ARCHITECT i1000SR

Field Service Training

Manual
INTRODUCTION

Notes Page

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 INTRODUCTION

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
206065-101 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, i2000, i2000SR, i4000SR, ci4100, c8000, ci8200, c16000, ci16200, Chemiflex,
AxSYM, AEROSET, and MasterCheck are registered trademarks of Abbott Laboratories in various
jurisdictions.

i4000, i6000, i8000, c4000, cSystem, iSystem, ARCHITECT ARM, FlexRate, and SmartWash 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.

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INTRODUCTION

Notes Page

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 INTRODUCTION

CONTENTS

Introduction .................................................................................................................... 1

Module 1: Basic Operation......................................................................................... 1-1

Module 2: Service Tools............................................................................................. 2-1

Module 3: Power and Circuit Boards ........................................................................ 3-1

Module 4: Robotics..................................................................................................... 4-1

Module 5: Fluidics and Temperature Control........................................................... 5-1

Module 6: Optics ......................................................................................................... 6-1

Module 7: RSH............................................................................................................. 7-1

Module 8: Planned Maintenance and Installation .................................................... 8-1

Appendix A ..................................................................................................................A-1

Appendix B ..................................................................................................................B-1

Appendix C ..................................................................................................................C-1

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INTRODUCTION

Notes Page

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 INTRODUCTION

TRAINING OVERVIEW
The ARCHITECT System is a fully-automated system allowing random and continuous access. The
ARCHITECT i1000SR 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 i1000SR 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.

3. Perform key component removal and replacement procedures.

4. Perform key procedures and Maintenance and Diagnostic tests.

5. Perform the procedures associated with Planned Maintenance (PM) and an Instrument installation.

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INTRODUCTION

Materials
The information for the i1000SR System Service Training Class will be presented by instructors using the
following materials:
• ARCHITECT i1000SR System Service Training Manual
• ARCHITECT i1000SR System Service and Support Manuals
• ARCHITECT Systems Operations Manual
• ARCHITECT i1000SR 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 i1000SR 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.

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 INTRODUCTION

GRAPHIC CONVENTIONS
Throughout the training manual text, icons and signal words appear where the nature of the information
warrants special attention.

General Icons

Note

The note signal word appears adjacent to an important

point of information that is relevant to the current subject
matter. The note is preceded by an envelope icon.

Reference Materials

The laptop icon signals a location recommending the use of

Reference Materials (i.e. Service and Support Manual, TSB,
ISA, Operations Manual, etc.) during training. Alternate
media can be substituted at the instructor’s discretion.

Diagnostic Information

The tool icon signals an important point of diagnostic

information that is relevant to the current subject matter.

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INTRODUCTION

HAZARDS
The ARCHITECT i1000SR 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 i1000SR 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.

Hazard Signal Words

Standard warning conventions, including hazard signal words and symbols are described below:

Signal Word Definition

DANGER Denotes an immediate hazard which, if not avoided, could result in serious
injury or death. This signal word represents the highest level of any
hazardous situation.
WARNING Denotes a hazard which could result in moderate to serious personal injury.
CAUTION Denotes potential hazards that could result in minor injury.
Note Denotes operator or service information.

Review the Hazard and Safety Information contained in the ARCHITECT i1000SR System
Service and Support Manual Section: General Data and the ARCHITECT System
Operations Manual, Section; 7 Operational Precautions and 8 Hazards, for complete
information.

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Safety Icons and Hazard Symbols

Safety icons in this manual and on the ARCHITECT System identify potentially dangerous conditions.
Service Personnel must recognize the icons and understand the type and degree of potential hazard. If text
accompanies the icon, it describes the nature of the hazard and is labeled with DANGER, WARNING or
CAUTION.

Safety Icon Definition and Descriptions:

Safety Icon Hazard Description
WARNING: Potential Identifies an activity or area where potentially infectious materials
Biohazard may be present. Follow procedures as outlined in “Biological
Hazards” Section of Service and Support Manual.
WARNING: Electrical Shock Identifies the possibility of electrical shock if procedural or
Hazard engineering controls are not observed.

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.

CAUTION: Hot Surface Identifies an area where a hot surface is present.

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.

CAUTION: Possible Identifies an area where electrostatic discharge may be present. A

Electrostatic Discharge Shock ground strap must be worn while servicing the system.

Note: Card Cage Ground Identifies the location on the card cage where the ground strap is
clipped.

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INTRODUCTION

Hazard Symbol Definition and Descriptions

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.

Hazard Symbol Definition/Description (with Standard Abbreviation)

Indicates that the material is Highly Flammable (F) or Extremely
Flammable (F+).

Indicates that the material is Toxic (T) or Very Toxic (T+).

Indicates that the material is Harmful (Xn) or Irritant (Xi)

Indicates the material is Corrosive (C).

Indicates that the material is Dangerous for the environment (N).

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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 i1000SR System Service and Support Manual, System
Specifications for additional information.

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INTRODUCTION

Mechanical Hazards
The i1000SR 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 i1000SR minimizes mechanical hazards by providing guards to protect
against accidental contact with moving components.

The i1000SR 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 i1000SR.
• 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 i1000SR.
• Keep pockets free of items that could fall into the i1000SR.
• Be especially cautious when performing adjustment, maintenance, cleaning, or repair
procedures.
• Use caution when loading sample carriers and reagents.

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Laser Safety
The i1000SR 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.

Laser Caution labels

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INTRODUCTION

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.

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Spill Clean-up Procedure

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.

2. Absorb the spill with absorbent material.

3. Wipe the spill area with detergent solution.

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.

Instrument or Part Decontamination

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 i1000SR System Service and Support Manual; General Data; How
to use this Manual; Instrument or Part Decontamination, to view the decontamination
procedure.

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Waste Handling and Disposal

It is responsibility of each facility to label all waste containers and to characterize its waste stream to
ensure the waste is disposed of in accordance with the appropriate waste disposal regulations.

Dispose of sharps in an appropriately labeled, puncture-resistant, and leakproof container.

Products That Contain Thimerosal or Mercury

Some reagents, calibrators, and controls contain thimerosal or mercury, and may be considered hazardous
by various environmental regulatory agencies. Do not directly sewer waste fluids that contain thimerosal
or mercury.

Products That Contain Guanidine (Thiocyanate)

Do not mix oxidizing agents, such as sodium hypochlorite (chlorine bleach) or with liquid waste. Toxic
gases may be generated.

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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

In general, observe the following precautions when handling chemicals:

• Consult Material Safety Data Sheets for safe use instructions and precautions.
• Avoid contact with skin and eyes. If contact with material is anticipated, wear impervious gloves,
a lab coat, and protective eyewear.
• Always maintain good housekeeping. Do not eat, drink, or store food and beverages in areas
where chemicals are used.
• If irritation or signs of toxicity occur after exposure, seek medical attention.
Hazard symbols that appear on the i1000SR product labeling are accompanied by Risk (R) and Safety (S)
numbers and represent specific risk and safety phrases as defined by applicable European Community
Directives. These risk and safety phrases describe precautions to be used when working with a particular
chemical or chemical mixture.

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 i1000SR System Service and Support Manual; General Data; How
to use this Manual; Removal of Azides from drains, to view the removal procedure.

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Physical Hazards
To avoid potential injuries, safe practices should be observed while working with the following physical
hazards.

Sharps and Probes

In general, the use of sharps and glassware should be minimized.

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 i1000SR 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.

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Electrostatic Discharge (ESD)

Many of the electronic components on the i1000SR System circuit boards are susceptible to electrostatic
discharge (ESD). Static discharge of as little as 100-200 volts can damage or destroy a component. Always
wear a wrist ground strap and discharge static electricity from you body prior to touching and working on
the instrument.

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.

Handling Guidelines - Static sensitive Subassemblies

These guidelines assure protection against failures created by static:

• Retain spare subassemblies in static-protective bags.
• Use an approved static-protective kit, or ground strap shipped with the static sensitive subassembly
when available, whenever a static sensitive subassembly is removed from an instrument or protective
bag.
• Replace the defective subassembly in the same protective bag to return for repair.

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.

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i1000SR SYSTEM INTRODUCTION

The i1000SR System is a fully-automated immunoassay system allowing random and continuous access as
well as priority and automated retest processing. It processes up to 100 CMIA (chemiluminescent
microparticle immunoassay) tests per hour when using a one step 11 STAT protocol. It has the capability to
load up to 25 onboard reagent kits (100 test kits) in a temperature-controlled reagent carousel.

It consists of three main areas:

• System Control Center (SCC)
- The System Control Center is the computer that provides a common centralized user-interface
for the processing modules and related components. The SCC can provide an interface to a host
computer and is utilized for remote diagnostic capabilities.

• Processing Module (PM)

- The Processing Module is a diagnostic module with priority processing capability that performs
sample processing using the CMIA (chemiluminescent microparticle immunoassay) method.

- 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

- The Processing Module contains the following areas:

- Processing Center - is the main activity area of the PM. Samples and reagents are
dispensed and mixed into the RVs (reaction vessels) in the process
path where assay processing is performed.
- Supply and Waste Center - provides access to the bulk solutions and waste storage area.

• Robotic Sample Handler (RSH)

- The RSH is a transport module that presents samples to the processing module(s) for analysis
and retesting.
- Each ARCHITECT system has a single primary sample handler regardless of the number of
processing modules available. However, the RSH may differ in makeup between the
ARCHITECT systems and between a standalone system versus an integrated system.

NOTE: The RSH of a ci4000 System differs from a standalone i1000SR system. Additional information
will be presented during the RSH training module.
- The ARCHITECT i1000SR RSH transport system is used for loading calibrators, controls,
patient samples, and reagents. The design of the RSH allows random and continuous access for
loading/unloading samples and reagents. Two types of sections position samples for either
routine or priority processing. Reagent carriers can be loaded in any RSH section.

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System Control
Center

Processing Module

Robotic Sample Handler

Supply and Waste Center

RV
Loader

Reagent Carousel

RSH

Inside View (Open Processing Module Cover)

Bulk Solutions
and Waste

SCC
Computer

Supply and Waste Center (lower front doors removed)

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Architect System Software

The ARCHITECT software is the computer program or set of computer instructions that interprets system
and assay information, calculates results, and provides the interface for controlling the system hardware.
The software system runs using a graphical user interface (GUI).
• Icons and Menus - Icons represent a category of screens. When selected they list a menu of available items.
When an item is selected the associated screen displays. Icons blink when a condition requires attention.
• Information Area - Displays data and allows the operator to make selections and/or enter information to
perform various functions.
• Function Bar - Contains function buttons associated with the screen currently displayed in information area.
The touchscreen, keyboard, or mouse is used to navigate through the software.

ICONS
Processing Module
Graphic

Sample Handler Graphic

INFORMATION
AREA

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.

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ARCHITECT System Software Guide

Snapshot Exception Status
Sample Status
OVERVIEW EXCEPTIONS Rerun Status
Plan My Day
Operations Manual

Order Status
Patient Order Reagent Status
ORDERS
Control Order REAGENTS Reagent History
Calibration Order

Results Review
RESULTS Stored Results Supplies Status
SUPPLIES

QC Result Review Maintenance

QC Summary Diagnostics
QC-CAL Levey-Jennings Graph SYSTEM System Logs
Calibration Status Configuration
Calibration History Utilities
Stored QC Results
QC Results

To Do
Daily
Weekly
Maintenance Reaction Mechanisms Monthly
Pipettors Quarterly
Fluidics /Wash As Needed
Syringes /Pumps
Bar Code Readers
Modules
Diagnostics
Solenoids /Sensors
Fuses/Motors
Optics/Temperature
Carousels
Precison
ICT
Utilities
Other

SYSTEM Temporary Message Log

System Log Message History Log Sample Ordering
Host-Release Mode
Software Update
Reports - Printing
Reagents -Supplies
System Settings Password
System Control Center
Modules
Configuration
Sample Handler
Sample Bar Code Reader
Serial Ports

Software Install Assay Parameter

Utilities CC Reagent Settings
System Updates
Backup Software Assay Settings New Assay
Result Units
Panel Definition
Task Manager * Retest Rules

QC Single Analyte
QC-Cal Settings QC-Multi Constituent Analyte
* Available with FS Logon Only Bar Code SID
Westgard Rules
Calibrator Settings

Note: Menus and submenus may vary depending on software version utilized. These are for ARCHITECT software version 7.0.

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Log On

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:

Log On Description Password

General Operator • required to display operator ID on printouts • Not Required
and reports
ADMIN • required to perform: • ADM (Default)
(System Administrator) - system configuration
- specific diagnostic procedures
- approve maintenance log

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

FSE • requires FSE user name and password • Superuser Code

• used to perform procedures not available to (in reverse)
the administrator or CSC
- edit configuration settings
- diagnostic procedures
- access to Task Manager

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

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ARCHITECT i1000SR SYSTEM

BASIC OPERATION

OVERVIEW
This module discusses the following subjects:
• Instrument Setup and Maintenance
• Basic Run
• Status and Review Software Screens
• QC Analysis
• Assay Calibration
• Assay Processing

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INTRODUCTION
This module introduces basic operating principles and procedures associated with the ARCHITECT
i1000SR 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:

1. Perform a Basic Run.

2. Perform Maintenance.

3. Perform a Calibration.

4. Describe basic operational procedures/protocols including:

- When an assay calibration is required
- Sample and reagent handling
- Displayed and printed symbols and flags
- Calibration status
- Use of consumables

5. Use the ARCHITECT System Software to perform routine procedures including:

- Viewing result Exceptions
- Release and print results
- View and Print Levey-Jennings and QC reports

6. Locate, Print, and Evaluate Quality Control and Precision data.

7. Troubleshoot operational errors and flags.

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INSTRUMENT SETUP AND MAINTENANCE

In this section, you will be introduced to processes used to setup the ARCHITECT i1000SR System for
analysis including system status, supplies, reagents, and maintenance.

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.
Power on Select F5 Select F8 Select F7
the module Startup Run Pause
Offline Stopped Initializing Scheduled
Ready Initializing Running pause
3.5 minutes 3 minutes 1.5 minutes

0 - 30 minutes if tests are processing

NOTE: Times are approximate

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.
• The system loads or unloads reagent carriers from the Reagent Carousel when the
processing module status is Warming, Ready, Scheduled Pause or Running, and the RSH
status is Running.

• Reagents can be loaded onto the RSH during any status EXCEPT Maintenance.

• Trigger and Pre-trigger Bulk Solutions can be loaded during an Offline, Stopped, Warming, or
Ready status only.

• Wash Buffer Solution can be loaded during Stopped, Warming, Ready, Scheduled Pause, or
Running statuses.

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The ARCHITECT i1000SR System processing module has eight possible status types.
Status Indicators (one or more exists) Notes
Offline • Power to the processing module may be off. • Samples cannot be processed on the module.
• There may be a lack of communication between the • Reagents cannot be loaded or unloaded from the
processing module and SCC (system control center). reagent carousel.
Stopped • Processing Module has not completed a start-up. • Samples cannot be processed on the module.
• Stop function or key was selected. • Reagents cannot be loaded or unloaded from the
• A Processing module diagnostic procedure has reagent carousel.
completed.
• Processing module detected a fatal error while
processing.
Warming • Startup is complete, but temperature initialization is • Samples cannot be processed on the module.
not.
Ready • Startup is complete (including temperature • System must be in ready status to perform
initialization). maintenance procedures.
• Scheduled Pause status is complete.
Scheduled Pause • Pause was selected. • The processing center cover cannot be opened.
• Supplies ran out.
• Processing module detected an error while
processing.
Running • Run was selected. • The processing center cover cannot be opened.
Initializing • A temporary status that occurs when the run key, F8 • Samples cannot be processed on the module.
- Run, or F5 - Start-up is selected. • Reagents cannot be loaded or unloaded from the
• Once initialization is complete, the status changes to reagent carousel as it is not aligned correctly.
Running or Ready depending on whether run or • Wash Buffer cannot be loaded.
startup was selected.
Maintenance • A maintenance procedure is in process on the • Samples cannot be processed on the module.
module.

NOTE: Refer to the ARCHTECT System Operations Manual Section 1, Use or Function; System
statuses for current and/or additional information.

Status

SNAPSHOT Screen Example

Note: The displayed view is dependent on the Processing Module configuration and software version.

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Sample Handler Status

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.

The status condition can be located on the SNAPSHOT screen.

• To go from a Stopped status to a Ready status, select desired module and press F5 - Start-up on the
Snapshot screen
• To go from a Ready status to Running select desired module and press F8 - Run on the Snapshot
screen

Status

F5
Startup

F8 Run

SNAPSHOT Screen Example

Note: The displayed view is dependent on the Processing Module configuration and software version.

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Supply Status
Before processing samples, always check consumable inventory. This can be accomplished through use of
the Supply status screen.

Select Supplies

OR

SNAPSHOT screen Supply Status

Processing Module Graphic

From the Supply status screen, the operator can view and/or access screens to update the status of bulk
solutions, solid and liquid waste, and RV’s. 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

Supply Status Screen

Note: The displayed view is dependent on the Processing Module configuration and software version.

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 the 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: The system calculates supply volume and % remaining information based on tests required for
samples that have been scanned by the Sample Handler.

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Reagent Supply Status Screen

The operator can view information about the Assay Reagents contained on the system through the Reagent
Supply Status Screen.

Select Reagents
Reagent Status

OR

SNAPSHOT screen
Processing Module Graphic

From the i1000SR view of the Reagent status screen the operator can view information for reagents loaded
on the reagent carousel and RSH (robotic sample handler), such as:
• Reagent location and Assay name
• Calibration status (Active or No Cal) and Reagent status (Expired or OK)
• Remaining tests
• Carrier Status
• Scheduled Tests
• Ready to unload time (reagent kit becomes available to unload)

Reagent Status Screen

Note: The displayed view is dependent on the Processing Module configuration and software version.

Reagent positions may be colored as follows:

• White - No reagent is loaded in the position
• Teal - Reagent with an OK status loaded in the position
• Gold - Reagent with a Low Alert or Overridden status loaded in the position
• Red - Reagent with an error condition that requires your attention loaded in the position
• Cross hatch - Reagent is being loaded or unloaded from the position
NOTE: When the Reagent Cooler Lid is opened ALL Reagents will show a BC Fail status and must be
reloaded. This is because there is no bar code reader inside the cooler.

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Assay Reagents
Assay Reagents:
• Reagent kits are two or more bottles that contain all the necessary reagent components for an
ARCHITECT iSystem 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.

Load Reagent Bottles into Reagent Carrier(s)

1. Place the reagent carrier on a work surface with the handle to the left.
2. Place the bottle with the yellow color band securely into the position
with the yellow seat, pink color band with the pink seat and green
color band with the green seat on the reagent carrier. Ensure bottles
are not tilted.
The RSH must be in running status and the processing module in
ready or running in order to load reagents.

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Load Reagents on the RSH

1. Determine RSH status. The RSH must be in RUNNING status to load reagents.

2. Verify the indicators below the desired section are off, which indicates the section is available.
Reagent carriers can be loaded in any RSH section on a stand alone instrument. If the system is an integrated
ci4100 the reagent must be loaded in sections 5-8 of the i1000SR analyzer.

3. Load the reagent carrier into the section by pushing the carrier in until the indicator illuminates.
Once you place a new reagent(s) on the RSH 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.

Onboard stability is tracked after the reagent carrier is scanned by the barcode reader. Once the reagent carrier
has been unloaded from the reagent carousel and removed from the RSH, the onboard stability tracking timer
stops.

For information on reagent onboard stability, see the assay-specific package insert.

If green and amber indicator LEDs beneath a bay begin to toggle on and off, it means the carrier is improperly
inserted.

RSH Indicator Lights

Unloading Reagents
1. Select the Refresh button to display all records.
2. Select the Page scroll right button and verify there are no scheduled tests for the reagent kit to be unloaded.
If a reagent kit is unloaded, all scheduled tests for the reagent kit will go to exceptions.

Select the desired reagent kit(s) to be unloaded, and then select F7 Unload. The reagent carrier will be unloaded to
an available section of the RSH.

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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

Maintenance Screen
Note: The displayed view is dependent on the Processing Module configuration and software version.

To Perform Scheduled Maintenance:

Select the module
Select System Select Maintenance
Select the maintenance procedure
The procedure displays on the In process tab.

Select F5 Perform
Follow INSTRUCTIONS BOX information

Note: Pictures and videos are now available

for certain maintenance procedures.
(with release of Software version 7.0)

Note: The displayed view is dependent on the Processing Module configuration and software version.

NOTE: To obtain a Procedure Report, select PRINT prior to exiting the Maintenance task screen.

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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 maintenance procedures were due
• When maintenance procedures were performed

To access Maintenance Log

• From the SYSTEM ICON, select:
• MAINTENANCE
• desired MODULE
• F2 - MAINTENANCE LOG

Maintenance Log
Note: The displayed view is dependent on the Processing Module configuration and software version.

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.

(Continued)

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Component Replacement
The following i1000SR System components are customer replaceable items:

NOTE: Refer to the ARCHITECT System Operations Manual, Section 9 for the most current
information.

• Internal Component Cover

• Pipettor Probe and Probe Tubing
• Wash Zone Probe
• Wash Zone Temperature Tubing and Sensor
• RV Loader Assembly
• Wash Cup Baffle
• Pre-trigger or Trigger level sensor (straw)
• Buffer level sensor
• Buffer outlet assembly

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Online Operations Manual

The information and procedures provided in the online Operations Manual will provide complete
instruction on the operation and maintenance of the ARCHITECT System.

The online documentation is designed to provide the fastest, easiest, and most accurate resource for an
operators informational needs.
The online Operations Manual can be accessed by selecting Overview from the menu bar and then
selecting Operations manual.

Select Overview Select Operations Manual

The online Operations Manual appears:

Note: The displayed view is dependent on the Processing Module configuration and software version.

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Basic Run Procedures Overview 1 1

1. Verify the PM and RSH status is appropriate for each Basic Operation task.
3
2. Check Supply Status for onboard solutions, RVs, and waste.

2
3. Check Reagent Status.

4. Manually create Patient orders, or download from Host.

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: Manually create QC and/or calibration order, or use configured automated Control and/or
Calibration ordering. 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 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.

7. Verify, Load, and Run

• Verify acceptability of sample type (serum, plasma, etc.) and tube.
• Verify the sample volume and integrity:
- Sample volume requirement depend on the sample vessel type, the onboard sample
storage conditions, and the assay(s) ordered.
- The sample volume required for testing can be located on the ORDERLIST Report.
NOTE: If the minimum sample cup volume is less than 150 μL, you must priority load the sample to
avoid concentration effects due to sample evaporation. If you do not priority load the sample,
a minimum volume of 150 μL is required. To ensure accurate liquid level detection, do not fill
the sample cups above the 1400μL mark.
NOTE: For additional information on sample volume, refer to the ARCHITECT System Operations
Manual.
• Calibrators, controls, and patient samples are loaded on the RSH (robotic sample handler) for
routine, priority, or batch processing.

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Sample Cup in bar code-labeled tube

Bar Code
labeled tubes Sample Cup

1400 μL

500 μL
125 μL

Carrier
Bar Code ID Sample Gauge Label
Front View

Sample Carrier Carrier

To load samples for processing:

1. Place the sample in the sample carrier so that the bar code, if used, is visible in the sample bar code
label window.
NOTE: Ensure sample vessels are pushed completely down into the sample carriers and are not tilted.

2. Verify the indicators below the desired RSH section are off, which indicates the section is available.
NOTE: Carriers with calibrators must be physically placed in the sections in sequential order.
Carriers are processed in the order they are placed on the sample handler, not by the position
number.

3. Load the carrier into the desired section by pushing it in until the indicator illuminates.
NOTE: Default position for the priority bays are the seven bays to the far left. Priority bays have a
blue indicator. Priority sections can be configured. The number of priority sections range
from 0 - 7. The default is set to 4.

4. Position the sample carrier so that the carrier ID label is at the front of the RSH.

Indicator Lights RSH

Upon run completion, review patient and QC results, rerun and/or release.

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BASIC RUN CREATING PATIENT CREATING

ORDERS CALIBRATION ORDERS

Check Supply Status Select: Select:

• ORDERS
• Onboard Solutions • ORDERS
• PATIENT ORDERS
• RVs • CALIBRATION ORDERS
• SINGLE PATIENT
• Solid Waste

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

CREATING CONTROL Type:

ORDERS • Cal Lot Number
Check Reagent Status • Cal Expiration Date
• Prepare and load reagents as
needed (RSH Status must be Select:
Running) • ORDERS
• Unload reagents as needed • CONTROL ORDERS Select:
• DONE
• F2 ADD ORDER

Choose:
• Single Analyte
Add Patient and /or • Multiconstituent
Control Orders - Control Name

PRINT ORDER LIST

Type:
• C/P
• SID Select:
Print Order List • ORDERS
• ORDER STATUS
• F4 PRINT
Select:
• Control Lot Number
• Control Level(s) Select:
Load Samples in RSH Carriers
• Assay(s) or Panel(s) • ORDER LIST REPORT
• F3 ADD ORDER • DONE

Note: The steps above may vary depending on software version utilized These are for ARCHITECT software version 7.0.

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BASIC OPERATION ACTIVITY

Upon completion of this activity you should be familiar with:
• Checking and updating Supplies and Reagents
• Performing Scheduled Maintenance
• Ordering calibration
• Ordering patient and control samples and initiating a Run

WARNING: Potential Biohazard. Follow biosafety practices.

CAUTION: Chemical Hazard.
CAUTION Lifting Hazard (Liquid Waste Container)

Resources Needed

Refer to the ARCHITECT System Operations Manual Section 5: Operating Instructions

Assay processing for additional information.

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:
† Liquid and Solid Waste

† RVs

† Bulk Solutions (Trigger, Pre-trigger, and Manual Wash Buffer)

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 STAT and TSH

3. Perform scheduled Daily Maintenance M&D 6440:

• Select SYSTEM ICON
• Select MAINTENANCE
• TO DO tab
• F5-PERFORM
• Select PROCEED and follow the instructions shown in the Instructions Box on the display

(Continued)

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4. Perform M&D 2137 Flush Fluids

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.

• Select F2-ADD ORDER

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

Single Analyte Control Lot Levels

TSH Provided by Instructor ALL
B-hCG STAT Provided by Instructor ALL

(Continued)

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7. Configure a Single Analyte Control for use during Precision Analysis:

• Select SYSTEM, CONFIGURATION
• Select QC-CAL button (top of information area of screen)
• Select QC-Single Analyte:
• Select Assay: B-hCG STAT
• Select F6 CONFIGURE
• Select drop down menu box next to Lot No.
• Select NEW LOT and type SERVICE PRECISION in Lot number field.
• Enter MEAN and 1SD information for the CONTROL L
NOTE: Refer to Assay Control Insert for specific mean and target range information.

Example Assay Control insert shown in graphic below (Mean = 25, 1SD = 4.5)

• Select ADD LEVEL

• Select DONE

8. Order a Precision Run

a. Order 20 replicates of Precision Control:
• Select ORDERS, CONTROL ORDER
• Select SINGLE ANALYTE
• Type or Barcode in Carrier ID Number (C) and an unused Position Number (P)
• Select Assay B-hCG STAT
• Select Control, Lot, and Level (Service Precision)
• Select F5 ASSAY OPTIONS
• Enter 10 replicates beside UNDILUTED
• Select F2 ADD ORDER
• Repeat steps above to add another 10 replicates (software only allows 10 replicates per cup)

Procedures related to precision activities can be located in the ARCHITECT System

Service and Support Manual, and Installation and/or the ARCHITECT System Operations
Manual, Section 2 Installation procedures and special requirements.

(Continued)

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9. Once all orders have been placed, print the Order List:
• Select ORDERS
• Select ORDER STATUS
• Select F4-PRINT, Orderlist Report, Done

10. Load Specimens (QC and Samples) into carriers:

• Verify adequate volume loaded per Order List
• Verify sample placement per Order List

11. Load carriers onto RSH for routine Processing

Indicator Light Status Description

Green (steady) • Sample or Reagent Carriers are loaded, but processing
has not begun
• Samples can be accessed
Blinking Green • Processing is complete and Sample or Reagent Carriers
can be accessed
Amber (steady) • Sample or Reagent Carriers are processing and cannot
be accessed
Blinking Amber • A Reagent Carrier is in process of unloading so the
section is unavailable for loading carriers
Alternating Green and • Carrier encountered an error
Amber • Carriers can be accessed
OFF • No sample or reagent carriers loaded in that section

12. Prepare the Processing and Sample Handler Modules for testing:
• PM and RSH into Running Status

13. Initiate Run

RETURN TO LECTURE ROOM FOR ADDITIONAL INSTRUCTION WHILE INSTRUMENT RUNNING.

(Continued)

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14. Evaluate results of calibration and controls upon run completion and release results.

15. When the Precision run is complete,

• print the QC report for each assay
NOTE: Selecting the Assay Column Header in the Result Screen will sort and group all assays
together for review and/or to print.

• release results

16. Evaluate the recovered data for recovery with instrument specification and save results for use later in
class.

END OF ACTIVITY

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Patient and QC results review, rerun, release and storage

Basically there are four situations when a result, or order, is reviewed by the operator.
1. Specimen ordered and/or in processing
2. Specimen processing completed (results awaiting review and release)
3. Exception
4. Archived/Stored Results
This section, will introduce the software screens used for result and/or order review in the ARCHITECT
System.

Select Orders Select Order Status

(View Time to Completion)

Select Overview Select Sample Status

(View Time to Completion)

Select Results Select Results Review

(Release completed specimen results, request reruns, delete tests)

Select QC-Cal Select QC Results Review

(Release completed QC results, request reruns, delete tests)

Note: Calibration Release will be reviewed later in this module.

Select Exceptions
Select Exception Status

Select Rerun Status

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Status & Review Screens

Status and Review screens are use to manage orders and results.The specific information displayed for
specimen results and orders, and available functions, vary per screen.
NOTE: For additional information refer to the ARCHITECT System Operations Manual, Section 5
Operating Instructions.

The Status and Review screens include:

• Order Status screen
- View test information including time to completion.
- Delete pending tests.
Order Status can also be accessed by selecting the Tests In Process (order status) button on the
processing module graphic from the SNAPSHOT screen.

• Sample Status screen

- View order information collated by sample including time to completion.

• Results Review screen

- View COMPLETED patient results and release to stored results, request rerun, delete a
test, or enter a comment.
- Result icon blinks to indicate new completed results exist.
- When a Result is released, the result is:
- Removed from the RESULTS REVIEW screen.
- Transmitted to STORED RESULTS screen and host computer (if applicable).
Release requirements are dependent on Release Mode configuration setting.

• QC Results Review screen

- View COMPLETED control results and release to stored QC results, request rerun, delete
a test, or enter a comment.

• Exception Status screen

- Displays test orders that failed to complete; NO result is generated:
- The Exception status button displays on the Snapshot screen and indicates the
number of exceptions. Select this button to display the Exception status screen.
- Exceptions icon blinks to indicate new exceptions exist. Select this icon, and
the Exception status to display the Exception status screen.
- Identify the error code that caused the exception and troubleshoot.

• Rerun Status screen

- View information for the tests scheduled for rerun and delete a rerun.

• Stored Results screen

- Locate released patient results, print and/or retransmit to host.

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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.

Test Status Description Function availability

Pending • Test is ordered. • Delete
• Sample has not been scanned by the bar code reader.
Scheduled • Sample was scanned by the bar code reader. • Add Comment
• Test has been assigned to a processing module.
• Aspiration has not occurred.
Running • Aspiration has occurred. • Add Comment
• Test is being processed.
In Process • Batch Order - the sample labeled with the starting SID of a • Add Comment
batch order was scanned by the bar code
reader.
• Calculated Test - the tests required to calculate the result
of a calculated test are being processed.
Exception • Test did not complete successfully due to an error. • Delete
• Rerun
• Rerun with Dilution
• Release (only if analyzer is
configured with a track system)

Completed • Test is complete. • Delete*

• Rerun
• Rerun with Dilution
• Release

*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

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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.

EXAMPLE of RESULT FLAGS (partial list)

Flag* Description

EXP* • Sample run with expired reagents.

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.

HIGH** • Outside defined "normal" range as programmed in CONFIGURATION/ASSAY SETTINGS/ASSAY

LOW** PARAMETERS

*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.

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Notes Page

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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.

Example QC Summary Review Screen

Note: The displayed view is dependent on the Processing Module configuration and software version.

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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).

To access and print QC Summary data:

1. From the QC-CAL icon, select QC SUMMARY
2. Select Assay control name/lot and levels
3. Edit Date Range
4. Select PRINT F3
5. Select either:
a. QC Analysis Report for a printout of actual results
b. QC Summary for statistical data
c. Levey-Jennings Report for actual results, graphed results, and statistical summary of data

QC Summary Report Operator ID: FSE

System serial number: 100

Start Date: 05.01.2008 End Date: 03.18.2009

Control Name: BIO-RAD Module: 1

Control Lot Number: 15220 Module Serial Number: i800044

Actual Expected

Assay Level N Mean SD %CV Mean SD

Cl Level 2 23 79.73913 1.05388 1.32167 85.00000 5.00000

Cl Level 1 23 92.30435 1.36298 1.47661 98.00000 5.00000

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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 and be released

The Levey-Jennings data should be monitored for shifts, trends, accuracy, precision, and other quality
performance indicators.

The steps in displaying a Levey-Jennings Graph are:

1. From the QC-CAL ICON, select LEVEY-JENNINGS GRAPH.

2. Select F2 - QC SELECTION.

3. QC SELECTION WINDOW displays, Select desired criteria including:

• Module
• Date Range
• Comparison Type
• Assay

4. Graph displays.

5. Press F4 PRINT to obtain a printed report.

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.

Example Levey-Jennings Screen

Note: The displayed view is dependent on the Processing Module configuration and software version.

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ASSAY CALIBRATION
In this section, you will be introduced to Calibration procedures and requirements for the ARCHITECT
i1000SR 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.

• Certain system maintenance/component replacement procedures are performed.

• Certain errors occur.
NOTE: To determine whether recalibration is necessary when an error occurs, see the ARCHITECT
System Operations Manual, assay-specific error codes.

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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.

Calibration data can be viewed in the:

• Calibration History Screen - all assay calibrations.
• Calibration Status Screen - only assay calibrations with reagent presently loaded on the system.
Select QC-Cal
Select Calibration Status
(View status of calibration)

The assigned status includes the following:

• Active - the values fall within specifications. The system software calculates patient and
control test results from this curve.

• Failed - the values fall outside of the specifications. If an active curve exists for a reagent lot,
the system software calculates patient and control test results from the existing active curve.
NOTE: Calibrations cannot be selected for rerun, they must be reordered and loaded for
reprocessing.

• 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 i Systems 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.

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Cal Curve Details Report- Adjust

1 Cal Curve Details Report 2 Operator ID: Abbott
3 System serial number: 1000

4 Assay name: TSH 5 Assay number: 241

6 Reagent lot: 81234JS01 7 Expiration date: 12.31.2002
8 Serial no.: 10024

9 Cal status: Active 10 Module / Serial no.: 2 /iSR01000

11 Cal date: 06.27.2002 12 Cal time: 14:59
13 Cal type: Adjust 14 Operator ID: ADMIN
Calibrator lot: 12345M300 16 Expiration date: 12.20.2002
15

Cal 1 ratio: 0.909 17 Cal 2 ratio: 1.255

18 Cal ID 19 Mean RLU 20 Rep. 1 RLU 21 Rep. 2 RLU

Cal 1 279.0 283 275
Cal 2 2546524.0 2550529 2542519

22 Concentration 23 Ref. Cal 24 Fit Curve

uIU/mL RLU RLU

0.0000 307 278.3

0.5000 53419 67628.9
2.0000 201525 250077.1
10.0000 816305 1018668.8
40.0000 2029702 2575854.5
100.0000 3022348 3773862.6

Printed On: 07.02.2002

ARCHITECT Page: 1 of 1

1 Report Title 9 Cal status 17 Cal 1 ratio and Cal 2 ratio

ratios for cal adjustment
2 Operator ID (report printed) 10 Module/Serial no. 18 Cal ID (column)
3 System Serial Number 11 Cal date 19 Mean RLU (column)
4 Assay name 12 Cal time 20 Rep. 1 RLU (column)
5 Assay number 13 Cal type 21 Rep. 2 RLU (column)
6 Reagent Lot 14 Operator ID (report printed) 22 Concentration/Units (column)
7 Expiration date 15 Calibrator lot 24 Ref. Cal RLU (column)
8 Serial no. 16 Expiration date 24 Fit curve RLU

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Cal Curve Details Report- Full

1 Cal Curve Details Report 2 Operator ID: Abbott

3 System serial number: 1000

4 Assay name: B-hCG STAT 5 Assay number: 30

6 Reagent lot: 29876AC98 7 Expiration date: 12.31.2002
8 Serial no.: 10031

9 Cal status: Active 10 Module / Serial no.: 2 /iSR01000

11 Cal date: 06.27.2002 12 Cal time: 14:59
13 Cal type: Full 14 Operator ID: ADMIN
Calibrator lot: 12345M300 16 Expiration date: 12.20.2002
15

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

Printed On: 07.02.2002 ARCHITECT Page: 1 of 1

1 Report Title 9 Cal status 17 Cal ID (column)

2 Operator ID (report printed) 10 Module/Serial no. 18 Concentration/Units (column)
3 System Serial Number 11 Cal date 19 Fit curve RLU (column)
4 Assay name 12 Cal time 20 Mean RLU (column)
5 Assay number 13 Cal type 21 Rep. 1 RLU (column)
6 Reagent Lot 14 Operator ID (report printed) 22 Rep. 2 RLU (column)
7 Expiration date 15 Calibrator lot
8 Serial no. 16 Expiration date

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ASSAY PROCESSING - i1000SR SYSTEM

The CMIA reaction sequence is specific to the assay protocol. The reaction sequence is the order of
interactions between the analyte present in the sample and the reactants (reagents). As previously
presented, the reactants are:
• Paramagnetic microparticles coated with a capture molecule (antigen, antibody, or viral
particle) specific for the analyte being measured - pink reagent vials
NOTE: Paramagnetic microparticles have an iron core . While they are not magnetic , they can be
attracted by a magnet.

• 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

Many kinds of assay processing activities take place between sample aspiration and the final read. These
include:
• Pipetting of Sample
• Pipetting and/or dispense of Reactants
• Mixing
• Washing of Reaction Mixture
• Incubation in a temperature controlled environment
• Optical Read

The movement of the process path, the timing of these movements, and the position of the components
allow each reaction activity to occur at a specified time and location.
Process Path Motor Unloader Process Path

Unload Diverter
CMIA Optics

Pre-trigger/Trigger Manifold
Wash Zone Inlet Diverter

Vortexer 1
Wash Zone Outlet Diverter

RV Loader (partial view) Pipettor

Wash Zone Manifold RV Access Door

Wash Cup

Processing Components

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There are four basic assay protocols:

• In a one-step assay protocol method, the sample and all required reagents are added prior to
washing the microparticles.
• In a two-step assay protocol method, the sample and some reagents are added prior to the washing
of microparticles. Conjugate reagent is added and the microparticles are washed again.
• A Pretreatment assay protocol is where additional steps are performed prior to the performance
of a one-step or two-step assay protocol. The i1000SR System automatically performs
pretreatment steps if required.
• A STAT assay protocol is designed so the incubation time and total processing time of a one-step
or two-step assay protocol has been shortened.

Paramagnetic Analyte Captured analyte

Microparticle (specimen)

Microparticle Washing

acridinium-labeled
conjugate

Immuno-complex sandwich

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Troubleshooting
The following are tips for troubleshooting failures associated with Basic Operation:
NOTE: When troubleshooting ARCHITECT System errors refer to your ARCHITECT
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
- Improper Reagent and/or Calibrator handling
- Improper loading of Calibrator
• Non-performance of required maintenance
• Probe or mixer misalignment, or malfunction
• Dirty or scratched Cuvettes
• Fluidics or Optics component 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

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Symptom/Error Possible cause of failure

General Calibration Error Troubleshooting • Wrong calibrator was used
• Improper loading of Calibrators
• Calibrator or reagent is not performing as expected
due to improper handling
• Lack of Maintenance
• Bulk Solution impurities

Calibration failure, Intercept out of range • Fluidic component failure

• Calibrator or reagent is not performing as expected
due to improper handling
Calibration failure, maximum upper curve asymptote • Fluidic component failure
exceeded • Calibrator or reagent is not performing as expected
due to improper handling
Calibration failure, curve validity check failed • Fluidic component failure

Calibration failure, fit response too low for Cal “X” • Fluidic component failure
“X” equals A, B, C, D, E, F, 1, or 2 • Bubbles or foam in sample

Calibration failure, ratio too small for calibrators • Calibrator or reagent is not performing as expected
due to improper handling
• Dispense component failure
• Optics failure

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Key points

Basic Operation

Note Key Points

i1000SR System • Processing Module • Immunoassay system

(PM)
• Processes up to 100 CMIA (chemiluminescent microparticle
• RSH immunoassay) tests per hour when using a one step 11 STAT
- RSH is used to load protocol.
reagent cartridges • Has the capability to load up to 25 onboard reagent kits (100
tests) in a temperature-controlled reagent carousel
System Control • One per combined unit • Computer that provides a common centralized user-interface
Center for the processing modules and related components.
• Provides an interface to a host computer.
• Utilized for remote diagnostic capabilities (AbbottLink).
ARCHITECT • Icons and Menus - Icons represent a category of screens.
Software When selected they list a menu of available items. Icons
blink when a condition requires attention.
• Information Area - Displays data and allows the operator to
make selections and/or enter information to perform various
functions.
• Function Bar - Contains function buttons associated with the
screen currently displayed in the information area.
• Question Mark accesses Help.
Snapshot Screen • Processing module status.
• Test processing status - access to Order status screen.
• Reagent status - access to Reagent status screen.
• Supply and waste status - access to Supply status screen.
• Number of orders pending rerun - access to Rerun status
screen.
• Number of exceptions pending review - access to
Exception status screen.
Review, Release, • For Patient Results use the Results Review screen.
and/or Rerun • For Quality Control results use the QC Review screen.
Patient or Quality
Control Data • To rerun a Patient Result, a Control Result, or an Exception,
select a test(s) from the Sample status screen, the Results
review screen, the QC result review screen, or the Exception
status screen and select Rerun.
Print QC Data • To print QC Reports, including QC Analysis, QC Summary
and Levey-Jennings reports, use the QC Reports screen.

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Basic Operation

Note Key Points

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.

3. Check Reagent Status.

4. Manually create Patient orders, or download from Host.

5. Manually create order, or use configured automated Control

and/or Calibration ordering.
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.

6. Print Order List.

7. Verify, Load, and Run.

8. Review patient and QC results, rerun and/or release.

Indicator Light Status Description

Green (steady) • Sample or Reagent Carriers are loaded, but processing
has not begun
• Samples can be accessed
Blinking Green • Processing is complete and Sample or Reagent Carriers
can be accessed
Amber (steady) • Sample or Reagent Carriers are processing and cannot
be accessed
Blinking Amber • A Reagent Carrier is in process of unloading so the
section is unavailable for loading carriers
Alternating Green and • Carrier encountered an error
Amber • Carriers can be accessed
OFF • No sample or reagent carriers loaded in that section

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REVIEW QUESTIONS
1. Identify where you find the minimum sample volume required for testing.

2. What are the steps for accessing the Maintenance Log?

3. The graduation lines on the sample cups are at ________ μL, __________ μL and __________ μL.

4. The Service Personnel Log ON is _____________ and the password is ___________________?

5. When MUST you perform a calibration on an assay?

6. What three tasks can be performed during any status on the i1000SR System.

7. In order to load a reagent carrier the processing module must be in a _____________________ or

___________________ status and the RSH must be in a ____________________ status.

(Continued)

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8. Identify the i1000SR components labeled in the picture below.

a. k.
b. l.
c. m.
d. n.
e.
f.
g.
h.
i.
j.

a b c

n
d

e
m
f
L

k (partial view) g

j h

Processing Components

END OF MODULE

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Notes Page

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ARCHITECT i1000SR SYSTEM

SERVICE TOOLS

OVERVIEW
This module discusses the following Service Tools:
• Service Documentation
• Diagnostic Screen
• Hyper Terminal
• CLI Commands
• General Troubleshooting Principles
• AbbottLink

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Notes Page

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INTRODUCTION
The ARCHITECT System Operations Manual and the Service and i1000SR 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 i1000SR System.

In this section, you will be introduced to the various manuals, documents, diagnostic software programs
and commands required for servicing the i1000SR 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

4. Identify the STEPs utilized for effective troubleshooting.

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SERVICE TOOLS/RESOURCES ACTIVITY

Upon completion of this activity, you should be able to:
• Locate available i1000SR reference materials
• Identify the purpose of each reference material
• Identify the location of the i1000SR TSB Sticker
• Participate in discussion on possible common issues/failures

Resources Needed

Refer to the ARCHITECT i1000SR Service and Support Manual for additional
information.

Students Perform the following:

† Instructor Led discussion on available resources, their use, and location.

(Continued)

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Instructor Led review Service and Support Manual:

† The ARCHITECT i1000SR Service and Support Manual is the reference for repairing the
ARCHITECT i1000SR System. It contains instrument-specific information, including the follow-
ing sections:

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:
- i1000SR Overview
- ARM Overview
- SCC Overview
Troubleshooting • This section contains reference and normal operation information for the
system.
• The information may include block and functional diagrams, mechanism and
motor listings, and LED operating conditions.
- Block/Functional Diagrams
- Engineering Schematics
- i1000SR System Electronics
- Power Supply
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.
• CLI Commands.
• 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 • Activities required to install or relocate an ARCHITECT System.

† Lead group in demonstration of M&D Procedure Locator use.

† Lead group in locating key items in Troubleshooting section. This may include Card Cage Back-
plane, Card Cage Fuses, and/or Power Supply Backplane Pin Designation.

(Continued)

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† Instructor Led discussion on possible common issues/failures:

Common failures

Issue/Failure Symptoms, Errors, Notes Possible Repair

Commonly Used Parts

Issue/Failure Symptoms, Errors, Notes Possible Repair

END OF ACTIVITY

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M&D (MAINTENANCE AND DIAGNOSTIC) PROCEDURES

M&D procedures are grouped in two separate screen sections under the SYSTEM Menu, Diagnostics and
Maintenance.

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
i1000SR 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 i1000SR System Service and Support Manual.

To access the Maintenance or Diagnostics screen:

• Select the SYSTEM Icon
• Select the DIAGNOSTICS or MAINTENANCE menu item.
• The corresponding screen will display (Ensure the correct Module is selected to view options).

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

6008 Controller Configuration Fuses/Motors

6009 Log Utilities Optics

Temperature

6029 Assay Information Carousels

Precision
6114 Install/Delete Assays

ICT
6115 Install/Delete Procedures

Utilities
6116 Update 6115 Procedure
Other

Example Diagnostics Procedure Screen

Note: The displayed view is dependent on the Processing Module configuration and software version.

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Task Manager
The TASK MANAGER provides Service Personnel access to the system’s hard drive files for the
following situations:.
• performance of an ISA or TSB • SCC installation procedures
• obtain data for investigation(s) • setup or edit printer or replacements
• troubleshoot system or software related errors • perform Touch Screen calibration

To access the TASK MANAGER

1. Log on as an FSE

2. Select SYSTEM Icon

3. Select TASK MANAGER

4. Type "explorer"

5. Select New Task

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.

Example Task Manager Screen

Note: The displayed view is dependent on the Processing Module configuration and software version.

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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 i1000SR 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
i1000SR Service and Support Manual, Section 5.

To perform a CLI Command:

1. Log on as an FSE

2. Select SYSTEM Icon

3. Select DIAGNOSTICS

4. Select M&D 6200 CLI Terminal Simulator

5. Choose Perform

6. The first command entered must be which module you are going to control.
SET_MODULE X X = 1 (for Standalone i1000SR PM), 0 (for RSH), OR 2 (for integrated iPM)

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.

Example CLI Screen

Note: The displayed view is dependent on the Processing Module configuration and software version.

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HYPERTERMINAL ACTIVITY Fuses/Motors

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 back of the Process Module Card Cage for
SCC platform E or higher.

NOTE: For additional information refer to the ARCHITECT i1000SR Service and Support
Manual and ISA Database.

NOTE: DO NOT attempt to drive CLI commands via HyperTerminal.

Resources Needed
Refer to the ARCHITECT i1000SR Service and Support Manual for additional
information.

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.

Students Perform the following:

Section 1 Hyperterminal Icon

† Create an icon on your laptop to start the HyperTerminal program:

1. From the WINDOWS screen, Select:
• Start
• Programs
• Accessories
• Communications
• HyperTerminal
2. At the Connection Description Window Type: Architect_i1000 Hyperterminal
3. Select the Any Icon and OK
Once this Icon has been programmed this will be the only Icon needed to start this program.

(Continued)

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Section 2 Hyperterminal Configuration

† Program HyperTerminal Icon created in prior step:
1. For “Connect Using” Select:
• COM 1
• OK
2. Configure the port settings then Select OK when finished:
• Bits per second: 9600
• Data bits: 8
• Parity: None
• Stop bit: 1
• Flow control: None
If any port settings were changed, the laptop will need to be rebooted prior to use.

3. From the top of the HyperTerminal window, Select:

• File
• Properties
• Settings Tab
• Windows Keys button
• OK
4. From the top of the HyperTerminal window, Select:
• File
• Save As
• Desktop
• Save
When finished with this procedure the icon will be on the Computer Desktop for use.

Section 3 Hyperterminal - Boot Sequence Observation

† Power ON the Processing Module

† Connect Laptop to J38 on i1000SR card cage. Open Laptop HyperTerminal

† Initialize Processing Module to READY & observe initialization sequence

† Press the 2 reset switches on the Module Controller Board simultaneously. Observe Laptop and
describe what happened?
_______________________________________________________________________
_______________________________________________________________________

† Exit from the HyperTerminal program and disconnect the laptop from the card cage

END OF ACTIVITY

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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.

To review message logs:

1. Select the SYSTEM ICON, and then select SYSTEM LOGS.

The System logs screen displays.

2. Select the LOG SELECTION LIST button, and then select the desired log.

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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 the ARCHITECT System Service and Support
Manual, Procedures section.

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

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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.

Installation, Maintenance and Troubleshooting

Installation, maintenance and troubleshooting materials are located on the GSS website. AbbottLink is
installed by Abbott Field Service per the instructions contained on the GSS website. Proper completion of
the pre-installation survey is important to the success of an installation.

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.

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Access to AbbottLink can be gained Log Into

through 2 addresses: AbbottLink
http://abbottlinkuser .web.abbott.com
(When connected to Abott LAN or AVPN,
for Abbott personnel and provides the
best connection) Search for Instrument/Device using
one of the following:
https://abbottllinkuser.abbott.com ƒ Serial/System Number
(For customer use & Abbott use if Abbott ƒ Customer/Company Name
network is unavailable)

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

Contact AbbottLink Global

Active Service Is Device
Yes No Service & Support
Ticket? Connected?
800-527-2547 X6307

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
ƒ Watch list
ƒ Pro-Active monitoring
ƒ Improved telephone troubleshooting
ƒ No need for customer to fax data
ƒ 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

Can action plan be

Yes Phone customer
initiated over phone?

Initiate action plan on-site

No, or cannot be determined and/or contact customer for
additional information

For AbbottLink Questions an email address is available for use:

E-mail: [email protected]

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ABBOTTLINK TROUBLESHOOTING ACTIVITY

Upon completion of this activity, you should be able to:
• navigate through the AbbottLink application
• retrieve instrument reports using your laptop computer

Necessary Materials
• AbbottLink ID and Laptop Computer

Time 20 minutes

Activity

Navigation and Dashboard

Refer to the AbbottLink resources located on the GSS website for additional information.

Perform the following:

1. Locate an instrument within AbbottLink
a. Type in the AbbottLink address:
Internet: https://abbottlinkuser.abbott.com
Intranet: http://abbottlinkuser.web.abbott.com

b. Login using your AbbottLink ID (or one provided by the instructor)

c. Click SERVICE tab from the Main Screen
- While in the SERVICE tab you can browse to the instrument serial number of
your choice
d. Over to the right of the screen locate "Search for devices"
e. Select "Device Name" from the drop down menu.
f. Type "*" then the instrument serial number, provided by instructor
g. Click Search
h. Locate instrument
- Note: connection status as indicated by the colored dot next to analyzer name.
Green -connected, Yellow-Disabled, Red- Disconnected, Blue-missing.
i. Then click on the instrument serial number hyperlink
- The instrument Dashboard for the selected instrument will display.
(Continued)

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2. From the Dashboard screen:

† Identify instrument location ______________________________________

† List current status____________________________

† Identify Notification Text:

1. Go to Historical Data
2. Enter Instrument Notification from Data item section
† Access and View Message History Log:
1. Go to Actions/View All and click on the action you want to execute (click on the
link to the Message History Log)
2. The Message History Log will appear at the top of the Actions section
3. Click on the most recent uploaded file and click open (the file opens via notepad)
† Review the Message History Log and list the Last Hardware message including error
and date:

† Review Maintenance History Log:

1. Go to Actions/View All and click on the action you want to execute (click on
Maintenance History Log)
2. The Maintenance History Log will appear at the top of the Actions section
3. Click on the most recent uploaded file and click open (the file opens via notepad)
† Record the last two system maintenance procedures performed:

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 3 useful ARCHITECT i1000SR logs, or reports, that AbbottLink will download:

_______________________ ___________________ ___________________

4. Per Instructors direction, locate LOG-IC Tool Quick Reference Guide with installation instructions.

END OF ABBOTTLINK ACTIVITY

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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?

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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

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Notes Page

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KEY POINTS

Service Tools

Note Key Points

Service • Online Manuals

Documentation • FRU
• TSB Sticker
Maintenace and • SYSTEM Icon • Grouped by Module Type and Category
Diagnostics Screen • Diagnostic programs are commonly used for troubleshooting
and system installation
Task Manager • SYSTEM Icon • Access to the system’s hard drive files
• Located under SYSTEM Icon

CLI Commands • Used to manually control assemblies unrestricted

• M&D 6200 CLI Terminal Simulator
• Must be properly performed or components can be damaged
Use commands as listed in ARCHITECT i1000SR Service and
Support Manual Section 5.
HyperTerminal • Can be used to monitor the Boot-Up sequence for
troubleshooting purposes
• HyperTerminal is used with the SCC or Field Personnel’s
laptop computer to connect to the CPU
Logs • There are three types of MESSAGES on the system,
software updates, non-critical and critical:
- Temporary Message Logs display non-critical
- Message History Log display critical messages
• Logs can be captured from AbbottLink and decoded to
provide important instrument information to be used during
troubleshooting
AbbottLink • User Password needed • Remote Diagnostic tool
• Internet: https://abbottlinkuser.abbott.com
• Intranet: http://abbottlinkuser.web.abbott.com
• E-mail: [email protected]
• GSS 800-527-2547 x6307
Effective • Four Logical STEPs:
Troubleshooting - STOP -Identify Problem
Model - THINK - Gather information/Data
- EVALUATE - Identify and test potential causes against
data
- PROCEED - Perform repair, verify problem resolution, and
complete documentation

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REVIEW QUESTIONS
1. Where is the TSB Sticker located on the i1000SR System?

2. Using the GSS website, locate a resource document containing the Assay (Pipetting) Protocol type for
the ARCHITECT iSystem assays. List the steps to get to the document below. Then use the resource to
identify the Assay Protocol Type for the TSH assay.

3. What is the expected Total %CV recovery for a 20 rep precision on TSH with a mean of approx. 5.5?

4. What is the product code for the i1000SR System?

5. What is the CLI command to turn on the Vacuum Pump on a standalone i1000SR System?

6. Besides data gathering for troubleshooting, list a minimum of one advantage/benefit for using
AbbottLink.

END OF MODULE

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ARCHITECT i1000SR SYSTEM

POWER AND CIRCUITRY

OVERVIEW
This module discusses the following subjects:
• Power Distribution
• Main Power Supply
• Card Cage
• Minimum Board Configuration
• Other Circuitry

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INTRODUCTION
This module introduces the principles, diagnostics, and components associated with the power, power
distribution, and circuit boards including:
• Power Specification
• 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.

3. Perform removal and reinstall procedures.

4. Perform applicable alignment and/or verification procedures.

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POWER
This module will focus on the i1000SR 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 i1000SR power subsystem provides the voltage required to operate fans, motors, solenoids, the
reagent cooler and the system electronics within the processing module and RSH. It includes components
for power generation and power distribution such as the following:
• Main Power Supply
• Card Cage Backplane and fuses
• Cables
• Circuit Breakers
• Distribution Boards

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Main Power Supply

The i1000SR System has one Main Power Supply (PS). The power supply develops DC voltages that are
distributed throughout the system. There are no AC Voltages used in the i1000SR System.
The power supply is accessed from the rear of the analyzer and connects directly to the card cage
backplane. The power supply is replaced as one self contained unit if needed. The power supply fan is
replaceable separately.
There are no replaceable fuses in the power supply, however there are fuses on the card cage backplane
that are used to protect the instrument from power related issues.
NOTE: A list of card cage back plane fuses can be accessed from the ARCHITECT i1000SR System
Service and Support Manual, Troubleshooting section, i1000 System Electronics subsection.

Status LEDs

Main Power Supply

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Power Distribution
• Incoming power can be in the range 110-240VAC +10% and 47-63Hz and is automatically
selected by the power supply circuitry. The AC input passes through an EMI filter.
• The main instrument Power Supply connects to the card cage backplane through a single direct
connector, and supplies the various DC voltages to the card cage boards.
• The card cage boards then supply power to the different system sub assemblies and components.
• These signals are carried by cables that interface to the card cage boards through the card cage
backplane.
• The backplane has additional fuses for protection of the various DC loads:
- 16 fuses on back of card cage (one not active, orderable as a kit).
- Separate fuse kit for i1000SR boards.

NOTE: A list of card cage back plane fuses can be accessed from the ARCHITECT i1000SR System
Service and Support Manual, Troubleshooting section, i1000 System Electronics subsection.

Main Power Supply

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Load Voltage MAIN POWER SUPPLY DC Outputs

DC Load +5VDC • Card Cage Backplane and Logic Boards:
- Indexer 1 and 2
- LLS/PM
- CMIA Optics
- Temperature Controller
- Module Controller
• Distribution Boards:
- Processing Center Distribution Board
- Reagent Distribution Board
- Fluidics Distribution Board
- RSH Distribution Board

+12VDC • Distribution Boards:

- Processing Center Distribution Board
- Reagent Distribution Board
- Fluidics Distribution Board
- RSH Distribution Board
• Analog electronics on LLS Board
• Card Cage Logic Boards:
- Indexer 1 and 2
- LLS/PM
- CMIA Optics
- Temperature Controller
- Module Controller

+12VDC • LLS Sample Antenna Board

+17.5VDC • Reagent Cooler
+24VDC • Cooling Fans and Heaters
• Vacuum Pump
• Transfer Pump
+36VDC • Card Cage Backplane - Power Boards:
- Motor Driver 1 and 2
- DC solenoid Driver I/O
- Heater/Cooler
• Stepper Motors
• Solenoids
• FMI Pumps
• Waste Pump

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Status LEDs

The Main Power Supply Input Panel contain LEDs that display voltage status information about the Power
Supply. These are useful when troubleshooting a possible power situation.

Main Power Supply

Status LEDs

Service Tips:

• Power supply will not remain on if disconnected from card cage, unless pins 2 and 18 are
jumpered together.

• "Maintenance Mode" - disables +36VDC output so that solenoids and stepper motors can be
safely unplugged without powering down the instrument. There are two ways to enter the
Maintenance mode:
- M&D 6200 CLI commands: Enable type DIO 37 SET 1 Disable type DIO 37 SET 0.
- M&D 5716 Turn 36V Power Off and On

• Power Supply fan is replaceable – the fan is the same as the card cage fans – use the existing Field
Replacement Unit (FRU) fan repair kit.

• Alignment of power supply with card cage connector is critical for proper operation.

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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: For the i1000SR, the SCC CPU power switch is located behind the Card Cage/SCC Center
Door. The processing module power switch is located on the rear of the instrument at the main
power supply.

However, 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. The processing module power must be
cycled to re-establish proper communication.

• To power OFF all processing modules in a multi-module system, you must turn the power to each
processing module OFF.
NOTE: Power ON/OFF procedures will differ between a stand alone i1000SR and an integrated
ci4100 System. Note that on a stand alone i1000SR when the main power is turned OFF the
RSH will also be powered OFF. However on an integrated ci4100 System, the RSH is powered
from the c4000 Processing Module so the c4000 Processing Module must be turned off to
power off the RSH.

• 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.

NOTE: Refer to the ARCHITECT System Operations Manual for the procedures to perform an
instrument start up, pause, shut down, power cycle, and long term shutdown.

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 MODULE 3: POWER AND CIRCUITRY

Cycling Power Sequence

re-establishing communication
Step 1. Shutdown SCC Step 2. Power Off SCC Step 3. Power Off PM(s)
1. Ensure both SH and PM(s) are either 1. Turn OFF power to SCC when screen 1. Turn OFF power to PM(s).
Ready, Stopped, or Offline. instructs you. Move the power switch on the lower center
SCC Power button is located on front of the rear of the i1000SR processing module
2. Select F3-Shutdown from Snapshot CPU. Open the i1000SR card cage and SCC down to the OFF/O position to turn off the
screen. center door to access the power switch. power.
3. Select OK to confirm shutdown. In a single module system, powering off the
You may need to press and hold the button for
processing module also turns off power to
4. Press Ctrl+Alt+Delete keys when several seconds for the power to go off.
the sample handler. In a multi-module system
message appears. all PMs may have to be turned off to power
5. Select Shutdown the computer and off the RSH. Refer to the instrument Opera-
press OK when message displays. tions Manual for instruction.

Step 4. Power On SCC Step 5. Power On PM(s) Note

1. Turn power ON to SCC. 1. Turn power ON to PM(s). If PM(s) power is ON when you
Verify the Processing Module power is OFF before Ensure the SCC power is ON before powering on power ON the SCC, communication
applying power to the SCC. the PM. will not be properly established
NOTE: If the Processing Module(s) power between the system components, and
the SH and PM(s) status will remain
is ON when you power ON the SCC,
Offline indefinitely. If this occurs,
communication is not properly initialized SH and PM(s) stay at Offline status
between the system components. power off the PM(s), wait 30
approximately 3.5 minutes prior to changing to seconds, then power on the PM(s).
2. Allow the system software to initialize. Stopped. No user intervention is needed at this
time.
3. Wait for Snapshot screen to display.
No user intervention is needed during this time.
2. Select the Sample Handler and
Processing Module graphics.
3. Select F5- Start-up.

Snapshot Screen Example

Note: The displayed view is dependent on the Processing Module configuration and software version.

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MODULE 3: POWER AND CIRCUITRY

Notes Page

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 MODULE 3: POWER AND CIRCUITRY

POWER TROUBLESHOOTING ACTIVITY

Upon completion of this activity, you should be able to:
• Locate and evaluate measurement data against voltage specifications
• Locate key power components and perform key M&D procedures
WARNING: Electrical Shock Hazard. Follow electrical safety practices.

Resources Needed
• Multimeter
• Power and Total Wire Diagrams

Refer to the ARCHITECT i1000SR Service and Support Manual for additional information
on performing the procedures in these activities.

Students Perform the following:

Section 1 Components and Maintenance Mode

With instrument powered ON

† Identify and observe the following:

 Power Supply AC input connection
 Power Supply Indicator LEDS
 Power Supply Rear Fan

† Perform M&D 6200 Terminal Simulator and initiate the CLIA commands below:
NOTE: must be logged in as FSR to perform CLIA commands

1. Set the correct module by typing SET_MODULE X

X= 1 for Standalone i1000SR Processing Module or 2 for an integrated ci4100

2. DIO 37 set 1 (enters maintenance mode and disables 36 VDC)

a) What error occurs when the Maintenance Mode is activated?

b) Describe the led pattern on the Power Supply in Maintenance Mode:

(Continued)

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MODULE 3: POWER AND CIRCUITRY

3. DIO 37 set 0 (disables Maintenance Mode and re-enables 36VDC)

4. DIO 24 set 0
a. What effect does this last CLI command have?

b. What effect does the command DIO 24 set 1 have?

† Power OFF the Processing Module

† Remove the Power Supply R&R L1.01 (leave PS out of instrument until directed to replace)

† Remove, examine and replace Power Supply fan

† Locate backplane /card cage and identify the following:

 Identify the backplane fuses and locations; remove and replace a fuse
 Identify the DC voltage test points on card cage backplane

(Continued)

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 MODULE 3: POWER AND CIRCUITRY

† Reinstall the Power Supply

† Measure Voltage at DC voltage test points on card cage backplane and record your results in the
table below
 Verify Voltages are within the values listed in Service Manual; General Data Section

Test Measurement Voltage Reg. DC Load

Point
TP1 +5VDC + 0.10 • Card Cage Backplane and Logic Boards
• Distribution Boards

TP2 +12VDC - 0.36 to +0.96 • Distribution Boards

• Analog electronics on LLS Board
• Card Cage Logic Boards

TP3 +12VDC - 0.96 to +0.36 • LLS Sample Antenna Board

TP5 +36VDC + 0.36 • Card Cage Backplane Power Boards

• Stepper Motors
• Solenoids
• FMI Pumps
• Waste Pump

TP6 +24VDC + 1.20 • Cooling Fans and Heaters

• Vacuum Pump
• Transfer Pump
TP7 +17. 5VDC + 0.875 • Reagent Cooler

Section 2 Procedures
† Perform the following M&Ds:
 5720 fuse status
 5716 turn 36V OFF and ON (this is a M&D procedure that enters Maintenance Mode without the
need to use CLI commands)

† Initialize Processing Module to READY

END OF ACTIVITY

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MODULE 3: POWER AND CIRCUITRY

CARD CAGE CIRCUIT BOARDS

Control, drive, and detection circuitry on the i1000SR System is contained on printed circuit boards located
in the Card Cage. The Card Cage is divided into an Upper and Lower section. The table on the next page
describes the boards contained within the Card Cage along with their basic functionality.

Card Cage

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 MODULE 3: POWER AND CIRCUITRY

Location Board(s) Function Type

UPPER Indexer 1 and 2 • Motor Control: • Logic
- Tracks motor encoder signals
- Monitors Home Sensor Signals (motor position)
• Indexer Boards are swapable.
• Communicates with:
- Controller Boards, Motor Driver Boards and Other Boards
Liquid Level • Sets the transmitting frequency (100KHz) for the Pipettor Probe LLS. • Logic
Sense • Controls LLS function by processing data from LLS antenna.
• Controls Pressure Monitor function by processing PM data.
CMIA Optics • Controls CMIA Reader sensitivity by controlling the high voltage going to • Logic
the photomultiplier tube (PMT).
• Amplifies CMIA Reader output and converts output to digital signal.
• Works in conjunction with Indexer 1 to analyze sensor outputs:
- FMI buffer, wash zone, trigger & pre-trigger pump home sensor
- Reagent access door open sensor
- Reagent carrier detect sensor
- Reagent carousel interlock sensor
- Reagent carrier latch sensor
- RSH
Temperature • Receives and processes thermistor signals. • Logic
Controller • Issue heater control signal to Heater Cooler Board.
Module • Functions as CPU for Processing Module, controls all Processing Module • Logic
Controller functions.
• CPU controller for the Standalone RSH.
• Communicates with SCC, Reagent Bar Code Reader, and Device
Controllers.
LOWER Motor Driver 1 • Motor Driver Boards are swapable. • Power
and 2 • Provides power to energize system motors (motor movement).
• Receives motor control signals from Indexer Boards.
Heater Cooler • Provides power to system heaters and reagent cooler: • Power
- +24 VDC heaters and 17.5 VDC reagent cooler
• Receives heater control commands from Temperature Controller Board.
• Power to Vacuum, Transfer, and Waste Pumps; receives on/off control
signal from CPU:
- +24 VDC vacuum pump & transfer pump
- +36 VDC waste pump
• Contains surface mounted fuses.
- Contains fuse to protect Buffer Transfer Pump
DC Driver I/O • Provides Power to engage Solenoids, Valves and Vortexers. • Power
• Contains fuses and a 2 digit 7 segment display that can be used to in
troubleshooting situations to determine what fuse on the board is blown.

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Minimum Board Configuration

Occasionally systems fail to complete the Boot Sequence. Some board failures can affect the Card Cage
suppressing the system from successfully completing a normal Boot-up and Initialization to the Main
Menu. The Minimum Board Configuration helps diagnose the cause of:
• system lock-up errors
• boot-up failures
• voltage problems
• and software errors

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 Snapshot
screen are:
• Module Controller
• CMIA Optics Board

NOTE: Refer to the ARCHITECT i1000SR Service and Support Manual for additional information.

NOTE:HyperTerminal connection, previously presented in Module 2, can be a good troubleshooting

tool for boot sequence failures.

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 MODULE 3: POWER AND CIRCUITRY

Other Circuitry
Board(s) Function and Notes
Processing Center • Located in process area under the top lid, located on left side of back panel.
Distribution Board • Receives power and logic signals through cables from card cage backplane.
• Uses cables to route power and logic signals to Process Path sub assemblies and
components such as Diverters, Wash Zones and RV Loader.
• Diagnostic LEDs.
Refer the ARCHITECT i1000SR Service and Support Manual; Module Overview Section;
Process Path and locate the Functional Links to the Process Center Distribution Board for
a complete listing of connections and LEDs.

Reagent Distribution Board • Located to the right of the Process Distribution Board.
• Receives power and logic signals through cables from card cage backplane.
• Uses cables to route power and logic signals to Reagent sub assemblies and
components mainly located in the Reagent Carousel Area.
• Has removable battery to monitor reagent cooler lid when power is OFF.
Refer the ARCHITECT i1000SR Service and Support Manual; Module Overview Section;
Reagent Management and locate the Functional Links to the Reagent Distribution Board
for a complete listing of connections and LEDs.
Fluidics Distribution Board • Located behind the fluidics rear panel.
• Receives power and logic signals through cables from card cage backplane.
• Uses cables to route power and logic signals to Fluidic sub assemblies and
components located throughout the instrument.
• Diagnostic LEDs and Testpoints.
Refer the ARCHITECT i1000SR Service and Support Manual; Module Overview Section;
Fluidics and Vacuum and locate the Functional Links to the Fluidics Distribution Board for
a complete listing of connections and LEDs.

RSH Distribution Board • Located on the left end of the RSH.

• Receives power and logic signals through cables from card cage back plane.
• Uses cables to route power and logic signals to sub assemblies and components
mainly located in the RSH.
Refer the ARCHITECT i1000SR Service and Support Manual; Module Overview Section;
Robotic Sample handler and locate the Functional Links to the RSH Distribution Board for
a complete listing of connections and LEDs.

Pipettor Board • Controls the horizontal (theta) and vertical (z) movement:
- Receives +36V for pipettor motor from Motor Driver #1
- Receives Home Sensor Signals
- Communicates with Indexer #1
• PM circuitry contained on Pipettor Board.
• Receives 100KHz Signal from LLS Board.

Pipettor Board

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Board(s) Function and Notes

LLS Antennas • LLS Antenna Reagent.
• LLS Antenna Process Path.
• LLS Antenna Sample:
- All signals (process path & reagent) route through sample antenna
- Sample antenna receives +12VDC from Card Cage Backplane

LLS
Antenna
Reagent

LLS
Antenna
Process
Path
Cover

LLS Antenna Sample

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CIRCUIT BOARD TROUBLESHOOTING ACTIVITY

Upon completion of this activity, you should be able to:
• Locate key circuitry components and perform key M&D procedures
WARNING: Electrical Shock Hazard. Follow electrical safety practices.

Resources Needed
• Total Wire Diagrams

Refer to the ARCHITECT i1000SR Service and Support Manual for additional information
on performing the procedures in these activities.

Students Perform the following:

Section 1 Components
With instrument powered ON

† Identify and observe the following:

 Card Cage – open access door and identify the various boards while installed

† Power OFF the Processing Module

† 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)
 CPU board (controller) and Temperature Controller boards
 Heater Cooler and DC Driver I/O board

NOTE: The Heater Cooler Board has an RS232 port for use in troubleshooting. Refer to the
ARCHITECT i1000SR Service and Support Manual P-402 for additional information.

† Identify the reset switches on the removed CPU board and Temperature Controller Board

† Identify the surface mounted fuses on the removed Heater Cooler and DC Driver I/O boards
a. How many different types of replaceable fuses are there?_________________________

† Locate backplane /card cage and identify the following:

 Identify the ESD Board
 Identify the Optics and LLS Coaxial connectors

(Continued)

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MODULE 3: POWER AND CIRCUITRY

† Reinstall all Card Cage Boards

† Locate the following Boards:

 RSH Distribution Board
 Processing Distribution Board
 Reagent Distribution Board
 Fluidics Distribution Board
 Pipettor Board
 Carrier Transport Board

Section 2 Procedures
† Perform the following M&Ds:
 3850 PC board test
 4150 Functional Test Areas

† Initialize Processing Module to READY

END OF ACTIVITY

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 MODULE 3: POWER AND CIRCUITRY

Troubleshooting
The following tips are for troubleshooting Power and/or Circuitry System failures:

NOTE: When troubleshooting ARCHITECT i1000SR System errors refer to your

ARCHITECT i1000SR Service and Support Manual, Technical Service Bulletins,
Instrument Service Advisories, Troubleshooting Information (eSolutions), and/or the
ARCHITECT System Operations Manual.

Symptom Possible cause of failure

Instrument PM will not power ON • Incoming power is OFF, or not to specifications
• Power Cord is loose
• Power Supply failure
• Tripped Circuit Breaker on Main Power Supply
No motor holding current • Failed Motor Driver Board or failed Power Board
• Failed Connector
• Blown fuse on Card Cage Backplane
SCC and PM are not communicating • SCC power cycled while PM was powered ON or PM was powered
on before SCC
Liquid Level Sense errors • Loss of +12VDC
• Damaged or mispositioned Probe
• Sample Antenna failure
• LLS Board failure
Sample Handler OFFLINE or will • Power is OFF
not boot-up • Communications error
• Poor network Hub connections (use HyperTerminal to troubleshoot)
• Failed Module Controller Board
• Failed Indexer Board

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 MODULE 3: POWER AND CIRCUITRY

PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and
component replacement, refer to the ARCHITECT System Operations Manual
and the ARCHITECT i1000SR System Service and Support Manual.

Power and Boards

Hardware Issues/symptoms Diagnostics
Motor • No holding current • M&D 5700 Fuse Status
• No movement • M&D 5150 Motor Test
• Time out errors • M&D 3850 PC Board Test
• Swap Motor Driver Boards and/or Indexer Boards
• Power Status LEDs
• Testpoints
• CLI Commands
Fuse • No mechanical movement • M&D 5700 Fuse Status
• Power loss to a subsystem • 2 digit 7 segment display on DC Driver I/O Board
• LEDs and Testpoints
• M&D 4150 Functional Test Areas
Power Supply • Instrument will not power on • Power Status LEDs
• Loss of voltage • Voltage Measurement
• Motors and/or pumps not functioning • M&D 4150 Functional Test Areas
Module Controller • Instrument will not boot-up • Minimum Board Configuration
• Hyperterminal

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KEY POINTS

Power and Circuitry

Note Key Points

Main Power • Located behind the • Generates the required voltages for the i1000 system.
Supply middle rear panel • Connects to card cage backplane through a single direct connector
- Alignment with Card Cage is critical.
• Self-contained unit:
- 8.5 A at 220 VAC / 16 A at 110 VAC
• Auto-selecting no voltage configuration required.
• Field-replaceable fan.
• No 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 5716

Master Card • Minimum Card Cage • Houses the system control (logic) and driver (power) boards.
Cage Configuration:
• Six Logic Boards (Bd):
- Module Controller
- Indexer 1 and 2
- CMIA Optics
- LLS/PM
- CMIA Optics
- Temperature Controller
- Module Controller

• Four Power Boards:

- Motor Driver 1 and 2
- DC Driver I/O
- Heater Cooler

Indexer 1 and 2 • Master Card Cage • Motor Control.

• Logic Board • Indexer Boards can be swapped.

LLS/PM • Master Card Cage • Sets transmitting frequency (100KHz) for LLS.
• Logic Board • Controls LLS function (processes data from LLS antenna).
• Controls Pressure Monitor function (processes PM data).

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.

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MODULE 3: POWER AND CIRCUITRY

Power and Circuitry

Note Key Points

Temperature • Master Card Cage • Receives and processes thermistor signals.

Controller • Logic Board • Issue heater control signal to Heater Cooler Board.

Module • Master Card Cage • Functions as CPU for Processing Module, controls all Processing
Controller • Logic Board
Module functions.
• CPU controller for the RSH.

Motor Driver 1 • Master Card Cage • Motor Drive; Supplies power to energize motors (motor movement).
and 2 • Power Board • Motor Driver Boards can be swapped.

DC Driver I/O • Master Card Cage • Provides Power to engage Solenoids, Valves and Vortexers
• Power Board • Contains fuses and 2 digit 7 segment display that can be used in
troubleshooting situations to determine what fuse on the board is
blown.

Heater Cooler • Master Card Cage • Provides power to the following devices:
- +24 VDC heaters, vacuum pump & transfer pump
• Power Board
- +36 VDC waste pump
- +17.5 VDC reagent cooler
• Has replaceable surface mounted fuses.
• RS232 port for troubleshooting. Refer to P-402.

Process • Located in the process • Routes power and logic signals to sub assemblies and components
Distribution area under the top lid, mainly located in the Process Path.
Board located on the left side
• Diagnostic LEDs and Testpoints.
of back panel

Fluidic • Located behind the • Routes power and logic signals to Fluidic sub assemblies and
Distribution fluidics rear panel components.
Board • Diagnostic LEDs and Testpoints.

Reagent • Located to the right of • Routes power and logic signals to sub assemblies and components
Distribution the Process mainly located in the Reagent Management Area.
Board Distribution Board
• Diagnostic LEDs and Testpoints.

RSH • Located on the left end • Routes power and logic signals to sub assemblies and components
Distribution of the RSH mainly located in the RSH.
Board • Diagnostic LEDs and Testpoints.

Pipettor Board • Located in the Pipettor • Controls the horizontal (theta) and vertical (z) movement.
Arm
• PM circuitry contained on pipettor board.

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 MODULE 3: POWER AND CIRCUITRY

REVIEW QUESTIONS AND CASE STUDIES

SCENARIO 1 The 36 V LED is not lit on an ARCHITECT i1000SR Power Supply and none of the 36 VDC
assemblies are operational (vacuum pump, motors, solenoids).

The FSR replaces the Power Supply assembly but the issue persists…

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?

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MODULE 3: POWER AND CIRCUITRY

1. What voltage(s) is used by the Reagent Cooler?

2. The i1000SR Instrument uses no internal AC Voltages. TRUE FALSE

3. If connector J45 on the card cage backplane became dislodged, what sub assembly would fail to
operate?

4. Which card cage board does the RV Present Sensor signal return to?

5. In the table below, list the component that best matched the description or function shown.

DESCRIPTION or FUNCTION COMPONENT

Routes power and logic signals to Reagent Management Area

sub assemblies
Provides power to energize Solenoids, Valves, and Vortexers
Provides 36 VDC to waste pump
Sets transmitting frequency (100KHz) used for LLS
Develops the DC voltages and connects to the Card Cage
Backplane

END OF MODULE

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 MODULE 4

ARCHITECT i1000SR SYSTEM

ROBOTICS

OVERVIEW
This module discusses the following subjects:
• Process Path
• Diverters
• Vortexers
• RV Loader
• Pipettors Assembly
• Reagent Carousel

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MODULE 4: ROBOTICS

Notes Page

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 MODULE 4: ROBOTICS

INTRODUCTION
his module introduces the principles, diagnostics, and components associated with each robotic component
including:
• Functionality
• 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.

3. Describe the functionality of each robotic device.

4. Perform removal and reinstall procedures.

5. Perform applicable alignment and/or verification procedures.

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MODULE 4: ROBOTICS

ROBOTICS
The robotic systems on the i1000SR System are used to perform tasks associated with assay processing.
These include loading the RV into the process path, liquid aspiration and dispense, mixing (vortexing),
reaction mixture washing, the optics reading and unloading the RVs to waste.
Common characteristics of the robotic motors include:
• motors use 36VDC
• sensors are used for homing
• motors will have holding current shortly after power ON (not immediate, usually takes 2-3
minutes)
• M&D or CLI commands test functions of robotic assemblies

NOTE: Refer to the ARCHITECT i1000SR System Service and Support Manual for
additional information.

Process Path

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 MODULE 4: ROBOTICS

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 is encoded so that each RV position
• Rotates the Process Path Disk. has a "home" position.
• Encoder signals return to indexer board #1.
and are routed through the processing center
distribution board.
• Motor is driven by Motor Driver board #1.
Process Path with Heater • Machined circular assembly that • Heaters are mounted to the underside of the
has two channels or tracks. assembly:
• Provides the incubated - All heaters use DC voltage
environment for the reaction - 1 pad with 3 independent zones
process to occur. • Three thermistors embedded in the
• Provides access points for various assembly measure the process path
sub assemblies to perform steps temperature.
involved in the assay sequence • Two replaceable magnets mounted in the
and reaction process. process path, at the optics read and wash
zone locations, are used for microparticle
capture when the RVs are positioned in front
of these locations.
Process Path Disk • Supports and guides the RVs as • Rotated by the process path motor.
they are moved to various
• An optical home sensor is used as an
locations.
absolute reference point during the process
• 23 RV positions. path disk homing operation:
• Indexes one RV position every 18 - home reference can be at any one of the
seconds, in a counter-clockwise 23 RV locations.
direction. - home sensor uses the edge of the RV
slot in the disk to monitor the disk
position.
- home sensor signal returns to Indexer
board #1 via the processing center
distribution board.
Process Path Cover • A mounting platform for the various • Cover sits over the disk, mounted to the
sub-assemblies that are attached process path assembly.
to the path.
• Blocks stray light during the optics
read process.
• Assists in maintaining the heated
environment for RV incubation.

RV Access Door • Used for diagnostic purposes only. • Used during M&D 2052 Wash Zone
• Allows access to one position on Aspiration Test.
outer track.

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Process Path Motor Unloader Process Path

Unload Diverter

Wash Zone Inlet Diverter

Wash Zone Outlet Diverter

RV Access Door

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 MODULE 4: ROBOTICS

Diverters
Diverters are used to move RVs located in the Process Path Disk. The i1000SR System has four Diverters.
• Unloader
• Unload Diverter
• Wash Zone Inlet Diverter
• Wash Zone Outlet Diverter
All motorized diverters are powered by 36VDC from the DC Driver I/O board and logic is from the CMIA
Optics Board.
Component Function/Description Service Notes
Unloader • Molded plug that acts as a passive • Can be removed and reinserted upside
diverter. down, allowing RVs to bypass waste
• RVs unloaded from Process Path unload and continue in process path track
and discarded into solid waste. during designated M&Ds or
troubleshooting.
• Optical sensor positioned in process path
ensures that unloader is in position;
otherwise the system will not run:
- sensor signal returns to CMIA Optics
board via the Processing Center
Distribution board.
Unload Diverter • Unloads RVs used for • Solenoid controlled.
pretreatment or sample dilutions, • Power: 36VDC from DC Driver I/O board.
from the inner track to the solid
waste container. • "On" sensor signal returns to module
controller board while "off" sensor signal
returns to CMIA Optics board.
• All power and sensor signals are routed
through Processing Center Distribution
board.

Wash Zone Inlet Diverter • Directs RVs into the Wash Zone • Solenoid controlled.
outer track or keeps the RVs in the • Power: 36VDC from DC Driver I/O board.
inner track.
• "On" sensor signal returns to module
Inlet and Outlet Diverters direct RVs controller board while "off" sensor signal
to the track opposite of their name: returns to CMIA Optics board.
• Inlet Diverters - direct to outer track
• All power and sensor signals are routed
• Outlet Diverters - direct to inner track through Processing Center Distribution
board.

Wash Zone Outlet Diverter • Directs RVs into the inner track or • Solenoid controlled.
keeps them in the outer track. • Power: 36VDC from DC Driver I/O board.
• Used during 2-step assays to • "On" sensor signal returns to module
accommodate receipt of more controller board while "off" sensor signal
reagent and incubation. returns to CMIA Optics board.
• All power and sensor signals are routed
through Processing Center Distribution
board.

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Notes Page

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Vortexers
Two vortexers are mounted to the process path and are used to mix the sample and reagent reaction
mixture.

The vortexer motors are powered by 36VDC supplied by the DC Driver I/O board. The vortexer up/down
sensor signals return to the DC Driver I/O board. All power and sensor signals are routed through the
processing center distribution board.

Component Function/Description Service Notes

Vortexer 1
Advanced
Customer
Training Guide

Vortexer 2

Vortexer • Mixes the reaction mixture. • Motor power: 36VDC from DC

Driver I/O board.
• Up/down sensor signals return to
Vortexer 1: DC Driver I/O board.
• Mounted to inside of process path. • All power and sensor signals are
• Mixes RV after sample and reagent have been routed through the Processing
dispensed, at RV position 3, before incubation period Center Distribution board.
commences.

Vortexer 2:
• Mounted on outside of process path.
• Mixes RV after pre-trigger solution added, prior to
addition of trigger solution and optics read process.

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RV Loader
The RV Loader provides onboard storage for the reaction
vessels (RVs) orients the RVs and inserts the RVs into the inner
track on the process path. It consists of:
• Upper Hopper
• Lower Hopper
• RV Picker and Motor
• RV Loader Chute
• Sensors

The solenoid is powered by 36VDC supplied by the DC Driver I/O board.

The motor is power by 36VDC from the Motor Driver board #1. The sensor signals and logic are processed
by the CMIA Optics board and Indexer #1. Power and sensor signals are routed through the Processing
Center Distribution board.

Component Function/Description Notes

RV Loader • RV Loader: • Mechanical RV detection: one upstream
- Onboard storage of RVs sensor at loader and one downstream sensor
- Orients and inserts RV into the inner in process path.
track on process path (23) • RVs dumped at System Initialization.
• RVs loaded in real time as needed meaning
• Picker arm installed at system installation
on each startup RVs are dumped and 23
(ensure orientation is correct and screw is
RVs reloaded.
tight).
• Upper Hopper - RV Staging:
- holds up to 125 RVs
- between the upper and lower hopper is a
solenoid driven door
• Lower Hopper:
- main RV Storage area
- holds up to 175 RVs
- infrared sensor detects when RV inventory
falls below ~50
• RV Picker and Stepper Motor:
- Picks and orients RVs
- Each finger (3) is aligned with a slot in
home sensor flag
• RV Loader Chute:
- Guides the RV from loader assembly and
drops it into process path track
• Sensors:
- RV Picked Sensor
- RV Present Sensor Microswitch
- Hopper Level Sensor

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1. RV are loaded in to the Upper Hopper.

2. A sensor in the Lower hopper signals the SCC when the inventory falls below approximately 50 RVs.
• The Architect software also tracks RV usage and monitors inventory.

3. When needed, the SCC sends a signal to actuates the RV hopper door solenoid, allowing the RVs
stored in the upper hopper to fall through into the lower hopper.

4. The picker rotates engaging with and picking up an individual RV on each of three fingers.
• An RV remover brush located on the side of the RV hopper, just before the load chute entrance,
will push into place any RVs not fully seated on the picker finger.

5. At the top of the picker rotation, the RV is dropped into the top of the loader chute.
• The RV Picked Sensor sits at the top of the loader at the opening to the RV loader chute. When the
RV picker drops an RV into the loader chute, the RV moves an arm, which interrupts an optical
sensor, telling the system that an RV was successfully picked up.

6. The loader chute lower opening interacts with the process path at the RV insertion point, allowing the
RV to fall cleanly into place in the process path disk.
• The RV Present Sensor sits in the process path, one position down from the insertion point,
confirming the successful placement of an RV in the path.

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Pipettor
NOTE: Fluidic functions of the 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.
The ARCHITECT i1000SR System has a single pipettor device that detects, aspirates, transfers, and
dispenses samples and reagents into the reaction vessel. The pipettor also transfers pretreated samples into
a new reaction vessel after the appropriate incubation period. A fluid sense/pressure monitoring system is
included in the pipettor assembly to help identify errors in aspiration.

The Pipettor Assembly controls the probe movement through horizontal (theta) and vertical (z) movement.
In consists of a the following:
• Theta Motor (Stepper motor) +36VDC from Motor Driver #1
• Z Motor (Stepper Motor) +36VDC from Motor Driver #1
• Home Sensors
• A Crash, or Guard, Sensor is used to tell the system when an obstacle has been detected during
downward travel

Pipettor Board
PM Transducer

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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 i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.

Students Perform the following:

Removal and Replacement

† Power OFF Processing Module

† Remove Pipettor Probe R&R E1.01

† Remove Pressure Monitor R&R E1.08

† Remove Pipettor Assembly R&R E1.01 and examine; DO NOT remove Pipettor Board

† Examine Crash Sensor assembly (underside of the Pipettor Arm)

† Locate and REMOVE the RV Loader R&R A1.01

† Examine Loader and locate the following Loader components:

 RV Hopper door and solenoid
 Lower Hopper Level Sensor
 RV Picked Sensor
 RV Remover Brush

† Remove the RV Picker ARM from the RV Loader

† Remove both vortexers R&R B2.09, examine and replace

† Remove Process Path Antenna R&R E2.02, examine and replace

(Continued)

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† Locate the Process Path Motor

† Locate the WZ Inlet Diverter, WZ Outlet Diverter, RV Unload Diverter and the RV Unloader
Diverter:
 SELECT ONE Diverter to REMOVE, examine and replace

† Remove the Process Path Cover and set aside in the RV Loader mounting area (leave diverters
connected)

† Locate the Process Path Home Sensor

† Remove the RV Present Switch (detect sensor) R&R B1.04

† Remove the Process Path Disk:

 Examine the Process Path Track, and identify the 3 Thermistor connections
 Identify the Process Path Heater mounted to the underside – the track can be loosened off and lifted
up to observe the heater pad (care must be taken because the optics and shutter will still be
attached)
 Clean Process Path as needed (use Distilled Water and Applicators)

† Locate and identify the Upper Waste Manifold, and identify the 3 WZ Thermistor tubings with
bead thermistors

† REINSTALL all removed components

† Power ON the Processing Module

Procedures

† Perform M&D 4150 Functional Area Tests:

 Select RV Loading function
 Verify proper RV loading occurs without error

† Perform M&D 3120 Vortexer Test

† Perform M&D 2052 Wash Zone Aspiration Test

† Perform M&D 5420 Crash Sensor Test

† Perform M&D 1110 Pipettor Calibration

END OF ACTIVITY

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Reagent Management System

The Reagent Management System stores, refrigerates and monitors the on-board reagents, and positions
the reagents for aspiration by the pipettor when required during assay processing. It is an insulated
chamber that houses both the reagent carousel and reagent cooler. The following main hardware
components are used in the Reagent Management System:
• Reagent Carousel Area (cooling bay)
• Reagent Carousel
• Dispersion Ring Gear
• Reagent Carousel Motor
• Carrier Latch Actuator
• Reagent Carrier Advanced
Customer
NOTE: The Reagent Cooler willTraining
be presented in additional detail in the Fluidics and Temperature
Guide
Module.

Reagent Cooler

Reagent Carousel

Carrier Transport

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1. When a reagent carrier is inserted into the load/unload platform of the RSH, the system software
determines when an acceptable timing opportunity exists in between sample processing, to allow the
reagent to be loaded without interrupting the lockstep routine.

2. Upon initiation of reagent loading, the Carrier Transport picks the reagent carrier and performs a
barcode scan. The bottle rotator disks engages with the microparticle seat cogwheel and spins the
microparticle bottle so that the barcode label can be read. All three bottle positions are scanned.

3. Next, the Carrier Transport places the reagent carrier back onto the load/unload platform where it picks
it up again and travels down to the Reagent Cooler for loading while the Reagent Access Door opens.

4. The Carrier Transport slowly steps down to the Reagent Cooler engaging the Carrier Latch Actuator
until the Carrier Latch Sensor is triggered.

5. The Carrier Transport arm places the reagent carrier on the Reagent Carousel and then retracts while
the Reagent Access Door is closed. The Carrier Detect Sensor verifies the reagent carrier is properly
loaded.

6. The Reagent Carousel begins to rotate back and forth to maintain suspension of the Microparticles
before testing begins.

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Carrier Transport
RSH Top View

Bottle Rotator Load/Unload

Platform
Barcode Reader

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Component Function/Description Service Notes

Reagent • Positions the reagents for aspiration by • Held in position by three v-wheels:
Carousel the pipettor as required. - Two fixed position
• Continuous access loading and - One spring loaded structure
unloading. • Mounted to central dispersion ring gear.
• Can hold 25 reagent carriers: • Inner edge of carousel is a molded gear
- Each carrier is held in an individual ring.
position on the carousel and is
locked in place by a retaining slide • Embedded pin home flag also used as
(known as a carrier slide) and training tool for pipettor alignment.
spring. • Home Sensor.
• Home Sensor signals route through
reagent distribution board to Indexer #1.
• Removable spring and slides on carousel.
V-Wheels • Two fixed & One spring-loaded mount • Refer to current version of ISA 117-013
V-wheel holds the Reagent Carousel in and/or Service and Support Manual for
place during rotation. information on V-wheels:
- V-wheels have a blue colored hub
• Located on inner portion of carousel.
- V-wheels have larger bearings and are
sealed and lubricated to resist dust,
moisture and corrosion.
V-wheel inner hub and outer bearing
assemblies may separate during shipping.
It is acceptable to simply reassemble the
parts prior to installing on the ring gear.

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Component Function/Description Service Notes

Reagent Carousel Motor • Carousel Rotates when molded • Spring-loaded assembly.
gear ring on inner edge of carousel
• Locked & unlocked position:
engages with the carousel drive
motor. - Turning the release lever counter-
clockwise unlocks and releases the
• Stepper Motor. motor.
• Power: +36VDC.
• Motor Driver #1.
• Encoder signals route through reagent
distribution board to Indexer #1.
Dispersion Ring Gear • Fixed gear interacts with gears on • Reagent Carrier Detect Sensor, mounted to
Assembly individual reagent carriers to rotate the ring gear, detects the presence of
microparticle reagent bottle. reagent carrier in each position of the
carousel as carousel rotates:
- Sensor signal - CMIA Optics Board
• The Carrier Positioner ensures the reagent
carriers are fully engaged with dispersion
ring gear while seated on carousel.

Reagent Carrier and Carrier • Each carrier can hold up to three • 2 retaining tabs on underside of base slide
Latch Actuator Architect assay reagent bottles for into corresponding retaining slots, located in
a kit. each carrier position on the reagent
carousel:
• Reagent carrier is placed into the
- Ensure carrier remains locked into
initial load position on the carousel
position and engaged with dispersion
by the RSH carrier transport.
ring gear.

Carrier Latch Actuator

Reagent Access Door • Sliding door that moves on a linear • Two through-beam sensors:
bearing, driven by a gear assembly - One sensor is home position, when door
connected to a motor. is closed.
• Stepper Motor. - The other sensor is door open position.
• Power: +36VDC.
• Motor Driver #1, Indexer #1.
• Pin must be lubed on PM.

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Notes Page

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ROBOTICS ACTIVITY - 2
Upon completion of this activity, you should be able to:
• Perform key procedure(s) for servicing Reagent Management System components
• Perform key M&D procedures
WARNING: Potential Biohazard. Follow biosafety practices.
CAUTION: Moving Parts.

Resources Needed

Refer to the ARCHITECT i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.

Students Perform the following:

Reagent Carousel Bay

† Identify Carousel Motor Release Lever and disengage motor by turning counter-clockwise;
confirm by spinning carousel freely in V-wheels

† Remove Reagent Carousel

† Locate and remove the Carrier Slide & Retaining Spring R&R D1.01

† Identify Carousel section features that retain the Reagent Carrier

† Identify Carrier Latch Actuator, and Sensor:

 Review how this assembly interacts with Carrier Transport, Carousel and Carrier Slide

† Identify Reagent LLS Antenna board

† Remove Reagent Carousel Motor Assembly from housing without disconnecting; then reseat

† Identify Carrier Detect Sensor

† Identify Reagent Carousel Home Sensor

† Remove Dispersion Gear Ring (set aside without disconnecting cable connectors)

† Replace ALL removed assemblies

(Continued)

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Reagent Access Door

† Remove the access door assembly cover (loosen the 2 green captive screws)

† Remove the 4 securing screws on top of the motor / gear plate and turn the top assembly over to
expose the pin and slot

† Check the lubrication of the pin and slot

† Reassemble, ensuring the ground lug is attached to the rear screw

† Perform M&D 3002 Reagent Carousel Test

END OF ACTIVITY

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Troubleshooting
The following are tips for troubleshooting Robotic System failures:

NOTE: When troubleshooting ARCHITECT i1000SR System errors refer to your

ARCHITECT i1000SR Service and Support Manual, Technical Service Bulletins,
Instrument Service Advisories, Troubleshooting Information (eSolutions), and/or the
ARCHITECT System Operations Manual.

Area of failure/Error Possible cause of failure

Motor Stalls/Step Loss/RV • Damaged RVs
Jams • RV Loader not seated properly
• Misaligned RV Loader
• Robotic Device jammed or blocked
• Motor failure
• Motor Driver Board failure
Motor Step Loss Reagent • Replace V-wheels (ensure V-wheel with blue hub is used)
Carousel • Ensure Carousel is properly seated.
Pick/Place errors for • Inspect/Replace V-wheels
Reagent Carousel • Clean sensors (i.e. Carousel Home, Carrier Latch, etc.)

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PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and
component replacement, refer to the ARCHITECT System Operations Manual
and the ARCHITECT i1000SR System Service and Support Manual.

Power and Boards

Hardware Issues/symptoms Diagnostics
RV Loader • Jams • M&D 4150 Functional Test

Reagent Carousel • Noisy Operation • M&D 3002 Reagent Carousel Test

• Step Loss errors • M&D 4150 Functional Test
• Pick and Place errors • Clean Sensors
• Inspect V-wheels
• M&D 1114 Carrier Transport Calibration
Process Path • Step Loss errors • M&D 4150 Functional Test
• Jams • CLI Commands
Vortexer • Assay Imprecision • M&D 3120 Vortexer Test

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KEY POINTS

Robotics Control

Note Key Points

Process Path • Covered circular track that provides proper incubation

(PP) temperatures, liquid dispense/aspiration points, and wash points as
necessary for the supported assay protocols.
• Rotates in a counter-clockwise direction, moving one position every
18 seconds.
• Process path disk is rotated by a 36VDC stepper motor:
- driven by Motor Driver board #1
- encoder signals return to Indexer board #1
- home sensor signal returns to Indexer board #1

Diverters • On Process Path Four Diverters:

• Unloader:
- Molded plug that acts as a passive diverter.
- RVs unloaded from Process Path and discarded into solid
waste.
• Unload Diverter:
- Unloads RVs used for pretreatment or sample dilutions, from the
inner track to the solid waste container.
• Wash Zone Inlet Diverter:
- Directs RVs into the Wash Zone outer track or keeps the RVs in
the inner track.
• Wash Zone Outlet Diverter:
- Directs RVs into the inner track or keeps them in the outer track.
- Used during 2-step assays to accommodate receipt of more
reagent and incubation.

• Unload, Wash Zone Inlet, and Wash Zone Outlet Diverters:

- Solenoid controlled.
- Power: 36VDC from DC Driver I/O board.
- "On" sensor signal returns to module controller board while "off"
sensor signal returns to CMIA Optics board.
- All power and sensor signals are routed through Processing
Center Distribution board.

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Robotics Control

Note Key Points

Vortexer • Vortexer 1 (inside PP) mixes the RV after sample and reagent have
been dispensed, at RV position 3, before the incubation period
commences.
• Vortexer 2 (outside PP) mixes the RV after pre-trigger solution has
been added, prior to the addition of trigger solution and the optics
read process.
• Motor power: 36VDC from DC Driver I/O board.
• Up/down sensor signals return to DC Driver I/O board.

RV Loader • Orients and inserts RV into the inner track on process path (23).

• Upper Hopper - holds up to 125 RVs.

• Lower Hopper - holds up to 175 RVs:
- Infrared sensor detects when RV inventory falls below ~50
- Solenoid opens to load RVs from Upper Hopper into Lower
- Solenoid powered by 36VDC from DC Driver I/O board
• RV Picker and Stepper Motor:
- Picks and orients RVs
- Each finger (3) is aligned with a slot in home sensor flag
- Motor is power by 36VDC from the motor driver board #1
- Sensor signals and logic are processed by the CMIA Optics
board and Indexer #1
- Power and sensor signals are routed through the Processing
Center Distribution board
• RV Loader Chute:
- Guides the RV from loader assembly and drops it into process
path track

Pipettor • Theta Motor (Stepper motor) +36VDC from Motor Driver #1.
• Z Motor (Stepper Motor) +36VDC for Motor Driver #1.
• Home Sensors.

Reagent • Reagent Carousel and • Stepper Motor, Motor Driver #1:

Management Motor Assembly - Turning the release lever counter-clockwise unlocks and
Area • Dispersion Ring Gear
releases the motor
Assembly • Home Sensor and encoder signals route through Reagent
Distribution board to card cage Indexer #1.
• Reagent Carrier Detect
Sensor • Held in position by three v-wheels, mounted to the central
dispersion ring gear:
• Carrier Positioner and - Two fixed & One spring-loaded mount
Carrier Latch Actuator
• Reagent Carrier Detect Sensor, detects the presence of reagent
• Reagent Access Door carrier in each position of the carousel as carousel rotates:
- Sensor signal - CMIA Optics Board
• The Carrier Positioner ensures the reagent carriers are fully
engaged with dispersion ring gear while seated on carousel.
• Sliding door that moves on a linear bearing, driven by a gear
assembly connected to a motor (Motor Diver #1).

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REVIEW QUESTIONS
1. Which Diverter is used only during Pre-Treatment assays?

2. What voltage(s) are used by the stepper motors on the ARCHITECT i1000SR ?

3. What voltage is used by the Reagent Carousel Motor?

4. The Carrier Transport slowly steps down to the Reagent Cooler engaging the ____________________
until the _________________________ Sensor is triggered. The _______________________ Sensor
verifies the reagent carrier is properly loaded.

5. What sensor is used to confirm that an RV was successfully loaded into the Process Path?

6. Which Motor Driver Board is used by the Reagent Carousel Motor?

7. Describe the purpose/function of the Crash Sensor used on the Pipettor Assembly.

END OF MODULE

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Notes Page

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ARCHITECT i1000SR SYSTEM

FLUIDICS AND TEMPERATURE CONTROL

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)

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Notes Page

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 MODULE 5: FLUIDICS AND TEMPERATURE CONTROL

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.

2. Identify the physical location of the sub system components.

3. Perform key procedures.

4. Describe the functionality and key signal pathways used by heater and/or fluidic components.

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Notes Page

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FLUIDIC SUBSYSTEM
The Fluidics subsystem is responsible for the movement of buffer, reagents and liquid waste throughout
the ARCHITECT i1000SR 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

Process Path

Trigger/Pre-trigger Bulk Solutions

Liquid Waste

Buffer Reservoir

Supply and Waste Center

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Buffer System Diagram

Buffer is manually reconstituted by the user and loaded in the supply area via a quick disconnect port.
During a manual load, buffer is moved into the buffer reservoir through the buffer transfer pump.

Buffer is used during test processing.

36VDC 24VDC

36VDC
36VDC

24VDC

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Component Function/Description Notes

Buffer • Delivers buffer to Probe through • Located behind Trigger/Pre-trigger tray.
Pump Syringe. • Receives 36VDC from Motor Driver #1.
• Buffer for internal probe wash. • Logic CMIA Optics board, Indexer #1 &
LLS Board.
• Dual Head FMI pump.

Wash Zone (WZ) Pump • Moves buffer from onboard reservoir • Located behind Trigger/Pre-Trigger tray.
to washzone manifold and valves.
• Receives 36VDC from Motor Driver #2.
• Dual head FMI pump.
• Logic CMIA Optics board & Indexer #2.

WZ Buffer • Warms solution to 30-37.6oC before • Mounted to side of Wash Zone Manifold.
Heater dispense through Wash Zone. • 24VDC from Heater Cooler Board.
• Cylindrical tubing block with heating
element and thermistor.
• Thermistor signals return to Temperature
Controller Board (TCB).

Wash Zone • Dispenses heated wash buffer and • During the CMIA wash process:
Manifold removes and discards unbound - 3 nozzles & 3 valves dispense heated
analyte. wash buffer into RVs.
• Comprised of: - wash assembly lowers probes into RVs.
- 3 dispense nozzles. - wash aspirate probes aspirate waste
- 4 valves (Blue collared valve is for fluid using vacuum.
flushing). - 4th valve flushes and primes manifold.
- 3 wash aspirate probes & tubing Bypass line to waste.
with embedded thermistor.
• Wash Assembly: 36VDC stepper motor.
- wash assembly.
• 36VDC Manifold valves; DC Driver I/O.

Wash Buffer Reservoir Figure Components: • Sensor signals to CMIA Optics Board.
1. Onboard storage for up to 12 • Level Sensor Outlet Assembly - tube with
Level Sensor Outlet Assembly
liters wash buffer. three magnetic float sensors.
and Filter
2. Level Sensor dispenses wash
buffer into the reservoir and
3 measures remaining volume.
2
1 3. Outlet assembly draws wash
buffer from the reservoir during
test processing.
4
4. Filter protects fluidics
components by eliminating
particulates.

Transfer Pump • Used to load buffer from the • 24VDC from Heater Cooler Board.
preparation container, into the on- • Logic - CPU.
board buffer reservoir.
• Heater Cooler Board contains fuse to
• Buffer filter between the pump and protect Buffer Transfer Pump.
the on-board reservoir. • Air detect sensor located between the inlet
and the transfer pump monitors buffer flow.
If air detected, stops pump.

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Pre-trigger/Trigger Fluidics Diagram

Pre-trigger and Trigger are dispensed into the RV during the reaction process through the Pre-trigger/
Trigger Manifold.

24VDC

36VDC 36VDC

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Component Function/Description Notes

Manifold • Dispenses Pre-trigger Solution and • 36VDC Manifold valves; DC Driver I/O
Trigger Solution into the RVs. board.
• Two valves for each reagent: • Pre-trigger Solution is in a Black Bottle:
- A dispense valve - Pre-trigger tubing is coated (black) to
- A bypass valve that flushes protect solution from light.
manifold and directs solution to
waste line (Blue collared valves are
for flushing).

Trigger/Pre-Trigger • Same Heater used for both Trigger and • Located near manifold on Process Path.
Heater Pre-trigger, 2 lines.
• 24VDC from Heater Cooler Board.
• Thermistor signal returns to Temperature
Controller Board.
• Power and thermistor signals route
through Reagent Distribution Board.

Pre-Trigger Pump • Moves a specific volume of Pre-trigger • Located to left of processing area under
solution from on-board reservoir to RV Loader.
Pre-trigger dispense manifold and
valves. • 36VDC from Motor Driver Board #2.

• Single head FMI Pump. • Logic CMIA Optics Board & Indexer #2.

Trigger Pump • Moves a specific volume of Trigger • Located to left of processing area under
solution from on-board reservoir to RV Loader.
Trigger dispense manifold and valve.
• 36VDC from Motor Driver Board #2.
• Dual Head FMI Pump.
• Logic CMIA Optics Board & Indexer #2.
When ordering use Trigger pump
specific part number. Trigger pumps
have specific test requirements unlike
other 100ul FMI pumps.
Pre-Trigger/Trigger Tray • Provides onboard storage for
Pre-trigger Solution and Trigger
Solution.

1 2 • Figure Components:
1. Trigger
2. Pre-trigger

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
- Trigger Level Sensor of straw - replace straw.
- Pre-trigger Level Sensor

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Fluidics Diagram

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Fluidic Sensors

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MODULE 5: FLUIDICS AND TEMPERATURE CONTROL

Vacuum System

The vacuum system is used to supply vacuum to the sample wash cup and the upper waste manifold, which
removes liquid waste from the wash zone manifold and the Trigger /Pre-trigger manifold. It is used for the
following:
1. Remove wash buffer waste from the wash cup.
2. Aspirate liquid from the reaction vessels at the CMIA Wash Zone during the CMIA wash process.
3. Remove liquid waste from the pre-trigger, trigger and wash zone prime / flush bypass lines.

System Software tracks usage to 225ml waste in vacuum accumulator, then waste pump turns on & drains
vacuum accumulator. Contains a Level Sensor/Float Switch for backup.

(Not present on new version)

24VDC

36VDC

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Component Function/Description Notes

Upper Waste • Directs liquid waste from the RVs after washing into the • 36VDC Manifold valves; DC Driver I/O
Manifold waste area. board.
• Manifold holds wash zone thermistor tubing in place. • Pre-trigger, Trigger, and Wash Zone
manifold bypass waste lines all connect
• The upper waste manifold wash zone aspirate valve,
to this manifold.
opens to allow vacuum to remove waste liquid sending it
to the vacuum accumulator. • Sits to the left of the wash zone buffer
heater and wash zone assemblies,
near front of RV Loader.
Vacuum Pump • Creates the vacuum used in the vacuum subsystem, • 24VDC from Heater Cooler Board.
and distributes it via a vacuum accumulator.
• Logic - CPU.
- Generates up to 27" Hg
• Pump exhaust is directed through a
• When vacuum is required to aspirate liquid waste, a muffler to reduce noise.
solenoid valve opens at the relevant manifold.
• Diaphragm pump.
Vacuum Filter • Used to filter the vacuum pump air supply, preventing • Drying valve only opens during Daily
with Drying debris from reaching vacuum pump. Maintenance.
Valve • Drying valve is for removal of condensate build-up.
Waste Pump • Waste pump turns on & drains vacuum accumulator • 36VDC from Heater Cooler Board.
when reaches 225ml waste. • Logic - CPU.
• Removes condensation from Reagent Cooler Area: • Peristaltic pump.
- Approximately every three hours, the software will
• Head replaced annually during Planned
run the waste pump for about one minute to
Maintenance.
evacuate any cooler condensate that has collected.
Accumulator • Holds the vacuum for the system. • A level sensor monitors liquid levels in
the event that the waste pump fails.
• Waste liquid is drawn to, and collected in, the vacuum
accumulator and is then pumped to a floor drain, or to • Vacuum Sensor triggered at <9"Hg.
the onboard waste container, via peristaltic waste pump.
Lower Waste • Two solenoid valves: • Mounted to the left side wall of the
Manifold - One opens to drain reagent cooler condensate. lower fluidics bay, at the back of the
- One opens to remove liquid in Vac. accumulator. instrument.

• Two inlet waste liquid lines and one outlet waste line
connected directly to waste pump.

Upper Waste Manifold

Filter Vacuum Pump

Vacuum
Accumulator
Drain valve Vacuum Sensor

Reagent Cooler Condensation Drain Valve

Vacuum Vessel

15PSI
Waste Lower Waste Waste Pump (peristaltic)
Pressure Manifold
Switch

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Wash Cup Diagram

The Wash Cup is used to wash remaining fluid from the probe interior and exterior surfaces.

Component Function/Description Notes

Wash Cup • A block manifold with three solenoid valves • Outer waste well contains removable insert
and two wells: called a baffle:
- outer oblong well is waste well - baffle can be removed for cleaning.
- central circular well is main wash well
• Central well has a threaded insert that can be
• Active Wash Cup used to wash pipettor removed for cleaning.
probe during the aspiration and dispense
• Solenoid Valves are connected to Vacuum:
cycles.
- S1 - Upper Solenoid Valve
• Valve S1 used to vacuum aspirate wash - S2 - Outer Drain Valve
buffer from central wash well and to air dry
the probe.
• Valve S2 drains the outer waste well.
Valve S3 is only present on early versions of
wash cup. It has been replaced with a plug.
Refer to ISA 117-14(current version) for
information on S3 valve removal from Wash
Cup.
Always refer to the FRU for latest part
information.

Side View

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ACTIVE WASH SEQUENCE

Step #1:
• Spits out any residual sample/reagent into outer oblong waste well
• S2 opens to empty waste

S2

Step #2:
• Probe moves to center wash well
• Aspirates a small air sip (10 µl) during this move

Step #3:
• Probes moves down further into central wash well
• Aspirates 150µl buffer to wash probe internally and externally

Step #4:
S1
• S1 opens
• 6ml of buffer is dispensed through probe while vacuum pulls waste out

Step #5:
• Probe retracts up
• As probe moves past upper waste orifice, air is drawn under vacuum over
the probe surface, drying the probe surface
• 6ml of clean buffer remains in central wash well from step #4

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Liquid Level Sense and Pressure Monitor Diagram

Liquid level sense and pressure monitoring are used to detect liquid and ensure that the aspiration of
sample and reagent liquids occur correctly in the assay reaction sequence.
The liquid level sense hardware is used to detect when the pipettor probe makes contact with liquid:
• 100 KHz frequency signal used for LLS.
• 3 LLS antennae. All signals (process path & reagent) route through sample antenna.
• LLS and Pressure Monitoring are performed on aspiration only. No functionality on dispense.

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 Hardware is designed to require no adjustments.

LLS
Antenna
Reagent

LLS
Antenna
Process
Path
Cover

LLS Antenna Sample

Power Supply

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 MODULE 5: FLUIDICS AND TEMPERATURE CONTROL
Liquid Level Sense and Pressure Monitor process
1. As the pipettor lowers the probe, the frequency transmitted from the probe is received by the antenna.

2. When the probe contacts fluid the signal received by the antenna increases abruptly.

3. The signal is analyzed to determine if fluid has been contacted.

4. Once fluid is contacted, the downward movement of the pipettor stops.

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.

Component Function/Description Notes

Antenna Boards • Amplified antennas in aspiration locations. • All LLS signals route through the Sample
antenna board.
• Three antennas: Reagent, Process Path,
and Sample. • + 12VDC.
Pipettor PCB • Contains PM Circuitry.
• Receives LLS frequency from LLS Board.

Pipettor Board
PM Transducer

LLS Board • Sets the frequency (100KHz) that is routed • During Aspiration sends commands to stop
to and transmitted from pipettor probe. the Z motion of the pipettor when fluid is
detected.
• Enables pipettor to detect fluid and monitor
the quality of an aspiration:
- uses features that detect signals
transmitted from probe.
- monitors the pressure in fluid lines
during aspiration.

Pipettor Probe • Transmits LLS frequency.

Signal Cables • Route signal to desired location.

Pressure Monitor • In the fluid line between syringe and probe. • Receives +5 and +12VDC from Pipettor
Transducer • Monitors changes in fluid pressure.
Board.

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Notes Page

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Syringe Components
The syringe controls the aspiration and dispense of samples and reagents.
Component Function/Description Notes
Fluid Vessel • Clear molded plastic that accepts piston
and valve.
• Sealed in the factory.
Piston/Plunger • Controls the aspiration and dispensing of • Lubricate drive shaft.
samples and reagents.

Stepper Motor • Drives Syringe Plunger. • 36VDC stepper motor.

• Motor Driver Board provides power to motor.
• Indexer Board Motor Control.
Home Sensor • Sensor board for home positioning and • Replaceable.
Board valve control.
• Indexer Board receives sensor signals.

Valve and O-Ring • A syringe valve controls buffer flow to the • Syringe valve: 36 VDC.
syringe.
• Blue label on valve.
• Normally Closed.
• O-Ring for valve port.
• DC Driver I/O Board provides power to
energize.

Stepper Motor

Lubrication
Valve and O-Rings Point

Piston

Fluid Vessel

Syringe

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Notes Page

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FLUIDICS ACTIVITY
Upon completion of this activity, you should be able to:
• Perform key procedure(s) for servicing fluidic and vacuum system components
• Perform key M&D procedures
WARNING: Potential Biohazard. Follow biosafety practices.
WARNING: Splash/Spray Hazard.

Resources Needed

Refer to the ARCHITECT i1000 System Service and Support Manual for additional
information on performing the procedures in these activities.

Students Perform the following:

Fluidics function

With instrument powered ON

† Perform “as required” Maintenance FLUSH FLUIDS (M&D 2137) and observe the pipettor
probe flush into the wash cup, and the Trigger / Pre-trigger drainage into the Upper Waste
Manifold
a. Which wash cup well does the probe flush into?
____________________________________________________________________
____________________________________________________________________

† Perform M&D 2052 Wash zone Aspiration Test and observe the Upper Waste Manifold

† Perform M&D 3630 LLS Test (on sample position)

Test Vacuum Pump function

† Perform M&D 3180 Vacuum System Test, and test Vacuum Integrity

(Continued)

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Fluidic Components

Perform Shutdown and Power OFF instrument as instructed in procedure and/or as directed by instructor.

† Remove the Wash Cup Assembly:

 Disconnect the solenoids before removing assembly

† Replace Wash Cup Assembly:

 Ensure waste tubing is not kinked (the aspiration platform may need to be removed to access the
tubing)

† Remove Trigger/Pre-trigger Manifold from Process Path (leave heater and tubing connections
as is, and sit to right of Process Path, near optics or on top of reagent cooler)

† Identify the Upper Waste Manifold with Vacuum Drain Solenoid

† Locate the Wash Zone (WZ) Assembly and remove the 3 WZ probes (put carefully aside)
Probe straightness can be checked by placing the probe against the molded slot on the WZ Wash Mechanism.
If the probe is bent, replace.

† Remove the Wash Zone (WZ) Assembly (leave cabling connected, and place out of way to left
of Process Path)

† Remove the buffer heater & bracket. (leaving tubing & cables connected, move out of way to left
of Process Path)

† Locate the locking mechanism that allows for the removal of the Syringe assembly and perform
the following:
 Remove the panel to the syringe drive
 Locate the syringe drive lubrication points
 Replace the panel

† Locate the Trigger and Pre-trigger pumps and note the location and orientation of the securing
screws that will be required to remove these pumps

† Locate and Identify the Sample Antenna Board and perform the following:
 Remove the cover and examine
 Carefully slide the antenna board up to observe the signal cables and connectors (DO NOT remove
the board entirely (R&R E2.01)
 Reseat the Sample Antenna Board, and Cover

(Continued)

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† Access the Bulk Solution Center and locate the following:

 Buffer Reservoir
 Trigger / Pre-trigger bottles and tray
 Buffer Pump
 Wash zone Pump
 Transfer Pump
 Buffer Flow (Air Detect) Sensor and Buffer Filter
 Liquid Waste Bottle and Waste Platform
 Solid Waste Container and Optical Sensor
 Liquid Waste Bottle Sensor
 Vacuum Muffler

† Remove Lower Fluidics Area access panel located on back of analyzer

† Trace the condensate drain tubing from the Reagent Cooler to the Lower Waste Manifold:
 Locate and Identify the condensate filter (looks similar to a check valve)

† Identify the Lower Waste Manifold with 2 solenoid valves

† Disconnect all cap fittings and remove Vacuum Accumulator:

 Locate and Identify the Vacuum Filter Drying Valve

† Remove the Vacuum Pump, Vacuum Filter, and Muffler

† Remove the Waste Pump Head, and identify motor body

† Locate and identify the Waste Pump Pressure Switch

† Replace ALL removed components

Perform the following M&D Procedures:

† M&D 1109 Wash Cup Pre-Alignment
Whenever M&D 1109 is performed, performance of M&D 1110 must follow to avoid a possible probe crash.

† M&D 1110 Pipettor Calibration

† Perform M&D 2137 Flush Fluids

† Perform M&D 2052 Wash Zone Aspiration Test

END OF ACTIVITY

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Notes Page

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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 Cooler Board.

Temperature Controlled Areas are:

• Process Path
- The Process Path temperature is an controlled temperature environment designed to incubate
the reaction mixture for efficiency.
- Divided into three heating zones on 1 replaceable pad located under the Process Path.
• 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.

• Reagent Cover
- Has a heater embedded into the cover to prevent condensation from forming around the
pipettor access holes in conditions of extreme humidity.

• Reagent Cooler
- A monitored temperature area designed to maintain a cool environment to ensure optimal
reagent kit performance and stability.

Process Path

Reagent Cooler

Reagent Carousel

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Temperature Subsystem Components

Component Function/Description Notes
Temperature • Receives and processes thermistor signals. • Located in Master Card Cage.
Controller • Issue heater control signal to Heater Cooler Bd.
• Monitors temp. of each heater zone for stability.
Heater Cooler • Power for system heaters and thermoelectric • Increases or decreases power to heater to
Board coolers. maintain temperature at specific set point and
within a specific range.
• Receives heater control commands from
Temperature Controller Board. • Surface fuses for each circuit.
• Power to Vacuum, Transfer, and Waste Pumps; • Located in Master Card Cage.
receives on/off control signal from CPU.
• RS232 port for diagnostics.
Thermistors • Six active thermistor channels: • Thermistor Signals are sent to Temperature
- process path x 3 Controller Board.
- buffer heater (wash zone) • Thermistors are embedded in heater or
- trigger / pre-trigger heater process path.
- Reagent Cooler (on base of cooler)
• Five thermistor monitoring-only channels:
- Wash Aspiration Monitoring (WAM) (3)
- Reagent cooler / Carousel area (on handle)
- Ambient (at RSH distribution board)
Buffer, Trigger/ • Each heater consist of a Heating Element and • All heaters on i1000SR are DC voltage.
Pre-Trigger Thermistor and is used to heat fluid.
• Thermistor Signals sent to Temp. Controller.
Heaters Fluid Heaters were presented earlier in module.

Process Path • Provides the heat necessary to maintain • 24VDC.

Heaters reaction temperature.
• Thermistor Signals sent to Temp. Controller.
• 3 independently controlled heating zones.
• 1 Flexible heater pad mounted to the base.
Reagent • Thermoelectric device (TED) based cooling • +17.5VDC from Heater Cooler Board.
Refrigerator system:
• Controlled by Heater Cooler Board, LEDs
(Cooler) - Consists of 8 TEDs paired in 4 sets of 2.
present for over and under Temperature.
• 2 Thermistors:
• Mounted on instrument base, inside the
- One on handle used for monitoring
reagent carousel area:
- One on base used for cooler control
- A handle is provided to lift cooler out of
• Maintains correct temperature by providing and reagent carousel area.
circulating chilled air:
- Upper fan circulates cooled air
- Lower fan removes heat
Reagent Cover • Prevent condensation from forming around the • Embedded in reagent cover.
Heater pipettor access holes in conditions of extreme • 24VDC from Heater Cooler Board.
humidity.
• NOT replaceable, must replace entire reagent
cover assembly.
Fans • Two Card Cage Fans. • Cool components on the analyzer through air
circulation and removal to maintain proper
• Power Supply Fan.
operating temperature.
• Reagent Cooler Fan.
• Regulating incubation area air temperatures
to assure proper assay performance.

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TED

Reagent Cooler

Reagent Carousel

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WASH ASPIRATE MONITOR (WAM)

The dispense and aspiration of heated wash buffer solution into an RV during the wash process, is
monitored using Wash Aspirate Monitoring (WAM). Wash Aspirate Monitoring confirms that the wash
buffer was dispensed and subsequently aspirated completely within the allotted time.

The WAM thermistor is located inside the temperature tubing and sensor that is connected to the Wash
Zone Probe. 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.

WAM includes the following components and/or systems:

• WAM Thermistor (located inside the temperature tubing) connected to Wash Zone Probe
• Vacuum System
• Buffer Dispense System (dispense nozzles, valves, etc.).

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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 first position of the wash cycle:

• 400μL of warm buffer is dispensed into the RV via valve 1

In the next position, two washes are performed on the RV:

• WZ Probe 1 aspirates the buffer and the WAM value is recorded but ignored by software
• 500 μL of warm buffer is dispensed via valve 2
• WZ Probe 1 aspirates the buffer and the WAM value is recorded and checked by software
• 1mL of warm buffer is dispensed via valve 2

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

In the final position:

• WZ Probe 3 aspirates the buffer and the WAM value is recorded and checked by software
• WZ Probe 3 aspirates again, although the RV should not have liquid in it
• the WAM value is recorded but ignored by software

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WAM - creating a temperature profile

• As the wash aspiration probe descends into the reaction vessel, vacuum is applied causing
ambient air to be drawn through the tubing. This results in a small decrease in temperature
sensed by the thermistor.
• As heated buffer is aspirated from the RV and drawn into the tubing, the temperature sensed
by the thermistor rises abruptly.
• When the RV is empty and the probe is clear, free-flowing air over residual buffer droplets
result in evaporative cooling. This is sensed by the thermistor as a drop in temperature.
• In a normal aspiration, the magnitude of evaporative cooling is substantial. The resulting
temperature drop, from evaporative cooling, is compared to a pre-determined threshold. From
this comparison, determination of failure or success of the aspiration is made.

Wash Manifold

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 i1000SR 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)

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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:

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

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Notes Page

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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 i1000 System Service and Support Manual for additional
information on performing the procedures in these activities.

Refer to the GSS Website and the LOG-IC Tool Quick Reference Guide for additional
information related to the activities performed.

Students Perform the following:

† Perform reagent unload to unload all reagents

† Remove Reagent Cooler R&R D3.01

† Examine the Reagent Cooler and locate the 2 thermistors on the Cooler:

a. List below the locations of the 2 Thermistors and whether they are active or monitoring.
_______________________________________________________________________
_______________________________________________________________________

† Replace ALL removed assemblies

† Perform M&D 3540 Temperature Status

(Continued)

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Perform only as Directed by Instructor (optional):

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.

† Pull a WAM Log using AbbottLink and LOG-IC Tool:

A. Log in to AbbottLink
B. Locate instructor designated instrument serial number within AbbottLink
C. Go to Actions and View All
D. Locate Troubleshooting Package 1 for the appropriate analyzer and select
E. Click Execute and wait for logs to load (appear) on the Upload File page. Refresh screen
as needed
It may take several minutes for logs to load.

F. Locate the loaded WAM Log and open the file (file opens in Notepad)
G. Record displayed date range from open file:
End date________________ Start date________________

H. Save the WAM Log file to your computer desktop

I. Open the LOG-IC Tool
J. Select appropriate settings:
 Check Log Type (WAM)
 Browse to locate file
 Set Module #
 Set Date Range to match date range of file

K. Select View Data

EXAMPLE WAM LOG

END OF ACTIVITY

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Troubleshooting
The following are tips for troubleshooting Fluidic System failures:

NOTE: When troubleshooting ARCHITECT i1000SR System errors refer to your

ARCHITECT i1000SR Service and Support Manual, Technical Service Bulletins,
Instrument Service Advisories, Troubleshooting Information (eSolutions), and/or the
ARCHITECT System Operations Manual.

Area of failure/Error Possible cause of failure

Wash Aspirate Monitoring • Wash aspiration failure can be caused by vacuum system malfunction,
probe or tubing blockage, or buffer dispense system malfunction.
- Failed Thermistor or Wash Valve:
- Clogged or bent Probe
- Insufficient vacuum
• Diverter is not properly seated to route RVs
• Daily Maintenance not performed

Vacuum pressure errors • Obstructed Valve or waste outlet

• S1 Valve failure on Wash Cup
• Obstructed or kinked tubing
• Plugged vacuum filter

LLS Errors • Bent or damaged probe

• Insufficient liquid or too much liquid
• Loose or damaged cable
• LLS Board failure
• Sample Antenna failure

Pressure Monitor Errors • Bent or damaged probe

• Poor sample integrity (fibrin)
• Loose or damaged cable
• Pipettor Board failure
• PM Transducer failure

Assay Imprecision • Syringe or valve failure

• Improper Wash due to bent probe, tubing failure, or wash valve failure
• Improper Probe Wash

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PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and
component replacement, refer to the ARCHITECT System Operations Manual
and the ARCHITECT i1000SR System Service and Support Manual.

Power and Boards

Hardware Issues/symptoms Diagnostics
Wash Cup • Vacuum pressure errors • M&D 1109 Pre Wash Cup Alignment
Assembly • Incomplete drying of probe • M&D 2137 Flush Fluids
Vacuum System • Premature Filter Replacement • Inspect System for obstructions:
• Condensation build up in Reagent - Tubing, Waste Manifold, & Valves
Cooler • M&D 3180 Vacuum System Test
• Accumulator not emptying
• CLI Commands
• Increased Vacuum Pressure errors
LLS System • LLS Errors • M&D 3630 LLS Test
• LLS Board • Crash Sensor errors • M&D 1110 Pipettor Calibration
• Pipettor probe • Measure Frequency at Probe
• Cables • CLI Commands
PM System • PM errors • M&D 2137 Flush Fluids
• PM Transducer
• Pipettor Board
Heater Cooler • Temperature Errors • M&D 3540 Temperature Status
Board • Verify LED Status
• M&D 3850 PC Board Test
• P-402 Heater Cooler Board Diagnostics
Wash Zone • WAM • M&D 2052 Wash Zone Aspiration

• M&D 3540 Temperature Status

• M&D 3180 Vacuum System Test
• M&D 2160 Prime Wash Zone
• M&D 2137 Flush Fluids
• Visually inspect / replace thermistor tubing if needed
• CLI Commands
Syringe • Assay Imprecision • M&D 2137 Flush Fluids
• Leakage • Precision Run
• Motor Step Loss

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KEY POINTS

Fluidics and Temperature Control

Note Key Points

Bulk Solutions • Wash Buffer • FMI pumps.

• Trigger • Pre-trigger Solution uses a light sensitive tubing between the
solution container and pump.
• Pre-Trigger
• Trigger Solution uses a DUAL head pump.
• Pre-trigger Solution uses a SINGLE head pump.
• Buffer system uses DUAL head pumps.
• Pre-Trigger and Trigger Solution Level Sensors are monitored by
the CMIA Optics Board.
• Logic: CMIA Optics Board and an Indexer Board.
• Drive: 36VDC from Motor Driver Board.

Liquid Level • LLS Board • Liquid Level Sense Board controls both PM and LLS Systems.
Sense (LLS) and • Conductive pipettor • During all aspirations and dispenses, the pressure signal from the
Pressure probe pressure monitor is monitored for over and under pressure
Monitoring (PM) conditions.
• Pipettor Board
• LLS Board sets the LLS frequency (100KHz).
• PM Transducer
• When the probe touches fluid the signal amplitude received by the
LLS Antenna significantly increases.
• All antenna signals route through sample antenna.
• Pipettor Board contains Pressure Monitor circuitry.
• PM Transducer is an in-line sensor located between syringe and
probe.

Wash Cup • Used to wash pipettor probe during the aspiration and dispense
cycles (active wash).
• Block manifold with two solenoid valves and two wells:
- solenoid valves are all connected to vacuum
• S1 in upper position is called the Upper Solenoid Valve:
- used to vacuum aspirate wash buffer from central wash well
- used to air dry the probe

• S2 in middle position is called the Outer Drain Valve:

- drains the outer waste well
• S3 in the lower position is only found on early versions of the wash
cup. It has been removed from later versions.
• Baffle can be removed for cleaning as required.
• 36VDC Solenoids; DC Driver I/O Board.

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Fluidics and Temperature Control

Note Key Points

Vacuum • Vacuum Pump • Vacuum Pump 24VDC from Heater Cooler Board. Logic from CPU.
Subsystem • Vacuum Filter - Diaphragm Pump capable of 27" Hg Peristaltic Waste Pump
36VDC from Heater Cooler Board. Logic from CPU.
• Drying Filter
• Accumulator:
• Waste Pump - has a level sensor monitors liquid levels
• Accumulator - waste liquid is drawn into the accumulator
• Lower and Upper - 225ml liquid waste maximum
Waste Manifolds - Vacuum Sensor Triggered at <9"Hg
• Manifolds contain 36VDC Solenoids that open to let waste flow.
power provided from DC Driver I/O Board.
• Filters are replaced as part of planned maintenance.

Temperature • Thermistors • Allows for the monitoring and control of components that are
Subsystem required to operate at specific temperatures.
• Heaters
• Temperatures monitored using embedded thermistors in heater
• Temperature Controller
assemblies:
Board
- signals sent to Temperature Controller Board
• Heater Cooler Board
• Temperature Control Areas:
• Reagent Cooler - Process Path (3 areas)
• Fans - Wash Zone
- Pre-trigger/Trigger Manifold
- Reagent Cover and Reagent Cooler

• All Heaters 24VDC.

Temperature • Master Card Cage • Receives and processes thermistor signals.

Controller Board • Issues heater control signal to Heater Cooler Board.

Heater Cooler • Master Card Cage • Provides power to system heaters and thermoelectric coolers.
Board • Power Board • Receives heater control commands from Temperature Controller
Board.
• Provides power to Vacuum, Transfer, and Waste Pumps; receives
on/off control signal from CPU.

Reagent Cooler • Thermoelectric device • Maintains reagent carousel area at correct temperature by providing
(TED) based cooling and circulating chilled air .
system • +17.5VDC from Heater Cooler Board.
• 8 TEDs paired in 4 sets • Mounted on instrument base, inside the reagent carousel area:
of 2 - A handle provided to lift cooler out of reagent carousel area
• Replaceable.

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

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REVIEW QUESTIONS
1. What is maximum amount of liquid waste that should be found in the Vacuum Accumulator?

2. On the probe wash station, which solenoid is responsible for waste evacuation in outer waste well?

3. The Vacuum Pump receives power from _____________. List the voltage supplied to the pump.

4. Explain the difference between temperature monitoring and temperature control. Then list the areas
that are controlled.

5. ALL Liquid Level Sense Antenna signals (process and reagent) route through which antenna board?

6. LLS and Pressure Monitoring are performed on aspiration only. They have no functionality during
dispense. TRUE FALSE

7. The 100KHz LLS signal is set by the ______________ board.

8. All Heaters are 24VDC and receive power from the Heater Cooler Board. TRUE FALSE

END OF MODULE

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Notes Page

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 MODULE 6

ARCHITECT i1000SR SYSTEM

OPTICS

OVERVIEW
This module discusses the following subjects:
• Optic System
• Optical System Theory
• Optics Assembly

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MODULE 6: OPTICS

Notes Page

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 MODULE 6: OPTICS

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 Optic System failures.

2. Identify the physical location of the Optic System components.

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.

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MODULE 6: OPTICS

Notes Page

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 MODULE 6: OPTICS

OPTICS SUBSYSTEM
The Optics Assembly on the i1000SR System is located within the Process Path near the Trigger/Pre-
trigger Manifold. The optics subsystem and associated components are designed to detect and measure
photo emissions produced by a chemiluminescent reaction. The optical read is then analyzed by the system
software to produce patient results.

Process Path

CMIA Optics

Pre-trigger/Trigger Manifold

Pipettor

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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

Component Function/Description Notes

CMIA Reader • Detects light photons produced from • Does not require a lamp light source to
CMIA reaction. produce a detectable light emission.
• Consists of a light pipe that collects • Replaced as an assembly.
photons and directs them onto a PMT.
• Receives power from the CMIA Optics Board.
• Sends photoelectric signal to CMIA Optics
Board for processing into a count value.
Shutter • No field Normalization; comes calibrated.
During installation & replacement be sure to
enter in Linearity and Normalization factors.
Some values may be (-) negative and require the
dash (-).

Shutter • Isolates the RV from background light. • Replaceable.

Assembly • During CMIA read the shutter closes off • Actuating Solenoid, +36VDC.
process path around the RV, isolating it
from background light. • Sensor Board.

Reader Magnet • Attracts the paramagnetic microparticles • Replaceable.

Assembly contained in the reaction mixture to the
wall of reaction vessel.
• Prevents microparticles from interfering
with chemiluminescent reaction.
Circuitry • CMIA Optics Board.
• Module Controller Board.
• DC Driver I/O Board.
• Processing Center Distribution Board.

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Service Tips:
• Shutter spring may be easily dislodged during service, if service personnel hands are in the Optic
shutter location during instrument service.
• All Optics will be "dry-calibrated" at factory. No field normalization procedure.

• M&D 1022 Optics Background:

- procedure passes at counts of <500, counts of <50 are recommended
- if high background reads are recovered:
• check for possible Trigger spills around Process Path/Optical Reader location

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MODULE 6: OPTICS

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.

• Sample is added to an RV in the Process Path.

• Microparticles (paramagnetic microparticles coated with capture molecules) are added to the sample.
• The solution is mixed and incubated.
• During the incubation the analyte present in the sample binds to the corresponding capture
molecules on the microparticles forming an immune complex.

Paramagnetic Analyte Captured analyte

Microparticle

• After incubation, a magnet in the process path attracts the

paramagnetic microparticles (bound to the specific analyte) to
the wall of the reaction vessel.

• The reaction mixture is washed to remove unbound materials.

• Analyte detection is accomplished with a

chemiluminescent acridinium-labeled
conjugate.

• The conjugate binds to the immune complex

to complete the reaction mixture.
acridinium-labeled
conjugate
• After incubation, the reaction mixture is
washed to remove unbound materials. Immuno-complex sandwich

• Pre-trigger Solution (hydrogen peroxide) is added and the CMIA optical system takes a background
read.

(Continued)

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 MODULE 6: OPTICS

• The Pre-trigger Solution (hydrogen peroxide) is used to:

• create an acidic environment to prevent early release of energy (light emission)
• help keep microparticles from clumping
• split acridinium dye off the conjugate bound to the microparticle complex

• 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.

• The oxidative reaction causes the chemiluminescent reaction

to occur.
• N-methylacridone forms and releases energy (light
emission) as it returns to its ground state.

• The CMIA optical system measures the chemiluminescent

emission (activated read) over a predefined time period to
quantitate the analyte concentration or to determine qualitative interpretations for index (cutoff)
assays.
• The chemiluminescent emission is reported in RLU (relative light unit) readings.

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CMIA Optics Normal Read Process

1. The RV is indexed to the pre-trigger dispense position, where pre-trigger is added. The RV is vortexed.

2. The RV is then moved to the optics read

position in the Process Path.
- This position is in front of the reader
magnet which pulls the microparticles to
the wall of the RV

3. The Shutter closes to block external light

from entering the RV.

4. A High voltage control signal to the PMT

(in the CMIA reader) is turned ON.

5. Six second delay occurs, during which time

the PMT response stabilizes.

6. A background read is taken:

- The light pipe directs the emitted light to
the PMT in CMIA reader
- CMIA reader converts detected photons
to a count value
- PMT output signal is interfaced through
CMIA Optics Board.
- Count data is transferred to Module
controller and is used to calculate an RLU
value

7. A foreground (activated) read is taken, and

Trigger Solution is dispensed into the RV:
- This initiates the chemiluminescent
reaction that results in the emission of
photons of light
- The light pipe directs the emitted light to
the PMT in CMIA reader
- CMIA reader converts detected photons
to a count value
- PMT output signal is interfaced through CMIA Optics Board
- Count data is transferred to Module Controller and is used to calculate an RLU value for that sample
- RLU Value is converted to a result unit by the ARCHITECT Software

8. The High voltage signal to the PMT is turned OFF.

9. 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.

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Activated Optics Read and Data Reduction

The activated 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 subreads at 100 millisecond intervals.
• When the thirty subreads are plotted for a normal read, a bell shaped curve with a left bias is
obtained (See example below):
- The first subread 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 foreground reads.
• The corrected or final count is obtained by subtracting the background from the foreground read
(Final Read (RLU) = Activated Read - 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.

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Troubleshooting
The following tips are for troubleshooting Optic System failures:

NOTE: When troubleshooting ARCHITECT i1000SR System errors refer to your

ARCHITECT i1000SR Service and Support Manual, Technical Service Bulletins,
Instrument Service Advisories, Troubleshooting Information (eSolutions), and/or the
ARCHITECT System Operations Manual.

Symptom Possible cause of failure

Zero Reads • Damaged or disconnected connector

• Blown F2 fuse on Card Cage Backplane
• Failed CMIA Optics Board
• Failed CMIA Reader

High Background Reads • Stray light (covers off, improperly seated)

• Trigger spills (Leaking Trigger Valve)
• Failed Cable (Noise)

Service and Troubleshooting Tips

Cover light pipe whenever removing optics to prevent reader PMT excitation
• If exposed for even a short time to light, it may take several minutes, hours, or a day for reader
PMT to settle down
High background reads:
• Inspect reader/Process Path area for Trigger spills
• Disconnect J30 from Card Cage to determine if Optics noise may be the issue, or remove and
cap optics

When Optics are replaced:

• Ensure cable is fully seated & locked
• Enter new System Configurations in Module for Optics Normalization & Linearity

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PROCEDURE OVERVIEW
NOTE: For additional information regarding M&D procedures, procedures, and
component replacement, refer to the ARCHITECT System Operations Manual
and the ARCHITECT i1000SR System Service and Support Manual.

Power and Boards

Hardware Issues/symptoms Diagnostics
Optics • High Background Reads • M&D 1022 Optics Background
• Zero Read • M&D 1032 Shutter Test
• M&D 1047 Optics Verification
• M&D 2162 Prime Trigger/Pre-trigger
• M&D 2004 Pre-Trigger Check (precision)
• M&D 2005 Trigger Check (precision)
Shutter Assembly • Read Errors • M&D 1032 Shutter Test

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Notes Page

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 MODULE 6: OPTICS

OPTICS SYSTEM TROUBLESHOOTING ACTIVITY

Upon completion of this activity, you should be able to:
• Perform key procedure(s) for servicing the optics components
• Interpret optic diagnostic and maintenance procedures

WARNING: Electrical Shock Hazard. Follow electrical safety practices.

Resources Needed

Refer to the ARCHITECT i1000 System Service and Support Manual for additional
information on performing the procedures in these activities.

Section 1 Key Procedures

With instrument powered ON

† Perform M&D 1032 Shutter Test and listen for shutter solenoid actuation

† Perform M&D 1022 Optics Background Test

 Record obtained values below:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

(Continued)

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Section 2 CLI Commands

† Perform M&D 6200 Terminal Simulator and initiate the CLIA commands below:
 Ensure the Processing Module Lid is Closed.
NOTE: must be logged in as FSR

The following commands will look at background light with shutter in open state; the commands
return 10 sets of numbers which represent background with empty RV. If zero’s are obtained, the PMT
is faulty.
1. Set the correct module by typing SET_MODULE X
X= 1 for Standalone i1000SR PM or 2 for integrated i1000SR PM
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 a (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

2. Actuate the shutter solenoid by typing SOL 33 SET 0

3. OPTICS PMT 1
4. READ 100 10
5. OPTICS PMT 0
6. Record results below (lid closed):
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

7. Open the Processing Module lid and repeat steps 2 through 5

8. Record the result with the lid open below:

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

9. How much difference was seen between the results in step 6 vs step 8?
_______________________________________________________________________
_______________________________________________________________________

(Continued)

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 MODULE 6: OPTICS

† Use the following CLI commands to check background with shutter in closed state:
1. SHUTTER_MOVE CLOSE
2. OPTICS PMT 1
3. READ 100 10
4. OPTICS PMT 0

† Use the following CLI commands to return the shutter to an open state:
1. SHUTTER_MOVE OPEN

TIER 2 Section 2 Removal and Replacement Procedures (OPTIONAL)

ONLY PERFORM THE FOLLOWING IF DIRECTED BY INSTRUCTOR

† Power OFF Processing Module

† Locate and REMOVE the following components:

 Optics Reader Assembly RR C1.07
NOTE: Cap the light pipe immediately upon removal.

 Shutter Assembly RR C1.02

† REINSTALL all removed components

† Power ON the Processing Module

† Perform the following M&D Procedures:

 M&D 1032 Shutter Test
 M&D 1022 Optics Background Check
a. Record the values obtained for the optics background and compare with those
obtained before removing and replacing CMIA Reader:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

END OF ACTIVITY

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MODULE 6: OPTICS

KEY POINTS

Optics

Note Key Points

CMIA • Capture Molecule - microparticles.

Reactants • Acridinium-labeled conjugate - used to form immuno-complex
sandwich.
• Pre-trigger Solution:
- creates an acidic environment to prevent early release of energy
(light emission)
- help keep microparticles from clumping
- splits acridinium dye off the conjugate bound to the microparticle
complex
• Trigger Solution - causes the chemiluminescent reaction to occur.

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.
• No field Normalization; comes calibrated.
During installation & replacement be sure to enter in Linearity and
Normalization factors. Some values may be (-) negative and require the
dash (-).

Shutter • Isolates the RV from background light.

Assembly • Replaceable.
• Actuating Solenoid +36V.
• Shutter Sensor Board.

Reader Magnet • Pulls the microparticles to the side of the RV for optimal read.
Assembly • Replaceable.

Circuitry • CMIA Optics Board.

• Module Controller Board.
• DC Driver I/O Board.
• Processing Center Distribution Board.

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.

DC Driver I/O • Master Card Cage • Engages Solenoid.

Board • Power

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REVIEW QUESTIONS AND CASE STUDIES

SCENARIO 1 The analyzer is reporting optical reads of zero.

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 1022 Optics Background 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)

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1. What is the purpose of the Trigger Solution during the CMIA Reaction?

2. List two possible causes of High Background reads.

3. What board in the Card Cage accepts read data from the CMIA Optics Assembly?

4. Which board Actuates the Shutter Solenoid?

5. What symptom(s) would you expect to observe if the Trigger and Pre-trigger Solutions were switched?

END OF MODULE

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 MODULE 7

ARCHITECT i1000SR SYSTEM

ROBOTIC SAMPLE HANDLER

OVERVIEW
This module discusses the following subjects:
• Operation
• Hardware Overview
• Hardware Activity

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Notes Page

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INTRODUCTION
This module introduces the principles, diagnostics, and components associated with the RSH including:
• Operation
• Comparison to other ARCHITECT Systems
• Hardware Overview

Objectives
Upon completion of this module, the student will be able to:

1. Locate and identify the key components.

2. Explain the RSH interface and control system.

3. Perform RSH robotic calibrations.

4. Perform Removal and Replacement of RSH and Carrier Transport.

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RSH OPERATION
The RSH (robotic sample handler) is a transport system used for loading calibrators, controls, patient sam-
ples, and reagents. Two types of sections position samples for either routine or priority processing. Sample
carriers can be loaded in any RSH section.
• The operator places samples into carriers (five sample positions per carrier), which are inserted
into the load/unload platform.
- Carriers in the priority section are processed first, in the order they were inserted,
followed by carriers loaded in routine sections.

• The Carrier Transport (robotic arm) picks up the sample carrier from the load/unload platform,
positions it at the barcode reader for carrier and sample barcode label identification, and then
places the sample carrier on the aspiration platform for sample processing.
- Module Optimization software maximizes sample processing throughput, by determining
the most efficient processing order for all tests on the samples in each carrier.
- The software sets the order in which tests in a carrier are scheduled, and applies
optimization rules to each test to find the most efficient lockstep for that test initiation.

RSH Top View

Carrier
Transport

Load/Unload
Platform
Bottle Rotator
Sample
Carrier
Aspiration
Platform Indicator
Lights

• When sample processing is complete, the Carrier Transport also returns the sample carrier to the
load/unload platform for unloading.
Indicator lights indicate the instrument processing status and when carriers can, or cannot, be accessed:
Indicator Light Status Description
Green (steady) • Sample or Reagent Carriers are loaded, but processing has not begun
• Samples can be accessed
Blinking Green • Processing is complete and Sample or Reagent Carriers can be accessed
Amber (steady) • Sample or Reagent Carriers are processing and cannot be accessed
Blinking Amber • A Reagent Carrier is in process of unloading so the section is unavailable for
loading carriers
Alternating Green and • Carrier encountered an error
Amber • Carriers can be accessed
OFF • No sample or reagent carriers loaded in that section

NOTE: If tests for a sample are added, or rerun, before it is unloaded, the indicator for the section.

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RSH Reagent Processing

Reagent carriers can only be loaded in an i1000SR section. Each carrier has a specific, color-coded seat for
each type of reagent bottle. The microparticle bottle position is a rotating seat, connected to a cogwheel.
The cogwheel engages with:

• the bottle rotator at the bar code reader scan position so that when a reagent carrier is presented for
scanning, the microparticle bottle is rotated in front of the bar code reader beam, allowing a
successful label read.

• the support gear ring on the reagent carousel causing microparticle bottle dispersion when the
reagent carousel rotates.

Barcode Reader

Bottle Rotator

When a reagent kit is presented to the load unload platform for loading, the system software determines
when an acceptable timing opportunity exists in between sample processing, to allow the reagent to be
loaded without interrupting the lockstep routine.

Upon initiation of the reagent loading,

• The carrier transport (CT) picks up the reagent carrier and moves it to the bar code read position.

• The CT lowers the carrier until the microparticle seat cogwheel engages with the spinning bottle
rotator disk. All 3 bottle positions are then scanned.

• If a valid read is obtained, the carrier transport then moves the reagent carrier to the reagent
carousel load position and loads it on the carousel.

• The system software automatically schedules an empty reagent kit or a kit with LLS failure for
unloading.

• When there is a timing opportunity as determined by the software, the carrier transport picks up
the reagent carrier from the reagent carousel and moves it back to the load unload platform for
removal by the operator.

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Hardware Overview - Integrated System

The ARCHITECT i1000SR RSH (Robotic Sample Handler) is designed very differently than the i2000SR
and c4000 Systems. It does not contain a Carrier Positioner. Also, unlike other ARCHITECT Systems, the
i1000SR RSH handles loading and unloading of reagents onto the reagent carousel while in a RUNNING
status.

Similar to other ARCHITECT, the RSH uses a Carrier Transport, Bar Code Reader, and Card Cage Boards.

However, there are differences in hardware from a standalone system vs. and integrated system. Be careful
as boards may have similar names but are not interchangeable between systems.

When servicing an integrated system it is important to understand the c4000 System RSH Card Cage. The
RSH card cage is located on the right side of the c4000 Processing Module. The Card Cage communicates
with SCC via Ethernet connection and is always configured as Module 0.
The major components of the c4000 System RSH card cage are:
• Motor Driver Board - provides the drive current to the stepper motor windings
• Controller Board - CPU controller for the RSH
• Indexer Board - provides motor control data (speed, direction and power), monitors home sensor
and encoder signals.
• Card Cage Back Plane - interface for +5VDC, +12VDC, +36VDC power, analog, and digital
signals connecting the RSH card cage to the system power supply, SCC, and the electronic devices
of the RSH.
• Card Cage fans - forces air downward through the card cage in order to dissipate heat generated
by the RSH card cage boards.

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RSH Platform Comparison

i1000SR Standalone c4000 Standalone ci4000 Integrated
OPERATIONS
Priority Bays Configurable: 0-7 Configurable: 0-7 Configurable: 0-10
Default:4 Default:7
Routine Bays 1 large bay 4 bays 8 bays
13 sections 5 sections/ bay cSystem = 5 sections/bay
iSystem = 4 sections/bay
Aspiration Platforms 1 0 1
Carrier Positioners 0 1 1
Carrier Pockets 0 1&2 1&2
Carriers Sample & Reagent Sample Sample & Reagent
Reagent Carrier positions Any None 5-8 of the i1000SR analyzer
Indicators Same Same Same
Hardware
Carrier Transport Abbott Toshiba Toshiba
Load/Unload Platform Abbott Toshiba Toshiba (for i and cSystems)
Power i1000SR Power Supply PS7 & PS8 in c4000 Power PS7 & PS8 in c4000 Power
Supply Supply
RSH Boards Abbott: Toshiba: Toshiba:
• Indexer • Indexer • Indexer
• Controller • Controller • Controller
• Motor Driver • Motor Driver • Motor Driver

Unload/Load boards Unload/Load boards differ Unload/Load boards differ

differ from c4000 from i1000SR from i1000SR and c4000
standalone
RSH Distribution Board RSH Distribution Board
RSH Distribution Board
Fuses F7 (+5VDC) • F1 (5VDC) 10A
10A • F2 (12VDC) 2A

Jumpers Mod 1 for i1000SR • JU1 & JU2 on RSH Card • JU1 & JU2 on RSH Card
Cage Cage
• PS iRSH & RSH • Mod 2 for i1000SR
• PS iRSH & RSH
Integration
Integration Several components Anchor or reference for • c4000 contains the RSH
are removed and ci4100 power & control
replaced with Toshiba • Components may not be
components depending compatible with i1000SR;
on i1000SR check FRUD
classification type
(A-D)

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Notes Page

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Hardware Overview - Standalone i1000SR RSH

The following main hardware components are used in the RSH sub-assembly on a standalone i1000SR
System:
• Load /Unload Platform
• Priority and Standard Load/Unload Boards
• Carrier Transport
• Left and Right Supports
• Aspiration Platform
• Bottle Rotator
• Barcode Reader
• RSH Distribution Board
• Card Cage Boards (Module Controller, CMIA Optics, Motor Driver, Indexer)

Carrier Transport

Bottle Rotator

Barcode Reader

Sections

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Load/Unload Platform

The load unload platform, positions each carrier for transporting by the carrier transport. The base of the
load unload platform is called the section tray, and is separated into 13 sections by partitions. Each section
accommodates either a sample or a reagent carrier and can distinguish between the two carrier types.

In the base of each section is a lever mechanism with a flag, which interacts with a set of sensors mounted
on the load/unload sensor board.

Lever Mechanism

Load/Unload Boards

Priority

Standard

NOTE: The standalone i1000SR load/unload sensor boards are not compatible with the c4000 load/
unload sensor boards.

Priority and Standard Load/Unload Sensor Boards

• The load unload sensor board is actually 2 sensor boards linked using a single connector.

• The two boards mount to the front of the load unload platform, behind a cover. They are held in
place by three screws.
- the first sensor board is the priority load/unload board
- the second board is the standard load/unload board
NOTE: The connection to the first and second sensor board is fragile, handle with care.

• LEDs on the load unload sensor board indicate carrier status:

- Green LEDs indicate the section is available or completed
- Amber LEDs indicate a processing state
- Blue LEDs indicate that the section is a priority section
NOTE: Default is 4, configurable sections 1 through 7.

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Carrier Detection

The load/unload platform contains a carrier detection sensor system

that can detect the presence of a carrier, and can differentiate between
a sample and a reagent carrier.

• Each section has a sensor arm (carrier present flag) recessed

in the base of the section tray. This sensor arm is spring
loaded and in the resting state, remains in the raised position.

• When a carrier is inserted into that section, the carrier presses down on the carrier present flag
which then interrupts a set of optical sensors.

• There are 2 optical sensors in a staggered position, which can distinguish 4 states:
- State 1 - No carrier inserted
- State 2 - Partial carrier inserted - error status
- State 3 - Sample carrier fully inserted
- State 4 - Reagent carrier fully inserted

• Sample and reagent carriers are differentiated through their different widths:
- The narrower sample carrier presses down on the front section of the carrier present flag
which drives the carrier present flag down to interrupt both optical sensors.
- The reagent carrier is wider and rides up on a ridge on the section tray. When sitting on
this ridge, the reagent carrier presses down on an extra sensor arm feature, which drives
the carrier present flag down completely through the first optical sensor and leaving it
interrupting only the second optical sensor.

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Carrier Transport

The carrier transport is a robotic device that interacts with the load unload platform, the aspiration platform
and the reagent carousel.

The carrier transport assembly moves along the length of the load unload platform, riding on a linear rail
guide.
It interacts with each section to pick up the sample or reagent carrier, and then places that carrier on the
aspiration platform (sample) or on the reagent carousel (reagent).

It also returns sample carriers and empty reagent kits to the load unload platform for unloading.

The carrier transport consists of the following major components:

• Carrier Transport Board: printed circuit board mounted to the carrier transport frame that
interfaces all motor and sensor signals.
• Carrier Transport Arm: attaches to theta shaft, supporting and retaining the carrier during pick
and place operations.
• Carrier Transport Arm Sensor: sensor in carrier transport arm that detects presence of a carrier.
Also referred to as the rail guide sensor.
• Theta Shaft with Motor: moves carriers in theta axis during pick and place operations.
• Lifter with Leadscrew and Motor: attaches to the carrier transport arm and moves carriers in the
Z (vertical) direction, raising and lowering carriers during pick and place operations.
• X-axis Motor: drives the carrier transport along the rail guide in the x axis.
• Flex Cable: cable that carries the control and power signal information between the carrier
transport board and the RSH distribution board.
- The cable chain guide, located behind the load unload platform, provides a guide for the
movement of the carrier transport flex cable, and protects the load unload carrier
detection system from damage through flex cable movement.
- It also provides support for the load unload platform.

Carrier
Transport

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Carrier
Transport Board

Service Tips:

• If x-sensor is loose it may cause step loss errors

• The flex cable connector cables need to be tucked in or else jams may occur

• Ensure cover is properly installed for optimal operation

• Ensure arm sensor is installed correctly – otherwise carrier detection errors may occur

• May get an error if carrier is sat in bay and not fully engaged

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Left and Right Supports

The left and right supports provide the mounting structure for the load unload platform. The left support
also provides the mounting structure for the bottle rotator, the barcode reader and the RSH distribution
board.

Aspiration Platform

The aspiration platform sits behind the load unload platform and in front of the pipettor and washcup. It is
the location at which the sample carrier is placed for sample aspiration.

Bottle Rotator

The bottle rotator mounts to the left support. It is a rotating disk that engages with the reagent carrier drive
cog, spinning the microparticle bottle during the barcode scanning process.

Bar Code Reader

The bar code reader mounts to the left support and scans reagent bar codes, sample carrier ID bar codes
and sample ID bar codes.

Bar Code Symbologies:

• Codabar (checksum is user configurable)

• Code 3 of 9 (checksum is user configurable)

• Interleaved 2 of 5 (checksum is user configurable)

• Code 128 subset A, B, and C (checksum is always enabled)

NOTE:RSH components differ on a standalone i1000SR versus a ci4100 System.

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RSH Distribution Board

The RSH distribution board is mounted to the left RSH support, behind a protective cover.
It provides the interface circuitry between the i1000SR card cage and the following RSH components:

• Carrier Transport PCB (via the flex chain) - stepper motors and sensor signals

• Load/unload board sensors and LED indicators

• Barcode Reader Signals

• Reagent bottle rotate

• Ambient Temperature thermistor

Barcode Reader

Bottle Rotator

RSH Distribution
Board

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i1000SR Card Cage Boards

The RSH operation is supported by boards in the i1000SR card cage. These card cage boards are:
• Module Controller - CPU controller for the RSH

• CMIA Optics - Works in conjunction with Indexer to analyze sensor outputs

• Motor Driver #2 - provides the drive current to the stepper motor windings

• Indexer #2 - logic for motors

RSH Power
• Card Cage Back Plane - interface for +5VDC and +36VDC power, analog, and digital signals
for the electronic devices of the RSH.

Card Cage
Backplane

Rear view of Analyzer with middle cover removed

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 MODULE 7: RSH

Robotic Sample Handler Diagram

NOTE: Refer to the c4000 Service and Support Manual for information regarding the ci4100 integrated system.

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Notes Page

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 MODULE 7: RSH

RSH ACTIVITY
Upon completion of this activity, you should be able to:

• Perform Removal and Replacement of Key RSH System Hardware

• Perform Key M&D Procedures for the RSH System.
CAUTION: Moving Parts.
CAUTION: Class 2 Laser Radiation. Avoid eye exposure.

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

Refer to the ARCHITECT i1000SR System Service and Support Manual for additional
information.

AS DIRECTED BY INSTRUCTOR PERFORM THE FOLLOWING:

NOTE:The RSH components and R&Rs differ between a standalone i1000SR and an integrated
ci4100 System.

STANDALONE SYSTEMS BEGIN HERE:

† Power OFF the Processing Module
† Remove the following RSH components:
 Load Platform (disconnect ribbon cable first and slide out)
 Section tray with sensors
- Examine section tray base for sensors
 Front sensor overlay/Bezel
 Load/Unload Boards R&R N2.07

† Remove and Examine the Carrier Transport R&R N1.01 including the following subcomponents:
 Remove, examine, and replace CT Arm Detect Sensor R&R N1.07
 Examine the X-sensor (take care not to break the retaining clips)
 Examine the Lead Screw / Lifter Assembly

(Continued)

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† Reinstall all removed components

† Perform the following procedures after installation is complete:

 Load Platform alignment
 M&D 1114 Carrier Transport Calibration
 M&D 3310 RSH Test
 M&D 3240 Bar Code Calibration
 M&D 3330 RSH Alignment Test
 M&D 5550 RSH Motor Test
 M&D 5555 RSH Sensor Test
NOTE: For training purposes all motors, nor all sensors, need to be tested, select 2-3 to test.

INTEGRATED SYSTEMS BEGIN HERE:

† Turn OFF the ci4100 Power

† Remove the following:

 iRSH cover/Bezel
 Carrier Transport
 iRSH

† Examine components and reinstall

† Power ON ci4100

† Perform the following procedures:

 M&D 1114 Carrier Transport Calibration
 M&D 1110 Pipettor Calibration i1000
 M&D 3240 Bar Code Calibration
 M&D 3310 RSH Test
 M&D 5550 RSH Motor Test
 M&D 5555 RSH Sensor Tests
NOTE: For training purposes all motors, nor all sensors, need to be tested, select 2-3 motors
to test.

END OF ACTIVITY

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 MODULE 7: RSH

KEY POINTS

RSH

Note Key Points

RSH • The standalone RSH differs from the c4000, c8000, c16000,
i2000SR and integrated ci4100 Systems.
• Accepts Reagent Kits loaded onto Reagent Carriers.
• Uses Sample Carriers (no loading carrier trays).

Load/Unload • Positions each carrier for transport by the carrier transport.

Platform • Up to 7 sections can be configured for priority processing on a
stand-alone i1000SR RSH. The Default is 4.

• Up to 10 sections can be configured for priority processing on a

ci4100 integrated system.

Load/Unload • Contain LEDs that indicate the state of each section to the operator:
Sensor Boards - Blue LEDs indicate that the section is a priority section
- Green LEDs section is available or completed
- Amber LED section is in a processing state

• Detect whether a sample carrier, or a reagent carrier was loaded:

- Differentiate through different widths

• First sensor board is priority load/unload.

• Second board is standard load/unload.

The connection to the first and second sensor board is fragile, handle
with care.
• NOT the same as the c4000 System Load/Unload Sensor Boards.
• +5VDC.

Carrier • Interacts with each section to pick up the sample carrier, move it to
Transport the bar code reader and then place the carrier on the aspiration
platform (sample) or on the reagent carousel (reagent).

• Returns sample, and reagent, carriers from the carrier positioner to

the load/unload platform for operator removal.

• +36V Motors (Theta and X-axis).

• Motor Driver Board #2, Indexer Board #2.

• Carrier Transport Board Replaceable.

• Flex Cable carriers control and power signal information between

carrier transport and RSH Distribution Board.

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RSH

Note Key Points

RSH • Provides the interface between the Card Cage and Carrier
Distribution Transport Board (via the flex chain), bar code signals and the
Board Load/unload board sensors and LED indicators.

i1000SR Card • Interface with RSH components - CMIA Optics Board, Module
Cage Boards Controller (CPU), Motor Driver, Indexer, and Card Cage Back Plane:
- Module Controller acts like CPU for RSH
- CMIA Optics board works in conjunction with Indexer to analyze
sensor outputs
- Motor Driver #2 provides drive current to stepper motors
- Indexer #2 provides logic to stepper motors

Bottle Rotator • Unique to i1000SR System, mounts to left support.

• Rotating disk used to spin microparticle reagent bottle during

barcode read.

Aspiration • Behind Load/Unload • Sample carrier is placed there for sample aspiration.
Platform platform and in front of
Pipettor Wash cup

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REVIEW QUESTIONS

1. A blue indicator status light signifies what?

2. Explain the RSH interface and control on a Standalone i1000SR System.

3. Explain how power is distributed to the RSH system on a Standalone i1000SR and what voltages are
used.

4. What do alternating green and amber lights indicate on the Load/Unload platform?

END OF MODULE

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Notes Page

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 MODULE 8

ARCHITECT i1000SR SYSTEM

PLANNED MAINTENANCE & INSTALLATION

OVERVIEW
This module discusses the following subjects:
• Installation
• Planned Maintenance

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Notes Page

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 MODULE 8: PLANNED MAINTENANCE & INSTALLATION

INTRODUCTION
This module introduces the procedures associated with Installation and Planned Maintenance including:
• Location of Checklists
• Installation Overview
• Planned Maintenance Procedures
• Troubleshooting

Objectives
Upon completion of this module, the student will be able to:

1. Perform System Installation procedures.

2. Locate Planned Maintenance (PM) Checklist.

3. Perform Planned Maintenance Procedures to include:

• Component Replacement
• Component Inspection
• Cleaning
• Maintenance and Diagnostic (M&D) procedures

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INSTALLATION OVERVIEW
ARCHITECT iSystem Installation procedures are designed to install system hardware and verify the
system hardware is performing within specification. It consists of 2 basic processes:
• Pre-site Inspection
• Installation
NOTE:Installation does not include assay correlation or performance testing. That would be included
in integration and startup activities.

Use the ARCHITECT i1000SR 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 i1000SR 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 and Delivery Pathway Clearance
• Environment Specifications and Water Quality Requirements
• Storage Requirements and Waste Disposal
• Sample Bar Code and LIS Interface data

Installation

The Installation Checklist can be located in the ARCHITECT i1000SR System Service and Support
Manual, Section 8 Installation. It contains the procedures that are required to unpack, setup, and verify
performance of an ARCHITECT i1000SR System. Follow checklist for efficiency and proper sequence.

Use the ARCHITECT i1000SR 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, mixers, SCC Hardware, and Cabling
• Software installation to include, configuration, calibrations, setup for system and assay data.
• Verification of all robotics positions

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 MODULE 8: PLANNED MAINTENANCE & INSTALLATION

SOFTWARE INSTALL AND BACKUP PROCEDURES

The SCC (System Control Center) is a computer system that provides the software interface to the
ARCHITECT System (i and cSystems) and can provide an interface to a host computer.
For information refer to the ARCHITECT i1000SR System Service and Support Manual,
ISA and TSB All Products Database.

Procedure Purpose Notes

Software • ARCHITECT System Software: • C Drive or partition contains WINDOWS
Installation - Copies software on the C and D Drives on the SCC Operating System, ARCHITECT System
Software, and configurable files.
- Sets up Boot Sequence
- Performed: • D-drive, D partition, or F-drive contains
- at installation before PM powered ON backup files.
- Software upgrades Software is a field personnel tool and
- Troubleshooting system software file should be removed from customer site after
corruption use.
• ARCHITECT Base Configuration Software:
- Contains WINDOWS Software and drivers
necessary for ARCHITECT software function
- Installed during SCC CPU replacement, software
reload, and installation as indicated in procedure
instruction
Refer to ISA/TSB Database and ARCHITECT System
Service and Support Manual for Software verification
and installation instructions.
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.
System • Part of recommended maintenance. • Backups copy three files:
Backup and • Provide a means to transfer files to a system drive and - Module Calibrations
Restore external media to protect against data loss in the event - System Configuration
of a hard disk failure or software database error.
- Database
• Up to three different backups are stored.
• Up to three different backups are stored.
• Step 1: Create Backup:
- System/Utilities/F4 Create Backup
• Step 2: Copy Backup to Disk:
- Diagnostics/Module 5/Utilities/Copy
Backup Software (M&D 6004)

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Configuration

Configuration settings define the information the ARCHITECT System needs to meet the site's specific
requirements. Configuration is performed during system integration and installation as directed.

ARCHITECT System configuration settings are located under the SYSTEM ICON. These settings
consists of three main areas.
• System Settings
• Assay Settings
• QC-Cal Settings

Not all configuration files will be discussed in this module.

NOTE: For additional information and procedures refer to the ARCHITECT System
Operations Manual, Section 2 Installation procedures and special requirements.

Must be logged on as Admin. Instrument status must be in a Status other than "Running" to edit/change
configuration parameters.

Select System
Select Configuration Select System Settings

Select Assay Settings

Select QC-Cal Settings

System Settings
In order to configure system settings the user must be logged on as ADMIN or higher. Parameters cannot
be edited while the module is running. System settings include, but are not limited to:
• Host Interface settings
• Modules
• Sample bar code reader settings

Assay Settings
Assay Setting configurations are performed whenever a new assay is installed. This includes adding a user
defined assay. Procedures for configuring assays include:
• Assay parameters
• Result Units

QC-Cal Setting
QC-Cal Setting configurations are performed whenever a new control or calibrator is installed.

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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
Refer to the ARCHITECT i1000SR System Service and Support Manual for additional
information.

Students Perform the following:

† Read the following tips then Perform M&D 2190 Internal Decontamination:
- Read the instructions carefully and perform each steps exactly as stated before
continuing.
- On Install, log on as an FSE so you will not be asked to bypass the buffer filter. This is
because it will not be installed yet.
- When reconnecting fittings listen for a click to ensure the connection is tight avoiding
leaks.
- When rinsing the buffer reservoir, rotate to ensure every corner is rinsed, even the top, to
get all the bleach and potential contamination out.

END OF INSTALLATION ACTIVITY

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PLANNED MAINTENANCE
The Planned Maintenance (PM) section in the ARCHITECT i1000SR System Service and Support Manual,
contains suggestions for planned and as needed maintenance procedures for the i1000 System. Any
deviation or change from these suggestions due to, or based on, local, country, or area operating procedures
and business needs must be documented and approved locally.
NOTE: A translated, locally approved, copy of planned maintenance checklist(s)
may be provided by the local service area/country organization.

PM: Planned Maintenance

• Consists of procedures designed to maintain the performance of the system

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PLANNED MAINTENANCE ACTIVITY

Upon completion of this activity, you should be able to:
• Perform an Instrument PM as directed by Instructor
• Verify instrument performance following PM by running precision
• Troubleshoot and resolve any issues created during performance of PM
• As directed by the instructor, present information to the class
CAUTION: Moving Parts.

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.

You and your partner will work through the designated PM checklist together. 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 i1000SR System Service and Support Manual for information
related to activity.

(Continued)

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MODULE 8: PLANNED MAINTENANCE & INSTALLATION

Students Perform the following:

† Locate PM Checklist designated by instructor.

PM Notes PM Notes
Items in need of correction/replacement: • Reagent Access Door Lubrication
• Areas demonstrating fluid spills/leaks
• Frayed V-wheels
• Damaged or dirty components
• Bent or cracked tubing

• RVs and Process Path

• Manifolds

(Continued)

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 MODULE 8: PLANNED MAINTENANCE & INSTALLATION

† Perform QC analysis on STAT B-hCG and TSH.

† Record a brief record of any errors that occurred following PM and their resolution:

Error Resolution

END OF ACTIVITY

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MODULE 8: PLANNED MAINTENANCE & INSTALLATION

Notes Page

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 MODULE 8: PLANNED MAINTENANCE & INSTALLATION

MODULE SUMMARY
Now that you’ve completed the Planned Maintenance Module, you should be able to perform preventative
maintenance on the i1000SR 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

• Planned Maintenance Overview:

- Performance of PM procedures
- PM kits and tools

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MODULE 8: PLANNED MAINTENANCE & INSTALLATION

REVIEW QUESTIONS

1. What type of grease is used to lubricate the Reagent Access Door?

2. List the components that should be replaced on a PM?

3. What are quick disconnect o-rings lubricated with?

4. What should the screw holes be lubricated with on an initial PM?

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 MODULE 8: PLANNED MAINTENANCE & INSTALLATION

TROUBLESHOOTING ACTIVITY AND PRACTICAL EXAM

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

The troubleshooting exercise will be focused upon practicing your skills in determining the root cause of
an instrument error and in using the troubleshooting process. You will 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.

A portion of the troubleshooting activities will consists of a Practical Exam. The practical exam will
consist of resolving instrument errors (i.e.”bugs”). 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.

CAUTION: Moving Parts.

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, and/or instructor, including how you
arrived at the solution.

(Continued)

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(Optional)

Error Notes Resolution

END OF ACTIVITY

END OF MODULE

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 APPENDIX

ARCHITECT i1000SR SYSTEM

APPENDIX A ISYSTEM COMPARISON

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APPENDIX A :iSystem COMPARISON

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 APPENDIX A: iSystem COMPARISON

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

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APPENDIX A :iSystem COMPARISON

i2000SR System i1000SR System

Hardware - PROCESSING CENTER

RV Loader NOT compatible with i1000SR NOT compatible with i2000SR
• RV Loader: • NEW Design RV Loader:
- RV Hopper - Upper and Lower Hopper
- RV Loader Wheel - RV Picker
- RV Transport - RV Load Chute
• Sensor Board 6 • NO Sensor Board 6
Process Path NOT compatible with i1000SR NOT compatible with i2000SR
• Process Path: • Process Path:
- 112 process path positions - 23 process path positions
- Rotates counter-clockwise - Rotates counter-clockwise
- Indexes one RV position every 18 - Indexes one RV position (832 steps)
seconds every 18 seconds
Pipettor NOT compatible with i1000SR NOT compatible with i2000SR
• 4 Pipettors: • 1 Pipettor (New design):
- Sample Pipettor - Aspirates and dispenses Sample and
- STAT Pipettor Reagent
- Reagent 1 Pipettor
- Reagent 2 Pipettor
Probe Same - compatible Same - compatible
Wash Zone NOT compatible with i1000SR NOT compatible with i2000SR
• 2 wash zone manifolds • 1 wash zone manifold
Wash Cup NOT compatible with i1000SR NOT compatible with i2000SR
• 4 cups • New 1 cup design
Vortexers Same - Vortexer is compatible Same - Vortexer is compatible
• 4 vortexers • 2 vortexers
Diverters NOT compatible with i1000SR NOT compatible with i2000SR
• 4 Diverters: • 3 Diverters:
- Load - Inlet
- Unload - Outlet
- Wash Zone - Unload Diverter
- STAT • RV Unloader (passive)
Hardware - TEMPERATURE
Heaters NOT compatible with i1000SR NOT compatible with i2000SR
• 9 Heaters: • 7 Heaters:
- Pre-trigger - Pre-trigger /Trigger
- Trigger - Buffer
- Buffer - Reagent Cover Heater
- Process Path (6) - Process Path (3)
• 27VAC • 24VDC
• Powered through direct AC power • Powered through Heater Cooler Board
from Heater Module • Fused on Heater Cooler Board
• Fused on Power Supply Board • 7 active channels, 5 passive channels
• 10 active channels 8 passive channels

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 APPENDIX A: iSystem COMPARISON

i2000SR System i1000SR System

Hardware - REAGENT AREA

Reagent Carousel NOT compatible with i1000SR NOT compatible with i2000SR
• Reagent Carousel: • Reagent Carousel:
- Operator Load and unload - Automatic continuous load and
- Reagent Carousel: unload
- Inner - Reagent Carousel:
- Middle (dispersion) - Ring Gear
- Outer - Holds 25 Reagent Carriers
- Holds 25 onboard reagent kits - Reagent LLS Antenna
- Motor Assembly

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

Manifold Valve kit Same - compatible; 36VDC Same - compatible; 36VDC

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APPENDIX A :iSystem COMPARISON

i2000SR System i1000SR System

Hardware - POWER and CIRCUITRY

Power Supply NOT compatible with i1000SR NOT compatible with i2000SR
• Power Supply: • NEW Power Supply:
- Voltage must be jumpered to - Self contained unit, auto adjusting
correlate with incoming power - DC power output only
- Provides AC and DC power - Fan only FRU
- Replaceable fans, fuses, switches - No fuses
and internal modules

Card Cage • 5 compatible Logic Boards: • 5 compatible Logic Boards:

- Indexer - Indexer
- CMIA Optics - CMIA Optics
- Temperature Controller - Temperature Controller
- Module Controller (CPU Bd) - Module Controller (CPU Bd)
- *Motor Driver - *Motor Driver
Always confirm board compatibly in Always confirm board compatibly in FRU
FRU database. database.

• NOT Compatible boards:

• NOT Compatible boards: - LLS/PM
- DC Driver I/O Board
- DC Driver I/O (solenoid driver)
- Liquid Level Sense
- Heater Cooler (NEW)
• Multiple power connections on
• Single direct connector on backplane to
backplane
Power Supply
• 16 fuses
*Compatibility dependent on part number
used *Compatibility dependent on part number used

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)

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 APPENDIX A: iSystem COMPARISON

i2000SR System i1000SR System

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

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APPENDIX A :iSystem COMPARISON

Notes Page

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 APPENDIX

ARCHITECT i1000SR SYSTEM

APPENDIX B - OPTIONAL ACTIVITES

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 APPENDIX B: OPTIONAL ACTIVITIES

DAILY MAINT & BASIC RUN ACTIVITY

Time to complete: 45 minutes
Debrief Session: 10 minutes

Activity Instructions
In this activity you will:
• Verify and update (as needed) Supplies and Reagents
• Perform Scheduled Maintenance
• Order patient and control samples and initiate a Run
WARNING: Potential Biohazard. Follow biosafety practices.
CAUTION: Chemical Hazard.
CAUTION Lifting Hazard (Liquid Waste Container)

Resources Needed
Refer to the ARCHITECT System Operations Manual Section 5: Operating Instructions
Assay processing for additional information.

To complete this activity you will need:

• Reagents, Controls, and Supplies

Students Perform the following:

NOTE: Ensure Processing Module and RSH are in proper status for activity tasks.

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:
† Liquid and Solid Waste

† RVs

† Bulk Solutions (Trigger, Pre-trigger, and Manual Wash Buffer)

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)

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APPENDIX B: OPTIONAL ACTIVITIES

3. Perform scheduled Daily Maintenance M&D 6440:

• Select SYSTEM ICON
• Select MAINTENANCE
• TO DO tab
• F5-PERFORM
• Select PROCEED and follow the instructions shown in the Instructions Box on the display

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) if displayed
• Select Assay(s)
• Select Control, Lot, and Levels (Low, Mid, and High)
• Select F2-ADD ORDER
• Repeat for additional controls

Single Analyte Control Lot Levels

TSH Provided by Instructor ALL
B-hCG STAT Provided by Instructor ALL

5. Place the following specimen orders as described in table below:

• Select ORDERS, PATIENT ORDER
• Select Single Patient
• Type in or scan Bar Code, Carrier bar code ID number (C), unused position number (P), and
SID
• Select Assay(s)
• Select F5-ASSAY OPTIONS to request duplicates or dilutions
• Select F3-ADD ORDER
• Repeat for additional samples
SID NAME Assays
SIDs on Bar Bug, Ada B-hCG STAT
Code Cord, Ben G. TSH
Labeled
Tubes Dayo, Long B-hCG STAT and TSH

(Continued)

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 APPENDIX B: OPTIONAL ACTIVITIES

6. Once all orders have been placed, print the Order List:
• Select Orders
• Select Order Status
• Select F4 Print, Orderlist Report, Done

7. Load Specimens (QC and Samples) into carriers:

• Verify adequate volume loaded per Order List
• Verify sample placement per Order List

8. Load carriers onto RSH for routine Processing

Indicator Light Status Description

Green (steady) • Sample or Reagent Carriers are loaded, but processing has not begun
• Samples can be accessed
Blinking Green • Processing is complete and Sample or Reagent Carriers can be
accessed
Amber (steady) • Sample or Reagent Carriers are processing and cannot be accessed
Blinking Amber • A Reagent Carrier is in process of unloading so the section is
unavailable for loading carriers
Alternating Green and • Carrier encountered an error
Amber • Carriers can be accessed
OFF • No sample or reagent carriers loaded in that section

9. Initiate Run

RETURN TO LECTURE ROOM FOR ADDITIONAL INSTRUCTION WHILE INSTRUMENT RUNNING.

10. Evaluate results of controls upon run completion

END OF ACTIVITY

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APPENDIX B: OPTIONAL ACTIVITIES

Notes Page

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 APPENDIX B: OPTIONAL ACTIVITIES

BASIC RUN ACTIVITY - CALIBRATION

Time to complete: 45 minutes
Debrief Session: 10 minutes

Activity Instructions
In this activity you will:
• Order a Calibration and initiate a RUN

WARNING: Potential Biohazard. Follow biosafety practices.

WARNING: Splash/Spray Hazard.
CAUTION: Chemical Hazard.

Resources Needed
Procedures for these activities can be located in the ARCHITECT Service and Support
Manual, or ARCHITECT System Operations Manual, Section 5 Operating instructions.

To complete this activity you will need:

• Reagents, Calibrators, Controls, and Supplies

Students Perform the following:

NOTE: Ensure Processing Module and RSH are in proper status for activity tasks.

1. Check Supplies and Reagents. Add and update inventory as needed:

• TSH and B-hCG

2. 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.

• Select F2-ADD ORDER

(Continued)

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APPENDIX B: OPTIONAL ACTIVITIES

3. 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

Single Analyte Control Lot Levels

TSH Provided by Instructor ALL
B-hCG STAT Provided by Instructor ALL

4. Print Order List Report and load calibrators and controls into carriers:
• Select ORDER/ORDERSTATUS
• Select F4-PRINT to print a report for all orders

5. Load carrier(s) in RSH and initiate RUN

Once the run is started, please return to classroom for further training.

6. Evaluate results of calibration and controls upon run completion

7. From the QC reports screen, print out the following reports:

† QC Analysis report for today’s B-hCG STAT results
† QC Summary report for the today’s TSH
† Levey-Jennings charts for last 30 days for TSH and B-hCG STAT

END OF ACTIVITY

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 APPENDIX B: OPTIONAL ACTIVITIES

MAINTENANCE ACTIVITY
Time to complete: 30 minutes
Debrief Session: 5 minutes

Activity Instructions

In this activity you will:

• Perform Maintenance Procedures
WARNING: Potential Biohazard. Follow biosafety practices.
WARNING: Splash/Spray Hazard.
CAUTION: Chemical Hazard.

Resources Needed
• ARCHITECT iSystem, onboard solutions, accessories, and consumables

Procedures for these activities can be located in the ARCHITECT i1000SR System
Operations Manual, Section 5 Operating Instructions and/or the on-line ARCHITECT
Operations Manual.

Students Perform the following:

NOTE: Ensure Processing Module and RSH are in proper status for activity tasks.

† Perform Daily Maintenance M&D Procedure 6440

† Perform Pipettor WZ Cleaning M&D Procedure 6445

† Perform Manual Probe Cleaning M&D Procedure 6407

† Review Air Filter Cleaning M&D Procedure 6405

† Perform Internal Decontamination M&D Procedure 2190

END OF MAINTENANCE ACTIVITY

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APPENDIX B: OPTIONAL ACTIVITIES

Notes Page

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 APPENDIX B: OPTIONAL ACTIVITIES

BASIC OPERATIONS ACTIVITY - CONFIGURATION

Time to complete: 30 minutes
Debrief Session: 15 minutes

Activity Instructions
In this activity you will:
• Install assays
• Configure calibrators
• Perform a Calibration
• Perform Precision analysis
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 i1000SR System
Service and Support Manual, and Installation and/or the ARCHITECT System
Operations Manual, Section 2 Installation procedures and special requirements.
To complete this activity you may need:
• Reagents, Controls, Calibrators, and Supplies

Students Perform the following:

Instrument Setup - Assay Installation
NOTE: Ensure Processing Module and RSH are in proper status for activity tasks.

1. Perform key Setup Procedure:

† Remove/delete the following Assays from the system:
• Perform M&D for assay removal.
• Follow the instructions on screen to delete the assays.
Note: INSTRUCTOR may provide an alternate assay list and/or modify the list below.

† ALT † TP
† Creat † Total PSA
† Estradiol

• Install an Assay using Assay Installation Utilities 6114

(Continued)

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APPENDIX B: OPTIONAL ACTIVITIES

Configuration - Single Analyte Control

NOTE: When configuring calibrators and/or controls during instrument installation,

configuration, and/or during other instrument service activity, obtain the
product values from the manufacturer documentation such as the calibrator,
control, or assay-specific package inserts for the appropriate lot numbers.

1. Single Analyte Control:

• Select SYSTEM, CONFIGURATION
• Select QC-CAL button (top of information area of screen)
• Select QC-Single Analyte:
• Select Assay: TSH
• Select F6 CONFIGURE
• Select drop down menu box next to Lot No.
• Select NEW LOT and type SEVICE TSH 1 in Lot number field.
• Enter MEAN and 1SD information for the CONTROL L
NOTE: Refer to Assay Control Insert for specific mean and target range information.

• Select ADD LEVEL

• Select DONE
• Repeat for M and H Control Level

Perform a Calibration Run (OPTIONAL - perform as directed by instructor)

Procedures for these activities can be located in the ARCHITECT i1000 Service and
Support Manual, or ARCHITECT System Operations Manual, Section 5 Operating
instructions.
1. Load the following reagents:
• TSH

(Continued)

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 APPENDIX B: OPTIONAL ACTIVITIES

2. 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(s)
- TSH
• Select F5 ASSAY OPTIONS:
- Type Calibrator Lot number
- Type Calibrator expiration date
- Select DONE
• Select F2-ADD ORDER

3. Order TSH Controls:

• 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 (SERVICE TSH 1)
• Select F2-ADD ORDER

4. Once all orders have been placed, print the Order List

5. Load Samples:
• Verify adequate volume of sample loaded per Order List
• Verify sample placement per Order List

6. Initiate Run

7. Evaluate results of calibration and controls upon run completion

END OF BASIC OPERATIONS ACTIVITY-CONFIGURATION

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APPENDIX B: OPTIONAL ACTIVITIES

Notes Page

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 APPENDIX B: OPTIONAL ACTIVITIES

ACTIVITY - i1000SR SYSTEM ROBOTIC SAMPLE HANDLER

Time to complete: 45 Minutes
Debrief Session: 15 minutes

Activity Instructions
In this activity you will:
• Perform key procedure(s) for servicing RSH components
• Perform key M&D procedures
CAUTION: Moving Parts.

Resources Needed

Refer to the ARCHITECT i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.

Students Perform the following:

With instrument powered ON

† Locate the following components:

 Load/Unload Platform with individual sections, partitions, support bar and section tray
 RSH Status LEDS
 Left Support with RSH Distribution board (remove cover)
 Bar Code Reader
 Reagent Bottle Rotator
 Carrier Transport – remove cover to expose Carrier Transport Board
 Flex Cable – identify connections at RSH Distribution board and Carrier Transport board
 Aspiration Platform
 Card Cage – open access door and identify the various PCB’s while installed

Observe "Normal" RSH Operation

† Perform M&D 3310 RSH Test, using both sample and reagent carriers

† Observe Status LEDS during RSH operation

(Continued)

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APPENDIX B: OPTIONAL ACTIVITIES

† Place a carrier in at an angle.

a. Did an error occur?
_______________________________________________________________________
_______________________________________________________________________

b. What LED combination indicates an error status?

_______________________________________________________________________
_______________________________________________________________________

† Complete the following removal and replacement procedures:

 Carrier Transport Board N1.04
 Bottle Rotator Assembly, Wheel and Cap N2.02

† Perform the following M&Ds:

 M&D 3230 Bar Reader Test
 M&D 3330 RSH Alignment Test

END OF RSH ACTIVITY

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ACTIVITY - i1000SR SYSTEM FLUIDICS CLI COMMANDS

Time to complete: 30 Minutes
Debrief Session: 5 minutes

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 i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.

Students Perform the following:

CLI Commands

† Perform M&D 6200 Terminal Simulator and initiate the CLIA commands below.
NOTE: must be logged in as FSR

High Level Command

1. First enter required High Level Command: MOD_COMP_INIT SYSTEM_VACUUM

Low Level Command

2. DIO 25 SET X - turns vacuum pump on (1) or off (0)

† Power OFF Processing Module

END OF ACTIVITY

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Notes Page

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 APPENDIX B: OPTIONAL ACTIVITIES

ACTIVITY - i1000SR SYSTEM FUNCTIONAL TEST

Time to complete: 4 Hours
Debrief Session: 15 minutes

Activity Instructions
In this activity you will:
• Perform key procedure(s) for servicing an i1000SR 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 i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.

Students Perform the following:

† Reassemble Instrument, power ON and initialize to STOPPED status

† Perform M&D 1114 Carrier Transport Calibration

† Perform M&D 1110 Pipettor Calibration

† Perform a START-UP and initialize to READY status

† Perform M&D 3240 BCR Calibration

† Perform M&D 3310 RSH Test (using both sample and reagent carriers)

† Perform M&D 1032 Shutter Test

† Perform M&D 1022 Optics Background Test

† Perform M&D 3540 Temperature Status (Disregard errors Ambient Temperature. Not active at
this time.)

† Perform M&D 5420 Crash Sensor Test

† Perform M&D 3630 LLS Test (on sample position)

(Continued)

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† Perform M&D 3180 Vacuum System Test (test vacuum integrity only)

† Perform M&D 2052 Wash zone Aspiration Test

† Functional Test M&D 4150 can also be performed to test various sub-systems at a system level.

† Perform a RUN initialization

† Load one or more reagent kits and successfully run at least 3 levels of QC on one assay

† Troubleshoot any errors encountered

END OF FUNCTIONAL TEST ACTIVITY

END OF MODULE

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 APPENDIX

ARCHITECT i1000SR SYSTEM

APPENDIX C - REFERENCE

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Notes Page

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 APPENDIX C: REFERENCE

CLI COMMAND REFERENCE

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 i1000SR 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
i1000SR Service and Support Manual, Section 5.

To perform a CLI Command:

1. Log on as an FSE

2. Select SYSTEM Icon

3. Select DIAGNOSTICS

4. Select M&D 6200 CLI Terminal Simulator

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 i1000SR Processing Module use the command: SET_MODULE 1

On the ci4100 for the i1000SR Processing Module use the command: SET_MODULE 2

For the RSH use the command: Set_MODULE 0

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General CLI Commands

Set Module Command

SET_MODULE X X = 1 (for Standalone i1000SR PM), 0 (for RSH), OR
2 (for integrated iPM)
Required to set correct model before running specific CLI
Commands

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

EIEIO Commands EIEIO commands are used for indexer boards

EIEIO X read Returns 0 for inactive, 1 for active
EIEIO X set 0 / 1 Sets the bit to active / or inactive

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)

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Fluidics CLI Commands

DIO 25 SET X turns vacuum pump on (1) or off (0)

VACUUM ON / OFF turns vacuum on or off

Optics CLI Commands

OPTICS PMT X X = 1 to turn ON PMT, 0 to turn OFF PMT
READ X Y X = time interval between sub reads (msec)
Y = number of reads to take

Useful for optics background troubleshooting:

OPTICS PMT 1
READ 100 10 (See note below)
OPTICS PMT 0

This command will return 10 sets of numbers - obviously 10 sets 0’s are bad. The
numbers represent background readings with an empty RV.

Useful for inspecting light tightness:

SHUTTER_MOVE CLOSE
OPTICS PMT 1
READ 100 10
OPTICS PMT 0
SHUTTER_MOVE OPEN

Power CLI Commands

DIO 37 set 1 Enters maintenance mode and disables 36VDC
DIO 37 set 0 Disables maintenance mode and re-enables 36VDC

DIO 24 set 0 Turns Power Supply Off

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LLS CLI Commands

LLS 0 Enable
LLS 0 Disable

Get_ LLS_DATA 0
Used for troubleshooting LLS frequency issues
For i1000SR 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)

*Threshold value is normally set to 100 for sample pipettor

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.

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Process Path (PP) CLI Commands

PROC_PATH X X = number of locations to move (1-23)
Moves the track X positions relative to the current
position in a counter clockwise direction.

PROC_PATH_MOVE X Y X = process path location number (1-23)

Y = station location

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

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Initialization CLI Commands

MOD_COMP_INIT X X = Specific component

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

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Temperature CLI Commands

TCB BOARD_STATUS Returns all board status information
Normal status: all values = 0

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)

TCB CHAN_STATUS X Returns channel information for channel X

X = channel (0-31, 32=all)

The CHAN_STATUS returns thirteen columns of information about a given channel.

The information appears on a single line (32 lines when all channels are specified), with each column
separated by a space.

CHAN_Status Column Descriptions:

channel number ( 0 - 31)
channel type 0 = reference, 1 = monitor, 2 = control, 3 = WAM
on/off state 0 = channel off, 1 = channel on
temperature Integer temperature, in thousands of a degree (6 characters)
high alarm limit Integer temperature, in thousands of a degree (6 characters)
low alarm limit Integer temperature, in thousands of a degree (6 characters)
alarm on/off state 0 = channel off, 1 = channel on
alarm pending 0 = no alarms pending, 1 = alarm(s) pending
alarm count number of samples which had alarm conditions
set point the PID temperature set point
heater ticks the current heater tick count (0 - 960)
heater on ticks output of PID determines how many ticks the heater needs to be on (0 - 960)
heater period ticks the number of ticks in the heater update period (960)

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Key Procedures:
Procedure FUNCTION

M&D 3630 LLS Test

M&D 3120 Vortexer Test

M&D 4150 Functional Area Test

M&D 1109 Wash Cup Pre Alignment

M&D 1110 Pipettor Calibration

M&D 2052 Wash Zone Aspiration Test

M&D 2137 Flush Fluids

M&D 2160 Prime Wash Zone

M&D 2162 Prime Trigger/Pre-trigger

M&D 3180 Vacuum System Test

M&D 5420 Crash Sensor Test

M&D 3002 Reagent Carousel Test

M&D 1022 Optics Background

M&D 1032 Shutter Test

M&D 1047 Optics Verification

M&D 5700 Fuse status

M&D 5716 Turn 36VDC off and on

M&D 5150 Motor Tests

M&D 5160 Pump Motor Tests

M&D 3002 Reagent Carousel Test

M&D 3850 PC Board Test

M&D 3540 Temperature Status

END OF MODULE

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