3D Histech ISaCS Manuel utilisateur

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

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.

September 22, 2016 3DHISTECH Ltd. 4(51)

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.

September 22, 2016 3DHISTECH Ltd. 9(51)

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.

September 22, 2016 3DHISTECH Ltd. 10(51)

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