Dako Autostainer Plus User Manual

Dako Autostainer Plus | User Guide

Document Number 0003107

Revision D

March 2007

For In Vitro Diagnostic Use

UL and cUL

Dako Colorado, Inc.

4850 Innovation Drive

Ft. Collins, CO 80525 USA

970-226-2200

Dako Autostainer Plus | User Guide

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Dako Autostainer Plus Universal Staining System

Dako Autostainer Plus Information

Dako Autostainer Model:	_______________________
Serial Number:	_______________________
Software Version:	_______________________
Computer Configuration:	_______________________
CPU:	_______________________
Hard Drive:	_______________________
Floppy Drive:	_______________________
Internal Memory:	_______________________
Monitor:	_______________________

Dako Autostainer Software Product License

IMPORTANT: Please read the license carefully before using this Software. The right to use this Software is granted only if the Customer agrees to the terms of this license. If you do not agree to the terms of this license, you may return the unused Software for a refund. HOWEVER, USE OF THIS SOFTWARE INDICATES YOUR ACCEPTANCE OF THESE TERMS AND CONDITIONS.

In return for the payment of the applicable one-time license fee included with the purchase price of the Dako Autostainer, Dako grants the user a license to use one copy of the Software subject to the following terms and conditions. No title or ownership of the Software is conferred with this license.

1.The Software may be used on one Dako Autostainer Plus.

2.The Software may not be copied.

3.The Software may not be disassembled, decompiled, decrypted or reverse engineered.

4.Dako reserves the right to terminate this license upon breach. In the event of termination at Dako’s election, all copies of the Software must be returned to Dako.

5.No title or ownership of the Software is conferred with this license.

Copyright © 2007 Dako Colorado, 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. Please note that under copyright law, copying includes translation into another language.

2	Dako Autostainer Plus | User Guide

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Dako Autostainer Plus | User Guide

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4	Dako Autostainer Plus | User Guide

Table of Contents
Section 1 | Introduction ........................................................................................................	9
Dako Autostainer Plus Features..........................................................................................	9
Universal System.............................................................................................................	9
Quick Start-up..................................................................................................................	9
Flexible Programming......................................................................................................	9
Economic Use..................................................................................................................	9
Data Management and Report Generation....................................................................	10
Slide and Reagent Labels..............................................................................................	10
Differences from the Autostainer System ......................................................................	10
Section 2 | System Specifications.....................................................................................	11
Hardware Specifications....................................................................................................	13
Software Specifications .....................................................................................................	13
Accessories included with the Dako Autostainer Plus.......................................................	14
Section 3 | Installation Requirements ...............................................................................	15
Requirements ....................................................................................................................	15
Recommendations ............................................................................................................	15
Section 4 | Typical Operation.............................................................................................	17
Section 5 | Programming Overview...................................................................................	19
Menu Bar Options .............................................................................................................	20
Slides Function ..............................................................................................................	20
File Menu .......................................................................................................................	20
Edit Lists Menu ..............................................................................................................	21
Copy Function................................................................................................................	22
Auto Function.................................................................................................................	22
Command Buttons .........................................................................................................	22
Section 6 | Accessing the Dako Autostainer Plus Software ...........................................	23
Section 7 | Initializing the Dako Autostainer Plus............................................................	25
Entering Institution Information..........................................................................................	26
Editing Institution Information ............................................................................................	27
Entering Staff Information..................................................................................................	27
Editing User Information....................................................................................................	28
Deleting User Information..................................................................................................	29
Adding a New Doctor ........................................................................................................	29
Deleting Doctor Information...............................................................................................	30
Entering Tissue Information ..............................................................................................	30
Adding a New Tissue.....................................................................................................	30
Deleting a Tissue ...........................................................................................................	30
Entering Default Reagent Information ...............................................................................	30
Assigning Default Reagent Dispense Volumes .............................................................	30
Assigning Reagent Drop Zone.......................................................................................	31
Cleaning Schedule.........................................................................................................	31
Label Printing Initialization.................................................................................................	32
Slide Labels ...................................................................................................................	32
Slide Labels with Bar Codes..........................................................................................	32
Slide Labels without Bar Code.......................................................................................	33
Reagent Labels..............................................................................................................	34
Label Adjustment ...........................................................................................................	35
Scanner Port..................................................................................................................	35
Communication Port ......................................................................................................	35
Printer Selection ............................................................................................................	36
Dako Autostainer Plus | User Guide	5

	The Options Screen ..........................................................................................................	36
	Program Grid .................................................................................................................	36
	IHC Report.....................................................................................................................	37
	Custom Options .............................................................................................................	37
Section 8 | Entering Slide Information ..............................................................................		39
	Slides Function..................................................................................................................	39
	Adding Slides.................................................................................................................	39
	Deleting a Slide..............................................................................................................	40
	The SLIDE INFORMATION Button ...................................................................................	40
	Entering Slide Information Through the SLIDE INFORMATION Button ........................	41
	Deleting Slide ID Information Through the SLIDE INFORMATION Button....................	42
	Deleting a Slide Identification ........................................................................................	42
	Deleting a Case # ..........................................................................................................	43
	Deleting a Block ID ........................................................................................................	43
	Deleting a Specific Slide ................................................................................................	44
	Slide Rearrangement ........................................................................................................	44
	Rearranging slide positions on the Programming Grid ..................................................	44
Section 9 | Designing a Protocol .......................................................................................		45
	Protocol Elements .............................................................................................................	46
	Standard Protocol Elements include:.............................................................................	46
	Rinse Buffer ...................................................................................................................	46
	Rinse Water ...................................................................................................................	46
	Standard Rinse Replacement........................................................................................	46
	Substrate-Batch .............................................................................................................	47
	Switch (*Swtch)..............................................................................................................	47
	Creating and Editing a Protocol Template .....................................................................	47
	Saving a Protocol Template...........................................................................................	48
	Deleting a Protocol Template ........................................................................................	49
	Using a New Protocol Template Without Saving It ........................................................	49
	Using a Saved Protocol Template .................................................................................	49
	Using a Saved Protocol Template for a Specific Auto Program ....................................	50
	Selecting and Editing the Reagent Dispense Volume.......................................................	50
	Selecting and Editing the Reagent Dispense Volume for All Steps in a Protocol..........	50
	Selecting and Editing the Reagent Dispense Volume for a Specific Step in a Protocol 51
Section 10 | Programming Slides ......................................................................................		53
	Defining Slide Specific Reagents ......................................................................................	53
	Defining Detection Reagents (Secondary, Tertiary, Substrate, etc.) .............................	53
	Defining Primary Antibodies ..........................................................................................	54
	Assigning Positive and Negative Control Reagents ......................................................	54
	Negative Controls ..........................................................................................................	55
	Assigning Negative Control Type to Antibodies.............................................................	55
	Using the Negative Control Tool....................................................................................	56
	Defining Specific Rinses ................................................................................................	56
	Auto Programming ............................................................................................................	57
	Creating and Saving an Auto Program ..........................................................................	57
	Deleting an Auto Programming Item..............................................................................	58
	Using an Auto Programming Item..................................................................................	58
	Getting Help with Auto Programming ............................................................................	59
	Copy/Paste........................................................................................................................	59
	Copy/Paste Individual Reagents....................................................................................	59
	Copy/Paste Entire Rows................................................................................................	60
	Editing a Protocol Step......................................................................................................	60
	Changing a reagent for a step: ......................................................................................	60
6	Dako Autostainer Plus | User Guide

Replacing a reagent with skip step (no reagent added to slide): ...................................	60
Editing a reagent in a staining step for one run only:.....................................................	61
Printing Options.................................................................................................................	61
Slide Labels ...................................................................................................................	61
Reagent Labels..............................................................................................................	62
The Main Grid Report ....................................................................................................	63
Immunohistochemical Report (IHC Report)...................................................................	63
Run Log Printout............................................................................................................	64
Viewing Programmed Slides .............................................................................................	64
When the Bar Code feature is disabled .........................................................................	64
Assigning Reagent Dispense Locations ........................................................................	65
Viewing Programmed Slides .............................................................................................	65
When the Bar Code feature is enabled..........................................................................	65
ALL SLIDES Tool...........................................................................................................	66
Printing a Slide Layout Map...........................................................................................	67
Section 11 | Reagent Management....................................................................................	69
Adding New Reagents to Reagent Lists............................................................................	69
Adding Detection Reagents (Secondary, Tertiary, Substrate, etc.) ...............................	69
Adding Primary Antibodies ............................................................................................	70
Editing Reagent Lists ........................................................................................................	72
Deleting Reagents from Reagent Lists..............................................................................	73
Updating a Reagent Lot Number and Expiration Date ......................................................	73
Printing Reagent Labels ....................................................................................................	74
Printing reagent labels from a programmed run. ...........................................................	74
Printing reagent labels not in a program........................................................................	74
Compatibility Check...........................................................................................................	75
Section 12 | Loading Reagents..........................................................................................	77
Reagent Layout Map Screen.............................................................................................	77
Reagent List Screen..........................................................................................................	78
Missing Reagent Error.......................................................................................................	78
Paused to Add Reagent.................................................................................................	79
Slides Skipped ...............................................................................................................	79
Partial Reagent Application ...........................................................................................	79
Section 13 | Loading and Scanning Slides.......................................................................	81
Loading Microscope Slides ...............................................................................................	81
Scanning Slides.................................................................................................................	82
Section 14 | Starting a Run ................................................................................................	83
Slides.................................................................................................................................	83
Racks ................................................................................................................................	83
Reagents ...........................................................................................................................	83
Buffer.................................................................................................................................	83
Water.................................................................................................................................	83
Waste ................................................................................................................................	83
Starting a Run without Delay.............................................................................................	83
Starting a staining run immediately................................................................................	83
Delaying the Start of a Run ...............................................................................................	85
Starting a staining run at a later time. ............................................................................	85
Adding Priority Slides ........................................................................................................	86
Using the Priority Slide Handling with Slide Bar Coding................................................	86
Unloading Priority Slides During a Run .........................................................................	88
Using the Priority Slide Handling without Slide Bar Coding...........................................	89
Delaying the Start of a Run using Substrate-Batch .......................................................	91
Section 15 | Completing a Staining Run ...........................................................................	93
Dako Autostainer Plus | User Guide	7

Printing a Run Log.............................................................................................................	94
Printing a Run Log Without Saving................................................................................	94
Printing and Saving a Run Log ......................................................................................	94
Printing a Temporary Run Log ..........................................................................................	94
Emergency Stop................................................................................................................	95
Immunohistochemical Report............................................................................................	95
Shutting Down the Autostainer Plus..................................................................................	96
Section 16 | Programming During Staining Run..............................................................	97
Reviewing the Current Program during a Staining Run ....................................................	98
Section 17 | System Maintenance .....................................................................................	99
Automated Cleaning Cycle................................................................................................	99
Cleaning Log................................................................................................................	100
Reservoir Cleaning..........................................................................................................	100
Wash Buffer and Water Container Cleaning ...................................................................	100
Slide Rack Cleaning ........................................................................................................	101
Reagent Vial Cleaning.....................................................................................................	101
Computer Maintenance ...................................................................................................	101
Backing Up Files..........................................................................................................	101
Annual Preventative Maintenance...................................................................................	101
Section 18 | Reagent Tracking.........................................................................................	103
Printing the Reagent Tracking Report .............................................................................	103
Printing the entire Reagent Tracking Report ...............................................................	103
Printing only selected reagents from the Reagent Tracking Report: ...........................	103
Remove Reagent from the Reagent Tracking Log..........................................................	104
Remove all Reagents from the Reagent Tracking Log................................................	104
Remove Selected Reagents from the Reagent Tracking Log .....................................	104
Section 19 | Wash Buffers................................................................................................	105
Dako Autostainer Plus Wash Buffer ................................................................................	105
Intended Use ...............................................................................................................	105
Materials Required.......................................................................................................	105
Reagent Preparation....................................................................................................	105
Shelf Life and Storage .................................................................................................	106
Tris-Buffered Saline.........................................................................................................	106
Intended Use ...............................................................................................................	106
Materials Required.......................................................................................................	107
Reagent Preparation....................................................................................................	107
Shelf Life and Storage .................................................................................................	108
Dako Phosphate Buffered Saline ....................................................................................	108
Intended Use ...............................................................................................................	108
Materials Required.......................................................................................................	108
Reagent Preparation....................................................................................................	108
Shelf Life and Storage .................................................................................................	109
Phosphate Buffered Saline..............................................................................................	109
Intended Use ...............................................................................................................	109
Reagent Preparation....................................................................................................	109
Shelf Life and Storage .................................................................................................	110
Section 20 | Troubleshooting...........................................................................................	111
Section 21 | Warnings and Symbols ...............................................................................	119
Symbol Definitions...........................................................................................................	120
Section 22 | General Limitations .....................................................................................	121

8	Dako Autostainer Plus | User Guide

Section 1 | Introduction

The Dako Autostainer Plus System is an automated slide processing system compatible with currently available reagents for the staining of 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 Plus. Alteration of standard reagents or experimental conditions may not be required.

This document is a comprehensive User Guide for the Dako Autostainer Plus System.

Dako Autostainer Plus Features

Universal System

The Dako Autostainer Plus is a universal system enabling the direct transfer of routine staining protocols from the laboratory bench.

Quick Start-up

Dako’s Autostainer Plus Support Team installs and tests the system to ensure proper operation.

The factory-installed software includes standard reagent protocols and commonly used Dako reagents such as Dako LSAB2, Dako EnVision +, Dako EnVision Dual Link +, and HercepTest™ visualization systems. The complete line of ready-to-use Dako N and NP-series primary antibodies and their recommended protocols are also listed.

Flexible Programming

The Dako Autostainer Plus enables the use of slide-specific programmed or user defined protocols. The system provides intuitive programming routines, reagent and slide loading maps and start/finish run time displays.

You can build and save 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 1 to 48 microscope slides. Individual slides can be programmed to receive different reagents, reagent dispense volumes and reagent dispense locations.

The Autostainer Plus also enables the addition of Priority Slides during a run, permitting the repeated addition of new slides in unoccupied positions while maintaining the integrity of the slides running.

Economic Use

The Dako Autostainer Plus provides the flexibility to program reagent volumes of 100, 150, 200, 400 and 600 µL for any step in a staining protocol. Each step can be programmed with a different reagent dispense volume. In addition, waste can be segregated into hazardous and nonhazardous collection containers, reducing disposal costs.

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Data Management and Report Generation

The Dako Autostainer Plus 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.

Slide and Reagent Labels

The Dako Autostainer Plus software provides a simple and efficient means to print slide labels through one-time programming of information for the staining run. Each label has a bar code to assure accuracy. The bar code feature also eliminates the need to insert slides in the proper position; the system will scan the bar codes and maintain the correct order of all slides in the run. The software enables items from the program (slide ID, slide #, case #, block ID, technician, antibody(s), pretreatment, date, doctor, tissue, run name, and static text) to be printed directly on the slide labels. You can also create reagent labels that include information stored in the reagent list (reagent name, lot number, expiration date, incubation time, and date). The printed label text is protected by a heat and chemical resistant laminate, allowing you to apply the labels to the slides at the start of the staining procedure.

Differences from the Autostainer System

If you are familiar with the earlier Autostainer System, the primary improvements in the Dako Autostainer Plus are:

•Addition of bar codes to slide labels, inclusion of Seymour label printer as part of the package

•Insertion of Priority Slides during a run

•Inclusion of a Universal Negative Control

•Modifications to the Programming Screen to simplify the programming of your protocols

•Through the Initialize screen, the Autostainer Plus may now be uniquely identified

These new features, plus others, are fully described in the appropriate section of this User Guide.

10	Dako Autostainer Plus | User Guide

Section 2 | System Specifications

The Dako Autostainer Plus is a combination of hardware and software integrated with the appropriate reagents to automate immunohistochemical and immunocytochemical staining methods. This section describes the hardware and software specifications and the accessories provided with the system.

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Slide Rack	is a slide carrier holding 12 microscope slides in a horizontal
	position. The instrument holds a maximum of 4 racks. These
	racks are removable and interchangeable for slide loading and
	unloading.
Glass Slide	is a standard microscope slide to which specimen(s) is mounted
	for processing on the instrument. Slide dimensions are 25 mm x
	75 mm x 1 mm.
Reagent Racks	hold the reagent vials. There are 2 reagent racks: reagent rack
1 and 2	1 (white) sits in the front right side of the sink; reagent rack 2
	(blue) sits behind reagent rack 1. The racks are identical in
	shape and size. Each rack holds up to 32 reagent vials and is
	marked with letters A-D and numbers 1-8 to designate each
	reagent vial position. The computer always assigns reagents to
	the front whit rack first. If additional reagents are required for a
	procedure or for running the cleaning protocol the computer will
	assign reagents to the blue rack.
Reagent Probe Wash	is a white, plastic assembly located in the rear right corner of
Station	the instrument and is used as a cleaning station for the
	Teflon™-coated reagent probe. The probe is washed in the
	wash station at the beginning of every run, prior to checking
	reagent volumes, and application of each reagent.
Sink	is the Teflon-coated tray that sits underneath the slide racks and
	channels the buffer/DI water washes and reagents into the
	waste reservoir.
Y Axis Mechanism	is the robotic arm extending from the back of the instrument
	towards the front carrying with it the Z head assembly. The Y
	arm moves from right to left across the instrument. When the
	Autostainer Plus is not in operation the Y arm rests on the left
	side of the machine, When the instrument is in operation and
	slides are incubating, the arm is located on the right side.
X Axis Mechanism	enables the Y arm to move from left to right across the
	instrument. The X axis is stationary across the back of the
	instrument.
Z Head Assembly	is the dome-shaped assembly that sits over the Y arm. The Z
	head consists of three components: the probe tip; the wash
	head and the blow head. These components move up and
	down along the Z axis while the instrument is in operation. The
	Z head moves back and forth along the Y axis mechanism,
	allowing access to all slides and reagents.

12	Dako Autostainer Plus | User Guide

Hardware Specifications

Dako Autostainer Plus

	Dimensions		1.02m W x 0.69 m D x 0.61 m H 40” W x 27” D x 24” H
	Weight		140 lb. (63.5 kg)
	Electrical Requirements		120 V 110/120 V (±10%) 60 Hz (±2Hz)
			220 V 220/240 V (±10%) 50 Hz (±2Hz)
	Normal operating		18º C-26º C (64º F-79º F)
	temperature
	Slide rack capacity		1 – 12 glass slides
	Total slide capacity		1 – 48 glass slides
	Reagent capacity		64 different reagents (15 Ml/reagent vial)
	Reagent dispense volumes		100, 150, 200, 400 and 600 µL
	Reagent probe volume		100 µL minimum, 1200
	capacity
Computer Controller
	These are the minimum		NOTE: Computer specifications may vary.
	features provided. Dako
	reserves the right to change
	the computer controller
	specifications at any time.
	Monitor		14” color
	Printer		LaserJet or Inkjet Printer
	Surge Protector		120 VAC, 15 Amps, 50/60 Hz
Software Specifications
	Operating System		Windows® 98, XP or equivalent.
	Operating Logic		Designed to calculate the most time-efficient sequence to
			complete a programmed staining run.
	Protocol Logic		Flexible selection of steps including rinses. Maximum of 35
			protocol steps (including rinse steps)
	Idle Rinse		Buffer is applied to slides during a staining run to keep
			specimens we when no reaction is occurring.
	Rinse Default Settings		Buffer rinse every 30 minutes prior to the start of a run, when
			delayed start is selected. Buffer rinse every 30 minutes during a
			staining run. Water rinse every 60 minutes after completion of
			run. Default setting for time and the amount of buffer dispensed
			can be changed by a Dako representative upon request.
	Incubation Time		Minimum time is 2 minutes.

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Accessories included with the Dako Autostainer Plus

Slide Racks	4 non-disposable slide racks with a 12-slide capacity/rack. The
	slide racks are suitable for standard glass slides; they are
	removable and interchangeable
Reagent Racks	2 removable reagent racks. Each reagent rack holds a maximum
	of 32 reagent vials.
Reagent Vials	100 reagent vials and caps. Each vial holds a maximum of 15
	mL of reagent.
Buffer Container	1 ten-liter plastic container.
Deionized Water Container	1 ten-liter plastic container (not available with the “01” hardware
	version of the Dako Autostainer Plus).
Waste Containers	2 ten-liter plastic containers.
User Guide	1 User Guide with detailed operating instructions.
Seymour Glass Label	The Seymour slide labeling system is a simple, efficient label
Printer	printing system for histology, cytology and research laboratories.
	This system allows you to print only the labels you need – when
	you them – for samples, microscope slides, reagent vials and
	other items.

14	Dako Autostainer Plus | User Guide

Section 3 | Installation Requirements

For installation of the Dako Autostainer Plus, the following requirements should be met to ensure that the instrument functions properly.

Requirements

Surface	Prior to unpacking the Dako Autostainer Plus, ensure that the
	area to be used for instrument is a solid, level surface that can
	safely support the weight of the system (approximately 240 lbs.
	for instrument plus computer).
Size	Minimum dimensions for the Dako Autostainer Plus work area
	are
	2.00 m wide x 0.8 m deep x 1.0 m height (78” w x 30” d x 37” h)
	clearance.
Environment	The work area must also be an environment with an ambient
	temperature between 18° C-26° C (64° F-79° F), not facing
	direct sunlight and not affected by a hood or vent.
Buffer Container	1 ten-liter plastic container.
Deionized Water Container	1 ten-liter plastic container (not available with the “01” hardware
	version of the Dako Autostainer Plus).
Waste Containers	2 ten-liter plastic containers.
User Guide	1 User Guide with detailed operating instructions.
Seymour Glass Label	The Seymour slide labeling system is a simple, efficient label
Printer	printing system for histology, cytology and research laboratories.
	This system allows you to print only the labels you need – when
	you them – for samples, microscope slides, reagent vials and
	other items.

Recommendations

Power source	Dako recommends a dedicated power source for the Dako
	Autostainer Plus to prevent interference from other instruments
	or equipment.

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16	Dako Autostainer Plus | User Guide

Section 4 | Typical Operation

A few “off instrument” preparations will make the staining run more time-efficient. Prior to starting a run you should have the following items:

•A list of slide cases to be run with requested protocols.

•Deparaffinized and rehydrated slides soaking in buffer. This buffer should contain 0.05% Tween 20. A minimum of 5 minutes soaking time is recommended.

•The reagents required for the staining run brought to room temperature.

•Sufficient buffer in the buffer reservoir and deionized water in the deionized water reservoir. The buffer should contain 0.05% Tween 20 (deionized water is not available with the “01” hardware version of the Dako Autostainer Plus).

•Containers for hazardous and non-hazardous waste with enough capacity to accommodate the waste from the staining run.

A typical set up for a staining run follows this order:

6.Start the software by double clicking on the Dako Autostainer Plus icon.

7.Enter your user name and password (see Accessing the Dako Autostainer Plus Software, Section 6).

8.Select the PROGRAM button on the MAIN MENU screen.

9.Select the SLIDE INFO button from the PROGRAMMING GRID, or Slides from the menu bar. When the SLIDE INFO button is selected the SLIDE INFORMATION screen is displayed. When the Slides menu item is selected the SLIDE COUNT window is displayed.

10.Enter slide information or slide count for the staining run (see Entering Slide Information, Section 8).

11.Select the FINISH ENTRY button when entering slide information or select OK when using SLIDE COUNT window. The PROGRAMMING GRID is displayed with the slide information.

12.Select the PROTOCOL TEMPLATE button. The PROTOCOL TEMPLATE DESIGN screen is displayed.

13.Select the protocol template for the run (see Designing a Protocol, Section 9).

14.Select the USE TEMPLATE button. The PROGRAMMING GRID is displayed with the selected protocol.

NOTE: Steps 7 through 9 can be skipped if the default template is used.

15.Assign specific reagents to all slides (see Programming Slides, Section 10).

16.Select the NEXT button. The user is prompted to “Save program on disk”.

Selecting YES displays the SAVE PROGRAM ON DISK window. Enter the program’s name and select OK. The program is saved and the PRINT SLIDE LABELS screen is displayed.

Selecting NO displays the PRINT SLIDE LABELS screen and the program is not saved.

17.Selecting the ALL button in the PRINT SLIDE LABELS screen will print all labels for slides assigned in the PROGRAMMING GRID and bring the user to the REAGENT LAYOUT MAP.

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Selecting the UNPRINTED LABELS button will print all labels that were not printed through the PRINT feature and bring the user to the REAGENT LAYOUT MAP.

Selecting the NONE button will direct the user to the REAGENT LAYOUT MAP. The CANCEL button will return the user to the PROGRAMMING GRID.

18.Load reagents using the REAGENT LAYOUT MAP.

19.Select the NEXT button. The LOAD AND SCAN SLIDES screen appears.

20.If the Bar Code feature is disabled, load slides using the SLIDE LAYOUT MAP. If the Bar Code feature is enabled, slides may be loaded into positions at the discretion of the user. It is recommended that each slide be flooded gently with buffer after it is placed on the instrument. This buffer should contain 0.05% Tween 20 (see Loading Slides, Section 13). At no time should the slides dry out.

21.Select the SCAN SLIDES button to scan all slides on the instrument.

22.The IS THE ARM CLEAR TO MOVE? Screen is displayed. Select OK to proceed. If no obstructions exist, select OK.

23.The SET START TIME screen is displayed (see Starting a Run, Section 14). The Autostainer Plus calculates the run time and amount of buffer and DI water needed to complete the run.

24.Select the PRIME PUMP (WATER) button. The DELAYED START dialog box appears (deionized water is not available with the “01” hardware version of the Dako Autostainer Plus). The user is prompted: “Is the pathway clear for the arm to move.”

25.Select the OK button and the pump is activated. Deionized water is flushed through the water intake line.

26.Select the PRIME PUMP (BUFFER) button and the pump is activated, flushing buffer through the buffer intake line. For the “01” hardware version of the Dako Autostainer Plus the user is prompted: “Is the pathway clear for the arm to move.”

27.Set Reagent Levels to Check Volumes or Do Not Check Volumes (see Starting a Run, Section 14).

28.Select the START RUN button and the run starts.

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Section 5 | Programming Overview

The Dako Autostainer Plus is a computer controlled system. The PROGRAMMING GRID is the main screen used to define slide information, primary antibodies, staining reagents and staining protocols.

1.Five menus are accessible from the menu bar. The Slides menu item is used to enter the number of slides to be run on the Autostainer Plus. The File menu is used for general information such as opening, saving and printing previously saved runs. The Edit Lists menu is used to establish lists of reagents utilized in programming a staining protocol. The Copy and Auto menu items are used during programming.

2.The grid header lists the steps and dispense volumes of the selected protocol template for the current staining run. Each column represents one step of the protocol template.

3.The programming grid is divided into rows and columns. Each row represents one slide and displays the complete slide identification (e.g. Slide ID, Case #, Block DI, Doctor Name, and Tissue) and all reagents applied. The grid will accommodate a maximum of 48 slides per staining run.

4.The 6 command buttons, located at the bottom of the screen, are used to enter slide information, develop staining protocols (templates) and print reports.

5.Below the command buttons is a line of text that is displays the software version, date/time, user name, security level, institution name, and Autostainer Plus serial number. This information is edited from the INITIALIZE screen (see Initializing the Dako Autostainer Plus, section 7). This line is on the bottom of most screens of the Autostainer Plus software.

6.The ALL SLIDES tool enables the user to alter drop zones and reagent application amounts for all slides in the program.

7.The INDIVIDUAL SLIDE tools enable the user to alter the drop zone and reagent application amount for that particular slide.

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Menu Bar Options

Slides Function

The Slides option may be used as an alternative to expedite programming by reducing the amount of information required to program a staining run. The Slides option may be used to enter the total number of slides for the current staining run.

The Slides function can be accessed by moving the mouse pointer to Slides on the menu bar and pressing the left mouse button. This selection displays the SLIDE COUNT window for entering the number of slides for the current staining run. This function is used to bypass the SLIDE INFORMATION screen when programming a staining run. Enter the desired number of slides in the text box or use the scroll bar to select the desired number of slides.

Once a run has been set up using the SLIDE COUNT window, slide ID, case number, doctor, block ID or tissue information cannot be added to the run. Selecting the SLIDE INFO button displays the SLIDE COUNT window.

NOTE: Slide Identification, Case #, Block ID, Tissue or Doctor Name will not be associated/displayed in the Programming Grid if the Slides function is used.

File Menu

The File menu can be accessed by moving the mouse pointer to File on the menu bar and pressing the left mouse button. The File menu commands include:

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New	displays a blank grid to program a new staining run
Open	displays the LOAD PROGRAM FROM DISK window
	with a list of all saved staining runs available to be
	opened.
Save	saves the current staining run program.
Save As	saves an existing staining run program under a new
	name while the original program remains under its
	saved name.
Print	prints the current Program Grid, IHC Report, Slide
	Labels, Reagent Labels, Reagent List, or any Run
	Log.
Note:	The list at the bottom of the file menu displays the last
	five programs accessed in the computer. This list is
	constantly updated.

Edit Lists Menu

The Edit Lists menu can be accessed by moving the mouse pointer to Edit lists on the menu bar and pressing the left mouse button. For instruction on the features of the Edit List menu item, see Reagent Management, section 11. The Edit Lists menu commands include:

End. Enz. Block	displays the EDIT REAGENT LIST screen for
	endogenous enzyme block, allowing programming
	and editing of endogenous enzyme block reagents.
Protein Block	displays the EDIT REAGENT LIST screen for protein
	block, allowing programming and editing of protein
	block reagents.
Primary Antibody	displays the EDIT REAGENT LIST screen for primary
	antibodies, allowing programming and editing of
	primary antibody reagents. The PRETREATMENT list
	is also accessible from this screen.
Pretreatment	displays the EDIT REAGENT LIST screen for primary
	antibody pretreatment, allowing programming and
	editing of pretreatment reagents.
Secondary Reagent	displays the EDIT REAGENT LIST screen for
	secondary reagents (e.g. biotinylated secondary
	antibodies or link), allowing programming and editing
	of secondary reagents.
Tertiary Reagent	displays the EDIT REAGENT LIST screen for tertiary
	reagents (e.g. enzyme-labeled streptavidin or label),
	allowing programming and editing of tertiary reagents.
Labeled Polymer	displays the EDIT REAGENT LIST screen for labeled
	polymer reagents used in the Dako EnVision
	visualization systems, allowing programming and
	editing of labeled polymer reagents.

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Substrate	displays the EDIT REAGENT LIST screen for
	substrates, allowing programming and editing of
	substrate reagents.
Auxiliary	displays the EDIT REAGENT LIST screen for auxiliary
	reagents (e.g. counterstain), allowing programming
	and editing of auxiliary reagents.

Copy Function

The Copy function can be accessed by moving the mouse pointer to Copy on the menu bar and pressing the left mouse button. This function activates the Select and Paste commands which allow selection of programmed tiles in the Programming Grid. The selected tiles can be copied over (pasted) on either unprogrammed or programmed tiles (see the Copy section of Programming Slides, section 10).

Auto Function

The Auto function can be accessed by moving the mouse pointer to Auto on the menu bar and pressing the left mouse button. This function is used to save all or any portion of a protocol to be used in other programs (see the Auto Programming section of Programming Slides, section 10). The Help function is also accessible from this menu.

Command Buttons

The command buttons on the PROGRAMMING GRID and their respective functions are:

Slide Info	displays the SLIDE INFORMATION screen to enter
	new or edit existing slide information (e.g. Slide ID,
	Case #, Block ID, # Slides, Tissue and Doctor Name).
Protocol Template	displays the PROTOCOL TEMPLATE DESIGN screen
	where a saved protocol template can be retrieved or a
	new one created. This template is applied to the
	current staining run
Next	displays the PRINT SLIDE LABELS screen
Print	prints the Slide Labels, Reagent Labels, Main Grid,
	IHC Report, Reagent List, or Run Logs.
Exit	returns to the MAIN MENU screen without saving the
	program.
Help	displays information to aid in the understanding and
	utilization of features in the PROGRAMMING GRID.

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Section 6 | Accessing the Dako Autostainer Plus

Software

The SIGN IN screen is the first screen that appears after the Dako Autostainer Plus icon is double clicked.

The SIGN IN screen allows you to enter your assigned user name (up to 28 alpha-numeric characters) and password (up to 8 alpha-numeric characters). Your user security status (programmed in the INITIALIZE screen) determines the functions you are able to access. If the sign-in process is executed correctly (i.e., valid user name and password entered), the system displays the MAIN MENU screen.

To add a new user or change a password of an existing user, see Initializing the Dako Autostainer Plus, Section 7.

1.The cursor is located in the name box. Type your name and press the ENTER key. The cursor moves to the password box.

2.Type your password and press ENTER. Only asterisks (*) will be displayed in the entry box during keystroke entry. The MAIN MENU screen is displayed.

If an unrecognizable name and/or password is entered, the software does not allow you to continue to the next entry. For example, if an unrecognized name is entered and the ENTER key is pressed the cursor remains in the name box and does not move to the password box.

If EXIT is selected a dialog box prompts, “Quit using Autostainer Plus?”. Select YES to return to the main Windows screen. Select NO to return to the SIGN IN screen.

The MAIN MENU screen appears when the sign-in process is properly executed. This screen allows high security level users access to all the software features. The INITIALIZE button is displayed for only high security level users. A user’s security status is entered from the INITIALIZE screen (see Initializing the Dako Autostainer Plus, section 7).

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If the accessing operator is assigned a middle or low security level, the INITIALIZE button is replaced with the CHANGE PASSWORD button. A middle or low security level does not allow access to set or change the parameters for slide labels, Main Grid and IHC Report printing formats, cleaning schedule or signing on new users and doctors.

NOTE: In the example above, the INITIALIZE button is displayed, indicating this user is set at high security level.

NOTE: The software version number, current date and time, user name, security level (indicated by asterisks), institution name, and Autostainer Plus serial number are displayed across the bottom of this screen.

NOTE: A cleaning run is recommended after 150 slides have been processed on the Autostainer Plus. Once the cleaning cycle is set up (see System Maintenance, section 17) this number and the number of slides processed since the last cleaning appear in red letters. Once the instrument has processed 150 slides, a message will prompt the user to clean the instrument.

The software allows up to 200 slides to be run between cleaning cycles. The additional 50 slides allows for flexibility in the laboratory work flow to perform an additional run before cleaning the instrument. If more than 200 slides have been run the instrument must be cleaned. The PROGRAM button becomes unavailable and the software does not allow additional programming until the instrument has gone through a cleaning cycle.

	PROGRAM	is used during routine operation of the Autostainer
		Plus and allow access to the PROGRAMMING GRID
	INITIALIZE	displays the INITIZLIZE screen used to establish and
		update default information for institution, staff, the
		number of slides per routine cleaning cycle, the
		default reagent volume and drop zone for reagent
		dispense. You may also name your system or identify
		your system by serial number on this screen. This
		button is only displayed for high security level users.
	CHANGE PASSWORD	displays the CHANGE PASSWORD screen used to
		edit the signed on user’s password. This button
		replaces the INITIALIZE button for users with middle
		and low security access.
	CLEAN	allows you to initiate a cleaning run. It gives a status
		report on the number of slides since the last cleaning
		cycle and the total number of runs and generates a
		Cleaning Log.
	REAGENT TRACKING	allows users to monitor the total volume of each
		reagent that has been used on the Autostainer Plus.
	PRIME PUMP	displays the PRIME PUMP screen used to flush the
		intake tubing with buffer or DI water without initiating
		an actual run.
	HELP	displays information to aid in understanding and
		utilizing the features on the MAIN MENU screen.
	SIGN OFF	exits the Autostainer Plus program.
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Section 7 | Initializing the Dako Autostainer Plus

The INITIALIZE screen is used to establish and update default information for the system. This includes the institution information, Autostainer Plus serial number, user names, the doctors requesting IHC tests, a library of tissues that may be used during staining, the number of slides allowed between routine cleaning runs, the default volume and the drop zone for reagent dispense. Slide and reagent label formatting, and user-defined printing formats for the Main Grid and IHC Reports, and custom options can also be configured from this screen.

This screen is used to enter information for: Institution, Autostainer Plus serial number, instrument ID, staff, default reagent volume and drop zone, slides per cleaning cycle, and to access the Slide and Reagent Design Label and Options screens.

The buttons on the INITIALIZE screen and their respective functions are:

	Institution Information	The Institution Information (name, address,
		department, phone, serial number) is stored and
		incorporated into reports
	Staff Information	The Staff Information includes lists of the Users and
		Doctors who frequently request IHC tests. The list of
		Doctors is accessed during the programming of the
		slide information
	Tissue Information	The Tissue Information list is used to save a list of
		tissues that are frequently used IHC tests. This list of
		tissues is accessed during the programming of slide
		information.
	Default Reagent Information	The Default Reagent Volume allows the selection of
		the default reagent volume to be used for all steps in
		any staining protocol. Reagent volume choices are:
		100, 150, 200, 400, and 600 µL. The Default Reagent
		Drop Zone is also selected, allowing application of
		reagent to single or multiple locations on each slide.
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Cleaning Schedule	The Slides/Cleaning permits you to program the
	number of slides stained between routine cleanings.
	Dako recommends a cleaning cycle after every 150
	slides. Once the programmed number is exceeded,
	the MAIN MENU screen displays the number of slides
	since the last cleaning. The maximum slides allowed
	between cleaning cycles is 200. Once this number is
	exceeded, the PROGRAM button is not available.

The buttons on the INITIALIZE screen and their respective functions are:

SLIDE LABELS	displays the DESIGN SLIDE LABEL screen used to
	define slide label printing of bar-coded slide labels.
REAGENT LABELS	displays the DESIGN REAGENT LABEL screen used
	to define the printing of reagent labels.
OPTIONS	displays the OPTION screen used to define the format
	for the Program Grid, Slide Layout Map, and printing
	format for IHC Reports.
OK	saves the entered information and returns to the MAIN
	MENU screen.
CANCEL	cancels any entries made and returns to the MAIN
	MENU screen.
PRINT	prints a report listing all of the institution, staff, tissue,
	default volume, default dispense zones, and cleaning
	schedule information.
HELP	displays information to aid in understanding and
	utilizing the INITIALIZE screen.

Entering Institution Information

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box.

2.Type in the institution’s name and press ENTER or TAB. The cursor moves to the Address box.

NOTE: Information entry is limited to the space displayed on the screen. When the end of an entry box is reached, an audible tone is made by the computer and no additional information can be added in that box.

3.Type in the institution’s address and press ENTER or TAB. The cursor moves to the Department/Lab box.

4.Type in the laboratory or department where the Dako Autostainer Plus will be operating and press ENTER or TAB. The cursor moves to the Contact Phone/Ext. box.

5.Type in the laboratory’s phone number and press ENTER or TAB. The cursor moves to the Serial Number box.

6.Type in the Autostainer Plus serial number located on the right side of the instrument. The number should start with “S38-“ and followed by 6 additional numbers. Press ENTER or TAB. The cursor moves to the Users box.

NOTE: Once entered, the instrument serial number will be located in the lower right corner of many of the screens in the Autostainer Plus software.

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7.Type in serial number, name, or unique identifier, for your Autostainer Plus and press ENTER or TAB.

8.Select the OK button to save the entered information. The MAIN MENU screen is displayed.

Select the CANCEL button to escape without saving the entered information. The MAIN MENU screen is displayed.

Editing Institution Information

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information listed.

2.Select the information to be changed and enter the new information.

3.Select the OK button to save the entered information. The MAIN MENU screen is displayed. Select the CANCEL button to escape without saving the changes. The MAIN MENU screen is displayed.

Entering Staff Information

Adding a New User

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information is listed.

2.Press ENTER or TAB key until the cursor flashes in the Users box.

3.Type a user’s name and press ENTER. The PASSWORD AND SECURITY LEVEL screen appears.

4.Type in a password for the new user in the Enter box and press ENTER. The cursor moves to the Reenter box.

NOTE: Passwords are not case sensitive; capital and lower case letters may be interchanged.

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5.Type in the same password again and press ENTER. The High security level option becomes highlighted. If a different password is entered the window “TRY AGAIN: Password must be identical” appears.

6.Using the mouse, select the desired security level. A mark appears in the raised diamond. Selecting the High Level option allows full access to the software features. Select OK and the INITIALIZE screen appears.

NOTE: Each security level is displayed at the bottom of each screen with asterisks in parenthesis “()”. (See below for details).

The security levels are defined as follows:

High Level (**): Users have full access to all features of the software.

Middle Level (*): Users do not have access to the INITIALIZE button in the MAIN MENU screen. This button is replaced with a CHANGE PASSWORD button. Middle level users cannot set or change the parameters for Institution info, default slide settings, slide/reagent labels, Main Grid and IHC printing formats, cleaning schedule, entering in new users and doctors, or adding new tissues.

Low Level: Users do not have access to the INITIALIZE button in the MAIN MENU screen. This button is replaced with a CHANGE PASSWORD button. Users with low level security are also restricted from the same features as users with middle level security and the following: no access to Reagent Tracking, the Edit List function, setting up Auto Program, creating/editing Protocol Templates.

7.Select the OK button to save the entered information. The new user name and password is added to the current list of users and MAIN MENU screen appears.

Select the CANCEL button to escape without saving the entered information. The MAIN MENU screen appears.

Editing User Information

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information listed.

2.Press ENTER or TAB key until the cursor flashes in the Technologists box.

3.Select the user name from the list and press ENTER. The PASSWORD AND SECURITY LEVEL screen appears.

NOTE: The Users list can be displayed by positioning and clicking the mouse pointer in the Users box and pressing the DOWN arrow key on your keyboard until the desired user’s name is highlighted in the Users box. The scroll arrows in the drop down list can also be used.

4.The Password boxes are empty. Enter the new password information.

5.To change a user’s security status, move the mouse pointer over the desired security level and press the left mouse button. A mark will appear next the selected security level. Select the OK button to save the changes.

Selecting the CANCEL button displays the INITIALIZE screen without saving the newly entered information.

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Deleting User Information

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information listed.

2.Press ENTER or TAB key until the cursor flashes in the Users box.

3.Select the user name from the list and press ENTER. The PASSWORD AND SECURITY LEVEL screen appears. The DELETE USER button located to the right of the entry boxes becomes available.

4.Select the DELETE USER button. A dialog box asking if you want to delete the selected user (by name) appears.

5.Select the YES button to delete the user from the current list of users and the INITIALIZE screen appears.

Select the NO button and the PASSWORDS AND SECURITY LEVEL screen is displayed without deleting the selected user. Select CANCEL to return to the INITIALIZE screen.

NOTE: A user cannot be deleted from the current user list if his/her name was used to sign in for the current session. The DELETE USER button is grayed out and not available.

Adding a New Doctor

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information listed.

2.Press ENTER or TAB key until the cursor flashes in the Doctors box.

3.Type in the Doctors name and press ENTER. A dialog box appears asking if you want to add the current doctor to the list.

4.Select the YES button. The INITIALIZE screen appears and the newly entered doctor’s name is added to the list.

Select the NO button. The INITIALIZE screen is displayed and the information is not saved.

5.To set the displayed doctor as the Default Doctor, move the mouse pointer over the Default Doctor check box and press the left mouse button. A check mark is placed in the box and the doctor’s name is displayed in the SLIDE INFORMATION screen as the default doctor. This name also appears in the Doctor column in the PROGRAMMING GRID.

To change the Default Doctor, select the name of the new default and select the Default Doctor check box. A check is placed in the box. The initial doctor is no longer set as the default.

NOTE: To edit a doctor’s name, first delete the name, then enter the new information.

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Deleting Doctor Information

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information listed.

2.Press ENTER or TAB key until the cursor flashes in the Doctors box.

3.Select a doctor from the current list of doctors.

4.Press ENTER. A dialog box appears asking if you want to delete the selected doctor.

5.Select the YES button. The selected doctor is deleted from the current list and the INITIALIZE screen appears.

Select the NO button and the INITIALIZE screen is displayed and the highlighted doctor is not removed from the list.

Entering Tissue Information

Adding a New Tissue

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information listed.

2.Press ENTER or TAB key until the cursor flashes in the Tissue box.

3.Type in the tissue and press ENTER. A dialog box appears asking if you want to add the current tissue to the list.

4.Select the YES button. The INITIALIZE screen appears and the newly entered tissue is added to the list.

Select the NO button. The INITIALIZE screen is displayed and the information is not saved.

NOTE: To edit a tissue, first delete the tissue, then enter the new information.

Deleting a Tissue

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed with the cursor in the Name box and the previously entered information listed.

2.Press ENTER or TAB key until the cursor flashes in the Tissue box.

3.Select a tissue from the current list of tissues.

4.Press ENTER. A dialog box appears asking if you want to delete the selected tissue.

5.Select the YES button. The selected tissue is deleted from the current list and the INITIALIZE screen appears.

Select the NO button and the INITIALIZE screen is displayed and the highlighted tissue is not removed from the list.

Entering Default Reagent Information

Assigning Default Reagent Dispense Volumes

1.Select INITIALIZE on the MAIN MENU screen. The INITIALIZE screen is displayed.

2.Select a default reagent volume by clicking on a raised diamond next to the appropriate volume. A smaller black diamond appears next to the selected volume.

3.Select the OK button to save. The MAIN MENU screen is displayed.

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