Dako Autostainer User Manual
Dako Autostainer | English Handbook
ii Autostainer Handbook
Dako Autostainer Handbook
Document Number 0000620
Revision A
July 2006
Autostainer Handbook
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iv Autostainer Handbook
Copyright © 2006 Dako, Inc. All rights reserved.
This document may not be copied in whole or in part or reproduced in any other media
without the express written permission of Dako, Inc. Please note that under copyright
law, copying includes translation into another language.
User Resources
For the latest information on Dako products and services, please visit the Dako Web site
at:
http://www.dako.com
Installation Procedure
Dako employees will perform the initial installation and setup of all new System
instruments.
Relocation Procedure
Contact Dako’s Technical Service Group before relocating your system.
Scope
This handbook contains basic information on the use and operation of the Autostainer
and assumes you have received basic training on the instrument. Please contact our
Technical Service Group or refer to the Autostainer User Guide for information not
provided in this manual. This manual does not provide instructions for the installation or
upgrade of hardware.
Disclaimers
This manual is not a substitute for the detailed operator training provided by Dako, Inc.,
or for other advanced instruction. Dako Technical Service Group should be contacted
immediately for assistance in the event of any instrument malfunction. Installation of
hardware or software on your Autostainer should be performed only by a certified Dako
Field Service Representative.
Contact Information
U.S. Customers
Dako, Inc
6392 Via Real
Carpinteria, CA 93013 USA
Tel 805-566-6655
Fax 805-566-6688
Technical Support 800-424-0021
Customer Service 800-235-5763
Outside U.S.
Dako Denmark A/S
Produktionsvej 42
DK-2600 Glostrup Denmark
Tel +45 4485 9500
Fax +45 4485 9595
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Table of Contents
Warnings, Precautions and Limitations............................................................................. 1
System Overview .............................................................................................................. 5
Software Overview ............................................................................................................7
Sign In Screen............................................................................................................... 7
Main Menu ....................................................................................................................7
Initialize ......................................................................................................................... 8
Label Printing Initialization ........................................................................................8
Communication Port.................................................................................................. 9
Printer Selection...................................................................................................... 10
The Options Screen ................................................................................................ 10
Format Program Grid ..............................................................................................10
IHC Report ..............................................................................................................10
Custom Options ......................................................................................................10
Reagent Volume and Drop Zone Default ................................................................11
Clean........................................................................................................................... 11
Sign Off and Help........................................................................................................ 11
Reagent Tracking........................................................................................................ 11
Prime Pump ................................................................................................................12
Programming Grid Overview....................................................................................... 12
Entering Slide Information............................................................................................... 13
Adding Slides .............................................................................................................. 13
The Slide Info Button................................................................................................... 13
Deleting Slides ............................................................................................................ 14
Deleting Slides With the Slides Function.................................................................14
Deleting Slide ID Information Using the Slide Info Button....................................... 14
Rearranging slide positions on the Programming Grid ...............................................14
Designing a Protocol....................................................................................................... 15
Standard Protocol Elements .......................................................................................15
Additional Protocol Elements ...................................................................................... 16
Rinse Buffer ............................................................................................................16
Rinse Water ............................................................................................................16
Standard Rinse Replacement ................................................................................. 16
Substrate-Batch ......................................................................................................16
Switch...................................................................................................................... 16
Creating and Editing a Protocol Template ..................................................................16
Deleting a Protocol Template...................................................................................... 17
Using a New Protocol Template Without Saving ........................................................17
Using a Saved Protocol Template............................................................................... 17
Using a Saved Protocol Template for a Specific Auto Program.................................. 18
Selecting Reagent Dispense Volume for All Steps in a Protocol ................................ 18
Selecting Reagent Dispense Volume for a Specific Step in a Protocol ......................18
Programming a Staining Run .......................................................................................... 19
Defining Detection Reagents ......................................................................................19
Defining Primary Antibodies........................................................................................ 20
Assigning Positive and Negative Control Reagents.................................................... 20
Adding Positive and Negative Control Reagents ....................................................21
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Negative Controls.................................................................................................... 21
Defining Specific Rinses .............................................................................................22
Auto Programming ...................................................................................................... 22
Deleting an Auto Programming Item .......................................................................23
Using an Auto Programming Item ...........................................................................23
Copy/Paste.............................................................................................................. 23
Editing a Protocol Step................................................................................................ 24
Printing Options........................................................................................................... 24
Slide Labels............................................................................................................. 24
Reagent Labels .......................................................................................................25
Reports.................................................................................................................... 25
Viewing Programmed Slides .......................................................................................25
Assigning Reagent Dispense Locations.................................................................. 26
Printing a Slide Layout Map ....................................................................................26
Selecting a new reagent-dispense location for all slides:........................................ 26
Reagent Management..................................................................................................... 27
Adding Detection Reagents (Secondary, Tertiary, Substrate, etc.) ............................27
Adding Primary Antibodies.......................................................................................... 28
Editing and Deleting Reagent Lists .............................................................................28
Updating a Reagent Lot Number and Expiration Date................................................ 28
Compatibility Check ....................................................................................................29
Loading Reagents........................................................................................................... 31
Reagent Layout Map Screen ......................................................................................31
Missing Reagent Notice .............................................................................................. 32
Loading Slides.................................................................................................................33
Load Slides .................................................................................................................33
Starting a Staining Run ...................................................................................................35
Preparing the System for a Staining Run.................................................................... 35
Quick Start ..................................................................................................................35
Run Log Screen ...................................................................................................... 36
Shutting Down the Autostainer.................................................................................... 36
Maintenance and Troubleshooting.................................................................................. 37
Troubleshooting ..........................................................................................................37
System Specifications ..................................................................................................... 43
Hardware Specifications .............................................................................................43
Software Specifications............................................................................................... 43
Standard Configuration ...................................................................................................45
viii Autostainer Handbook
Section 1
Warnings, Precautions and Limitations
Keep the cover closed during operation. The robotic arm will move unexpectedly
during the operation - stay clear. Do not impair the movement of the Autostainer robotic
arm in any way.
Do not pour liquid down the Autostainer sink. The system is not equipped to
drain large liquid volumes poured at high speed. Hazardous reagent wastes must be
disposed of according to local, state, and federal regulations. Wear appropriate personal
protective equipment to prevent exposure.
Do not use bleach in the Autostainer. Bleach may react with other chemicals and
create toxic fumes.
Do not attempt to service the Autostainer unless instructed to do so by an
authorized Dako representative. Doing so will void the warranty or service contract. Do
not relocate the Autostainer System within your facility before contacting your local Dako
representative for vital information that may affect your warranty.
Contact your local Dako representative prior to using non-Dako reagents or
solutions on your Autostainer. Some solvents, acids, and other solutions may cause
damage to internal components of the Autostainer and affect your instrument's
performance and warranty.
Remove caps from reagent vials before starting a run on the system. Place the reagent
racks firmly in their seated position before starting a run.
Place the slide racks in the down position before starting a run on the system.
Do not use the scroll bars to select reagents from the reagent lists when setting up
subsequent runs while the Autostainer is processing. Using the scroll bars during
operation will cause the Autostainer to pause temporarily.
Do not use symbols when programming reagents or protocols. Doing so may cause
errors during the run.
Do not run more than one software application during operation (this includes the CD
player and screen savers). Do not install third-party software or hardware products.
Installing third-party products may lock up the Autostainer and may void the warranty.
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Do not print slide labels while the Autostainer is running.
Immunohistochemistry is a multi-step diagnostic process that requires specialized
training in the selection of the appropriate reagents, tissue selection, fixation, and
processing, preparation of the IHC slide, and interpretation of the staining results.
Tissue staining is dependent on the proper handling and processing of tissues prior to
staining. Improper fixation, freezing, thawing, washing, drying, heating, sectioning or
contamination with other tissues or fluids may produce artifacts, antibody trapping, or
false-negative results. Inconsistent results may be due to variations in fixation and
embedding methods, or to inherent irregularities within the tissue. Excessive or
incomplete counterstaining may compromise proper results.
Use of old or unbuffered fixatives, or exposure of tissues to excessive heat (greater than
60°C) during processing may result in decreased staining sensitivity.
Normal/non-immune sera from the same animal source as the secondary antisera used
in blocking steps may cause false-negative or false-positive results due to autoantibodies or natural antibodies. False-positive results may be seen due to nonimmunologic binding of reagents to tissue sections. In some case the application of an
alternate blocking reagent prior to incubation with the primary antibody may be useful for
reducing background. A recommended blocking reagent is Dako Protein Block SerumFree (Code No. X0909).
Unexpected negative reactions in poorly differentiated neoplasms may be due to loss or
marked decrease of antigen expression or nonsense mutation in the gene(s) coding for
the antigen. Unexpected positive staining in tumors may be from expression of an
antigen not usually expressed in morphologically similar normal cells, or from
persistence or acquisition of an antigen in a neoplasm that develops morphologic and
immunohistochemical features associated with another cell lineage (divergent
differentiation). Histopathologic classification of tumors is not an exact science and some
literature reports of unexpected staining may be controversial.
The clinical interpretation of any positive staining or its absence should be
complemented by morphological and histological studies with proper controls.
Evaluations should be made within the context of the patient’s clinical history and other
diagnostic tests. It is the responsibility of a qualified pathologist who is familiar with the
antibodies, reagents and methods used to interpret the stained preparation. Staining
must be performed in a certified licensed laboratory under the supervision of a
pathologist who is responsible for reviewing the stained slides and assuring the
adequacy of positive and negative controls.
Reagents may demonstrate unexpected reactions in previously untested tissues. The
possibility of unexpected reactions in tested tissue groups cannot be completely
eliminated due to biological variability of antigen expression in neoplasms, or other
pathological tissues. Contact your local Dako representative with documented
unexpected reactions. Tissues from people infected with hepatitis B virus and containing
hepatitis B surface antigen (HBsAg) may exhibit nonspecific staining with horseradish
peroxidase.
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Correct Disposal of this Product
(according to Directive 2002/96/EC on Waste Electrical and
Electronic Equipment [WEEE] applicable in the European Union
and other European countries with separate collection systems).
Contact a Dako representative for disposal of the equipment at
the end of its working life. This product should not be mixed with
other commercial waste for disposal.
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Section 2
System Overview
The Autostainer System is an automated slide processing system compatible with
currently available reagents for staining paraffin-embedded and frozen tissue sections,
cytospins, cell smears, and fine-needle aspirates. This system is designed to automate
manual staining methods routinely used in immunohistochemistry and cytochemistry,
enabling the transfer of established protocols from the bench to the Autostainer.
Flexible programming allows for an unlimited number of protocols containing up to 35
steps (including rinse and blow steps between reagent incubations) and 64 different
reagents. A staining run can process from 1 to 48 microscope slides. Individual slides
can be programmed to receive different reagents, of specified volume, during any step in
a staining protocol, and waste is segregated into hazardous and non-hazardous
collection containers, reducing disposal costs.
The Autostainer is designed to track a variety of data. It can generate patient, reagent,
and real-time operation data reports, as well as track reagent usage and log instrument
maintenance.
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Section 3
Software Overview
Sign In Screen
The Sign In screen appears when you double-click the Autostainer icon on the desktop.
After your name and password have been validated, the Main Menu appears.
Main Menu
The buttons on the Main Menu allow you to access the other Autostainer screens.
Note: Change Password replaces the Initialize button for users with middle and low
security access.
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Initialize
The Initialize screen is used to establish and update default information for the system.
This includes the institution information, Autostainer serial number, user names, the
doctors requesting IHC tests, a library of tissues that may be used during staining, the
default volume and the drop zone for reagent dispensation, and the number of slides
allowed between routine cleaning runs. Slide and reagent label formatting, user-defined
printing formats for the Programming Grid, and IHC Reports can also be configured
from this screen.
Label Printing Initialization
The Slide Labels and Reagent Labels buttons are displayed on the Initialize screen
and are used to access the Design Label screens for configuring and adjusting slide
and reagent label printing.
Slide Labels
The Slide Labels button is displayed on the Initialize screen and it is used to access
the Design Slide Label screen for configuring and adjusting slide label printing. Slide
labels are printed from the Print button on the Programming Grid. Do not print labels
while the Autostainer is operating.
1. Select the Slide Labels button.
Note: If Slide ID, Doctor, or Tissue is selected to print on the label, then these items
must be selected from the Options button in the Initialize screen. If these
Programming Grid items are not selected by using the Options button in the
Initialize screen, then these fields will not be present in the Slide Information
screen.
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