I1000 SR Differences Field Service Training Guide

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i1000SR Differences

Field Service Training Guide

ARCHITECT i1000SR Differences FS Training Guide


206039-101 FOR ABBOTT INTERNAL USE ONLY
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
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.

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Introduction

CONTENTS

Module 1: System Overview .................................................................................1-1

Module 2: RSH........................................................................................................2-1

Module 3: Planned Maintenance ..........................................................................3-1

Module 4: Installation ............................................................................................4-1

Module 5: Troubleshooting...................................................................................5-1

Appendix A - iSystem Comparison ......................................................................A-1

Appendix B - Reference Information....................................................................B-1

Appendix C - Optional Activities ..........................................................................C-1

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Introduction

Notes Training Overview


The ARCHITECT i1000SR Field Service Training Program is a modular program
designed to provide the student with the skills and knowledge required to service
and support the ARCHITECT System and it's many configurations.

The ARCHITECT i1000SR System is a fully-automated immunoassay system


allowing random and continuous access as well as priority and automated retest
processing. The i1000SR Processing module is a diagnostic module with priority
processing capability that performs sample processing using the CMIA
(chemiluminescent microparticle immunoassay) method.
The ARCHITECT System is designed to be a multi-module system. That means
multiple Processing Modules (PMs) can be combined 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.

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 diagnostic tools and interpret troubleshooting data to isolate the root cause
of failure.

3. Perform key component removal and replacement procedures.

4. Perform the procedures associated with Planned Maintenance (PM) and an


Instrument installation.

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Introduction

Graphic Conventions Notes


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

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.

Activity
The clock icon appears along with an activity header to identify a
student activity.

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Introduction

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:

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. Also
used for conditions or activities that could interfere with proper
functioning or performance of the instrument.
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; 8 Hazards, for complete information.

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.

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Introduction

Safety Hazards and Warnings


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

Notes 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 the material has Oxidizing (O) properties.

Indicates that the material has Highly Flammable (F) or Extremely


Flammable (F+) properties.

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

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


properties.

Indicates the material has Corrosive (C) properties.

Indicates that the material has Dangerous for the environment (N)
properties.

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Introduction

Laser Safety Notes


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

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

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MODULE 1 - SYSTEM OVERVIEW

ARCHITECT i1000SR Differences FS Training Guide 1-1


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System Overview

Notes Page

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System Overview

OBJECTIVES Notes
After completing this module, you should be able to:

• Identify and describe instrument hardware (Fluidics, Optics, Robotics,


Temperature Control, and Power) components comparing it to other
ARCHITECT iSystems.

• Perform basic instrument operation including:


• Calibration, QC, and Precision
• Instrument Maintenance

• Describe operational and software differences between the i1000SR System


and other ARCHITECT iSystems.

• Identify and locate Abbott Service Documentation including use of


AbbottLink.

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System Overview

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

Robotic Sample Handler

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.

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System Overview

Notes

Activity - Hardware

Time to complete: 60 minutes


Debrief Session: 60 minutes

Activity Instructions

In this activity you will:


• Remove instrument covers.
• Locate and view instrument components identified in activity tables.
• Use your knowledge and experience about other iSystems to contrast and
compare the listed hardware/components. Within the activity, mark
components as either the same, different, or new.
• Prepare to discuss component function, location, and similarity/differences
with other iSystems during the class debrief session.
• As directed by the instructor, present information to the class.

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

Refer to the ARCHITECT i1000SR System Service and Support


Manual R&R section (P1.01 & P1.02) for cover removal instruction
and for additional information on the components presented.

Students Perform the following:


† Remove the following instrument covers:
 All three rear panels (SCC, Card Cage, and Fluidics from left to right)
 Left and right front access panel (open two front doors to access)
 Open processing lid
 Top deck covers

† Locate and compare (to other iSystems) main instrument components as


identified in the tables and areas on the activity pages that follow.
(Continued)

ARCHITECT i1000SR Differences FS Training Guide 1-5


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System Overview

System Control Center Components:


The SCC is a computer system that provides the software interface to the ARCHITECT System and can
provide an interface to a host computer.

Component Comparison Function Service Notes


Touchscreen † Same • Make onscreen selections by touching • Observe support arm and
Monitor, Mouse and † Different text areas and graphics, icons and cable routing.
Keyboard menu items, and function bar buttons.
† New
• Mouse and Keyboard are used to make
onscreen selections or to enter
information.

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

Lower Front Right

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.

Optional † Same • Printer • DO NOT plug printer into


Components analyzer power strip or
† Different • Bar code Scanner
UPS.
† New • UPS (uninterruptible power supply)

(Continued)

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System Overview

Top View - Processing Center components


The processing center is the main activity area of the processing module. Samples and reagents are
dispensed and mixed into the RVs (reaction vessels) in the process path where assay processing is
performed.
Component Comparison Function/Description Service Notes
Process Path Motor Unloader Process Path

Unload Diverter
CMIA Optics

Pre-trigger/Trigger Manifold
Wash Zone Inlet Diverter

Vortexer 1
Wash Zone Outlet Diverter

Pipettor

Wash Zone Manifold


RV Access Door

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)

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System Overview

Component Comparison Function/Description Service Notes


Process Path † Same • 36VDC Stepper Motor. • Motor is encoded so that each RV position
Motor has a "home" position.
† Different • Rotates the Process Path Disk.
• Encoder signals return to indexer board #1.
† New
and are routed through the processing center
distribution board.
• Motor is driven by motor driver board #1.

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
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System Overview

Component Compari- Function/Description Service Notes


son

Process Path Motor Unloader Process Path

Unload Diverter
CMIA Optics

Pre-trigger/Trigger Manifold
Wash Zone Inlet Diverter

Vortexer 1
Wash Zone Outlet Diverter

Pipettor

Wash Zone Manifold


RV Access Door

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.

CMIA Optics † Same • Measures the chemiluminescent • Three principal assemblies:


emissions from RVs over a pre- - CMIA Reader Assembly
† Different
defined time and outputs data - Reader Magnet
† New corresponding to the quantity of - Shutter Assembly
emission detected.
• Circuitry:
• The final read is measured in relative
- CMIA Optics Board
light units (RLU).
- Module Controller Board
During installation & replacement the - DC Driver I/O Board
Linearity and Normalization - Processing Center Distribution
parameters from the CMIA optics Board
assembly must be entered into the
module configuration window on the • Each CMIA Optics Assembly comes
SCC . Some values may be (-) negative from the factory with Linearity and
and require the dash (-). Normalization parameters attached.

(Continued)
ARCHITECT i1000SR Differences FS Training Guide 1-9
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System Overview

Component Comparison Function/Description Service Notes

RV Loader
Syringe Pre-trigger/Trigger Manifold

Wash Cup Pipettor Assembly


Wash Zone Manifold Upper Waste 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.

Pre-trigger/ † Same • Dispenses Pre-trigger Solution and • Manifold valves: 36 VDC.


Trigger Trigger Solution into the RVs.
† Different • Pre-trigger Solution is a hydrogen peroxide
Manifold • Two valves for each reagent: solution used to split the acridinium dye off
† New
- A dispense valve the conjugate bound to the microparticle
complex.
- A bypass valve that flushes
manifold and directs solution to - Pre-trigger Solution is in a dark (black)
waste line (Blue collared valves Bottle and the Pre-trigger tubing is
are for flushing). coated (black) to protect the solution from
light
• Trigger Solution is a sodium hydroxide
solution used to produce chemiluminescent
reaction that provides the final read.

(Continued)
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System Overview

Component Comparison Function/Description Service Notes


Upper Waste † Same • Directs liquid waste from the RVs • Manifold vacuum solenoid valve: 36 VDC.
Manifold after washing into the waste area.
† Different • Pre-trigger, Trigger, and Wash Zone
† New • Manifold holds wash zone manifold bypass waste lines all connect to
thermistor tubing in place. this manifold.
• The upper waste manifold wash zone
aspirate valve, opens to allow vacuum to
remove waste liquid sending it to the
vacuum accumulator.

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).

Pre-trigger † Same • Moves Pre-trigger reagent from • 36 volt DC stepper motor.


Pump on-board reservoir to Pre-trigger
† Different • Displacement 100 µl / rev. (100 µl/head)
dispense manifold and valves.
† New Flow rate 0.4 ml / sec.
• Single head 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)

ARCHITECT i1000SR Differences FS Training Guide 1-11


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System Overview

Notes Page

(Continued)

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System Overview

Component Comparison Function/Description Service Notes


Pipettor † Same • Controls the probe movement • 36 VDC stepper motors.
Assembly through horizontal (theta) and
† Different • Probe is washed with wash buffer solution
vertical (z) movement. via active wash protocols.
† New
• The pipettor probe (together with • Crash Sensor assembly in underside of
syringe & valve assembly) are Pipettor Arm.
used to aspirate:
• Liquid Level Sense (LLS):
- sample from sample tubes or
- 100KHZ frequency developed at LLS
cups and dispense into RV
Board routed to, and transmitted from,
- reagent from reagent bottles the pipettor probe
and dispense into RV
- Three antennas in aspiration locations
• A fluid sense/pressure monitoring - All LLS signals route through Sample
system is included in the pipettor antenna board
assembly to help identify errors
during aspiration only. • Pressure Monitor (PM):
- Pressure transducer (PT) is placed in
Pipettor Board the fluid line between syringe and probe
PM Transducer
- PM circuitry contained on pipettor board

RV Loader † Same • RV Loader: • Mechanical RV detection: one upstream


Assembly - Onboard storage of RVs sensor at loader and one downstream
† Different
- Orients and inserts RV into the sensor in process path.
† New
inner track on process path (23) • RVs dumped at System Initialization.

• 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).

• 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

(Continued)

(Continued)

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System Overview

Top View - 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.
Component Comparison Function/Description Service Notes

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
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System Overview

Component Comparison Function/Description Service Notes


Reagent † Same • Provides on-board refrigerated • Held in position by three V-wheels,
Carousel and storage for the assay reagents. mounted to the central dispersion ring gear.
† Different
Motor - Reagent carousel can hold 25 - Two fixed & One spring-loaded mount
† New
Assembly reagent carriers. • Turning the release lever counter-clockwise
- Continuous access loading and unlocks and releases the motor.
unloading.
• Home Sensor and encoder signals route
• Carousel Rotates when molded through reagent distribution board to card
gear ring on inner edge of carousel cage Indexer #1.
engages with the carousel drive • +24VDC Motor, Motor Driver #1
motor.
• Embedded pin home flag also used as
training tool for pipettor alignment
• Optical Home Sensor.
• Removable spring and slides on carousel.
Dispersion Ring † Same • Fixed gear interacts with gears on • Reagent Carrier Detect Sensor, mounted to
Gear Assembly individual reagent carriers to rotate the ring gear, detects the presence of
† Different
microparticle reagent bottle. reagent carrier in each position of the
† New 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 † Same • Each carrier can hold up to three • 2 retaining tabs, on underside of base, slide
Carrier ARCHITECT assay reagent bottles into corresponding retaining slots located in
† Different
for a kit. each carrier position on the reagent
† New carousel.
• Reagent carrier is placed into the
initial load position on the carousel - Ensure carrier remains locked into
by the RSH carrier transport. position and engaged with dispersion
ring gear.

Carrier Latch Actuator

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)

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System Overview

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.

Wash Buffer † Same • Onboard storage for wash buffer.


storage area † Different - Wash buffer reservoir: onboard storage
for up to 12 liters wash buffer.
† New
- Wash buffer level sensor and outlet
assembly:
- Tube with three magnetic float
sensors
- The buffer level sensor dispenses
Filter wash buffer into the reservoir.
- The outlet assembly draws wash
buffer from the reservoir during test
processing.
- Wash buffer filter: Protects fluidics
components by eliminating particulates.

Transfer Pump † Same • Buffer Transfer Pump. • Transfer Pump receives


24VDC from Heater Cooler
† Different • Move buffer from preparation container
Board.
† New to on-board reservoir.

(Continued)
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System Overview

Component Comparison Function/Description Notes


Buffer Fluidics † Same • Buffer Pump - Delivers buffer to • Buffer pump:
Probe. - 36VDC from Motor Driver #1
† Different
• Wash Zone Pump - Delivers buffer - CMIA optics board (home I/O
† New
to Wash Zone Dispense valves. - Indexer #1 (motor limit and
- Buffer Heater warms solution to home sensor
30-37.6oC before dispense - LLS board (stop)
• Wash Zone Pump:
- 36VDC from Motor Driver #2
- CMIA optics board (home I/O
- Indexer #2 (motor limit and
home sensor
Waste storage † Same • Provides storage for liquid and solid • Waste Pump Pressure Switch is
area waste. responsible for sending an error if
† Different
- Waste Drawer the Liquid Waste Container is left
† New - Liquid Waste Container unplugged for more than 15
minutes while running.
- Solid Waste Container
- Waste Pan • Customer can choose to have
continuous waste option installed.

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

• Four Power Boards: • Heater Cooler Bd distributes power


- Motor Driver 1 and 2 to the following devices:
- DC Solenoid Driver I/O - 24 VDC heaters, vacuum pump
& transfer pump
- Heater Cooler
- 36 VDC waste pump
- 17.5 VDC reagent cooler
- has replaceable surface
mounted fuses
• Indexer boards are swapable.
• Motor Driver Boards are swapable.
• DC Driver I/O Board contains
fuses, and a 2 digit 7 segment
display, that can be used in
troubleshooting situations to
determine what fuse on the board
is blown.
• 16 fuses on back of card cage (one
not active). Backplane fuse kit.
• i1000SR fuse kit for boards.
(Continued)

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System Overview

Hardware Rear View - components

Component Comparison Function/Description Notes


• Figure Components:
1. SCC Rear Panel
2. Card Cage Rear Panel
3. Fluidics Rear Panel

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

• Electronic (logic) needs 5V, 12V and -12VDC


• Thermo-electric (TED) Reagent Cooler 17.5VDC
• Vacuum and Transfer Pumps 24VDC
• Heaters 24VDC
• FMI and Waste Pumps 36VDC
• Motors and solenoids 36VDC
Power Supply will not stay powered up without a load.
Pins 2 and 18 on the power supply can be jumpered to
enable the power supply to be powered on when not
connected to the analyzer during troubleshooting.

(Continued)

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System Overview

Component Comparison Function/Description Notes


Distribution † Same • The logic and power signals from the card • Distribution Boards are located
Boards cage are routed to four distribution boards: throughout instrument:
† Different
- Processing Center Distribution Board - Process Distribution Board is
† New
- Reagent Distribution Board in the process area under the
top lid, located on the left
- Fluidics Distribution Board
side of back panel.
- RSH Distribution Board
- Reagent Distribution Board
is located to the right of the
Fluidics Distribution Board Process Reagent Process Distribution Board.
Distribution Board Distribution Board
- Fluidics Distribution Board is
located behind the fluidics
rear panel.
- RSH Distribution board is
located on the left end of the
RSH.

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.

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

END OF ACTIVITY

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System Overview

Notes Page

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System Overview

BASIC OPERATION Notes


Software
The ARCHITECT System software uses a graphical user interface. It includes a:
• Touch screen interface with icon driven software
• On-line operator manuals, on-line help, automatically updated
maintenance logs, and computer-based training
• Modem diagnostic capability

The i1000SR ARCHITECT System software is similar to other ARCHITECT


Systems. The following screens contain modifications/updates:
• RSH icon on Snapshot screen was modified
• Reagent Status and Supply Screens were modified to include new columns:
Carrier Status, Scheduled Tests, and Ready to unload

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

• Supply Status screen and update supplies window were modified

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

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System Overview

Notes Basic Run Procedures


1. Check Supply Status for onboard solutions, RVs, and waste
• Use Snapshot screen and the Supply status screen.
- Empty solid waste and replenish RVs
- Prepare and replace bulk solutions as needed
- Replace Pre-Trigger/Trigger solutions as needed
- Update Supply Status - F2

2. Check Reagent Status.


• Use the Snapshot screen and the Reagent status screen.
- Prepare and load reagents as needed
- Update the Reagent status screen
- Unload reagent bottles

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.

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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System Overview

Load Reagents on the RSH Notes


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.
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.

3. Download from Host, or manually create Patient orders.

(Continued)

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System Overview

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.

5. Verify, Load, and Run


• Verify acceptability of sample type (serum, plasma, etc.) and tube.
• Verify the sample volume and integrity:
- Sample volume requirements depend on the sample vessel type,
the onboard sample storage conditions, and the assay(s) ordered.
NOTE: For additional information refer to the ARCHITECT System
Operations Manual; Section 5 Operating Instructions; Sample
Management.
• Calibrators, controls, and patient samples are loaded on the RSH (robotic
sample handler) for routine, priority, or batch processing.

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

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System Overview

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:
Ready or 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
• 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.

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System Overview

Notes 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.

RSH Indicator Lights

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

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System Overview

Notes

Activity - Operation

Time to complete: 45 minutes


Debrief Session: 15 minutes

Activity Instructions

In this activity you will:


• Observe instrument operation and sample progression. Answer activity
questions
• Perform Calibration
• Perform Precision Run and evaluate results against pass or fail criteria
• Prepare to review your results with class as directed by instructor

WARNING: Potential Biohazard. Follow biosafety practices.


CAUTION: Chemical Hazard.

Resources Needed

Refer to the ARCHITECT i1000SR System Service and Support


Manual for additional information.
Refer to the ARCHITECT System Operations Manual Section 3:
Principles of Operation, iSystem Principles of Operation, Assay
processing for additional information on sample progression.

students Perform the following:

1. Perform Daily Maintenance M&D 6440

2. Load the following reagents:


• TSH
• Total B-hCG

3. Prepare the Processing and Sample Handler Modules for testing:


• Place PM and RSH into Running Status

(Continued)

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System Overview

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

Single Analyte Control Lot Levels


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

6. Order Precision Run


a. Order 10 replicates of Precision Control

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)

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System Overview

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

RETURN TO LECTURE ROOM FOR ADDITIONAL INSTRUCTION WHILE


INSTRUMENT RUNNING.

10. Evaluate results of calibration and controls upon run completion

11. Print a QC Analysis Report of the Precision Control for both assays and save for
later.

† Printed B-hCG precision results

† Printed TSH precision results

END OF BASIC OPERATIONS ACTIVITY-CALIBRATION

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System Overview

Notes Notes Page

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Notes

Activity - Service Tools

Time to complete: 10 minutes


Debrief Session: 5 minutes

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

Refer to the ARCHITECT i1000SR System 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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System Overview

† 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

(Continued)

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

2. Where do you find the steps for different Assay Pipetting Protocols
and what protocol is used for TSH?

3. What is an expected Total %CV recovery for a 20 rep precision on


TSH with a mean of 5.5?

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

5. Besides data gathering for troubleshooting, list a minimum of one


advantage/benefit for using AbbottLink.

END OF ACTIVITY

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System Overview

Notes MODULE SUMMARY


Now that you’ve completed the System Overview Module, you should be able to
identify the components of the i1000SR System, perform basic operation procedures,
and identify service resources. This included the following items:
• Hardware Overview
- Component differences and similarities to other iSystems
- New Hardware components
- Location of i1000SR System Components
- Key Service Notes

• 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

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System Overview

REVIEW QUESTIONS Notes

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

DESCRIPTION or FUNCTION COMPONENT

This Diverter is used during all pre-treatment assay


protocols
Is powered by 17.5VDC
Distributes 36VDC for waste pump
Generates 100KHz used for LLS
Orients the RV and inserts the RV into the inner track on
the process path
Diverter used for diverting RV back into the inner track
during 2 step assays

2. There are 23 RV positions on the Process Path Disk. TRUE FALSE

3. List the 4 Processing Distribution Boards and include a brief description of


where each board is located.

4. What is the minimum number of times the microparticle reagent bottle should
be mixed (inverted) prior to loading on a reagent carrier?

5. What sections on the RSH are used to load priority carriers?

END OF MODULE

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Notes Notes Page

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MODULE 2 - RSH

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RSH

Notes Page

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RSH

OBJECTIVES Notes
After completing this module, you should be able to:

• Locate and identify the key components.

• Explain the RSH interface and control system.

• Perform RSH robotic calibrations.

• Perform Removal and Replacement of RSH and Carrier Transport.

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RSH

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.

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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 4 bays 4 bays 8 bays
4 sections/ bay 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
Third pocket is unused.
Carriers Sample & Reagent Sample Sample & Reagent
Reagent Carrier positions Any None Reagent can only be loaded in
positions 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 PS7 & PS8 in c4000 Power
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 from
differ from c4000 from i1000SR i1000SR
RSH Distribution Board RSH Distribution Board RSH Distribution Board
Toshiba and Abbott Indexer, Controller, and Motor Driver boards are NOT interchangeable.
Fuses F7 (+5VDC) • F1 (5VDC) 10A
10A • F2 (12VDC) 2A
Jumpers Mod 1 for i1000SR • JU1 & JU2 on RSH • JU1 & JU2 on RSH Card Cage
Card Cage • Mod 2 for i1000SR
• Power Supply iRSH &
• Power Supply iRSH & RSH
RSH
Integration
Integration Several components are Anchor or reference for • c4000 contains the RSH power
removed and replaced ci4100 & control
with Toshiba • Components may not be
components depending compatible with i1000SR;
on i1000SR classification
check FRUD
type (A-D)

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RSH

Notes Notes Page

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System Overview

RSH Reagent Processing

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.

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 carrier transport 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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RSH

Notes Page

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System Overview

Hardware Overview - standalone i1000SR RSH System


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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RSH

Notes 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
• 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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System Overview

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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RSH

Notes 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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System Overview

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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RSH

Notes 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

RSH Distribution Board Notes


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 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

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RSH

Notes 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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System Overview

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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RSH

Notes

Activity - RSH R&R

Time to complete: 1 hours


Debrief: 15 minutes

Activity Instructions

In this activity you will:


• 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.

Resources Needed

Refer to the ARCHITECT i1000SR System Service and Support


Manual for additional information.
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.

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

(Continued)

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RSH

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

† 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 NOT 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 i1000SR
 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 NOT all motors, nor all sensors, need
to be tested, select 2-3 to test
END OF ACTIVITY

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RSH

MODULE SUMMARY Notes

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.

• Hardware Components include:


- Load/Unload Platform - positions each carrier for transport by the
carrier transport.
• Up to 7 sections can be configured for priority processing on a
stand-alone i1000SR RSH. The Default is 4.
• Up to10 sections can be configured for priority processing on a
ci4100 integrated system.
- Load/Unload Sensor Boards - contain LEDs that indicate the state of
each section to the operator. The Load/Unload boards also detect
whether a sample carrier, or a reagent carrier was loaded.
- Carrier Transport - interacts with each section to pick up the sample
carrier, move it to the bar code reader and then place the carrier on the
aspiration platform (sample) or on the reagent carousel (reagent). It also
returns sample, and reagent, carriers from the carrier positioner to the
load/unload platform for operator removal.
- Bar Code Reader - scans sample carrier ID and sample ID bar codes.

- 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.

• The key RSH robotic calibrations are:


- M&D 1114 Carrier Transport Calibration
- M&D 3240 Bar Code Calibration

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RSH

Notes 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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MODULE 3 - PLANNED MAINTENANCE

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Planned Maintenance

Notes Page

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Planned Maintenance

OBJECTIVES Notes
After completing this module, you should be able to:

• Locate Planned Maintenance (PM) Checklist

• Perform Planned Maintenance Procedures to include:


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

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Planned Maintenance

Notes 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 i1000SR 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

Notes

Activity - PM

Time to complete: 4 Hours


Debrief Session: 15 - 30 minutes

Activity Instructions

In this activity you will:


• 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

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

Refer to the ARCHITECT i1000SR System Service and Support


Manual for information related to activity.

(Continued)

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Planned Maintenance

Students Perform the following:

† Locate PM Checklist designated by instructor.

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

• Ajar RVs in Process Path

• Clean Manifolds

Unloader Process Path

Process Path Motor CMIA Optics

Unload Diverter Pre-trigger/Trigger


Manifold
Wash Zone Inlet Diverter
Vortexer 1
Wash Zone Outlet Diverter

Pipettor

Wash Zone Manifold


RV Access Door

Wash Cup

(Continued)
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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

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Planned Maintenance

Notes Page

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Planned Maintenance

MODULE SUMMARY Notes

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

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Planned Maintenance

Notes 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?

END OF MODULE

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MODULE 4 - INSTALLATION

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Installation

Notes Page

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Installation

OBJECTIVES Notes
After completing this module, you should be able to:

• Perform System Installation, including Pre-Site procedures.

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Installation

Notes 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
• Delivery Pathway Clearance
• Environment Specifications
• Water Quality Requirements
• Storage Requirements
• Waste Disposal
• Sample Bar Code and LIS Interface data

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Installation

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.

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 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.

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Notes Page

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Installation

Notes

Activity - Installation

Time to complete: 2.25 hours


Debrief Session: 10 minutes

Activity Instructions

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 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)

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Installation

Notes † Perform the following M&Ds:


 3540 Temperature Status
 1022 Optics Background
 5420 Crash Sensor Test
 3630 LLS Test

† Run a QC on B-hCG STAT and TSH


 If errors occur during operation, perform corrective action
 Verify control results are within range
 Provide printout with Control Data, including your name, to
instructor

END OF INSTALLATION ACTIVITY

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Installation

MODULE SUMMARY Notes

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

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Installation

Notes REVIEW QUESTIONS


1. What is the transmit frequency for the LLS system on the i1000SR?

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?

4. If connector J45 on the card cage backplane became dislodged, what


subassembly would fail to operate?

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

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MODULE 5 - TROUBLESHOOTING

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Troubleshooting

Notes Page

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Troubleshooting

OBJECTIVES Notes
After completing this module, you should be able to:

• Identify the root cause of an instrument failure and perform instrument


repair using service and support documentation.

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Troubleshooting

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

• THINK - Gather Information/Data/Symptoms


- Look for Comparison (the problem IS vs. the problem IS NOT)
Comparisons can include, but are not limited to:
• Systems with errors vs those without errors.
• Component(s) not working vs components within the
system that are working.
• Assay(s) that are not working vs. those that are.
- Gather Clues and Meaningful data/information
- Use Measurements and/or M&D tests
This can be, but are not limited to:
• Voltage Readings and/or Pressure Readings
• Software initiated component (diagnostic) test
• Manual initiation of component using CLI commands
- Identify Symptoms
Symptoms can be, but are not limited to:
• Error codes and warning messages
• Observed problems, such as noise, misalignment, lack of
movement, leakage, etc.
• LED status
• Information from system logs
- Ask Questions (What, Where, When, and How often or How
Many)

- 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.)

• EVALUATE - Identify potential Causes


- Ask yourself does the probable cause explain/match the Information/
Data/Symptoms gathered - If yes, that is the cause. If no, it is not.

• PROCEED - Resolution/Corrective action


- Perform Repair, then verify Problem Resolution
- Complete all verifications and documentation

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Troubleshooting

Categorizing Failure Notes


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

ARCHITECT i1000SR Differences FS Training Guide 5-5


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Troubleshooting

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.

When troubleshooting the ARCHITECT i1000SR System, consider the following.

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

General Issues That Can Impact ARCHITECT i1000SR operation:


• Instrument not level
• Sample Debris
• Improper Reagent Handling and Mixing
• Power Quality not to specification

Activity Instructions
In order to complete this exercise you will do the following, as directed by your
instructor:
1. Begin processing specimens. If an error is detected or there is an error state,
stop. Review Troubleshooting reference documentation (ISA, Troubleshooting
Database, Service Manual, Diagrams, etc.)

2. Observe, make comparisons, perform repair procedures, gather data/information


etc. for use in isolating the reason for the failure.

3. Identify the root cause of the error, perform the repair, then perform the required
verification procedures and return the instrument to a “Ready” state.

4. Be prepared to share your Troubleshooting process with the class including how
you arrived at the solution.

(Continued)

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Troubleshooting

Final Exam Introduction Notes

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

The practical exam will consist of resolving instrument errors (i.e.”bugs”).

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 instructor including


how you arrived at the solution.

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Troubleshooting

(Optional)

Error Notes Resolution

END OF ACTIVITY

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Troubleshooting

Troubleshooting Case Studies


(OPTIONAL CASE STUDIES)

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?

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Troubleshooting

(OPTIONAL CASE STUDIES)

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.

The FSR performed the following without resolution of the problem:


• Check Fluidics and Bulk Solutions and all appeared to be functioning properly
• After extensive troubleshooting replaced optics assembly

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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Troubleshooting

Troubleshooting
The following are tips for troubleshooting failures associated with i1000SR System

NOTE: When troubleshooting ARCHITECT System errors refer to your


ARCHITECT i1000SR 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


General Calibration Error Troubleshooting • Wrong calibrator used or improper loading of Calibrators
• Calibrator or reagent is not performing as expected due to
improper handling
• Lack of Maintenance
• Bulk Solution impurities
• Dispense/Fluidic component failure
Assay Imprecision • Leaking or defective Syringe
• Mispositioned Sample Probe
• Bent Wash Aspirate Probe
Reagent Carousel Step Loss or Noisy • V-Wheel failure
Operation
• Obstruction

Vacuum Failure • Faulty or obstructed Vacuum Filter


• Lack of Maintenance
• Damaged or kinked tubing
RV Load Detection • RV Jam
• RV Detect Sensor failure
LLS Error • Loose cable connections
• Possible Sample Antenna Board failure
• Obstruction

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Troubleshooting

Notes MODULE SUMMARY


Now that you’ve completed the Troubleshooting Module, you should be able to
isolate the root cause of an error and resolve. This included the following items:
• Troubleshooting Overview
- Effective Troubleshooting/Step Model
• Four Logical STEPs
• STOP -Identify Problem
• THINK - Gather information/Data
• EVALUATE - Identify and test potential causes against
data
• PROCEED - Perform repair, verify problem resolution,
and complete documentation

- Categorize Area of Failure


• Operator
• Reagent
• Analyzer
• Environment

END OF MODULE

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APPENDIX A - iSYSTEM COMPARISON

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Appendix A

Notes Page

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Appendix A

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

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

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

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

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

Notes Notes Page

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APPENDIX B - REFERENCE INFORMATION

This module includes reference on the following topics:


• Test Status................................................... page 2
• Result Flags ................................................page 3
• Software Reference Map.............................page 4
• Control Reports............................................page 5
• Calibration....................................................page 7
• Card Cage.....................................................page 8
• Reagent Management Area..........................page 11
• Power Supply................................................page 12
• RV Loader.....................................................page 14
• Optics............................................................page 15
• Sample Progression.......................................page 19
• Temperature...................................................page 20
• WAM.............................................................page 22
• Fluidics..........................................................page 27
• CLI Commands.............................................page 39

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Appendix B

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.

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 • 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.

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*


Located in Stored Results detailed Screen only. • 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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Appendix B

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

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.

>< • Outside defined dynamic, or linear range

HH** • Outside "Extreme" ranges as defined in CONFIGURATION/ASSAY


LL** SETTINGS/ASSAY PARAMETERS

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


LOW** SETTINGS/ASSAY PARAMETERS

EDIT • Result manually edited by the operator and was not calculated by the system
(cSystem)

EXPC* • Result was calculated using an expired calibration curve


(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.

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Appendix B

ARCHITECT System Software Guide


Snapshot
Exception Status
Sample Status
OVERVIEW EXCEPTIONS Rerun Status
Operations Manual

Order Status Reagent Status


Patient Order REAGENTS Reagent History
ORDERS
Control Order
Calibration Order

Results Review Supplies Status


RESULTS SUPPLIES
Stored Results

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

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
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.

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Appendix B

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: c800044

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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Appendix B

Notes Page

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Appendix B

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

To order a calibration on one or more assays:


• Select Orders from the menu bar, then select Calibration order.

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

Calibration data review

Calibration data can be viewed in the:


• Calibration History Screen - all assay calibrations
• Calibration Status Screen - only assay calibrations with regent presently loaded on the system.

Select QC-Cal Select Calibration Status

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Appendix B

Card Cage Circuit Boards


Control, drive, and detection circuitry on the i10000SR 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 below describes the
boards contained within the Card Cage along with their basic functionality.
Location Board(s) Function Type
UPPER Indexer 1 and 2 • Motor Control • Logic
• Monitors Home Sensor Signals (motor position)
• Tracks motor encoder signals
• Communicates with:
- Controller Boards, Motor Driver Boards and Other Boards
Liquid Level • Generates the 100KHz transmitting frequency for the Pipettor Probe • 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 • Logic
going to 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
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 • Logic
Controller Module functions
• Communicates with:
- SCC
- Reagent Bar Code Reader
- Device Controllers
LOWER Motor Driver 1 • Multiple Boards • Power
and 2
• Energizes motor (motor movement)
• Receives motor control signals from Indexer Boards
Heater Cooler • Power control for system heaters and thermoelectric coolers. • Power
• Receives heater control commands from Temperature Controller Bd
• Power drive to Vacuum, Transfer, and Waste Pumps; receives on/off
control signal from CPU
• Contains Fuses
DC Driver I/O • Engages Diverters, Solenoids, and Valves • Power
• Controls DC motors used in Vortexers and Pumps
• Contains F1 fuse to protect Buffer Transfer Pump

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Appendix B

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Appendix B

Notes Page

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Appendix B

Reagent Carousel Area


The Reagent Carousel Area is an insulated chamber that is built up from the instrument base. It houses the
Reagent Carousel, Reagent Cooler and associated structures.

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Appendix B

Main Power Supply


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. DC voltages are developed and then
distributed throughout the system. There are no AC Voltages used in the i1000SR Instrument. Status LEDs
provide status information on each voltage.
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 Driver I/O
- Heater/Cooler
• Stepper Motors
• Solenoids
• FMI Pumps
• Waste Pump

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Appendix B

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.

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Appendix B

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.

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Appendix B

CMIA Optics System


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 depending on
the specific assay.

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.

Paramagnetic Analyte Captured analyte


Microparticle

• After incubation, a magnet attracts the


paramagnetic microparticles (bound to the
specific analyte) to a 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
• After incubation, reaction mixture is conjugate
washed to remove unbound materials.
Immuno-complex sandwich
• Pre-trigger Solution (hydrogen peroxide)
is added and the CMIA optical system takes a background read.
• 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.

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Appendix B

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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Appendix B

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.

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Appendix B

Notes Page

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Appendix B

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.

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Appendix B

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

• Heater Cooler Board


• Power
• Surface fuses for each circuit

• Thermistors (throughout system)


• Six active thermistor channels:
- process path x 3
- buffer heater (wash zone)
- trigger / Pre-trigger heater
- 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)
• Heaters
• All heaters on i1000SR are on DC voltage

• Reagent Refrigerator (cooler)


• Consists of 8 Thermoelectric device (TED) pairs in 4 sets of 2

• 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.

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Appendix B

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Appendix B

WASH ASPIRATE MONITOR (WAM)


Wash Aspirate Monitoring (WAM) is used during wash aspiration to:
• verify that a temperature change of 1.2oC or greater occurred during the wash process
• provide assurance that the wash fluid was dispensed and subsequently aspirated completely
within the allotted time.

Dispense of wash solution and its subsequent aspirations from reaction vessels are essential steps in the
assay protocol.

WAM includes the following components and/or systems:


• WAM Thermistor (located inside the waste tubing approximately 11 inches from the probe tip)
• Wash Zone Probe and tubing
• Vacuum System
• Buffer Dispense System (dispense nozzles, valves, etc.).

• WAM determination is based on temperature measurements taken at 1millisecond intervals. A


normal wash aspiration produces a temperature profile with predictable characteristics
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 aspiration failure can be caused by probe or tubing blockage, vacuum system
malfunction or buffer dispense system malfunction.
• WAM temperature measurements are saved in a WAM log file on the module.

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Appendix B

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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Appendix B

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

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Appendix B

Probe 1
Max. Temp

|74209|28150|7970

Wash Station ID Temp. Δ

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Appendix B

WAM LOG ERROR

1.079 degree C change in temperature - Recognized


by software as WAM error for WZ Probe 1 (<1.2C)

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

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Appendix B

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

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Appendix B

Fluidics Diagram

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Appendix B

Fluidic Sensors

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Appendix B

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

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Appendix B

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
can be automatically diluted and loaded by using an Automated Reconstitution Module (ARM).

Buffer is used during test processing.

36VDC 24VDC

36VDC
36VDC

24VDC

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Appendix B

Notes Page

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Appendix B

Wash Cup Diagram


Active Probe Wash Cycle
• Step #1: The probe moves to the outer waste well and discards any residual liquid (serum, reagent
or buffer). This liquid waste is removed under vacuum by the Outer Drain Valve - S2
opens.
• Step #2: Probe moves to central wash well and aspirates 10µl of buffer left over from previous
wash cycle.
• Step #3: Probes moves down further into central wash well and aspirates 150µl buffer to wash
probe internally and externally.
• Step #4: S1 opens and vacuum aspiration commences at the upper waste orifice, near the top of
the wash well. 6ml of clean buffer is dispensed through the probe to flush the inner
surface. This also flushes out the 150 µl of aspirated buffer in step 3. Wash buffer is
vacuum aspirated through the upper waste orifice, to the waste system.
• Step #5: Probe retracts up and as it moves past upper waste orifice probe is dried by vacuum. 6ml
of buffer still remains in central wash well from step #4.

NOTE:Note: S3 is only used during initialization to completely drain central wash well

Side View

Top View

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Appendix B

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

Valve and O-Rings

Piston

Fluid Vessel

Syringe

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Appendix B

Liquid Level Sense and Pressure Monitor Diagram


• 100 KHz frequency signal used for LLS
• 3 LLS antennae. All signals (process path & reagent) route through sample

LLS and PM only performed on aspiration only. No functionality on dispense.

LLS
Antenna
Reagent

LLS
Antenna
Process
Path
Cover

LLS Antenna Sample

Power Supply

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Appendix B

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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Appendix B

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

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Appendix B

Notes Notes Page

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Appendix B

CLI COMMAND REFERENCE Notes


To prevent component or system damage, these commands must be used in
accordance with the instructions located in the ARCHITECT i1000SR System
Service and Support Manual, Section 5 procedures, CLI Commands.

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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Appendix B

Notes
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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Appendix B

Notes

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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Appendix B

Notes

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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Appendix B

Notes

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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Appendix B

Notes

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)

END OF MODULE

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APPENDIX C - OPTIONAL ACTIVITIES

This module includes the following activities:


• Maintenance.................................................... page 3
• Basic Operations ..............................................page 5
• Basic Operations -Configuration......................page 7
• Power and Circuitry..........................................page 11
• Optics................................................................page 15
• Robotics............................................................page 19
• Temperature......................................................page 21
• Fluidics and Vacuum........................................page 23
• RSH..................................................................page 27
• Process Path and Pipettor.................................page 29
• Functional Test.................................................page 31
• AbbottLink.......................................................page 33

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Appendix C

Notes Page

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Appendix C

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 System Operations
Manual, Section 5 Operating Instructions and/or the on-line ARCHITECT Operations
Manual.

Students Perform the following:

† 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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BASIC OPERATIONS ACTIVITY


Time to complete: 30 minutes
Debrief Session: 10 minutes

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.

Students Perform the following:

1. Verify PM and RSH Status and change to appropriate status as applicable.

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


SID NAME Assays Dilution Replicates
Use SIDs on Bug, Ada B-hCG STAT 1
Bar Code
Cord, Ben G. TSH 1:5 1
Labeled
Tubes Dayo, Long TSH 5

3. Order Controls:

Control Lot Assays


All Levels Provided by Instructor B-hCG STAT, TSH

4. Print Order List Report and load samples into carriers.

(Continued)

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5. Load samples for routine testing on RSH.

Once the run is started, please return to classroom for further training regarding result status, flagging and
control evaluation.

6. Upon completion of testing, evaluate and release QC results

7. Release test results and print out the following reports:


† Sample report for Bed Cord
† Results Detail report for Long Dayo

8. 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

9. Be prepared to discuss result and control data during activity debrief session.

END OF BASIC OPERATIONS ACTIVITY

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Appendix C

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.

Students Perform the following:

Instrument Setup - Assay Installation

1. Perform key Setup Procedure:


† Install an Assay using Assay Installation Utilities 6114

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.

(Continued)

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1. Single Analyte Control


• Select SYSTEM/CONFIGURATION
• Select QC-Single Analyte
• Assay: B-hCG STAT
• F6 NEW LOT
• Click on the Drop Down Menu Box next to LOT NUMBER
• Select NEW LOT and enter PRECISION in Lot number field. Then enter the information
contained in table below
Single Analyte Control
Expected Values
Control Level Name Enter in:
SERVICE PRECISON 1 EXPIRATION DATE Refer to Assay
EXPECTED MEAN Specific Package
Insert and enter in
Standard Deviation (1SD) expected mean and
SERVICE PRECISON 2 EXPIRATION DATE calculate 1SD
(Mean subtract
EXPECTED MEAN
lower range value
Standard Deviation (1SD) divided by 2)

• Select ADD LEVEL

Perform a Calibration Run


Procedures for these activities can be located in the ARCHITECT i1000SR Service and
Support Manual, or ARCHITECT System Operations Manual, Section 5 Operating
instructions.
1. Load the following reagents:
• TSH and Total B-hCG

2. Prepare the Processing and Sample Handler Modules for testing


• PM and RSH into Running Status

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)

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Appendix C

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

Single Analyte Control Lot Levels


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

5. Order Precision Run


a. Order 10 replicates of Precision Control

NOTE: The Precision Control was created earlier during this Configuration Activity.

• 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):TSH and B-hCG STAT
• Select Control, Lot, and Level (Precision Control)
• F5 ASSAY OPTIONS
• Enter 10 replicates
• F2 ADD ORDER

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

9. Evaluate results of calibration and controls upon run completion

10. Print a QC Analysis Report of the Precision Control for the B-hCG STAT assay.

END OF BASIC OPERATIONS ACTIVITY-CONFIGURATION

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Appendix C

ACTIVITY - i1000SR SYSTEM POWER & CIRCUITRY


Time to complete: 45 minutes
Debrief Session: 15 minutes

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.

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

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

1. Set the correct module by typing SET_MODULE X


X= 1 for Standalone i1000SR PM or 2 for integrated iPM

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


Describe the led pattern on the Power Supply in Maintenance Mode:
______________________________________________________________________
______________________________________________________________________
(Continued)

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


What error occurs when the Maintenance Mode is activated?
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

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 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?
____________________________________________________________________

† Locate backplane /card cage and identify the following:


 Identify the backplane fuses and locations; remove and replace a fuse
 Identify the ESD Board
 Identify the Optics and LLS Coaxial connectors
 Identify the DC voltage test points

(Continued)

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Appendix C

† Reinstall the Power Supply

† 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 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)

† Initialize Processing Module to READY

END OF POWER AND CIRCUITRY ACTIVITY

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Notes Page

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Appendix C

ACTIVITY - i1000SR SYSTEM OPTICS


Time to complete: 30 minutes to 2 hours
Debrief Session: 10 minutes

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

WARNING: Electrical Shock Hazard. Follow electrical safety practices.

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

TIER 1 Students Perform the following:

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 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

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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† 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

† 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 OPTICS ACTIVITY

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ACTIVITY - i1000SR SYSTEM ROBOTICS


Time to complete: 45 Minutes
Debrief Session: 10 minutes

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.

Students Perform the following:

† Power OFF Processing Module.

† 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

† REINSTALL all removed components.

† Power ON the Processing Module.

† Perform M&D or Verification Procedures associated with Loader Removal

END OF ROBOTICS ACTIVITY

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Appendix C

ACTIVITY - i1000SR SYSTEM TEMPERATURE


Time to complete: 90 Minutes
Debrief Session: 15 minutes

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.

Students Perform the following:

† Perform reagent unload to unload all reagents

Reagent Carousel Bay

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

† Remove Reagent Carousel per R&R D1.01

† Locate and remove one each of 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 (R&R D1.01) from housing without disconnecting;
then reseat

† Identify Carrier Detect Sensor

† Identify Reagent Carousel Home Sensor

† Remove Dispersion Gear Ring (R&R D3.01, set aside without disconnecting cable connectors)

(Continued)

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† Remove Reagent Cooler R&R D3.01 and examine

† Locate the 2 thermistors on the Reagent Cooler

a. What are the 2 Thermistors on the cooler?


_______________________________________________________________________
_______________________________________________________________________

† Replace ALL removed assemblies

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 3540 Temperature Status

† Perform M&D 3002 Reagent Carousel Test

END OF TEMPERATURE ACTIVITY

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Appendix C

ACTIVITY - i1000SR SYSTEM FLUIDICS AND VACUUM


Time to complete: 90 Minutes
Debrief Session: 15 minutes

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.

Students Perform the following:

Fluidics function

With instrument powered ON

† 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

Test Vacuum Pump function

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

(Continued)

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Appendix C

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

Fluidic Components

† 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)

† 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.

† Locate the Trigger and Pretrigger pumps


 Note the location and orientation of the securing screws that will be required to remove these pumps

(Continued)

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† Access the Bulk Solution Center and locate the following:


 Buffer Reservoir
 Trigger / Pretrigger bottles and tray
 Buffer Pump
 Wash zone Pump
 Transfer Pump
 Buffer Flow (Air Detect) Sensor
 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.

† Trace the condensate drain tubing from the Reagent Cooler to the Lower Waste Manifold
 Locate and Identify the condensate filter

† 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

† Replace all removed components:


 Waste Pump Head
 Vacuum Pump, Filter and Muffler
 Vacuum Accumulator

† Locate and identify the Waste Pump Pressure Switch

† Perform M&D 1109 Wash Cup Pre-Alignment

† Perform M&D 1110 Pipettor Calibration

† Perform M&D 2137 Flush Fluids

† Perform M&D 2052 Wash Zone Aspiration Test

END OF FLUIDIC AND VACUUM ACTIVITY

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Notes Page

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Appendix C

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 C

† 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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Appendix C

ACTIVITY - i1000SR SYSTEM PROCESS PATH AND PIPETTOR


Time to complete: 1.5 Hours
Debrief Session: 15 minutes

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.

Students Perform the following:

Pipettor Assembly, PM and LLS subsystems

† 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)

† Replace Pipettor and Pressure Monitor

† Locate and Identify the Sample Antenna Board


 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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Appendix C

Processing Center

† Remove the RV Loader Assembly R&R A1.01 and set aside

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

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

† 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)

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

† Reassemble Process Path

† Replace Pipettor Probe

† Perform M&D 1110 Pipettor Calibration

† Perform M&D 2052 Wash Zone Aspiration Test

END OF PROCESS PATH AND PIPETTOR ACTIVITY

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Appendix C

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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Appendix C

† 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

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Appendix C

ABBOTTLINK TROUBLESHOOTING ACTIVITY-i1000SR SYSTEM


Time to complete: 30 minutes
Debrief Session: 5 minutes

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.

Students Perform the following:

Navigation and Dashboard


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 "*" and 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
i. Then click on the instrument serial number hyperlink
- The instrument Dashboard for the selected instrument will display
(Continued)

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206039-101 FOR ABBOTT INTERNAL USE ONLY
Appendix C

2. From the Dashboard screen:


† Identify instrument location
† List current status____________________________
† Identify Notification Text
† Open Message History Log, record date (on bottom)__________
† List the Last Hardware message including error and date_____________________

_______________________________________________________________
______________________________________________________________
† 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 ABBOTTLINK ACTIVITY

END OF MODULE

C-34 ARCHITECT i1000SR Differences FS Training Guide


FOR ABBOTT INTERNAL USE ONLY 206039-101

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