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I1000 SR Differences Field Service Training Guide
I1000 SR Differences Field Service Training Guide
I1000 SR Differences Field Service Training Guide
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
206039-101 NOV 2009 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, i2000SR, c8000, ci8200, and c16000 are registered trademarks of Abbott Laboratories
in various jurisdictions.
c4000, ci4100, cSystem, iSystem, ARCHITECT ARM, and FlexRate are trademarks of Abbott Laboratories
in various jurisdictions.
All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories, its
subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade dress, or product name may be
made without the prior written authorization of Abbott Laboratories, except to identify the product or
services of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the
property of their respective companies. All rights reserved.
Except as permitted above, no license or right, express or implied, is granted to any person under any patent,
trademark, or other proprietary right of Abbott Laboratories.
This guide was developed and produced by U.S.Commercial Training in Irving, TX.
Copyright 2009 Abbott Laboratories, Abbott Park, Illinois.
CONTENTS
Module 2: RSH........................................................................................................2-1
Module 5: Troubleshooting...................................................................................5-1
Goals
Upon completion of the training program you will be able to:
2. Use diagnostic tools and interpret troubleshooting data to isolate the root cause
of failure.
Note
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.
Activity
The clock icon appears along with an activity header to identify a
student activity.
Notes HAZARDS
The ARCHITECT i1000SR System has been designed for optimal operator safety.
However, this does not reduce the importance of safety awareness where hazards
exist. Standard warning conventions, including hazard signal words and symbols
are described below:
Wear appropriate personal protective equipment (PPE) such as gloves, lab coat, and
protective eyewear when working in the Lab Environment.
Dispose of all biohazardous materials in accordance with local, state, and federal
regulations governing the treatment of regulated medical waste. Dispose of sharps
(e.g. probes, needles, broken glass, and slides) that are contaminated with potentially
infections materials in an appropriately labeled, puncture-resistant, and leak proof
container.
CAUTION: Class 2 Laser Warns against direct viewing into the bar code laser beam or
Radiation reflections from the beam.
Avoid eye exposure to laser light.
WARNING: Probe Stick Identifies the possibility of puncture in noted activity or at posted
Hazard location.
Identifies an activity that may present a safety related hazard, and advises the Operator to consult
caution/warning instructions. Examples Include:
CAUTION: Lifting Hazard Identifies an activity where one may be required to lift or move a
heavy object. Obtain assistance when moving and/or use appropriate
lifting devices.
CAUTION: Moving Parts Identifies an activity or area where moving parts are present.
WARNING: Chemical Identifies an activity or an area where hazardous chemicals are
Hazard present. Refer to the Material Safety Data Sheet (MSDS) or package
insert for specific safety information.
WARNING: Splash/Spray Identifies where fluids may be under pressure.
Hazard
DANGER! High Voltage Identifies high voltage areas over 600 volts.
Note: Card Cage Ground Identifies the location on the card cage where the ground strap is
clipped.
Indicates that the material has Toxic (T) or Very Toxic (T+)
properties.
Indicates that the material has Dangerous for the environment (N)
properties.
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.
Notes
Training Agenda
The organization of the training program is focused on the differences of the
i1000SR as compared to other ARCHITECT iSystems along with common service
procedures.
Topic Content
PRE- Completion of ARCHITECT iSystem (i2000SR) FS Training
REQUISITE Required prior to attendance in class.
Introduction • Class Introduction Day 1
• System hardware overview activity
• Basic Operation activity
• Service resources and AbbottLink activity
RSH • RSH Overview Day 2
• RSH Hardware Overview and Activity
Preventative • Perform an instrument PM
Maintenance
Installation • Installation review and activity Day 3
Miscellaneous • Optional Service Activities
Troubleshooting • Troubleshooting Repair Scenarios Day 4
• Final Exam
• Class Evaluation
END OF MODULE
Notes Page
OBJECTIVES Notes
After completing this module, you should be able to:
Notes INTRODUCTION
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 system has many similarities, and some differences, with other ARCHITECT
systems.
The system consists of the i1000SR Processing Module, the Robotic Sample Handler
(RSH), and a separate System Control Center (SCC) for initiating and monitoring
operations.
System Control
Center
Processing Module
It processes up to 100 CMIA 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 and provides stat processing.
Notes
Activity - Hardware
Activity Instructions
During the debrief sessions, use the service notes section within the activity tables to
document additional service information, provided by the instructor.
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
CPU (central Same • Houses the microprocessor and other • SCC drive configuration
processing unit) & computer components. varies per SCC platform.
Different
Drives New Depending on style of drive it may be used
• Floppy Drive for one or more of the following functions:
• DVD/CD-RW Drive • Collect system logs
• USB Flash Drive • Import and export assay files
• Backup software database
• Upgrade system software
• Import QC and calibration data
Network hub and Same • Provides connection between the SCC • SCC rear panel provides
CPU back panel and modules for information exchange. access to the SCC CPU
Different
back panel connectors.
New
• Note 220 VAC Power Strip.
(Continued)
Unload Diverter
CMIA Optics
Pre-trigger/Trigger Manifold
Wash Zone Inlet Diverter
Vortexer 1
Wash Zone Outlet Diverter
Pipettor
Wash Cup
Process Path Same • Machined circular assembly that has • Heaters are mounted to the underside of
Track w/Heater Different two channels or tracks. the assembly.
• Provides the incubated environment - All heaters use DC voltage
New - 1 pad with 3 independent zones
for the reaction process to occur.
• Provides access points for various sub • Three thermistors embedded in the
assemblies to perform steps involved assembly measure the process path
in the assay sequence and reaction temperature.
process. • Two replaceable magnets mounted in the
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 Same • Supports and guides the RVs as they • Rotated by the process path motor.
Disk are moved to various locations.
Different • An optical home sensor is used as an
New • 23 RV positions. absolute reference point during the
• Indexes one RV position every 18 process path disk homing operation.
seconds, in a counter-clockwise - home reference can be at any one of
direction. the 23 RV locations.
- 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.
(Continued)
Unloader Same • Molded plug that acts as a passive • Can be removed and reinserted upside
diverter. down, allowing RVs to bypass waste unload
Different
• RVs unloaded from Process Path and continue in process path track during
New designated M&Ds or troubleshooting.
and discarded into solid waste.
• 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 Same • Unloads RVs used for • Solenoid controlled.
Diverter pretreatment, or sample dilutions,
Different • Power: 36VDC from DC Driver I/O board.
from the inner track to the solid
New waste container. • "On" sensor signal returns to module
controller board while "off" sensor signal
- It is used in all pre-treatment
returns to CMIA optics board.
protocols and some sample
dilution assay protocols • All power and sensor signals are routed
through processing center distribution board
Wash Zone Same • Directs RVs into the Wash Zone • Solenoid controlled.
Inlet Diverter outer track or keeps the RVs in the
Different • Power: 36VDC from DC Driver I/O board.
inner track.
New • "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 Same • Directs RVs into the inner track or • Solenoid controlled.
Outlet Diverter keeps them in the outer track.
Different • Power: 36VDC from DC Driver I/O board.
- Used during 2-step assays to
New • "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.
RV Access Same • Used for diagnostic purposes only. • Used during M&D 2052 Wash Zone
Door Different • Allows access to one position on Aspiration Test.
New outer track.
(Continued)
1-8 ARCHITECT i1000SR Differences FS Training Guide
FOR ABBOTT INTERNAL USE ONLY 206039-101
System Overview
Unload Diverter
CMIA Optics
Pre-trigger/Trigger Manifold
Wash Zone Inlet Diverter
Vortexer 1
Wash Zone Outlet Diverter
Pipettor
Wash Cup
Vortexer Same • Mixes the reaction mixture. • Motor power: 36VDC from DC
Driver I/O board.
Different
• Up/down sensor signals return to
New 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 routed through the Processing
have been dispensed, at RV position Center Distribution board.
3, before incubation period
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.
(Continued)
ARCHITECT i1000SR Differences FS Training Guide 1-9
206039-101 FOR ABBOTT INTERNAL USE ONLY
System Overview
RV Loader
Syringe Pre-trigger/Trigger Manifold
Wash Cup Same • Active Wash Cup used to wash • Outer waste well contains removable insert
pipettor probe during the aspiration called a baffle.
Different
and dispense cycles. - baffle can be removed for cleaning
New
• A block manifold with three • Central well has a threaded insert that can
solenoid valves and two wells: be removed for cleaning.
- outer oblong well is waste well
• Solenoid Valves are connected to Vacuum:
- central circular well is main - S1 - Upper Solenoid Valve
wash well
- S2 - Outer Drain Valve
- S3 - Inner Drain Valve
Wash Zone Same • Dispenses heated wash buffer and • During the CMIA wash process:
Manifold removes and discards unbound - 3 dispense nozzles and 3 valves
Different
Assembly analyte. dispense heated wash buffer into RVs
New
• Comprised of: - wash assembly lowers probes into RVs
- 3 dispense nozzles - wash aspirate probes aspirate waste fluid
- 4 valves (Blue collared valve is using vacuum
for flushing)
- 4th valve flushes and primes manifold,
- 3 wash aspirate probes and Bypass line to waste
tubing
• Wash Assembly: 36 VDC stepper motor.
- wash assembly
• Manifold valves: 36 VDC.
(Continued)
1-10 ARCHITECT i1000SR Differences FS Training Guide
FOR ABBOTT INTERNAL USE ONLY 206039-101
System Overview
Trigger Pump Same • Moves trigger reagent from on- • 36 volt DC stepper motor.
board reservoir to trigger dispense
Different • Displacement 200 µl / rev. (100 µl/head)
manifold and valves.
New Flow rate 0.8 ml / sec.
• Double headed FMI pump.
• Motor Driver #2.
• Located on left side of processing
• CMIA Optics board (home I/O).
area.
• Indexer #2 (motor limit and home sensor).
Pipettor Same • Controls the aspiration and • Syringe plunger is driven by a 36VDC
Syringe dispensing of samples and stepper motor.
Different
Assembly reagents.
New • Sensor board for home positioning and
• A syringe valve controls buffer flow valve control.
to the syringe. • Syringe valve: 36 VDC.
• Locking mechanism to hold in place.
(Continued)
Notes Page
(Continued)
• RVs loaded in real time as needed • Picker arm installed at system installation
meaning on each startup RVs are (ensure orientation is correct and screw is
dumped and 23 RVs reloaded. tight).
• 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
(Continued)
(Continued)
Reagent Cooler
Reagent Carousel
Reagent Carousel Same • An insulated chamber that houses • Sensor monitors reagent carousel
Area both the reagent carousel and area cover.
Different
reagent cooler. - If the cover is opened, the system
New software will initiate the unloading
of all reagent carriers currently
loaded on reagent carousel
because there is no Barcode
Reader.
Reagent Cooler Same • Maintains the reagent carousel • Thermo Electric Device (TED).
area at the correct temperature by
Different • +17.5VDC from Heater Controller Bd.
providing and circulating chilled
New air. • Mounted on instrument base, inside
the reagent carousel area
- A handle is provided to lift cooler
out of reagent carousel area
(Continued)
1-14 ARCHITECT i1000SR Differences FS Training Guide
FOR ABBOTT INTERNAL USE ONLY 206039-101
System Overview
Reagent Same • Sliding door that moves on a linear • Two through-beam sensors:
Access Door bearing, driven by a gear assembly - One sensor is home position, when
Different
connected to a motor. door is closed.
New
- The other sensor is door open position.
• 24VDC stepper motor, Motor Driver #1.
• Pin must be lubed on PM.
(Continued)
Front View - Supply and Waste Center and Card Cage components
The supply and waste center is the onboard storage area for bulk solutions and waste.
Component Comparison Function/Description Notes
• Figure Components:
1. Pre-trigger/Trigger storage
6
area
1 2. Wash Buffer storage area
3. Waste storage area
4. Card Cage
4
5 5. CPU
2 6. Cooler Fan
3
Pre-trigger/ Same • Provides onboard storage for Pre-trigger • Same Heater use for both
trigger storage Solution and Trigger Solution. Trigger and Pre-trigger near
Different
area - Pre-trigger/trigger tray manifold on Process Path.
New
- Trigger level sensor: magnetic float • Pre-trigger Pump
sensor indicates when the liquid level is
• Trigger Pump
low.
- Pre-trigger level sensor: magnetic float • 2 FMI pumps located behind
sensor indicates when liquid level is low. tray are for Wash Zone and
Pipettor buffer dispense.
(Continued)
1-16 ARCHITECT i1000SR Differences FS Training Guide
FOR ABBOTT INTERNAL USE ONLY 206039-101
System Overview
Card Cage Same • Houses the system control (logic) • Receives voltage from Power
and driver (power) boards. Supply connection to card cage
Different
backplane.
New • Six Logic Boards (Bd):
- Indexer 1 and 2 • Minimum board configuration
required for instrument boot-up and
- LLS/PM
initialization to snapshot screen
- CMIA Optics are:
- Temperature Controller - Module Controller
- Module Controller - CMIA Optics board
Power
Supply
Power Supply Same • Generates the required voltages for • Self-contained unit:
the i1000SR system. - 8.5A at 220 VAC / 16A at 110 VAC
Different
• Power Supply connects to card cage • Auto-selecting no voltage configuration
New
backplane through a single direct required.
Card connector, and supplies the various
• Field-replaceable fan.
Cage DC voltages to the card cage boards.
Fans • No field-replaceable fuses in power
supply.
• LEDs display voltage status information.
Card
Cage • Alignment with card cage is critical.
Backplane • "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
PS
- Disable type DIO 37 SET 0
- M&D 5716
(Continued)
RSH
Distribution
Board
Vacuum Same • Removes buffer waste from wash cup. • System Software Tracks Usage.
System Different • Aspirates liquid from RV at Wash Zone • Waste Pump turns on & drains
during CMIA wash process. Vacuum Accumulator when
New
• Removes liquid waste from Pre-trigger, reaches 225ml waste.
Trigger and Wash Zone prime / flush • 36VDC Waste Pump.
bypass lines.
15PSI
Waste Lower Waste Waste Pump (peristaltic)
Pressure Manifold
Switch
END OF ACTIVITY
Notes Page
Note: the displayed software view is dependent on Processing Module configuration and software version
Note: the displayed software view is dependent on Processing Module configuration and software version
Prepare Reagents
1. Invert a new microparticle bottle gently 30 times to resuspend microparticles that
may have settled during shipment. Inspect the bottle to ensure microparticles are
resuspended. If microparticles still adhere to the bottle or cap, continue to invert
the bottle until the microparticles have been completely resuspended.
DO NOT USE if microparticles do not resuspend.
2. Open the reagent bottle and discard the white cap.
3. Check each bottle for bubbles. If bubbles are present, remove them with a clean
applicator stick.
4. (Wear clean gloves to prevent contamination before handling septums) Squeeze
septum gently in half to confirm that slits are open, then snap a septum onto the top
of each reagent bottle.
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.
3. 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.
(Continued)
Notes 4. Print the Order List report to ensure that samples are loaded in the correct C/P
(carrier/position).
NOTE: This step is optional when using bar code labels on samples
for positive ID.
Bar Code
labeled tubes Sample Cup
1400 μL
500 μL
125 μL
Carrier
Bar Code ID Sample Gauge Label
Front View
Type: Type:
• C (Carrier ID) • C/P
• P (Position) • SID
Initiate Run on PM • SID (Sample ID)
• SNAPSHOT
• PM Graphic
• F8 RUN Select: Select:
• Assay(s) or Panel(s) • Assay(s)
• F5 ADD OPTIONS
- Replicates
Initiate Run on RSH - Dilutions Select:
• SNAPSHOT • F3 ADD ORDER
• F5 Assay Options
• RSH Graphic
• F8 RUN
Choose:
• Single Analyte
Add Patient and /or • Multiconstituent
Control Orders - Control Name
Select:
• Control
• Control Lot Number Select:
Load Samples in RSH Carriers • Control Level( s)
• ORDER LIST REPORT
• Assay(s) or Panel(s)
• DONE
• F2 ADD ORDER
Note: Steps may vary slightly depending on software version utilized. These are for ARCHITECT software version 6.0.
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.
Upon run completion, review patient and QC results, rerun and/or release.
Notes
Activity - Operation
Activity Instructions
Resources Needed
(Continued)
4. 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 and B-hCG STAT
• Select F5 ASSAY OPTIONS
- Type Calibrator Lot number
- Type Calibrator expiration date
- Select DONE
• Select F2-ADD ORDER
5. Order Controls:
During this activity refer to the table below for the necessary information to complete the control order
• Select ORDERS/CONTROL ORDER
• Select SINGLE ANALYTE
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P)
• Select Assay(s)
• Select Control, Lot, and Levels (Low, Mid, and High)
• Select F2-ADD ORDER
• Repeat for additional controls
NOTE: A Precision Control should exist on the system however, for instructions on how to
configure an control file, refer to the ARCHITECT System Operations Manual, Section
2 System Configuration.
• 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): B-hCG STAT and TSH
• Select Control, Lot, and Level (Precision Control)
• F5 ASSAY OPTIONS
• Enter 10 replicates
• F2 ADD ORDER
(Continued)
7. Once all orders have been placed, print the Order List Notes
• Select Orders
• Select Order Status
• Select F4 Print, Orderlist Report, Done
8. Load Samples
• Verify adequate volume of sample loaded per Order List
• Verify sample placement per Order List
9. Initiate Run
11. Print a QC Analysis Report of the Precision Control for both assays and save for
later.
Notes
Activity Instructions
In this activity you will:
• Participate in discussion on available i1000SR Reference Materials
• Identify the location of the i1000SR TSB Sticker
• Answer activity questions
• Participate in discussion on possible common issues/failures
Resources Needed
(Continued)
(Continued)
2. Where do you find the steps for different Assay Pipetting Protocols
and what protocol is used for TSH?
END OF ACTIVITY
• Basic Operation
- Software differences as compared to other iSystems
- Review of Basic Operation steps
- Loading RSH
- Performance of Precision
- Normal Operation and Sample Progression
• Service Tools
- Available Service Resources and use
- AbbottLink
- Common failures
1. In the table below, list the component that best matched the description or
function shown.
4. What is the minimum number of times the microparticle reagent bottle should
be mixed (inverted) prior to loading on a reagent carrier?
END OF MODULE
Notes Page
OBJECTIVES Notes
After completing this module, you should be able to:
Notes OVERVIEW
The ARCHITECT i1000SR RSH (Robotic Sample Handler) is designed very
differently than the i2000SR and c4000 Systems. It does not contain a Carrier
Positioner and unlike other RSH Systems it is the interface through which reagents
are loaded on the reagent carousel.
However, similar to other ARCHITECT, the RSH uses a Carrier Transport, Bar
Code Reader, and Card Cage Boards.
Also, similar to other ARCHITECT Systems, the RSH is the interface through
which samples are presented to the system for identification and aspiration.
• 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.
• 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 changes back to amber while the sample is re-
aspirated.
Kits are loaded on reagent carriers. 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.
Notes Page
Carrier Transport
Bottle Rotator
Barcode Reader
Sections
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.
Carrier Detection
• 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.
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.
Carrier
Transport
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
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.
The bar code reader mounts to the left support and scans reagent bar codes, sample
carrier ID bar codes and sample ID bar codes.
It provides the interface circuitry between the i1000SR card cage and the following
RSH components:
• Carrier Transport Printed Circuit Board (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
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
Notes Page
Notes
Activity Instructions
Resources Needed
(Continued)
Notes Remove and Examine the Carrier Transport (CT) 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
NOTE: For training purposes NOT all motors, nor all sensors, need to be
tested, select 2-3 to test.
Power ON ci4100.
Now that you’ve completed the RSH Module, you should be able to install, integrate
and troubleshoot the RSH. This included the following items:
• The standalone RSH differs from the c4000, c8000, c16000, i2000SR and
integrated ci4100 Systems.
• RSH samples are presented to the system for identification and aspiration.
- RSH Distribution Board - provides the interface between the Card Cage
and Carrier Transport Board (via the flex chain), bar code signals and
the Load/unload board sensors and LED indicators.
- i1000SR Card Cage Boards that interface with RSH components - CMIA
Optics Board, Module Controller (CPU), Motor Driver, Indexer, and
Card Cage Back Plane.
END OF MODULE
Notes Page
OBJECTIVES Notes
After completing this module, you should be able to:
Notes
Activity - PM
Activity Instructions
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.
Both you and/or 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, run precision run and perform any necessary
repair procedures to return the instrument to a fully functional state.
Resources Needed
(Continued)
PM Notes PM Notes
Items in need of correction/replacement: • Proper Reagent Access Door Lubrication
• Areas demonstrating fluid spills/leaks
• Frayed V-wheels
• Damaged or dirty components
• Bent or cracked tubing
• Clean Manifolds
Pipettor
Wash Cup
(Continued)
3-6 ARCHITECT i1000SR Differences FS Training Guide
FOR ABBOTT INTERNAL USE ONLY 206039-101
Planned Maintenance
Perform Precision Test on B-hCG STAT and TSH compare with results from operation
activity.
Record a brief record of any errors that occurred following PM and their resolution:
Error Resolution
END OF ACTIVITY
Notes Page
Now that you’ve completed the Preventative Maintenance Module, you should be
able to perform preventative maintenance on the i1000SR System. This included the
following items:
• Planned Maintenance Overview
- Performance of PM procedures
- PM kits and tools
END OF MODULE
Notes Page
OBJECTIVES Notes
After completing this module, you should be able to:
Pre-Site Inspection
Installation Notes
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.
Installation consists of, but is not limited to, the procedures listed below:
• Unpacking instrument and all accessories
• Leveling the instrument
• Tubing installation for in-coming water and drains
• Installing probes and mixers
• SCC Hardware and Cabling
• Software installation to include, configuration, calibrations, setup for
system and assay data.
• Verification of all robotics positions
NOTE: Verify ISA and TSB status of instrument and for updates to
procedures.
Notes Page
Notes
Activity - Installation
Activity Instructions
Resources Needed
Read the following tips then Perform M&D 2190 Internal Decontamina-
tion:
- 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.
(Continued)
Now that you’ve completed the Miscellaneous Module, you should be able to install,
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
2. What is the maximum amount of fluid that should be observed in the Vacuum
Accumulator assuming the fluidics system is working correctly?
3. What device inside the reagent carousel area allows the Carrier Transport to
interact with the reagent carousel, and load / unload reagent carriers?
5. Which board does the LLS signal from the Reagent LLS Antenna travel through
to get back to the card cage backplane?
6. Which card cage board does the RV Present Sensor signal return to?
7. If a wash zone valve failed to open and dispense heated wash buffer into an RV
during the CMIA wash process, what error would most likely be generated?
END OF MODULE
Notes Page
OBJECTIVES Notes
After completing this module, you should be able to:
Notes TROUBLESHOOTING
Instrument troubleshooting always begins with use of the Effective Troubleshooting
(STEP) model. The model includes information gathering techniques along with
knowledge about the major systems of the ARCHITECT to aid in the identification
of the root cause of the failure. The STEPS are:
• STOP - Identify/Confirm the Problem
- Categorize Failure
- Group Symptoms into possible sources of failure (i.e. Operator,
Environment, Analyzer {Hardware or Software}, Reagent)
- Group Analyzer symptoms into Instrument systems (Fluidics,
Optics, Robotics, Temperature Control, Power, Circuitry, etc.)
Notes TROUBLESHOOTING
NOTE:Refer to ARCHITECT i1000SR System Service and Support Manual,
ISAs and TSBs, and the Troubleshooting Database for information
Troubleshooting and repairing the ARCHITECT i1000SR System.
Remember to:
• Keep sensors and devices clean
• Lube
• Look for wear; inspect moving parts
• Inspect fittings and connectors
• Listen for unusual noises
• Maintain proper alignment
• Observe fluid level in pumps and syringes
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.)
3. Identify the root cause of the error, perform the repair, then perform the required
verification procedures and return the instrument to a “Ready” state.
4. Be prepared to share your Troubleshooting process with the class including how
you arrived at the solution.
(Continued)
Troubleshooting Activity
The Final Exam will consist of both a practical and question assessment. The
practical assessment will be coordinated by the instructor.
Practical Exam
You will work independently through the problem identifying the information and
procedures necessary to isolate the cause of the error. APPROACH THIS AS YOU
WOULD ANY NORMAL REPAIR. Employ an Effective Troubleshooting process.
After you have completed the repair, perform any necessary procedures to return the
instrument to a fully functional state.
Activity Instructions
In order to complete this exercise you will do the following, as directed by your
instructor:
1. Begin processing specimens. If an error is detected or there is an error state,
stop. Review Troubleshooting reference documentation (ISA, Troubleshooting
Database, Service Manual, Diagrams, etc.)
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.
(Optional)
END OF ACTIVITY
SCENARIO 1 The 36 V LED is not lit on an ARCHITECT i1000SR Power Supply and none of the
36VDC 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?
SCENARIO 2 Upon wrapping up two i1000SR Installations the FSR is performing performance
verifications by running B-hCG and TSH precision studies.
After reviewing the data several samples went to exceptions with Invalid Read Errors
and/or poor precision recovery.
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?
Troubleshooting
The following are tips for troubleshooting failures associated with i1000SR System
END OF MODULE
Notes Page
NOTE: Parts and components on the ARCHITECT System can vary depending on the instrument
manufacturing date and/or replacement of components during service. Always refer to the
ARCHITECT Service and Support Manual, FRUD, and/or ISA/TSB Database for the most
current information.
i2000SR System i1000SR System
OPERATIONS
CMIA assay throughput Up to 200 tests/hour Up to 100 tests/hour (1 Step STAT assays)
ARCHITECT • software • software
commonality • reagents • reagents
• sample carrier • sample carrier
• Flexible Chemiluminescent • Flexible Chemiluminescent
(CHEMIFLEX) technology (CHEMIFLEX) technology
Sampling • Random & continuous access, priority • Random & continuous access, priority
loading loading
- 135 primary/aliquot tubes (35 - 65 samples (Number of Priority/
priority 100 Routine) Routine sections configurable)
• Multiple size tubes (10-16mm W x 75- • Multiple size tubes (10-16mm W x 75-
100 mm H) 100 mm H)
• Liquid level sensing & clot detection • Liquid level sensing & clot detection
Consumable Walk away • Up to 5 hours • 3 Hours minimum
time
Onboard Solutions • Pre-trigger solution • Pre-trigger solution
• Trigger solution • Trigger solution
• Concentrated wash buffer • Concentrated wash buffer
Reagents • To access, must PAUSE the system • Continuous Access to reagents via the
and manually load/unload. Robotic Sample Handler (RSH).
• 25 on board reagents, refrigerated. • 25 on board reagents, refrigerated.
• 100 & 500 test kit sizes. • 100 test kit size.
• Reagent Stability -30 days on board. • Reagent Stability -30 days on board .
Customer Maintenance • 6440 Daily Maintenance • 6440 Daily Maintenance -Tap Water
• 6445 Pipettor/WZ probe cleaning daily • 6445 Pipettor/WZ probe cleaning weekly
• 2190 Internal Decontamination FSR • 2190 Internal Decontamination monthly
performed customer procedure
• 6405 Air filter cleaning weekly • 6405 Air filter cleaning monthly
• 6450 Wash Cup cleaning
Processing Module Status • Nine • Eight (no scanning)
Hardware - STORAGE and WASTE CENTER
Pre-trigger/Trigger Same - compatible Same -compatible
Storage Area • Tray • Tray
• Level Sensors • Level Sensors
Wash Buffer Storage • 25 Liter Wash Buffer Reservoir • 12 Liter Wash Buffer Reservoir
Area
Waste Storage Area • Solid Waste Container • Solid Waste Container
• Optional 10L Liquid Waste Container
Reagent Cooler NOT compatible with i1000SR NOT compatible with i2000SR
• Reagent Cooler • Reagent Cooler
- 200VAC - 17.5VDC
- Replaceable Fan - Replaceable Fan
- Condensation Cooler - Uses Thermoelectric Device (TED)
for cooling
Hardware - OPTICS
Shutter Assembly NOT compatible with i1000SR NOT compatible with i2000SR
• New Design
CMIA Reader Same - compatible Same - compatible
Hardware - FLUIDICS
Vacuum System NOT compatible with i1000SR NOT compatible with i2000SR
• New Vacuum System capable of
generating 27" Hg
Syringes Same - compatible Same - compatible
• 4 Syringes • 1 Syringe
- Sample Pipettor
- STAT Pipettor
- Reagent 1 Pipettor
- Reagent 2 Pipettor
FMI Pumps Same - compatible Same - compatible
• Pre-trigger and trigger pumps • Pre-trigger and trigger pumps
Buffer Pump 50uL Buffer Pump (WZ) Same - 50uL Buffer Pump (WZ) Same - compatible
compatible
Transfer Pump NOT compatible with i1000SR NOT compatible with i2000SR
Distribution boards NOT compatible with i1000SR NOT compatible with i2000SR
• None - i2000SR uses sensor boards • 4 boards located throughout system
- Fluidics Distribution Board
- RSH Distribution Board
- Reagent Distribution Board
- Processing Distribution Board
Other Boards NOT compatible with i1000SR NOT compatible with i2000SR
• Other Boards • Other Boards
- Carrier Transport PCB - Carrier Transport PCB
- Pipettor Board(s) - Pipettor Board
- LLS Antenna Boards - LLS Antenna Boards (3)
SPECIFICATIONS
Power Requirements • Voltage: 200 - 240 ± 10% VAC (176 - • Voltage: 110 - 120 or 200 - 240 ±10%
264 VAC) VAC (99 - 264 VAC)
• Frequency: 50 or 60 Hz (47 - 63 Hz) • Frequency: 50 or 60 Hz Self adjusting
• U.S. with Re-setable circuit breaker • U.S. with Re-setable circuit breaker
- With UPS - 30 amp - 110 volts - 20 amp
- Without UPS - 20 amp - 220 volts - 10 amp
Plug (North America) One i2000SR System: Outlet within 7' (2.1m) of the processing
• NEMA L6-20R (250 VAC, 20A, twist- module:
lock) • NEMA L5-20R (125 VAC, 20A, twist
lock)
• NEMA L6-20R (250 VAC, 20A, twist
lock)
Power Cord Length 15' (4.6 m) 8' (2.5 m)
Rated Power 3000 volt amp (3 kVA) maximum 1760 volt amp (1.76 kVA) maximum
Consumption
Weight 1081 lbs. (490.3 kg) 636 lbs (288 kg)
Size (door entry) Floor Standing 48” H x 61” W x 49” D Floor Model – 49” H x 58” W x 30” D
RSH
Sections NOT compatible with i1000SR NOT compatible with i2000SR
• 13 Routine / Priority sections for loading
samples & reagents
• Priority sections configurable [sections 0
– 7; default 4] /designated by blue LEDs
• 65 Sample load up capacity
Indicator lights • Same Indicator lights • Same indicator lights except an added
blinking amber indicator to show a
reagent carrier is in the process of
unloading to a section
Loading • Sample Carriers in Priority Section • Sample Carriers in Routine and Priority
• Carrier Trays in Routine Bays sections
• Reagent carriers used to transport
reagent
Status Types Same Same
RSH Card Cage NOT compatible with i1000SR NOT compatible with i2000SR
• Separate RSH Controller Board • NO separate Card Cage for RSH or RSH
Controller Board
END OF MODULE
Test Status
The test status information is displayed on most 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.
Scheduled • Sample was scanned by the bar code reader. • Add Comment
• Test has been assigned to a processing module.
• Aspiration has not occurred.
In Process • Batch Order - the sample labeled with the starting • Add Comment
SID of a 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.
*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
Result Flags
When reviewing Results, flags may appear to alert the operator to a particular condition regarding the
sample result. These flags, abbreviations or symbols, may appear on the flag column in the RESULTS
screen. The table below identifies result flag along with a description of the alert condition.
Flag* Description
CNTL* • The result was calculated after the quality control failed for the same control
name and control level
• Flag will continue to appear on subsequent results until the failed quality control
result is rerun and the result is within acceptable limits
• Control result out of range as defined in control parameters under
CONFIGURATION/CAL-QC SETTINGS
NOTE: Only Westgard rules configured as a failure produce a CNTL flag for a
patient result.
EDIT • Result manually edited by the operator and was not calculated by the system
(cSystem)
A#1 • The result was calculated using the only read, out of all reads in the main read
(cSystem) window, with measured absorbance within the defined absorbance range
• This condition can occur when the result concentration is high or the sample is
lipemic
A#2 • Result was calculated using only two reads, out of all reads in the main or flex
(cSystem) read window, with measured absorbance within the defined absorbance range
• Condition can occur when the result concentration is high or the sample is
lipemic
FLEX • Result was calculated using the read data measured during the flex read time
(cSystem)
PSHH • Result may be affected by the ICT sample that was measured immediately prior
(cSystem to this sample because the result of the previous sample was above the extreme
ICT assays) range
• Rerun sample to verify that there was no effect
*These flags are carried over from a constituent result to a calculated result.
**If the operator has not defined extreme or normal ranges in the assay settings, the system will not check
for these flags.
QC Result Review
QC Summary
Maintenance
QC-CAL Levey-Jennings Graph Diagnostics
Calibration Status
SYSTEM System Logs
Calibration History
Configuration
Stored QC Results Utilities
QC Results
To Do
Daily
Weekly
Monthly
Quarterly
Reaction Mechanisms
As Needed
Pipettors
Maintenance Fluidics /Wash
Syringes /Pumps
Bar Code Readers
Diagnostics Modules
Solenoids /Sensors
Fuses/Motors
Optics/Temperature
Carousels
Precison
ICT
Utilities
Other
Temporary Message Log
System Log Message History Log
Software Update
SYSTEM
Sample Ordering
Host-Release Mode
Reports - Printing
Reagents -Supplies
System Settings Password
System Control Center
Modules
Configuration
Sample Handler
Sample Bar Code Reader
Serial Ports
QC Single Analyte
QC-Cal Settings QC-Multi Constituent Analyte
Bar Code SID
Westgard Rules
*FSR LOGIN ONLY
Calibrator Settings
Note: Menus and submenus may vary depending on software version utilized These are for ARCHITECT software version 6.0.
Control Reports
The operator has 2 screen options to obtain PRECISON DATA on configured controls:
• QC Reports
• QC Summary
The QC Report provides only a printed copy of QC data once the assay, control level(s) and lot are selected
on a configured control.
The QC Summary screen provides displayed QC statistics on all configured controls. Selected data may be
printed (F4) or displayed as a Levey-Jennings graph (F7).
Actual Expected
Notes Page
Calibration
Single analyte calibrators are used on an i System. Refer to the assay-specific package insert to identify the
calibrators used for each assay.
Calibration Ordering
NOTE: Assay calibration parameters must be entered (configured) into the system
prior to the performance of a calibration. For additional information refer to
the ARCHITECT System Operations Manual, Installation procedures and
special requirements; System Configuration.
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 calibration curve has expired
• The ARCHITECT System is installed
• The Hard Drive is replaced on the ARCHITECT System and the assay and system files have not been
backed up
Notes Page
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 the only FRU – the fan is the same as the card cage fans – use the existing
FRU fan repair kit.
• Alignment of power supply with card cage connector is critical for proper operation.
RV Loader
RV Loader provides onboard storage of RVs and orients and inserts RV into the inner track on process path.
It is comprised of:
• Upper Hopper - holds up to 125 RVs
• Lower Hopper
- 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
Service Tips:
• Picker Arm screw may come loose if not properly tightened during Installation.
Reaction
• 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 the immune complex.
1. The RV is indexed to the Pre-trigger dispense position, where Pre-trigger is added. The RV is vortexed.
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
Service Tips:
• Shutter spring may easily dislodge if service personnel hand is in location during instrument
service.
• All Optics will be "dry-calibrated" at factory. No field normalization procedure.
Notes Page
Sample Progression
Many different sample processing activities take place between sample aspiration and the final read. These
activities are carried out by multiple components located around the process path. The process path
movement and the position of the components allow each reaction activity to occur at a specified time and
location. Depending on the type of protocol, assay processing steps occur at different positions on the
process path.
Depending on the assay, there are basically two types of sample progression on the i1000SR. One is a one-
step assay, the other is a two-step.
• A one-step assay is a method of sample processing in which the sample and all required reagents
are added prior to washing the microparticles.
• A two-step assay is a method of sample processing in which the sample and some reagents are
added prior to washing the microparticles. The conjugate reagent is added after the microparticles
are washed.
There are more than one type of one-step and two-step assay protocols. There are also assay that require
the use of a pre-treatment protocol. These protocols vary in the amount of time that is needed for
incubation and therefore the total processing time required. One-step and two-steps assays also have a
STAT protocol for faster processing.
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 temperature subsystem consists of the following components:
• Temperature Controller Board
• Fans
• Two Card Cage Fans
• Power Supply Fan
• Reagent Cooler Fan
The Temperatures devices are controlled through a control loop between temperature monitoring
thermistors, the Temperature Controller Board and the Heater Cooler Board.
Dispense of wash solution and its subsequent aspirations from reaction vessels are essential steps in the
assay protocol.
Wash Sequence:
The following is an overview of the events that occur during a normal Wash Zone cycle.
The Wash Zone Magnet pulls the microparticles to the side of the RV and keeps the microparticles from
being aspirated out of the RV during the wash.
In the next position another two washes are performed on the RV:
• WZ Probe 2 aspirates the buffer and the WAM value is recorded and checked by software
• 1mL of warm buffer is dispensed via valve 3
• WZ Probe 2 aspirates the buffer and the WAM value is recorded and checked by software
• 1mL of warm buffer is dispensed via valve 3
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
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 iSystem Service and
Support Manual. When reading a WAM Log consider the following:
• Heating is performed by Buffer Heater and controlled by Temperature Controller Board
• Temperature is monitored by thermistor in Wash Zone Probe Tubing
• Maximum temperature is from warm Wash Buffer read during aspiration
• Subsequent cooling magnitude (Temp.) is measured as air passes over thermistor
• Temperature entries in the log are reported in degrees Celsius
• Temp. readings greater than 1.25 are expected (1250)
NOTE: Wash Station #2= Wash Zone 1, Wash Station #3= Wash Zone 2
Probe 1
Max. Temp
|74209|28150|7970
Diagnostic Information:
• Loose tubing effects WAM readings as it may let air seep in
• Tubing of an incorrect length can effect the timing
• Microparticles should form a small line on the side of the RV
• Three consecutive WAM errors will result in a failure and 1 exception instance
• Buildup on thermistors can cause errors. Clean as needed using M&D 6043 WZ Probe Cleaning -
Bleach
• When Troubleshooting WAM errors:
- Check Probe for clogs
- Verify tubing integrity and correct connections
- Check valve function (M&D 2006 and 2007 Wash Zone Checks, and 2050 Aspiration Test)
- Check thermistors
- Verify Vacuum System integrity
- Ensure Daily Maintenance is performed
FLUIDIC SUBSYSTEM
The Fluidics subsystem is responsible for the movement of buffer, reagents and liquid waste throughout
the ARCHITECT i1000SR System. Fluidics Subsystems include:
• Vacuum System and Liquid Waste
• Buffer Delivery System
• Wash Cup
• Syringe
• Trigger/Pre-trigger Delivery System
• Liquid Level Sense and Pressure Monitor
Fluidics Diagram
Fluidic Sensors
Vacuum System
The vacuum system is used to:
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.
4. System Software tracks usage. 225ml waste in vacuum accumulator, waste pump turns on & drains
vacuum accumulator. Level sensor backup.
24VDC
36VDC
36VDC 24VDC
36VDC
36VDC
24VDC
Notes Page
NOTE:Note: S3 is only used during initialization to completely drain central wash well
Side View
Top View
Syringe Components
Components Function/Description
• Fluid Vessel • Clear molded plastic that accepts piston and valve
• Sealed in the factory
• Piston • Lubricate drive shaft
• Stepper Motor • Motor Driver Board
• Home Sensor Board • Replaceable
• Indexer Board receives sensor signals
• Valve and O-Rings • Normally Closed
• Blue label on valve
• O-Ring for valve port
• Valve removed and replaced using a torque wrench for proper tensioning
• DC Driver I/O Board for valve control
Stepper Motor
Piston
Fluid Vessel
Syringe
LLS
Antenna
Reagent
LLS
Antenna
Process
Path
Cover
Power Supply
24VDC
36VDC 36VDC
Key Procedures:
Procedure FUNCTION
DIO Commands DIO commands are used for controller or optics boards
DIO X read Returns 0 for inactive, 1 for active
DIO X set 0 / 1 Sets the bit to active / or inactive; such as power supply commands
Motor Commands
HOME X Y Homes a motor (X) for (Y) steps
OMS X JG Y Homes a motor (X) at a constant velocity (Y)
OMS X MR Y Moves a motor (X) a set number of steps (Y) from current position
OMS X MA Y Moves a motor (X) to an absolute step number (Y)
Solenoid Commands
SOL X SET Y Actuates or retracts solenoid number (X):
(Y) = 1 to actuate or 0 to retract
SOL X READ Returns a value of 0 (off) or 1 (on) for solenoid number (X)
Notes
Fluidics CLI Commands
DIO 25 SET X turns vacuum pump on (1) or off (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.
Notes
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)
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.
Notes
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
Notes
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
Notes
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)
END OF MODULE
Notes Page
MAINTENANCE ACTIVITY
Time to complete: 30 minutes
Debrief Session: 5 minutes
Activity Instructions
Resources Needed
• ARCHITECT iSystem, onboard solutions, accessories, and consumables
Procedures for these activities can be located in the ARCHITECT System Operations
Manual, Section 5 Operating Instructions and/or the on-line ARCHITECT Operations
Manual.
Notes Page
Activity Instructions
In this activity you will:
• Verify adequate Supply and Reagent inventory is present for activity
• Set Processing and Sample Handler Modules into Running Status
• Perform Sample analysis
• Print QC Reports
WARNING: Potential Biohazard. Follow biosafety practices.
CAUTION: Chemical Hazard.
Resources Needed
• System Reagents and Single Analyte Controls
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.
3. Order Controls:
(Continued)
Once the run is started, please return to classroom for further training regarding result status, flagging and
control evaluation.
9. Be prepared to discuss result and control data during activity debrief session.
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.
(Continued)
3. Order Calibration:
• Select ORDERS/CALIBRATION ORDER
• Select Carrier
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P)
• Select Assay(s)
- TSH and B-hCG STAT
• Select F5 ASSAY OPTIONS
- Type Calibrator Lot number
- Type Calibrator expiration date
- Select DONE
• Select F2-ADD ORDER
(Continued)
4. Order Controls:
During this activity refer to the table below for the necessary information to complete the control order
• Select ORDERS/CONTROL ORDER
• Select SINGLE ANALYTE
• Type in the Carrier Bar Code ID Number (C) and an unused Position Number (P)
• Select Assay(s)
• Select Control, Lot, and Level
• Select F2-ADD ORDER
• Repeat for additional controls
NOTE: The Precision Control was created earlier during this Configuration Activity.
6. Once all orders have been placed, print the Order List
7. Load Samples
• Verify adequate volume of sample loaded per Order List
• Verify sample placement per Order List
8. Initiate Run
10. Print a QC Analysis Report of the Precision Control for the B-hCG STAT assay.
Notes Page
Activity Instructions
In this activity you will:
• Perform key voltage measurement procedure(s)
• Locate and evaluate measurement data against voltage specifications
• Locate key circuitry 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 System Service and Support Manual for additional
information on performing the procedures in these activities.
Perform M&D 6200 Terminal Simulator and initiate the CLIA command below
NOTE: must be logged in as FSR
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?
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Remove the Power Supply R&R L1.01 (leave PS out of instrument until directed to replace)
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
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?
____________________________________________________________________
(Continued)
Section 2 Hyperterminal
Power ON the Processing Module & Initialize Processing Module to READY
Connect Laptop to J38 on i1000SR card cage. Open Laptop HyperTerminal & observe initializa-
tion sequence
a. Select, Start, All Programs, Accessories, Communications
b. HyperTerminal, Type name for HyperTerminal i.e. Test Terminal 1
c. Select OK,
d. Select Com 1 under Connect Using
e. Select Configure
f. Select baud rate = 9600, Data Bits = 8, Parity = none, Stop Bits = 1
g. Flow Control = None
h. Select Apply
i. Select OK
Press the 2 reset switches on the Module Controller Board simultaneously. What happens?
_______________________________________________________________________
_______________________________________________________________________
Section 3 Procedures
Perform the following M&D’s:
5720 fuse status
3850 PC board test
4150 Functional Test Areas (Inform students of troubleshooting benefits)
5716 turn 36V off and on (this is a M&D procedure that enters Maintenance Mode without the
need to use CLI commands)
Notes Page
Activity Instructions
In this activity you will:
• Perform key procedure(s) for servicing the optics components
• Interpret optic diagnostic and maintenance procedures
This is a tiered activity. The Tier directs what portions of the activity you should perform based on your
prior service training and experience.
• Tier 1 - all students
• Tier 2 - only students directed by instructor
Resources Needed
Refer to the ARCHITECT i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
Perform M&D 1032 Shutter test and listen for shutter solenoid actuation
(Continued)
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 iPM
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
9. How much difference was seen between the results in step 6 vs step 8?
_______________________________________________________________________
_______________________________________________________________________
(Continued)
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
Notes Page
Activity Instructions
In this activity you will:
• Perform key removal and replacement procedures
• 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.
Notes Page
Activity Instructions
In this activity you will:
• Perform key procedure(s) for servicing Temperature and Reagent Carousel Area components
• Perform key M&D procedures
Resources Needed
Refer to the ARCHITECT i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
Identify Carousel Motor Release Lever and disengage motor by turning counter-clockwise; con-
firm by spinning carousel freely in v-wheels
Locate and remove one each of the Carrier Slide & Retaining Spring (R&R D1.01)
Remove Reagent Carousel Motor Assembly (R&R D1.01) from housing without disconnecting;
then reseat
Remove Dispersion Gear Ring (R&R D3.01, set aside without disconnecting cable connectors)
(Continued)
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 .
Activity Instructions
In this activity you will:
• 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 i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
Fluidics function
Perform “as required” Maintenance FLUSH FLUIDS 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 3180 Vacuum System Test, and test Vacuum Integrity
(Continued)
CLI Commands
Perform M&D 6200 Terminal Simulator and initiate the CLIA commands below.
NOTE: must be logged in as FSR
Fluidic Components
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)
Locate the Wash Zone (WZ) Assembly and remove the 3 WZ probes (put carefully aside)
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 the removal of the Syringe assembly but DO NOT
remove.
(Continued)
Trace the condensate drain tubing from the Reagent Cooler to the Lower Waste Manifold
Locate and Identify the condensate filter
Notes Page
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.
Perform M&D 3310 RSH Test, using both sample and reagent carriers
(Continued)
Activity Instructions
In this activity you will:
• Perform key procedure(s) for servicing the Process Path and Pipettor
• Perform key M&D procedures
WARNING: Potential Biohazard. Follow biosafety practices.
WARNING: Splash/Spray Hazard.
CAUTION: Moving Parts.
WARNING: Probe Stick Hazard
Resources Needed
Refer to the ARCHITECT i1000SR System Service and Support Manual for additional
information on performing the procedures in these activities.
Remove Pipettor Assembly R&R E1.01 and examine; DO NOT remove Pipettor Board
(Continued)
Processing Center
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 and identify the Upper Waste Manifold, and identify the 3 WZ Thermistor tubings with
bead thermistors
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.
Perform M&D 3310 RSH Test (using both sample and reagent carriers)
Perform M&D 3540 Temperature Status (Disregard errors Ambient Temperature. Not active at
this time.)
(Continued)
Perform M&D 3180 Vacuum System Test (test vacuum integrity only)
Functional Test M&D 4150 can also be performed to test various sub-systems at a system level.
Load one or more reagent kits and successfully run at least 3 levels of QC on one assay
Activity Instructions
In this activity you will:
• navigate through the AbbottLink application
• retrieve instrument reports using your laptop computer
Resources Needed
• AbbottLink ID and Laptop Computer
Refer to the AbbottLink resources located on the GSS website for additional information.
_______________________________________________________________
______________________________________________________________
Record the last three 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 5 useful ARCHITECT logs or reports that can be downloaded via AbbottLink:
_______________________________________________________________
_____________________________________________________________
______________________________________________________________
_____________________________________________________________
_______________________________________________________________
END OF MODULE