pipettor. Restoration of operation occurs only following an initialization
procedure that can only be intentionally invoked by an operator.
LAS
requirements Section 2
Third-party vendor LAS guidelines
Integration with other emergency stop controls
If the installation environment includes emergency stop controls for other related equipment, the control
added shall be integrated so that all related equipment is disengaged simultaneously.
Physical requirements
LAS physical requirements are described in the following table.
Table 2.5: LAS physical requirements
Requirement Description LAS tube stop calibration The LAS shall provide a mechanical tube stop
adjustment parallel to the X-axis. See Table 2.6. LAS to module clearance
(pipettor reach)
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
The POR (Point of Reference) shall be no more than:
• 1.69 inches (43 mm) from the front panel of the c System processing module
• 1.97 inches (50 mm) from the side of the i2000 processing module
• 1.5 inches (38.1 mm) from the front panel of the i2000
SR The POR is defined as the outside bottom of the sample container located in the aspiration position of the LAS.
See Figures 2.6, 2.7, and 2.12. Tube bottom elevation The POR (Point of Reference) shall be located
approximately 34 inches (868 mm) from the laboratory floor. See Figures 2.6, 2.7, and 2.12. This dimension is
referred to as the Z-axis.
NOTE: A tube spacer may be required for lifting tubes on a LAS set at the CLSI standard 33.5 inches (850 mm)
POR.
LAS positioning accuracy The LAS tube centering hardware shall position tube
centers repeatable to the trained aspiration point within 0.04 inches (1 mm) diameter. LAS isolated electrically from
processing module
No electrical connection is allowed between the ARCHITECT processing module and the LAS, per UL
(Underwriter's Laboratories), unless the LAS is also UL listed. The LAS vendor shall be responsible for any
physical connection between the ARCHITECT processing module to the LAS tube positioning hardware.
NOTE: The connection points are not intended to be ground points, and shall require use of an insulating
Section 2-15
LAS requirements Third-party vendor LAS guidelines Section 2
Requirement Description
material as an integral part of the connection to avoid unintentional grounding.
If the LAS is to be physically connected to the ARCHITECT processing module, insulators to prevent electrical
connection between the LAS and the processing module are required. If the LAS is not physically connected to the
processing module, the LAS and the processing module shall each be immobilized by independent means. Physical
mounting Contact Abbott Laboratories for detailed mechanical
drawings of the ARCHITECT processing modules. LAS sample containers The LAS shall accommodate sample
containers as described in CLSI AUTO-1, Laboratory Automation: Specimen Container/Specimen Carrier, which
includes the following nominal sized:
• 13 x 75 mm
• 13 x 100 mm
• 16 x 75 mm
• 16 x 100 mm In addition, sample containers must meet requirements described in the ARCHITECT System
Operations Manual.
NOTE: Use of sample cups in conjunction with sample tubes is not recommended for some laboratory automation
systems. Contact Abbott Laboratories and/or your LAS vendor for further details.
LAS sample access The user must be able to remove samples from the
LAS if a mechanical or electrical failure occurs. LAS sample access must be limited by interlocks or covers that
require tools for removal. Emergency stop facility (if required by area-specific regulations)
Section 2-16 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24 The LAS vendor must provide an emergency stop switch at the physical interface of the LAS and the
ARCHITECT processing module. See Emergency stop.
The following table defines the calibration adjustments provided by the LAS and ARCHITECT
processing module.
Table 2.6: LAS calibration definitions
Degrees of freedom Ownership Calibration definition X-Direction LAS Adjustment of sample tube
position along the track to a point that intersects with the
LAS
requirements Section 2
Third-party vendor LAS guidelines
Degrees of freedom Ownership Calibration definition
processing module probe travel. Y-Direction Processing module Adjustment of probe position
to intersect with the sample travel path. Z-Direction (vertical) LAS Height adjustment to position
sample tube in the specified height range. Rotation about X-axis and Y- axis
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
LAS Adjustment of sample tube
axis parallel to the probe.
front view
LAS requirements Third-party vendor LAS guidelines Section 2
Figure 2.13: i2000
SR
Section 2-22 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
top view
LAS
requirements Section 2
Third-party vendor LAS guidelines
Figure 2.14: i2000
SR
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 2-23
detailed view
LAS requirements Third-party vendor LAS guidelines Section 2
NOTES
Section 2-24 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Section 3 ARCHITECT standard interface specification Introduction
ARCHITECT standard interface specification topics include:
• Assumptions and dependencies, page 3-2
• Communications overview, page 3-3
• Message format, page 3-5
• Cyclical redundancy checks, page 3-6
• Sequence numbers, page 3-7
• Interface initialization sequence, page 3-9
• Messages, page 3-10
• LAS/processing module interaction diagrams, page 3-27
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 3-1
ARCHITECT standard interface specification Assumptions and dependencies Section 3
Communications overview
Tests may be ordered on the ARCHITECT System manually or downloaded by the LIS (laboratory
information system). The ARCHITECT System communicates to the LAS when queried for status and
then when the sample is complete. A typical sample process is as follows:
• The LAS sends SIDs (sample identifications) for samples routed to the processing module through the
PREPARE TO RUN command.
NOTE: The SID must be a minimum of 1 character and a maximum of 20 characters. Characters ASCII
32 (space) through and including ASCII 126 (tilde) area acceptable. The ASCII 124 (vertical pipe)
character is excluded.
• The processing module determines what test to run on the sample by checking its on board database for
an order that was ordered manually or previously downloaded by the LIS. If the ARCHITECT System is
configured for Query mode: On, an Order query message is sent to the LIS asking for tests to run on the
specified SID.
• The PREPARE TO RUN message should be sent to the processing module as soon as the decision to
route the sample to that module is made by the LAS. This maximizes the time the module has to complete
the host query and minimize impact to throughput. The PREPARE TO RUN message for additional
samples can be sent before the LAS positions the sample at the aspiration point.
• The LAS queries the processing module for the current status before sending the SAMPLE IN
POSITION / STAT SAMPLE IN POSITION message. Given the proper status (processing module status
is Ready to Run) the LAS sequence continues.
• For routing samples to both pipettors of the i2000
SR
processing module:
– When the tube carrier arrives at the STAT aspiration point the LAS sends a SAMPLE IN STAT
POSITION message with the SID to the processing module. – The processing module initiates processing
for each requested test by aspirating the required sample aliquot from the sample container. This
continues until all requested STAT tests have been initiated. – The processing module sends a STAT
SAMPLING COMPLETE
message to the LAS indicating it is finished with the sample in the STAT location and is ready to receive
a new STAT sample. – When the carrier or tube arrives at the Routine aspiration point, the LAS sends a
SAMPLE IN POSITION message with the SID to the processing module. – The processing module
initiates processing for each requested test by aspirating the required sample aliquot from the sample
container. This continues until all requested Routine tests have been initiated.
Section 3-3
ARCHITECT standard interface specification Communications overview Section 3
– The processing module sends a SAMPLING COMPLETE message to
the LAS indicating it is finished with the sample in the Routine location and is ready to receive a new
Routine sample.
• For the i2000
SR
processing module with Pipettor bypass enabled, see LAS/ processing module interaction
diagrams, page 3-27.
• For the i2000 and c System processing modules:
– When the tube carrier arrives at the aspiration point the LAS sends a
SAMPLE IN POSITION message with the SID to the processing module.
– The processing module initiates processing for each requested test by aspirating the required sample
aliquot from the sample container. This continues until all requested tests have been initiated.
– The processing module sends a SAMPLING COMPLETE message to
the LAS indicating it is finished with the sample and is ready to receive a new sample.
• The LAS moves the sample down the track and repeats the cycle for the next sample.
• If configured, the processing module sends test results to the LIS when they become available.
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ARCHITECT standard interface
specification Section 3
Message format
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Message format
The processing module shall transmit and receive all data using messages. The format for commands and
status information numbers in this document uses hexadecimal notation for software written in the "C"
language. For example, 0x02 equates to 2 Hex. The following is a list of message format guidelines:
• Messages begin with the Start of Transmission character (STX) and end with the End of Transmission
(ETX)
STX: 0x02
ETX: 0x03
• Messages will consist of the following information:
Byte 1: STX
Byte 2: Message length
Byte 3: Message type
Byte 4: Sequence number
Byte 5 to N-2: Message content
Byte N-1: CRC
Byte N: ETX
• The message length will be the total number of bytes in the message excluding the STX and ETX
characters.
Example: [STX] 04 01 00 11 [ETX] has a message length of 4
• Message types will be the following:
0x00: Data/Physical Routing
0x01: ACK
0x02: NAK
0x03: Virtual Routing
• The optional sequence number is incremented by one with each successful message. For more
information see Sequence numbers, page 3-7.
• The CRC (Cyclical Redundancy Checks) calculation excludes the STX, ETX, and CRC bytes. For more
information, see Cyclical redundancy checks, page 3-6.
Example: [STX] 04 01 00 11 [ETX] calculates the CRC using the three bytes 04 01 00
Section 3-5
ARCHITECT standard interface specification Cyclical redundancy checks Section 3
Sequence numbers
Sequence numbers can be used to detect message delivery errors. The use of sequence numbers in
communications is optional and is determined by the LAS. Sequence numbers can only be enabled or
disabled by the LAS during the interface initialization sequence.
Messages received from the LAS (incoming) shall use one set of sequence numbers while messages sent
from the processing module (outgoing) shall use another set of sequence numbers.
To enable sequence numbers:
The LAS sends valid incrementing sequence numbers in the ACK messages during the interface
initialization sequence. This causes the processing module to use and check sequence numbers during
communications. The incoming sequence number is set to the sequence number received in the second of
the two ACK messages, however, the outgoing sequence number will always be reset to 0x00.
To disable sequence numbers:
The LAS sets the sequence number in the ACK messages during the interface initialization sequence to
0x00. This causes the processing module to transmit 0x00 for the sequence number and to not check the
validity of sequence numbers during subsequent communications.
Valid sequence numbers:
• 0 through 255
• increment by one
• restart at 0 after reaching 255
Incoming sequence numbers are not incremented when the processing module sends:
• A NAK message in response to a message received from the LAS that has a CRC error.
• An ILLEGAL COMMAND RECEIVED message in response to an unrecognized message received
from the LAS.
Outgoing sequence numbers are not incremented when the processing module:
• Resends a message if the ACK or NAK for the message sent originally was not received within the
configured response timeout.
• Receives a NAK message in response to a message sent to the LAS.
If sequence numbers are enabled and the processing module receives an ACK/NAK message from the
LAS, the processing module attempts to match the sequence number in the last message it sent out. If the
sequence numbers
Section 3-7
ARCHITECT standard interface specification Sequence numbers Section 3
match the message, transaction is considered complete. If the sequence number does not match the last
outgoing message, the ACK/NAK message is ignored, an entry is made in the processing module
Temporary message log, and the processing module resends the message (with the original sequence
number) after the user configurable Response timeout expires. For more information on the default and
range of values for Response timeout, see the ARCHITECT System Operations Manual.
If sequence numbers are enabled and the processing module receives a non- ACK message from the LAS,
and the incoming message sequence number is out of order compared to the expected sequence number,
the processing module takes the following action:
• ACK the incoming message.
• Send an ILLEGAL COMMAND RECEIVED message with error type 0x02, the expected sequence
number, and the sequence number received. For more information see Illegal command received, page
3-17.
• Ignore the incoming message with the incorrect sequence number.
To correct this error condition and resynchronize the sequence numbers, the LAS sends a REINITIALIZE
COMMUNICATIONS message with one of the following recovery options:
• Recovery type 0x00: resets both the incoming and outgoing sequence numbers to the sequence number
found in the REINITIALIZE COMMUNICATIONS message.
• Recovery type 0x01: forces a complete re-initialization sequence of the LAS to Processing Module
communication interface. The incoming sequence numbers is set to what is received in the second of the
two ACK messages to the initialization sequence and sets the outgoing sequence number to 0x00.
After the recovery option completes the LAS resends the message with the expected sequence number.
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ARCHITECT standard interface
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Interface initialization sequence
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Messages
Messages are sent from and received by both the LAS and the processing module. These bi-directional
messages are acknowledged (ACK) or not acknowledged (NAK) based on certain criteria.
The criteria are explained in the following topics:
• ACK (message acknowledged), page 3-10
• NAK (message not acknowledged), page 3-11
• LAS to processing module messages, page 3-11
• Processing module to LAS messages, page 3-17
only)
Message Type 0x00:
This message is sent to the processing module after the sample is moved to the STAT aspiration point and
serves to inform the processing module that the sample is in position for pipetting.
When the processing module receives this message, the processing module has control of the sample and
the LAS must not move the sample until the processing module sends a STAT SAMPLING COMPLETE
message to the LAS. In addition, the LAS must not send another SAMPLE IN STAT POSITION message
until it receives the STAT SAMPLING COMPLETE message from the processing module.
IMPORTANT: The LAS must detect any condition whereby an incorrect sample was presented during
aspiration. To prevent the processing module from generating results, the LAS must send a
REINITIALIZE COMMUNICATIONS (recovery 0x03) message to stop the processing module. For
additional information, see Safety provisions, page 2-8.
Message Type 0x03:
This message can be sent to the processing module when Pipettor Bypass is Enabled, and the LAS
determines that no STAT test orders are present for the Sample. The sample does not have to stop at the
STAT sampling position.The
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ARCHITECT standard interface
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Messages
processing module will respond with a virtual STAT SAMPLING COMPLETE message after receiving
this message.
NOTE: No STAT test requests will be scheduled or aspirated when this virtual message is received.
Table 3.6: Description of STAT sample in position fields
Byte Field Description Field Contents 1 STX Start of Transmission 2 Message Length 3 Message Type 0x00 -
Physical Routing
0x03 - Virtual Routing 4 Sequence number 0x00 or next sequence
number 5, 6 Message ID 0xC008 7 Sample ID length
20 8 through N Sample ID Maximum of 20 characters N
+ 1 CRC Cyclical Redundancy Check N + 2 ETX End of Transmission
Example (with and without sequence numbers):
[STX] 0f 00 3e c0 08 08 50 61 74 69 65 6e 74 31 bd [ETX]
[STX] 0c 00 00 c0 08 05 31 32 33 34 35 ac [ETX]
Reinitialize communications
The LAS issues this command to the processing module in an attempt to recover from errors. The type of
error recovery desired must be specified as a parameter in this message. The LAS may use this to
resynchronize the processing module to the LAS.
Table 3.7: Description of reinitialization communications fields
Byte Field Description Field Content 1 STX Start of Transmission 2 Message Length 0x07 3 Message Type 0x00 4
Sequence number 0x00 or next sequence number 5, 6 Message ID 0xC00A 7 Recovery type 0x00 - Restart sequence
numbers using
the sequence number byte in this message 0x01 - Recovery attempt from an interface communications failure
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 3-15
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ARCHITECT standard interface specification Messages Section 3
Byte Field Description Field Content
0x02 - LAS Sample Handler for this analyzer has been stopped 0x03 - Stop processing module See the following
table for a description of recovery types. 8 CRC Cyclical Redundancy Check 9 ETX End of Transmission
Example (with and without sequence numbers):
[STX] 07 00 3e c0 0a 00 d8 [ETX]
[STX] 07 00 00 c0 0a 01 1e [ETX]
The following table describes the recovery type field content.
Table 3.8: Description of recovery type field content
Recovery type field content Description 0x00 - Restart sequence numbers using the sequence number byte in this
message
Section 3-16 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24 This recovery type is sent in response to a sequence number error that is reported by the processing
module whenever an unexpected sequence number is received from the LAS. Both the incoming and outgoing
sequence numbers are reset to the sequence number specified in this message. This REINITIALIZE
COMMUNICATIONS message should be sent when the ILLEGAL COMMAND RECEIVED with "Sequence
number error was detected" (0x02) message is received by the LAS. 0x01 - Recovery attempt from an interface
communications failure
This recovery type is sent in response to an interface communication failure. If this type of recovery is possible, the
processing module acknowledges (ACK) this message then issues a READY message to start the initialization
sequence (see Interface initialization sequence, page 3-9). The processing module does not check the sequence
number of this message. If the processing module does not ACK the message and start the initialization sequence,
the error recovery cannot occur and operator intervention is required. 0x02 - LAS Sample Handler for this analyzer
has been stopped
This recovery type is sent when the LAS needs to clear the sample handler queue at the processing module. This
message causes the processing module to purge all scheduled test orders and send them to exceptions, except for the
sample at the sampling position. If these samples are rerouted to this processing module, the PREPARE TO RUN
message must be sent for each tube since the test orders have been purged from the processing module run queue.
0x03 - Stop processing module This recovery type is sent when the LAS detects a scenario
that requires the processing module to be stopped. This
ARCHITECT standard interface
specification Section 3
Messages
Recovery type field content Description
message causes the processing module to enter the Stopped state and send all tests in process to exceptions. Operator
intervention is required to transition the processing module back to the Running state. Example: This message
should be sent when the LAS cannot ensure that the sample at the aspiration position was held in place until the
processing module returned a SAMPLING COMPLETE / STAT SAMPLING COMPLETE message (0xC005 and
0xC00B). For more information see Safety provisions, page 2-8.
Sampling complete
This message is used by the processing module to indicate to the LAS that processing of the sample at the
aspiration point (Routine aspiration point for i2000
SR
) is complete. This message serves as a way to hand over control of the sample to the LAS and
communicate the sample status. A status of 0x00 indicates that sampling completed successfully. All
other status codes indicate that there was a problem sampling and that operator intervention may be
required.
Table 3.14: Description of sampling complete fields
Byte Field Description Field Content 1 STX Start of Transmission 2 Message Length 3 Message Type 0x00 -
Physical Routing
0x03 - Virtual Routing 4 Sequence number 0x00 or next sequence
number 5, 6 Message ID 0xC005 7 Completion status 0x00 - Successful completion
0x01 - No test is ordered for the SID 0x02 - Consumable error 0x03 - Complete with errors
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ARCHITECT standard interface
specification Section 3
Messages
Byte Field Description Field Content
0x04 - Manual (internal) sample has priority (i2000 only) 0x05 - Reagent allocation error 0x06 - Not used 0x07 -
Processing module is not available 0x08 - Aspiration failed in the sample (do not move the sample, see the caution
described in the following table) See the following table for a description of the completion status types. 8 Sample
ID length
20 9 through N Sample ID Maximum of 20 characters N
+ 1 CRC Cyclical Redundancy Check N + 2 ETX End of Transmission
Example (with and without sequence numbers):
[STX] 11 00 02 c0 05 00 09 50 41 54 49 45 4e 54 31 33 74 [ETX]
[STX] 0b 00 00 c0 05 00 03 31 30 31 8a [ETX]
The following table describes the completion status type field content.
Table 3.15: Description of completion status types
Completion status type field content Description 0x00 - Successful completion Message type 0x00 - The processing
module has
successfully completed aspiration of the sample. Message type 0x03 - The processing module has successfully
bypassed the routine sampling position. 0x01 - No test is ordered for the SID If a sample is presented for testing by
the LAS and the
system finds no corresponding orders for the sample, the sample is not aspirated. 0x02 - Consumable error Sample
processing could not be completed due to an
insufficient consumable. The LAS should not route samples to this processing module until it returns to "Processing
module is ready to sample" (0x00). 0x03 - Complete with errors Sample processing could not be completed due to a
sample
integrity error. 0x04 - Manual (internal) sample has priority
(i2000 only)
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
The processing module is currently processing internal tests. The LAS should not route samples to this processing
module until it returns to "Processing module is ready to sample" (0x00). 0x05 - Reagent allocation error Sample
processing could not be completed due to an
insufficient reagent. 0x06 - Not used This status is not used.
Section 3-23
1 and
ARCHITECT standard interface specification Messages Section 3
Completion status type field content Description 0x07 - Processing module is not available The processing module
is not in the Running state and
cannot currently process samples. The LAS should not route samples to this processing module until it returns to
"Processing module is ready to sample" (0x00). 0x08 - Aspiration failed in the sample During a sample aspiration, a
probe failure occurred that
could potentially leave the probe within the sample container.
CAUTION: Do not move the sample until the QUERY PROCESSING MODULE STATUS message returns to
"Processing module is ready to sample" (0x00). The processing module recovery for this condition involves state
transitions that will cause the processing module to return a PROCESSING MODULE STATUS of "Processing
module is not available" (0x05) before the probe is removed from the sample.
only)
This message is used by the processing module to indicate to the LAS that processing of the sample at the
STAT aspiration point is complete. This message serves as a way to hand over control of the sample to
the LAS and communicate the sample status. A status of 0x00 indicates that sampling completed
successfully. All other status codes indicate that there was a problem sampling and that operator
intervention may be required.
Table 3.16: Description of STAT sampling complete fields
Byte Field Description Field Content 1 STX Start of Transmission 2 Message Length 3 Message Type 0x00 -
Physical Routing
0x03 - Virtual Routing 4 Sequence number 0x00 or next sequence
number 5, 6 Message ID 0xC00B 7 Completion status 0x00 - Successful completion
0x01 - No test is ordered for the SID 0x02 - Consumable error 0x03 - Complete with errors 0x04 - Not used 0x05 -
Reagent allocation error 0x06 - Not used 0x07 - Processing module is not available 0x08 - Aspiration failed in the
sample (do not move the sample, see the caution described in the following table)
Section 3-24 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
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ARCHITECT standard interface
specification Section 3
Messages
Byte Field Description Field Content
See the following table for a description of the completion status types. 8 Sample ID length
20 9 through N Sample ID Maximum of 20 characters N
+ 1 CRC Cyclical Redundancy Check N + 2 ETX End of Transmission
Example (with and without sequence numbers):
[STX] 0d 00 23 c0 0b 00 05 31 32 33 34 35 30 [ETX]
[STX] 10 00 00 c0 0b 00 08 39 31 33 31 30 35 30 33 c7 [ETX]
The following table describes the completion status type field content.
Table 3.17: Description of completion status types
Completion status type field content Description 0x00 - Successful completion Message type 0x00 - The processing
module has
successfully completed aspiration of the sample. Message type 0x03 - The processing module has successfully
bypassed the STAT sampling position. 0x01 - No test is ordered for the SID If a sample is presented for testing by
the LAS and the
system finds no corresponding orders for the sample, the sample is not aspirated. 0x02 - Consumable error Sample
processing could not be completed due to an
insufficient consumable. The LAS should not route samples to this processing module until it returns to "Processing
module is ready to sample" (0x00). 0x03 - Complete with errors Sample processing could not be completed due to a
sample
integrity error. 0x04 - Not used This status is not used. 0x05 -
Reagent allocation error Sample processing could not be completed due to an
insufficient reagent. 0x06 - Not used This status is not used.
0x07 - Processing module is not available The processing module is not in the Running state and
cannot currently process samples. The LAS should not route samples to this processing module until it returns to
"Processing module is ready to sample" (0x00). 0x08 - Aspiration failed in the sample During a sample aspiration, a
probe failure occurred that
could potentially leave the probe within the sample container.
CAUTION: Do not move the sample until the QUERY PROCESSING MODULE STATUS message returns to
"Processing module is ready to sample" (0x00). The processing module recovery for this condition involves state
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 3-25
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ARCHITECT standard interface specification Messages Section 3
Completion status type field content Description
transitions that will cause the processing module to return a PROCESSING MODULE STATUS of "Processing
module is not available" (0x05) before the probe is removed from the sample.
Section 3-26 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
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LAS/processing module interaction diagrams
The following topics include diagrams of LAS/processing module messaging for these procedures:
• Establishing communication, page 3-27
• Running samples, page 3-28
• LAS sample startup interrupted by sample on the i 2000 processing module sample carousel, page 3-31
• LAS sample startup interrupted by sample on the c System processing module sample carousel, page
3-32
• Using sequence numbers, page 3-33
• Running samples with Pipettor bypass enabled, page 3-36
• Error scenario 1 - Double sample in position, page 3-37
• Error scenario 2 - Probe failure in tube, page 3-39
• Error scenario 3 - Failure of sample to remain at aspiration point until processing module completes
sampling, page 3-40
• Error scenario 4 - Using virtual messaging with Pipettor bypass disabled, page 3-41
Establishing communication
The following diagrams show the interface initialization for establishing communication. For more
information on establishing communication, see Interface initialization sequence, page 3-9.
Figure 3.1: Interface initialization sequence (LAS does not respond to READY within the initialization
configured timeout)
ARCHITECT standard interface
specification Section 3
LAS/processing module interaction diagrams
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 3-27
Figure 3.2: Interface initialization sequence (Processing module does not respond to double ACK from
LAS)
ARCHITECT standard interface specification LAS/processing module interaction diagrams
Section 3
Running samples
The following diagrams show the interaction when running samples on the different processing modules.
For more information on running samples from the LAS, see Communications overview, page 3-3.
Section 3-28 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Figure 3.3: Running samples on a c System or i2000 processing module
ARCHITECT standard interface
specification Section 3
LAS/processing module interaction diagrams
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 3-29
Figure 3.4: Running samples on an i2000
SR
processing modules.
Figure 3.10: Virtual Message - STAT Bypass
ARCHITECT standard interface specification LAS/processing module interaction diagrams
Section 3
Section 3-36 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Figure 3.11: Virtual Message - Routine Bypass
ARCHITECT standard interface
specification Section 3
LAS/processing module interaction diagrams
processing module.
For more information, see Communications overview, page 3-3, Sample in position, page 3-13, and
Illegal command received, page 3-17.
Figure 3.12: LAS sends two SAMPLE IN POSITION messages without waiting for the SAMPLING
COMPLETE message to be returned for the first sample (ARCHITECT software versions prior to
8.00)
ARCHITECT standard interface specification LAS/processing module interaction diagrams
Section 3
Section 3-38 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24
Figure 3.13: LAS sends two SAMPLE IN POSITION messages without waiting for the SAMPLING
COMPLETE message to be returned for the first sample (ARCHITECT software versions 8.00 and
higher)
ARCHITECT standard interface
specification Section 3
LAS/processing module interaction diagrams
processing modules.
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 3-41
Figure 3.16: Virtual Message - Option Not Enabled
ARCHITECT standard interface specification LAS/processing module interaction diagrams
Section 3
Section 3-42 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
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Section 4 Processing module/LAS/LIS configurations Introduction
There are two general Processing module/LAS/LIS configurations.
Configuration type 1 does not have the order/result information pass through the LAS. In this
configuration, the LIS/Middleware is responsible for handling sample query/order/result information for
all connected processing modules. The LAS is responsible for positioning samples to those processing
modules connected to the LAS.
Configuration type 2 has the order and result information pass through the LAS. In this configuration the
LAS serves as the Host connection to the processing module and the LAS must comply with the
processing module's host specification. This communication is outside the scope of this manual. Refer to
the Abbott ARCHITECT RS-232 Standard Interface Manual or the ARCHITECT System HL7 Interface
Manual.
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 4-1
Processing module/LAS/LIS configurations Introduction Section 4
Section 4-2 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 5 Risk mitigation Introduction
The LAS vendor assumes responsibility to mitigate risks associated with the integration of the
ARCHITECT processing module onto the LAS. The list of potential hazards below must be considered in
the design of the LAS interface to the ARCHITECT processing module. This list is not all inclusive since
hazards will vary by LAS design. The LAS vendor must evaluate their LAS interface to identify
additional potential hazards (patient safety, operator safety, and impact to the environment). These
hazards must be eliminated or controlled through system design and/or customer labeling. Risks that are
strictly controlled within the ARCHITECT System are not shown.
Hazard Impact Mitigation ARCHITECT stops with sample probe inside sample
Spilled sample When the ARCHITECT System sends a SAMPLING COMPLETE / STAT SAMPLING
COMPLETE status 0x08 message, do not move the sample. For more information, see Sampling complete, page
3-22 and STAT sampling complete (i2000
SR
only), page 3-24.
Misalignment of LAS with ARCHITECT sampling location
Incorrect sample aspiration
Comply with mechanical specifications for sample tube alignment. For more information, see Mechanical interface,
page 2-9 and Physical requirements, page 2-15. Damage to sample probe or sample container
Use only sample containers acceptable for the ARCHITECT System. For more information, see Physical
requirements, page 2-15 or refer to the ARCHITECT System Operations Manual. Communication failure between
LAS and ARCHITECT System
Delay in processing samples
LAS must detect communications errors and notify the operator. LAS hardware design interferes with the
ARCHITECT System LLS (liquid level sensing)
Delay in processing samples
Comply with mechanical specifications to ensure proper LLS performance. For more information. see Mechanical
interface, page 2-9. Sample to sample carryover due to sample probe diving into samples.
Verify ARCHITECT LLS performance when integrated to LAS.
LAS generates electromagnetic interference which impacts the ARCHITECT System performance.
Incorrect patient results Comply with agency specifications. For more information, see Safety provisions, page 2-8.
Do not connect the LAS system electrical ground to the ARCHITECT System ground. If the LAS will be physically
connected to the ARCHITECT System, insulators to prevent electrical connection between the LAS and the
ARCHITECT System are required. LAS sends multiple SAMPLE IN POSITION / SAMPLE IN STAT POSITION
messages before receiving SAMPLING COMPLETE / STAT SAMPLE
Incorrect patient results due to a sample misassociation.
The LAS is responsible for ensuring the sample at the aspiration position is held in place until the processing module
returns a sampling complete message. The LAS must detect any condition whereby the sample is moved prior to
receiving this message and an incorrect sample is presented for
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Section 5-1
Risk mitigation Introduction Section 5
Hazard Impact Mitigation COMPLETE message for the first sample.
Section 5-2 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24 aspiration. For more information, see Communications overview, page 3-3, Sample in position, page
3-13, and Illegal command received, page 3-17. If the processing module/LAS/LIS configuration is type 1, then the
LAS must send a REINITIALIZE COMMUNICATIONS 0x03 to stop the processing module. For more
information, see Processing module/LAS/LIS configurations, page 4-1. For ARCHITECT Systems running software
versions prior to 8.00, when the ILLEGAL COMMAND RECEIVED message is received for Command violates
logical order of operations (error type 0x01) with the message ID of the message that was received out of order
(0xC005 or 0xC00B), the LAS must send the REINITIALIZE COMMUNICATIONS (recovery type 0x03) message
to stop the processing module and to prevent the misassociation of patient IDs. For ARCHITECT Systems running
software version 8.00 or higher, this scenario is detected by the ARCHITECT software and the orders are
automatically sent to exception. If the processing module/LAS/LIS configuration is type 2, the LAS must suppress
the impacted results. For more information, see Processing module/LAS/LIS configurations, page 4-1. Sample to
sample carryover due to sample probe diving in to samples (c System only).
The impacted samples must be discarded and the sample probe must be replaced and calibrated before proceeding.
LAS failure leads to multiple samples transitioning through the aspiration position while the processing module is
performing an aspiration for a single SID
Incorrect patient results due to sample misassociation
The LAS is responsible for ensuring the sample at the aspiration position is held in place until the processing module
returns a sampling complete message. The LAS must detect any condition whereby the sample is moved prior to
receiving this message and an incorrect sample is presented for sample aspiration. The LAS must provide a robust
mechanical interface to prevent the unintentional release of sample tubes at the aspiration position. Sample to
sample carryover due to sample probe diving in to samples (c System only).
The impacted samples must be discarded and the sample probe must be replaced and calibrated before proceeding.
LAS misreads sample bar code Incorrect patient results
due to sample misassociation
Use of bar code symbology with check digits is recommended. Configure the bar code reader safety parameters to
require multiple bar code reads.
Risk
mitigation Section 5
Introduction
Hazard Impact Mitigation
Design the LAS to only allow one sample in the view of the bar code reader. Positive identification failures
Incorrect patient results
due to sample misassociation
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
The LAS is responsible for ensuring sample positive identification.
LAS interface allows light to leak in to processing module (i System only)
Incorrect results The LAS must limit the amount of light entering the
processing module. Contact Abbott Laboratories for additional details. Ergonomics Operator injury, for
example, injury could occur from LAS track interface requiring excessive operator reach while using or performing
maintenance on the processing module.
LAS vendors are responsible to ensure proper ergonomic design. Reference Human factors engineering - Design of
medical devices (ANSI/ AAMI HE75).
Operator entanglement Operator injury The LAS must prevent operator entanglement. For
more information, see Sample pipettor safety guard, page 2-9. Capped tube presented to the processing module.
Delay in patient results. Damage to the sample probe or sample container.
Ensure that only uncapped tubes are presented to the processing module.
Uncentrifuged tube presented to the processing module
Incorrect patient results Ensure that only uncapped centrifuged tubes are
presented to the processing module. Follow the reagent manufacturer's assay-specific documentation for specimen
preparation. Sample contamination (for example sample to sample contamination or debris)
Incorrect patient results The LAS must ensure the sample integrity
throughout the LAS processing.
ARCHITECT subsystem failure Delay in processing
samples
Query processing module status prior to presenting samples. For more information, see Query processing module
status, page 3-12. ARCHITECT depletes consumables
Delay in processing samples
Query processing module status prior to presenting samples. For more information, see Query processing module
status, page 3-12. Operator exposure to sample probe
Operator injury Ensure the LAS covers prevent operator access to
the sample probe. LAS sends virtual messages for
pipettor with orders for that pipettor
Delay in processing samples
The LAS must have knowledge of orders on samples and be able to determine the difference between STAT and
routine assays.
Section 5-3
Risk mitigation Introduction Section 5
NOTES
Section 5-4 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Glossary
Exceptions Test orders that fail to complete.
Field A subdivision of a record containing one specific piece of information such as an
address.
Host An auxiliary computer system that can communicate with the ARCHITECT System.
LAS Laboratory Automated System; an automated transport system that routes laboratory
samples to laboratory instrumentation with minimal operator intervention.
LAS-to-module clearance
Space that exists between the Point of Reference for the LAS and the ARCHITECT System.
LAS-to-tube stop calibration
Information from the LAS to the ARCHITECT System to aid in tube-to- probe calibration.
Misassociation Assigning results from one patient to another.
Pipettor Bypass A feature for the i2000
SR
processing module that when enabled allows for Virtual Routing.
POR Point of Reference; LAS position located approximately 868 mm (34 in) from the lab
floor.
RSH Retest Sample Handler
SCC System control center computer workstation that provides a centralized interface by
which the operator can control one or more processing modules.
System software Software that controls operation of the ARCHITECT System.
UI User interface.
Virtual Routing Allows the LAS to communicate to the i2000
SR
processing module that a tube will not be delivered to one of the
pipettors.
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Glossary-1
Glossary
NOTES
Glossary-2 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Revision History
Revision History
Document control numbers
Revision date Content revised
90937-101 February 2001 Original issue 90937-102 March 2001 All sections 90937-103 November 2006 • Added c
System LAS requirements and
standard interface specifications.
• Added i2000
SR
LAS requirements.
• Updated i System standard interface specifications to include i2000
SR information. 90937-104 December 2008 • Corrected processing module references
in Figure 3.2 from i2000 to c System.
• Corrected 0x05 field description in Table 3.12.
• Added safety provision description for incorrect sample aspiration and remediation of the failure. 90937-105
2014-10-24 • Edited the content to remove duplicate content that is common for processing modules.
• Updated incorrect messaging information.
• Updated module drawings.
• Combined module interface sections into one common interface section.
• Clarified language in sequence numbers section.
• Added descriptions for message fields.
• Updated and added new sequence diagrams.
• Removed Troubleshooting section.
• Removed ARCHITECT simulator section.
• Added Risk mitigation section.
• Added description for the new Pipettor Bypass feature.
ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105) 2014-10-24
Revision History-1
Revision History Revision History
NOTES
Revision History-2 ARCHITECT System Laboratory Automation System Standard Interface Manual (PN 90937-105)
2014-10-24