Abbott ARCHITECT RHS Training manual

Service Training Guide

Retest Sample Handler

INTRODUCTION

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Notes Page

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The Abbott ARCHITECT

®

System is manufactured and/or distributed by Abbott Laboratories, U.S.A.,

Abbott Park, IL 60064.

All samples (printouts, graphics, displays or screens, etc.) are for information and illustration purposes

only and shall not be used for clinical or maintenance evaluations.

Any product information in this document should be used in conjunction with the latest version of the

Operations and Service Manuals. If any discrepancies in information exist within this document or any

other, the latest version of the Operations and/or Service Manual takes precedence.

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

Except as permitted above, no license or right, expressed or implied, is granted to any person under any

patent, trademark, or other proprietary right of Abbott Laboratories.

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.

This guide was developed and produced by U.S. Commercial Training Dallas, TX.

REVISION STATUS

Document Control

Number

Revision Date

Content or Pages Revised, Added, or

Deleted

201532-101 December 2005 New Release

201532-102

August 2006 Pages revised: 3, 12, 13, 16, 1-8, 1-12, 2-23, 2-20,

2-29, 2-30, 3-23, 4-15, 5-15, A-14, and Exam-4

Trademark Trademark Statement

ARCHITECT ARM

TM

and SmartWash

TM

Systems

ARCHITECT ARM

and SmartWash are trademarks of Abbott

Laboratories.

ARCHITECT ci8200

®

, c8000

®

, i2000

®

i2000

SR

®

and

Systems

ARCHITECT ci8200, c8000, i2000, and i2000

SR

Systems

are

registered trademarks of Abbott Laboratories.

ARCHITECT

®

Systems

ARCHITECT Systems are registered trademarks of Abbott

Laboratories.

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CONTENTS

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

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

Module 2: Basic Operation......................................................................................... 2-1

Module 3: Robotics..................................................................................................... 3-1

Module 4: Power and Logic ....................................................................................... 4-1

Module 5: Miscellaneous............................................................................................ 5-1

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

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TRAINING OVERVIEW

The ARCHITECT

®

System is a fully-automated system allowing random and continuous access. The

Retest Sample Handler (RSH) module is the portion of an integrated instrument system with which the

operator interacts to load and unload samples. The sample-handling module moves samples from the

loading platform to each aspiration point on any processing module through an instrument system. When

testing is complete, the samples are returned to the loading platform for operator removal and storage.

The ARCHITECT System is designed to be a multi-module system. That means you can combine multiple

Processing Modules (PMs) to form one workstation that is controlled by a single System Control Center

(SCC). A single, primary Sample Handler 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 system.

The ARCHITECT

RSH training program is an integrated, ongoing approach designed to provide the

knowledge and skills needed to perform service calls effectively on the ARCHITECT System.

Goals

Upon completion of the training program you will be able to:

1. Perform Basic Operations including Maintenance, Operation, and Calibration.

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

3. Perform component removal and replacement procedures.

4. Perform the procedures associated with Planned Maintenance (PM) and/or Preventative Maintenance

Inspection (PMI), Instrument installation and Instrument Integration.

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Materials

The information for the RSH Service Training Class will be presented by instructors using the following

materials:

• ARCHITECT RSH Service Training Guide

• ARCHITECT RSH Service and Support Manuals

• ARCHITECT Systems Operations Manual

• Technical Service Bulletins (TSB)

• Instrument Service Advisories (ISA)

ARCHITECT

System and RSH Service and Support Manuals, ARCHITECT System Operations Manual,

Technical Service Bulletins, and Instrument Service Advisories can be accessed through the Abbott Global

Service and Support (GSS) intranet site unless otherwise noted.

Service Personnel should keep their laptop updated to contain current revision levels of materials through

timely installation of CD-ROM updates and/or replication.

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GRAPHIC CONVENTIONS

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

attention.

General Icons

Note

Reference Materials

Diagnostic Information



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.

The refer to signal word appears adjacent to an important

document contained elsewhere within the training guide.

The refer to is preceded by a book icon.

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.

The tool icon signals an important point of diagnostic

information that is relevant to the current subject matter.

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HAZARDS

The ARCHITECT RSH has been designed for optimal operator safety. However, this does not reduce the

importance of safety awareness where hazards exist. This section describes the types and locations of

potential hazards that could cause physical harm or damage to the laboratory environment or where failure

to follow instructions may result in instrument failure or generation of erroneous patient results.

This section describes the types and locations of potential hazards that could cause physical harm.

Warnings are inserted throughout this Service Training Guide to alert Service Personnel to potential

hazards.

Hazard Signal Words

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

Review the Hazard and Safety Information contained in the ARCHITECT RSH Service

and Support Manual Section: General Data and the ARCHITECT Systems Operations

Manual, Section; 8 Hazards, for complete information.

Signal Word Definition

WARNING Denotes a physical, mechanical, or procedural condition that

could result in moderate to serious personal injury.

CAUTION Denotes a condition or activities that could result in minor

injury or interfere with proper functioning of the System.

Note Denotes operator or service information.

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Safety Icons and Hazard Symbols

Safety icons in this manual and on the ARCHITECT System identify potentially dangerous conditions.

Service Personnel must recognize the icons and understand the type and degree of potential hazard. The

following icons may be used with text or in lieu of text. If text accompanies the icon, it describes the

nature of the hazard and is labeled with DANGER, WARNING or CAUTION. In some situations,

instrument labels refer Service Personnel to the manual for specific information.

Safety Icon Definition and Descriptions:

Safety Icon Hazard Description

WARNING: Potential Biohazard Identifies an activity or area where potentially infectious

materials may be present. Follow procedures as outlined below

in “Biological Hazards” Section.

WARNING: Electrical Shock

Hazard

Identifies the possibility of electrical shock if procedural or

engineering controls are not observed.

CAUTION: Class 2 Laser

Radiation. Avoid eye exposure

to laser light. Do not stare into

beam.

Warns against direct viewing into the bar code laser beam or

reflections from the beam.

WARNING: Hot Surface

CAUTION: Hot Surface

Identifies an area where a hot surface is present or may be

present in case of an instrument malfunction.

WARNING: Probe Stick Hazard Identifies an activity or area where probes may be present.

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.

CAUTION: Chemical Hazard Identifies an activity or area where hazardous chemicals are

present. Refer to the Material Safety Data Sheet (MSDS) or

package insert for specific safety information.

WARNING: Splash/Spray

Hazard

Identifies an area where fluids may be under pressure.

CAUTION: Possible

Electrostatic Discharge Shock

Identifies an area where electrostatic discharge may be present.

A ground strap must be worn while servicing the system.

Note: Card Cage Ground

A protective grounding symbol appears on the ARCHITECT

®

System at any electrical terminal that must be connected to

earth ground before any other connections can be safely made

to the equipment.

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Other Related Symbols

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.

Icon Description

NOTE: The alternating current symbol appears on the

ARCHITECT

®

System at a terminal to which or from

which an alternative (sine wave) current or voltage can

be applied or supplied.

NOTE: On an electrical switch, a vertical bar identifies the ON

position.

NOTE: On an electrical switch, a circle identifies the OFF

position.

Hazard Symbol Definition/Description (with Standard Abbreviation)

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

Flammable (F+).

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

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

Indicates the material is Corrosive (C).

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

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Electrical Hazards

The ARCHITECT System does not pose uncommon electrical hazards if it is installed properly and

connected to a power source that meets required specifications.

Basic electrical hazard awareness is essential to the safe operation of any system. It is recommended that a

ground fault circuit interrupter be used when working in a wet environment. Only qualified personnel

should perform electrical servicing. Elements of electrical safety include, but are not limited to the

following:

• Inspect electrical cabling into and on the ARCHITECT System periodically for signs of wear and

damage.

• Determine the cause of blown fuse or thrown circuit breaker and correct the problem before attempting

to resume operation of the equipment. Only use replacement fuses of the specified type and electrical

rating.

• Assure the power to the instrument is turned OFF when designated within the performance of certain

service procedures. Be aware that a high voltage charge may remain on the power supply with the

power OFF.

• Use an electrically insulated tool to disconnect the Power Supply and short both male pins to the

instrument chassis.

• Keep liquids away from all connectors of electrical or communication components. Unplug the

instrument before clean-up of major liquid spills.

• Make sure hands are dry prior to touching any switches or outlets.

• Keep the floor dry and clean under and around the ARCHITECT System.

• Follow the ARCHITECT System’s instructions to remove power to the processing module(s) and

sample handler when designated within the performance of certain procedures.

NOTE: Refer to the ARCHITECT Systems Operation Manual, Section 5 Operating

Instructions to view the SHUTDOWN procedure.

• Use only approved power cords and electrical accessories, such as those supplied with the instrument,

to protect against electrical shock. Connect power cords only to properly grounded outlets.

NOTE: Refer to the ARCHITECT System Service and Support Manual, System

Specifications for additional information.

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Mechanical Hazards

The RSH System is an automated system that operates under computer control. As with most automated

equipment there is potential for injury and bodily harm from moving mechanical components whenever

the instrument is in operation. The ARCHITECT System minimizes mechanical hazards by providing

guards to protect against accidental contact with moving components.

The ARCHITECT System requires accurate positioning of all sample, reagents, calibrators, controls, and

consumables before executing any program. If safe guards must be removed or disconnected during setup

and testing procedures, use caution. Stay a safe distance away from the moving components; fast moving

parts may cause injury. Always replace the safe guards upon completion of setup and testing procedures. It

is never acceptable for instrument operators to reach into the instrument when it is in an operating mode.

Should intervention be necessary during a run, the run should be interrupted according to instructions

defined in the ARCHITECT Systems Operations Manual.

Injury may result in the event of an instrument malfunction or an unexpected sequence of mechanical

component movements. Basic elements of mechanical equipment safety include but are not limited to:

• Never bypass or override a safety device unless during setup or testing activities.

• Never operate the instrument without protective covers and barriers in place unless during setup or

testing activities.

• Never allow any part of the body to enter a range of mechanical movement during system operation.

• Do not wear articles of clothing or accessories that could catch on the ARCHITECT System.

• Keep pockets free of items that could fall into the system.

• Keep all protective covers in place when instrument is running.

• Be especially cautions when performing adjustment, maintenance, cleaning, or repair procedures.

• Use caution when loading sample carriers.

• Learn your system, and follow instructions carefully.

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Laser Light

Laser classification schemes are used to describe the capability of the laser or laser system to cause injury

to personnel. The higher the classification number, the greater the potential hazard. The lasers on the RSH

System emits a Class 2 laser radiation.

When these products are used according to its operating instructions, the laser does not present a hazard to

the eyes. Never stare directly into the beam, look into the aperture, place any optics into the beam or

bypass interlocks. Failure to follow proper procedures may result in an eye injury.

Only Abbott trained personnel or Service Personnel should remove the inner protective covers that enclose

the embedded laser.

Do not remove, damage or obliterate any of the laser warning labels. If any label becomes illegible, replace

it.

Proper warning wording and labeling:

Laser Caution Labels

Laser Aperture Label

• RSH (Retest Sample Handler), the label below affixed above the Sample Bar Code Reader under the priority bay

cover

Laser Class Wording Figure

1 CLASS 1 LASER PRODUCT Figure 1

2 LASER RADIATION

DO NOT STARE INTO BEAM

Figure 2

Figure 1

Figure 2

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Biological Hazards

The following activities may involve the presence of potentially infectious materials:

• Handling samples, reagents, calibrators, and controls.

• Cleaning spills.

• Handling and disposing of waste.

• Moving the System.

• Performing maintenance procedures.

• Performing decontamination procedures.

• Performing component replacement procedures.

Precautions

All instruments that have been used to process clinical specimens, reagents, controls, calibrators, etc., that

contain human sourced material must be treated as potentially infectious. Follow ADD’s Biosafety

procedures, which include, but are not limited to the following precautions:

• Wear gloves, lab coats, and protective eye wear when handling human sourced material or

contaminated instrument components.

• Do not pipet by mouth.

• Do not eat, drink, smoke, apply cosmetics, or handle contact lenses when handling human sourced

material or contaminated instrument components.

• Clean spills of potentially infectious materials and contaminated instrument components with a

detergent followed by an appropriate disinfectant, such as 0.1% sodium hypochlorite or other suitable

disinfectant.

• Decontaminate and dispose of all potentially contaminated materials into the appropriate biohazard

waste system in the facility. Probes and other sharp objects should be placed in puncture resistant

sharps containers for disposal.

Refer to the ADD Biosafety Guidelines for Field Service on ADDonline.

If exposed to infectious or potentially infectious materials, immediately cleanse the affected area, then seek

medical attention as soon as possible:

• Eyes - rinse with water for 15 minutes.

• Mouth - rinse with water.

• Skin - wash the affected area with soap and water.

• Puncture wound - allow to bleed freely. Wash the affected area with soap and water.

Report all accidents to your Manager and Workman’s Compensation Administrator. Additional

information is available on ADDonline.

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Spill Clean-up Procedure

Clean spills in accordance with established biosafety practices and follow instructions provided in the

Material Safety Data Sheet. In general, safe work practices for cleaning spills include:

1. Wear appropriate personal protective equipment such as gloves, lab coat, and protective eye wear.

2. Absorb the spill with absorbent material.

3. Wipe the spill area with detergent solution.

4. Wipe the area with an appropriate disinfectant such as 0.1% sodium hypochlorite.

5. Dispose of spilled and contaminated material in accordance with the facilities waste disposal

procedures.

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Instrument or Part Decontamination

Any part subject to user handling (for instance; keyboards, printers, monitors, front panels, etc.) requires

decontamination prior to servicing or shipment. When handling or decontaminating spare parts for

shipping or repair, use safety precautions as listed below:

Always wear appropriate personal protective equipment (protective eye wear, gloves, lab coat) while

performing decontamination activities.

NOTE: Refer to the ARCHITECT RSH (or appropriate Processing Module) Service

and Support Manual, Procedure Section, to view the pre-service

decontamination procedure.

1. Remove all specimens, reagents, controls, calibrators, etc., from the instrument.

2. Cycle 0.5% sodium hypochlorite solution (chlorine bleach) through the fluid pathway (including

probes, if applicable) that contacted the human sourced material or products containing potentially

infectious material. Allow the solution to stand for a minimum of 10 minutes. If a chlorine bleach

solution cannot be used, cycle buffer or water through the fluid pathway to thoroughly flush the fluid

pathway.

3. Remove all liquid materials from the instrument, if present.

4. Rinse waste containers with 0.1% sodium hypochlorite or other suitable disinfectants prior to shipping

or disposal.

5. Wipe down the surface of the instrument and each component with a detergent solution followed by an

appropriate disinfectant such as 0.1% sodium hypochlorite.

Under normal circumstances, printed circuit boards, Field Replaceable Units enclosed inside the skins of a

computer, and peripheral equipment are not considered contaminated. Decontamination may affect the

performance of such materials.

Waste Handling and Disposal

It is responsibility of each facility to label all waste containers and to characterize its waste stream to

ensure the waste is disposed of in accordance with the appropriate waste disposal regulations.

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

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Chemical Hazards

Service Personnel may be exposed to hazardous chemicals when handling reagents, calibrators, controls,

or liquid consumables.

The following activities may involve the inadvertent exposure to hazardous chemicals:

• Handling reagents, calibrators, and controls.

• Cleaning spills.

• Handling and disposing of waste.

• Moving the c8000 System.

• Performing maintenance procedures.

• Performing decontamination procedures.

Exposure to hazardous chemicals is minimized by following instructions provided in the assay-specific

Package Inserts and Material Safety Data Sheets (MSDS). Exposure levels are further reduced by the

design features to the instrument when it is used properly.

Precautions

In general, observe the following precautions when handling chemicals:

• Consult Material Safety Data Sheets for safe use instructions and precautions.

• Avoid contact with skin and eyes. If contact with material is anticipated, wear impervious gloves and

protective eyeware and clothing.

• Always maintain good housekeeping. Do not eat, drink, or store food and beverages in areas where

chemicals are used.

• If irritation or signs of toxicity occur after exposure, seek medical attention.

Hazard symbols that appear on ARCHITECT

®

System product labeling are accompanied by Risk (R) and

Safety (S) numbers and represent specific risk and safety phrases as defined by applicable European

Community Directives. The risk and safety phrases describe precautions to be used when working with a

particular chemical or chemical mixture. For all Risk (R) and Safety (S) numbers that appear on product

labeling, refer to the corresponding phrases indicated in the respective package inserts. Other country

specific warning and precautions may be included on the labeling.

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Abbott ARCHITECT RHS Training manual

Abbott ARCHITECT RHS Training manual

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