| Service Manual

Document Number D01434

Revision 01
January 2010

Dako Autostainer Link 48 | Service Manual 1

Section 1 | Introduction, Scope and Tools List
Autostainer Link 48 Introduction
The Autostainer Link 48 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. The 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 Link 48, and analysis at automated workstations operating
either singly or in networked configurations.

The Autostainer Link 48 can be programmed to dispense reagent onto a maximum of 48 slides during
a single pre-programmed run. Reagent is delivered by a single aspirate/dispense probe. De-ionized
water, buffer and compressed air are dispensed by the wash/blow head, which is a combination air
nozzle and fluid head. The instrument uses a 3-axis robotic arm to move the probe and wash/blow
head from the reagent racks to the slides and finally to the wash station.

The Autostainer Link 48 is controlled by a proprietary software program. The workstation computer
contains a Motion Controller card that provides the interface to the instrument. Commands from the
Motion Controller card are sent to the instruments Controller board, where they are routed to the
appropriate components.

Scope
The Dako Autostainer Link 48 Field Service Manual is for Field Service Engineers and authorized
agents who have completed the Basic Autostainer Link 48 FSE Training Course and have received a
certificate.

This manual is designed for certified DAKO Autostainer repair personnel, to aid in maintenance, repair
and troubleshooting. Damage to the instrument by persons other than trained and certified DAKO
personnel will void any and all warranties and is not covered under service maintenance agreements.

The DAKO Autostainer Link 48 must be installed by a DAKO-certified technician. This manual is not
written for the journeyman technician. It assumes a general knowledge of this type of instrument,

strong electro-mechanical skills, familiarity with digital electronics and experience with Windows XP.

This document includes information regarding the following:

Tools list

Instrument safety

Instrument and environmental specifications

System and sub-system information

Troubleshooting

Component replacement procedures

Calibration procedures

Verification procedures

PM procedures

Schematics and Diagrams

This document does not provide:

Instructions for use

Installation Information

6 Dako Autostainer Link 48 | Service Manual

Tools and Equipment Required for Service
Technicians servicing the Autostainer Link 48 in the field should have the following tools and
equipment with them or available for use.

General Tools:

Digital Multi-meter
3/16" slot-head screwdriver
1/16" slot-head screwdriver
#2 cross-head (Phillips) screwdriver
#1 cross-head (Phillips) screwdriver
Soldering iron (35W max.)
Standard hex-head (Allen) wrench set (0.05 to 1/4")
Mirror
Flashlight
Wire cutters
Wire ties (tie wraps)
Anti-seize compound
Bubble level
Lubricant
Large slot-head screwdriver
Socket wrench
9/16" socket
1/2" socket
7/16" open-end wrench

Dako Tools:

Laptop computer

Calibration Bottle Kit

7 Dako Autostainer Link 48 | Service Manual

Section 3 | Instrument and Facility Specifications

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Instrument Specificat ions

Item Description

Autostainer Link 48

Stainer dimensions 0,89 m W x 0,66 m D x 0,58 m H (35" W x 26" D x 23" H)

Electrical requirements 1
(stainer) 110 - 240 V CA (10%) 50/60 Hz (2 Hz)

Normal operating temperature 18C26C (64F79F)

Slide rack capacity 1 12 glass slides

Total slide capacity per stainer 1 48 glass slides

Reagent capacity 42 reagents (5 mL, 12 mL, 25 mL, 50 mL bottle sizes).

All reagent bottles have the same outer dimensions regardless of
volume.

Reagent dispense volumes 100 - 1600 L

Note: Typical reagent dispenses volume is 200 L per slide. Dako
does not recommend dispense volumes of < 100 L per slide drop
zone.

Autostainer Link 48 Workstation

Printer (reports) Standard printer

Printer (labels) Thermal label printer as specified by Dako

Client/Server PC with Intel x86 compatible PC specified by Dako

Operating system Windows XP Professional with SP2.

Monitor and keyboard 17 in. flat panel, screen resolution 1024 x 768 (XVGA)

Pollution degree 2

Installation category II

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 Facility Specifications
Autostainer Link 48

The instrument shall be operated in an environment not exceeding 26 C

The instrument shall not be placed underneath or next to heating or cooling vents.

The instrument shall have a dedicated power source

The Customer location must be accessible during normal business hours for instrument service

The customer shall provide an internet connection for Dako Field Service to use for Software updates
and driver downloads. This connection will also be used for remote connectivity for the purpose of
troubleshooting

Service Specifications
The Autostainer Link 48 is designed to be reliable with minimal work to be performed during the
recommended annual maintenance or maintenance based on usage. The instrument will be
maintained based on usage (after every 15000 slides processed) when installed under the Dako PPS
(Price Per Slide) agreement. This is based on the normal operations and the assumption that the
customer cleans the Autostainer Link 48 periodically. The lack of cleaning after the use of high pH
buffer may cause the some parts to fail prematurely.

The Mean Time to Install (MTTI) is 4 hours. This includes the time to uncrate the Autostainer Link 48,
computer and peripherals and installing the hardware, software update if applicable and related
supplies. This does not include any unforeseen difficulties in getting the Autostainer link 48 from the
shipping dock to the installation location.

The Autostainer Link 48 is shipped in a crate 48L x 42W x 30H and the total package weight
approximately 150 Kg (300 pounds and depends on the water content of the crate). The crate is
designed to be moved by a fork lift or pallet jack.

The Mean Time to Repair (MTTR) is 2 hours.

The recommended annual maintenance should take 3 hours. The main purpose of the annual
maintenance is to check for excessive wear and tear, check for proper lubrication, perform cleanup if
salts have migrated to the inside of the Autostainer and replace the parts included the Preventive
Maintenance Kit. The routine should take 2 hours and an additional 1 hour should be allowed to
replace parts. Guidance is available in the Autostainer Link 48 PM Manual document no TP0934.

The power requirements are 2 amps at 230V and 4 amps at 115V. The Autostainer is designed to
accept 50Hz or 60Hz and has a switching power supply.

The Autostainer is 0,89 m W x 0,66 m D x 0,58 m H (35" W x 26" D x 23" H) and weights 63,5 Kg (140
pounds). It will take 2 people to move the Autostainer Link 48 from the crate to the installation site.
The computer, monitor, printers and UPS have to be ordered separately but accessories are
standard. It is recommended that the computer be installed to the right of the Autostainer Link 48. If
the customer wants it on the left side, a longer (5 meters - 15 feet) communications cable might be
required (instead of the standard 4 meters - 12 feet). This special length needs to be ordered ahead of
time because only the 4 meters 12 feet cable is shipped with the Autostainer Link 48.

The containers for the buffer and the waste have to be located below the Autostainer Link 48
(normally on the floor). If the waste containers are placed above the Autostainer, the waste liquid will
not flow back into the container after pump activity.

14 Dako Autostainer Link 48 | Service Manual

Installation specifications

Item Description

Service Port The Autostainer Link 48 instrument includes remote diagnostics and
Connection software update capabilities. An outbound Internet connection (open
port 5900) is required for installation. Only available under the PPS
agreement

Surface Prior to unpacking Autostainer Link 48, ensure that the area to be used
for the instrument is a solid, level surface that can safely support the
weight of the system :
140 lb. (63.5kg) instrument only
240 lb. (108 kg) instrument plus peripherals

Recommended A clear space of a minimum 0,25 m (10 inches) is required above the
Instrument Space instrument. Dimensions for the Autostainer Link 48 work surface are:
Instrument only:
0,89 m W x 0,66 m D x 0,58 m H (35" W x 26" D x 23" H)
Instrument and Peripherals: 2,40 m W x 0,85 m D x 0,71m H (8 W x
33 D x 28 H)

Instrument Size Minimum dimensions for the Dako Autostainer Link 48 work area are
2.10 m W x 0,81 m D x 0,85 m H (7 W x 32 D x 34 H) clearance.

Workstation Space The PC is a desktop computer, specified and validated by Dako, and
may be placed at any location within the reach of the system cables to
the instrument.

Client/Server PC 115/240 VAC

Power 6.0/3.0 A
50 60 Hz

15 Dako Autostainer Link 48 | Service Manual

Section 4 | System Functional Overview

Intended use: For in vitro diagnostic use

The Autostainer Link 48 system is an automated slide processing system compatible with reagents for
the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle
aspirates. The 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 Link 48 automated workstations operating either singly or in networked
configurations.

Autostainer Link 48 Workstation DakoLink Server

Peripherals

System Hardware
This section describes the hardware components and operational configuration options associated
with the Autostainer Link 48 system.

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 Autostainer Link 48

The Autostainer Link 48 is a combination of hardware and Dako Link software integrated with the
appropriate reagents to automate immunohistochemical and immunocytochemical staining
methods.

The Autostainer Link 48 comprises the following components:

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 Slide Racks
A slide carrier holding 12 microscopic slides in
a horizontal position. The instrument holds a
maximum of 4 racks. These racks are
removable and interchangeable for
convenient slide loading and unloading.

Reagent Racks
Two identical reagent racks hold up to 21
reagent vials each. Vials come in 4 different
capacities (5 ml, 25 ml, 12 ml, and 50 ml).
Each vial comes pre-marked with a Data
Matrix identifier label. True Positive reagent
tracking calculates how much reagent has
been used during a test.

X, Y, Z Robotic Arm
The robotic arm extending along the Y Axis
mechanism from the back of the instrument
towards the front, carrying with it the Z head
assembly. The X arm moves from right to left
across the instrument. When the Autostainer
Link 48 is not in operation the Y arm rests on
the left side of the machine. When the
machine is in operation and slides are
incubating, the arm is located on the right
side.

The 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.

The Z Head assembly is the dome-shaped assembly that sits over the Y arm. The Z head consists
of three components: the probe, 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.

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 Slide and Reagent Scanner
A mechanism inside the Z head that scans slides to determine position of the slide and which
slides are designated to run on the instrument. It will also confirm the accuracy of the reagent
positioning and volume entered via the Dako Link Software.

Reagent Probe Wash Station

A white plastic assembly located in the rear right corner of the instrument, 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 prior to application of each reagent.

Sink
The plastic tray that sits underneath the slide racks and channels the buffer/DI water washes and
reagents into the waste reservoir.

Humidity Chamber (Lid & Hood)

When closed, creates a sealed humidity
chamber to ensure slides will not dry out
during the run.

Rinsing Buffer Containers

Two 10-liter plastic containers used for rinsing off slides in De-
Ionized water and Buffer fluid respectively. Slides are rinsed
before, during and after each run.

Waste Separation Containers

Two 10-liter plastic containers for separating the used reagent
into hazardous (black tube) and non-hazardous waste.

20 Dako Autostainer Link 48 | Service Manual

 Autostainer Link 48
Workstation
The Autostainer Link 48 Workstation is
a Microsoft Windows-XP based PC
that runs the Autostainer Link 48
Control software (ACS).

Multiple Workstations can be deployed,

each running Dako Link software. Each
Workstation PC can host up to three
staining instruments.

Each workstation PC has full access to a central database that contains all data and historical slide
information for the entire installation. Each instance of Dako Link software can manage and
monitor all staining instruments on the LAN.
Autostainer Link 48 Workstation components include:

Workstation PC
A Windows-XP PC runs the Autostainer Link 48 software, which provides your primary control and
interaction with the system.

Note: Each installation maintains a central database where all information is stored,
including a detailed record for every stained slide. The database resides on a single
server computer, no matter how many stainers and workstations are connected. This
database server PC can also run Dako Link software. The database is automatically
managed and maintained by the software.

Note: Specifications for the workstation PC and monitor are subject to change.

Dako Glass Slide Labeling System

Generates chemical-resistant self-adhesive
customizable labels designed for use in high
stress, chemically rigorous laboratory
environments. Each label comprises a surface
for printed test and an over label material
(FLAP) which protects the text. Chemical
resistance is provided by applying the over
label material after data printing. Slides can
be labeled prior to processing.

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System Software
The following software components are used to interface with and control Autostainer Link 48:

Dako Link (Client)

The Dako Link software serves as the main user interface for Autostainer Link 48. All slide
programming, reagent tracking, instrument monitoring and reporting capabilities are accessed
through Dako Link. If multiple instruments are connected via a Local Area Network (LAN), all
instruments can be programmed from any instance of Dako Link software, and slide and reagent
information from all instruments is stored in a single database (Dako Link Server) accessed
through Dako Link Managers equals all Dako Link User interfaces.

Autostainer Control Software (ACS)

All staining functions of Autostainer Link 48 are controlled by the Autostainer Control Software,
also referred to as the ACS. Although the ACS will always be operating while staining is in
progress, users only need to access it to perform the instrument cleaning cycle. Generally, the
ACS is a hidden window but can be accessed by the Dako logo that appears in the Windows
system tray. If multiple instruments are controlled by a single Autostainer Link 48 workstation,
there will be multiple ACS on the workstation (one for each Autostainer Link 48).

Dako Link Server (System Manager)

The System Manager Software located on the server computer provides services to other
computers (known as client computers) connected to the same network. In the case of
Autostainer Link 48, the server acts as a repository for all information generated by instruments
and users. Meaning that all slide and reagent data is stored in a central location that can be easily
backed up. Reporting information on cases can be obtained easily even if slides were processed
on different instruments, without searching for information in several locations.

Operational Configurations
The Autostainer Link 48 system can be configured to operate in three modes:

Standalone Setup

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 Two Stainer Setup

Three Stainer Setup

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 LAN (Networked)

LIS (Networked to Central Server)

Note: For more information on LAN or LIS configurations, consult your Dako
representative.

24 Dako Autostainer Link 48 | Service Manual