3D Histech iSaCS User manual

iSaCS – IHC Stainer,
Automated Coverslipper and
Scanner
User's Guide
September 22, 2016

iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
Contents
Disclaimer....................................................................................................................................4
Character Formats and S mbols...................................................................................................6
Notes Regarding Operational Safet .............................................................................................7
Notes on Warrant .....................................................................................................................10
1 Installation..............................................................................................................................11
2 Product Description.................................................................................................................12
2.1 Overview..................................................................................................................................12
2.1.1 Intended use...................................................................................................................................................12
2.1.2 Features and benefits.....................................................................................................................................13
2.2 Main outer parts of the device................................................................................................13
2.3 Main inner parts of the device................................................................................................1
3 Preparation procedures...........................................................................................................16
4 Commissioning........................................................................................................................17
4.1 Switching on/off.......................................................................................................................17
4.2 Software startup......................................................................................................................17
4.3 Hardware startup.....................................................................................................................18
4.4 Loading the supplies................................................................................................................19
4.4.1 Fluids..............................................................................................................................................................19
4. Incubation unit.........................................................................................................................21
4. .1 Preparation of slides and trays.......................................................................................................................21
4. .2 Filling up the incubation compartment..........................................................................................................22
4. .3 Initialization....................................................................................................................................................24
4. .4 Unthreading/threading the reagent chain.....................................................................................................24
4. . Filling up the reagent chain with pipette tips and reagent vials....................................................................2
4. .6 Filling the coverslipper unit............................................................................................................................2
4. .7 Initialization....................................................................................................................................................26
4.6 Reagent handling.....................................................................................................................26
4.7 Protocol assignment................................................................................................................28
4.8 Protocol Sequencing................................................................................................................29
5 Scheduling...............................................................................................................................37
6 Service....................................................................................................................................39
7 Running the process................................................................................................................41
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
8 Troubleshooting and Maintenance..........................................................................................42
8.1 Safety Information...................................................................................................................42
8.2 Maintenance............................................................................................................................43
8.2.1 Preventive maintenance.................................................................................................................................43
8.2.2 Cleaning the device........................................................................................................................................43
8.2.3 Cleaning the tray............................................................................................................................................43
8.2.4 Replacing fuses of the main power switch.....................................................................................................43
8.2. Opening the protective cover.........................................................................................................................4
8.3 Troubleshooting.......................................................................................................................4
9 Transporting of iSaCS...............................................................................................................47
10 Technical Data.......................................................................................................................48
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
Disclaimer
Disclaimer
Copyright © 2001-2016 3DHISTECH Ltd.
All rights reserved.
3DHISTECH Ltd. as the manufacturer declares that the product iSaCS, an automated slide stainer for
IHC, coverslipper and scanner, is a -labeled laboratory device that is designed and produced with
consideration of specified requirements, and conforms to Directives 2004/108/EC and 2006/9 /EC.
Intellectual property related to the 3DHISTECH products are as follows:
EP 1,789,831; US 7,663,078; EP 2,024,772; JP 2009- 1268 ; US 12/301,781; EP 1,644,767; JP 2007-
164 1; US 7,327, 1 ; EP 1,994,398; JP 2008- 783 ; US 12/281, 66; U0700210; US 6,246,78 ;
HU0900142; HU0700404; PCT/HU2007/00006 ; PCT/HU2014/000020; EP 08762668. ; US
12/663, 37; PCT/AT2006/000492; JP 2008- 42 2; EP 06817469; US 12/09 , 4 ;
PCT/AT2006/000493; EP 06817470. ; US 12/09 , 96; HU0900741; US 61/264,732; US 11/826,7 2;
P0401870; PCT/IB200 /0 0344; US 11/662,976; HU0700409; US 12/042,0 0; US 77/636,144 és
007 02032.
The above mentioned granted patents, granted utility model, registered trademarks, pending
international and national patent applications and the other corresponding IP are the sole properties
of the 3DHISTECH Ltd.
3DHISTECH Ltd. is not liable for damage of whatever nature (including, but not limited to, general
or specific damage, indirect damage, consequential damage or incidental damage, including the
results of the anal sis of the digitized slides, for example, change of health status related to
erroneous diagnosis from the digitized slide(s) that stems from or is associated with use of Product,
digitized slides, qualit of staining, qualit of stained slides, qualit of used method of staining.
3DHISTECH Ltd. assumes no responsibilit for the functionalit and fault-free condition of our
“application programs” (Workflows, VBA macros, Commander scripts).
CAUTION
This product has not been approved or cleared as a medical device by the U.S. Food and Drug
Administration.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these may interfere with the proper operation.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
Disclaimer
Third-Part Disclaimer (LibTIFF – TIFF Librar and Utilities)
3DHISTECH Ltd. is not liable for damage of whatever nature (including, but not limited to, general or
specific damage, indirect damage, consequential damage or incidental damage, including damage
resulting from lost profits, interruption of business, loss of business information, pecuniary loss or
similar damage) that stems from or is associated with the incorporated part of this Product that is
made by third parties.
Further Information
For the latest information on 3DHISTECH products and services, please visit our website at the
following URL: http ://www.3dhistech.com.
Company Address: 29-33 Konkoly-Thege Miklos street, Building 6
1121 Budapest – HUNGARY
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
Character Formats and Symbols
Character Formats and S mbols
Example Words or characters that appear on the screen. These include field names, screen
and window titles, push-buttons and menu names, paths or options.
Keys on the keyboard. For example, function keys (such as F11) or the Ctrl+M key
combination.
Example Cross-references within this document or to other documents.
Warning! It might cause irreversible damage or harm to the user of the product or the
product itself if this instruction is not followed.
Caution! It might cause the product to not work properly if this instruction is not followed
and alerts to a potential danger situation.
Note: Calls attention to some important features.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
otes Regarding Operational Safety
Notes Regarding Operational Safet
The below section of this User’s Guide contains information and warnings of a kind that must be
followed by owner/operator personnel.
Any of the following notes should be strictly observed:
Caution!
In the event of any non-conforming type of use, including non-conforming
use of assemblies or single parts, no liability will be assumed by the
Manufacturer. This shall also apply to service or repair work of any kind,
which is performed by other than authorized service personnel. All claims
for warranty and warranty services will be null and void in any such case.
Warning!
Insert the power cord plugs only into a grounding outlet. The protective
action must not be rendered ineffective by extension cables without
protective conductor. The iSaCS has a built-in protection which must not be
rendered ineffective by extension cables without protective (earth-ground)
conductor.
Warning!
The operation of the instrument in explosion-risk environments is not
allowed.
Warning!
If protective devices are found to be ineffective, the device of iSaCS must be
shut down and precautions must be taken to prevent unintended usage. For
necessary repair work or work to restore proper operating condition, you
should contact the 3DHISTECH Customer Service.
Warning!
Check that your local line voltage is compatible with specifications of iSaCS
before you turn the power on.
Warning!
The device of iSaCS does not include any special facilities to protect from
samples with an etching, potentially infectious, toxic, radioactive or other
health-damaging effect. You are under obligation to comply with all
currently binding legislation, notably, national accident prevention rules
when handling samples of this kind.
Caution!
Dirt or dust may adversely impact the operating capability of iSaCS. For this
reason, measures must be taken to eliminate such influences to a maximum
possible degree. During periods of non-use, iSaCS must be protected with a
dust cover. Check that power is turned off before you put the cover on.
Warning!
A defective iSaCS is not classified as domestic waste. It must be properly
disposed in accordance with currently valid legal requirements.
Warning!
The device may not be operated by other than properly instructed persons.
Operating personnel must be fully aware of the potential dangers which a
particular field of application involves. This device is a precision laboratory
instrument which may suffer a significant reduction in operational functions
or even physical destruction following intervention performed in any
nonconforming manner.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
otes Regarding Operational Safety
Operations Notices
General
•Do not operate the device near strong electromagnetic radiation sources (non-shielded RF
radiation sources), because this may prevent the device from operating properly.
•The device must be operated in an air-conditioned room with a permanent temperature set
to 20°-2 ° Celsius, and air humidity of 40%-70%.
•The air flow within the room must be kept as little as possible.
•Do not expose the equipment to direct sunlight or strong light.
•The device can only be placed on a completely flat, horizontal, and sturdy surface.
•The device and all of the attached equipments must be turned on before starting the
software.
•Dive into the device only when wearing chemically resistant laboratory gloves and coat.
•Periodic maintenance must be carried out by using a lint-free, clean, and slightly damp cloth
in the following areas: incubation tray, reagent tray, scanner tray, reagent window, the surface
of slide moving arm, the surface of coverslip lifter cup.
•Use water-based cleaning solvents only; do not use aggressive, or corrosive liquids for
cleaning.
•In the event of system failure, turn off and disconnect the device immediately, create snap-
shots of the errors can be seen in the device (from multiple camera angles), make a copy of
the log file. Remove the parts of the device, and consumables carefully. Keep the device in a
dry place, then contact your distributor.
•All consumables and liquids must be kept in room-temperature before filling them into the
device.
Liquid containers
•Both of the containers „Hazardous” and „Non-Hazardous” must be emptied properly.
•Prevent the filling cap hose from twisting during removal and reattachment.
•Only one container can be removed from the device at a time.
•Defective fluid containers cannot be inserted into the device, otherwise leakage may occur.
The effused hazardous material may harm your health or the environment.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
otes Regarding Operational Safety
Filling up containers
•DI Water: Distilled water, final 0.04% Tween20 non-ionic detergent solution (min. 0. l)
•Wash Buffer: Diluted (1x), final 0.04% Tween20 non-ionic detergent solution (min. 0. l)
If using a different type of container for Wash Buffer, you must ensure that the container
does not contain detergent, and must be completed with Tween20.
Coverslip
•Coverglass measurements: 22x 0 mm, 170μm thickness, clean and non-adhering
•Mounting medium vial (DAKO Faramount, 1000μl), cap and insert must be removed before
insertion
•Fill 1 ml distilled water into the pipetting tip holder
Reagent chain
•All reagents should contain final 0.2% Tween20, reagent dead volume approx. 600μl
•Reagents should not contain any air bubbles at the time of use, all fluid must form a single
volume unit, no droplets are allowed anywhere at the reagent container area.
Slide
•Use only SuperFrost Ultra Plus slides after baking, deparaffinization and after at least 20 min.
of over 90 C HIER.
•Slide dimensions: 2 .2x7 . x1 mm, label area: 19 mm, white label coating
•Check tissue sample placement on slides: leave 2. mm margin on both sides and mm
margin from bottom and top
•Tissue should adhere firmly to the glass surface on the entire area
Pipette tip
•Use obbins AUTOTIP, 200μl pipette tips only (Manuf: Molecular BioProducts Inc., Product
Code: 1043-04- ). Other types of pipette tips cannot be used.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
otes Regarding Operational Safety
Notes on Warrant
3DHISTECH Ltd. – as the Product Manufacturer – warrants iSaCS to be free from faults in material and
workmanship at the moment of installation. Defects must be notified immediately on identification
and maximum efforts must be undertaken in order to minimize damage. On receiving notice of a
fault, the Product Manufacturer will be under obligation to remove the fault, at his own option,
either by providing adequate repair services or by delivering a faultless product for replacement. No
warranty will be accepted in cases of natural wear (notably, wear and tear) or improper product
handling.
The Product Manufacturer will refuse any liability in the event of damage resulting from faulty
operation, negligence or unauthorized intervention into the product, notably, from the replacement
of product parts or the usage of accessory parts from other manufacturers. Any such case will void
the user’s claim for warranty.
Except for actions which are explicitly described in this User’s Guide, you are prohibited from
performing any kind of maintenance or repair work at iSaCS. Only authorized 3DHISTECH Service
personnel or specifically authorized representatives are allowed to handle repair work. In case of
malfunction contact 3DHISTECH Service Support first.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
1 In tallation
1 Installation
Warning!
The installation of iSaCS must be carried out by a trained professional!
The equipment is ready for use after the installation is complete.
In any other case the warranty will be automatically voided.
The supplier or distributor is not liable for any damages caused by an
installation carried out by an unauthorized person.
Warning!
The device of iSaCS must be operated only when placed on a heavy-
duty rolling workbench.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
2 Product De cription
2 Product Description
2.1 Overview
2.1.1 Intended use
The iSaCS combines IHC/immunofluorescent staining, coverslipping, and scanning processes within a
single device that is capable to perform these tasks within one single session. The device is designed
for users who work in educational, research, industrial, and medical sectors.
Warning!
The device of iSaCS can be operated by qualified professionals only. The
operator must be a person who is fully aware of the sources of potential
hazards during the operation. The iSaCS is a precision medical device
which can suffer can significant functional and physical damages when
operated incorrectly.
Warning!
After each scanning make sure to inspect the digital slide for over-
exposed areas. In case the slide is scanned based on improperly set
parameters, it can highly affect the diagnostic result because of
information loss.
Warning!
Any modification to a hardware or software component of the PC will
highly affect the functionality of the scanner program.
Warning!
The installation of software applications other than required by the
control software is strictly prohibited!
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
2 Product De cription
2.1.2 Features and benefits
•Fully automated workflow from staining to scanning
•Standardized IHC/IF staining
•Patented automated sample detection ensures the staining of tissue area only, but manual
staining of the used-defined area is also available
•Quick protocol definition, easy handling of fluids
•Direct and indirect IHC staining, IF staining
•Fast, high-quality Brightfield and Fluorescent scanning
•Immediate scanning after staining
•Up-to-date scanning technology with minimal bleaching effect
•Initially stained slides can be accessed through LAN almost promptly after scanning, it is not
necessary to wait until the batch process is finished.
2.2 Main outer parts of the device
The below image illustrates the main outer parts of the iSaCS:
Figure 1.– Main outer parts of the device
1. Upper door
2. Door opening button
3. Lower door (container store compartment)
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
2 Product De cription
4. Main power switch (ON/OFF)
. Connector panel
6. Power supply and switch compartment
7. Lumencor SPECTRA fluorescent illumination unit (optional)
8. Optical cable (optional)
9. Tray feeding slot
10. FL optical adapter (optional)
Figure 2.– Main outer parts of the device
11. Incubation compartment feeding slot
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
2 Product De cription
2.3 Main inner parts of the device
The below image illustrates the main inner parts of the iSaCS:
Figure 3.– Main inner parts of the device
1. Pipetting unit
2. Coverslipper
3. Reagent chain
4. Fluid containers (Washing buffer, DI water, Hazardous- and Non-hazardous waste)
. Darkfield preview unit
Figure 4 – Main inner parts of the device
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
3 Preparation procedures
3 Preparation procedures
1. Before switching on the device and the control computer make sure that:
•the doors of the device are closed
•the device is connected properly to the power supply
•the necessary amount of slides is loaded into the incubation compartment
Note:
Slides, reagents, coverslips, etc. can be filled into the device only when
the control computer and the device both are switched on, and the
control software is running.
•adequate amount of reagents, coverslips, mounting fluid, pipetting tips are filled
into the device
•DI and Buffer containers are filled up
•Waste containers are empty
•there is no slide in the pipetting or coverslipping modules
•caps of reagent vial and mounting vial both are removed
•there is no pipette tip in the pipetting or coverslipping modules (stuck to the arm)
•there is no slide on the lifting arm
2. Switch on the control computer and the device
Note:
If the status light of the main switch button is blue, the device is swithed
on and in operating state.
3. Initial parameters of the camera, hardware, and control units are set.
Warning!
By releasing the main door it may suddenly drop, therefore during
closing the door make sure that the gap is clear, and be careful with your
hands. Contact service personnel (or distributor) if the tension gas spring
is not operating effectively.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
4 Commissioning
4 Commissioning
4.1 Switching on/off
1. After connecting the device with the power supply cord, make sure that the main power
rocker switch (marked with red on Figure 5) is on (I).
Figure 5 – Location of the main power switch
2. To turn on the device that it is ready to operate, push the power button (see section 2.2).
3. Switch the main power rocker switch off to turn off the device.
4.2 Software startup
1. Launch the control software of iSaCS by double-clicking the iSaCS program icon.
2. Open Services window from under the Service menu, and start processes that are not yet
running by clicking the Start buttons. Wait until each of the state indicators is lit green.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
4 Commissioning
Note:
When shutting down, after you have clicked the Shutdown button, all of
the running processes must be stopped before restarting the control
software.
3. Both of he Door Open buttons are active on the main window of the control software.
4.3 Hardware startup
After software initialization, make sure that the necessary amount of fluids and consumables
(washing fluid, DI water, coveslips, mounting material) are loaded into the device.
Before hardware initialization, click Service first, then Startup.
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
4 Commissioning
4.4 Loading the supplies
4.4.1 Fluids
1. Open the lower door of the device according the following:
I. Click the Door open button at the lower section of the main window.
I. Push the door opening button (flashing in red-green) on the front door.
II. Pull up the door until it stops at its peak position, then open lower door.
2. Pull out the fluid container you want to fill up not further than the marker line.
Figure 6 – Fluid compartment
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iSaCS – IHC Stainer, Automated Coverslipper and Scanner
User's Guide
4 Commissioning
Warning!
The pump unit must be removed before refilling or emptying the
container by rotating the cap by 20° clockwise.
3. Fill up Buffer and DI water containers with distilled water, and empty the rest of the
containers.
4. During placing back the containers, make sure that the cable chain runs freely between the
two containers, and above the guide-rail.
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