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3DHISTECH iSaCS, Руководство пользователя

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

Notes Regarding Operational Safety

Notes Regarding Operational Safety

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.

September 22, 2016

3DHISTECH Ltd.

7(51)

Содержание iSaCS

Страница 1: ...iSaCS IHC Stainer Automated Coverslipper and Scanner User s Guide September 22 2016 ...

Страница 2: ...g 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 5 Incubation unit 21 4 5 1 Preparation of slides and trays 21 4 5 2 Filling up the incubation compartment 22 4 5 3 Initialization 24 4 5 4 Unthreading threading the reagent chain 24 4 5 5 Filling up the reagent chain with pipette tips and reagent vials 25 4 5 6 Filling the cov...

Страница 3: ...nformation 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 5 Opening the protective cover 45 8 3 Troubleshooting 45 9 Transporting of iSaCS 47 10 Technical Data 48 September 22 2016 3DHISTECH Ltd 3 51 ...

Страница 4: ... 007502032 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 includ...

Страница 5: ...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 Add...

Страница 6: ...ard 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...

Страница 7: ...ecessary 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 dam...

Страница 8: ...tly 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 m...

Страница 9: ... 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 ...

Страница 10: ...o 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 us...

Страница 11: ...e 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 September 22 2016 3DHISTECH Ltd 11 51 ...

Страница 12: ...n 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 r...

Страница 13: ...ect 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 illustrat...

Страница 14: ...N OFF 5 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 Incubationcompartment feedingslot September 22 2016 3DHISTECH Ltd 14 51 ...

Страница 15: ...e 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 5 Darkfield preview unit Figure 4 Main inner parts of the device September 22 2016 3DHISTECH Ltd 15 51 ...

Страница 16: ...e 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 butt...

Страница 17: ... 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 Wai...

Страница 18: ...tarting 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 September 22 2016 3DHISTECH Ltd...

Страница 19: ...llowing 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 September 22 2016 3DHISTECH Ltd 19 51 ...

Страница 20: ...ing 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 September 22 2016 3DHISTECH Ltd 20 51 ...

Страница 21: ...it is broken or its edges are not properly cut or grounded Using such slides may lead to injury Important Only original 3DHISTECH trays can be loaded into the device Do NOT insert slides into tray positions 1 and 12 Feeding the slide tray Figure 7 Feeding the slide tray 1 Insert the tray marked with blue that contains at least one slide onto the guide rail marked with red at the left side of the d...

Страница 22: ...er thus preventing the slides to fall out of the tray Keep the tray clean free from dust and mounting residue Slide movement can be ensured only if the tray is clean Warning Do not reach into the movement area of the tray while it is moving 4 5 2 Filling up the incubation compartment 1 Prepare the disinfected and dry incubation compartment placed to the working table to its bottom feeding slots fa...

Страница 23: ...em Warning Slides which are wet at their edges or bottom cannot be inserted To prevent misfeeding incorrect placement and erroneous scanning always dry the surface of the slide before insertion 3 Click Door Open at the upper panel of the main window 4 Slide the door at the right side of the device 5 Place incubation compartment onto the guide rail behind the door Figure 9 Insertion of incubation c...

Страница 24: ... displayed on the upper panel 4 5 4 Unthreading threading the reagent chain Unthreading 1 Open the door 2 Disassemble the chain at the access 3 Close the door 4 Click Chain unload under the Service menu Threading 1 Open the door 2 Push the chain at the access until it stops smaller eye to the front 3 Close the door 4 Click Chain load under the Service menu September 22 2016 3DHISTECH Ltd 24 51 ...

Страница 25: ... Inserting pipette tips and reagent vial 3 With their caps removed insert reagent vials into their racks of the chain 3 4 5 6 Filling the coverslipper unit 1 Open the upper door 2 Replace the used pipette tip with a new one 1 Note The unused pipette tip must be placed to the lower collar of the pipette rack 3 Insert the vial of the mounting material to its place 2 4 Fill up the coverslip container...

Страница 26: ...n an error message is received stating that there is an issue with the coverslipper sensor unit first pull the coverslip container to the front clean the sensor gap then push the container back to its place 4 6 Reagent handling To setup reagent parameters select Reagent sub menu under Inventory menu If you type the reagent name into the Search field of the Reagent Catalog window the search results...

Страница 27: ...ady existing ones cannot be modified Reagent types that are listed are predefined Reagent data are not editable therefore fields in the Reagent data pane are inactive displayed with gray background Click the star icon to mark a reagent as favorite and if it is already marked its status can be dissolved September 22 2016 3DHISTECH Ltd 27 51 ...

Страница 28: ...ral slides with mouse or keyboard then right double click the thumbnail of one of the selected slides The Protocol section of the Slide Editor window appears on the right side in which protocol selection is available only and slide data cannot be modified Enter the following data in the Slide data section BarCode Patient Block Slide Case September 22 2016 3DHISTECH Ltd 28 51 ...

Страница 29: ... If activated area can be modified or erased in accordance with the mode of selection Freehand Rectangle Ellipse Area selection modes Clear Erases area selection Reset Restores the loaded saved status 4 8 Protocol Sequencing Protocol builder can be accessed by clicking Protocol parts under the Inventory menu Sequencing of steps is available in the Properties section of the Protocol Part Catalog wi...

Страница 30: ...f Staining and Scanning is added to the sequence Covering must be added between these two steps Covering cannot be followed by Staining Washing or Rinsing There can be only one Covering step present Quant can be present as post processing only Quant step must be preceded by a Scanning step Pipetting Select the protocol related reagent from the drop down menu Incubating Set incubation time for the ...

Страница 31: ...nt It is available for you to select washing cycle from Buffer or DI Water fluid containers Set washing time by dragging the slider to a required value Material Buffer DI Water Profile Washing Rinsing Time minute slider is inactive if Rinsing is selected only a 30 second long quick washing step can be set Covering September 22 2016 3DHISTECH Ltd 31 51 ...

Страница 32: ...n in the Target field Local or CaseCenter II Set the profile to be loaded in the Scanner Data field of Scan Properties panel The profile type BF of FL automatically appears in Profile type and Scan area fields together with the scannable area preview image or stained area September 22 2016 3DHISTECH Ltd 32 51 ...

Страница 33: ...d Scanner User s Guide 4 Commissioning Post processing QuantCenter I Select Post processing list item from the Category drop down menu II Click III Choose the Quant scenario you want to use during processing September 22 2016 3DHISTECH Ltd 33 51 ...

Страница 34: ...uide 4 Commissioning 1 Double click an item in the protocol list to select or type a character string into the Name field to show result then select the appropriate one 2 To assign the selected protocol to the slide click OK September 22 2016 3DHISTECH Ltd 34 51 ...

Страница 35: ...tocol List items or click to define a new protocol Edit protocol parameters in Current Protocol and Available Protocol Parts panels Click OK to apply and save settings the window closes 4 Switch between slides by clicking the arrow buttons 5 With the Rerun automatic recognition option the already recorded label area cab be reloaded barcode parsing is also available September 22 2016 3DHISTECH Ltd ...

Страница 36: ...ueued Parts panel of the Slide Editor window are displayed so that by double clicking the protocol it will be assigned to the slide Click OK to accept and return to main window 7 Protocol status is marked as valid by displaying a green belt area at the bottom of the slide September 22 2016 3DHISTECH Ltd 36 51 ...

Страница 37: ...hen the slide that can be finalized the fastest will be the first in the queue Simple Advanced Complex Simple Does not interrupt the protocol one slide is finalized at a time Advanced Complex Interrupts the protocol one unit from pipetting to washing When selecting Complex a slide is finalized in each 5 minutes The selection of the upper three options Quick Moderate Intense is not mandatory the pr...

Страница 38: ...which the probably completion times can be seen at the bottom of the slide thumbnails Click on the Reagens panel and if there are several reagents filled in their statuses are displayed with narrower marking icons and further data is displayed in a tooltip of the reagent September 22 2016 3DHISTECH Ltd 38 51 ...

Страница 39: ...s will be discarded into the Hazardous Waste container Slides left in the Coverslipping Washing and Darkfield units are searched for and you receive a warning message if the system finds any If a slide is left in the Washing unit it will be moved to the bottom position of the incubation compartment in case it is empty Rerun Slide Recognition Slide data will be refreshed for all of the slides loade...

Страница 40: ...pper and Scanner User s Guide 6 Service Recognition settings Setting of parameters of Barcode parsing Important This function is NOT compatible with HL7 system Services Managing services Start or Stop September 22 2016 3DHISTECH Ltd 40 51 ...

Страница 41: ... 2 Click Run to launch the process 3 After scheduling the calculated completion time is visible at the bottom of the slide thumbnail The following error messages might come up during processing Reagent set in the protocol is missing Not enough quantity of reagent Not enough quantity of fluid in DI or Buffer containers September 22 2016 3DHISTECH Ltd 41 51 ...

Страница 42: ...nly plug the device in a socket with protective grounding earth contact Do not operate the device in explosive environment Disconnect the device from the power outlet before opening it or replacing a part The product is not equipped with protection against hazardous materials infectious toxic radioactive corrosive substances or other effects damaging to health Decontaminate infectious materials af...

Страница 43: ...e cotton cloth You can moisten the cloth with water To clean greasy surfaces it is recommended to apply Isopropanol on a piece of lint free cotton cloth and gently rub the surface Do NOT use alcohol for cleaning plastic surfaces or the cover 8 2 3 Cleaning the tray NEVER clean the trays with Xylene because it might harm the plastic We recommend to apply Isopropanol on a piece of lint free cotton c...

Страница 44: ...lever to the left so the insert 2 can be pulled out Figure 12 Fuse compartment 4 Remove insert from the compartment Figure 13 Removing the fuse insert 5 Replace fuses put the insert back into its mounting and push it inwards until you hear a snap so the lever locks Figure 14 Replacing the fuses September 22 2016 3DHISTECH Ltd 44 51 ...

Страница 45: ...oes not start Power supply is interrupted 1 Make sure that both the main power supply switch and the side switch are on 2 Check cable connections 3 Fuses must be replaced see section 8 2 4 Replacing fuses of the main power switch Control software has stopped A Coverslipping unit error message is received during initialization Pull the coverslipper unit forward clean the sensor slot then push the u...

Страница 46: ...xample chromatic aberrations Contact 3DHISTECH Service for support Warning Do not modify the camera driver settings as the default settings adjusted by 3DHISTECH give the most accurate images Virtual slides show poor stitching in Pannoramic Viewer Scan camera is not properly adjusted for example due to loose fixture Contact 3DHISTECH Service for support September 22 2016 3DHISTECH Ltd 46 51 ...

Страница 47: ...cannot be moved on the workbench it must be packed and into its original box 4 6 people are needed for lifting the device to place it into the box The device must be lifted strictly at its bottom plate the number of people lifting the device is described in the effective by law You can find the weight related data of the base unit in section 10 Technical Data For the in house transport of iSaCS fo...

Страница 48: ... Fluorescent scanning Yes Yes Available magnification 40x FL illumination 6 channels 15 000 hour lifespan Digital slide format MRXS JPG JPG2000 coding Measurements width x depth x height Base Unit Approx 112 66 78 cm Weight Base Unit Approx 120 kg Base Unit with FL option Approx 125 kg Ambient conditions Dispatch boxed Range of allowed temperature Between 40 C and 70 C Storage Range of allowed tem...

Страница 49: ...0 2 101 2002 IEC 61010 1 2001 IEC 61010 2 101 2002 Over voltage category II Radio interference suppression in accordance with EN 55011 class B Noise immunity in accordance with EN 61326 2 6 2005 Base unit input voltage 100 240V AC Power consumption of the complete device max 350W Fuses 2x T3 15A 250V Light sources Halogen lamp transmitted light operation Precision Aligned Pulsed Xenon Light Source...

Страница 50: ...oding EAN13 Numeric encoding UPC A Numeric encoding DataMatrix Numeric encoding Alpha encoding AlphanumericPunc encoding AlphaNumeric encoding ASCII encoding IS08 encoding Maxicode Encoding mode 2 3 4 5 6 MicroPDF417 Standard encoding type PDF417 Standard encoding type QR QR code Model 1 2 encoding Scan camera CIS VCC FC60FR19CL Global Shutter Type CMOS Diagonal 15 930mm Pixel size 5 5µm 5 5µm Cam...

Страница 51: ...tem Microsoft Windows 7 Professional SP1 64 bit EN CPU 2x Intel Xeon 8 core 12 MB l2 cache RAM Recommended 12 GB DDR3 Hard disk 1 5 TB Optical drive DVD RW Display 96 dpi Graphics SXGA 1280 1024 True color Input devices Keyboard mouse Ports 2xDouble CameraLink port 1 FireWire 1394 A 4 USB 2 0 GB Ethernet September 22 2016 3DHISTECH Ltd 51 51 ...

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