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Manual
INTRODUCTION
Notes Page
The Abbott ARCHITECT System is manufactured and/or distributed by Abbott Laboratories, U.S.A.,
Abbott Park, IL 60064.
REVISION STATUS
Document Control
Revision Date Content or Pages Revised, Added, or Deleted
Number
206042-101 June 2010 New Release
Any product information in training materials should be used in conjunction with the latest version of the
Operations/Service Manual, Operations Manual addendum, ISA or TSB, or Product Information Letter. If
discrepancies in information exist within training materials or any other materials, the latest version of the
Operations/Service Manual, Operations Manual addendum, ISA or TSB, or Product Information Letter
takes precedence.
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.
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.
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.
ARCHITECT, i1000SR, ci4100, i2000, i2000SR, c8000, ci8200, c16000, Chemiflex, AxSYM, and
MasterCheck are registered trademarks of Abbott Laboratories in various jurisdictions.
i4000, c4000, cSystem, iSystem, ARCHITECT ARM, and FlexRate are trademarks of Abbott Laboratories
in various jurisdictions.
All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories,
its subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade dress, or product name may
be made without the prior written authorization of Abbott Laboratories, except to identify the product or
services of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the
property of their respective companies. All rights reserved.
Except as permitted above, no license or right, express or implied, is granted to any person under any
patent, trademark, or other proprietary right of Abbott Laboratories.
This guide was developed and produced by U.S. Commercial Training in Irving, TX.
Copyright 2010, Abbott Laboratories, Abbott Park, Illinois.
Notes Page
CONTENTS
Introduction .................................................................................................................... 1
Appendix A ..................................................................................................................A-1
Appendix B ..................................................................................................................B-1
Appendix C ..................................................................................................................C-1
Notes Page
TRAINING OVERVIEW
The ARCHITECT System is a fully-automated system allowing random and continuous access. The
ARCHITECT i2000SR is a fully-automated immunoassay system allowing random and continuous access
as well as priority and automated retest processing using the CMIA (chemiluminescent microparticle
immunoassay) method.
The ARCHITECT System is designed to be a multi-module system. That means you can combine multiple
Processing Modules (PMs) to form one workstation that is controlled by a single System Control Center
(SCC). A single, primary Sample Handler (SH) transports samples through the system regardless of the
number of processing modules and types. The number of tests performed per hour and the types of assays
performed vary depending on the configuration of the system.
The ARCHITECT i2000SR System training program is an integrated, ongoing approach designed to
provide the knowledge and skills needed to perform service calls effectively on the ARCHITECT System.
Goals
Upon completion of the training program you will be able to:
1. Perform Basic Operations including Daily Maintenance, Basic Run, and Calibrations.
2. Use resources to interpret troubleshooting data isolating the root cause of failure.
5. Perform the procedures associated with Planned Maintenance (PM) and an Instrument installation.
Materials
The information for the i2000SR System Service Training Class will be presented by instructors using the
following materials:
• ARCHITECT i2000SR System Service Training Manual
• ARCHITECT i2000SR System Service and Support Manuals
• ARCHITECT System Operations Manual
• ARCHITECT i2000SR System Assay-specific Package Inserts
• GSS Troubleshooting Database (eSolutions) and AbbottLink
• Technical Service Bulletins (TSB)
• Instrument Service Advisories (ISA)
NOTE: All example printouts, graphics, displays, screens, etc. are for information and illustration
purposes only. Actual printouts, graphics, displays, screens, etc. may vary depending on
software revision, hardware revision, and instrument configuration.
ARCHITECT i2000SR System Service and Support Manuals, ARCHITECT System Operations Manual,
Assay-specific Package Inserts, Technical Service Bulletins, and Instrument Service Advisories can be
accessed through the Abbott Global Service and Support intranet site unless otherwise noted.
Service Personnel should keep their laptop updated to contain current revision levels of materials through
timely installation of updates and/or replication.
GRAPHIC CONVENTIONS
Throughout the training manual text, icons and signal words appear where the nature of the information
warrants special attention.
General Icons
Note
Reference Materials
Diagnostic Information
HAZARDS
The ARCHITECT i2000SR has been designed for optimum operator safety. However, this does not reduce
the importance of safety awareness where hazards exist. This section provides a general overview of the
types of potential hazards that could cause physical harm or damage to the laboratory environment or
where failure to follow instructions may result in instrument failure or generation of erroneous patient
results. Refer to the ARCHITECT System Operations Manual and i2000SR System Service and Support
Manual for complete information about Hazards and Operational Precautions.
Warnings are inserted throughout this Service Training Guide to alert Service Personnel to potential
hazards.
Review the Hazard and Safety Information contained in the ARCHITECT i2000SR System
Service and Support Manual Section: General Data and the ARCHITECT System
Operations Manual, Section; 7 Operational Precautions and 8 Hazards, for complete
information.
CAUTION: Class 2 Laser Warns against direct viewing into the bar code laser beam or
Radiation reflections from the beam.
Avoid eye exposure to laser light.
WARNING: Probe Stick Identifies the possibility of puncture in noted activity or at posted
Hazard location.
Identifies an activity that may present a safety related hazard, and advises the Operator to consult
caution/warning instructions. Examples Include:
CAUTION: Lifting Hazard Identifies an activity where one may be required to lift or move a
heavy object. Obtain assistance when moving and/or use appropriate
lifting devices.
CAUTION: Moving Parts Identifies an activity or area where moving parts are present.
WARNING: Chemical Identifies an activity or an area where hazardous chemicals are
Hazard present. Refer to the Material Safety Data Sheet (MSDS) or package
insert for specific safety information.
WARNING: Splash/Spray Identifies where fluids may be under pressure.
Hazard
DANGER! High Voltage Identifies high voltage areas over 600 volts.
Note: Card Cage Ground Identifies the location on the card cage where the ground strap is
clipped.
The labeling of ARCHITECT System reagents/calibrators/controls or liquid consumables may include one
or more of the following hazard symbols. The symbols and/or other country specific warnings are used to
convey properties of the chemical or chemical mixture, and to notify the user that precautions should be
taken when handling material. Always consult the Assay-specific Package Insert or Material Safety Data
Sheet for further information.
Electrical Hazards
The ARCHITECT System does not pose uncommon electrical hazards if it is installed properly and
connected to a power source that meets required specifications.
Basic electrical hazard awareness is essential to the safe operation of any system. It is recommended that a
ground fault circuit interrupter be used when working in a wet environment. Only qualified personnel
should perform electrical servicing. Elements of electrical safety include, but are not limited to the
following:
• Inspect electrical cabling into and on the ARCHITECT System periodically for signs of wear and
damage.
• Determine the cause of blown fuse or thrown circuit breaker and correct the problem before attempting
to resume operation of the equipment. Only use replacement fuses of the specified type and electrical
rating.
• Assure the power to the instrument is turned OFF when designated within the performance of certain
service procedures. Be aware that a high voltage charge may remain on the power supply with the
power OFF.
• Use an electrically insulated tool to disconnect the Power Supply and short both male pins to the
instrument chassis.
• Keep liquids away from all connectors of electrical or communication components. Unplug the
instrument before clean-up of major liquid spills.
• Make sure hands are dry prior to touching any switches or outlets.
• Keep the floor dry and clean under and around the ARCHITECT System.
• Follow the ARCHITECT System’s instructions to remove power to the processing module(s) and
sample handler when designated within the performance of certain procedures.
NOTE: Refer to the ARCHITECT System Operation Manual, Section 5 Operating Instructions to view
the SHUTDOWN procedure.
• Use only approved power cords and electrical accessories, such as those supplied with the instrument,
to protect against electrical shock. Connect power cords only to properly grounded outlets.
NOTE: Refer to the ARCHITECT i2000SR System Service and Support Manual, System Specifications
for additional information.
Notes Page
Mechanical Hazards
The i2000SR is an automated system that operates under computer control. As with most automated
equipment, there is potential for injury and bodily harm from moving mechanical components whenever
the instrument is in operation. The i2000SR minimizes mechanical hazards by providing guards to protect
against accidental contact with moving components.
The i2000SR requires accurate positioning of all samples, reagents, calibrators, controls, and consumables
before executing any program. If safeguards must be removed or disconnected during setup and testing
procedures, use caution. Stay a safe distance away from the moving components. Fast moving parts may
cause injury. Always replace the safeguards upon completion of setup and testing procedures. It is never
acceptable for instrument operators to reach into the instrument when it is in an operating mode. Should
intervention be necessary during a run, the run should be interrupted according to instructions defined in
the Operation Manual.
Injury may result in the event of an instrument malfunction or an unexpected sequence of mechanical
component movements.
Basic elements of mechanical equipment safety include but are not limited to:
• Never bypass or override a safety device unless during setup or testing activities.
• Never operate the instrument without protective covers and barriers in place unless during
setup or testing activities.
• Never perform manual tasks on the work surface of the i2000SR.
• Never allow any part of the body to enter a range of mechanical movement during system
operation.
• Do not wear articles of clothing or accessories that could catch on the i2000SR.
• Keep pockets free of items that could fall into the i2000SR.
• Be especially cautious when performing adjustment, maintenance, cleaning, or repair
procedures.
• Use caution when loading sample carriers and reagents.
Laser Safety
The i2000SR is a Class 2 laser product. The bar code readers of the sample handler, use a low power,
visible laser diode and emit laser light. Because of normal human aversion response such as blinking, eye
movement, and so forth, these lasers normally do not present a hazard to eyes.
When this product is used according to its operating instructions, the laser does not present a hazard to the
eyes. Failure to follow proper procedures may result in an eye injury.
• Only Abbott trained Field Service Representatives should remove the inner protective covers that
enclose the embedded laser.
• Do not remove, damage or obliterate any of the laser warning labels.
• Never stare directly into the beam, look into the aperture, place any optics into the beam or bypass
interlocks.
• Replace any label that becomes illegible.
Figure 1 Figure 2
• On the ARCHITECT iSystem, this label is affixed on the underside of the rear processing center cover.
Biological Hazards
The following activities may involve the presence of potentially infectious materials:
• Handling samples, reagents, calibrators, and controls.
• Cleaning spills.
• Handling and disposing of waste.
• Moving the System.
• Performing maintenance procedures.
• Performing decontamination procedures.
• Performing component replacement procedures.
Precautions
All instruments that have been used to process clinical specimens, reagents, controls, calibrators, etc., that
contain human sourced material must be treated as potentially infectious. Follow ADD’s Biosafety
procedures, which include, but are not limited to the following precautions:
• Wear gloves, lab coats, and protective eye wear when handling human sourced material or
contaminated instrument components.
• Do not pipet by mouth.
• Do not eat, drink, smoke, apply cosmetics, or handle contact lenses when handling human sourced
material or contaminated instrument components.
• Clean spills of potentially infectious materials and contaminated instrument components with a
detergent followed by an appropriate disinfectant, such as 0.1% sodium hypochlorite (10% solution of
chlorine bleach containing at least 5% sodium hypochlorite), or other suitable disinfectant.
• Decontaminate and dispose of all potentially contaminated materials into the appropriate biohazard
waste system in the facility. Probes and other sharp objects should be placed in puncture resistant
sharps containers for disposal.
Refer to the ADD Biosafety Guidelines for Field Service located in the ADD Health and Safety Database
on ADDonline.
If exposed to infectious or potentially infectious materials, immediately cleanse the affected area, then seek
medical attention as soon as possible:
• Eyes - rinse with water for 15 minutes.
• Mouth - rinse with water.
• Skin - wash the affected area with soap and water.
• Puncture wound - allow to bleed freely. Wash the affected area with soap and water.
Report all accidents to your Manager and Workman’s Compensation Administrator. Additional
information is available in the ADD Health and Safety Database.
Clean spills in accordance with established biosafety practices and follow instructions provided in the
Material Safety Data Sheet. In general, safe work practices for cleaning spills include:
1. Wear appropriate personal protective equipment such as gloves, lab coat, and protective eye wear.
4. Wipe the area with an appropriate disinfectant such as 0.1% sodium hypochlorite (10% solution of
chlorine bleach containing at least 5% sodium hypochlorite).
5. Dispose of spilled and contaminated material in accordance with the facilities waste disposal
procedures.
Any part subject to user handling (for instance; keyboards, printers, monitors, front panels, etc.) requires
decontamination prior to servicing or shipment. When handling or decontaminating spare parts for
shipping or repair, use safety precautions.
Always wear appropriate personal protective equipment (protective eye wear, gloves, lab coat) while
performing decontamination activities.
NOTE: Refer to the ARCHITECT i2000SR System Service and Support Manual; General Data; How
to use this Manual; Instrument or Part Decontamination, to view the decontamination
procedure.
Do not mix oxiding agents, such as sodium hypochlorite (chlorine bleach) or with liquid waste. Toxic
gases may be generated.
Chemical Hazards
Service Personnel may be exposed to hazardous chemicals when handling reagents, calibrators, controls,
or liquid consumables. Exposure to hazardous chemicals is minimized by following instructions provided
in the assay Package Inserts and Material Safety Data Sheets (MSDS). Exposure levels are further reduced
by the design features of the instrument when it is used properly.
Precautions
Sodium Azide
For products containing sodium azide, do not autoclave. Sodium azide has been reported to form metal
azides on lead or copper pipes in laboratory plumbing. These azides can explode upon percussion, such as
hammering. To prevent formation of lead or copper azide, flush drains thoroughly with water after
disposing of solutions containing sodium azide.
NOTE: Refer to the ARCHITECT i2000SR System Service and Support Manual; General Data; How
to use this Manual; Removal of Azides from drains, to view the removal procedure.
Physical Hazards
To avoid potential injuries, safe practices should be observed while working with the following physical
hazards.
The probes, vent needles, aspiration probes, and leaf springs are sharp and potentially contaminated with
infectious materials. Avoid contact with these components and handle them cautiously in order to prevent
injury. Use mechanical means to remove contaminated broken glassware.
Dispose of sharps in an appropriately marked, puncture-resistant, and leakproof container before treatment
and disposal.
Heavy Objects
The system is heavy and sections of the shell are unsupported. Ensure that you have adequate help before
attempting to move the system.
Push only on solid sections of the housing; do not exert pressure on unsupported sections of the shell.
The high-concentration waste container and wash buffer reservoir is heavy when full. Use care when
handling the container to reduce the risk of injury.
When moving or lifting heavy objects, obtain assistance and always use proper lifting techniques.
Trip Hazard
The i2000SR System is equipped with a power cord and various computer connectors. To avoid a tripping
hazard, ensure cords in high traffic areas are properly stowed.
Static Hazard
Static protective procedures are used during the manufacture of PC boards. Replacement PC board
assemblies are also protected by use of static protective packaging, as well as boxed to prevent physical
damage. Assemblies that have failed and are returned for repair are also handled at the repair shop under
static protection procedures.
Continued use of the protective shipping boxes, both during shipping and storage, eliminates most failures
caused by physical damage.
Follow the “ESD Damage Prevention Procedure" outlined in ISA EDOC-028 current version.
- The SCC can provide an interface to a host computer and is utilized for remote diagnostic
capabilities.
i2000SR System
ICONS
Processing Module
Graphic
Help Icon
FUNCTION BAR
Example SNAPSHOT Software Screen
Note: The displayed view is dependent on the Processing Module configuration and software version.
From the Snapshot screen key system information can be viewed such as:
• Processing module status - displays on the processing module graphic(s).
• Test processing status - displays on the order status button. Select this button to display the Order
status screen.
• Reagent status - displays on the reagent status button. Select this button to display the Reagent
status screen.
• Supply and waste status - displays on the supply status button. Select this button to display the
Supply status screen.
• Number of orders pending rerun - displays on the Reruns status button. Select this button to
display the Rerun status screen.
• Number of exceptions pending review - displays on the Exceptions status button. Select this
button to display the Exception status screen.
• Additionally, the Printer, LIS, ARM, LAS status buttons and Sample find button display if the
system is configured with these optional components. A caution symbol indicates a condition that
requires attention.
QC Result Review
QC Summary Maintenance
Levey-Jennings Graph
QC-CAL Diagnostics
Calibration Status SYSTEM System Logs
Calibration History
Configuration
Stored QC Results Utilities
QC Reports
To Do
Daily
Weekly
Monthly
Quarterly
Reaction Mechanisms
As Needed
Pipettors
Maintenance Fluidics /Wash
Syringes /Pumps
Bar Code Readers
Diagnostics Modules
Solenoids /Sensors
Fuses/Motors
Optics/Temperature
Carousels
Precison
ICT
Utilities
Other
Temporary Message Log
System Log Message History Log
Software Update
SYSTEM
Sample Ordering
Host-Release Mode
Reports - Printing
Reagents -Supplies
System Settings Password
System Control Center
Modules
Configuration
Sample Handler
Sample Bar Code Reader
Serial Ports
QC Single Analyte
QC-Cal Settings QC-Multi Constituent Analyte
* Available with FS Logon Only Bar Code SID
Westgard Rules
Calibrator Settings
Note: Menus may vary slightly depending on software version utilized. These are for ARCHITECT software version 5.10.
Log On
The Log on/off procedure is provided in the ARCHITECT i2000SR System Service and
Support Manual, P-201 Service Log ON/OFF (SCC Module).
Access to areas of the ARCHITECT System is controlled through log on. The ARCHITECT System log
on and a description of access are listed in the table below:
In addition to general user and administrator log on, Abbott representatives can log on as:
CSC • requires CSC user name and password • Day +5
• used to perform procedures not available to
the administrator:
- restore software
- diagnostic procedures
NOTE: Ensure the system is returned to a non-FSE log on upon completion of your service activities
to avoid untrained individuals having access to otherwise unavailable areas.
END OF MODULE
OVERVIEW
This module discusses the following subjects:
• Instrument Setup and Maintenance
• Basic Run
• Status and Review Software Screens
• QC Analysis
• Assay Calibration
• Assay Processing
Notes Page
INTRODUCTION
This module introduces basic operating principles and procedures associated with the ARCHITECT
i2000SR System including:
• Instrument Setup
• Daily, Weekly, Monthly, Quarterly, and As Needed Maintenance
• Basic Run
• Software Navigation
• Assay Calibration, Quality Control, and Results
Objectives
Upon completion of this module, the student will be able to:
2. Perform Maintenance.
3. Perform a Calibration.
System Status
System status refers to the operational modes of the ARCHITECT System. Key information displays on
the Snapshot screen, providing an immediate overview of your system. The Processing Modules and
Sample Handlers have several status types. There is a progression of statuses to move from Offline to a
Running status. The ARCHITECT i2000SR System processing module has nine possible status types:
• Offline
Status
• Stopped and Scanning
• Warming and Ready
• Running F5
Startup
• Scheduled Pause
• Initializing
• Maintenance F8 Run
NOTE: Refer to the ARCHTECT System Operations Manual Section 1, Use or Function; System
statuses for current and/or additional information.
3 to 4 minutes 5 minutes
-Components home
-Reagents are scanned
0 to 30 minutes 8 minutes -Microparticles are mixed
Various tasks, such as reagent loading, can only be performed during certain statuses. The following is a
list of operational items and their relationship to system status:
• The following can be performed in any status:
- Order patient samples
- Load RVs
- Empty Waste
• A Run can only be initiated during the Ready or Scheduled Pause status.
• QC and calibrations orders should only be performed in the Running status to ensure the system
calculates the required sample volume.
• Reagents can only be loaded during the Warming/Ready status.
• Trigger and Pre-Trigger Bulk Solutions can be loaded during an Offline, Stopped/Scanning,
Warming, or Ready status only.
The RSH (Robotic Sample Handler) has seven possible status types:
• Offline
• Stopped
• Ready
• Running
• Scheduled Pause
• Initializing
• Maintenance
NOTE: Refer to the ARCHTECT System Operations Manual Section 1, Use or Function; System
statuses for current and/or additional information.
Supply Status
Before processing samples, always check consumable inventory. This can be accomplished through use of
the Supply status screen.
Select Supplies
OR
Trigger Solution
Pre-Trigger Solution
RV’s
NOTE: Results and inventory status can be adversely affected if you do not align the Trigger and/or
Pre-trigger level sensor correctly. The arrow on top of the level sensor should face towards
the front.
NOTE: Stability displays number of days remaining for onboard stability of the trigger and Pre-tigger
solutions. When the stability reaches zero days, EXPIRED displays next to the name. If either
solution is configured for expiration override, OVERRIDDEN displays next to the name.
NOTE: Periodic flushes are performed on all pipettors by pumping wash buffer through the pipettor
probes into the wash stations. Wash zones and pre-trigger/trigger manifold are also flushed
Ensure adequate inventory is onboard.
From the Supply status screen, the operator can view and/or access screens to update the status of bulk
solutions, solid waste, and RVs. Generally, the screen contains the following information:
- The approximate number of RVs or Waste volume remaining
- The amount of bulk solution (Trigger, Pre-trigger, and Manual Wash Buffer) remaining
- If the remaining amount or volume is approximately 20%, the indicator arrow changes to red
- Once the waste is emptied the software must be updated, using F2 Update Supplies.
Supplies:
• The solid waste contains used RVs.
- RVs are directed into the container by a waste chute device in
the supply and waste center.
- The waste chute receives used RVs (reaction vessels) by gravity
and directs them into the solid waste container.
- A trap door holds up to 50 RVs when the solid waste container
is removed during processing.
- The container must be properly oriented to the waste chute.
- Sensors in the waste chute direct the open and close of the door. Waste Chute
Select Reagents
Reagent Status
OR
SNAPSHOT screen
Processing Module Graphic
From the i2000SR view of the Reagent status screen the operator can view information for reagents loaded
on the reagent carousel, such as:
• Reagent location and Assay name
• Calibration status (Active or No Cal) and Reagent status (Expired or OK)
• Remaining tests
Note: The displayed view is dependent on the Processing Module configuration and software version.
Assay Reagents
• Reagent kits are two or more bottles that contain all the necessary reagent components for an
ARCHITECT i System assay.
• Septums are placed on all open reagent bottles prior to loading the bottle into the processing
module. The septums are membranes with slits that are used to prevent reagent evaporation and
contamination, and to ensure reagent integrity.
• Color bands are located at the top of the reagent label to aid in loading reagents.
• Reagent labels are unique identifiers on Abbott pre-packaged reagents that contain 2D (two-
dimensional) bar codes. The bar codes contain information about the reagent such as lot number,
assay name, and expiration date.
Prepare Reagents
1. Invert the microparticle bottle gently a minimum of 30 times to resuspend microparticles that may have
settled during shipment.
DO NOT USE if microparticles do not resuspend.
2. Open the reagent bottle and discard the white cap.
3. Remove any air bubbles with a clean applicator stick.
4. Wear clean gloves to prevent contamination, and then remove a septum from
the bag.
Squeeze septum gently in half to confirm that the slits are open.
5. Carefully seat the septum onto the top of the bottle. Ensure the reagent does not contaminate your gloves.
Once you have placed a septum on a reagent bottle, do not invert the bottle as this results in reagent leakage and
may compromise assay results. Reagent bottles with septums installed must be stored UPRIGHT. Do not remove
septums once they have been installed on reagent bottles.
2. Place the reagent bottles securely into their coordinating ring location. Ensure each bottle is not tilted and the
reagent bar code faces the center of the reagent carousel.
- Place the black bottle with the yellow color band securely
into the yellow ring (inner location). Yellow
- Place the bottle with the pink color band securely into the
pink ring (middle location)
- Place the bottle with the green color band securely in the
green ring (outer location) Green
Pink
If the reagent kit has more than three bottles, load the bottle
designated with a #2 in the color band to the left of the same color-band bottle designated #1.
Pressing the carousel advance key will rotate the carousel and provide access to additional open positions.
3. Close the reagent carousel cover and front processing center cover. Select F-5 Reagent Scan to update
inventory.
Once you place a new reagent(s) on a processing module and the bar code reader scans the bar code label, the
system software links individual bottles together as a kit. If the bottles are not kept together, the reagent status of
Missing bottle or Extra bottle displays.
Maintenance
Proper maintenance of the ARCHITECT System is one of the most important aspects of a complete quality
assurance program. Maintenance procedures are performed at daily, weekly, monthly, quarterly, and as
needed intervals.
From the Maintenance screen you can view information for maintenance procedures and initiate a
procedure. Maintenance procedures display by module and by maintenance category:
• SCHEDULED ("due") procedures to be performed on a module from the Daily, Weekly,
Monthly, and Quarterly maintenance categories
• NON-SCHEDULED (procedures that are not yet "due") procedures for a module
Select F5 Perform
NOTE: To obtain a Procedure Report, select PRINT prior to exiting the Maintenance task screen.
Maintenance Log
The system has a maintenance log which displays up to 3 months of maintenance history. On the
maintenance log screen the operator can view
• When procedures were due
• When procedures were performed
NOTE: When a number appears in one of the colored fields on the maintenance log, it means that the
maintenance procedure has been performed more than once on any given day. A solid color
indicates the procedure has been performed. A shaded color is an indication that the
procedure is pending, did not complete successfully or was not performed when scheduled.
Component Replacement
The following i2000SR System components are customer replaceable items:
NOTE: Refer to the ARCHITECT System Operations Manual, Section 9 for the most current
information.
1. Verify the PM and RSH status is appropriate for each Basic Operation task.
3
NOTE: IMPORTANT for ARCHITECT iSystem assays do not order more than 10 tests per sample
for samples loaded in sample cups.
NOTE: Not all assays support manual dilutions. An assay displays unavailable if you select manual
dilution, and the assay does not support this type of dilution. See the reagent manufacturer's
assay-specific documentation for information.
5. Manually create order, or use configured automated Control and/or Calibration ordering.
NOTE: Order QC and calibrations in the Running status only to ensure the system calculates the
required sample volume. Patient samples can be ordered in any status.
NOTE: Automated ordering is a process the system uses to automatically order control, or
calibrator, tests by associating a configured bar code SID (sample ID) with a predefined
test(s).
NOTE: Control and calibration parameters must be entered (configured) into the system prior to use.
For additional information refer to the ARCHITECT System Operations Manual, Installation
procedures and special requirements; System Configuration.
6. Print the Order List report to ensure that samples are loaded in the correct C/P (carrier/position).
NOTE: This step is optional when using bar code labels on samples for positive ID.
• Calibrators, controls, and patient samples are loaded on the RSH (robotic sample handler) for
routine, priority, or batch processing.
8. Review patient and QC results, rerun and/or release.
Sample Carriers
Sample carriers are racks used on the RSH (Robotic Sample Handler) to transport patient samples,
calibrators, or controls to the sample pipettor(s). Sample carriers are:
• bar coded for identification
• hold five primary tubes, aliquot tubes, or sample cups
Sample Cup
Bar Code
labeled tubes
1400 μL
Carrier
500 μL
Carrier 125 μL
Bar Code ID
Front View Sample Gauge Label
Sample Carrier
Sample Trays
Sample trays hold up to 5 sample carriers and are used to load samples in the routine bays of the RSH. The
tabs on the carrier are designed to aid in proper placement of the carrier in the tray.
When inserting carriers into the tray, verify the sample carrier(s) sits flush with the bottom of the tray.
Position the sample carrier(s) so that the carrier ID label(s) is at the front of the tray where the handle is
located.
Keypad
Routine Bays
Routine Bay
Indicator Light
Priority Bays
Reference Sheet
BASIC RUN CREATING PATIENT CREATING
ORDERS CALIBRATION ORDERS
Type: Type:
• C (Carrier ID) • C/P
• P (Position) • SID
Initiate Run on PM • SID (Sample ID)
• SNAPSHOT
• PM Graphic
• F8 RUN Select: Select:
• Assay(s) or Panel(s) • Assay(s)
• F5 ADD OPTIONS
- Replicates
Initiate Run on RSH - Dilutions Select:
• SNAPSHOT • F3 ADD ORDER
• F5 Assay Options
• RSH Graphic
• F8 RUN
Choose:
• Single Analyte
Add Patient and /or • Multiconstituent
Control Orders - Control Name
Select:
• Control
• Control Lot Number Select:
Load Samples in RSH Carriers • Control Level(s)
• ORDER LIST REPORT
• Assay(s) or Panel(s)
• DONE
• F3 ADD ORDER
Note: Steps may vary depending on software version utilized. These are for ARCHITECT software version 5.10.
Notes Page
Resources Needed
Time 45 minutes
Activity
NOTE: For additional information refer to the ARCHITECT System Operations Manual, Section 5
Operating Instructions.
1. Using the Supply Status Screen, check Supplies and Reagents. Add and update inventory as needed:
Solid Waste
RVs
NOTE: Results and inventory status can be adversely affected if you do not align the Trigger and/or
Pre-trigger level sensor correctly. The arrow on top of the level sensor should face towards
the front.
2. Check assay reagents to ensure a minimum of 35 tests remain for B-hCG and TSH
5. Order Calibration:
• Select ORDERS, CALIBRATION ORDER
• Select Carrier
NOTE: When multiple assays are selected, the software automatically assigns the calibrators in
sequential carriers.
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P) if displayed
• Select Assay(s)
- TSH and B-hCG STAT
• Select F5 ASSAY OPTIONS
- Type Calibrator Lot number
- Type Calibrator expiration date
- Select DONE
NOTE: For i System assays the last calibrator lot number and expiration date entered display.
6. Order Controls:
During this activity refer to the table below for the necessary information to complete the control order
• Select ORDERS, CONTROL ORDER
• Select SINGLE ANALYTE
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P) if displayed
• Select Assay(s)
• Select Control, Lot, and Levels (Low, Mid, and High)
• Select F2-ADD ORDER
• Repeat for additional controls
(Continued)
7. Once all orders have been placed, print the Order List
• Select ORDERS
• Select ORDER STATUS
• Select F4-PRINT, Orderlist Report, Done
Operator ID: Abbott
Order List Report
System serial number: 1000
10. Prepare the Processing and Sample Handler Modules for testing
• PM and RSH into Running Status
- From a Stopped status to a Ready status, select desired module and press F5 - Start-up
on the Snapshot screen
- From a Ready status to Running select desired module and press F8 - Run on the
Snapshot screen
END OF ACTIVITY
Select Results
Select Results Review
(Release completed specimen results, request reruns, delete tests)
Select Exceptions
Select Exception Status
Test Status
The test status information is displayed on the status screens and identifies the progress of an ordered test.
The system tracks one of the following test statuses for each ordered or completed test.
*Can only delete patient results. There is no "Delete" button on the QC Result Review screen nor in Stored QC Results.
Processing Codes
Processing code information indicates how a sample(s) was processed.
Code Description
S • Sample is ordered as a STAT
D • Test is an automated dilution with a dilution faction >1, or an
automated dilution that is not the first configured dilution
M • Sample is manually diluted
R • Test is a rerun
* • Test is an original result for a rerun
B • Test is part of a batch order
C • Test has a comment
Flags
When reviewing Results, flags may appear to alert the operator to a particular condition regarding the test
result and indicate that additional review is needed. Flags can occur on both patient and control results.
These flags, abbreviations or symbols, may appear on the flag column in the displayed screen.
• When a control result has a flag, the information displays in red on the QC result review, Stored
QC results, and QC summary review screens.
• When a patient result has a flag, the information displays in red on the Results review and Stored
results screens.
The table below provides an example of a few result flags along with a description of the alert condition.
This is NOT a complete list.
NOTE: For a complete and current listing of patient and QC result flags refer to the ARCHITECT
System Operations Manual; Section 5 Operating Instructions; Patient and QC results review,
rerun, and release.
Flag* Description
CNTL* • The result was calculated after the quality control failed for the same control name and control level
• Flag will continue to appear on subsequent results until the failed quality control result is rerun and
the result is within acceptable limits
• Control result out of range as defined in control parameters under CONFIGURATION/CAL-QC
SETTINGS
NOTE: Only Westgard rules configured as a failure produce a CNTL flag for a patient result.
>< • Result outside of dynamic, or linear, range.
*These flags are carried over from a constituent result to a calculated result.
**If the operator has not defined extreme or normal ranges in the assay settings, the system will not check for these
flags.
QC Analysis
Quality control analysis is the process of monitoring control activity. The ARCHITECT System allows the
operator to monitor control activity using standard Levey-Jennings graphs and Westgard rules.
NOTE: Refer to the ARCHITECT System Operations Manual, Section 5 Operating Instructions, for
more information about the Westgard rules and monitoring control activity.
Control Reports
The operator has 2 screen options to obtain PRECISON DATA on configured controls:
• QC Reports
• QC Summary
The QC Report provides only a printed copy of QC data once the assay, control level(s) and lot are selected
on a configured control.
The QC Summary screen provides displayed QC statistics on all configured controls. Selected data may be
printed (F4) or displayed as a Levey-Jennings graph (F7).
Actual Expected
Levey-Jennings Graph
Levey-Jennings graphs are a trend plot of data for a selected control.
The ARCHITECT System allows the operator to monitor control activity with the standard Levey-
Jennings graph.
To graph controls on the Levey-Jennings screen:
• The Assay Controls must be configured
• The Assay Controls must be ordered as controls
• The Assay Controls must complete
The Levey-Jennings data should be monitored for shifts, trends, accuracy, precision, and other quality
performance indicators.
2. Select F2 - QC SELECTION.
4. Graph displays.
Data values are plotted within a range of ± 3SD from the specific assay mean. All Levey-Jennings graphs
are limited to 31 days. A maximum of six Levey-Jennings graphs, three per page, displays.
NOTE: Refer to the ARCHITECT System Operations Manual, Section 5: OPERATING
INSTRUCTIONS, for more information about the graphs and the steps in creating a Levey-
Jennings graph.
Note: The displayed view is dependent on the Processing Module configuration and software version.
ASSAY CALIBRATION
In this section, you will be introduced to Calibration procedures and requirements for the ARCHITECT
i2000SR System.
Purpose of Calibration
Assays must be calibrated before samples can be analyzed on the ARCHITECT System. To run an assay
calibration, assay-specific calibrators are required.
• The calibrators contain known concentrations of analyte.
• During calibration samples of known concentrations are analyzed, the instrument response
value(s) are recorded, and the measured value(s) are plotted against the known concentration to
create a curve.
• To determine the concentration of analyte in a patient specimen, the results of the samples are
compared to the calibration curve.
NOTE: Calibrator values are loaded on the system via the Assay disk for immunoassays. Assays with
master calibration have the master calibration data encoded in the 2D barcode on the
microparticle bottle.
Calibration Frequency
The frequency of calibration is determined by whether the calibration is mandatory or optional.
Mandatory Calibration
A calibration must be run under the following circumstances:
• A new reagent lot number is used
• Documentation accompanying a new version of an existing assay file states calibration is required
• A new assay file that requires calibration is installed
• The ARCHITECT System is installed (no existing calibration data on analyzer)
• ARCHITECT System Hard Drive is replaced and assay and system files have not been backed up
Optional Calibration
A calibration may need to be performed on an assay under the following circumstances:
• Assay control values are out of specification.
NOTE: For specific information regarding quality control, see the reagent manufacturer’s assay-
specific documentation.
Notes Page
CALIBRATION REVIEW
After calibrators are processed, the system verifies the results by comparing them to the assay-specific
calibration parameter specifications.
• If the results of a calibration fall within the specified range for that assay, the new calibration
replaces any previous calibration curve and the previous calibration curve status changes to
inactive.
• If the results of a calibration do not fall within the specified range, then the new calibration curve
is assigned a status of failed; if there is an existing calibration curve for that assay it is not
replaced.
• Inactive - this is an older, previously active curve that has been superseded by a more recent
calibration. An inactive curve status displays only on the Calibration history screen.
NOTE: Refer to the ARCHITECT System Operations Manual, Section 6 Calibration Procedures, for more
information including information about the sampling process when multiple lot numbers of
reagent are loaded on the system.
Calibration Data
Calibration methods used by ARCHITECT iSystems measure RLU (relative light unit) values and use
different mathematical methods to calculate results. The calibration methods are assay-specific and are
defined in the assay parameter file. Detailed calibration curve information can be viewed from the Calibration
curve window.
Cal ID 17 18 Concentration. 19 Fit Curve 20 Mean RLU 21 Rep. 1 RLU 22 Rep. 2 RLU
ulU/mL RLU
Cal A 0.00 682.4 611.5 610 613
Cal B 10.00 3048.1 3264.5 3372 3157
Cal C 250.00 72910.0 70765.5 69102 72429
Cal D 1,000.00 301847.5 297533.5 300669 294398
Cal E 7500.00 1736819.4 1790547.5 1777954 1803141
Cal F 15000.00 2586173.0 2559207.5 2545874 2572541
Many kinds of assay processing activities take place between sample aspiration and the activated read.
These include:
• Pipetting of Sample
• Pipetting and/or dispense of Reactants
• Mixing and Washing of the Reaction Mixture
• Incubation in a temperature controlled environment
• Optical Read
The process path movement and the position of the components allow each reaction activity to occur at a
specified time and location.
• The process path advances a reaction vessel (RV) every 18 seconds and positions it at designated
positions according to the assay protocol in order to execute the CMIA reaction. Total of 112 RV
positions.
i2000SR System
The table below describes the activities which occur at the various positions along the process path.
i2000SR
Process Path Description
Position
1 • RV Moves from inner track to outer track using the Load Diverter
1 • Sample Pipetting Station
2 • Reagent 1 Pipetting Station
3 • Vortexer #1
24 • Pre-treated Sample Pipetting Station
28 • Process Path Access Door
45 • RV is loaded into the inner track of the Process Path
47 • RV moves from inner track to outer track using the STAT Diverter on
i2000SR Systems Only
47 • STAT Pipetting Station
48 • Reagent 2 Pipetting Station at position 48
49 • STAT Vortexer
60 • RV bypasses Wash Zone 1 using the Wash Zone Diverter
64 • Wash Station 1 Position 1
65 • Wash Station 1 Position 2
66 • Wash Station 1 Position 3
67 • Wash Station 1 Position 4
71 • Reagent 2 Pipetting Station at Position 71
72 • Vortexer #2
87 • Wash Station 2 Position 1
88 • Wash Station 2 Position 2
89 • Wash Station 2 Position 3
90 • Wash Station 2 Position 4
94 • Pre-Trigger dispense and Vortexer #3
98 • Trigger addition and CMIA Optical Read
100 • Liquid Waste is aspirated from the RV
109 • RV is unloaded into the waste chute using the Unload Diverter
Process Path
Notes Page
Time 45 minutes
Activity
Procedures for these activities can be located in the ARCHITECT i2000SR Service and
Support Manual, or ARCHITECT System Operations Manual, Section 5 Operating
instructions.
Example Assay Control insert shown in graphic below (Mean = 25, 1SD = 4.5)
(Continued)
4. Once all orders have been placed, print the Order List
• Select ORDERS, ORDER STATUS, F4-PRINT, Orderlist Report, Done
8. Initiate Run
Troubleshooting
The following are tips for troubleshooting failures associated with Basic Operation:
NOTE: When troubleshooting ARCHITECT System errors refer to your ARCHITECT
i2000SR System Service and Support Manual, Troubleshooting Information
(eSolutions), Technical Service Bulletins, Instrument Service Advisories, and/or the
ARCHITECT System Operations Manual.
Area of failure Possible cause of failure
Control Issues • Incorrect control/sample utilized
Control values Out Of Range (OOR) • Calibration instability
• Reagent and/or Control improperly handled or stored
• Non-performance of required maintenance
Calibration Issues • Operator Error:
- Bubbles or foam
- Wrong Calibrator used or not loaded correctly
- Improper Reagent and/or Calibrator handling
• Bulk Solution Impurities
• Non-performance of required maintenance
• Probe or mixer misalignment, or malfunction
• Dirty or scratched Cuvettes
• Fluidics or Optics component failure
Calibration failure • Fluidic component failure
Intercept out of range • Calibrator or Control issue
Calibration failure, max upper curve asymptote • Fluidic component failure
exceeded • Improper handling of reagents
Calibration failure, curve validity check failed • Fluidic component failure
Calibration failure, fit response too low for Cal “x” • Fluidic component failure
• Bubbles or foam in sample
Calibration failure, ratio too small for calibrators • Improper handling of reagents
• Dispense component failure
• Optics failure
Exceptions • Improper sampling handling:
- Bubbles or foam
- Poor sample integrity (fibrin)
- Improper sample collection and/or storage
• Bulk solutions loaded incorrectly
• Non-performance of required maintenance or
maintenance recently performed
• Insufficient Reagents
• Calibrator expired
• Hardware failure
KEY POINTS
Basic Operation
Basic Operation
Basic Run • 150µL (minimum) 1. Verify the PM and RSH status is appropriate for the basic
Overview sample volume for non- operation task performed.
priority processing.
2. Check Supply Status.
REVIEW QUESTIONS
1. Identify the ARCHITECT iSystem Bulk Solutions described in the table below:
2. Identify where you find the minimum sample volume required for testing.
6. RVs can be loaded in the hopper on the ARCHITECT iSystem while the system is processing samples.
TRUE FALSE
7. The graduation lines on the sample cups are at _______ μL, ________ μL and ________ μL.
END OF MODULE
Notes Page
OVERVIEW
This module discusses the following Service Tools
• Service Documentation
• Diagnostic Screen
• Hyper Terminal
• CLI Commands
• General Troubleshooting Principles
• AbbottLink
Notes Page
INTRODUCTION
The ARCHITECT System Operations Manual and the Service and i2000SR System Support Manual
contains instrument-specific information designed to provide the knowledge and skills needed to operate
and perform service calls effectively and safely on the i2000SR System.
In this section, you will be introduced to the various manuals, documents, diagnostic software programs
and commands required for servicing the i2000SR System.
Objectives
After completing this module, the student will be able to:
1. Access information necessary to identify and resolve operational and hardware errors.
2. Identify the various sources of service documentation and describe the types of information contained
in each.
3. Use AbbottLink
Notes Page
Resources Needed
Refer to the ARCHITECT i2000SR Service and Support Manual for additional information.
Online Operations Manual can be accessed by selecting Overview from the menu bar and then
selecting Operations manual.
Select Overview
Select Operations Manual
(Continued)
SECTION TOPIC
Proprietary Info • Liability disclaimer, trademarks listing and the service manual revision log.
General Data • Product overview, information on manual usage, accident prevention symbols
and functional description Includes:
- i2000 and i2000SR.Overview
- ARM Overview
- SCC Overview
- SSH Functional Description
Troubleshooting • This section contains reference and normal operation information for the
system.
• The information includes block and functional diagrams, mechanism and
motor listings, and LED operating conditions:
- Contains card cage, board, and Power Supply reference.
- Cable Locator
- Fuses and jumpers
- LEDs
- SCC and SSH Troubleshooting
Refer to troubleshooting information (eSolutions) for error code and/or observed
problem troubleshooting.
Parts Lists • Provides lists of Supplemental Tools and Supplies, Customer and Field
Service replaceable parts which are indexed by item number and description
Removal and • Removal & Replacement procedures indexed by number to linked Parts list.
Replacement
Procedures • Section contains configuration, adjustment, calibration, checks, and test
procedures used to setup or verify instrument operation.
• Procedures are also used to assist in troubleshooting.
• A Procedure Locator is used to access M&Ds and Procedures.
Planned Maintenance • Planned Maintenance (PM) recommendation checklist.
• Recommendations may be subject to change due to local business or
regulatory needs.
Pre-Site Interview & • Site specifications and a checklist that outlines the activities of Field
Inspection Personnel.
• An action item summary is included in the checklist.
Installation & Setup • Activities required to install or relocate an ARCHITECT System
(Continued)
END OF ACTIVITY
Notes Page
The procedures in each section are grouped by module type, and then by category. Each category is
represented by a tab on the screen. Once a procedure is initiated, step-by-step instructions walk the user
through completion. Depending on user logon, available Diagnostic Procedures vary. The ARCHITECT
i2000SR Service and Support Manual provides guidance regarding module, category, user logon, time
required, along with a brief description of each procedure.
NOTE: For additional information regarding M&D procedures refer to the ARCHITECT System
Operations Manual and the ARCHITECT i2000SR System Service and Support Manual.
NOTE: Diagnostics will be discussed throughout the training guide. For additional information
regarding Diagnostic Controls refer to the ARCHITECT System Operations Manual, Section
10; Troubleshooting and Diagnostics.
Module
Diagnostics for 08:00:2002
DIAGNOSTIC PROCEDURES
Precision
6114 Install/Delete Assays
ICT
6115 Install/Delete Procedures
Utilities
6116 Update 6115 Procedure
Other
The TASK MANAGER provides Service Personnel access to the system’s hard drive files for the
following situations:
• performance of an ISA or TSB
• obtain data for investigation(s)
• troubleshoot system or software related errors
• SCC installation procedures
• setup or edit printers or replacements
• perform Touch Screen calibration
1. Log on as an FSE
4. Type "explorer"
NOTE: Prior to leaving the site, you are required to return the system to the general operator level of
access to prevent untrained individuals from accessing otherwise unavailable areas.
Notes Page
CLI Commands
CLI commands are used to manually control assemblies unrestricted. This is done through the use of
commands using M&D 6200 CLI Terminal Simulator or HyperTerminal to assist in the diagnostics of
hardware issues. To prevent component or system damage, these commands must be used in accordance
with the instructions loaded in the ARCHITECT i2000SR Service and Support Manual, Section 5
procedures, CLI Commands. Additionally, modules must be reinitialized after using CLI commands.
NOTE: For additional information regarding CLI Commands refer to the ARCHITECT
i2000SR Service and Support Manual, Section 5.
1. Log on as an FSE
3. Select DIAGNOSTICS
5. Choose Perform
6. The first command entered must be which module you are going to control. This command will
generally be one of the following examples:
For stand alone i2000SR Processing Module use command: SET_MODULE 1 (use 2 for integrated iPM)
For the RSH use the command: SET_MODULE 0
NOTE: Prior to leaving the site, you are required to return the system to the general operator level of
access to prevent untrained individuals from accessing otherwise unavailable areas.
HYPERTERMINAL ACTIVITY
Upon completion of this activity, you should be able to:
• Configure laptop for use of HyperTerminal
• Use HyperTerminal to observe boot sequence
HyperTerminal can be used to monitor the Boot-Up sequence for troubleshooting. HyperTerminal is used
with the SCC or Field Personnel’s laptop computer to connect to the CPU (controller) board through a
direct serial connection to the RS232 serial port located on the front of the Process Module Card Cage.
NOTE: For additional information refer to the ARCHITECT i2000SR Service and Support
Manual and ISA Database 116-068 current version.
Resources Needed
In order to connect the laptop to the instrument card cage, two cables are required:
• Cable Debug Kit (for ARCHITECT i1000SR, i2000SR, c8000, and c16000)
• Laptop cable (for AxSYM)
NOTE: Refer to the FRUD for cable part numbers.
(Continued)
Exit from the HyperTerminal program and disconnect the laptop from the card cage.
END OF ACTIVITY
---------------------
CPU Board Command Line Interpreter---------------------
------------------------------ TFTP Bootup Mode ------------------------ 2>04.13.2010 10:56:43 Updated Module state to STOPPED/WARMING
Preparing to Download the Application File: IAMV.BIN
Starting the TFTP Turbo Download...
................................................................................
----------------------
I1000 Assay Module Controller #2 ---------------
BSP Revision: Version 0.29
Boot Code Revision: Version 0.29
Copyright (c) 1998 by Abbott Laboratories
Booting Up from DRAM ...
---------------------------
CPU Bootup Diagnostics --------------------------- ---------------------------
CPU Bootup Diagnostics ---------------------------
Dual Port RAM Test -> PASS Dual Port RAM Test -> PASS
I2C Loopback Test -> PASS I2C Loopback Test -> PASS
DRAM Test [ 64MB ] ................................. -> PASS DRAM Test -> SKIPPED
Clearing Uninitialized Data ... -> DONE Clearing Uninitialized Data ... -> DONE
RISC Master Timer Test-> PASS RISC Master Timer Test -> PASS
RISC Slave Timer Test ................ -> PASS RISC Slave Timer Test ................ -> PASS
Periodic Interrupt Timer Test -> PASS Periodic Interrupt Timer Test -> PASS
General Purpose Timer 1 Test -> PASS General Purpose Timer 1 Test -> PASS
General Purpose Timer 2 Test -> PASS General Purpose Timer 2 Test -> PASS
General Purpose Timer 3 Test -> PASS General Purpose Timer 3 Test -> PASS
General Purpose Timer 4 Test -> PASS General Purpose Timer 4 Test -> PASS
Flash Erase/Program Test -> PASS Flash Erase/Program Test -> PASS
SMC2 UART Loopback Test -> PASS SMC2 UART Loopback Test -> PASS
SMC1 UART Loopback Test -> PASS SMC1 UART Loopback Test -> PASS
SCC1 Ethernet Loopback Test -> PASS SCC1 Ethernet Loopback Test -> PASS
SCC2 UART Loopback Test -> PASS SCC2 UART Loopback Test -> PASS
SCC3 UART Loopback Test -> PASS SCC3 UART Loopback Test -> PASS
SCC4 UART Loopback Test -> PASS SCC4 UART Loopback Test -> PASS
SPI Loopback Test -> PASS SPI Loopback Test -> PASS
FPGA Digital I/O Loopback Test -> PASS FPGA Digital I/O Loopback Test -> PASS
FPGA Digital I/O IRQ Test -> PASS FPGA Digital I/O IRQ Test -> PASS
-------------------Auto Retest Sample Handler Controller -------------------- ------------------------------ TFTP Bootup Mode ------------------------------
BSP Revision: Version 0.29 Preparing to Download the Application File: RSH.BIN
Boot Code Revision: Version 0.29 Starting the TFTP Turbo Download...
Copyright (c) 1998 by Abbott Laboratories ................................................................................
Booting Up from FLASH ... .......
TFTP Turbo Download Completed.
Transferring Control to the Downloaded Code...
---------------------------
CPU Bootup Diagnostics ---------------------------
Dual Port RAM Test -> PASS
I2C Loopback Test -> PASS
DRAM Test [ 64MB ] ................................. -> PASS
Clearing Uninitialized Data ... -> DONE -------------------Auto Retest Sample Handler Controller --------------------
RISC Master Timer Test-> PASS BSP Revision: Version 0.29
RISC Slave Timer Test ................ -> PASS Boot Code Revision: Version 0.29
Periodic Interrupt Timer Test -> PASS Copyright (c) 1998 by Abbott Laboratories
General Purpose Timer 1 Test -> PASS Booting Up from DRAM ...
General Purpose Timer 2 Test -> PASS
General Purpose Timer 3 Test -> PASS
General Purpose Timer 4 Test -> PASS ---------------------------
CPU Bootup Diagnostics ---------------------------
Flash Erase/Program Test -> PASS Dual Port RAM Test -> PASS
SMC2 UART Loopback Test -> PASS I2C Loopback Test -> PASS
SMC1 UART Loopback Test -> PASS DRAM Test -> SKIPPED
SCC1 Ethernet Loopback Test -> PASS Clearing Uninitialized Data ... -> DONE
SCC2 UART Loopback Test -> PASS RISC Master Timer Test -> PASS
SCC3 UART Loopback Test -> PASS RISC Slave Timer Test ................ -> PASS
SCC4 UART Loopback Test -> PASS Periodic Interrupt Timer Test -> PASS
SPI Loopback Test -> PASS General Purpose Timer 1 Test -> PASS
FPGA Digital I/O Loopback Test -> PASS General Purpose Timer 2 Test -> PASS
FPGA Digital I/O IRQ Test -> PASS General Purpose Timer 3 Test -> PASS
General Purpose Timer 4 Test -> PASS
Flash Erase/Program Test -> PASS
----------------------
Operating System Initialization ----------------------- SMC2 UART Loopback Test -> PASS
Enabling CPU Instruction Cache -> DONE SMC1 UART Loopback Test -> PASS
Transferring Control to pSOS/pROBE ... SCC1 Ethernet Loopback Test -> PASS
SCC2 UART Loopback Test -> PASS
SCC3 UART Loopback Test -> PASS
SCC4 UART Loopback Test -> PASS
pSOSystem V2.2.2 SPI Loopback Test -> PASS
Copyright (c) 1991 - 1997, Integrated Systems, Inc. FPGA Digital I/O Loopback Test -> PASS
-------------------------------------------------------------------------- FPGA Digital I/O IRQ Test -> PASS
START-UP MODE:
Run the TFTP Bootloader / CLI
NETWORK INTERFACE PARAMETERS: ----------------------
Operating System Initialization -----------------------
IP address on LAN is 192.168.1.2 Enabling CPU Instruction Cache -> DONE
HARDWARE PARAMETERS: Clearing Free Memory ... -> DONE
Serial channels will use a baud rate of 9600 Transferring Control to pSOS/pROBE ...
Bootup Diagnostics are Enabled
DRAM Code Area Memory Protection is Disabled Architecture started for module 0
Processor: MPC860 CPU Rev 3.1 running at 50 Mhz
Flash Memory: 4MB of FLASH
Dynamic Memory: 64MB of 8-bit 8ns AVED8P664LB48-GHMI SDRAM --------------------------
Hardware Initialization ---------------------------
Ethernet Hardware Address: 08:00:3E:03:04:04 04.13.2010 11:04:16|0| 2576|Starting POST on Module Number 0
BSP Revision: Version 0.29 04.13.2010 11:04:21|0| 7734|Initializing Motor Indexer Board #0...
TFTP BOOTLOADER / CLI PARAMETERS: 04.13.2010 11:04:21|0| 8022|Initializing CPU Board I/O Interrupts...
The application will bootup into TFTP mode 04.13.2010 11:04:21|0| 8122|Initializing Barcode Reader...
IP address of the TFTP host is 192.168.1.1 04.13.2010 11:04:35|0| 21720|Initializing Load Queue Barcode Reader...
The file to download and start is rsh.bin 04.13.2010 11:04:49|0| 36428|Initializing Sensor Interface Board...
Boot Code Revision: Version 0.29 04.13.2010 11:04:52|0| 38560|Initializing TCP CLI Server Task...
After board is reset, start-up code will wait 15 seconds 04.13.2010 11:04:52|0| 38636|TCP CLI Server Up: IP = 0.0.0.0, Port = 4000
-------------------------------------------------------------------------- 04.13.2010 11:04:52|0| 38722|TCP CLI Server Waiting for Client...
To change any of this, press any key within 15 seconds
Logs
The ARCHITECT System generates logs for most of the hardware movements as software activities on the
system. These logs can be captured from AbbottLink and decoded to provide important instrument
information to be used during troubleshooting. Examples of the types of issues that can be addressed by
analyzing the logs are:
• Assay-related problems
• Liquid level sense (LLS) related errors and Pressure monitoring errors
• Robotic errors
• System software lock-ups
To properly interpret system logs, additional training and tools are required.
Message Logs
There are three types of MESSAGES on the system, software updates, non-critical and critical.
From the System logs screen you can view (by module) the:
• SOFTWARE UPDATE LOG - allows user to install software updates that have been
downloaded to the SCC via AbbottLink.
• TEMPORARY MESSAGE LOG – displays non-critical error-related messages that you can
address, and then delete
• MESSAGE HISTORY LOG – displays and stores a record of error-related messages that you
use to troubleshoot problems associated with system performance and/or results reporting
Non-critical messages
The non-critical messages are sent to the Temporary Messages Log. Some of the non-critical messages you
may find in the temporary Messages Screen are:
• Bar Code read errors, Host transmission errors, and Printer errors
Critical Messages
Critical messages are all other messages and error codes that occur on the system. These messages are sent
to the Message History Log for troubleshooting purposes. The History Log serves as a permanent log of all
error events on the system.
The MESSAGE HISTORY LOG screen provides critical information you will need to correct problems
with the ARCHITECT System
2. Select the LOG SELECTION LIST button, and then select the desired log.
Notes Page
LOG FILES
The ARCHITECT system contains retrievable log files and the ARCHITECT database which can be used
to aid in troubleshooting and gathering data for investigations.
The D:\Logs folder on the SCC stores system logs. Logs should be captured if data from a run is needed,
or if a run was terminated due to a hardware or software problem. These features are available to all users.
Access from SYSTEM, DIAGNOSTICS, SCC Selection, UTILITIES, M&D 6009. Log data can be
exported to a Spreadsheet to aid the user interpretation
NOTE: Refer to the GSS web site for additional information and instruction on LOG-IC Tool and
other available ARCHITECT Tools.
NOTE: Retrievable log files are only available when using the Field Service Personnel (FSE) or CSC
Log ON. For additional information refer to ARCHITECT i2000SR System Service and
Support Manual.
CLI LOG
LOG NAME DESCRIPTION/STEPS WHEN TO USE
NAME
History Message History • Last 12000 error codes logged in message • Hardware
history category • Software
Temp Temporary • Last 200 messages logged in the temporary • Bar Code read errors
category • Host Communication errors
POST Power ON Self • Last record for each PM, SCC or SH power on • Boot-up issues
Test sequence
• Captures PM, SCC or SH Boot-up execution or
error messages
Trace Trace • Hardware interactions to and from hardware
devices
Result Result • Last 11,200 attempted tests run on the system • Result Issues
• LLS Issues
• PM Issues
Assay Assay Activity • Assay performance activities associated with • Timing Errors
performing tests
Cal Cal • Last 500 attempted calibrations • Calibration issue
• Result issue
ASTM_DL ASTM Data Link • ASTM Records/frames transferred between the • Host or LIS Issues
system and different remote systems using ASTM • ARM Issues
Communication protocol
LLS Liquid Level Sense • Records for fluid aspirate events including • Liquid Level Sense Issues
aspirate and wickoff
PM Pressure Monitor • Records for pressure monitoring results of fluid • Pressure Monitoring Issues
aspirate events
Maint Maintenance • Records for maintenance performed • Maintenance Issue
History • One log is maintained for all modules • Diagnostic procedure Issue
QC QC • Event records of interactions to QC configuration • QC event details
and QC data points
SCR Script • Records script commands and responses from a • Investigate maintenance or
maintenance or diagnostic procedure diagnostic procedure errors
AbbottLink
AbbottLink is a premiere data-sharing laboratory software package used to create a secure connection
between an Abbott instrument in a customer lab and Abbott’s internal systems. The AbbottLink option is
available on many of Abbott’s products including the ARCHITECT Systems.
The AbbottLink technology offers a new approach to servicing medical instruments by remotely tapping
into the data already available on the systems. The overall benefits include:
• Remote access to instrument information (logs, files, historical data, etc.)
• Reduced Instrument repair time and Reduced system downtime
• Increased customer satisfaction
AbbottLink also provides valuable reports that document instrument utilization and assay efficiency.
AbbottLink Application
AbbottLink is a browser-based application and can be accessed from any computer that supports access to
the Internet. The application is optimized for use with Microsoft Internet Explorer version 5.5 or higher.
The web address for the AbbottLink application is listed below. It is suggested that you bookmark these
addresses for easy access to the web site.
Internet: https://abbottlinkuser.abbott.com
Intranet: http://abbottlinkuser.web.abbott.com
After searching for, and locating, the desired Abbott Instrument within AbbottLink you will use the
Dashboard Screen as your main source to access information. The Dashboard Screen contains several key
area that are detailed below:
• Location: Where the instrument is physically located.
• Contacts: Area Support contact information.
• Data Window: Displays a snapshot of the real-time data that is collected from the instrument.
- The Historical Data link at the bottom of the Data window is used to access message
history.
• Task/Action Window: Displays a short list of logs and files that are available for retrieval from
the instrument.
- The complete list of logs and files can be located by clicking in the Jump to Drop down
box and selecting Action or select view all in the Action window.
• Uploaded Files Window: Displays links to each of the last 5 files retrieved from the instrument.
The complete list of files that have been recently retrieved can be accessed by clicking View All.
• Jump To: Displays a drop down list of items that you can quickly move to by clicking the desired
selection.
- Historical Data is stored on the server for 120 days.
Device Monitoring:
• Add instrument/device to Watch List
• Monitor Highly Serviced Instruments (HSI) Access Device
• Review Logs prior to on-site visit Dashboard
• Follow-up after Service Call
No
Yes
AbbottLink Benefits
• Unobtrusive monitoring of instrument performance
• No access to patient information (HIPPA complaint)
Prior to on-site visit , remotely
• Access to troubleshooting information via internet/Abbott intranet
Retrieve and Review Device Logs
Watch list
Pro-Active monitoring
Improved telephone troubleshooting
No need for customer to fax data
Reduces customer frustration during troubleshooting
Determine an appropriate Abbott Link Users
action plan based on • Field Service & Customer Support
information received • Assay & Software Development
• Product Development & Engineering
• Reliability
• Sales
Notes Page
Necessary Materials
• AbbottLink ID and Laptop Computer
Time 20 minutes
Activity
_____________________________________________________________
______________________________________________________________
3. Activity Questions:
If you are experiencing issues accessing AbbottLink what number do you call for help?
_______________________________________________________________
Which log would you review to determine how many times an instrument has experi-
enced aspiration errors during the last week?
______________________________________________
List 5 useful ARCHITECT logs or reports that can be downloaded via AbbottLink:
_______________________________________________________________
_____________________________________________________________
4. Per Instructors direction, locate LOG-IC Tool Quick Reference Guide with installation instructions.
TROUBLESHOOTING
General Troubleshooting
Effective troubleshooting and problem resolution requires four logical STEPs:
• STOP - Identify the Problem
• THINK - Gather Information/Data
- Look for Comparison (What IS working vs. What IS Not)
- Gather Clues
- Categorize Failure
• EVALUATE - Identify potential Causes
- Verify problem
- Check Causes against data
• PROCEED - Resolution/Corrective action
- Isolate and correct Root cause of failure - Perform Repair
- Verify Problem Resolution
- Complete all checklists and verifications
Information Gathering
Gather pertinent system information. This includes asking questions surrounding What, Where, When, and
How Often or How Many. Questions such as:
• When was the recommended preventative maintenance last performed?
• What Reagent kit, Calibrator, Control, Bulk Solutions, lot numbers are in use and what are the
expiration dates?
• What tests aren’t being affected?
• When did the problem first occur (Date/Time)?
• When was the last time the problem was not occurring?
• What troubleshooting steps have been taken?
• Is the problem observed or is an instrument error displayed/printed?
Categorizing Failure
Errors or observed problems can generally be traced to one of four categories of variables affecting the
generation of a result:
• Analyzer • Operator
• Reagent • Environment
• Analyzer Errors refer to instrument hardware and software problems which can interfere or influence
generation of correct results. These will be discussed further in later modules.
• Operator Errors refer to human-associated interventions which can interfere with correct result
generation such as:
- Improper sample type for analysis
- Improper sample loading and/or handling
- Incorrect sample vessel and/or consumable
- Bubbles present in reagent and/or sample
Failure Symptoms include:
- Level Sense Errors caused by bubbles or foam
- Failed calibration attempts
- Failed run attempts
• Reagent Errors refer to problems with Reagent, Calibrators and/or Controls such as:
- Improperly stored products
- Expired Reagent, Calibrators and/or Controls
- Control ranges established incorrectly
- Caps not sealed
Failure Symptoms include:
- Curve instability
- Control shifts
- Imprecision
- Failed calibration attempts
• Environment Errors refer to laboratory and surrounding conditions that can influence the generation
of a correct result. These will be discussed further in later modules and include:
- Electrical Specification
- Physical Specifications (Spatial Layout)
- Computer and Interface Specifications
KEY POINTS
Service Tools
REVIEW QUESTIONS
1. Where is the TSB Sticker located on the i2000SR System?
2. List the step required to access the Operation’s Manual located on the i2000SR System
3. Locate the B-hCG assay within the ARCHITECT iSystem Assay Quick Reference Guide. Record
below the assay protocol type for the B-hCG assay.
5. Locate the CLI command to home the process path motor on a i2000SR System. List below where the
command is located and what the command was.
6. Besides data gathering for troubleshooting, list a minimum of one advantage/benefit for using
AbbottLink.
END OF MODULE
OVERVIEW
This module discusses the following subjects:
• Main Power Supply
• Power Distribution
• Card Cage
• Minimum Board Configuration
Notes Page
INTRODUCTION
This module introduces the principles, diagnostics, and components associated with the power, power
distribution, and circuit boards including:
• Main Power Supply
• Power Distribution
• Card Cage
• Board Theory
Objectives
Upon completion of this module, the student will be able to:
1. Use diagnostic tools and interpret data to isolate the root cause of power system and board failures.
2. Identify the physical location of the power system components and circuit boards.
Notes Page
POWER
This module will focus on the i2000SR power subsystem.
NOTE: Electrical Specifications will be reviewed in a later training module associated with
instrument installation. Electrical specifications and requirements include information about
the circuits, outlet types, and outlet requirements and are specific to the instrument module,
and/or configuration of the analyzer. Electrical specifications are stated in the instrument
Operations and Service and Support Manual.
The i2000SR power subsystem provides the voltage for the processing module and RSH.
• The AC subsystem provides power and isolation to the refrigeration system, the vacuum pump
system, and heating system.
• The DC subsystem provides power to fans, stepper motors, valves, and other electronic
components. Five different DC voltages are provided by the DC subsystem.
It includes components for power generation and power distribution such as the following:
• Main Power Supply
• Card Cage Backplane and fuses
• Cables
• Circuit Breakers
• Power Switch:
- A combined power switch and circuit breaker
- 30 Amp fuse (Hold Switch up 3 seconds to go past surge)
Heater Board
Quad Board DC Power
+5V, +/-12V, & +24VDC +36VDC
Power
Switch
Vacuum Pump
Input and Refrigerator
Power Circuit Breaker
AC Power
Frequency Selector
(not used)
• Heater Board directs power to heater via relays based on control signals from Temperature
Controller Board
• LEDs illuminate indicating duty cycle to Heater
- Heater Board LEDs blink ON and OFF - Duty Cycle; Fused
• An unplugged thermistor may shut down the circuit, cycle power to reinitialize
• Fuses protect 27VAC to Heaters
Signals monitored for error conditions by the module controller (PM CPU) are:
• AC Power Fail, indicates AC power is insufficient to maintain regulation of DC outputs
• Over Temperature, indicates excessive AC-DC converter temperatures
• Under Voltage, indicates under voltage condition
• Over Voltage, indicates an over voltage condition
If an error condition is detected, the switch will move to the off position and the power supply is shutdown.
Test points are provided on the power supply for each DC voltage for diagnostic purposes.
Power Supply connectors J907, J908, J909, J928 and J930 must be connected for the power supply to
remain on. Also make sure Power Supply Fans are fully seated or the Power Supply will turn off.
The backplane is used to distribute power to the instrument logic and power boards by supplying
connections between the power supply and the boards. Testpoints are provided for use in determining the
presence or absence of voltage. The card cage I/O signals are routed from the backplane via cables
throughout the system.
To access the backplane, the On Board Wash Buffer Reservoir must be removed in order to open the Card
Cage.
Jumpers on Card Cage Backplane determine processing module number on a multi-module system.
Stress relief system designed to remove stress from connectors and make easier to open/close. During Card
Cage replacement, simply unplug cables and disconnect existing stress relief and mount to new Card Cage.
Backplane
VDC i2000SR
+36 TP 8
+36 Sense TP 1
+36 Sense Return TP 4
+12 TP 5
-12 TP 7
+5 TP 2
+5 Sense
Filter +5 Sense Return
underneath SIG GND TP3
DIG GND TP 6
Card Cage
Card Cage
(Refer to Service and Support Manual Troubleshooting Section; Card Cage; i2000SR Card Cage Backplane and
and Test Points for current information)
NOTE: J907, J908, J909, J928 and J930 must be connected for Power Supply to remain ON
Power ON/OFF
There are times when you may need to start up, pause, shut down, cycle power to, or power OFF the
system and its components. Refer to the information contained in the service and/or operating procedures
to determine when these are required.
NOTE: Refer to the ARCHITECT System Operations Manual for the procedures to perform an
instrument start up, pause, shut down, power cycle, emergency shutdown and long term
shutdown.
It is important to understand the following key principles related to removing power and cycling power:
• The sample handler and processing module(s) are not functional when the system control center is
OFF.
NOTE:To prevent flooding when your system is connected to an ARCHITECT ARM (Automatic
Reconstitution Module) accessory, do not shut down the SCC if the ARM is in the process of
filling the wash buffer reservoir.
• If the processing module(s) power is ON when you power ON the SCC, communication is NOT
properly initialized between the system components. In this situation, the processing module
power must be cycled to re-establish proper communication.
NOTE:Verify the processing module power is off before applying power to the SCC. Press the power
switch on the front of the CPU (central processing unit) to turn on the SCC.
• To power OFF all processing modules in a multi-module system, you must turn the power to each
processing module OFF.
• To power OFF the Sample Handler on a multi-module system, you must determine which module
to power off.
NOTE: Power ON/OFF procedures will differ between a stand alone and an integrated system. In a
ci8200 multi-module system, powering off the processing module farthest to the right (when
facing the front of the system) powers off the sample handler. ALWAYs verify power has been
removed before servicing.
• Cycling power (with SCC in a power ON status) involves powering OFF the processing module
and sample handler followed by applying power. Once the power is ON, a startup must be
performed to attain a Ready status.
NOTE: In a single module system, powering off the processing module also turns off power to the
sample handler.
NOTE: Ensure the processing module has been powered off for one minute before reapplying power.
Before applying power to the PM, ensure that the SCC (system control center) power is on and
that the Snapshot screen displays.
Notes Page
Resources Needed
• Multimeter
• Power Distribution Diagram (section 2.4 in Service Manual)
Refer to the ARCHITECT i2000SR Service and Support Manual to access the procedures
listed in this activity and for additional information.
Remove right back instrument cover. Then identify and observe the following items (DO NOT
REMOVE):
Quad Board LEDs
Heater Board and LEDs
+36VDC Boards LEDs
Power Configuration Jumper and Frequency setting
(Continued)
USE the Power Distribution Diagram located in the troubleshooting section, power
supply, Power Distribution from the Power Supply, and General Data section of the
ARCHITECT i2000SR Service and Support Manual to answer the questions below.
1. If there was a Quad Board failure and +5VDC was not present at the Card Cage, what systems or
components would be affected?
____________________________________________________________________________
_____________________________________________________________________________
a. Where would you measure the +5VDC voltage output? ________________________________
2. If there was a +12VDC power failure, what systems or components would be affected?
___________________________________________________________________________
___________________________________________________________________________
3. If there was a +36VDC power failure, what systems or components would be affected?_________
____________________________________________________________________________
END OF ACTIVITY
Upper Section
Lower Section
Card Cage
The Card Cage Backplane incorporates system interconnects between boards within the card cage and
between a board and connectors. Jumpers on the Card Cage Backplane determine the Processing Module
number for a multimodule system. The Processing Modules are numbered from left to right; therefore, the
left most Processing Module is Module #1. Jumpers are also used to set Process Module and Sample
Handler type.
Temperature Controller • Provides Heater Control instructions to the Power Supply Heater Board
• Receives and processes thermistor signals
• Must cycle power to Processing Module to reset
Module Controller • Functions as CPU for Processing Module, controls all Processing Module
functions
• Communicates with:
- Sample Handler (SH) Module Controller Board and SCC
- Reagent Bar Code Reader(s) and device controllers
• Identical to SH Module Controller
LOWER Motor Driver • Motor Driver Boards are swapable
(power) • Energizes/Drives motor (motor movement)
• Receives motor control signal from Indexer Board
1
1
Indexer #0 (SH) 2
Indexer #3 5
Motor Driver #3 3
Indexer #2 7
Motor Driver #2 4
Indexer #1 9
Motor Driver #1 5
Indexer #0 11
Motor Driver #0 6
CMIA Optics 12
Temperature Controller 13
DC Driver I/O 7
Module Controller 14
LOWER UPPER
on the ARCHITECT System by eliminating all but the essential boards needed for the system to complete
a Boot-up and Initialization to the Main Menu. Then through a process of elimination the failed board(s)
suppressing the system from successfully completing a normal Boot-up can be located.
Minimum number of boards needed to perform an instrument Boot-up and Initialization to the Main Menu:
• Processing Module Controller (#14)
• CMIA Optics Board (#12)
NOTE: Refer to the ARCHITECT i2000SR Service and Support Manual for additional information.
Resources Needed
Refer to the ARCHITECT i2000SR Service and Support Manual for additional information
on performing the procedures in these activities.
Locate the card cage and using ESD precautions, remove the boards identified below and place
carefully on the ESD Mat (do not replace until directed to in activity)
Module controller board (CPU)
Temperature Controller board
DC Driver I/O board
Identify the surface mounted fuses on the removed DC Driver I/O board
a. How many different types of replaceable fuses are there?
____________________________________________________________________
END OF ACTIVITY
Notes Page
Troubleshooting
The following tips are for troubleshooting Power and/or Circuitry System failures:
PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and
component replacement, refer to the ARCHITECT System Operations Manual
and the ARCHITECT i2000SR System Service and Support Manual.
KEY POINTS
Main Power • Located behind the • Provides the voltage for the processing module and RSH.
Supply right rear panel
• AC subsystem provides power and isolation to the refrigeration
system, the vacuum pump system, and heating system.
• DC subsystem provides power to fans, stepper motors, valves, and
other electronic components. Five different DC voltages are
provided by the DC subsystem.
- +5VDC, +12VDC, +24VDC, +36VDC
• Field-replaceable fans (+24VDC).
• Field-replaceable fuses in power supply.
• LEDs display voltage status information.
• "Maintenance Mode" - disables +36VDC output so that solenoids
and stepper motors can be safely unplugged without powering down
the instrument.
- M&D 6200 - CLI commands
- Enable type DIO 37 SET 1
- Disable type DIO 37 SET 0
- M&D 5715
Main Power • Input Panel • Input Panel (200VAC):
Supply - AC • Heater Board - Provides 200VAC to Refrigerator and Vacuum Pump
Module - Power Switch: A combined power switch and circuit breaker
- Voltage input jumper is used to strap the Main Transformer to
accommodate various line voltages
If the correct voltage is not selected, the switch will open and the
System will not power up
• Heater Board (27VAC):
- Provides 27VAC to Heaters
- Protected by card cage backplane fuses
- Fuses are located on Heater Board
Main Power • Quad Board • Quad Board:
Supply - DC • +36VDC Module Board - Provides +5VDC & +/-12VDC power to Card Cage Backplane -
Module (PM)
Logic Boards
- Provides +24VDC directly to cooling fans
• +36VDC Sample
- Board contains replaceable fuses
Handler Board
• +36VDC Module Boards:
- Provides +36 VDC power to Card Cage Backplane - Power
Boards
- Board contains replaceable fuses
Master Card • Minimum Card Cage • Backplane contains fuses and power test points.
Cage Configuration: • Jumpers on Card Cage backplane determine Processing Module
- PM Controller (#14) number in a multimodule system.
- CMIA Optics (#12)
• Logic Boards (Upper):
• Accessed from Waste - Indexer
and Supply Center - Sample Handler (SH) Controller and Module Controller
- Liquid Level Sense
- CMIA Optics
- Temperature Controller
The following troubleshooting STEPs were performed or observed and the issues were
unresolved:
• Main Power Switch Kicks OFF after 1 Second
• Incoming Voltage was checked and was found to be within specification
• Power Supply is configured for the incoming voltage
What checks, measurements, procedures, etc. would you use to help isolate the root cause of
the failure? What would you do to try and resolve this error? What do you think may be
causing the failure?
SCENARIO 2 Processing Module does not come to "STOPPED" status after Power ON.
The following troubleshooting STEPs were performed or observed, but the errors remain
unresolved:
• Power to Ethernet HUB was checked
• Sampler Handler was OK
• Controller Boards were swapped
What checks, measurements, procedures, etc. would you use to help isolate the root cause of
the failure? What would you do to try and resolve this error? What do you think may be
causing the failure?
3. If connector J476 on the card cage backplane became dislodged, what sub assembly would fail to
operate?
5. In the table below, list the component that best matched the description or function shown.
END OF MODULE
OVERVIEW
This module discusses the following subjects:
• Process Path
• RV Loader
• Diverters
• Vortexers
• Pipettors
• Reagent Carousel
Notes Page
INTRODUCTION
his module introduces the principles, diagnostics, and components associated with each robotic component
including:
• Motor operation
• Card Cage boards used for control
• Power Distribution
• Sensors
Objectives
Upon completion of this module, the student will be able to:
1. Use diagnostic tools and interpret data to isolate the root cause of robotic system failures.
2. Identify the physical location of the components associated with each robotic device.
Notes Page
ROBOTICS
The robotic systems on the i2000SR System are used to perform tasks associated with assay processing.
Most assay processing functions take place on the Process Path including loading the RV into the process
path, liquid aspiration and dispense, mixing (vortexing), reaction mixture wash, optics read and unloading
the RVs to waste. The Reagent Carousel area is also motorized.
NOTE: RSH robotic devices, will be covered in a separate training guide or module.
Assembly
and Hopper
Process Path
NOTE: Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information.
Sensors
Sensors provide a reference or starting point used by the system to move a robotic component. By
controlling the number of “steps”, or length of time current is applied to the motor, the system can direct
the position of the device.
Optical sensors and flags are used to determine the home, rotational, or vertical position of each device. A
flag attached to the device interrupts the sensor signal by passing between the send and receive portions of
the sensor.
There are multiple Motor Driver and Indexer Boards that control and drive various robotic devices on the
Processing Module. Each board consists of individual circuits that are used for specific devices. When
troubleshooting a robotic situation the boards can be swapped to determine if the board is the source of the
error. It is important to understand that if a defective board is moved to a new location the failure will most
likely be transferred to the device that is using the same circuit from that location.
Circuit
Motor # Motor Description BD & Card Cage Slot # Fuse
Axis
0 Process Path Slot Upper 11 Slot Lower 6 X F5
Indexer 0 Motor Driver 0
1 Reagent CRSL (Outer) Indexer 0 Motor Driver 0 Y
2 Reagent CRSL (Inner) Indexer 0 Motor Driver 0 Z
3 Dispersion CRSL Indexer 0 Motor Driver 0 T
4 Sample Pipettor, Theta Indexer 0 Motor Driver 0 U
5 Sample Pipettor, Z Indexer 0 Motor Driver 0 V
6 Sample Syringe Indexer 0 Motor Driver 0 R
7 Wash 1 Switch Diverter Indexer 0 Motor Driver 0 S
Process Path
Assay processing takes place in the Process Path, a covered circular track that provides proper incubation
temperatures, liquid dispense/aspiration points, and wash points as necessary for the supported assay
protocols. Reaction vessels containing sample and reagent are held in a disk that sits on top of a circular,
heated track. This disk rotates in a counter-clockwise direction, moving one position every 18 seconds.
Component Function/Description Service Notes
Process Path Motor • 36VDC Stepper Motor (Motor #0) • Motor is encoded so that each RV position
• Rotates the Process Path Disk has a "home" position
• Encoder signals return to Indexer board #0
• Motor is driven by Motor Driver board #0
Process Path • Machined circular assembly that • Three replaceable magnets mounted in the
has two channels or tracks process path, at the optics read and two
wash zone locations, are used for
• Provides: microparticle capture when the RVs are
- an incubated environment for positioned in front of these locations
assay reaction process
- access points for various sub
assemblies to perform steps
involved in the assay sequence
and reaction process
Process Path Heaters • Heaters are mounted to the • Heaters receive 27VAC from Heater board
underside of the assembly:
• Each heater is independently controlled
- All heaters use AC voltage
using an embedded thermistors to measure
- Six zones the process path temperature for that
specific zone
Sensor Board #5 • An optical home sensor used as an • Home sensor uses edge of RV slot in disk to
absolute reference point during the monitor disk position
process path disk homing operation
• Sensor signal returns to Indexer board #0
• Reads homing hole in disk found
during initialization only
Process Path Disk • Supports and guides the RVs as • Rotated by the process path motor
they are moved to various locations
• 112 RV positions
• Indexes one RV position every 18
seconds, in a counter-clockwise
direction (lock step)
• Homing Holes
Process Path Cover • A mounting platform for the various • Cover sits over the disk, mounted to the
sub-assemblies attached to the path process path assembly
• Blocks stray light during optics read
process
• Assists in maintaining heated
environment for RV incubation
Process Path
Sensor Board #5
inner track
RV Loader
The RV Loader orients the reaction vessels (RVs) and inserts
them into the inner track on the process path. The loader
consists of two main assemblies: RV Wheel
• RV Loader (orienter) Wheel
• RV Transport
• RV Loader Transport:
- Receives RV from RV loader wheel
and moves the RV into the inner track
on the process path.
- Loader transport home sensor detects
when the transport is home.
- Three RV Load Sensors are used to
monitor RV insertion process:
RV Loader Sensor Bd #1 - Drop point sensor
- Load point sensor
- Process path insertion RV sensor.
- Sensor Board #6 (calibrated)
- Alignment Bracket keeps loader wheel
RV Loader Transport oriented straight with loader transport
- Motor (#21) and Home Sensor Board
RV Loader
RV Load Sensors
Component Function
• Insertion Point Sensor • The Insertion Point Sensor detects an RV at the position in the Process Path inner
track where an RV is loaded from the RV Transport (Insertion Point)
• The sensor detects an open spot on the Process Path for an RV to be loaded
• If an RV is not detected at the Process Path by the Insertion Point Sensor, the RV
Transport advances until an RV is detected at the Load Point Sensor
• Load Point Sensor • The Load Point Sensor detects an RV in the RV transport position just prior to
delivery into the Process Path inner track (Load Point)
• Once an RV is detected at the Load Point, the RV Loader waits for the end of the
lock step interval. If an RV is detected at the Load Point Sensor it indicates the
transport is full of RVs
• Drop Point Sensor • The Drop Point Sensor detects an RV at the position where the RV transfers from
the RV Loader Wheel to the RV Transport (Drop Point)
• When an RV is detected at the Drop Point, the RV Transport advances one
position
RV Loader Functionality
RV Loader Wheel
Load
Point
RV Loader Transport
CMIA Optics
Drop Home
DIO Insertion Point Point Sensor
Read
Sensor Board 6
RV Loader Sensors
Initialization
1. The RV loader transport is homed and the home sensor is verified.
2. When a RV is not detected at process path insertion point, the RV loader transport advances until a RV is one
position from the load point.
3. RV loader transport advances RV one position and the RV drops into the inner track of the process path:
- RVs are inserted into the inner track whenever an empty slot appears at position 45 for i 2000 SR.
- Step 3 is performed while process path is idle, in synchronization with 18 second process path lock step.
4. After insertion is accomplished, RV loader wheel rotates 90 degrees in an attempt to fill empty slot at drop point:
- RV loader wheel picks a single RV, orients it, and drops it into the RV loader transport at the drop point.
- After each attempt to pick a RV from the hopper, the RV loader wheel pauses to allow the picked RV to settle in
the RV loader transport (Several attempts can be made to pick a RV during the 18 second lock step interval).
5. Drop point sensor is checked.
6. When a RV is detected at the drop point, the RV loader transport advances one position.
8. When a RV is at the load point, the RV loader waits for the end of the lock step interval.
Demand RV in
Synch w/lockstep
RV Needed in No
Process Path?
Check Drop Point Sensor
No
Yes
Advance Transport 1
Position to Insert RV into
Process Path Advance RV loader
transport 1 Position
No
Retract RV Transport N No
Positions if the RV transport Check Load Position Sensor
is not full
RV at Load
Position?
Diverters
Diverters are used to move RVs located in the Process Path Disk. The i2000SR System has four Diverters.
• RV Load Diverter
• RV Unload Diverter
• Wash Zone Diverter
• STAT Diverter
All diverter solenoids are powered by 36VDC from the DC Driver I/O board.
Component Function/Description Service Notes
RV Load Diverter • Energized solenoid, moves clean • Solenoid controlled
RVs from Inner Process Path Track • Shutter
to Outer track when RVs are
• Power: 36VDC from DC Driver I/O board
needed for routine processing:
- Shutter solenoid energizes to lift • Located at Process Path position 1:
shutter arm up - Solenoid 42, Sensor Board (Bd) 15
- Load solenoid energizes to push • Diverter Shutter:
RV from inner to outer track - Solenoid 32, Sensor Bd 14
• When idle, shutter acts like a gate • Sensor board 15 monitored by CMIA
blocking RVs from moving into Optics Board
process path diversion area (opening • Sensor board 14 monitored by Module
between inner and outer tacks) Controller Board
Notes Page
ROBOTIC ACTIVITY - 1
Upon completion of this activity, you should be able to:
• Perform key procedure(s) for servicing Process Path and RV Loader system components
• Perform key M&D procedures
WARNING: Potential Biohazard. Follow biosafety practices.
CAUTION: Moving Parts.
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual and TSB Database
for additional information on performing the procedures in these activities.
NOTES:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
• Enter CLI Command to STOP motor:
OMS 0 ST
• Remove Process Path Cover and clean paying special attention to areas noted above.
• Repeat, as directed by instructor, until Process Path is clean
• Tighten all components
Perform Startup
END OF ACTIVITY
Vortexers
The fluid (Microparticles) in the RVs are mixed and kept in suspension by the rotating action of the
Vortexers. The Vortexer:
Vortexer #2
Vortexer #3
• cup lifts and engages the RV on the Process Path
72
94
• spins to mix (vortex) the RV
49 STAT
Vortexer
3
Vortexer #1
Notes Page
Vortexer Diagram
Pipettor
NOTE: Fluidic functions of pipettor are presented in the fluidics training module. Level Sense and
Pressure Monitor functions of the Pipettor are also discussed in the Fluidics training module.
Pipettors are used to aspirate (using LLS and Pressure Monitoring functions) and dispense reagents and
samples. All pipettors have the same functionality. The ARCHITECT i2000SR System consists of the
following Pipettors:
• Sample Pipettor
• Reagent 1 (R1) Pipettor
• Reagent 2 (R2) Pipettor
• STAT Pipettor
The Pipettor Assembly robotic hardware controls the probe position through horizontal/rotational (theta)
and vertical (z) movement. In consists of the following hardware:
• Theta Motor (Stepper motor): 36VDC from Motor Driver; Sensor Board 13
• Z Motor (Stepper Motor): 36VDC from Motor Driver; Sensor Board 12
• The Z Crash, or Guard, Sensor is used to tell the system when an obstacle has been detected
during downward travel.
Component Function/Description Notes
Pipettor • Pipettor Bodies are all the same • Indexer and Motor Driver Boards can be
Assembly swapped for troubleshooting
The Pipettor arm is curved on the R1, R2,
Sample Pipettors and straight for the • Each pipettor uses a syringe and a pump:
STAT Pipettor. - Pump provides buffer for internal probe
The arm is replaced separately from the wash
Pipettor body. - Syringe precision controls aspiration and
dispense
• Includes fluid sense/pressure monitoring
Z Crash Limit • Detects if probe encounters a vertical • Requires pipettor arm to move down about
Sensor obstruction such as hitting the bottom of 1/8", after it hits bottom, before sensor board
a tube or the side of the wash cup will be triggered
Located under end of Pipettor Arm. • M&D 5400 Cash Sensor Test
Stat Pipettor
Sample Pipettor
Clamps
Clamps
Pipettor Arm
Pipettor
• Locations for Sample Pipettor Calibrations are performed using LLS at the:
• RSH position
• RV 1/2 position target
• RV 24 position target
• Wash Cup Target
• If the Probe misses the target at RSH position during installation, then the RSH may have been
incorrectly attached and/or the i2000SR System may have been improperly leveled.
• If the probe misses the RSH target during installation, then the RSH may have been incorrectly
attached and/or the i2000SR System may have been improperly leveled.
R1 Pipettor Diagram
NOTE: The R1 Pipettor is not used for STAT assay protocols on the i2000SR System.
• During R1 Pipettor Calibration, LLS is used to find the targets for all carousel positions and Wash
Cup.
R2 Pipettor Diagram
• 2 different methods are used to find Reagent Carousel targets during R2 Pipettor Calibration:
• Crash Sensor is used to find the Inner Reagent Carousel target
• LLS is used to find the Outer Reagent Carousel target
• During STAT assay procedures, the R2 Pipettor performs all reagent pipetting.
NOTE: Parts and components on the ARCHITECT System can vary depending on the instrument
manufacturing date and/or replacement of components during service. Refer to the
ARCHITECT i2000SR Service and Support Manual, TSBs, and ISAs, for additional
information.
Wash Aspirate Probe Positioning and Probe Integrity is important for proper system and assay operation.
The probes are notched at the end so they will not create a seal at the bottom of the RV. The probe tubings
should be snug and properly routed to the vacuum vessel so that it is not rubbing or catching on any other
part of the instrument.
Verify the Wash Aspirate Probes are positioned correctly in the wash manifold guide holes and that they
are not bent (The probes should ride on the front edge of the holes {toward the center of the instrument}).
Components Function/Description
• Linear Motor • Motor Driver #2 - WZ1
- Motor #19 WZ1 • Motor Driver #1 - WZ2
- Motor #11 WZ2
The Wash Zone and Shutter motors are the same
• Sensor Board #1 • Indexer Board #2 receives home sensor signals - WZ1
• Indexer Board #1 receives home sensor signals- WZ2
• Vertical Slide Bearing Mechanism • Vertical movement
• Mount • Mount and holding features for three Wash Zone Probes
---------------------------------------------------------------------------------------------------------------------------
Reagent Carousel
The Reagent Carousel stores, cools, and positions the on-board reagents for aspiration by the reagent
pipettors when required during assay processing.
The system provides physical positions for reagent bottles on two concentric rotatable carousels - outer and
inner. The outer carousel has two rings (outer and middle) and the inner carousel has one ring. Each ring
can hold 25 reagent bottles. All positions on the middle ring can also be rotated to provide mixing action.
A bar code reader, located at the center of the carousels, is used for identifying reagents. The bar code
reader is located at a fixed axis and any ring position can be positioned in front of it. A 26th position,
located in the inner ring, for the purpose of providing an unobstructed pathway between the bar code
reader and the middle and outer rings. The position, called a wedge position, does not permit a reagent
container to be placed in it.
NOTE:The Reagent Cooler will be presented in the Fluidics and Temperature Module.
Inner Carousel • Driven by an encoder motor #2 in theta • Motor located above buffer reservoir,
direction underneath carousel
• Home sensor is located underneath the • Motor is mounted with Outer Carousel
carousel Motor (dual pack)
Outer Carousel • Two carousel rings connected together • MIddle carousel is also referred to as the
(Middle & Outer) Dispersion carousel
• Outer carousel motor is mounted with
inner carousel Motor (dual pack) • Dispersion Carousel Motor
• Outer encoder motor (#1) rotates
carousel in the theta direction
• Middle Ring driven by separate motor
(#3) located under carousel at 10
o’clock position
• Home sensor is located underneath the
carousel
• When the system is in a RUNNING
state the middle ring, containing the
Microparticles, is rotated continuously
Dispersion
Carousel V-Wheels
Motor
200VAC
R1 Pipettor
R2 Pipettor
Dispersion Carousel
Outer Reagent Carousel
Sample Pipettor
Processing Center
Module Initialization
1. Reagent carousel cover sensor is check to verify that cover is closed.
2. Inner reagent carousel is initialized and home sensor is checked to verify carousel is in home position.
3. Outer reagent carousel is initialized and home sensor is checked to verify carousel is in home position.
4. Reagent bar code reader is initialized.
1.Run Initialization
1. Reagent carousel cover sensor is check to verify that cover is closed.
2. Inner reagent carousel is initialized and home sensor is checked to verify carousel is in home position.
3. Outer reagent carousel is initialized and home sensor is checked to verify carousel is in home position.
5. Dispersion is stopped.
8. Dispersion is started.
9. Desired reagent on inner carousel is positioned at aspiration point for reagent pipettor 2.
Notes Page
ROBOTICS ACTIVITY - 2
Upon completion of this activity, you should be able to:
• Perform key procedure(s) for servicing pipettors and Reagent Carousel components
• Perform key M&D procedures
WARNING: Potential Biohazard. Follow biosafety practices.
CAUTION: Moving Parts.
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
(Continued)
2. INSTRUCTOR LED:
Perform Pipettor Calibration (M&D 1111, 1112, 1113, and 1117 )
END OF ACTIVITY
Troubleshooting
The following are tips for troubleshooting Robotic System failures:
PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and component
replacement, refer to the ARCHITECT System Operations Manual and the ARCHITECT
i2000SR System Service and Support Manual.
KEY POINTS
Robotics
• RV Loader Transport:
- Receives RV from RV loader wheel and moves the RV into the
inner track on the process path.
- Three RV Load Sensors are used to monitor RV insertion
process:
- Drop point sensor
- Load point sensor
- Process path insertion RV sensor.
- Sensor Board #6 (calibrated)
- Alignment Bracket keeps loader wheel oriented straight with
loader transport
- Motor (#21) and Home Sensor Board
RV Hopper • Enclosed bin capable of holding 1200 RVs in any orientation:
- Front - Fill storage area
- Rear - Pickup area
• Hopper contains an RV Level Sensor that detects when the RV
inventory is empty; reports to CMIA Optics Board
Pipettor • Sample Pipettor • Theta Motor (Stepper motor): 36VDC from Motor Driver.
• STAT Pipettor • Z Motor (Stepper Motor): 36VDC for Motor Driver.
• R1 Pipettor • Home Sensors monitored by Indexer Board.
• R2 Pipettor • Bodies are the same for all pipettors, Arm differs.
• Z Limit Crash Detector under arm.
Robotics
Diverters • Four Diverters On • Solenoids receive 36VDC from DC I/O Driver Board.
Process Path
• Motor controlled receive 36VDC from motor driver board.
• RV Load Diverter (process path position 1):
- Energized solenoid moves clean RVs from Inner Process Path
Track to Outer track when RVs are needed for routine
processing.
- Solenoid Controlled
• RV Unload Diverter: (process path position 109):
- Rotates RV 90 degrees to allow used RV to drop from the Outer
Process Path Track into the Waste Chute
- Solenoid Controlled
• Wash Zone Diverter (process path position 60):
- Directs RVs to Wash Zone #1 for 2- Step Assays
OR
- Moves the RV to the outer track to bypass the Wash Zone for
1-Step Assays
- Motor Controlled
• STAT Diverter (process path position 47):
- Energized solenoid moves clean RVs from Inner Process Path
track to Outer Process Path track during STAT sample
processing
- Solenoid Controlled
The following troubleshooting STEPs were performed or observed, and the issues remain
unresolved:
• Checked/Ensured RV Loader was mounted properly to Process Path
• RVs were inspected and no defective RVs were found
What checks, measurements, procedures, etc. would you use to help isolate the root cause
of the failure? What would you do to try and resolve this error? What do you think may
be causing the failure?
SCENARIO 2 Instrument generates intermittent 5900 Step Loss Detected on (Process Path Motor)
during processing of samples.
The following troubleshooting STEPs were performed or observed, but the errors remain
unresolved:
• RVs were inspected and no defective RVs were found
• RV Loader Assembly mounting tab and foot was inspected for proper seating
What checks, measurements, procedures, etc. would you use to help isolate the root cause
of the failure? What would you do to try and resolve this error? What do you think may
be causing the failure?
Shutter Motor 14
2. If you suspected a problem with the R1 Pipettor Theta Home Sensor, what diagnostic test could you
perform to test the functionality of the sensor?
3. If a defective Motor Driver Board in slot #5 is causing Wash Zone 2 Step Loss errors, and the board is
swapped with the Motor Driver Board in slot #6, which device would you now suspect would recover
an error?
4. Which Diverter moves RVs from the inner lane of the Process Path to the outer lane of the Process
Path for routine assay protocols?
5. Which RV Loader Sensor detects an open spot on the Process Path for an RV to be loaded into?
6. What diagnostic test can be used to verify the functionality of the RV Load Diverter Shutter Sensor?
END OF MODULE
OVERVIEW
This module discusses the following subjects:
• Optics System
• Optical System Theory
• Optics Assembly
Notes Page
INTRODUCTION
This module introduces the principles, diagnostics and components associated with Optics Systems
including:
• CMIA Reader
• Shutter Assembly
• Reader Magnet Assembly
Objectives
Upon completion of this module, the student will be able to:
1. Use diagnostic tools and interpret data to isolate the root cause of Optics System failures.
3. Perform the procedures required to remove and install key components of the Optics Systems.
4. Perform the processes used to verify the functionality of the components used in the Optics Systems.
5. Perform the maintenance procedures for the components used in the Optics Systems.
Notes Page
OPTICS SUBSYSTEM
The Optics Assembly on the i2000SR System is located within the Process Path between Wash Zone 2 and
the R1 Pipettor. The optics subsystem and associated components are designed to detect and measure
photo emissions produced by a chemiluminescent reaction. Using this subsystem, the light emitted by the
reaction mixture in the RV is read and the data is sent to the:
• CMIA Optics board
and to the
• Module Controller, both within the Card Cage
The optical read is then analyzed by the system software to produce patient results.
Optics Assembly
Process Path
Optics Hardware
The Optics Subsystem has three principle assemblies:
• CMIA Reader Assembly
• Reader Magnet
• Shutter Assembly
Trigger Manifold
CMIA Reader
PMT
Magnet
Shutter Assembly
Light Pipe
Optics Values
Notes Page
Chemiluminescent Reaction
The reactants necessary for CMIA assays include the following:
• Paramagnetic microparticles coated with a capture molecule (antigen, antibody, or viral particle)
specific for the analyte being measured - pink reagent vials
• Acridinium-labeled conjugate - yellow reagent vials
• Assay Diluent - teal reagent vials (where required by assay)
• Pre-trigger Solution (Hydrogen Peroxide) and Trigger Solution (Sodium Hydroxide)- Bulk
Solutions
Basic Reaction
NOTE: The exact sequence of the events listed below will differ based on the specific assay. Refer to
the ARCHITECT Operations Manual; principles of operation, for more information.
• Pre-trigger Solution (hydrogen peroxide) is added and the CMIA optical system takes a background
read.
(Continued)
• The system then adds Trigger Solution (sodium hydroxide) to the reaction mixture.
• The acridinium undergoes an oxidative reaction when exposed to peroxide and an alkaline solution.
8. After a specified delay, a command to open the Shutter is generated by the Module Controller Board
and the process path is free to advance.
The optic read is the measurement of the chemiluminescent emission over a pre-defined time.
• The optics read is taken over 3 seconds for both the background read and activated (foreground)
read.
• Each read involves 30 sub-reads at 100 millisecond intervals.
• When the thirty sub-reads are plotted for a normal read, a bell shaped curve with a left bias is
obtained (See example below):
- The first sub-read is usually very low or zero as the reaction has not initiated yet.
- As the chemiluminescent flash occurs with the trigger addition, the peak signal occurs
between the 4th and 6th reads, and typically at the 5th read.
NOTE: The peak signal will vary depending on the specific assay, and analyte concentrations.
- The reaction then degrades over the remainder of the 3 seconds to near zero again at the
final read.
• The signal in the result log file is the sum of these 30 background reads and 30 activated reads.
• The corrected or final count is obtained by subtracting the background from the activated read
(Final Read (RLU) = Activated- Background).
EXAMPLE:
Low RLU Calibrator (example)
Time RLU Time RLU Time RLU
0.1 0 1.1 214 2.1 14
0.2 35 1.2 123 2.2 11
0.3 1377 1.3 77 2.3 10
0.4 7231 1.4 52 2.4 11
0.5 10417 1.5 37 2.5 8
0.6 7686 1.6 27 2.6 9
0.7 3713 1.7 23 2.7 9
0.8 1715 1.8 20 2.8 8
0.9 827 1.9 15 2.9 8
1.0 400 2.0 15 3.0 7
Data reduction calculation is the method used to calculate the final read in RLUs (relative light units). In
performing the data reduction calculation the system:
1. Sums the signal measured by the CMIA optical system.
2. Verifies that:
- Background counts fall within an acceptable range
- Activated read profile falls within an acceptable set of ranges
3. Subtracts the background counts from the activated read counts to calculate the final read
and converted it to concentration units.
Notes Page
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
(Continued)
CLI Commands
1. Set the correct module by typing SET_MODULE X (X= 1 for Standalone i2000SR PM or 2 for integrated iPM)
Option 1
The following commands will look at background light; the commands return 10 sets of numbers which represent
background with an empty RV.
The example (in blue) below is designed to show that the first parameter after the optics PMT command determines the
state of the PMT. A (1) turns the optics PMT on and (0) turns the PMT off. Also during a read, the (X) or first parameter
after the read command is the time interval between sub reads and the (Y) or second parameter after the read command is
the number of reads to take.
OPTICS PMT X (1 turns PMT on, 0 turns PMT off)
READ X Y ( X = time interval between sub reads (msec) , Y = number of reads to take)
1. SHUTTER_MOVE CLOSE
2. OPTICS PMT 1
3. OPTICS START
4. READ 100 10
5. OPTICS PMT 0
Record results (lid closed):
6. SHUTTER_MOVE OPEN
7. Open the Processing Module lid and repeat steps 1 through 6
Record results (lid open):
8. How much difference was seen between the results in step 5 vs step 7?
Option 2
The following commands will exercise the Optics. This test will move an RV from the test access point to the optics
area, close the shutter, dispense 300 μL of Trigger, read and report the result, open the shutter, and then return the
RV back to the access point for removal.
1. Add one drop of (mixed) microparticles to an RV using a disposable pipette. Then place the RV into the test
access location.
2. PROC_PATH_MOVE 28 CMIA
3. CMIA_READ 300
4. PROC_PATH_MOVE 98 ACCESS
5. Review Results
Note how the microparticles have been pulled to the side of the RV.
END OF ACTIVITY
Troubleshooting
The following tips are for troubleshooting Optic System failures:
PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and
component replacement, refer to the ARCHITECT System Operations Manual
and the ARCHITECT i2000SR System Service and Support Manual.
Service Tips:
• Shutter spring may easily dislodge if service personnel hand is in location during instrument
service.
• Cover Light Pipe whenever removing Optics Assembly; cap is in Customer Maintenance kit.
• After replacement of new Optics, enter new Normalization and Linearity data into System
Configuration files.
• All Optics will be "dry-calibrated" at factory. No field normalization procedure.
KEY POINTS
Optics
CMIA Reader • Located on Process • Detects light photons produced from CMIA reaction.
Path • Replaced as an assembly.
• Receives power from CMIA Optics Board in Card Cage.
• Each CMIA Optics Assembly comes from the factory with Linearity
and Normalization parameters attached.
During installation & replacement the Linearity and Normalization
parameters from the CMIA optics assembly must be entered into the
module configuration window on the SCC . Some values may be (-)
negative and require the dash (-).
Reader Magnet • Pulls the microparticles to the side of the RV for optimal read.
Assembly • Replaceable
CMIA Optics • Master Card Cage • Controls CMIA Reader sensitivity by controlling the high voltage
going to the photomultiplier tube (PMT).
• Logic Board
• Works in conjunction with Indexer to analyze sensor outputs.
The following troubleshooting STEPs were performed and/or observed, but the error
remains unresolved:
• CMIA Optics Board was reseated
• Pre-trigger and Trigger Solutions were replaced
What checks, measurements, procedures, etc. would you use to help isolate the root cause
of the failure? What would you do to try and resolve this error? What do you think may
be causing the failure?
SCENARIO 2 Customer states that all QC Results are low and their calibrations are failing do to invalid
read errors.
The following troubleshooting STEPs were performed and/or observed, but the error
remains unresolved:
• M&D 1020 Optics Background Check passes
What checks, measurements, procedures, etc. would you use to help isolate the root cause
of the failure? What would you do to try and resolve this error? What do you think may
be causing the failure?
(Continued)
1. The Shutter Motor Cable connects to which connector on the Card Cage?
3. What board in the Card Cage accepts read data from the CMIA Optics Assembly?
4. What symptom(s) would you expect to observe if the Trigger and Pre-trigger Solutions were
switched?______________________________________________________________________
5. What board in the Card Cage controls the opening and closing of the Shutter?
END OF MODULE
Notes Page
OVERVIEW
This module discusses the following subjects:
• Bulk Solution Fluidics
• Vacuum and Liquid Waste System
• Pressure Monitor System
• Liquid Level Sense (LLS) System
• Syringes
• Temperature Subsystem
• Wash Aspirate Monitor (WAM)
Notes Page
INTRODUCTION
This module introduces the principles, diagnostics, and components associated with fluidic and
temperature subsystems including:
• Functionality
• Power and Circuitry
• Hardware
• Wash Aspirate Monitoring
• Heaters and thermistors
• Reagent Cooler
Objectives
Upon completion of this module, the student will be able to:
1. Use diagnostic tools and interpret data to isolate the root cause of Fluidic and Temperature sub system
failures.
4. Describe the functionality and key signal pathways used by heater and/or fluidic components.
Notes Page
FLUIDIC SUBSYSTEM
The Fluidics subsystem is responsible for the movement of buffer, reagents and liquid waste throughout
the ARCHITECT i2000SR System. Fluidics Subsystems include:
• Buffer Delivery System
• Trigger/Pre-trigger Delivery System
• Vacuum System and Liquid Waste
• Wash Cup
• Syringe (sample and reagent aspiration and dispense)
• Liquid Level Sense and Pressure Monitor
Wash Zone 2 Vortexer
Wash Zone 1
R2 Syringe
R1 Pipettor
STAT Syringe
Reagent Pipettor R2
R1 Syringe
Reagent
Carousel
Sample Syringe
Hopper
Sample Pipettor
Stat Pipettor
Trigger
Pre-Trigger
Wash Zone (WZ) Pump • Moves buffer from onboard reservoir • Located on back of analyzer in Pump Bay
to wash zone manifold and valves
• Receives 36VDC from Motor Driver #3
• Dual head 50μL FMI pump
• Logic CMIA Optics board & Indexer #3
WZ Buffer • Warms solution to 30-37.6oC before • Mounted to side of Wash Zone Manifold
Heater dispense through Wash Zone • 27VAC from Heater Board
• One heater for each Wash Zone • Cylindrical tubing block with heating
(interchangeable) element and thermistor
• Each heater independently • Thermistor signals return to Temperature
controlled Controller Board (TCB)
Wash Zone • Two Wash Zones • 36VDC stepper motor - vertical movement
Manifold • During the CMIA wash process: • 36VDC Manifold valves; DC Driver I/O
- 3 nozzles & 3 valves dispense
• Vertical Slide Bearing mechanism
heated wash buffer into RVs
- wash assembly lowers probes • Valve Removal tool
into RVs
- wash aspirate probes aspirate
waste fluid using vacuum
- 4th valve flushes and primes
manifold. Bypass line to waste
Wash Buffer Reservoir Figure Components: • Sensor signals to Module Controller Board
Level Sensor Outlet Assembly 1. Onboard storage for up to 25 • Level Sensor Outlet Assembly - tube with
liters wash buffer three magnetic float sensors
and Filter
2. Level Sensor draws wash buffer • Buffer Manifold in pump bay
into reservoir and measures
remaining volume
3. Inlet assembly dispenses wash
buffer into reservoir from wash
buffer preparation container or
ARCHITECT ARM
4. Filter protects fluidics
components by eliminating
particulates
Transfer Pump & Buffer Filter • Used to load buffer from the • 36VDC from DC Driver I/O Board
preparation container, into the on-
board buffer reservoir
• Buffer filter between the pump and
the on-board reservoir
V3 V4 V1 V2
Trigger and Pre-Trigger • Magnetic float sensor indicates when • Signal returns to CMIA Optics Board
Level Sensors the liquid level is low
• If hairline cracks are observed on top part
• One for each solution of straw - replace straw
Notes Page
Pump Bay
Front Row Back Row
Buffer Manifold
Rear of Instrument
Front Row
Pump Function Size
ST P provides wash buffer to Stat Pipettor Probe dual head
(Stat Pipettor Pump) 100 μl
R2W P provides wash buffer to Reagent Pipettor #2 active wash cup dual head
(Reagent Pipettor #2 Wash Pump) 100 μl
R1W P provides wash buffer to Reagent Pipettor #1 active wash cup dual head
(Reagent Pipettor #1 Wash Pump) 100 μl
PT P delivers Trigger solution to Trigger/Pre-trigger manifold single head
(Pre-trigger Pump) 100 μl
Back Row
Pump Function Size
WZ2 P provides wash buffer to WZ#2 for dispense into RVs dual head
(Wash Zone #2 Pump) 50 μl
WZ1 P provides wash buffer to WZ#1 for dispense into RVs dual head
(Wash Zone #1 Pump) 50 μl
R2 P provides wash buffer to Reagent Pipettor #2 Probe dual head
(Reagent #2 Pipettor Pump) 100 μl
R1 P provides wash buffer to Reagent Pipettor #1 Probe dual head
(Reagent #1 Pipettor Pump) 100 μl
SP provides wash buffer to Sample Pipettor Probe dual head
(Sample Pipettor Pump) 100 μl
TP delivers Trigger solution to Trigger/Pre-trigger manifold dual head
(Trigger Pump) 100 μl
Vacuum System
NOTE: For information on troubleshooting the Vacuum System. Refer to the ISA Database,
ARCHITECT System.
The vacuum system consists of the vacuum accumulator assembly, vacuum vessel assemblies and the
vacuum pump with filter. The vacuum system is used to supply vacuum to the active wash cups, wash zone
aspirate probes and waste aspirate probe. The vacuum is used by the system to:
• extract wash fluid waste during the CMIA Wash process
• remove waste from the sample and reagent wash cups
• aspirate liquid from the Reaction Vessel
• provide drainage for the instruments liquid waste
Vacuum Valve
Vacuum Vessel
Waste Drain
• Operation:
- Solenoid valves are opened, allowing the
vacuum to suction liquid
- Liquid is drawn into a liquid separation vessel
where it is held until vacuum cycle is complete
- When vacuum cycle is done, the solenoid valve
closes and the liquid drains into the laboratory
drain or liquid waste reservoir
Vacuum Pump • Creates the vacuum used in the vacuum • 200/230 VAC
subsystem, and distributes it via a vacuum • Module Controller Board
accumulator (Generates up to 27" Hg)
• Pump exhaust is directed through a
• When vacuum is required to aspirate liquid waste, muffler to reduce noise
a solenoid valve opens at the relevant manifold.
• Diaphragm pump
Accumulator (see picture • Holds the vacuum for the system • DC Driver I/O: Solenoid power
below)
• Drain Valve, Vacuum Sensor, Liquid Sensor: • Vacuum Sensor triggered at <9"Hg
- Liquid sensor monitors liquid levels in case of
waste pump failure
Manifold • Liquid waste is distributed to a manifold, which can • If liquid waste is saturated or
be connected to an external liquid waste floor drain, blocked, the liquid is distributed to
waste 50 µL pump, or container solid waste container via RV Waste
Outlet Ports
Reagent Pipettors
Buffer dispensed both
through Probe and into
wash cup
Sample Pipettors
Buffer Dispensed through Probe Only
The Pressure Monitor hardware is used to determine that the correct volume of liquid is aspirated and that
clots, bubbles, or other types of interference do not interrupt the liquid aspiration.
Pressure monitoring is accomplished by placing a pressure transducer in the fluid line between the syringe
and probe. During liquid aspiration, the full pressure profile is measured and analyzed for conformance to
a normal pattern. If an abnormality is detected, an aspiration error will be generated for that aspiration
cycle. The PM Board is used to condition and digitize the signal. The digitized signal is sent to appropriate
LLS Board for analysis. The PM Hardware is designed to require no adjustments. Each Pipettor has its
own PM Board.
2. When the probe contacts fluid the signal received by the antenna increases abruptly.
5. The pipettor then moves the desired depth down into the fluid for aspiration.
6. The pressure monitoring circuitry is activated as the probe moves down into the liquid and while the
syringe draws fluid from the vessel.
7. As the syringe draws fluid from the vessel, the pipettor moves down to keep the probe at the desired
depth.
8. During the aspiration the LLS system is monitoring for error conditions.
9. At the conclusion of aspiration the system verifies all PM and LLS conditions were in specification.
The pipettor is then ready to begin the dispense process.
NOTE: The Sample Pipettor and STAT Pipettor can use the same LLS frequency because they
do not aspirate at the same time.
LLS Board • Located in Card Cage • Separate board for each pipettor
• Develops a frequency that is routed to and • During Aspiration sends commands to stop the
transmitted from pipettor probe Z motion of the pipettor when fluid is detected
• Enables the pipettor to detect fluid and • R1 and R2 transmit at different frequencies
monitor the quality of an aspiration:
• Sample and STAT pipettor pipet same
- uses features that detect signals frequency
transmitted from probe
- monitors the pressure in fluid lines • LLS Board DAC data is >2000 when probe is
during aspiration on antenna
• LLS is used during normal operation and for
pipettor calibration
PM Boards • Mounted on the Processing Module • Separate board for each pipettor
structure near each pipettor
• Used to condition and digitize signal from
pressure monitor transducer
• Sends signal to appropriate LLS board for
analysis
Pressure Monitor • In the fluid line between syringe and probe • +5 and
Transducer • Monitors changes in fluid pressure
+12VDC
Syringe Components
The syringe controls the aspiration and dispense of samples and reagents. The Syringes are:
• Sample Syringe
• Reagent 1 (R1) Syringe
• Reagent 2 (R2) Syringe
• STAT Syringe
Valve and O- • A syringe valve controls buffer flow to the • Syringe valve: 36 VDC
Rings syringe
• Blue label on valve
• Normally Closed
• O-Ring for valve port
• DC Driver I/O Board for valve control
• NOT compatible with the AxSYM System
Stepper Motor
Lubrication
Valve and O-Rings Point
Piston
Fluid Vessel
Syringe
Syringe Diagrams
---------------------------------------------------------------------------------------------------------------------------
FLUIDICS ACTIVITY 1
Upon completion of this activity, you should be able to:
• Perform key procedure(s) for servicing fluidic system components
• Perform key M&D procedures
WARNING: Potential Biohazard. Follow biosafety practices.
WARNING: Splash/Spray Hazard.
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
Example Data: 04095 04095 04095 00000 00000 00000 00000 00000 00000 00008
00071 00095 04095 04095 04095 04095 04095 04095 04095 04095
04095 04095 04095 04095 04095 04095 04095 04095 04095 04095
04095 65534
NOTE: A value of 2000 to 4095 is output if the probe is in liquid, or near a LLS antenna, and
fluid sense components are detecting the signal.
NOTES:______________________________________________________________________
(Continued)
• CHOOSE ONE other location from the list below and use the LLS CLI command to verify proper
LLS Antenna Board function.
R1 LLS Antenna Board R2 LLS Antenna Board
RV 47/48 LLS Antenna Board RV 24 LLS Antenna Board
STAT Probe Antenna LLS Board RV 1/2 LLS Antenna Board
Sample Probe Antenna LLS Board
NOTES:______________________________________________________________________
END OF ACTIVITY
TEMPERATURE SUBSYSTEM
The temperature subsystem allows the monitoring and control of subassemblies that are required to operate
at specific temperatures.
• Temperature control includes the ability to both monitor a temperature and provide feedback to
adjust that temperature in order to maintain a desired set point.
• Temperature monitoring involves reading a temperature for reporting purposes, but without the
means to adjust that temperature.
The Temperatures devices are controlled through a control loop between temperature monitoring
thermistors, the Temperature Controller Board and the Heater Board.
• Wash Zone
- Wash Buffer is a controlled temperature environment. Buffer is heated to ensure the wash
buffer solution introduced into RVs does not adversely change the incubation temperature of
the reaction mixture.
• Pre-trigger/Trigger Manifold
- Pre-trigger and Trigger are controlled heating environments. The solution is heated to ensure
its introduced into the RV does not adversely change the temperature of the reaction mixture.
The areas with temperature monitoring only are:
• Wash Aspirate Monitor
• Reagent Refrigerator
• Ambient Temperature
Process Path Heaters • Provide the heat necessary to maintain • 27VAC from Heater Board
reaction temperature.
• Thermistor Signals are sent to
• Six heating zones: Temperature Controller Board
- Each zone is independently controlled • Replaceable heater pads mounted to
base
Reagent Refrigerator • Air is re-circulated through a refrigerator unit • 200 VAC; supplied whenever the main
(Cooler) and reagent chamber: power switch is ON
- blower fan inside unit
• Temperature can range from 2-12oC
• Maintains correct temperature by providing
• Condensation drains into the Waste
and circulating chilled air:
Manifold
- Internal Temperature Sensor and
Thermostat provides internal control • Temperature errors are reported as
- Thermistor located next to Reagent Bar Channel 7
Code reader
Fans • Three Card Cage Fans • Air circulation and heat removal to
• Power Supply Fan maintain proper operating temperature
MODULE
CONTROLLER
Module BOARD 27 VAC
VDC
Ambient Temp.
Sensor
Pre-Trigger
Heater
Carousels
Area Temp.
Sensor
Trigger
signals Heater
Monitoring
Heater
Aspirate
WZ #1
Buffer
WZ #1
3 Lines
Monitoring
Aspirate
Heater
WZ #2
WZ #2
Buffer
3 TEMPERATURE
Lines
Process Path
Process Path
Process Path
Process Path
Process Path
Process Path
CONTROLLER
Zone #4
Zone #3
Zone #2
Zone #1
Zone #6
Zone #5
BOARD
Control Signals to
Heater Board
ZONE 5
ZONE 4
ZONE 6
Thermistor
ZONE 1
ZONE 2
ZONE 3
Ambient Thermistor
Six Process Path Zones
The WAM thermistor is located inside the waste tubing approximately 11 inches from the probe tip. A
normal wash aspiration produces a temperature profile with predictable characteristics.
• WAM determination is based on temperature measurements taken at 1millisecond intervals. A
normal wash aspiration produces a temperature profile with predictable characteristics
Wash Zone
Valve 4
Valve 3
Valve 2
Valve 1
Wash Sequence:
The following is an overview of the events that occur during a normal Wash Zone cycle.
The Wash Zone Magnet pulls the microparticles to the side of the RV and keeps the microparticles from
being aspirated out of the RV during the wash.
In the next position another two washes are performed on the RV:
• WZ Probe 2 aspirates the buffer and the WAM value is recorded and checked by software
• 1mL of warm buffer is dispensed via valve 3
• WZ Probe 2 aspirates the buffer and the WAM value is recorded and checked by software
• 1mL of warm buffer is dispensed via valve 3
WAM temperature measurements are saved in a WAM log file on the module.
NOTE:The LOG-IC Tool provides users the capability to represent data exported from ARCHITECT
immunoassay instrument log files, including the WAM Log, in a user-friendly, graphical
format. AbbottLink can be used to remotely access WAM logs.
WAM Log:
The WAM log file is a useful troubleshooting tool. The information saved in the WAM log includes peak
temperature read during aspiration, as well as the subsequent cooling magnitude.
To use the WAM Log Data, refer to P-216 WAM Log Interpretation in the ARCHITECT i2000SR Service
and Support Manual. When reading a WAM Log consider the following:
• Heating is performed by Buffer Heater and controlled by Temperature Controller Board
• Temperature is monitored by thermistor in Wash Zone Probe Tubing
• Maximum temperature is from warm Wash Buffer read during aspiration
• Subsequent cooling magnitude (Temp.) is measured as air passes over thermistor
• Temperature entries in the log are reported in degrees Celsius
• Temp. readings greater than 1.25 are expected (1250)
NOTE: Wash Station #2= Wash Zone 1, Wash Station #3= Wash Zone 2
Wash aspiration failure can be caused by probe or tubing blockage, vacuum system malfunction or buffer
dispense system malfunction. When troubleshooting WAM errors, consider the following questions as a
guide to locate the root cause of the failure:
Notes Page
TEMPERATURE ACTIVITY
Upon completion of this activity, you should be able to:
• Perform key procedure(s) for servicing Temperature components
• Perform key M&D procedures
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
(Continued)
Retrieve WAM Log using M&D 6009 Log Utilities and the criteria listed below:
• Option #1 (copy current data) Retrieve and copy current logs to Disk and/or Hard Drive
• Choose CD or Hard Drive per Instructor direction
NOTE:The LOG-IC Tool should of been loaded onto your laptop computer prior to performing this
activity. Refer to the GSS website, Diagnostic Tools, LOG-IC Tool for additional information.
1. Pull a WAM Log using AbbottLink and then view using LOG-IC Tool.
This may be conducted as an instructor led activity.
END OF ACTIVITY
Troubleshooting
The following are tips for troubleshooting Fluidic System failures:
NOTE: When troubleshooting ARCHITECT i2000SR System errors refer to your
ARCHITECT i2000SR Service and Support Manual, Technical Service Bulletins,
Instrument Service Advisories, Troubleshooting Information (eSolutions), and/or the
ARCHITECT System Operations Manual
PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and component
replacement, refer to the ARCHITECT System Operations Manual and the
ARCHITECT i2000SR System Service and Support Manual.
• Pipettor Board
Heater Cooler • Temperature Errors • M&D 3540 Temperature Status
Board • Verify LED Status
• M&D 6035 PC Board Test
Wash Zone • WAM • M&D 2050 Wash Zone Aspiration
KEY POINTS
Liquid Level • LLS Board • Liquid Level Sense Board Logic for both PM and LLS Systems.
Sense (LLS) and • Conductive pipettor • During all aspirations, the pressure signal from the pressure monitor
Pressure probe is monitored for over and under pressure conditions.
Monitoring (PM)
• PM Transducer
• LLS Board generates the LLS frequency:
• PM Board - Separate board for each pipettor
• LLS Antenna Boards - R1 and R2 transmit at different frequencies
- Sample and STAT pipettor pipet same frequency
• When the probe touches fluid the signal amplitude received by the
LLS Antenna significantly increases:
- LLS Board DAC data is >2000 when probe is on antenna
- During Aspiration LLS Board sends commands to stop the Z
motion of the pipettor when fluid is detected
• Accumulator • 36VDC Solenoids that open to let waste flow. Drive from DC Driver
I/O Board.
• Manifold
WAM • WAM Thermistor • Confirms that the wash buffer was dispensed and subsequently
• Wash Zone Probe and aspirated completely within the allotted time.
tubing • Based on temperature measurements.
• Vacuum System • Failure can commonly be caused by probe or tubing blockage,
• Buffer Dispense vacuum system malfunction or buffer dispense system malfunction.
System
• Troubleshooting:
1. Is there an RV consistently under the Wash Zone?
- Verify RV loading and process path positioning
2. Is fluid dispensed into the RV?
- Inspect Buffer Dispense System
3. Is fluid aspirated by the Wash Zone Probe?
- Verify Vacuum System Operation
4. Is the Thermistor operational?
- Verify operation of Temperature System
The following troubleshooting STEPs were performed and/or observed and the issues
remained unresolved:
• Trigger Tubing Heater was replaced
• Temperature Controller Board was reseated
• Heater Cables and Connections were checked
What checks, measurements, procedures, etc. would you use to help isolate the root cause of
the failure? What would you do to try and resolve this error? What do you think may be
causing the failure?
SCENARIO 2 You are receiving Error code 3700, unable to process test, (Wash Zone 1) wash aspiration
error for Probe (3).
The following troubleshooting STEPs were performed or observed, but the errors remain
unresolved:
• Tubing/Sensor for Probe 3 was replaced
• Temperature Controller Board was replaced
What checks, measurements, procedures, etc. would you use to help isolate the root cause of
the failure? What would you do to try and resolve this error? What do you think may be
causing the failure?
1. If the 125kHz signal is absent, which board in the card cage might you suspect as the area of failure?
3. The Vacuum Pump receives power from __________________. List the voltage supplied to the pump.
4. What M&D procedure is used to print a WAM log and what other remote diagnostic device can be
used to obtain a WAM report?
6. All Heaters are 27VAC and receive power from the Heater Board. TRUE FALSE
END OF MODULE
OVERVIEW
This module discusses the following subjects:
• Planned Maintenance
• Installation
Notes Page
INTRODUCTION
This module introduces the procedures associated with Planned Maintenance and Installation including:
• Location of Checklists
• Planned Maintenance Procedures
• Installation Overview
Objectives
Upon completion of this module, the student will be able to:
This activity will be focused upon practicing your skills in the performance of preventative maintenance
procedures and in returning the instrument to a fully functional state.
Work through the designated PM checklist. Approach this as you would any normal PM with the following
exceptions:
• When reasonable, you and your partner should perform procedures together such as inspection
and lubrication procedures.
• Components designated for replacement, should be removed and reinstalled unless some type of
damage is apparent, or otherwise instructed.
• Repeat procedures as needed to ensure that both you and/or you and your partner are comfortable
with performing all procedures associated with the PM.
After you have completed the PM, perform QC run, and perform any necessary repair procedures to return
the instrument to a fully functional state.
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual, Planned
Maintenance Section for information related to activity.
(Continued)
PM Notes PM Notes
Items in need of correction/replacement: • Replace Frayed V-wheels
• Areas demonstrating fluid spills/leaks
• Frayed V-wheels
• Damaged or dirty components
• Bent or cracked tubing
• Inspect PP - Chamfered Slot Edges • Inspect RVs for clarity and/or burs
• Observe RV Movement in PP - look for disrupted RVs indicating areas in need of cleaning
(Continued)
Record a brief record of any errors that occurred following PM and their resolution:
Error Resolution
END OF ACTIVITY
Notes Page
INSTALLATION OVERVIEW
ARCHITECT i2000SR Installation procedures are designed to setup the instrument system and verify the
system is performing within specification. It consists of 2 basic processes:
• Pre-site Inspection
• Installation
NOTE:Installation does not generally include assay correlation or performance testing. That
would be included in integration and startup activities.
Use the ARCHITECT i2000SR System Service and Support Manual, Section 7 Pre-Site
Interview and Inspection and Section 8 Installation to view the checklists discussed below.
Pre-Site Inspection
The Installation Checklist (pre-site) can be located in the ARCHITECT i2000SR System Service and
Support Manual, Section 7, Pre Site Interview and Inspections, and Section 8 Installation. It contains
system requirements that must be met prior to system installation or whenever system is relocated. This
includes verifying:
• Incoming Electrical Specifications
• Instrument Clearance
• Delivery Pathway Clearance
• Environment Specifications
• Water Quality Requirements
• Storage Requirements
• Waste Disposal
• Sample Bar Code and LIS Interface data
Installation
The Installation Checklist can be located in the ARCHITECT i2000SR System Service and Support Manual,
Section 8 Installation. It contains the procedures that are required to unpack, setup, and verify
performance of an ARCHITECT i2000SR System. Follow checklist for efficiency and proper sequence.
Use the ARCHITECT i2000SR System Service and Support Manual, Section 8
Installation to view the checklist.
Installation consists of, but is not limited to, the procedures listed below:
• Unpacking instrument and all accessories
• Leveling the instrument
• Tubing installation for in-coming water and drains
• Installing probes and mixers
• SCC Hardware and Cabling
An external device called the network hub joins the communication lines and enables the
electronic transfer of information between the SCC and processing module(s):
• Cables run from the hub to ethernet connectors on the back of the SCC and processing
module(s).
• Ethernet connectors provide the physical connection between the network hub and
each module, and the network hub and the SCC.
• Additional I/O (input/output) ports and connectors on the back panel of the CPU
(central processing unit) provide connections to other external devices, such as a
keyboard, mouse, printer, and monitor.
• Software installation to include, configuration, calibrations, setup for system and assay data.
• Verification of all robotics positions
NOTE: Verify ISA and TSB status of instrument and for updates to procedures.
NOTE: Different SCC, CPUs, and internal hardware have different installation procedures.
Refer to the TSB and ISA All Products Database, and ARCHITECT System Service
and Support Manual for most current information.
For information on Software installation refer to the ARCHITECT System Service and
Support Manual, ISA and TSB All Products Database.
BIOS (Basic • BIOS is the program that starts the computer and • BIOS parameters are codes for control of:
Input Output communicates between devices in the computer - Keyboard
System) system using Erasable Programmable Read Only - Display
parameters Memory (EPROM) - Disk Drive
• Some SCC CPU platforms may require BIOS - Serial Communication
parameter verification during System Installation, - Misc. functions
platform replacement, and or reloading software
• BIOS Parameters are not damaged by
Refer to ISA/TSB Database and/or ARCHITECT System Hard Drive failure
Service and Support Manual for instruction.
Configuration
In this section, you will be introduced to ARCHITECT System configuration settings that are located
under the SYSTEM ICON. Configuration settings consists of three main areas.
• System Settings
• Assay Settings
• QC-Cal Settings
The ARCHITECT System configuration settings are located under the SYSTEM ICON. Configuration
settings consists of three main areas.
• System Settings
• Assay Settings
• QC-Cal Settings
Select System
Select Configuration Select System Settings
System Settings
System Setting configurations are mainly performed during system installation. Parameters cannot be
edited while the module is running. System Setting include, but at not limited to, the following:
Category Description
Host Release • Configure the host interface settings for result release mode, LIS communications, and
Mode result transmission to the host
System Control • Configure the settings for the SCC (system control center), which include:
Center - System date, date format, time, time zone, and automatic adjustment for daylight
savings time
- Number format- thousands separator, System language, screen time-out, beep volume
and QC def.
- ARCHITECT system number and SCC serial (FSR Only)
Sample Bar Code • Settings for sample bar code types (Code 128, Code 39, Codabar, and I 2 of 5) and
Reader specifications
Assay Settings
Assay Setting configurations are generally performed during system integration and whenever a new assay
is installed. However, assays must be loaded onto the system during installation to allow for verification
testing.
For the i2000SR System, all assays are Abbott assays and are installed from a CD. Use M&D 6114
Install/Delete Assays and follow instructions on the screen.
QC-Cal Setting
QC-Cal Setting configurations are performed during system installation, integration, and whenever a new
control or calibrator is installed. A couple of the settings, along with a description of what is configured,
are listed in the table below.
Category Description
QC Single Analyte • Configure single analyte lot, mean, Standard deviation (SD) and bar code SID.
QC Multiconstituent • Configure multiconstituent lot, mean, and SD.
NOTE: Refer to the procedures contained in the ARCHITECT System Operations Manual, Section 2
Installation procedures and special requirements for additional information.
System Backup stores up to three backups (First In First Out - FIFO). System Backup will create a backup
of the following three files to the D-drive, D partition, or F-drive as applicable:
• Module Calibrations - system calibration files, robo.cal, & ish.cal files
• Module Database - system database file, M&D procedures, assay files and calibrations,
results, module and SCC configuration
Backup
• Step 1: Create Backup
- SYSTEM / UTILITIES / F4 Create Backup
NOTE: When the Backup is copied to a CD, it copies the last Backup created in the Utilities screen.
INSTALLATION ACTIVITY
In this activity you will:
• Perform selected installation and pre-site procedures
NOTE: Parts and components on the ARCHITECT System can vary depending on the instrument
manufacturing date and/or replacement of components during service. Refer to the
ARCHITECT Service and Support Manual and/or ISA/TSB Database for additional
information.
Resources Needed
Procedures for these activities can be located in the ARCHITECT i2000SR System
Service and Support Manual, Installation and/or Procedures. ARCHITECT System
Operations Manual, Section 2 Installation procedures and special requirements.
(Continued)
2. Complete the Processing Module Verification Checklist procedures listed below (OR as directed by
instructor):
M&D 3700 Keypad Test
Configure QC Setting
Activity Objectives
• Locate/use the procedures and tools to resolve error situation
• Recognize error messages
• Use service documentation and instrument based procedures to troubleshoot errors
• Perform repair procedures
This exercise will be focused upon practicing your skills in determining the root cause of an instrument
error and in using the troubleshooting process.
Work through the problem identifying the information and procedures necessary to isolate the cause of the
error. APPROACH THIS AS YOU WOULD ANY NORMAL REPAIR. Employ an Effective
Troubleshooting process.
When notified by your instructor, you will work independently through the problem identifying the
information and procedures necessary to isolate the cause of the error. APPROACH THIS AS YOU
WOULD ANY NORMAL REPAIR. Employ an Effective Troubleshooting process.
After you have completed the repair, perform any necessary procedures to return the instrument to a fully
functional state.
Activity Instructions
In order to complete this exercise you will do the following, as directed by your instructor:
1. Begin processing specimens. If an error is detected or there is an error state, stop. Review
Troubleshooting reference documentation (ISA, Troubleshooting Database, Service Manual,
Diagrams, etc.)
2. Observe, make comparisons, perform repair procedures, gather data/information etc. for use in
isolating the reason for the failure.
3. Identify the root cause of the error, perform the repair, then perform the required verification
procedures and return the instrument to a “Ready” state.
4. Be prepared to share your Troubleshooting process with the class including how you arrived at the
solution.
(Continued)
(Optional)
END OF ACTIVITY
MODULE SUMMARY
Now that you’ve completed the Planned Maintenance Module, you should be able to perform preventative
maintenance on the i2000SR System. This included the following items:
• Installation
- Installation is designed to provide direction for system hardware and the verification of
operation prior to turning the system over to the customer.
• It consists of two processes, Pre-site Inspection and Installation
• Installation includes software installation and configuration of certain parameters
REVIEW QUESTIONS
1. List the components that should be replaced on a PM?
5. The Backup procedure is located under what icon and menu item?
END OF MODULE
OVERVIEW
This module discusses the following subjects:
• Automatic Reconstitution Module (ARM)
Notes Page
INTRODUCTION
This module introduces the principles, diagnostics, and components associated with:
• Automatic Reconstitution Module (ARM)
Objectives
Upon completion of this module, the student will be able to:
Notes Page
It delivers an accurate dilution of concentrate buffer while providing a final check of all necessary
parameters of the buffer.
Specifications
The water quality, pressure and temperature are monitored by the ARM hardware and if any of these
requirements are not met, the hardware will not function.
Rear Connections
Description Normal Operation
• Diluted Wash Buffer Output • Connected to the Buffer Input on the rear left of the
Processing Module
• Decontamination Port 1 • Not connected during normal operation
• DI Water Inlet • Connected to pressurized DI Water source
• Waste 1 (pressurized) • Connected to the waste drain or waste pump
• Waste 2 (gravity) • Connected to the waste drain or waste pump
• Must be routed downward and vented to the atmosphere
• RS-232 Port • Connected to P5 of the SCC Digi cable
Top Connections
Description Normal Operation
• Concentrated Wash Buffer inlet • Tubing to allow the concentrated Wash Buffer to be pumped
into the mixing chamber
• Level Sensor cable • Transmits Level Sense signal to the main PCB in the ARM
• Concentrated Wash Buffer • 10L cubitainer of concentrated Wash Buffer
cubitainer
• Level Sensor • Silicone pressure sensor that converts head pressure reading
to signal-conditioned voltage
• Level sensor and pickup tubing placed into a 10L cubitianer
of concentrated Wash Buffer
• Software interprets the signal and the appropriate level LED
indicator on the keypad is activated
• Decontamination Port 2 • Not connected during normal operation
• Tubing assembly holder • Holds the level sensor and pickup tubing during a cubitainer
change
to i2000SR System
Level Sensor Cable
Decontamination Port 1
Decontamination Port 2
DI Water Inlet
Waste 1
(Pressured)
Level Sensor Tubing
Assembly
Waste 2 Holder
(gravity)
Concentrated
Cubitainer
Wash Buffer
RS-232
(SCC Communication)
Rear View
Top View
Fuses
Power Switch
Fuse Compartment
(Valve)
Notes Page
For buffer transfer to occur between the ARM and ARCHITECT i2000SR on-board Buffer Reservoir the
inlet valve on the i2000SR must open. If it fails to open, a output pressure high error may occur on the
ARM.
The valve is located in the pump bay area above the Vacuum Pump and behind the Transfer Pump for
manual loading of buffer.
Initialize • initiated by ARCHITECT System giving command to START • Green indicator below key is full on
deliver buffer (unit must be in standby):
- Initial 15 second flush of water to drain
- Checks all failure possibilities
- Begins the pump and verifies temperature, water,
and buffer quality before entering Run mode
Run • instructed by ARCHITECT System to deliver buffer: START • Green indicator below key flashes
- delivery mode when buffer is being delivered to
- initilization measurements have passed ARCHITECT Buffer Reservoir
Flush • initiated by ARCHITECT System during normal run FLUSH • Flushes inlet water to drain
sequence • Orange LED fully illuminated when
• manually initiated in test mode only by pressing Flush flush performed
key:
ARCHITECT ARM should be in
- diverts inlet water directly to pressurized drain for stop mode before pressing key.
15 seconds then returns to stop mode
Manual operation of the Flush mode key is not
available on software version 2.13 and higher.
Decontamination • initiated from keypad pressing Start and Decon keys START • Left orange decontamination LED
mode 1 simultaneously & flashes during first mode of decon
• tubing must be reconfigured to decon mode prior to DECON
start:
- draws bleach solution through system for a 3 minute
timed soak
Decontamination • initiate second portion of decontamination mode by DECON • Left orange LED full on
mode 2 pressing Decon key again: • Right orange decontamination LED
- 15 min. flush to remove bleach from system flashes during second mode of decon
• return tubing to original configuration at end
NOTE: Refer to ARCHITECT i2000 Service and Support Manual procedure P-06 for information on
placing the ARM in Service Mode by installing a jumper on Main Board J35.
Operational
Description Keypad Function
Mode
System Flush • intended for recovery from aborted decontamination STOP & • Left orange LED will flash
procedure DECON • Green start LED illuminated for full 15
• tubing must be reconfigured to decon mode prior to minutes
start
• initiated from keypad pressing Stop and Decon keys
simultaneously:
- 15 min. flush to remove bleach from system
Bottle Load • initiated from stop mode by pressing Bottle load key BOTTLE • Red stop indicator LED full on
- reads level of the wand in the Buffer cubitainer LOAD • Bottle load orange LED is on and green
- assumes full buffer level start indicator full on during procedure
- calibrated level indications INVENTORY • Level of concentrated wash buffer is
LEVEL indicated by number of bars illuminated:
- 3= Full
- 2= 50%
- 1= Low (<20%)
- None= empty (<2%)
- system goes to stop
- red LED illuminates
Calibration • occurs automatically on first start command after BOTTLE
Check power up and after all errors (15 seconds) LOAD &
• manually initiated from stop mode by pressing START
Bottle Load and Start keys simultaneously:
- checks calibration values of inlet water
temperature and quality, and buffer out quality
- doesn’t check sensors
Test Mode • manual mode of operation does not require
connection to ARCHITECT System
NOTE: If STOP button is selected the ARM will not deliver buffer to the Processing Module until the
START key is pressed.
Error Conditions:
NOTE: Refer to the ARCHITECT iSystem Service and Support Manual, Procedures P-06
ARCHITECT ARM Troubleshooting Information.
Sixteen error states are associated with the ARCHITECT ARM. In an error state, buffer delivery will be
discontinued and error LED will illuminate. The ARCHITECT System will be notified via the RS-232
interface and an error will be placed into the ARCHITECT SYSTEM error log.
Error Condition Description
• Inlet Water Pressure too low (<0.5 psi) • Pressure switch detects pressure below 0.5 psi:
- detected through the A-D main board
• Inlet water error LED indicates full ON
• Inlet Water quality too low (<1Mς -cm) • Conductivity sensor detects low resistivity:
- detected through meter board to main board processor
• Inlet water Mς LED indicates full ON
• Outlet buffer pressure too high (>15 psi) • Pressure switch detects pressure above 15 psi:
- detected through the A-D on the main board
• Outlet water LED indicated full ON
• Output buffer conductivity too high • Buffer sensor detects high conductivity:
- detected through the meter board to the main board
• Upper conductivity LED indicates full ON
• Output buffer conductivity too low • Buffer sensor detects low conductivity:
- detected through the meter board to the main board
• Lower conductivity LED indicates full ON
• Conductivity indication is fully temperature compensated by the sensor
meter board
• Flood condition in ARM detected • Flood sensor at the bottom of the drain catch pan detects flood
condition:
- detected through the A-D on the main board
• Flood indicator LED is full ON
• Concentrate Buffer is empty • Buffer pickup sensor detects a level that is below the minimum pickup
volume in the buffer cubitainer:
- detected via the pressure transducer through the A-D on the main
board
• Inventory Level indicator LED is red and full ON
• Decontamination cycle aborted • Decontamination procedure is aborted:
- Stop and Decon keys must be pressed together to initiate a system
flush
- Other keys will be inactive, this prevents decon solution from
being drawn into the ARCHITECT System
- Wait for Flush cycle to fully complete
• Decon LED will flash
• Inlet water temperature out of range • Inlet water sensor detects temperature below 15oC or above 37oC:
- detected through the meter board to the main board
• Water Temperature LED is full ON
PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and
component replacement, refer to the ARCHITECT System Operations Manual
and the ARCHITECT i2000SR System Service and Support Manual.
ARCHITECT ARM
ARM ACTIVITY
Upon completion of this activity, you should be able to:
• Locate components
• Perform removal and replacement of key components
• Perform key procedures
Activity
(Continued)
END OF ACTIVITY
MODULE SUMMARY
In this module, you learned about ARM. You were familiarized with:
ARM
• Designed to automatically dilute concentrated wash buffer to the correct concentration and to
deliver it to the wash buffer reservoir on the Processing Module
• Configuration is controlled by System Software
• 12 Normal Operating Modes, including:
• Stop Mode
• Bottle Load Mode
• Ready Mode
• Initialize Mode
• Run Mode
• Fluidic Components:
• Pump
• Outlet Block
• Valve Block
• Electrical Components:
• Power Supply
• Main Board
• Stepper Motor Board
• Sensor Board
REVIEW QUESTIONS
1. If you are getting an Inlet pressure low on the ARCHITECT ARM, which components would you
investigate as a possible failure?
3. What ARM component checks the incoming water quality and temperature?
END OF MODULE
Notes Page
NOTE: Parts and components on the ARCHITECT System can vary depending on the instrument
manufacturing date and/or replacement of components during service. Always refer to the
ARCHITECT Service and Support Manual, FRUD, and/or ISA/TSB Database for the most
current information.
i2000SR System i1000SR System
OPERATIONS
CMIA assay throughput Up to 200 tests/hour Up to 100 tests/hour (1 Step STAT assays)
ARCHITECT • software • software
commonality • reagents • reagents
• sample carrier • sample carrier
• Flexible Chemiluminescent • Flexible Chemiluminescent
(CHEMIFLEX) technology (CHEMIFLEX) technology
Sampling • Random & continuous access, priority • Random & continuous access, priority
loading: loading:
- 135 primary/aliquot tubes (35 - 65 samples (Number of Priority/
priority 100 Routine) Routine sections configurable)
• Multiple size tubes (10-16mm W x 75- • Multiple size tubes (10-16mm W x 75-
100 mm H) 100 mm H)
• Liquid level sensing & clot detection • Liquid level sensing & clot detection
Consumable Walk away • Up to 5 hours • 3 Hours minimum
time
Onboard Solutions • Pre-trigger solution • Pre-trigger solution
• Trigger solution • Trigger solution
• Concentrated wash buffer • Concentrated wash buffer
Reagents • To access, must PAUSE the system • Continuous Access to reagents via the
and manually load/unload Robotic Sample Handler (RSH)
• 25 on board reagents, refrigerated • 25 on board reagents, refrigerated
• 100 & 500 test kit sizes • 100 test kit size
• Reagent Stability -30 days on board • Reagent Stability -30 days on board
Customer Maintenance • 6440 Daily Maintenance • 6440 Daily Maintenance -Tap Water
• 6445 Pipettor/WZ probe cleaning daily • 6445 Pipettor/WZ probe cleaning weekly
• 2190 Internal Decontamination FSR • 2190 Internal Decontamination monthly
performed customer procedure
• 6405 Air filter cleaning weekly • 6405 Air filter cleaning monthly
• 6450 Wash Cup cleaning
Processing Module Status • Nine • Eight (no scanning)
Hardware - STORAGE and WASTE CENTER
Pre-trigger/Trigger Same - compatible Same -compatible
Storage Area • Tray • Tray
• Level Sensors • Level Sensors
Wash Buffer Storage • 25 Liter Wash Buffer Reservoir • 12 Liter Wash Buffer Reservoir
Area
Waste Storage Area • Solid Waste Container • Solid Waste Container
• Optional 10L Liquid Waste Container
Reagent Cooler NOT compatible with i1000SR NOT compatible with i2000SR
• Reagent Cooler: • Reagent Cooler:
- 200VAC - 17.5VDC
- Replaceable Fan - Replaceable Fan
- Condensation Cooler - Uses Thermoelectric Device (TED)
for cooling
Hardware - OPTICS
Shutter Assembly NOT compatible with i1000SR NOT compatible with i2000SR
• New Design
CMIA Reader Same - compatible Same - compatible
Hardware - FLUIDICS
Vacuum System NOT compatible with i1000SR NOT compatible with i2000SR
• New Vacuum System capable of
generating 27" Hg
Syringes Same - compatible Same - compatible
• 4 Syringes: • 1 Syringe
- Sample Pipettor
- STAT Pipettor
- Reagent 1 Pipettor
- Reagent 2 Pipettor
FMI Pumps Same - compatible Same - compatible
• Pre-trigger and trigger pumps • Pre-trigger and trigger pumps
Buffer Pump 50uL Buffer Pump (WZ) Same - 50uL Buffer Pump (WZ) Same - compatible
compatible
Transfer Pump NOT compatible with i1000SR NOT compatible with i2000SR
Distribution boards NOT compatible with i1000SR NOT compatible with i2000SR
• None - i2000SR uses sensor boards • 4 boards located throughout system:
- Fluidics Distribution Board
- RSH Distribution Board
- Reagent Distribution Board
- Processing Distribution Board
Other Boards NOT compatible with i1000SR NOT compatible with i2000SR
• Other Boards: • Other Boards:
- Carrier Transport PCB - Carrier Transport PCB
- Pipettor Board(s) - Pipettor Board
- LLS Antenna Boards - LLS Antenna Boards (3)
SPECIFICATIONS
Power Requirements • Voltage: 200 - 240 ± 10% VAC (176 - • Voltage: 110 - 120 or 200 - 240 ±10%
264 VAC) VAC (99 - 264 VAC)
• Frequency: 50 or 60 Hz (47 - 63 Hz) • Frequency: 50 or 60 Hz Self adjusting
• U.S. with Re-setable circuit breaker: • U.S. with Re-setable circuit breaker:
- With UPS - 30 amp - 110 volts - 20 amp
- Without UPS - 20 amp - 220 volts - 10 amp
Plug (North America) One i2000SR System: Outlet within 7' (2.1m) of the processing
• NEMA L6-20R (250 VAC, 20A, twist- module:
lock) • NEMA L5-20R (125 VAC, 20A, twist
lock)
• NEMA L6-20R (250 VAC, 20A, twist
lock)
Power Cord Length 15' (4.6 m) 8' (2.5 m)
Rated Power 3000 volt amp (3 kVA) maximum 1760 volt amp (1.76 kVA) maximum
Consumption
Weight 1081 lbs. (490.3 kg) 636 lbs (288 kg)
Size (door entry) Floor Standing 48” H x 61” W x 49” D Floor Model – 49” H x 58” W x 30” D
RSH
Sections NOT compatible with i1000SR NOT compatible with i2000SR
• 13 Routine / Priority sections for loading
samples & reagents
• Priority sections configurable [sections 0
– 7; default 4] /designated by blue LEDs
• 65 Sample load up capacity
Indicator lights • Same Indicator lights • Same indicator lights except an added
blinking amber indicator to show a
reagent carrier is in the process of
unloading to a section
Loading • Sample Carriers in Priority Section • Sample Carriers in Routine and Priority
• Carrier Trays in Routine Bays sections
• Reagent carriers used to transport
reagent
Status Types Same Same
RSH Card Cage NOT compatible with i1000SR NOT compatible with i2000SR
• Separate RSH Controller Board • NO separate Card Cage for RSH or RSH
Controller Board
END OF MODULE
Notes Page
Notes Page
Activity
Match i2000SR components to the graphic below by writing the number for each component name ( Note:
Some components may be used more than once.)
a. Process Path k. RV Access Door u. CMIA Reader
b. Pre-trigger/Trigger Manifold l. Sample Pipettor v. Process Path Motor
c. Liquid Waste Arm m. Sample Syringe w. Dispersion Carousel
d. Reagent Pipettor 1 n. Sample Wash Station x. Inner Reagent Carousel
e. Reagent Pipettor 2 o. STAT Pipettor y. Outer Reagent Carousel
f. Reagent Syringe 1 p. STAT Syringe z. Stat Diverter
g. Reagent Syringe 2 q. STAT Wash Station a.a. Load/Unload Diverter
h. Reagent Wash Stations r. Vortexers b.b. Wash Zone Diverter
i. RV Hopper Assembly s. Wash Zone 1
j. RV Loader Assembly t. Wash Zone 2
END OF ACTIVITY
Notes Page
Resources Needed
Procedures for these activities can be located in the ARCHITECT i2000SR System
Service and Support Manual, ARCHITECT System Operations Manual, Section 5
Basic Operation.
Assay Runs - The purpose of this activity is to observe different assay types and review the differences on
their printouts.
Refer to reference chart on page 1-15 if assistance needed in software navigation to complete steps below.
4. Print Order List Report and load calibrators and controls into carriers:
• Select ORDER, ORDER STATUS
• Select F4-PRINT to print a report for all orders
(Continued)
6. Evaluate results of calibration and controls upon run completion. Release control results.
END OF ACTIVITY
Activity Instructions
Resources Needed
1. Using the Supply Status Screen, check Supplies and Reagents. Add and update inventory as needed:
Liquid and Solid Waste
RVs
NOTE: Results and inventory status can be adversely affected if you do not align the Trigger and/or
Pre-trigger level sensor correctly. The arrow on top of the level sensor should face towards the
front.
2. Check assay reagents to ensure a minimum of 35 tests remain for B-hCG and TSH
(Continued)
5. Order Calibration:
• Select ORDERS/CALIBRATION ORDER
• Select Carrier
NOTE: When multiple assays are selected, the software automatically assigns the calibrators in
sequential carriers.
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P) if displayed
• Select Assay(s)
- TSH and B-hCG STAT
• Select F5 ASSAY OPTIONS
- Type Calibrator Lot number
- Type Calibrator expiration date
- Select DONE
NOTE: For i System assays the last calibrator lot number and expiration date entered display.
6. Order Controls:
During this activity refer to the table below for the necessary information to complete the control order
• Select ORDERS/CONTROL ORDER
• Select SINGLE ANALYTE
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P) if displayed
• Select Assay(s)
• Select Control, Lot, and Levels (Low, Mid, and High)
• Select F2-ADD ORDER
• Repeat for additional controls
(Continued)
8. Once all orders have been placed, print the Order List:
• Select Orders
• Select Order Status
• Select F4 Print, Orderlist Report, Done
12. Evaluate results of controls upon run completion and release results as applicable
END OF ACTIVITY
Notes Page
MAINTENANCE ACTIVITY
Time to complete: 90 - 45 minutes
Debrief Session: 5 minutes
Activity Instructions
Resources Needed
• ARCHITECT iSystem, onboard solutions, accessories, and consumables
Procedures for these activities can be located in the ARCHITECT System Operations
Manual, Section 5 Operating Instructions and/or the on-line ARCHITECT Operations
Manual.
Notes Page
Activity Instructions
In this activity you will:
• Install assays
• Configure control
• Perform a Calibration
WARNING: Potential Biohazard. Follow biosafety practices.
CAUTION: Chemical Hazard.
Resources Needed
• System Reagents and Single Analyte Controls
• ARCHITECT System Assay Disk
Procedures for these activities can be located in the ARCHITECT i2000SR System
Service and Support Manual, and Installation and/or the ARCHITECT System
Operations Manual, Section 2 Installation procedures and special requirements.
(Continued)
3. Order Calibration:
• Select ORDERS/CALIBRATION ORDER
• Select Carrier
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P)
• Select Assay
- TSH
• Select F5 ASSAY OPTIONS
- Type Calibrator Lot number
- Type Calibrator expiration date
- Select DONE
• Select F2-ADD ORDER
(Continued)
4. Order Controls:
During this activity refer to the table below for the necessary information to complete the control order
• Select ORDERS/CONTROL ORDER
• Select SINGLE ANALYTE
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P)
• Select Assay(s)
• Select Control, Lot, and Level
• Select F2-ADD ORDER
• Repeat for additional controls
5. Once all orders have been placed, print the Order List
6. Load Samples:
• Verify adequate volume of sample loaded per Order List
• Verify sample placement per Order List
7. Initiate Run
9. Print a QC Analysis Report of the Precision Control for the TSH assay
Notes Page
Activity Instructions
In this activity you will:
• Perform Minimum Board Configuration
• Perform Hyperterminal
CAUTION: Moving Parts.
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
• Exit from the HyperTerminal program and disconnect the laptop from the card cage.
Notes Page
Activity Instructions
In this activity you will:
• Perform key CLI Commands
WARNING: Potential Biohazard. Follow biosafety practices.
WARNING: Splash/Spray Hazard.
CAUTION: Moving Parts.
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
CLI Commands
Perform M&D 6200 Terminal Simulator and initiate the CLIA commands below.
NOTE: must be logged in as FSR
END OF ACTIVITY
Notes Page
Activity Instructions
In this activity you will:
• Perform key procedure(s) for servicing an i2000SR System
• Perform key M&D procedures
WARNING: Potential Biohazard. Follow biosafety practices.
WARNING: Splash/Spray Hazard.
CAUTION: Moving Parts.
Resources Needed
Refer to the ARCHITECT i2000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
Perform M&D 3540 Temperature Status (Disregard errors Ambient Temperature. Not active at
this time.)
(Continued)
Perform M&D 3180 Vacuum System Test (test vacuum integrity only)
Functional Test M&D 4200 can also be performed to test various sub-systems at a system level.
Load one or more reagent kits and successfully run at least 3 levels of QC on one assay
END OF MODULE
Notes Page
NOTE: For additional information regarding CLI Commands refer to the ARCHITECT
i2000SR System Service and Support Manual, Section 5
1. Log on as an FSE
3. Select DIAGNOSTICS
5. Choose Perform
6. The first command entered must be which module you are going to control. This command will
generally be one of the following examples:
For the stand alone i2000SR Processing Module use the command: SET_MODULE 1
DIO Commands DIO commands are used for controller or optics boards
DIO X read Returns 0 for inactive, 1 for active
DIO X set 0 / 1 Sets the bit to active / or inactive; such as power supply commands
Motor Commands
HOME X Y Homes a motor (X) for (Y) steps
OMS X JG Y Homes a motor (X) at a constant velocity (Y)
OMS X MR Y Moves a motor (X) a set number of steps (Y) from current position
OMS X MA Y Moves a motor (X) to an absolute step number (Y)
Solenoid Commands
SOL X SET Y Actuates or retracts solenoid number (X):
(Y) = 1 to actuate or 0 to retract
SOL X READ Returns a value of 0 (off) or 1 (on) for solenoid number (X)
Sensor Commands
DIO READ X Command to read specified sensor (X)
Diverters:
DIVERT LOAD Moves and RV to outer lane position 1
DIVERT STAT Moves and RV to outer lane position 47
Trigger 12 48
- Dispense Valve 17
- Waste Valve 18
Pre-Trigger 13 49
- Dispense Valve 19
- Waste Valve 20
Wash Zone 1 Manifold Valves:
- V1 Probe 1 Dispense Valve 9
- V2 Probe 2 Dispense Valve 10
- V3 Probe 3 Dispense Valve 11
- V4 Probe Waste Valve 12
Wash Zone 2 Manifold Valves:
- V1 Probe 1 Dispense Valve 13
- V2 Probe 2 Dispense Valve 14
- V3 Probe 3 Dispense Valve 15
- V4 Probe Waste Valve 16
Wash Zone 1 Vacuum Vessel - Valve/Drain 30/35
Wash Zone 2 Vacuum Vessel - Valve/Drain 31/37
This command will return 10 sets of numbers - obviously 10 sets 0’s are bad. The
numbers represent background readings with an empty RV.
Get_ LLS_DATA 0
Used for troubleshooting LLS frequency issues
For i2000SR Pipettor # = 0
32 values obtained:
1 Minimum
2 Average
3 Maximum
4 Max - Min should be less than 20-25 (ideally 1/3 of threshold value*)
5 Max - Average
6 Average - Min
7 Mode should be between 0 and 15
8 Noise Reading (refer to note below)
9 ADA count air during aspiration count
10 FNF count fluid not found count
11 Phase Ground Value used by engineering ONLY
12 Phase Normal Value used by engineering ONLY
13-31 Data Points collected by ADC
32 End marker value either 65535 (normal) or 65534 (data overflow)
If value 8 is high, there is noise interference. The problem LLS antenna can be isolated
by disconnecting the Process Path (PP) antenna and then the reagent antenna from
the sample antenna. The noise value will drop if the PP or reagent antenna is
interfering.
If the data points are reading 0 then, most likely, there is no signal frequency for LLS
transmission.
Values of 2000 - 4095 indicate the probe is in liquid or close to the antenna.
Station: Description
ACCESS Access port to processing lane
CMIA CMIA Optical read and Trigger2 Addition station
ITV1 Vortexing Station
ITV2 Vortexing Station
REAGENT1 Reagent 1 Pipetting Station
RV_PASSIVE_UNLOAD Passive RV unload position
RV_UNLOAD RV unload position
RV_XFER Point where RVs are loaded from the RV loader onto the
inner process path
SAMPLE Sample pipetting station at position 1
STAT_SAMPLE Sample pipetting station at stat position
TEMP_PROBE1 Temperature probe insertion position 1
TEMP_PROBE2 Temperature probe insertion position 2
WASH_1 Wash Station Position 1
WASH_2 Wash Station Position 2
WASH_3 Wash Station Position 3
WASH_4 Wash Station Position 4
WASH_BP1 Wash Station Bypass 1
WASH_BP2 Wash Station Bypass 2
Component: Description
CMIA_Reader CMIA Reader
ITV1 In-Track Vortexer #1
ITV2 In-Track Vortexer #2
PIPETTER_FLUIDICS Pipettor Fluidics
PIPETTER_THETA Pipettor Theta Axis
PIPETTER_Z Pipettor Z Axis
PROCESS_PATH Process Path Carousel
RGNT_CAROUSEL Reagent Carousel
RV_LOADER RV Loader
RV_UNLOADER RV Unloader
SHUTTER CMIA Shutter mechanism
SYSTEM_VACUUM System Vacuum
TRIGGER1 Trigger1 Dispenser (pretrigger)
TRIGGER2 Trigger2 Dispenser (trigger)
WASH_ZONE Wash Zone Fluidics
WASH_ZONE_ASP Wash Zone Aspirate Mechanism
WASH_ZONE_SWITCH1 Wash Zone Bypass Switch 1
WASH_ZONE_SWITCH2 Wash Zone Bypass Switch 2
TCB CHAN_CTRL X Y Enables / disables control & alarms for a specific channel
X = channel (0-31, 32=all)
Y = value (1 = enable, 0 = disable)
Notes Page
Aspiration
• PM Board awaits LLS signal indicating Probe is in fluid
• PM Board acquires and conditions the PM signal
• Pressure Monitor (transducer) monitors pressure throughout aspiration and sends signal to PM
Board
• LLS Board compares received signal to expected value
• If value is not within the expected value range, an error is generated
An external device called the network hub joins the communication lines and enables the electronic
transfer of information between the SCC and processing module(s).
• Cables run from the hub to ethernet connectors on the back of the SCC and processing module(s).
• Ethernet connectors provide the physical connection between the network hub and each module,
and the network hub and the SCC.
• Additional I/O (input/output) ports and connectors on the back panel of the CPU (central
processing unit) provide connections to other external devices, such as a keyboard, mouse, printer,
and monitor.
As long as the SCC stays powered ON, the PM can be powered OFF/ON and it will re-establish
communications with the SCC.
If the SCC is powered OFF or communication to the PM is disrupted, the Processing Module power must
be cycled AFTER the SCC is rebooted or the SCC will be unable to re-establish communications with
Processing Module.
NOTE: Refer to the ARCHITECT System Operations Manual for additional information.
Cart Assembly
Keyboard Mouse
Printer
Central Processing Unit (CPU)
NOTE: SCC Components and component style will vary depending on SCC model and
component replacement.
NOTE: Refer to ISA Database and/or FRU Database to obtain current information on SCC
replaceable parts for applicable SCC platform.
Touchscreen • Make onscreen selections by touching text areas • 100-240 VAC (Self adjusting)
Monitor, Mouse and and graphics, icons and menu items, and
Keyboard function bar buttons
• Mouse and Keyboard are used to make
onscreen selections or to enter information
CPU (central • Houses the microprocessor and other computer • SCC drive configuration varies per
processing unit) & components. SCC platform
Drives Depending on style of drive it may be used for one
Refer to the ARCHITECT TSB
• Floppy Drive or more of the following functions: database for current platform and
• DVD/CD-RW Drive • Collect system logs setup information.
• USB Flash Drive • Import and export assay files • Internal CPU components RAM,
Motherboard, power Supply and Fan
• Backup software database
• SCC Diagnostic software disk that
• Upgrade system software
comes with CPU can be used for
• Import QC and calibration data troubleshooting computer issues
• Task Manager used to access Hard
Drive files
Network hub and • Provides connection between the SCC and • The Network Hub and External
CPU back panel modules for information exchange Multiport Serial Adapter (EMSA may
not be used on all platforms
Refer to ISA database for current
information.
Key Procedures:
Procedure FUNCTION
M&D 1020 Optics Background
M&D 1030 Shutter Test
M&D 1045 Optics Verification
M&D 1100 Pipettor Test
M&D 1109 Wash Cup Pre Alignment
M&D 1111 Sample Pipettor Calibration
M&D 1112 R1 Pipettor Calibration
M&D 1113 R2 Pipettor Calibration
M&D 1114 STAT Pipettor Calibration
M&D 1150 Probe Alignment Test
M&D 2050 Wash Zone Aspiration Test
M&D 2006 Wash Zone Check 1
M&D 2007 Wash Zone Check 2
M&D 2130 Flush Fluids
M&D 2110 Syringes and Pumps Test
M&D 2151 Prime Wash Zone
M&D 2162 Prime Trigger/Pre-trigger
M&D 3000 Reagent Carousel Test
M&D 3115 Vortexer Test
M&D 3180 Vacuum System Test
M&D 3540 Temperature Status
M&D 3600 LLS Test
M&D 3800 Pressure Monitor Test
M&D 4200 Functional Area Test
M&D 5400 Crash Sensor Test
M&D 5700 Fuse status
M&D 5715 Turn 36VDC off and on
M&D 5100 Process Path and Carousel Motor Tests
M&D 5120 Pump Motor Tests
M&D 6035 PC Board Test
END OF MODULE