Leica Biosystems Nussloch SPECTRAST Multistainer User Manual DRAFT 14051280101J SPECTRA ST IFU 1v3J en

Leica Biosystems Nussloch GmbH Multistainer DRAFT 14051280101J SPECTRA ST IFU 1v3J en

Contents

14051280101J_SPECTRA_ST_IFU_1v3J_en.pdf

HistoCore SPECTRA STStainerThe Pathology CompanyInstructions for UseEnglishOrder No. 14 0512 80101 - Revision JAlways keep this manual with the instrument.Read carefully before working with the instrument.Version 1.3, Revision J - 01.2017
3HistoCore SPECTRA STThe information, numerical data, notes and value judgments contained in this manual represent the current state of scientific knowledge and state-of-the-art technology as we understand it following thorough investigation in this field. We are under no obligation to update the present manual periodically and on an ongoing basis according to the latest technical developments, nor to provide our customers with additional copies, updates etc. of this manual.To the extent permitted in accordance with the national legal system as applicable in each individual case, we shall not be held liable for erroneous statements, drawings, technical illustrations etc. contained in this manual. In particular, no liability whatsoever is accepted for any financial loss or consequential damage caused by or related to compliance with statements or other information in this manual.Statements, drawings, illustrations and other information regarding the contents or technical details of the present Instructions for Use are not to be considered warranted characteristics of our products.These are determined only by the contract provisions agreed between ourselves and our customers.Leica reserves the right to change technical specifications as well as manufacturing processes without prior notice. Only in this way is it possible to continuously improve the technology and manufacturing techniques used in our products.This document is protected under copyright laws. All copyrights to this documentation are held by Leica Biosystems Nussloch GmbH.Any reproduction of text and illustrations (or of any parts thereof) by means of print, photocopy, microfiche, web cam or other methods – including any electronic systems and media – requires express prior permission in writing by Leica Biosystems Nussloch GmbH.For the instrument serial number and year of manufacture, please refer to the nameplate on the back of the instrument.NoteLeica Biosystems Nussloch GmbHHeidelberger Str. 17 - 19D-69226 Nussloch, GermanyGermanyPhone: +49 - (0) 6224 - 143 0Fax: +49 - (0) 6224 - 143 268Web: www.LeicaBiosystems.com
4Version 1.3, Revision J Table of Contents1. Important Information ................................................................................................................................ 81.1 Symbols and their meanings.......................................................................................................................... 81.2 Instrument type .............................................................................................................................................. 121.3 User Group ...................................................................................................................................................... 121.4 Intended use ................................................................................................................................................... 121.5 Copyright - Instrument software ................................................................................................................. 132. Security ....................................................................................................................................................... 142.1 Safety Notes ................................................................................................................................................... 142.2 Warnings ......................................................................................................................................................... 152.3 Safety features on the instrument .............................................................................................................. 183. Instrument Components and Specifications ........................................................................................ 193.1 Standard delivery ........................................................................................................................................... 193.2 Specifications ................................................................................................................................................. 203.3 General overview - front view ..................................................................................................................... 223.4 General overview - rear view ...................................................................................................................... 233.5 General overview - inside view ................................................................................................................... 244. Installation and Starting up .................................................................................................................... 254.1 Installation site requirements ...................................................................................................................... 254.2 Rinsing water connection ............................................................................................................................ 254.2.1 Joint connection of all 6 rinsing water stations ....................................................................................... 264.2.2 Combined connection 4+2 rinsing water stations .................................................................................... 274.2.3 Wastewater connection ............................................................................................................................... 294.3 Electrical connection .................................................................................................................................... 294.3.1 Using an external uninterruptible power supply (UPS) ........................................................................... 304.4 Exhaust air connection ................................................................................................................................. 314.5 Switching the instrument on and off .......................................................................................................... 315. Operation .................................................................................................................................................... 335.1 User interface - overview ............................................................................................................................. 335.2 Elements of the status display ..................................................................................................................... 345.3 Process status display .................................................................................................................................. 355.4 Displaying the drawers ................................................................................................................................. 375.5 Main menu - overview .................................................................................................................................. 385.5.1 The keyboard .................................................................................................................................................. 395.6 User settings ................................................................................................................................................... 405.7 Basic settings ................................................................................................................................................. 425.7.1 Language settings ......................................................................................................................................... 435.7.2 Regional settings ........................................................................................................................................... 445.7.3 Date and time ................................................................................................................................................. 455.7.4 Alarm and signal tones ................................................................................................................................. 45
5HistoCore SPECTRA STTable of Contents5.7.5 Oven settings .................................................................................................................................................. 475.7.6 Movement speed - up/down movement (agitation) ................................................................................. 485.7.7 Data management ......................................................................................................................................... 495.7.8 Service access ............................................................................................................................................... 535.7.9 Event viewer ................................................................................................................................................... 535.7.10 Network settings ............................................................................................................................................ 555.8 Reagent list ..................................................................................................................................................... 565.8.1 Defining heated reagent (optional) ............................................................................................................. 575.8.2 Copying a reagent .......................................................................................................................................... 595.8.3 Changing the RMS data for a reagent........................................................................................................ 605.8.4 Process classes ............................................................................................................................................. 605.9 Staining programs ......................................................................................................................................... 635.9.1 Assigning a rack handle color to a staining program.............................................................................. 645.9.2 Leica staining programs (preinstalled) ...................................................................................................... 665.9.3 Adapting the Leica H&E staining program ................................................................................................ 675.9.4 User-defined staining programs ................................................................................................................. 685.9.5 Creating or copying a new staining program............................................................................................ 695.9.6 Inserting or copying a new program step ................................................................................................. 715.9.7 Re-sorting program steps............................................................................................................................. 725.9.8 Prioritizing programs for creating the bathlayout .................................................................................... 745.9.9 Creating the bathlayout ................................................................................................................................ 755.9.10 Filling reagents after bathlayout creation ................................................................................................. 765.9.11 Adapting a bathlayout ................................................................................................................................... 826. Daily instrument setup ............................................................................................................................. 856.1 Preparing the instrument for daily setup ................................................................................................... 856.2 Daily instrument setup .................................................................................................................................. 866.2.1 Preparation and handling of reagent vessels ........................................................................................... 866.2.2 Automatic fill level scan ............................................................................................................................... 886.3 Reagent management system (RMS) ......................................................................................................... 896.4 Station details ................................................................................................................................................. 906.5 Preparing the rack ......................................................................................................................................... 966.6 The staining process ..................................................................................................................................... 996.6.1 Starting the staining process..................................................................................................................... 1006.6.2 Monitoring the staining process ............................................................................................................... 1026.6.3 Staining process completed ...................................................................................................................... 1026.6.4 Canceling the staining program ................................................................................................................ 1046.6.5 Operation as a workstation ........................................................................................................................ 106
6Version 1.3, Revision J Table of Contents6.6.6 Finishing the daily operation ...................................................................................................................... 1067. Cleaning and Maintenance ...................................................................................................................1087.1 Important notes about cleaning this instrument .................................................................................... 1087.2 Exterior surfaces, varnished surfaces, instrument hood ...................................................................... 1087.3 TFT touchscreen .......................................................................................................................................... 1087.4 Interior and drain pan ................................................................................................................................. 1087.5 Transport arms ............................................................................................................................................. 1097.6 Specimen slide reader station................................................................................................................... 1097.7 Input and output drawers ........................................................................................................................... 1097.8 Dry transfer station ...................................................................................................................................... 1107.9 Transfer station (optional) .......................................................................................................................... 1117.10 Reagent vessels, rinsing water vessels and (optional) heated vessels ............................................. 1117.11 Rack and handle .......................................................................................................................................... 1127.12 Water drainage ............................................................................................................................................ 1137.13 Water drain hose ......................................................................................................................................... 1147.14 Replacing the filter cartridge of the water intake filter ......................................................................... 1147.15 Changing the active carbon filter.............................................................................................................. 1157.16 Cleaning the ovens ...................................................................................................................................... 1167.17 Oven air filter ................................................................................................................................................ 1187.18 Maintenance and cleaning intervals........................................................................................................ 1187.18.1 Daily cleaning and maintenance............................................................................................................... 1197.18.2 Cleaning and maintenance as necessary ............................................................................................... 1197.18.3 Weekly cleaning and maintenance .......................................................................................................... 1197.18.4 Monthly maintenance and cleaning ......................................................................................................... 1207.18.5 Cleaning and Maintenance Every Three Months .................................................................................. 1207.18.6 Annual maintenance and cleaning ........................................................................................................... 1208. Malfunctions and Troubleshooting .....................................................................................................1218.1 Fault remedies for instrument malfunctions ........................................................................................... 1218.2 Power failure scenario and instrument malfunction ............................................................................. 1238.2.1 Procedure after a power failure................................................................................................................ 1268.2.2 Resuming the staining process after a power failure ........................................................................... 1278.2.3 Canceling all staining processes after a power failure ........................................................................ 1298.2.4 Detaching a rack from the gripper mechanism ...................................................................................... 1308.3 Replacing main fuses .................................................................................................................................. 1328.4 Remote Care ................................................................................................................................................. 1328.5 Water drain system blocked ...................................................................................................................... 133
7HistoCore SPECTRA STTable of Contents9. Instrument Components and Specifications ......................................................................................1359.1 Optional instrument components .............................................................................................................. 1359.2 Optional accessories .................................................................................................................................. 13510. Warranty and Service ............................................................................................................................14111. Decommissioning and disposal ........................................................................................................... 14212. Decontamination Confirmation ............................................................................................................143Appendix 1 - Compatible reagents ................................................................................................................. 144
8Version 1.3, Revision J Important Information11. Important Information1.1 Symbols and their meaningsCaution Leica Biosystems GmbH assumes no liability for consequential loss or damage due to failure to observe the following instructions, particularly in relation to transportation and package handling, and failure to observe the instructions for handling the instrument carefully.Symbol: Title of the symbol: DangerDescription: Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injuries.Symbol: Title of the symbol: WarningDescription: Indicates a potentially hazardous situation which, if not avoided, may result in death or serious injury.Symbol: Title of the symbol: CautionDescription: Indicates a potentially hazardous situation which, if not avoided, may result in death or serious injury.Symbol: Title of the symbol: NoteDescription: Indicates a situation with the potential for property damage which, if not avoided, may result in damage to the machine or something in its vicinity.Symbol: Title of the symbol: Item number→ "Fig. 7 - 1"Description: Item numbers for numbering illustrations. Numbers in red refer to item numbers in illustrations.Symbol: Title of the symbol: Function keySave Description: Software symbols that have to be pressed on the input screen are displayed as bold, gray text.Symbol: Title of the symbol: Caution Description: Indicates the need for the user to consult the Instructions for Use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.Symbol: Title of the symbol: Warning, hot surface Description: Instrument surfaces which become hot during operation are marked with this symbol. Avoid direct contact to prevent risk of burning.Symbol: Title of the symbol: ManufacturerDescription: Indicates the manufacturer of the medical product.
9HistoCore SPECTRA STImportant Information 1Symbol: Title of the symbol: Manufacturing dateDescription: Indicates the date when the medical device was manufactured.Symbol: Title of the symbol: CE ComplianceDescription: The CE marking is the manufacturer's declaration that the medical product meets the requirements of the applicable EC directives.Symbol: Title of the symbol: CSA Statement (Canada/USA)Description: The CSA test mark means that a product has been tested and fulfills the applicable safety standards:CAN/CSA-C22.2 NO. 61010-1-04; CAN/CSA-C22.2 NO. 61010-2-010-04; CAN/CSA-C22.2 NO. 61010-2-101-04 Product is listed under Master Contract Number: 217333Symbol: Title of the symbol: In vitro diagnostic medical deviceDescription: Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.Symbol: Title of the symbol: China ROHSDescription: Environmental protection symbol of the China RoHS directive. The number in the symbol indicates the "Environment-friendly Use Period" of the product in years. The symbol is used if a substance restricted in China is used in excess of the maximum permitted limit.Symbol: Title of the symbol: WEEE SymbolDescription: The WEEE symbol, indicating separate collection for WEEE - Waste of electrical and electronic equipment, consists of the crossed-out wheeled bin (§ 7 ElektroG).Symbol: Title of the symbol: Alternating currentSymbol: Title of the symbol: Article numberDescription: Indicates the manufacturer's catalog number so that the medical device can be identified.Symbol: Title of the symbol: Serial numberDescription: Indicates the manufacturer's serial number so that a specific medical device can be identified.Symbol: Title of the symbol: Consult Instructions for UseDescription: Indicates the need for the user to consult the Instructions for Use.
10 Version 1.3, Revision J Important Information1Symbol: Title of the symbol: ON (Power)Description: The power supply is connected upon pushing the power switch.Symbol: Title of the symbol: OFF (Power)Description: The power supply is disconnected upon pushing the power switch.Symbol: Title of the symbol: Warning, risk of electric shock Description: Instrument surfaces or areas which become energized during operation are marked with this symbol. Therefore, direct contact is to be avoided.Symbol: Title of the symbol: Caution: danger of crushingSymbol: Title of the symbol: FlammableDescription: Flammable reagents, solvents and cleaning agents are labeled with this symbol.Symbol: Title of the symbol: Observe the laser beam warning and Instructions for UseDescription: The product uses a class 1 laser source. The safety notes for handling lasers and the Instructions for Use must be observed!Symbol: Title of the symbol: IPPC symbolDescription: The IPPC symbol includesIPPC symbol• Country code to ISO 3166, e.g. DE for Germany• Regional identifier, e.g. NW for North Rhine-Westphalia• Registration number, unique number beginning with 49.• Treatment method, e.g. HT (heat treatment)Symbol: Title of the symbol: Fragile, handle with careDescription: Indicates a medical device that can be broken or damaged if not handled carefully.Symbol: Title of the symbol: Store dryDescription: Indicates a medical device that needs to be protected from moisture.
11HistoCore SPECTRA STImportant Information 1Symbol: Title of the symbol: Stack limitDescription: The largest number of identical packages allowed to be stacked; "2" stands for the number of permitted packages.Symbol: Title of the symbol: This way upDescription: Indicates correct upright position of the transport package.Symbol: Title of the symbol: Temperature limit for transportDescription: Indicates the temperature limits for transport to which the medical device can be safely exposed.Symbol: Title of the symbol: Temperature limit for storageDescription: Indicates the temperature limits for storage to which the medical device can be safely exposed.Symbol: Title of the symbol: Humidity limitation for transport and storageDescription: Indicates the range of humidity for transport and storage to which the medical device can be safely exposed.Appearance: Indication: Tilt indicatorDescription: Indicator to monitor whether the shipment has been transported and stored in upright position according to your requirements. With a pitch of 60° or more, the blue quartz sand flows into the arrow-shaped indicator window and sticks there permanently. Improper handling of the shipment is immediately detectable and can be proven definitively.
12 Version 1.3, Revision J Important Information1Note Upon delivery of the instrument, the recipient must check that the tilt indicator is intact. The responsible Leica representative must be notified in the case that all indicators have been triggered. Note The Instructions for Use are accompanied by a bound "RFID Registration" brochure. The brochure contains country-specific information for the operator about the meaning of the RFID symbols and registration numbers available on the packaging or the HistoCore SPECTRA ST nameplate.1.2 Instrument typeAll information provided in these Instructions for Use applies only to the instrument type indicated on the title page. A nameplate (→ "Fig. 1-1") indicating the instrument serial number is attached to the rear side of the instrument. Furthermore, a plate with Chinese (→ "Fig. 1-2") and Japanese (→ "Fig. 1-3") registration information is located on the rear panel of the instrument. The figure below (→ "Fig. 1-1") is provided as an example only and shows a valid nameplate for this instrument.Fig. 1 1321.3 User Group• The HistoCore SPECTRA ST must only be operated by authorized personnel comprehensively trained in using lab reagents and their application in histology.• All laboratory personnel designated to operate this instrument must read these Instructions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it.1.4 Intended useThe HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
13HistoCore SPECTRA STImportant Information 1Danger Any use of the instrument that deviates from the designated use is considered improper. Failure to adhere to these instructions may result in an accident, personal injury, damage to the instrument or accessory equipment. Proper and intended use includes compliance with all inspection and maintenance instructions, along with the observance of all instructions in the Instructions for Use as well as the constant inspection of the reagents for storage life and quality. The HistoCore SPECTRA ST carries out the specified staining steps automatically. The manufacturer assumes no liability for the staining results in the case that the staining steps and programs are entered incorrectly. Thus, the end user is independently responsible for self-created reagents or program entries.1.5 Copyright - Instrument softwareThe software installed and used on the HistoCore SPECTRA ST is subject to the following license agreements:1. GNU General Public License Version 2.0, 3.02. GNU Lesser General Public License 2.13. additional software not licensed under the GPL/LGPLThe complete license agreements for the first and second can be found on the provided language CD (link to Standard Delivery) in the "Software Licenses" directory.Leica Biosystems provides a complete machine-readable copy of the source code to every third party in compliance with the agreements of the GPL/LGPL applicable for the source code or of the other applicable licenses. To contact us, go to www.leicabiosystems.com and use the corresponding contact form.
14 Version 1.3, Revision J Security22. Security2.1 Safety NotesCaution • The safety and caution notes in this chapter must be observed at all times. Be sure to read these notes even if you are already familiar with the operation and use of other Leica products.• The protective devices located on the instrument and the accessories must not be removed or modified.• Only qualified service personnel authorized by Leica may repair the instrument and access its internal components.Residual risks:• The instrument has been designed and constructed with the latest state-of-the-art technology and according to recognized standards and regulations with regard to safety technology. Operating or handling the instrument incorrectly can place the user or other personnel at risk of injury or death or can cause damage to the instrument or property. • The instrument may be used only as intended and only if all of its safety features are in proper working condition. • If malfunctions occur that can impede safety, the instrument must be put out of operation immediately and the responsible Leica service technician must be notified.• Only original spare parts and permitted original Leica accessories may be used.• Electromagnetic compatibility, emitted interference and immunity to interference are applicable, as are the requirements in accordance with IEC 61326-2-6. The requirements in accordance with IEC 61010-1, IEC 61010-2-101, IEC 62366 and ISO 14971 with regard to safety information are applicable. These Instructions for Use include important instructions and information related to the operating safety and maintenance of the instrument.The Instructions for Use are an important part of the product, and must be read carefully prior to startup and use and must always be kept near the instrument.Note These Instructions for Use must be appropriately supplemented as required by the existing regulations on accident prevention and environmental safety in the operator‘s country.The instrument's EC Declaration of Conformity can be found on the Internet at: http://www.LeicaBiosystems.comThis instrument has been built and tested in accordance with the safety requirements for electrical equipment for measurement, control, and laboratory use. To maintain this condition and ensure safe operation, the user must observe all notes and warnings contained in these Instructions for Use.
15HistoCore SPECTRA STSecurity 2Warning • The presence of malware on the system can lead to uncontrolled system behavior. Ensuring that the behavior of the instrument conforms to specifications is no longer possible in this case! If the user suspects malware is on the system, the local IT department must be notified immediately.• You must make sure that any data loaded onto the instrument is free of viruses. No anti-virus software is provided.• The instrument is only suited for integration in a firewall-protected network. Leica shall not assume any liability for errors due to integration in an unprotected network.• ONLY technicians trained and permitted by Leica can connect a USB input device (mouse/keyboard, etc.). This also applies to the network connection, which is to be used only together with Remote Care (service diagnostics).In the interest of specimen safety, the HistoCore SPECTRA ST indicates when it is necessary for the user to intervene using on-screen messages and audible signals. Therefore, the HistoCore SPECTRA ST stainer requires that the user is within hearing distance during operation.Danger The product uses a class 1 laser source.Caution, laser radiation! Do not look into the beam! This can cause injury to the retina of the eye. Danger LASER RADIATION - DO NOTSTARE INTO BEAMISO 60825-1: 2014P<1 mW, λ = 630 to 670 nmPulse duration = 500 μsClass 1 laser product2.2 WarningsThe safety devices installed in this instrument by the manufacturer only constitute the basis for accident prevention. Operating the instrument safely is, above all, the responsibility of the owner, as well as the designated personnel who operate, service or repair the instrument.To ensure trouble-free operation of the instrument, make sure to comply with the following instructions and warnings.Please note that electrostatic discharges can result due to direct or indirect contact with the HistoCore SPECTRA ST.Danger Markings on the instrument surface showing the warning triangle indicate that the correct operating instructions (as defined in these Instructions for Use) must be followed when operating or replacing the item marked. Failure to adhere to these instructions may lead to accidents causing personal injury and/or damage to the instrument or accessories or destroyed, unusable specimens.
16 Version 1.3, Revision J Security2 Danger Certain surfaces of the instrument are hot during operation under normal conditions. They are marked with this warning sign. Touching these surfaces without suitable safety measures can cause burns.Warnings - Transport and installationCaution • The instrument must only be transported in an upright position.• The empty weight of the instrument is 185 kg; therefore, four qualified persons are required to lift or carry the instrument! • Use non-skid gloves to lift the device!• Leica recommends commissioning a transport company to transport, install or (where applicable) relocate the instrument.• Retain the instrument packaging.• Place the instrument on a sturdy laboratory bench (load capacity 150 kg/m2) and adjust it to a horizontal position.• Prevent the instrument from being exposed to direct sunlight. • Only connect the instrument to a grounded power socket. Do not interfere with the grounding function by using an extension cord without a ground wire.• Exposure to extreme temperature changes between storage and installation locations and high air humidity may cause condensation inside the instrument. If this is the case, wait at least two hours before switching on the instrument.• The instrument must only be installed at the area of use with and under direction of Leica-trained staff. This also applies to the potential transport to a new area of use. We recommend using personnel trained by Leica to recommission the instrument.• In accordance with national rules and regulations, the operator may be obligated to provide long-term protection of the public water supply from contamination due to backflowing water from the building installation. In Europe, the protection device of the potable water installation to be connected is selected in accordance with the specifications of DIN EN 1717:2011-08 (information status August 2013).Warnings – Handling reagentsCaution • Take care when handling solvents!• Always wear protective clothing suitable for laboratory use, as well as rubber gloves and safety goggles when handling the chemicals used in this instrument. • The installation site must be well-ventilated. Alternatively, the instrument can be connected to an external exhaust air extraction system. The chemicals to be used in the HistoCore SPECTRA ST are flammable and hazardous to health.• Do not operate the instrument in rooms with an explosion hazard.• When disposing of spent reagents, observe the applicable local regulations and the waste disposal regulations of the company/institution in which the instrument is being operated.• Reagent vessels must always be filled outside of the instrument in compliance with the safety information.
17HistoCore SPECTRA STSecurity 2Warnings – Operating the instrumentCaution • The instrument may be operated by trained laboratory personnel only. It must only be operated for the purpose of its designated use and according to the instructions contained in these Instructions for Use. Antistatic protective clothing made from natural fibers (e.g. cotton) should be worn when working with the instrument.• When working with the instrument, wear suitable protective clothing (lab coat and gloves) for protection from reagents and potentially infectious micro-biological contaminations.• In the event of an emergency, switch off the power switch and unplug the instrument from the power supply (circuit breaker in accordance with EN ISO 61010-1).• For severe instrument faults, the warning and error messages on the screen must be followed. Samples located in the process must be removed from the instrument immediately. The user is responsible for the safe further processing of the samples.• There is a fire hazard if work with an exposed flame (e.g. Bunsen burner) is carried out in the direct vicinity of the instrument (solvent vapors). Therefore, keep all ignition sources at least 2 meters away from the instrument!• Be absolutely certain to operate the instrument with the active carbon filter, technical ventilation system and an exhaust air hose because use of the instrument may lead to the formation of solvent vapors that are both hazardous to health and flammable, even when the instrument is used according to its intended use! Note For instrument fume control, Leica recommends a delivery volume of 50 m3/h and an 8x air exchange rate (25 m3/m2/h) in the lab.Caution • Personal protective clothing in the form of a respirator must be worn when working directly with reagent vessels that contain solvents.• Opening the hood when one or more staining program(s) are active causes delays in the respective processing steps since no transport movements take place for this time frame. This can result in changes to the staining quality.• Make sure to keep the hood closed if the staining programs are active. Leica assumes no liability for loss of quality for staining programs caused by opening the hood during the staining process.• CAUTION when closing the hood: Crushing hazard! Do not reach into the swivel range of the hood!• Liquid must not get behind covers or in gaps while operating or cleaning the instrument. This also applies to the transport arms.• CAUTION for programs that start with an oven step! In this case, the input station from which the specimen slides are removed with the transport arm must NOT be filled with a flammable reagent (e.g. xylene, xylene substitute or alcohols). The oven temperature can be up to 70 °C. This can result in the reagent igniting and can cause damage to the instrument and specimens.• The water supply has to be shut off during pauses in use of the instrument and when the instrument is turned off.
18 Version 1.3, Revision J Security2Warnings - Cleaning and MaintenanceCaution • Before any maintenance, switch off the instrument and unplug it from its power supply.• When cleaning the instrument, wear suitable protective clothing (lab coat and gloves) to protect from reagents and potentially infectious micro-biological contaminations. • When using cleaners, please comply with the safety instructions of the manufacturer and the laboratory safety regulations.• Do not use any of the following for cleaning the outside surfaces of the instrument: alcohol, detergents containing alcohol (glass cleaners), abrasive cleaning powders, solvents containing acetone, ammonia, chlorine, or xylene!• Clean the hoods and housing using mild commercial, pH-neutral household cleaners. The finished surfaces are not resistant to solvents and xylene substitutes!• The plastic reagent vessels of the rinsing water and reagent stations can be cleaned in a dishwasher at a maximum temperature of +65 °C. Any standard cleaning agent for laboratory dishwashers may be used. Never clean the plastic reagent vessels at higher temperatures since higher temperatures can cause the reagent vessels to become deformed.2.3 Safety features on the instrumentAs soon as the hood of the instrument is opened, the movements of the transport arms are stopped in a horizontal plane (x and y-axis) for safety reasons to eliminate danger to the user and specimen damage due to collision with moving parts.Caution • Make sure to keep the hood closed if the staining programs are active. Leica assumes no liability for loss of quality for staining programs caused by opening the hood during the staining process. • Opening the hood when one or more staining program(s) is/are active causes delays in the respective processing steps since no transport movements take place for this time frame. This can result in changes to the staining quality.
19HistoCore SPECTRA STInstrument Components and Specifications 33. Instrument Components and Specifications3.1 Standard deliveryQty Designation Order No.1 HistoCore SPECTRA ST Basic instrument 14 0512 543541 Reagent vessel set consisting of:46 reagent vessels with covers6 blue rinsing water vessels6 O-rings 7x214 0512 475071 Set of label covers for the input and output drawers consisting of:10 pc. blank5 pc. "H2O"=Water5 pc. "A"=Alcohol 5 pc. "S"=Solvent, e.g. xylene)14 0512 551611 Active carbon filter set (2 pcs.) 14 0512 537721 Outlet hose, 2 m 14 0512 552791 Tubing band clamp 30 45/12 DIN 3017 RF 14 0422 319721 Water supply kit consisting of: 14 0512 493242 Inflow hoses, 10 mm, 2.5 m 14 0474 323251 Extension hose, 1.5 m 14 0512 493341 Y-piece G3/4 14 3000 003512 G3/4 - G3/8 double nipple 14 3000 003501 Filter housing 14 0512 493311 Filter cartridge 14 0512 493321 Bushing G3/4 14 3000 003601 Blind cap G3/4 14 3000 004341 Gasket 14 0512 547721 Single-head wrench SW30 DIN894 14 0330 547551 Exhaust hose, 2 m 14 0512 543652 Tubing band clamp 30 45/12 DIN 3017 RF 14 0422 319721 5.5 x 150 screwdriver 14 0170 107022 T16 A fuse 14 6000 046961 Molykote 111 grease, 100 g 14 0336 354603 Rack for 30 specimen slides; 3 pcs. per package 14 0512 524731 Handle for rack for 30 specimen slides; yellow, 3 pcs. per package 14 0512 524761 Handle for rack for 30 specimen slides; dark blue, 3 pcs. per package14 0512 524781 Handle for rack for 30 specimen slides; red, 3 pcs. per package 14 0512 524801 Handle for rack for 30 specimen slides; white, 3 pcs. per package 14 0512 52484
20 Version 1.3, Revision J Instrument Components and Specifications3Qty Designation Order No.1 Instructions for Use, printed (German/English, with Language CD 14 0512 80200)14 0512 80001The country specific power cord needs to be ordered separately- Please find a list of all power cords available for your device on our website www.LeicaBiosystems.com within the product section.Note The delivered components must be carefully compared against the packing list, delivery note, and your order. Should you find any discrepancies, please contact your Leica sales office without delay.3.2 SpecificationsNominal supply voltages: 100-240 V AC +10 %Nominal frequency: 50/60 HzPower draw: 1580 VAFuses: 2 x T16 A H 250 V ACIEC 1010 classification: Protection class 1Pollution degree 2Overvoltage category: IIFresh water connection: Hose material: PVC Hose length: 2500 mm Connecting piece: G3/8 Inner diameter: 10 mm Outer diameter: 16 mm Internal pressure: Maximum/maximum: 2 bar/6 bar Required flow rate: Min. 1.7 L/minute Required water quality: Type 1, ISO 3696Waste water connection: Hose length: 2000 mm/4000 mm Inner diameter: 32 mm Outer diameter: 36.8 mmExhaust air: Hose length: 2000 mm Inner diameter: 50 mm Outer diameter: 60 mm Exhaust performance: 27.3 m3/hExhaust extraction: Active carbon filter and exhaust hose for connecting with an external exhaust systemHeat emission: 1580 J/s
21HistoCore SPECTRA STInstrument Components and Specifications 3A-weighted noise level: < 70 dB (A)International protection class: IP20Connections: 1 x RJ45 Ethernet (rear): RJ45 - LAN (external data management)1 x RJ45 Ethernet (front): Only for service purposes2 x USB 2.0: 5 V/500 mA (service & data storage)Note When using an external uninterruptible power supply (UPS), it should be designed for a capacity of at least 1580 VA and secure operation over a time frame of at least 10 minutes.Ambient conditions: 100-240 V AC +10 %Operation: 50/60 Hz Temperature: +18 °C to +30 °C Relative humidity: 20 % to 80 %, non-condensing Operating elevation: Up to a max. of 2000 m above sea levelStorage: Temperature: +5 °C to +50 °C Relative humidity: 10 % to 85 %, non-condensingTransport: Temperature: –29 °C to +50 °C Relative humidity: 10 % to 85 %, non-condensingDimensions and weights: Dimensions (Width x depth x height): Hood closed: 1354 x 785.5 x 587.5 mmHood open: 1354 x 785.5 x 943 mm Empty weight (without reagents and accessories)185 kg
22 Version 1.3, Revision J Instrument Components and Specifications33.3 General overview - front viewFig. 2 19531172106481 Insert for active carbon filter2 Read-in area for Leica reagents3 Input drawer (loader)4 Output drawer (unloader)5 Screen holder with internal illumination6 Screen with user interface7 USB ports (2 pcs.)8 Service access9On/off switch (power switch)10 Lid11 Operating switchCaution • The service access (→ "Fig. 2-8") may only be used by Leica certified service technicians!• The read-in area cover (→ "Fig. 2-2") may only be removed by Leica certified service technicians.
23HistoCore SPECTRA STInstrument Components and Specifications 33.4 General overview - rear viewFig. 3 15372 6481 Network connection (Remote Care)2 Power supply3 Nameplate4 Wastewater connection5 Rinsing water connection (group of 4)6 Distilled water or rinsing water connection (group of 2)7 Exhaust air connection8 Water connection diagram
24 Version 1.3, Revision J Instrument Components and Specifications33.5 General overview - inside viewFig. 4 1537264810111 Left transport arm2 Specimen slide reader station 3 Loading stations, 5 pcs.4 Dry transfer station, 2 pcs.5 Unloading stations, 5 pcs.6 Fuse holder, 2 pcs.7 Right transport arm8 Rinsing water stations, 6 pcs.10 Drying oven stations, 6 pcs11 Transfer station for HistoCore SPECTRA CV (optional)
25HistoCore SPECTRA STInstallation and Starting up 44. Installation and Starting up4.1 Installation site requirementsNote • Installation and leveling are carried out as part of the instrument installation by personnel authorized by Leica only!• Use 4 qualified persons when lifting the device; grab under the frame at all corners and lift evenly.• It must be ensured that there is a mostly vibration-free floor and sufficient clear space (approx. 1.10 m) above the laboratory bench to allow unobstructed opening of the hood.• It is the user's responsibility to make sure that a compatible electromagnetic environment is maintained so that the instrument can work as intended.• Condensation water may form in the instrument if there is an extreme difference in temperature between the storage location and the installation site and if air humidity is high at the same time. A waiting time of at least two hours must be observed each time before switching on. Failure to comply with this may cause damage to the instrument.• Stable, exactly horizontal and level laboratory bench at least 1.40 m wide and 0.80 m deep.• The counter area must be designed for handling loads of at least 150 kg/m2, vibration-free and level. • Fume hood at a max. 2.0 m distance from the instrument.• The instrument is suitable for operation in indoor areas only. • The operating location must be well-ventilated and have an air exhaust. • A rinsing water connection must be available at a maximum distance of 2.5 m. This connection must also be easily accessible after installing the instrument.• A waste water connection must be available at a maximum distance of 2 m. This connection must be connected to the instrument with a constant outlet hose slope down and away from the instrument.Caution • A connection to an external exhaust system, a technical room ventilation system and an integrated exhaust system with an active carbon filter reduce the concentration of solvent vapor in the room air. The active carbon filters must be used for connecting to an external exhaust system as well. Compliance with this is mandatory. • The instrument operator bears responsibility for complying with workplace limits and the measures necessary for this, including documentation.• A grounded power supply socket must be available at a maximum distance of 3 m.4.2 Rinsing water connectionNote There is the option of choosing between two connection variants (→ p. 26 – 4.2.1 Joint connection of all 6 rinsing water stations). The device must be programmed to the connection variant used (see Chap. 6.4).
26 Version 1.3, Revision J Installation and Starting up4The following installation instructions apply for both types of connections:• Take the rinsing water supply hose (→ "Fig. 5-1") out of the packaging.• The connection for the water supply is straight (→ "Fig. 5-3"), the connection for the instrument side is angled (→ "Fig. 5-4").• Check whether the sealing rings (→ "Fig. 5-2") are attached to the connection for the water supply (→ "Fig. 5-3") and to the connection for the instrument side (→ "Fig. 5-4").Caution The hose cannot be connected if the sealing rings are missing! In this case, contact the responsible Leica service organization.Fig. 5 132412Warning Regardless of the selected connection variant (6 rinsing water stations or 4 rinsing water stations and 2 deionized/demineralized water stations), both supply hoses are always connected to the instrument.Shut off the water supply during pauses in use of the instrument and when the instrument is turned off.4.2.1 Joint connection of all 6 rinsing water stationsIf all the rinsing water vessels (6 rinsing water stations) are to be connected to a shared rinsing water connection, both supply hoses (→ "Fig. 6") are to be used in the manner shown. Both running water connections are (→ "Fig. 6-4") connected to a single water tap (→ "Fig. 6-8") using a Y-piece:
27HistoCore SPECTRA STInstallation and Starting up 4Fig. 6 153726481 Rinsing water supply hose 1 (2.5 m) Order No.: 14 0474 323252 Extension hose, 1.5 m Order No.: 14 0512 493343 Rinsing water supply hose 2 (2.5 m) Order No.: 14 0474 323254 Y piece Order No.: 14 3000 003515 Filter Order No.: 14 0512 493316 Rinsing water connection (group of 4)7 Distilled water or rinsing water connection (group of 2)8 Rinsing water connection in the lab4.2.2 Combined connection 4+2 rinsing water stationsIf the main connection (4 rinsing water stations) is to be connected to fresh water and the secondary connection (2 rinsing water stations) is to be connected to a supply in the laboratory with distilled water or desalinated water (demineralized water), proceed in accordance with the following connection diagram:
28 Version 1.3, Revision J Installation and Starting up4Fig. 7 153726481 Rinsing water supply hose 1 (2.5 m) Order No.: 14 0474 323252 Extension hose, 1.5 m Order No.: 14 0512 493343 Rinsing water supply hose 2 (2.5 m) Order No.: 14 0474 323254 Filter Order No.: 14 0512 493315 Rinsing water connection (group of 4)6 Distilled water or rinsing water connection (group of 2)7 Rinsing water connection in the lab8 Distilled water/demineralized water connection in the labCaution It is imperative that you observe the correct supply hose connection (→ "Fig. 3-8")!
29HistoCore SPECTRA STInstallation and Starting up 44.2.3 Wastewater connectionNote The instrument has a passive wastewater outflow. The lab outflow siphon must therefore be located at least 50 cm under the wastewater connection of the instrument.Caution The outlet hose (→ "Fig. 8-1") must be routed at a constant slope and must not be elevated.Fig. 8 14.3 Electrical connectionCaution • Use only the power cord provided, which is intended for the local power supply.• Before connecting the instrument to the power supply, make sure that the main switch on the front right side of the instrument is in the OFF ("0") position.Fig. 9 1• Connect the power cord to the power input socket on the rear panel of the instrument (→ "Fig. 9-1").• Plug the power plug into a grounded power socket.
30 Version 1.3, Revision J Installation and Starting up4Fig. 10 12• Switch on the power switch (→ "Fig. 10-1"). • After a short period of time, the operating switch lights up orange; once the software has completely started, it lights up red (→ "Fig. 10-2") and the instrument is in standby mode.• The operating switch can then be operated (→ p. 31 – 4.5 Switching the instrument on and off).4.3.1 Using an external uninterruptible power supply (UPS)An interruption of the staining process can be avoided in the event of a temporary power failure by connecting a battery-buffered uninterruptible power supply (→ "Fig. 11-1") (UPS). The UPS should enable an output of at least 1580 VA for the duration of 10 minutes. The UPS must be designed for operating voltage at the installation location. The connection is carried out by connecting the HistoCore SPECTRA ST power cord to the UPS power output socket. The UPS is connected to the power socket in the lab.Fig. 11 1Warning The UPS power cord must always remain in the power socket in the lab, even in the event of a power outage. Otherwise grounding of the instrument cannot be ensured!
31HistoCore SPECTRA STInstallation and Starting up 44.4 Exhaust air connection » Connect one end of the exhaust air hose (→ "Fig. 12-1") to the exhaust port (→ "Fig. 12-2") on the top side of the instrument. Connect the other end to an exhaust air device installed in the lab.Fig. 12 12Caution • A connection to an external exhaust system and an integrated exhaust system with an active carbon filter reduce the concentration of solvent in the room air and must be used. The vessels must be covered when not using the instrument to prevent the unnecessary evaporation of the reagents.• The owner/operator must verify compliance with the workplace limit values when work is done with hazardous materials.4.5 Switching the instrument on and offWarning The instrument must be connected to a grounded power socket. For additional electrical fuse protection, connecting the HistoCore SPECTRA ST to a socket with a residual current circuit breaker (RCCB) is recommended.Fig. 13 1• Switch the power switch on the front right side at the bottom of the instrument to ON ("I") (→ "Fig. 13-1").
32 Version 1.3, Revision J Installation and Starting up4Fig. 14 • A few seconds after switching on the power switch, the operating switch is illuminated in orange (→ "Fig. 14"). The software's start process ends when the operating switch illuminated in red.Note Pressing the operating switch in the orange phase does not start the instrument.Fig. 15 • To start the instrument, press the red flashing operating switch (→ "Fig. 14"); an acoustic signal sounds.• During initialization, a verification of all stations ("fill level scan") is carried out automatically. • The operating switch is illuminated in green whenever the instrument is ready to start.• After completing the initialization phase, the "main menu" (→ "Fig. 15") appears on the screen.Switching off the instrument• To switch the instrument into standby mode (e.g. overnight), press the operating switch (→ "Fig. 14") twice. It then illuminates in red.• For cleaning and maintenance, also switch off the instrument at the power switch (→ "Fig. 13-1").Note During the instrument setup or if no reagents have been added, non-filled stations are identified and highlighted on the screen (→ p. 88 – 6.2.2 Automatic fill level scan)Warning If an oven step is programmed as the first step of the staining program, the program can be marked "not bootable" after switching on the instrument since the oven has not yet reached the operating temperature. As soon as the operating temperature is attained, the program is displayed as startable.
33HistoCore SPECTRA STOperation 55. Operation5.1 User interface - overviewThe HistoCore SPECTRA ST is programmed and operated via a color touchscreen. The screen appears as follows after switching on if there is no staining process (program) running.Fig. 16 132451 Status bar2 Process status display3 Output drawer status display4 Input drawer status display5 Main menu (→ p. 38 – 5.5 Main menu - overview)
34 Version 1.3, Revision J Operation55.2 Elements of the status displayFig. 17 1537264891 Current date2 If alarms and error messages are displayed during operation, this alarm symbol appears. Pressing this symbol allows the last 20 active messages to be viewed again.3 If warnings and notes are displayed during operation, this notification symbol appears. Pressing this symbol allows the last 20 active messages to be viewed again.4 This symbol indicates that a connection to the Remote Care server has been established and a Leica service technician has access to the screen. The user can end the connection again by pressing this symbol.5 Local time6 The "Remote Care access" symbol indicates that this instrument is connected to the Leica Remote Care Service via a network connection. 7 The "process" symbol indicates that staining processes are currently active and that racks may still be in the output drawer.8 This "user" symbol indicates that the instrument is in user mode, which enables simplified operation of the instrument without a password. 9 The operation of this instrument in "Supervisor Mode" is displayed by this symbol. This mode provides additional operation and adjustment options for trained staff. Access to this mode is password-protected.
35HistoCore SPECTRA STOperation 55.3 Process status displayFig. 18 132The main window (→ "Fig. 18") displays all racks (→ "Fig. 18-3") located in the process.Note To display an active staining process, the upper part of the handle is displayed symbolically in the respective color (→ "Fig. 18-3"). If the number of racks in the process exceeds the maximum that can be displayed in the main window (max. 9), you can scroll through the display area vertically using the (→ "Fig. 18-1") key. If one of the buttons is grayed out, it is disabled and there are no other elements in an area that is not shown.The title bar of the main window (→ "Fig. 18-2") indicates the instrument type [SPECTRA ST] and lists the currently bootable staining programs with the defined abbreviations and the color assigned to the racks.
36 Version 1.3, Revision J Operation5Note Each ongoing staining process is illustrated by a rack handle symbol. It is shown in the same color as the actual rack handle. Various information is displayed on the handle symbol (→ "Fig. 19").If the HistoCore SPECTRA ST staining machine is permanently connected to a HistoCore SPECTRA CV robotic coverslipper, both devices can be operated as a workstation. This enables continuous work flow from the staining process up to the removal of the finished cover slipped slides. The time of transfer to the HistoCore SPECTRA CV is then also displayed in the process status bar (→ "Fig. 19-6").Fig. 19 1532641 Abbreviation of the program name2 Current position of the rack in the instrument3 Progress display of the entire staining process4 Estimated remaining time of the program (hh:mm)5 Real time at the end of the program6 Time of transfer to the robotic coverslipper HistoCore SPECTRA CV during operation as workstation (→ p. 106 – 6.6.5 Operation as a workstation)
37HistoCore SPECTRA STOperation 55.4 Displaying the drawersThe lower area of the main window illustrates the status of the input and output drawers.• The stations displayed with the direction of the arrow pointing into the instrument (→ "Fig. 20-1") symbolize the input drawer and the stations displayed with the direction of the arrow pointing out of the instrument (→ "Fig. 20-2") symbolize the output drawer, each with five positions.• The respective drawer is opened or closed automatically by pressing the drawer button (→ "Fig. 20-3") or (→ "Fig. 20-4"). • The instrument automatically recognizes if racks are inserted or removed when the drawer is closed.• The racks located in the input or output drawer are shown on the screen with the respective rack handle color and the assigned program abbreviation.• Available positions are shown in white.Note The input and output drawers can be opened if the drawer button lights up green (→ "Fig. 20-4"). When racks are being transported out of the input drawer or into the output drawer, the button on the corresponding drawer lights up red (→ "Fig. 20-3") and the drawer cannot be opened.1324Fig. 20
38 Version 1.3, Revision J Operation5Warning Exercise caution when opening or closing the drawers! Crushing hazard! The drawers are motorized and open automatically when the button is pressed. Do not block the extension range of the drawers.5.5 Main menu - overviewThe main menu is located on the left side of the display (→ "Fig. 16-5"), which is divided as described below. This menu is visible in all submenus and allows switching to another submenu at any time.The "Process status display" displays the current status of all racks in progress. Here, the respective handle of the rack is displayed symbolically with the respective color. This display shows the standard display.The "bathlayout" displays the top view of all stations within the instrument. The individual reagent stations are displayed with abbreviations of reagent names, station numbers and racks in progress.After activating the "program list", all staining programs available in the instrument are displayed in list form. The menu enables re-entering and changing staining programs, their prioritization and the creation of the bathlayout.After activating the "reagent list", all previously entered reagents are displayed in list form. The menu enables the modification or re-entering of staining reagents, e.g. for integrating new staining programs. The reagents must be entered before creating the program.Basic settings can be configured in the "Settings" menu. The language version, date and time as well as oven temperature and other parameters can be adjusted to the local requirements here.In the "User Settings" menu, an individual password can be set up to prevent modifications to the programs and reagent lists by unauthorized persons ("Supervisor mode"). However, the instrument can be used without a password in "User Mode".
39HistoCore SPECTRA STOperation 55.5.1 The keyboardNote A keyboard appears (→ "Fig. 21") for required entries (e.g. for creating programs, editing programs, or entering a password). It is operated using the touchscreen. Note that the keyboard display depends on the configured language.Fig. 21 1537264891 Title bar2 Input field3 Delete most recently entered character4 Confirmation5 Move cursor to left or right6 Space key7 Special character shift button (→ "Fig. 22")8 Cancel (entries are not saved!)9 Upper and lowercase (pushing the button twice activates caps lock, indicated by the button turning red. Pressing again re-activates lowercase.)
40 Version 1.3, Revision J Operation5Special character keyboardFig. 22 Other special charactersFig. 23 • To enter a special character or umlaut, etc. not included in the special character keyboard (→ "Fig. 22"), hold the corresponding normal button on the keyboard. • Example: Holding the standard "a" button brings up other selection options (→ "Fig. 23").• Select the required character from the new single-line keyboard by pressing it.Note The following lengths are applicable for passwords and designations:• Reagent names: max. 30 characters / reagent abbreviations: max. 10 characters• Program names: max. 32 characters / program abbreviations: max. 3 characters • Passwords: min. 4 to max. 16 characters5.6 User settingsThis menu can be used to configure the appropriate access level. A distinction is made between:• Standard user• Supervisor (password-protected)• Service technician (password-protected)
41HistoCore SPECTRA STOperation 5Fig. 24 12Standard user:The standard user does not need a password and can use the completely configured instrument for all routine applications. It is not possible for this user group to modify programs and settings.Supervisor:Supervisors have the same access options as the standard user, but can also create programs and perform the instrument setup functions. Therefore, supervisor access is password-protected.To activate supervisor mode, proceed as follows: 1. Press the "Supervisor" button (→ "Fig. 24-1").2. A keyboard (→ "Fig. 25") is then displayed which can be used to enter the password.3. The entry is finished by hitting "OK" and the entered password is checked for validity. 4. The current user status is displayed with the respective symbol in the status bar (→ "Fig. 17") on the top right.
42 Version 1.3, Revision J Operation5Fig. 25 Note The password configured at the factory should be changed during the initial setup.To change the supervisor password, proceed as follows:1. To change the password, press the "Change password" button (→ "Fig. 24-2") and enter the old password. 2. Then, enter the new password twice using the keyboard and confirm by hitting "OK".Note A password must have at least 4 characters and may have up to 16 characters.Service technician:The service technician can access system files and carry out basic settings and tests. 5.7 Basic settingsNote Changing some of the settings, for example when setting up the instrument for the first time, is only possible in Supervisor mode (→ p. 41 – To activate supervisor mode, proceed as follows:).
43HistoCore SPECTRA STOperation 5Touching the gear symbol (→ "Fig. 26-1") opens the "Settings" menu (→ "Fig. 26"). Basic instrument and software settings can be configured in this menu.• Touching a symbol (→ "Fig. 26-2") selects it and highlights it in red.• The respective settings window is displayed in the right area of the screen.• The individual submenus are described below.12Fig. 26 5.7.1 Language settings• The language selection menu is displayed by pushing the symbol for the "Language" (→ "Fig. 26-2"). This menu contains an overview of all languages installed in the instrument and allows the desired display language to be selected.• Select the desired language and confirm by hitting "Save".• The screen display, messages and labels are displayed immediately in the currently configured language.Note A supervisor or Leica service technician can add other languages using Import (→ p. 49 – 5.7.7 Data management).
44 Version 1.3, Revision J Operation55.7.2 Regional settingsBasic display settings (→ "Fig. 27") can be configured in this menu.Temperature Unit• Configure the temperature unit (→ "Fig. 27-1") in Celsius or Fahrenheit. To do so, position the slider at the desired unit.Time Format• The time display (→ "Fig. 27-2") can be changed from a 24-hour display to a 12-hour display (a.m. = morning/p.m. = afternoon) using the slider.Date format: • Configure the date display (→ "Fig. 27-3") to international, ISO or US format by pressing the corresponding radio button next to the sample format.• The activated setting is labeled by a red border (→ "Fig. 27-4"). • Pushing the "Save" button saves the settings.1324Fig. 27
45HistoCore SPECTRA STOperation 55.7.3 Date and timeThe current date and local time can be configured in this menu (→ "Fig. 28") by rotating the individual rollers.Note In the 12-hour display, a.m. (morning) and p.m. (evening) are displayed under the hour digits to enable a correct setting.The time and date settings cannot deviate more than 24 hours from the system time configured at the factory.• Pushing the "Save" button saves the settings.Fig. 28 5.7.4 Alarm and signal tonesThis menu can be used to select the alarm and signal tones, adjust the volume and check their functionality (→ "Fig. 29-6"). The current setting for alarm and signal tones is displayed after calling up the menu. Caution • After starting the instrument, an alarm sound is played. If this does not occur, the instrument may not be operated. This protects the specimens and the user. In this case, contact the responsible Leica service organization.• The acoustic alarm sounds cannot be disabled. The minimum configurable value for the volume is 2. The maximum value is 9.
46 Version 1.3, Revision J Operation515372645 76Fig. 29 Sound Type 1 - Note (→ "Fig. 29-1")Signal tones are issued if warning messages or notifications are displayed on the screen. You can select from a list of 6 sounds. To change the settings, press the "Edit" (→ "Fig. 29-3") button. The volume can be adjusted incrementally by turning the roller (0 to 9).Sound Type 2 - Error (→ "Fig. 29-2")Alarm sounds are issued if an error message is displayed on the screen. This requires immediate intervention from the user. You can select from a list of 6 sounds. To change the settings, press the "Edit" (→ "Fig. 29-4") button.• The volume setting for alarm sounds is adjusted using the "Volume" roller. Six different sounds are available for the alarm types. The "Test" (→ "Fig. 29-6") button can be used to listen to the respective sound.• Pushing the "Save" (→ "Fig. 29-7") button saves the settings. The "Cancel" (→ "Fig. 29-5") button is used to close the selection window without applying the settings.
47HistoCore SPECTRA STOperation 55.7.5 Oven settingsThe temperature of the oven and its operating mode can be configured in the menu for the oven settings (→ "Fig. 30"). The current oven settings are displayed after calling up the menu.Caution Changing the oven temperature will always have a potential impact on the staining result. An oven temperature that is set too high can have a negative impact on the sample.1324Fig. 30 Temperature: Turning the roller (→ "Fig. 30-1") sets the target temperature of the oven from 40 °C to 70 °C in 5 °C increments.Operating mode: For the operating mode (→ "Fig. 30-2"), you can choose between:• Heating the oven when starting a program (→ "Fig. 30-4") ("Program start") or • Starting the oven when switching on the instrument (→ "Fig. 30-3") ("Permanent"). • The slider can be brought to the corresponding position to change the settings.• Settings are saved by pressing the "Save" button.
48 Version 1.3, Revision J Operation5Note • The password-protected user mode "Supervisor" is required to save the changes. In the simple user mode, the "Save" button is shown in gray and is inactive.• If Leica staining programs have been integrated into the bathlayout (→ p. 75 – 5.9.9 Creating the bathlayout), the temperature setting cannot be changed. Refer to the information accompanying the Leica reagent kit for the default temperature.Caution We recommend using "Permanent" as a setting to prevent repeated waiting times caused by heating the oven. Warning Due to ambient conditions, the set oven temperature can occasionally deviate from the set value by –8 °C to +5 °C. Therefore, the set temperature should be selected accordingly for particularly sensitive specimens (e.g. reducing the set temperature by 5 °C and prolonging the oven step accordingly).5.7.6 Movement speed - up/down movement (agitation)In the "Agitation" menu (→ "Fig. 31"), the speed of up/down movement of the holding frame for the rack is adjusted. The rack handles lie on the holding frame which moves up and down in the staining process (agitation). The current setting is displayed after calling up the menu.Note Agitation helps stir the added reagents during ongoing staining processes. The password-protected "Supervisor" user mode is necessary for adjusting the movement speed (agitation).Speed:Rotating the "Speed" (→ "Fig. 31-1") roller can be used to configure the agitation frequency in 5 steps (0= agitation disabled, 5= highest speed). Higher values mean a higher agitation frequency.Settings are saved by pressing the "Save" button.Note • The agitation speed for user-defined programs can only be changed if no validated Leica program is active. In this case, the roller is displayed in black and active. • The agitation is preset (fixed) for validated Leica programs (see Leica Reagents kit instructions for use). The roller is grayed out and inactive.
49HistoCore SPECTRA STOperation 51Fig. 31 5.7.7 Data managementIn the "Data management" menu (→ "Fig. 32"), the data, settings and event logs (log files) can be exported and imported. A USB memory stick connected to one of the USB sockets on the front side of the instrument (→ "Fig. 2-7") is required for all exports and imports (except for remote software updates).Note The USB memory stick used must be formatted as FAT32.User export (→ "Fig. 32-1")The "User export" function is used to save information on a connected USB memory stick (→ "Fig. 2-7"):• A "zip" file with the event logs of the last 30 working days and RMS information in CSV format• An encrypted "lpkg" file that contains all user-defined programs and the reagent list.Note The "lpkg" file cannot be opened and viewed by the user.
50 Version 1.3, Revision J Operation513245Fig. 32 (→ "Fig. 32-3") User-defined programs and the reagent list can be transfered to another HistoCore SPECTRA ST with the identical configuration via the "Import" function.• The message "User data is being exported..." is displayed during the data export. • The message "Export successful" indicates to the user that the data transfer is finished and the USB memory stick can be removed safely.• If the message "Export failed" is displayed, an error occurred (e.g. the USB memory stick was removed too soon). In this case, the export process must be carried out again.Note After successfully setting up the instrument, we recommend exporting the data to be able to access it if the instrument has to be set up again.Service export (→ "Fig. 32-2")The "Service export" function is used to save "lpkg" files on a connected USB memory stick (→ "Fig. 2-7"):The encrypted "lpkg" file contains a predefined number of event logs as well as the following:• RMS information• User-defined programs• Reagent data• Additional service-relevant dataNote The encrypted lpkg file cannot be opened and viewed by the user.• After pressing the "Service Export" button, a selection menu appears in which the user can select the desired number of data records to be exported (5, 10, 15 or 30 days). • Press "OK" to confirm the selection.
51HistoCore SPECTRA STOperation 5• The message "Service data is being exported..." is displayed for the duration of the data export. • The message "Export successful" indicates to the user that the data transfer is finished and the USB memory stick can be removed safely.• If the message "Export failed" is displayed, an error occurred (e.g. the USB memory stick was removed too soon). In this case, the export process must be carried out again.Import (→ "Fig. 32-3")Note The password-protected user mode "Supervisor" is required for importing. If one or more files are present in the selection dialog, you can use the file name to assign the save date and instrument serial number. Select the file you want to import and press "OK" in the subsequent message on the screen.The instrument software makes sure that no existing Leica programs and reagents are overwritten during an import of data (programs and reagents). Redundant abbreviations for programs and reagents, as well as redundant reagent names, are automatically replaced by a placeholder or a placeholder is added to them. In the case of redundant specimen slide handle colors, the color of the imported program is set to white.Specimen slide handle color:• If a program is imported whose specimen slide handle color already has an assigned program, this color is replaced with white when imported. Program name abbreviation:• If a program is to be imported which has an abbreviation that is already used for an existing program, the software automatically replaces this abbreviation with a placeholder. The written-out program name remains the same.• Abbreviation of the existing program: PAS• Changed abbreviation of the imported program: +01Reagent name and reagent name abbreviation:• If a reagent is imported which has a name and/or abbreviation that is already in use, the software automatically adds a placeholder ("_?").• Existing reagent name: 100 % Alcohol Dehyd 1 S• Changed reagent name of the imported reagent: 100 % Alcohol Dehyd 1 S_?• Existing abbreviation 100Dhy 1S• Changed abbreviation of the imported reagent: 100Dhy 1+01Imported programs and reagents can be integrated into the bathlayout even with placeholders. They can be renamed later.Caution When importing data from a USB memory stick, all user-defined programs and reagents previously located on the instrument are overwritten and replaced by the imported data. It is not possible to select individual files for the Import! Leica recommends using this function only for importing backups or installing an additional HistoCore SPECTRA ST with the same parameters.
52 Version 1.3, Revision J Operation5The "Import" function enables the data import of the encrypted program and reagent list, additional validated Leica programs and additional language packages from a connected USB memory stick. This data can also be used to equip another HistoCore SPECTRA ST with the same data using the Export/Import function. • To do this, insert the USB memory stick with the previously exported data into one of the USB sockets on the front side of the instrument (→ "Fig. 2-7").• Then, select the "Import" function. The data is scanned.• A message confirms the successful import of the data.Warning In general, creating a new bathlayout is required when using the "Import" function (and when importing a new Leica staining program). All Leica reagents currently in the instrument will expire and must be replaced by a new, corresponding Leica reagent kit.Software update (→ "Fig. 32-4")If software updates and additional language packages are available, these may be run or installed as follows in the "Supervisor" user mode or by a service technician authorized by Leica.Carrying out a software update1. Copy the file for a software update onto a USB memory stick formated with FAT32.2. Plug the USB memory stick into in one of the two USB slots (→ "Fig. 2-7") on the front of the instrument.3. Subsequently, change to the "Data management" menu and click on "Software update" (→ "Fig. 32-4").4. The software update is started. A message notifies the user of a successful update.Warning If the update cannot be carried out successfully, this is reported to the user. If the cause is not obvious, please contact a responsible Leica service organization.Note Lab-specific settings are not deleted when updating the software for the HistoCore SPECTRA ST. After a software update, the instrument must be checked for proper operation.Remote software update (→ "Fig. 32-5")This function enables software updates over a connected network. For this purpose, the instrument must be integrated into the Leica Remote Care maintenance and diagnostic system. • The new software version is loaded automatically as soon as it is available for this instrument. Once the loading procedure has concluded, the button (→ "Fig. 32-5") is shown in black and is activated.• Pressing the "Remote software update" button starts the automatic update process when the instrument is idle.
53HistoCore SPECTRA STOperation 5Note The user will be notified about an available software update via a message.The HistoCore SPECTRA ST software is updated; lab-specific settings are not deleted.5.7.8 Service accessThis menu (→ "Fig. 33") gives Leica-authorized service technicians access to technical functions for diagnostics and repairs to the HistoCore SPECTRA ST.Fig. 33 Note Access to the service software is locked for all other user groups.5.7.9 Event viewerA separate log file is created for each day that the instrument was switched on. This file can be called up by selecting the "DailyRunLog" file in the event viewer (→ "Fig. 34").
54 Version 1.3, Revision J Operation5Fig. 34 • In the event viewer, an event log can be selected from a list of available logs and called up by pressing the "Open" button.Note The file name is supplemented by adding the respective creation date in ISO format, which makes organization easier. The file is created in the configured language. • All event entries begin with a time stamp (→ "Fig. 35-1"), which indicates the date and time when the entry was created.• The title bars of the event viewer also indicate the serial number (→ "Fig. 35-2") and the currently installed software version (→ "Fig. 35-3") of the HistoCore SPECTRA ST.• You can scroll up and down in the list and the log file using the arrow keys (→ "Fig. 35-4"). Pressing the left button allows you to scroll through the event viewer page by page. Pressing the right button takes you to the beginning or the end of the event viewer.
55HistoCore SPECTRA STOperation 51324Fig. 35 5.7.10 Network settingsThis menu can be used to configure the network parameters for connecting the instrument to a network. Note Leica service organizations can access the instrument's technical data via a service network (Remote Care) for diagnostic purposes and install software updates. The user can terminate an existing Remote Care connection by pressing the corresponding symbol (→ "Fig. 17-4").Caution • The instrument may only be connected to an available network, for example during the initial installation, by a service technician authorized by Leica in cooperation with the local IT department.• Remote Care uses the TCP/IP network protocol and, at the user level, https (128-bit encrypted).• If the network connection is interrupted (e.g. the network cable is removed), then the instrument has to be shut down in a controlled manner (→ p. 31 – 4.5 Switching the instrument on and off), the network cable has to be plugged in again, and the instrument has to be restarted.
56 Version 1.3, Revision J Operation55.8 Reagent listOpen the reagent list by pressing the adjacent button. This displays all defined reagents in alphabetical order. Fig. 36 19531172104138141Reagent name 8 Edit selected reagent2Abbreviation of the reagent name 9Create a new reagent3Process class 10 Copy selected reagent4Maximum number of specimen slides 11 Delete selected reagent5Maximum period of use13 Activate/deactivate RMS7Insert for special dye yes/no 14 You can scroll through the reagent list using the arrow keys.
57HistoCore SPECTRA STOperation 5Note • When setting up the instrument, the reagent list only contains reagents from the preinstalled Leica programs.• Additional reagents can be added or properties of the reagents can be changed as needed in the reagent list. • Creating or editing a reagent requires "Supervisor" mode. The "User" status only allows reagent data to be displayed.• Reagents that have been integrated into the bathlayout in active programs cannot be deleted from the reagent list.Caution • The "RMS: On – Off" slider ((→ "Fig. 36-13") allows the reagent management system = RMS (→ p. 89 – 6.3 Reagent management system (RMS)) to be switched on or off. This system controls reagent consumption monitoring. We always recommend keeping the RMS switched on and following the instructions for replacing a reagent. It is not possible to switch off reagent monitoring for the Leica staining kit reagents.• Failure to adhere to the specified intervals can have a negative effect on the staining quality. The RMS only works reliably if the data has been stored by the user correctly in advance. • The manufacturer assumes no liability for the staining results in case of errors when entering the reagent data. • The RMS data of the reagents validated by Leica and their designation can not be edited by the user. 5.8.1 Defining heated reagent (optional)Note A deactivated, heated reagent station cannot be used for long periods again until a new bathlayout (→ p. 75 – 5.9.9 Creating the bathlayout) has been generated.You can change from "Permanent" mode to "Program Start" mode (or vice versa) without generating a new bathlayout.• To add a new reagent to the reagent list, press the "New" button (→ "Fig. 36-9").• It opens the entry window (→ "Fig. 39") for the new reagent to be created.
58 Version 1.3, Revision J Operation515372648Fig. 39 The following parameters can be entered:Reagent name:Press the "Reagent name" (→ "Fig. 39-1") button and use the on-screen keyboard to enter a unique reagent name that has not yet been used. You can enter up to 30 characters (including spaces).Abbreviation:Press the "Abbreviation" button (→ "Fig. 39-2") to use the on-screen keyboard to enter a unique abbreviation for the reagent that has not yet been used (maximum 10 characters, including spaces).Slides max:The roller (→ "Fig. 39-3") is used to configure the maximum number of specimen slides that can be processed with this reagent before a reagent change is requested. By rotating the rollers, values between 1 through 3999 are permitted. Days max: The maximum number of days (→ "Fig. 39-4") that the reagent can remain in the instrument is configured by rotating the roller. Values from 1 through 99 are permitted when entering figures.
59HistoCore SPECTRA STOperation 5Insert:If a reagent vessel is equipped with an insert for special staining (→ p. 86 – 6.2.1 Preparation and handling of reagent vessels) in order to enable a smaller reagent volume, using the rack is only possible for 5 slides in this vessel. For this purpose, you must set the slide switch to "Yes"(→ "Fig. 39-5").Using a rack for 30 slides in this vessel is now disabled.Warning Using the insert for special staining in one or more reagent vessel (s) requires switching to the "Yes" position. If the switch is not set correctly for the affected reagent vessel (s), this may cause a rack for 30 slides to be used in this vessel, which inevitably leads to a serious equipment failure with possible specimen loss.Process class:Assigning the reagents to process classes (→ "Fig. 39-6") (→ p. 60 – 5.8.4 Process classes) is required since, along with prioritizing programs, it is essential for automatically calculating the individual positions of the bathlayout (→ p. 74 – 5.9.8 Prioritizing programs for creating the bathlayout).• Store the entry with the "Save" button (→ "Fig. 39-7") or close the entry window with the "Cancel" button (→ "Fig. 39-8") without applying the entry.Note Subsequently changing a process class is no longer possible after the initial save. The reagent can only be deleted and re-created or copied and then changed. 5.8.2 Copying a reagentNote If a reagent with different parameters is used in HistoCore SPECTRA ST, then an existing reagent can be copied.• Select the reagent to be copied in the reagent list (→ "Fig. 36") by tapping it and press the "Copy" (→ "Fig. 36-10") button.• It opens the entry window (→ "Fig. 39") for the new reagent to be created.• Apply the suggested reagent name or overwrite it with a new reagent name.• The suggested abbreviation can be applied or overwritten with a new abbreviation.• If necessary, change the parameters for the reagent accordingly or apply the existing parameters.• Store the entry with the "Save" button (→ "Fig. 39-7") or close the entry window with the "Cancel" button (→ "Fig. 39-8") without applying the entry.
60 Version 1.3, Revision J Operation55.8.3 Changing the RMS data for a reagentNote If changes are to be made to the RMS data ("Slides max" and/or "Days max"), the following steps must be carried out so that modified settings are displayed correctly in the station details (→ p. 94 – Fig. 76).• Select the reagent to be changed in the reagent list (→ "Fig. 36") by tapping it and press the "Edit" (→ "Fig. 36-8") button.• Using the rollers, set the new values for the "Slides max" (→ "Fig. 39-3") and/or "Days max" (→ "Fig. 39-4") and apply the changes using the "Save" button.• Note the subsequent message and confirm it with "Ok".• Then call up the bathlayout and tap the associated reagent station there to select the station by touching the screen.• In the station details that appear, press the "Update Reagent" (→ "Fig. 76-10") button.• The display with the station details is closed, and the RMS data has been applied.5.8.4 Process classesCaution Process classes must be assigned correctly since otherwise there is a risk of delayed work flows in the staining processes and deviating or inadequate staining results.
61HistoCore SPECTRA STOperation 5123Fig. 40 1 The preferred zone for dewaxing reagents is the left side of the bathlayout.2 The preferred zone for staining solutions or differentiating solutions are the two rows to the left and right of the rinsing water stations. 3 The preferred zone for dehydrating reagents is the right side of the bathlayout.Note No two successive rinsing water steps can be programmed (rinsing water step for distilled water or vice versa). If the sequence of the program steps is to occur in this way, one of the steps has to be defined as a reagent assigned to a process class (e.g. neutralizing).Process class Description Example of reagentsDewaxing (Dewaxing)• Solvents that remove the paraffin and, following the paraffin removal, the subsequent graded alcohol series, at the beginning of a staining program.• Xylene• Xylene substitute• Graded alcohol series: 100 %, 95 %, 70 % alcohol
62 Version 1.3, Revision J Operation5Process class Description Example of reagentsNeutralizing (Neutralizing)• Reagents that have little or no effect on the stain application or the stain development and that have a roughly neutral pH value.• Example: Distilled water step before a staining step.• Distilled water (demineralized)/fresh water (not in rinsing water stations!)• Thinners with distilled water• Aqueous alcoholic solutions (e.g. 70 % ethanol)Staining (Staining)• Staining solutions• Wood stains• Oxidizing agents (e.g. Periodic acid of the PAS dye)• All staining solutions• Wood stains and oxidizing agentsDifferentiating (Differentiating)• Reagents that remove excess color from the product. • Reagents that are required for the stain development or a color change.• HCl solution (alcoholic or aqueous)• Acetic acid• Ammonia water• Scott's tap water• Bluing solution• Blue Buffer• Lithium carbonate• Alcohols (various concentrations)Dehydrating (Dehydrating)• Reagents of the ascending alcohol series, at the end of a staining program.• Subsequent solvent steps (xylene or xylene substitute), at the end of a staining program, for preparing the coverslipping operation.Dehydration:• Ascending alcohol series: 70 %, 95 %, 100 % alcoholPreparing the coverslipping operation:• Xylene• Xylene substituteNo class (no class)Reagents that do not require any special assignment in the bathlayoutCaution The following must be observed for preparing the coverslipping operation:• The solvent used at the end of the program and in the following coverslipping process must be compatible with the coverslip mountant.
63HistoCore SPECTRA STOperation 5Note The correct assignment of the process classes is necessary so that the optimal bathlayout can be calculated and long transport paths and times can be avoided. Basic rules of automatic creation of the bathlayout include:• The transfer from the left vessel field to the right vessel field should occur via a rinsing water station whenever possible.• Programs that do not contain a rinsing water station as a step use the dry transfer station for this transfer.• Staining reagents that require a subsequent rinsing water step are positioned adjacent to the rinsing water vessels (→ "Fig. 40").• Reagents for which "No class" has been assigned as a process class can be set at any position during the automatic creation of the bathlayout.• Instead of the "No class" assignment, we recommend assigning these reagents to either the "Differentiating" or "Neutralizing" project class so that adjacent stations in the bathlayout can be taken into account for series.5.9 Staining programsThe list of the staining programs installed on the HistoCore SPECTRA ST is opened by pushing the "Programs" button.A distinction is made between two types of staining programs:• Preinstalled Leica staining programs (→ p. 66 – 5.9.2 Leica staining programs (preinstalled))• User-defined staining programs (→ p. 68 – 5.9.4 User-defined staining programs)
64 Version 1.3, Revision J Operation51953117210648Fig. 41 1 A check in this column means that the program is taken into account in the current bathlayout.2 Assigned program color3 Program abbreviation4 Program name5 Preinstalled Leica program6 Edit program7 Create a new program8 Copy selected program9 Delete selected program10 Assign a color to the selected program11 Define bathlayout5.9.1 Assigning a rack handle color to a staining programNote A rack handle color must be assigned to each program.The assignment of rack handle colors to programs requires the "Supervisor" user status.
65HistoCore SPECTRA STOperation 5• To assign a rack handle color to a program, tap the corresponding program in the program list (→ "Fig. 41") to select it. • Pressing the "Color" button (→ "Fig. 41-10") displays a selection field (→ "Fig. 42") that allows assignment of the rack handle color to the selected program.Fig. 42 Note All available colors are displayed in (→ "Fig. 42"). If an abbreviation is entered in the color field, this color has already been assigned to a program.If an already assigned color is selected, a dialog box appears with a confirmation prompt indicating that the existing assignment will be undone. This can be confirmed with "OK" or aborted with "Cancel".• Select a color that has not been assigned previously.• "Save" is used to assign the color and close the dialog.• "Cancel" is used to close the dialog without applying the changes.Note If there are not enough rack handles available in one color, then a rack handle in white, the so-called wildcard color, can be used. When inserting a rack with a white handle, a program selection window opens in which a color program activated in the bathlayout has to be assigned to the white handle for this program only.After termination of the selected program, this assignment expires again.
66 Version 1.3, Revision J Operation55.9.2 Leica staining programs (preinstalled)Designation of the reagent kitsNote In the following section, the HistoCore SPECTRA ST staining systems and programs produced by Leica are simplified in accordance with the user interface and named with the designation of the Leica reagent kit and Leica staining programs. New Leica staining programs can be obtained from the responsible Leica sales company.Caution The instructions for use provided with the Leica reagent kits contains important details regarding the preset values, logs and necessary amendments, and must therefore be strictly observed. Therefore, the instructions for use must be observed!To import new Leica staining programs, proceed as described in chapter (→ p. 49 – 5.7.7 Data management). New Leica programs are added to the existing program list (→ p. 63 – 5.9 Staining programs). No data is deleted.• Leica staining programs are preinstalled at the factory and have had their function and staining properties tested. They ensure consistent staining quality for a specified number of slides. • Leica staining programs are labeled in the last column with a cursive Leica- (→ "Fig. 41-5").132Fig. 43
67HistoCore SPECTRA STOperation 5Note • Leica staining programs require the use of the specific Leica reagent kit. • Leica staining programs cannot be copied, meaning that a Leica staining program can only be entered into the program list once.• The individual program steps of the Leica staining program cannot be shown, edited, copied or deleted.• A rack handle color (→ "Fig. 43-3") can be assigned to the Leica staining program.• If the Leica staining program provides for it, the oven step can be enabled or disabled in Supervisor mode (→ "Fig. 43-1") and the "Unloading station" or the "Transfer station" (→ "Fig. 43-2") can be defined as the final step. The "Transfer station" is only then displayed if the HistoCore SPECTRA ST is operated with a HistoCore SPECTRA CV as a workstation.• Reagents (e.g. xylene, alcohol) that are used in a Leica staining program cannot be deleted.Warning • If a paraffin removal step is not provided as the first step for the Leica staining program, then the oven step (→ "Fig. 43-1") (→ "Fig. 44-1") must not be enabled, as otherwise the specimens could be destroyed!• The fixed oven temperature for the Leica staining programs is also used for user-defined staining programs and cannot be individually adapted.5.9.3 Adapting the Leica H&E staining programNote • With the Leica H&E staining program, the staining intensity can be adjusted for hematoxylin and eosin in Supervisor mode. Other Leica staining programs do not allow for any adjustments to the staining intensities. • If the Leica staining program provides for it, the oven step can be enabled or disabled (→ "Fig. 44-1").• For Leica staining programs, the transfer to a connected robotic coverslipper HistoCore SPECTRA CV can be chosen as the final step by selecting "Transfer station" (→ "Fig. 44-4") or by setting aside the already-stained rack in the output drawer (→ "Fig. 44-3").• Adjustments and changes to Leica staining programs and user-defined staining programs can only be configured if no staining processes are active and all racks have been removed from the instrument.
68 Version 1.3, Revision J Operation5Fig. 44 1324Caution After the user adjusts the staining intensity, the staining results must be checked with a control slide containing representative tissue sections before the settings are used for patient specimens for clinical diagnostics.Select the Leica program in the program list and press "Edit" (→ "Fig. 41-6"). A dialog window opens in which the settings can be configured.• The staining intensity values can be set by turning the rollers (→ "Fig. 44-2"). Smaller numerical values cause a lighter staining intensity; higher numerical values cause a darker staining intensity. • A handle color must be assigned to the program (→ p. 64 – 5.9.1 Assigning a rack handle color to a staining program).• Use "Save" to save the settings and close the dialog.• Use "Cancel" to close the dialog without saving changes.5.9.4 User-defined staining programsWarning • Leica can provide neither testing nor a warranty for user-defined programs. • The testing of these staining programs using the respectively used reagents and adjusted temperatures must be carried out in the lab by the user. To do so, the staining result has to be checked with a specimen cycle (trial sections) before the program is used for patient specimens for clinical diagnostics.Note A new program can be created with the "New" (→ "Fig. 45-1") or "Copy" buttons (→ "Fig. 45-2"). Creating, copying or editing a program requires "Supervisor" mode. The "User" status only allows program steps to be displayed.
69HistoCore SPECTRA STOperation 55.9.5 Creating or copying a new staining program• Press the "New" button (→ "Fig. 45-1") in the list view of the program. 132Fig. 45 • A new program window opens (→ "Fig. 46").15324Fig. 46 Two empty buttons are shown in the upper area of this window. They are intended for the program name and its abbreviation.• Press the "--" button behind the "Program Name" designation (→ "Fig. 46-4"). An input mask with keyboard appears. • Enter the program name and apply the name entered with the "OK" button.
70 Version 1.3, Revision J Operation5Proceed as described above to enter the "Abbreviation" (→ "Fig. 46-5").Note To create a new staining program, multiple program steps are added to the program in sequence. Please note: User-defined programs cannot be saved with the designation "SPECTRA" as the program name. A message notifies the user of this when attempting to save. Saving is only possible after entering a different program name.1537264Fig. 47 • After a new program has been created, press the "New" button (→ "Fig. 46-1").• A window opens for defining the program step (→ "Fig. 47").• The reagents already predefined by the user are listed in the area on the left (→ "Fig. 47-1"). Tap the reagent to select it. • Turning the rollers (→ "Fig. 47-2") in the area on the right defines the reaction time (hh/mm/ss) of the specimens in the reagent .• The valid setting range goes from 1 second up to 23 hours 59 minutes and 59 seconds.• Here, the permitted "Tolerance" (→ "Fig. 47-3") of the step is configured. If an exact program step is needed that does not allow any temporal extension of the specified time, the tolerance 0 % must be selected. The tolerance can be selected in 25 % increments up to a maximum expansion of 100 %, i.e. the instrument can extend the step to twice the length of the configured time, if needed.
71HistoCore SPECTRA STOperation 5Note The times for the individual program steps are composed of the programmed step times plus the configured tolerances. If tolerance configurations for a program step are > 0 %, the remaining station times and expected remaining time for the program may be exceeded. Copying a programNote If you want to use an existing program with other parameters, then the program can be copied.• Select the program to be copied in the list view (→ "Fig. 45") by tapping it and press the "Copy" (→ "Fig. 45-2") button.• It opens the entry window (→ "Fig. 46") for the new program to be created.• Apply the suggested program name or overwrite it with a new program name.• Then, enter an abbreviation.• If necessary, change/edit the individual steps of the program as needed or add new program steps (→ "Fig. 46-1") (→ p. 71 – 5.9.6 Inserting or copying a new program step).• Save the entry with the "Save" button (→ "Fig. 46-2") or close the entry window with the "Cancel" button (→ "Fig. 46-3") without applying the entry.5.9.6 Inserting or copying a new program stepInserting a new program stepNote A high time tolerance setting is recommended if no negative effects on the staining result are to be expected. This gives the instrument more room to synchronize steps of multiple programs running at the same time.• If a check mark is in the "BL" (→ "Fig. 47-4") column, this means that this reagent is already integrated into the bathlayout.• To limit the display to reagents that are already actively used in the bathlayout, enable the radio button "Show only reagents of current bathlayout" (→ "Fig. 47-5").• If the "Exclusive" (→ "Fig. 47-6") box is activated, the selected reagent can only be used for the created program and no other program is available for selection.• The program step entry is completed with "OK" (→ "Fig. 47-7"). • Depending on need, other program steps can be added in the same way until all staining process steps are illustrated in the program.Note A program must always be concluded with a final target station step. As the final step, the output drawer or, in case HistoCore SPECTRA ST is permanently connected as a workstation with a HistoCore SPECTRA CV, the transfer station must be selected.A warning message (→ "Fig. 48") indicates that it is not possible to save the program without defining the target station as the last step.
72 Version 1.3, Revision J Operation5Fig. 48 Copying a program stepNote When creating or modifying a program, a program step can be copied with the previously set parameters and modified to a reagent which is currently in the reagent list.• Tap the respective program step and press the "Copy" button (→ "Fig. 49-5").• It opens the "Edit program step" window (→ "Fig. 49").• If a reagent with only one instance present has been selected, a message notifies the user of this fact. In this case, a different reagent is to be selected for the program step. • The parameters (tolerance, duration and exclusivity) of the originally selected program step are retained.• If necessary, change the parameters for the program step accordingly or apply the existing parameters and press the "Ok" button.• The program step is placed at the end of the program.• Reorder the program step as described in (→ p. 72 – 5.9.7 Re-sorting program steps).5.9.7 Re-sorting program steps• The program step is highlighted in red upon selection. Now the "Move" buttons (→ "Fig. 49-1") (→ "Fig. 49-2") (→ "Fig. 49-3") (→ "Fig. 49-4") are active.
73HistoCore SPECTRA STOperation 513245Fig. 49 1 Press to move the selected program step to the first row.2 Press to move the selected program step one row up.3 Press to move the selected program step one row down.4 Press to move the selected program step to the last row.Warning If an oven step is used as the first program step, a flammable solvent must not be present in the loading station of the input drawer under any circumstances.This may cause a ignition in the oven, which can cause the operator to be burned, specimen loss and damage to the instrument and equipment.• The "Save" button (→ "Fig. 49") is used to apply the changes. Press the "ESC" button to discard the entry.
74 Version 1.3, Revision J Operation55.9.8 Prioritizing programs for creating the bathlayout153264Fig. 50 After all desired staining programs have been entered, the bathlayout has to be generated. To do so, proceed as follows:• In the first step, the supervisor should define which programs are to be taken into the bathlayout. The programs are activated via the radio button(s) (→ "Fig. 50-1").• The position of the program determines its priority for integration into the bathlayout.Note Priority:• Only the positions of the user-defined programs can be moved. Leica staining programs are always listed at the upper positions of the reagent list.• The user-defined programs with low position numbers are easier to take into account when creating the bathlayout than programs with high position numbers.• We recommend positioning user-defined programs with high specimen throughput at the beginning of the program list, following the Leica staining programs.If a higher or lower priority is to be assigned to a staining program, select it in the list and move it higher or lower in the list using the "Move" buttons: - Program is moved to the first row (→ "Fig. 50-2") - Program is moved up one row (→ "Fig. 50-3") - Program is moved down one row (→ "Fig. 50-4") - Program is moved to the last row (→ "Fig. 50-5")• Due to the new priorities, the bathlayout must be recreated (→ p. 75 – 5.9.9 Creating the bathlayout).
75HistoCore SPECTRA STOperation 55.9.9 Creating the bathlayoutNote The arrangement of the reagent stations in the instrument is calculated using the prioritized staining programs (→ p. 74 – 5.9.8 Prioritizing programs for creating the bathlayout). These are some things to be observed when doing so:• Leica staining programs are taken into account first,• Staining and differentiation solutions are placed as close as possible to the rinsing water vessels,• The program prioritization and process class assignment are observed,• Sequential process reagents must be located close to each other.• To select the programs that are to be integrated into the bathlayout, push the "Define Bathlayout" (→ "Fig. 45-3") button. • Select and prioritize the respective programs, then press the "Execute Bathlayout" (→ "Fig. 50-6") button or "Cancel" to return to the program selection.Caution Be sure to observe the message (→ "Fig. 51") displayed after pressing the "Define bathlayout" button! Press the "Continue" button in order to display the result of the calculation of the bathlayout.Fig. 51 Note • The user is informed if more programs have been selected than were able to be integrated into the bathlayout by the display "Bathlayout Generation Result" (→ "Fig. 52"). Successfully integrated programs are marked by a check mark in the "Ready" column (→ "Fig. 52-1").• For programs that cannot be integrated the reason is specified in the "Not ready, Causes" (→ "Fig. 52-2") (→ "Fig. 52-3") column.• Note that the list must be inspected all the way through.
76 Version 1.3, Revision J Operation5Fig. 52 13245• Press the "Continue" (→ "Fig. 52-4") button to proceed or the "Cancel" (→ "Fig. 52-5") button to return to the program selection (→ "Fig. 50").Caution Additionally, the instructions for use provided with the Leica reagent kits must be observed before filling in Leica reagents! 5.9.10 Filling reagents after bathlayout creationNote • Create the bathlayout and proceed as described (→ p. 75 – 5.9.9 Creating the bathlayout).• If the bathlayout shown is only to be saved without configuring the reagent filling, press the "Save" button (→ "Fig. 53-3"). The stored bathlayout can then be called up in the bathlayout menu. If necessary, subsequent adjustments can be made in this menu (→ p. 82 – 5.9.11 Adapting a bathlayout). Filling the reagent vessel can also be configured to take place at a desired point in time using the bathlayout menu (→ p. 90 – 6.4 Station details).• After the software calculates the bathlayout using the prioritized programs, the user obtains an overview of the results displayed on the screen (→ "Fig. 53").Note • If no Leica programs were integrated into the bathlayout, the display (→ "Fig. 53") deviates from the one shown (not pictured). In this case, the reagents can be filled as described in (→ p. 78 – Filling the reagents).• If Leica programs were integrated into the bathlayout, the reagent "95 % Alcohol Dehyd 1" must first be duplicated. The station in question in the bathlayout is identified with a blue outline (→ "Fig. 53-1").• The reagent "95 % Alcohol Dehyd 1" to be duplicated is displayed with the abbreviation "95Dhy1" in the bathlayout.
77HistoCore SPECTRA STOperation 5Fig. 53 123Duplicating the reagent "95Dhy1"Note If there is no reagent station available due to the selected programs, attempt to optimize user-defined programs using the Leica sales organization.The procedure for duplicating the reagent "95Dhy1" is as follows:1. Press the "Adapt Bathlayout" (→ "Fig. 53-2") button.2. Note the subsequent message and confirm it with "Ok". A new "Clipboard" (→ "Fig. 54") window opens.132Fig. 54
78 Version 1.3, Revision J Operation53. Select the station "95Dhy1" (→ "Fig. 53-1") in the bathlayout by tapping it (station is marked in green) and click on the "Duplicate" (→ "Fig. 54-1") button in the "Clipboard" window. An identical copy of the selected station is now displayed in the "Clipboard" (→ "Fig. 54-2").4. Select the station in the "Clipboard" and then click on a free position in the "Bathlayout". The duplicated station is moved from the clipboard to the bathlayout (→ "Fig. 55-1").12Fig. 55 5. Press the "Finish" button (→ "Fig. 54-3") in the "Clipboard" and confirm the subsequent message with "Yes" in order to apply the change and close the clipboard. The successfully duplicated station "95Dhy1" and the original station are displayed with an equivalence symbol (∞) in the bathlayout (→ "Fig. 55-1").Filling the reagents1. Press the "Fill reagents" button (→ "Fig. 55-2").2. In the new "Fill reagents" (→ "Fig. 56") window, the stations to be filled are marked in orange (→ "Fig. 56-1"). Note Only user-defined and added reagents of Leica staining programs are displayed with an orange marking (→ "Fig. 56"). The reagents from the Leica reagent kit are subsequently fed in (→ p. 79 – Filling the Leica reagent kit reagents).3. Fill the marked reagent vessels outside of the instrument with the corresponding reagents in sequence and set them back in the correct position in the instrument.4. Confirm filling and resetting the reagent vessels by pressing the respective station (→ "Fig. 56-1") on the screen.5. Repeat these steps for all stations marked in orange.
79HistoCore SPECTRA STOperation 51Fig. 56 Warning The arrangement of the assignment plan is to be followed exactly. Any deviation can lead to undesired staining results.Filling the Leica reagent kit reagentsNote After duplicating the reagent station "95 % Alcohol Dehyd1" (→ p. 77 – Duplicating the reagent "95Dhy1") and filling the reagents (→ p. 78 – Filling the reagents), the Leica kit reagents are subsequently fed in.1. When prompted by an information message (→ "Fig. 57") on the screen, stop the carton's packaging label in front of the RFID sensor on the front of the instrument (→ "Fig. 58-1") to scan it.2. Then, begin to scan in the first Leica reagent bottle after being prompted by a message (→ "Fig. 58-2"). Hold the reagent bottle label in front of the RFID sensor on the front of the instrument (→ "Fig. 58-1") in order for it to be scanned.3. In the new window "Change Leica kit reagent" (→ "Fig. 59"), the station to be filled is marked in orange (→ "Fig. 59-1"). 4. Fill the marked reagent vessel outside of the instrument with the corresponding reagent and set it back in the correct position in the instrument. 5. Confirm filling and resetting the reagent vessel by pressing the respective station (→ "Fig. 59-1") on the screen.6. Then, scan the labels of the individual reagent bottles when prompted (→ "Fig. 58-2") and repeat steps 2-5.
80 Version 1.3, Revision J Operation5Fig. 57 12Fig. 58 1Fig. 59 Note The user has 5 minutes to scan the reagents for the carton's packaging label and 5 minutes per reagent bottle.If reading in a reagent bottle or packaging label fails, the user has 2 additional attempts before the reagent labels become invalid.
81HistoCore SPECTRA STOperation 5Caution Each Leica reagent kit can only be scanned once!• Scanning in the Leica reagent kit can only be canceled by using the "Cancel" button in the message shown in (→ "Fig. 57") and before starting to read in the package label without the Leica reagent kit expiring.• The scanning can be configured later. More information necessary for this procedure is described in (→ p. 95 – Reagent replacement) (→ "Fig. 76") and (→ "Fig. 77").• If the operation is not canceled until after reading in the first label (packaging cardboard), the Leica reagent kit expires. Note The reagent management system (RMS) automatically takes over the following data for the Leica reagents: • The use-by date (once opened) • The remaining number of specimen slides • The max. number of specimen slides • The expiration date • The batch numberWarning • The arrangement of the bathlayout is to be followed exactly. Any deviation can lead to undesired staining results.• All of the Leica reagent kit bottles are to be scanned.• Make sure that no Leica reagents from different Leica reagent kits are used.• Reagent vessels must always be filled outside of the instrument in compliance with the safety information.Note The user is finally prompted by a message on the screen to start the automatic fill level scan. Press "OK" in the message (→ "Fig. 60") to start the scan.Fig. 60
82 Version 1.3, Revision J Operation55.9.11 Adapting a bathlayoutCaution The automatically and optimally created bathlayout should be adjusted only if special user requirements were not taken into account or if this is required by a Leica program. For this reason, the instructions for use provided with the Leica reagent kits must be observed! Supervisor mode is needed to adjust the bathlayout.Each adjustment of the bathlayout can have a negative effect on the specimen throughput and staining result!The following rules must be observed when adjusting the bathlayout:• Reagent stations must not be moved from one side of the vessel field to the other because this causes unnecessarily long transfer times.• Duplicate stations have to be on the same side of the vessel field (→ "Fig. 40") (→ "Fig. 65"), otherwise the adjustment to the bath layout cannot be saved.If you need to adjust the bathlayout created by the HistoCore SPECTRA ST, which takes into account all rules for optimization, this can be done by means of the function "Adapt Bathlayout" (→ "Fig. 61-1").Using this function, station placements can be moved to their positions within the bathlayout and/or duplicated.To do so, proceed as follows:• In the bathlayout view (→ "Fig. 61"), press the "Adapt Bathlayout" button (→ "Fig. 61-1").• Observe the messages that follow (→ "Fig. 62") (→ "Fig. 63") and confirm them or press "Cancel" (→ "Fig. 63") to return to the bathlayout view.• After confirmation, the "Clipboard" (→ "Fig. 64") will open, to which up to 6 reagent stations (→ "Fig. 64-1") can be moved.1324Fig. 61
83HistoCore SPECTRA STOperation 5Fig. 62 Fig. 63 13245Fig. 64 Note • Leica reagent stations marked by an "L" before the reagent name (→ "Fig. 61-3"), can be moved but not duplicated.•
84 Version 1.3, Revision J Operation5Note • The clipboard can be closed only if no more reagent stations are in it.• A message on the screen prompts the user to start the automatic fill level scan after each change made using the "Adapt Bathlayout" function. Press "OK" in the message to start the scan. There are two options for changing the bathlayout:Moving reagent stations:1. To move reagent stations, select them individually in the bathlayout (→ "Fig. 61") by touching the screen and then tapping an available position in the clipboard (→ "Fig. 64-1"). 2. This moves the reagent station to the clipboard (→ "Fig. 64-1").3. Finally, select the reagent station in the clipboard by tapping and dragging it to the desired (available) station (→ "Fig. 61-2") in the bathlayout.4. To save your changes, press the "Finish" (→ "Fig. 64-3") button and confirm the subsequent message with a "Yes" or "No" to return to the clipboard.5. To delete the changes, press "Cancel" (→ "Fig. 64-2") and answer the subsequent message with a "Yes".Duplicate a reagent station1. To duplicate a reagent station, select it in the bathlayout by touching the screen.2. Subsequently press the "Duplicate" (→ "Fig. 64-5") button.3. As a result, the reagent station appears in the clipboard. This station and the original station are displayed with an equivalence symbol (→ "Fig. 61-4").4. After this, select the duplicate reagent station in the clipboard by touching the screen and place it in the desired (available) station, near the original station in the bathlayout. 5. To save your changes, press the "Finish" button and confirm the subsequent message with a "Yes" or "No" to return to the clipboard.6. To delete the changes, press "Cancel" and answer the subsequent message with a "Yes".Note • Duplicated reagent stations make sense for program steps with a long dwell time in a reagent. Duplicated stations make two equivalent reagent stations available for a program step, which ensures getting a high specimen throughput.• Duplicated reagent stations can be deleted using the "Delete" button (→ "Fig. 64-4"). To do so, mark them in the bathlayout by touching them and pressing the "Delete" button.
85HistoCore SPECTRA STDaily instrument setup 66. Daily instrument setup6.1 Preparing the instrument for daily setupNote • (→ "Fig. 65") shows an overview of the various stations in the vessel field.• Altogether, the vessel field consists of 36 reagent stations and 6 rinsing water stations. • The max. capacity of each reagent vessel is 380 ml.1537 6489Fig. 65 1 6 oven stations3 Left vessel field4 Rinsing water stations (group of four)5 Right vessel field6 5 unloading stations7 Dry transfer station8 Rinsing water stations (group of two)9 5 loading stations
86 Version 1.3, Revision J Daily instrument setup66.2 Daily instrument setupNote Before setting up the instrument every day, check the water inlet to the instrument and turn it on if necessary.• Open the instrument hood and remove the covers from the reagent vessels.• Switch on the instrument. Automatic fill level scan when initializing the instrumentDuring the initialization, fill level scans are automatically carried out in the following areas:• Reagent vessels• Rinsing water vessels• Reagent vessels of the loading and unloading stations• Oven stationNote If the instrument still contains racks, reagent vessels that are insufficiently filled or still covered, and/or rinsing water vessels that are not ready for use, this is detected during the automatic fill level scan and displayed when finished. 6.2.1 Preparation and handling of reagent vesselsTo ensure that everything runs smoothly in the instrument, observe the following notes and proceed as follows.Attaching the reagent vessel handleCheck whether the reagent vessel handle is correctly attached to the reagent vessel. If this is not the case, fasten the handle according to (→ "Fig. 66").Filling and draining reagent vesselsWarning The reagent vessels are always to be filled or drained outside of the instrument to avoid or reduce the risk of spilling reagents into other reagent vessels and onto interior instrument components. Proceed carefully when filling or draining the reagent vessels and follow the respectively applicable laboratory specifications. If reagents were spilled or another reagent station has been contaminated, it must be cleaned and re-filled. The vessels must be covered when not using the instrument to prevent the unnecessary evaporation of the reagents.
87HistoCore SPECTRA STDaily instrument setup 6Correct fill level of the reagent vessels• When filling either reagent vessel type, observe the fill level marks inside the reagent vessels (→ "Fig. 66") (→ "Fig. 67").• A sufficient filling level is ensured if the level of the reagents is between the maximum (→ "Fig. 66-1") and minimum (→ "Fig. 66-2") fill level marks. • If inserts for special dyes (→ "Fig. 67") are used in the reagent vessels in order to reduce reagent volume, insert these into the reagent vessel first and then fill the reagent at least up to the minimum filling level indicated (→ "Fig. 67-2"), but not over the maximum filling level (→ "Fig. 67-1").12Fig. 66 12Fig. 67 Inserting the reagent vessel into the vessel field• Select "Bathlayout" (→ p. 38 – 5.5 Main menu - overview) in the main menu and insert the reagent vessel into the correct position according to the arrangement of the bathlayout.Note Carefully insert the reagent vessel with handle into the vessel field so that the handle is on the right side of the reagent vessel when looking at the vessel field (→ "Fig. 68-1"). This orientation of the handle is recommended also for placing the reagent vessels in the loading or unloading station .Note A special coating is also applied when using special dyes (as with the rack handle for 5 slides) which prevents chemical interactions with reagents for special applications (e.g. Prussian blue staining for iron detection, silver stains such as Grocott or Gomori). For more information about reagents that should be used with coated accessories, see (→ p. 144 – Appendix 1 - Compatible reagents).
88 Version 1.3, Revision J Daily instrument setup6132Fig. 68 Caution Do not insert the reagent vessels into the instrument laterally offset from the station number. To do so, make sure that the notch on the front side of the reagent vessel (→ "Fig. 68-2") and the station number (→ "Fig. 68-3") are at the same height.6.2.2 Automatic fill level scanAfter filling and inserting the reagent vessels, the automatic fill level scan (→ "Fig. 69-1") should be carried out for verifying that all reagents used have the correct fill level.Note • The load and unload stations are not taken into account when creating the bathlayout. Reagents in the load and unload stations have to be defined and monitored by the user.• The reagents in the loading and unloading stations are not monitored by the reagent management system. Therefore the user is responsible for making sure the reagents in these stations are in flawless condition.To start the fill level scan manually, proceed as follows:1. Call up the "Bathlayout" (→ p. 38 – 5.5 Main menu - overview) in the main menu. 2. The "Fill Level Scan" (→ "Fig. 69-1") button is in the lower part of the menu screen. 3. Press this button to start the fill level scan.Note Irregularities during the fill level scan are displayed on the screen. Follow the information messages and, for example, correct the fill level, remove the cover, add reagent vessels, etc.
89HistoCore SPECTRA STDaily instrument setup 66.3 Reagent management system (RMS)The bathlayout (→ "Fig. 69") in the instrument is displayed by pressing the adjacent menu button. This display shows the current layout of the reagent stations, the rinsing water stations and the loading and unloading stations in the instrument.Fig. 69 1324The bathlayout is empty when the instrument is delivered, because reagents still have not been defined and a bathlayout has not yet been created. If reagents (→ p. 59 – Creating a new reagent or copying a reagent) and programs (→ p. 69 – 5.9.5 Creating or copying a new staining program) have been defined and the bathlayout has been created (→ p. 75 – 5.9.9 Creating the bathlayout), the overview (→ "Fig. 69") shows all stations in the instrument in their real order.Each reagent vessel shown in the bathlayout contains additional information: • Station number (→ "Fig. 69-2")• Abbreviating the reagent name (→ "Fig. 69-3")• A background color (→ "Fig. 70")• Equivalence symbol for a duplicated reagent station (→ "Fig. 69-4")
90 Version 1.3, Revision J Daily instrument setup6Note • The background color shows the consumption status of the reagent (→ "Fig. 70"). As the reagent is consumed, the color bar rises from the bottom to the top and changes color based on the consumption status.• As soon as the "Red" (→ "Fig. 70-3") consumption status has been reached, and absolutely no later than when the station flashes red, the reagent in question has to be replaced. If this is not done, Leica staining programs are no longer able to start. • For further information on the RMS, see (→ p. 56 – 5.8 Reagent list).132Fig. 70 1 Green: Consumption status between 0-80 % of the maximum use limit2 Yellow: Consumption status between 80-95 % of the maximum use limit3 Red: Consumption status between 95-100 % of the maximum use limit6.4 Station detailsTouching a station in the bathlayout will display more information (station details). The following station types are distinguished by their abbreviation:L01-L05 Load stationsSID Specimen slide reader station and title block identification (optional)O01-O06 Oven stations for drying the specimen slides and starting to melt the paraffinR01-R42 Reagent stationsW08-W09W22-W23Rinsing water stations (group of four)W36-W37 Rinsing water stations (group of two)D01-D02 Dry transfer stationsU01-U05 Unloading stations in the output drawer
91HistoCore SPECTRA STDaily instrument setup 6Specimen slide reader station (SID):Touching this station causes a note to appear indicating that this station is the specimen slide reader station. The "Close" (→ "Fig. 71") button is used to close the display.Fig. 71 Oven stations: The detail view (→ "Fig. 72") of an oven station shows:• The current temperature (→ "Fig. 72-1"),• The target temperature adjustment (→ "Fig. 72-2") and • The operating mode (→ "Fig. 72-3") of the 6 oven stations.The "Close" (→ "Fig. 72-4") button is used to close the display.Fig. 72 1324Rinsing water stations (group of four):The detail view of a rinsing water station (→ "Fig. 73") shows all other rinsing water stations that are connected to the same water circuit. The "Close" button is used to close the display.Fig. 73
92 Version 1.3, Revision J Daily instrument setup6Rinsing water stations (group of two): When you tap a rinsing water station of a group of two, an information window opens that shows the 2 water stations, which are connected to the second water circuit with, for example, distilled water or demineralized water (→ "Fig. 74-1") or rinsing water (→ "Fig. 74-2"). Note Based on the connected supply (→ p. 26 – 4.2.1 Joint connection of all 6 rinsing water stations) (→ p. 27 – 4.2.2 Combined connection 4+2 rinsing water stations), the corresponding selection must be made in this menu.The rinsing water stations (group of two) can only be programmed in supervisor mode.Warning The correct assignment and connection of the rinsing water vessels is absolutely necessary for achieving good staining quality.• To apply the settings, press the "Save"(→ "Fig. 74-3") button or press "Cancel" (→ "Fig. 74-4") to close the display without applying potential changes.1324Fig. 74 Loading stations in the input drawerNo reagents have been assigned yet to the loading stations in the factory condition of the instrument. If a reagent is to be assigned to a loading station, run the following steps:1. Select the corresponding station in the bathlayout (→ "Fig. 20-1") by touching it.2. In the newly opened "Station Details" window, press the black "Reagent name" (→ "Fig. 75-1") button to open the list of available reagents (→ p. 56 – 5.8 Reagent list).3. Select the desired reagent by touching it and then hit "Apply".4. To apply the settings, press the "Save" (→ "Fig. 75-2") button or press "Cancel" (→ "Fig. 16-3") to close the display without applying potential changes. The assigned reagent name is displayed in the bathlayout.
93HistoCore SPECTRA STDaily instrument setup 6If reagent is no longer required in the selected loading station, the assignment to the respective reagent can be removed using the "Clear" (→ "Fig. 75-4") and "Save" (→ "Fig. 75-2") buttons in the "Station details" window.Fig. 75 1324Note The load and unload stations are not taken into account when creating the bathlayout. Reagents in the load and unload stations have to be defined and monitored by the user.Warning The racks are transported into any free unloading station at the end of a program. Therefore, all unload stations must be filled with the same reagent. The samples can potentially become damaged if this is not observed.Reagent stationsAn information window opens when the reagent station is touched. It displays additional relevant data regarding the station type (reagent station (→ "Fig. 76"), Leica reagent station (→ "Fig. 77")).Reagent name (→ "Fig. 76-1"), Abbreviation (→ "Fig. 76-2")(→ p. 60 – Creating a new reagent or copying a reagent)Consumption status (→ "Fig. 76-3") (→ p. 89 – 6.3 Reagent management system (RMS))Remaining slides (→ "Fig. 76-4"), Slides max. (→ "Fig. 76-6")Displays the number of remaining processable specimen slides. When inserting a rack into the instrument, the slides contained in it are counted by the specimen slide reader station and subtracted from the number of remaining slides.
94 Version 1.3, Revision J Daily instrument setup6Slides since exchange (→ "Fig. 76-5") Displays the number of specimen slides processed since the last reagent changeover.Onboard shelf life (→ "Fig. 76-7") Displays the shelf life of the reagent filled into the reagent vessel.Insert yes/no (→ "Fig. 76-8") "Yes" indicates that the insert for special dyes and the slide holder for 5 slides is used. This station cannot be used for programs with slide holders for 30 slides (→ p. 56 – 5.8 Reagent list).Exclusive Yes/No (→ "Fig. 76-9") The setting "Yes" defines that the reagent is only assigned to one program. "No" allows use by multiple programs (→ p. 71 – 5.9.6 Inserting or copying a new program step).Expiry date (→ "Fig. 77-1"), Lot number (→ "Fig. 77-2")is applied automatically when scanning the packaging of the Leica reagent kit.Detail view of reagent station1953117210648Fig. 76
95HistoCore SPECTRA STDaily instrument setup 6Detail view of Leica reagent station12Fig. 77 Reagent replacement• If the RMS indicates that a reagent is almost or completely consumed, a reagent change must occur. This changeover must be confirmed by pushing the "Update Reagent" (→ "Fig. 76-10") button.• When replacing the Leica reagents, first press the "Update Reagent" button and follow the instructions for scanning and filling on the screen.• The "Close" (→ "Fig. 76-11") button is used to close the display.Note • Please note: Replacement of reagents followed by an update to the RMS data is only possible if the instrument is in an operational state and there are no longer any racks in the instrument (including the input and output drawers).If a user-defined staining program is still being used despite a required reagent changeover, the number of specimen slides will exceed the "Maximum specimen slide" (→ "Fig. 76-6") value. The exceeded number of specimen slides can be determined by comparing the information in the "Slides since exchange" and "Slides max" rows in the station details (→ "Fig. 76-5"). • A limit of 30 excess specimen slides applies to reagents in Leica reagent kits. This limit does not apply to additional reagents associated with the Leica program (e.g. alcohol, xylene).Caution Updating the reagent status without replacing the corresponding reagent will inevitably affect the staining quality negatively.Warning NEVER press the "Update Reagent" button if the reagent has not been replaced.
96 Version 1.3, Revision J Daily instrument setup6Note Each Leica reagent kit can only be scanned once! Already added Leica reagents expire before their use-by date if a bathlayout is newly created. 6.5 Preparing the rackWarning Each rack handle (→ "Fig. 79-1") contains 2 RFID chips. Therefore, the rack handles may only be attached to the rack (→ "Fig. 79-2") after a possible microwave step for specimen preparation.Two different types of slide holders with compatible handles are available for use in the HistoCore SPECTRA ST stainer:• Rack for 30 specimen slides for routine staining (→ "Fig. 79").• Rack for 5 specimen slides for special staining (→ "Fig. 80").The colored handles must be correctly attached prior to using the rack in the instrument.The rack handles must be attached corresponding to the previously defined program color (→ p. 64 – 5.9.1 Assigning a rack handle color to a staining program).The specimen slide handles are available in 9 colors (8 program colors & white) (→ p. 135 – 9.2 Optional accessories).Fig. 79 12
97HistoCore SPECTRA STDaily instrument setup 6Fig. 80 Note The rack handle for 5 slides has a special coating, which prevents chemical interactions with reagents for special applications (e.g. Prussian blue stain for iron detection, silver stains such as Grocott or Gomori). For more information about reagents that should be used with coated accessories, see (→ p. 144 – Appendix 1 - Compatible reagents).Note Special function of the white handle: • The white handle cannot be permanently assigned to a staining program. • Corresponding to a "wildcard function", the white handle has to be reassigned to a program color each time the program is started.• For this purpose, a selection menu opens on the screen automatically after inserting the rack.Proceed as follows to attach or replace the rack handles:Detach a handle from the rack:• Slightly pull the handle apart (→ "Fig. 81"), so that the handle wire can be pulled out of the holes in the rack.Attach a handle to the rack:• Slightly pull apart the handle and lift on the rack so that the handle wire snaps into the respective holes on the left and right in the rack (→ "Fig. 81-1") (→ "Fig. 81-2").
98 Version 1.3, Revision J Daily instrument setup612Fig. 81 Note • Be sure that the handle is correctly positioned in the upper position, centered above the rack (→ "Fig. 81").• For stable placement for filling (→ "Fig. 82-3"), fold the handle (→ "Fig. 82-1") to the side as far as it goes (→ "Fig. 82-2") so it can be used as additional protection to prevent tipping.Fig. 82 213Warning • When inserting the specimen slides (→ "Fig. 82-3"), be absolutely certain that the slide label is facing upwards and toward the user. The side of the slide with the specimen absolutely must be facing the front side of the rack. • The front side of the rack is labeled with the Leica logo. With the handle attached, "Front" can be read when looking at the handle (→ "Fig. 82").• If the specimen slides are not inserted correctly, the samples can become damaged during the staining process.• The stickers and/or labels used on the specimen slides must be resistant to the solvents used in the instrument.
99HistoCore SPECTRA STDaily instrument setup 6Note • Only specimen slides that meet the DIN ISO 8037-1 standard may be used.• When printable labels or handwritten labels are used on the rack handles and the specimen slides, they must be checked for solvent resistance prior to use. • When inserting the specimen slide into the rack, you have to make sure that the slides are inserted into the respective rack for the desired staining program. The colored rack handles enable reliable assignment to the respective staining program.• Make sure that only one specimen slide each is put into the insert space and that the slides are not jammed in.6.6 The staining processThe following requirements must be met to carry out the staining process:• All settings have been optimized (parameters for oven, etc.).• The programs required for staining have been created (→ p. 69 – 5.9.5 Creating or copying a new staining program).• The reagent stations are filled with the correct reagents (→ p. 86 – 6.2.1 Preparation and handling of reagent vessels).• A fill level scan has been carried out (→ p. 86 – 6.2 Daily instrument setup).• The racks intended for staining are filled and the correct handles are attached to them (→ p. 96 – 6.5 Preparing the rack).Note Controlled shutdown of the instrument is initiated if the operating switch (→ "Fig. 14") is pressed during an ongoing staining process (→ p. 106 – 6.6.6 Finishing the daily operation). To do so, the operator has to confirm shutdown of the instrument by pressing the operating switch twice.
100 Version 1.3, Revision J Daily instrument setup66.6.1 Starting the staining processWarning • To avoid injuries, do not enter the movement area of the input drawer.• The rack can be inserted only using the input drawer. Directly inserting it into any reagent or oven station by opening the instrument hood is not permitted. Racks inserted in this way cannot be recognized by the instrument and may cause collisions!• Opening the hood when staining programs are active causes delays in the respective processing steps since no transport movements can take place during this time frame. This can result in changes to the staining quality.• Make sure to keep the hood closed if the staining programs are active. Leica assumes no liability for loss of quality caused by this.• If racks with white handles have been placed into the input drawer and assigned to a program, the program will have to be reassigned after the drawer and/or hood is opened again. For this purpose, observe the messages displayed on the screen.Starting the staining process1. Fold the rack handle into the upright position (→ "Fig. 82").2. If the input drawer is illuminated in green (→ "Fig. 83-1"), press it and open the drawer.3. As shown in (→ "Fig. 83-2"), insert the rack into an available input drawer position.12Fig. 83 4. Insert the rack so that both the Leica logo on the front side of the rack and the "Front" label on the top of the colored handle are pointing toward the user. The arrow on the top of the colored handle must point into the instrument. 5. Press the input drawer button again to close it again.6. The user receives a message if the input drawer is open for longer than 60 seconds.Warning Exercise caution when opening or closing the drawers! Crushing hazard! The drawers are motorized and open automatically when the button is pressed. Do not block the extension range of the drawers.7. After the input drawer is closed, the instrument detects the RFID chip in the colored handle.
101HistoCore SPECTRA STDaily instrument setup 68. The detected handle color and the assigned program abbreviation are displayed in the bathlayout at the respective station (→ "Fig. 84").Fig. 84 Note • The instrument detects and indicates when a rack has been inserted in the wrong orientation and has to be corrected by the user.• If a rack has been inserted into the input drawer with a rack handle color for which no program is specified in the bathlayout (→ "Fig. 85"), the instrument detects this and informs the user by displaying a message. The rack must be removed from the instrument. Corresponding to the bootable programs (→ p. 69 – Fig. 45), attach the correct colored handle to the rack and re-insert it into the input drawer.Fig. 85 Note For the inserted racks, the instrument calculates throughput-optimized start times that can deviate from the order of the inserted racks.• Before the first program step, the instrument counts the slides that have been inserted into the rack in the specimen slide reader station (→ "Fig. 4-2"). • The determined number of specimen slides is recorded and processed in the RMS and the consumption status of the respective reagents is updated.• Afterwards, the rack is transported into an oven station or reagent station, depending on the defined first program step.
102 Version 1.3, Revision J Daily instrument setup6Warning If the input drawer and hood of the instrument were inserted simultaneously before starting a staining process (e.g. for visual inspection of the reagents), the instrument issues a message after 60 seconds that prompts the user to close the input drawer. If the rack is inserted before closing the input drawer, make sure that the hood is closed and the programs start.If the program does not start automatically, open the input drawer and close it once more.6.6.2 Monitoring the staining processUsing the following menu, the user can call up or monitor details for ongoing programs:• Bathlayout with station details (→ "Fig. 84").• Process status display with calculated remaining program times and step times (→ p. 35 – 5.3 Process status display).• The status bar (→ p. 34 – 5.2 Elements of the status display) with date, time and symbols that refer to messages and warnings that occurred.Note The last 20 active messages and warnings can be called up by touching the corresponding symbols in the status bar (→ "Fig. 17-2") (→ "Fig. 17-3"). This allows the user to learn about up-to-date situations after being absent from the instrument and to initiate any required actions.6.6.3 Staining process completed• After a rack has run through the staining process, it is transported into the output drawer (→ "Fig. 20-4") and placed in an available position (→ "Fig. 86"). The user is informed of this by a message and a signal tone.Fig. 86 • To remove the rack from the unloading station, press the button on the output drawer (→ "Fig. 20-4") to open it and remove the rack.• Press the button again after removal to close the output drawer.Warning To avoid injuries, do not enter the movement area of the output drawer.
103HistoCore SPECTRA STDaily instrument setup 6Caution The output drawer must be opened and the racks must be removed no later than when the warning message is received indicating that the output station is completely occupied (→ "Fig. 87"). Failure to comply with the warning message results in not being able to transport further racks into the output stations. Deviating step times and delays in the staining process may change and ultimately invalidate the staining results.Fig. 87 • The user receives a message (→ "Fig. 88") if the output drawer is open for longer than 60 seconds.Fig. 88 Note The warning message requests the user to close the output drawer to prevent potential delays. When the output drawer is open, the instrument cannot place completely processed racks into the unloading stations. Deviating step times and delays in the staining process may change and ultimately invalidate the staining results.• Press the button on the output drawer for closing.
104 Version 1.3, Revision J Daily instrument setup66.6.4 Canceling the staining programNote • Staining programs can only be canceled via the process status display. • A program that is already in the specimen slide reader station (→ "Fig. 4-2") cannot be canceled.1. To cancel a staining program, select the corresponding rack in the process status display (→ "Fig. 18-3") by touching it. 2. A list of program steps (→ "Fig. 89") appears; the current step is marked in red (→ "Fig. 89-1").12Fig. 89 3. The frame of the window displays the color assigned to the program, the program name and the stored abbreviation.4. Press the "Cancel program" (→ "Fig. 89-2") button.5. In the following message (→ "Fig. 90"), confirm the program termination with the "Yes" button or return to the process status display with "No".Fig. 90
105HistoCore SPECTRA STDaily instrument setup 6Note The information in the message (→ "Fig. 90") absolutely must be adhered to.6. The bathlayout is displayed after pressing the "Yes" button. The position of the rack in the instrument is marked orange (→ "Fig. 91-1").7. Open the instrument hood and remove the rack from the highlighted station.Caution If the marked station is an oven station, the left transport arm (→ "Fig. 4-1") may have to be shifted to the center of the instrument. Then, pull the oven cover forward and remove the rack.• Confirm the removal of the rack by pressing the marked station (→ "Fig. 91-1").1Fig. 91 • Then close the hood again.Caution When removing the rack, proceed quickly and make sure that the hood remains open only for a short amount of time. After opening the hood, for safety reasons, all movements are interrupted until the hood is closed again. Deviating step times, delays and changed staining results can be caused each time the hood opens in the staining process. Warning To avoid injuries, do not enter the movement range of the oven lid (swivel range of the oven).Note Remaining staining programs are continued after a program termination.
106 Version 1.3, Revision J Daily instrument setup66.6.5 Operation as a workstationThe HistoCore SPECTRA ST can be operated as a workstation together with a HistoCore SPECTRA CV robotic coverslipper. This enables an interruption-free workflow from the staining process up to the removal of the finished cover slipped slides. An optional transfer station is available for this purpose (→ p. 135 – 9.1 Optional instrument components). Note The optional transfer station and connection of a HistoCore SPECTRA CV to the HistoCore SPECTRA ST may be installed subsequently only by a Leica-certified service technician. Caution The user must adhere to the following in workstation mode!• The output stations of the HistoCore SPECTRA ST must be filled with the same reagent (xylene) as the input station(s) of the HistoCore SPECTRA CV.• Each reagent added must be compatible with the mountant used.• Filling the output stations of the HistoCore SPECTRA ST and the input stations of the HistoCore SPECTRA CV with the same reagent is absolutely necessary, because the racks are conveyed into the output station during the staining process in the event that the HistoCore SPECTRA CV is not available. This situation can occur if the reagent vessels of the input drawer are filled with racks in the HistoCore SPECTRA CV, because the operator did not refill the consumables in a timely manner or there is an instrument fault.• A rack for 5 specimen slides cannot be transferred to the HistoCore SPECTRA CV. These racks are always put into the output drawer at the end of the staining process, regardless of whether the transfer station was specified in the staining program as the last station.• The operation as a workstation is described in detail in the Instructions for Use of the HistoCore SPECTRA CV.Warning If the specified stations are not filled as recommended, this can lead to damaged specimens with lower staining result quality and coverslipping quality. Not filling the specified stations may result in specimens being ruined from drying out.6.6.6 Finishing the daily operationAfter completing the daily staining operation, the instrument must be set to standby mode:1. Check the following stations for remaining racks and remove them:• Input drawer (→ "Fig. 65-9")• Output drawer (→ "Fig. 65-6")• Oven (→ "Fig. 65-1")• Dry transfer station (→ "Fig. 65-7")• Reagent vessel field (→ "Fig. 65-3"), (→ "Fig. 65-4"), (→ "Fig. 65-5") and (→ "Fig. 65-8")2. Then cover all reagent vessels with the reagent vessel covers.3. Push the green operating switch (→ "Fig. 10-2") once.
107HistoCore SPECTRA STDaily instrument setup 64. The instrument prompts the user to confirm the shutdown of the device by pressing the operating switch again.5. After pushing the operating switch a second time, the instrument shuts down in a controlled manner. 6. The operating switch is now red and the instrument is in standby mode.7. Finally, shut off the water supply.Warning If cleaning or maintenance work are to be carried out on the instrument, the instrument must also be switched off at the main switch (→ "Fig. 10-1").
108 Version 1.3, Revision J Cleaning and Maintenance77. Cleaning and Maintenance7.1 Important notes about cleaning this instrumentWarning General instructions:• Before each cleaning, shut down the instrument using the operating switch (→ "Fig. 10-2") and then switch it off using the main switch (→ "Fig. 10-1")!• When cleaning the instrument, wear suitable protective clothing (lab coat and gloves) to protect from reagents and potentially infectious micro-biological contaminations. • Liquid must not come into contact with the electrical connections or get inside the instrument or in the housing below the transport arms.• When using cleaning agents, observe the manufacturer's safety instructions and the laboratory regulations valid in the country of use.• Dispose off spent reagents in accordance with the laboratory guidelines in force in your country! The following applies to all instrument surfaces:• Wipe up spilled solvents (reagents) without delay! The hood surface is only conditionally solvent-resistant at a longer exposure time!• Do not use any of the following for cleaning the outside surfaces of the instrument: alcohol, detergents containing alcohol (e.g. window cleaner), abrasive cleaning powders, solvents containing acetone or xylene. 7.2 Exterior surfaces, varnished surfaces, instrument hoodThe surfaces can be cleaned with a mild, pH-neutral, commercially available cleaning agent. After cleaning the surfaces, wipe them off with a cloth moistened with water.Caution Varnished instrument surfaces and plastic surfaces (e.g. the instrument hood) must not be cleaned with solvents such as acetone, xylene, toluene, xylene substitutes, alcohol, alcohol mixtures and abrasives! In case of long-term exposure, the surfaces and instrument hood are only conditionally resistant to solvents.7.3 TFT touchscreenClean the screen using a lint-free cloth. A suitable screen cleaner can be used in compliance with the manufacturer information.7.4 Interior and drain pan• To clean the interior and the drain pan, remove the reagent vessels and rinsing water vessels.
109HistoCore SPECTRA STCleaning and Maintenance 7Use a mild, pH-neutral, commercially available cleaning agent to clean these areas. • After cleaning the drain pan, rinse it thoroughly with water.7.5 Transport armsTo clean the surfaces of the transport arms (→ "Fig. 92-1"), these are to be wiped off with cloth moistened with water or with a mild cleaning agent with a neutral pH value.Warning Ensure that no liquids spill underneath the housing (→ "Fig. 92-2") of the transport arms because there are sensitive parts here.7.6 Specimen slide reader stationCheck the recess of the specimen slide reader station for dirt and reagent residue. If specimen slides that already have damaged edges are used, small glass shards and splinters may have collected there (→ "Fig. 92-3"). Therefore, all dirt in this area must be carefully removed to prevent injury.Warning Wear suitable protective clothing (lab coat and gloves) to protect against cutting injuries. Fig. 92 2137.7 Input and output drawers• Remove reagent vessels from both drawers and store them outside of the instrument.• Check the inside of the drawers for reagent residue and remove residue where appropriate.• Finally, insert the reagent vessels into the correct positions again.• Observe the existing labeling (→ "Fig. 93-1") for stations in the drawers.
110 Version 1.3, Revision J Cleaning and Maintenance71Fig. 93 Note Use the label covers contained in the (→ p. 19 – 3.1 Standard delivery) to label the reagent vessels in the input and output drawers. The imprinted letters have the following meanings:• H2O = water or distilled water• A= alcohol• S= solvent, for example, xylene7.8 Dry transfer station1Fig. 94 After inserting the dry transfer station, the reagents can drip down. This residue must be removed regularly. • To do so, remove the insert (→ "Fig. 94-1") of the dry transfer station by pulling upwards, check for contamination and clean if necessary.• Then, re-insert the insert and make sure it snaps in correctly.
111HistoCore SPECTRA STCleaning and Maintenance 77.9 Transfer station (optional)• Regularly check the transfer station (→ "Fig. 95") for reagent residue and, if necessary, clean it using a commercially available, mild cleaning agent with a neutral pH value.Fig. 95 7.10 Reagent vessels, rinsing water vessels and (optional) heated vessels• Remove the vessels individually from the handle. Ensure that the handle is in the correct position (→ p. 86 – 6.2.1 Preparation and handling of reagent vessels) to prevent spilling of the reagent. • The sealing ring (→ "Fig. 96-1") must remain attached to the rinsing water vessel.• Dispose of reagents in accordance with the local laboratory specifications.• Reagent and rinsing water vessels can be cleaned in a dishwasher, at a maximum temperature of 65 °C, using a standard, commercially available detergent for lab dishwashers. The handles can remain attached to the various vessels during this process.Caution • To prevent damage to the coating of coated accessories (inserts for special dyes and specimen slide handles for 5 specimen slides), these must not be cleaned in a dishwasher. Likewise, make sure the coating does not get damaged when cleaning manually. If coated accessories are damaged, they may cause chemical reactions with reagents for special applications (→ p. 144 – Appendix 1 - Compatible reagents).• Color reagent vessels have to be pre-cleaned by hand before cleaning in a dishwasher. Remove as much staining residue as possible to avoid discoloring the remaining reagent vessels in the dishwasher.• Never clean plastic reagent vessels at temperatures higher than 65 °C since this can deform reagent vessels!
112 Version 1.3, Revision J Cleaning and Maintenance721Fig. 96 Note • The rinsing water vessels are to be regularly checked for calcification, visible, microbiological deposits of bacteria, fungi, algae and permeability. Lime residue can be removed using a mild vinegar-based cleaning solution. Finally, rinse off the vessels with clear water until the cleaning agent residue has been removed. • After cleaning the rinsing water vessels and before inserting them into the instrument again, the connecting piece to the water inlet system must be checked for correct positioning on the black O-ring (→ "Fig. 96-1"). • If O-rings are left in the instrument when removing a rinsing water vessel (→ "Fig. 96-2"), remove them carefully with pincers and stick them back onto the connection port.• If an O-ring is missing or positioned incorrectly, the rinsing water vessels must not be put back into position after cleaning, because otherwise there is a danger of the rinsing function being defective during the staining process. • After attaching or correcting the position of the O-ring, lubricate it with the Molykote 111 grease included in the (→ p. 19 – 3.1 Standard delivery). • Then the rinsing water vessels can be put back into their position.Caution If the cleaned and filled reagent vessels are to be put back into the instrument, they need to be put in the correct position in accordance with the displayed arrangement of the bathlayout (→ p. 75 – 5.9.9 Creating the bathlayout). To do so, switch on and initialize the instrument. 7.11 Rack and handle• The rack is to be checked regularly for staining residue and other possible contamination.• The colored handle must be removed from the rack for cleaning.
113HistoCore SPECTRA STCleaning and Maintenance 7• To remove staining residue from the racks, immerse it in a bath of lukewarm water and a mild, pH-neutral lab cleaner and let the cleaner take effect. When doing so, carefully observe the additional manufacturer information regarding cleaning agents and the recommended application area. • Then, strong staining contamination can be removed using a brush.• Now, take your time to thoroughly rinse off the racks with fresh water until no more staining and cleaning agent residue remains.• If residue from the coverslip mountant remains on the racks, these can be placed in a bath of solvent. Caution The racks and handles must not remain in the solvent for a long time (e.g. several hours or overnight), because this can lead to deformation! It is essential to ensure that the solvent being used is compatible with the coverslip mountant. Xylene or toluene-based mountants can be removed using a xylene bath. Xylene substitute-based coverslip mountants are removed using a bath containing a corresponding xylene substitute.Note The maximum exposure time in a solvent bath is 1-2 hours. The solvent can be washed off with alcohol. Completely rinse the racks with water, then dry them. If an external drying oven is used for drying, the temperature must not exceed 70 °C.7.12 Water drainageCaution The draining system within the instrument must be regularly cleaned and checked for correct flow. If this measure is not completed, the water draining system must become clogged, which could lead to interruptions or malfunctions in the staining process.• To clean the water draining system, remove the 4 rear rinsing water vessels (→ "Fig. 65-4") and all surrounding reagent vessels. • The remaining reagent vessels have to be covered with lids. • Remove the drainage sieve and clean it if necessary (→ "Fig. 97-1").• Place one to two cleaning tablets with active oxygen (e.g. a denture cleanser) into the drain and dissolve in water to remove various residue (reagents, bacteria, fungi, algae).• Then, clean the entire curved drainage area inside the instrument with a long, flexible brush (→ "Fig. 97-2").• Check the flow by flushing thoroughly with water.• Insert the drainage sieve again, and put the vessels back in their original, defined positions.
114 Version 1.3, Revision J Cleaning and Maintenance721Fig. 97 7.13 Water drain hoseThe water drain hose must be checked once a year by a service technician authorized by Leica.7.14 Replacing the filter cartridge of the water intake filterThe water intake filter with filter cartridge should be checked and replaced once a year by a service technician authorized by Leica.The integrated water intake filter (→ "Fig. 98") protects instrument's internal water circuit components from damage due to sediments and mineral deposits. The water filter storage life depends on the water quality at the installation location. The maximum lifetime of the water filter is 1 year.The water intake filter should therefore be checked regularly by looking through the filter housing for visible dirt.
115HistoCore SPECTRA STCleaning and Maintenance 721Fig. 98 1 Filter housing2 Filter cartridge, Order No. 14 0512 49332Note If a significant amount of dirt is visible in the water filter before the maintenance interval (1 year) expires, it must be replaced by a Leica service technician.7.15 Changing the active carbon filterThe active carbon filters (→ "Fig. 2-1") installed in the instrument help reduce the amount of reagent vapors in the exhaust air. The life cycle of the filter can fluctuate strongly depending on intensity of use and the reagent configuration of the instrument. Therefore, replace the active carbon filter regularly (every 2-3 months) and dispose of it properly in accordance with the laboratory regulations applicable in the country of use.• The filter unit consists of two individual filter elements (→ "Fig. 99-1"), which are accessible to the user on the front of the instrument. • They can be accessed without tools and removed by pulling on the pull tabs (→ "Fig. 99-2"). • Insert the new filter elements so that the pull tabs can be reached after they are inserted fully and the article number (→ "Fig. 99-3") printed on them is legible.• Note the insertion date for the filter element on the white label and stick the label on the left or right side of the active carbon filter (→ "Fig. 99-4").• Both active carbon filters must be pushed in until you feel them make contact with the rear panel of the instrument.
116 Version 1.3, Revision J Cleaning and Maintenance71324Fig. 99 Caution If inserted incorrectly, the active carbon filters can protrude into the range of movement of the two transport arms, thereby impeding or interrupting the staining process.7.16 Cleaning the ovens Danger Beware of hot surfaces: After using the oven in the staining process, first switch the instrument off before cleaning it and wait at least 10 minutes for it to cool off. Only hold the oven inserts at the described positions.Caution The interior of the oven must not be cleaned using solvents, as there is a risk that solvent residues will get into the oven and evaporate in the oven when the process begins.Regularly check for dirt on the sheet metal inserts for catching paraffin residue in the oven.• Manually pull the movable oven cover (→ "Fig. 100-1") towards the front of the instrument. The oven cover should not be folded up to the side. • If necessary, carefully move the left transport arm to the side, so that the oven insert can be easily accessed.
117HistoCore SPECTRA STCleaning and Maintenance 7• First grab the front oven insert (→ "Fig. 100-2") by the sides and lift it upwards out of the instrument, then remove the rear oven insert (→ "Fig. 101-2").• Disconnect the two oven chambers by pulling them up in opposite directions.• You can then pull out the insert for catching paraffin residue from the respective oven insert (→ "Fig. 101-3") and (→ "Fig. 101-4").• Check the sheet metal inserts for paraffin residue and dirt. To melt the paraffin, the inserts can be placed in an external laboratory oven. • After heating, wipe off the paraffin residue with a lint-free cloth.• Check the ventilation flaps in the oven chambers for proper function. If they are visibly dirty, carefully clean them with a lint-free cloth.• Push the sheet metal inserts back into the respective oven insert in the correct orientation (perforated side facing up).• After cleaning, first put the rear oven insert (→ "Fig. 101-2") back into the instrument in the correct position and then put back the front oven insert (→ "Fig. 100-2"). Observe the correct positioning of the connected oven inserts.21Fig. 100 1324Fig. 101
118 Version 1.3, Revision J Cleaning and Maintenance77.17 Oven air filterThe air filter of the oven should be regularly checked, cleaned or replaced. • To do so, remove the filter insert (→ "Fig. 102-1") and shake it out or replace it with a new filter insert (→ p. 135 – 9.2 Optional accessories).• After checking and cleaning, re-insert into the oven in the same way.1Fig. 102 Note The installation is carried out in reverse order.7.18 Maintenance and cleaning intervalsCaution • You must carry out the maintenance and cleaning tasks listed below.• The instrument must be inspected once per year by a qualified service technician authorized by Leica in order to ensure the continuous functional capability of the instrument.To ensure trouble-free operation of the instrument over a long period of time, the following is strongly recommended:• At the end of the warranty period, enter into a service contract. For more information, contact the relevant customer service organization.
119HistoCore SPECTRA STCleaning and Maintenance 77.18.1 Daily cleaning and maintenanceCaution If sensitive instrument parts and areas get very dirty or if reagents are spilled, they must be cleaned immediately, as a reliable workflow is not guaranteed otherwise.1Checking and filling/refilling the reagent vessels. (→ p. 86 – 6.2.1 Preparation and handling of reagent vessels)2Covering the reagent vessels and, if necessary, storing them with covers in a refrigerator.3Checking the rack and handles for paraffin or dye residue and broken glass.(→ p. 112 – 7.11 Rack and handle)4Check the specimen slide reader station for reagent residue and clean it if necessary.(→ p. 109 – 7.6 Specimen slide reader station)5Check the surface in the area of the input and output drawers for solvent residue and clean it if necessary.(→ p. 109 – 7.7 Input and output drawers)6Clean the insert of the dry transfer station and clean if necessary.(→ p. 110 – 7.8 Dry transfer station)8Check the transfer station (optional) for reagent residue and clean it if necessary.(→ p. 111 – 7.9 Transfer station (optional))7.18.2 Cleaning and maintenance as necessary1Clean the screen using a lint-free cloth. A screen cleaner can be used according to manufacturer instructions.(→ p. 108 – 7.3 TFT touchscreen)2Clean outer/painted surfaces. (→ p. 108 – 7.2 Exterior surfaces, varnished surfaces, instrument hood)3Clean the instrument cover. (→ p. 108 – 7.2 Exterior surfaces, varnished surfaces, instrument hood)7.18.3 Weekly cleaning and maintenance1Check/clean the rinsing water vessels for bacterial contamination and check the sealing rings to make sure that they are present.(→ p. 111 – 7.10 Reagent vessels, rinsing water vessels and (optional) heated vessels)2Clean the reagent vessels. (→ p. 111 – 7.10 Reagent vessels, rinsing water vessels and (optional) heated vessels)
120 Version 1.3, Revision J Cleaning and Maintenance74Clean the racks and handles. (→ p. 112 – 7.11 Rack and handle)5Check the water drain and sieve within the instrument for proper function and clean it if necessary.(→ p. 113 – 7.12 Water drainage)6Checking transport arms for dirt and clean if necessary.(→ p. 109 – 7.5 Transport arms)7.18.4 Monthly maintenance and cleaning1Check the water intake filter (look through filter housing).(→ p. 114 – 7.14 Replacing the filter cartridge of the water intake filter)2Check, clean or, if necessary, replace the air filter of the drying oven with a new one.(→ p. 135 – 9.2 Optional accessories) (→ p. 118 – 7.17 Oven air filter)3Cleaning the drip tray. (→ p. 108 – 7.4 Interior and drain pan)4Checking the drying oven insert and catch tray for paraffin residue and cleaning it.(→ p. 116 – 7.16 Cleaning the ovens)7.18.5 Cleaning and Maintenance Every Three Months1Changing the active carbon filter. (→ p. 115 – 7.15 Changing the active carbon filter)7.18.6 Annual maintenance and cleaning1Checking and maintenance of the instrument by a service technician authorized by Leica.
121HistoCore SPECTRA STMalfunctions and Troubleshooting 88. Malfunctions and Troubleshooting8.1 Fault remedies for instrument malfunctionsError/problem Cause TroubleshootingRising water level in the drain pan with alarm.Water drain partially or completely blockedChecking and maintaining the water drain hose (→ "Fig. 8-1"). For this purpose, contact the responsible Leica service.Water drainage system inside the instrument and/or the drainage sieve partially or completely blocked.Checking and maintaining the water drain system in the instrument. Observe the cleaning instructions in the (→ p. 118 – 7.18 Maintenance and cleaning intervals).If the blockage remains, the water inflow to the rinsing water vessels is stopped and the staining process is interrupted. Therefore, the specimens have to be removed from the instrument and put into a safe position or temporary storage (→ p. 123 – 8.2 Power failure scenario and instrument malfunction). Decreased flushing during the staining cycles with possibly inconsistent staining results.Water inlet in rinsing water vessels attenuated/blocked.Possible causes:• Rinsing water vessels fit incorrectly (note O-ring).• Calcification of the rinsing water vessel.Monitoring and maintaining the rinsing water vessels.Observe the cleaning instructions (→ p. 111 – 7.10 Reagent vessels, rinsing water vessels and (optional) heated vessels).Observe regular maintenance intervals.Rinsing water vessels do not drain automatically during breaks in operation of the instrument. Standing water can be a source for microbiological contamination in the rinsing water vessel and the samples.The additional water drain hole at the base of the rinsing water vessels is blocked by calcification/dirt.Monitoring and maintaining the rinsing water vessels.Observe the cleaning instructions (→ p. 111 – 7.10 Reagent vessels, rinsing water vessels and (optional) heated vessels).Observe regular maintenance intervals.
122 Version 1.3, Revision J Malfunctions and Troubleshooting8Error/problem Cause TroubleshootingInsufficient flushing during the staining processes may yield inconsistent staining results.Water pressure too low in the intake drainage system of the lab or fluctuations at different times of the day. The specified minimum requirements for water pressure (→ p. 20 – 3.2 Specifications) must be fulfilled (even in the event of possible deviations during the daytime).Reagent vessels are deformed. Use of reagents that are not permitted (ex. phenol in Ziehl-Neelson dye or Gram dye, etc.).Incorrectly applied cleaning procedure.Monitoring the used reagents using the list of permitted reagents (→ p. 144 – Appendix 1 - Compatible reagents).Observe the cleaning instructions (→ p. 111 – 7.10 Reagent vessels, rinsing water vessels and (optional) heated vessels).Inconsistent staining results The tolerance of the program step for staining reagents is not correctly defined. Inspecting the staining programs and reagents.Most short program steps demand exact compliance with the staining step. The tolerance of the reagent must be set to 0 %.Varying staining results The process classes (paraffin removal, staining, etc.) for reagents were not correctly assigned. This means that the bathlayout might not have been optimally created.Inspection and correction of the assigned reagent classes (→ p. 60 – Creating a new reagent or copying a reagent).Reagents that are only to be used by one program are used by other programs. The reagent was dirty because it was not programmed as "Exclusive".Inspecting and correcting the programming of respective reagents.Insufficient staining quality Water quality does not satisfy Type 1, ISO 3696Test the water quality in accordance with ISO 3696 and adjust the water quality if necessary.After drying, tissue does not adhere well enough to the specimen slide, and floats away during the staining process.For customer-defined programs, the selected firing time and oven temperature (or both) are too low.Inspecting and correcting information about firing time and oven temperature for customer-defined programs.The staining processes are complete, but repeated or additional programming (supervisor mode) cannot be completed.Programming can only be completed when the instrument is in sleep mode; in other words, no racks may be in progress; this also includes the output drawer positions.Remove racks from the output drawer, then carry out programming.
123HistoCore SPECTRA STMalfunctions and Troubleshooting 8Error/problem Cause TroubleshootingInitialization of the instrument cannot be completed.Arms are blocked. Check that the active carbon filter is in the correct position.The automatic fill level scan shows incorrect results.Inserted reagent vessel clips protrude over the reagent vessel and are incorrectly interpreted in the fill level scan.Check the proper placement of the reagent vessel clip and, if necessary, correct it.The automatic fill level scan shows incorrect results for the input drawer stations and/or the dry transfer station. Individual stations are reported as "Missing".Deposits on the bottom of the empty reagent vessel and/or dry transfer station influence the measuring methods of the automatic fill level scan.Clean the reagent vessels and/or the dry transfer station and remove any clinging lime residue. Then, repeat the fill level scan (→ p. 88 – 6.2.2 Automatic fill level scan)8.2 Power failure scenario and instrument malfunctionNote For the event of a short-term power failure (in the range of a few seconds), the HistoCore SPECTRA ST has an internal UPS (uninterruptible power supply). The user is notified in the event of a short-term power failure via a message on the screen. The message goes away as soon as the power supply is restored. The event is entered into the event log.Circumventing longer-term power failure is possible only by using a external UPS (→ p. 30 – 4.3.1 Using an external uninterruptible power supply (UPS)).In the event of a longer-term power failure (lasting > 3 seconds), the instrument shuts down. The event is entered into the event log. The internal UPS ensures that transferable racks are placed in a secure position above two reagent stations (→ "Fig. 103") to prevent unintentional lowering into an incompatible reagent.Caution Reagent displacement can occur as a result of clinging reagents when setting aside a rack. The affected reagent vessels are to be checked for contamination before starting a staining process and replaced if necessary (→ p. 95 – Reagent replacement).
124 Version 1.3, Revision J Malfunctions and Troubleshooting8Fig. 103 The instrument restarts as soon as the power supply is restored.The instrument software issues a series of messages and instructions to the operator, which provide him/her with information about the power failure and instruct him/her regarding how to proceed. The user can cancel or resume the staining process software using the displayed assistance.Caution Racks in critical positions must immediately be removed from the instrument by the user.The reagent stations defined as "critical" positions are those at which excessively long dwell times may lead to the deterioration of the staining quality or to sample destruction.Critical positions: » Rinsing water (→ "Fig. 104-1") and DI water stations (→ "Fig. 104-2") LVessels can be drained and the specimens can be dried through continuous, automatic water draining on the floor of the vessel. The specimens are to be removed from the instrument and stored securely outside of the instrument, i.e. the staining process is to be completed manually. » Dry transfer station (→ "Fig. 104-3") LThe specimen are not located in a reagent and could dry out. The specimens are to be removed from the instrument and stored securely outside of the instrument, i.e. the staining process is to be completed manually.
125HistoCore SPECTRA STMalfunctions and Troubleshooting 8 » Specimen slide reader station (SID):(→ "Fig. 104-4") LIn the event of power failure, a rack inserted into the specimen slide reader station is placed in a secure location between two reagent stations (→ "Fig. 103"). Remove the rack as described (→ p. 130 – 8.2.4 Detaching a rack from the gripper mechanism) and re-insert it into the input drawer. » Oven stations (→ "Fig. 104-5") LA drop in temperature in the oven station can occur during longer-term power failure. This could result in specimens that have not dried properly. The affected racks are to be removed from the oven and reinserted into the input drawer. » Transfer station (→ "Fig. 104-8") LThe specimen are not located in a reagent and could dry out. The specimens are to be removed from the instrument and stored securely outside of the instrument or manually inserted and coverslipped in the HistoCore SPECTRA CV input drawer.Caution The user is to check whether additional racks are present in the remaining reagent stations (→ "Fig. 104-6") where excessively long dwell times may lead to a loss in staining quality due to the reagent used at those specific stations. The specimens are to be removed from the instrument and stored securely outside of the instrument, i.e. the staining process is to be completed manually.Fig. 104 1532648
126 Version 1.3, Revision J Malfunctions and Troubleshooting88.2.1 Procedure after a power failure LThe first message after the device restarts automatically notifies the operator of the power failure time (→ "Fig. 105"). Confirm this message by pressing the "OK" button to start the additional instructions for continuing the staining process. Fig. 105 1. After confirming this message, the user is informed that the staining periods may have been exceeded, i.e. individual racks have already spent too much time in a reagent under certain circumstances or in a critical station, which can impede the staining quality. Confirm this message (→ "Fig. 106") by pressing the "OK" button to resume.Fig. 106 2. Subsequently, this messages prompts the user to check (→ "Fig. 107") whether or not the instrument has placed one or two racks in a secure position between two reagent vessels (→ "Fig. 103"). Fig. 107
127HistoCore SPECTRA STMalfunctions and Troubleshooting 83. After pressing the "OK" button (→ "Fig. 107"), another messages appears (→ "Fig. 108") that provides the user with instructions regarding the correct procedure for removing the respective racks.Fig. 108 4. Subsequently, the user has the option of selecting whether or not the staining process is to be resumed (→ p. 127 – 8.2.2 Resuming the staining process after a power failure) or canceled (→ p. 129 – 8.2.3 Canceling all staining processes after a power failure) (→ "Fig. 109").12Fig. 109 8.2.2 Resuming the staining process after a power failure1. To resume the staining process, press the "Yes" button (→ "Fig. 109-1").
128 Version 1.3, Revision J Malfunctions and Troubleshooting8Note In the following menu, the racks in progress are displayed in the overview of the bathlayout (→ "Fig. 110"). 2. (→ "Fig. 109") Remove the critical racks from the instrument in accordance with the previous message and confirm the removal by pressing the corresponding station (→ "Fig. 110-1") on the screen.Note • It is only possible to remove the racks in progress at the time of the power failure using the method described here.• The specimen of the removed racks are to be stored secured outside of the instrument, i.e. the staining process is to be completed manually.Fig. 110 123. If all critical racks have been removed, press the "Resume" button, observe the following message and confirm by pressing the "OK" button.4. Finally, the instrument carries out an automatic level check and resumes the staining process for the racks remaining in the instrument.Caution • The remaining racks in the input drawer are not detected under certain circumstances. In this case, open the input drawer and close it again. • A program must be assigned to white racks again. • For white racks, the input drawer must also be opened and the specimen slide marking must be inspected for the identification of the correct program to determine which program is to be reassigned.
129HistoCore SPECTRA STMalfunctions and Troubleshooting 88.2.3 Canceling all staining processes after a power failure1. If the staining process for all racks is to be canceled, press the "No" (→ "Fig. 109-2") button and confirm the following warning message by pressing "OK" (→ "Fig. 111-1") to begin the removal of the racks. Note The cancellation of the staining process and the return to the previous selection menu (→ "Fig. 109") can be undone by pressing the "Cancel" button (→ "Fig. 111-2").Fig. 111 122. Open the instrument cover and remove all racks. 3. Confirm the removal of the rack by touching the corresponding station (→ "Fig. 112-1") on the screen .Fig. 112 124. After removing all of the racks successfully, press the "OK" button (→ "Fig. 112-2") to leave the menu and to resume the initialization of the instrument.
130 Version 1.3, Revision J Malfunctions and Troubleshooting8Caution • The remaining racks in the input drawer are not detected under certain circumstances. In this case, open the input drawer and close it again. • A program must be assigned to white racks again. • For white racks, the input drawer must also be opened and the specimen slide marking must be checked to identify the correct program. After removing the critical racks from the instrument, the remaining racks are further processed and new racks can be inserted into the input drawer.8.2.4 Detaching a rack from the gripper mechanism LThe racks are secured on the bottom of the gripper mechanism by the gripper mechanism using two hooks. In the event of a power failure, the rack must be released from the gripper mechanism for the removal from the instrument.1. Grasp with one hand under the colored rack handle (→ "Fig. 114-2") and push it upwards slightly (→ "Fig. 114-3").2. Slide the rack approx. 1 cm toward the inside of the specimen (→ "Fig. 114-4").3. Grasp the gripper mechanism (→ "Fig. 114-1") with your free hand, slide it upwards (→ "Fig. 114-5") and firmly hold.4. The rack can now be removed from the instrument and set aside.5. Finally, pull the gripper mechanism forwards and carefully place it on the free surface next to the left input drawer (→ "Fig. 115-3") or next to the right output drawer (→ "Fig. 115-6").13245Fig. 114
131HistoCore SPECTRA STMalfunctions and Troubleshooting 8536421Fig. 115 Caution After restarting the instrument, an error message appears which can be used to call up the bathlayout (→ "Fig. 40") for assistance in removing the specific rack. All racks in progress must be removed from the instrument by the user manually. Also check the specimen slide reader station (→ "Fig. 4-2") and the oven (→ "Fig. 4-10") on the rack and replace these if necessary:The specimens must be stored outside of the instrument in a suitable reagent and the steps of the already started staining programs must be continued manually until the end of the program. The user shall be responsible for further processing of the samples.• After the power supply is restored, the instrument can be restarted and loaded with new specimens.Note In the event of severe instrument malfunctions requiring removal of specimens from the instrument due to a disruption in the staining process, the procedure in the outlined power failure scenario must be followed. Severe instrument malfunctions are indicated by a defined alarm sound (→ p. 45 – 5.7.4 Alarm and signal tones).
132 Version 1.3, Revision J Malfunctions and Troubleshooting88.3 Replacing main fusesCaution The instrument should be switched off using the main switch and disconnected from the power supply in the case of a instrument failure. The main fuses can then be inspected.• To do so, open the hood and unscrew the two fuse holders on the top of the right cover (→ "Fig. 116-1") with a flat-head screwdriver and check for damage. Caution A suitable flat-head screwdriver must be used to prevent damage to the fuse holder.Warning Beware of defective fuses! Potential risk of injury due to broken glass!1Fig. 116 • If the fuse is defective, remove it from the fuse holder and replace it with a new fuse (→ p. 19 – 3.1 Standard delivery). • Installation occurs in the reverse sequence of operations.8.4 Remote CareA Leica service technician can use Remote Care to remotely monitor, access and repair products that are in use at the user's location. If the instrument is connected to Remote Care (→ p. 55 – 5.7.10 Network settings) and a malfunction occurs, Leica Service can access the screen directly after permission from the user.• To do so, contact the Leica Service team and let it know about the malfunction.• The Leica service technician now accesses the instrument via Remote Care.• The user is informed by a message on the screen and approves access to the instrument by confirming the message.
133HistoCore SPECTRA STMalfunctions and Troubleshooting 8• The Leica service technician attempts to remedy the malfunction together with the user.• At the end of remote access, Remote Care is disconnected again by the user (→ "Fig. 17-4") or by the Leica service technician.Note The user can disconnect an active Remote Care connection for service purposes at any time by pressing the connection symbol (→ "Fig. 17-4").8.5 Water drain system blockedWater drain system blockage (in the drainage sieve (→ "Fig. 97-1") or in the drain hose (→ "Fig. 8-1") can lead to rising water levels in the drain pan. As a result, a critical water level can be reached in the instrument. The user receives an error message (→ "Fig. 117") on the screen and an alarm sounds.Fig. 117 Caution Losses in quality and delays in the staining process can occur in the event of a critical rising water level in the instrument resulting from a water drainage system blockage. Ongoing staining programs are temporarily stopped. The blockage is to be remedied immediately by the user as described below.Removing a water drain system blockageCaution • If racks are still located in the rinsing water vessels, they are to be removed and stored temporarily in water outside of the instrument. • Write down the position of the removed rack to ensure that the staining process can be resumed again after removing the blockage. • The neighboring reagent vessels are to be covered for protection and can remain in the instrument for the time being.1. Open the instrument cover if the warning message appears (→ "Fig. 117").2. Carefully remove the rinsing water and, if necessary, the neighboring reagent vessels over the drainage sieve (→ p. 113 – 7.12 Water drainage).
134 Version 1.3, Revision J Malfunctions and Troubleshooting8Caution Be careful when removing the rinsing water vessels. Lift each individual rinsing water vessel and allow the water inside of it to run into the drain pan. In order to remove the vessels from the instrument without having water drip into the reagent vessel, it is necessary to drain them completely.3. Check the drainage sieve and the curved drainage in the inside of the instrument (→ "Fig. 97-2") for clogs and clean them as described in (→ p. 113 – 7.12 Water drainage) and (→ p. 114 – 7.13 Water drain hose), if necessary. 4. If the blocked water drains, the previously removed rinsing water vessels, reagent vessels and racks can be placed back on their original positions.Caution Please note that the covers of previously covered reagent vessels must be removed before closing the instrument cover again.5. Close the instrument cover and confirm the message (→ "Fig. 118") by pressing "OK".Fig. 118 Warning If the blockage cannot be removed by the user and if the water level in the drain pan remains at a critical level, all racks must be removed from the instrument. The report (→ "Fig. 119") on the screen regarding the removal of the rack must be observed. This message appears after closing the instrument cover, after the instrument has identified that the blockage cannot be removed. It is to be noted that the programs are no longer bootable and the responsible Leica service organization is to be notified.Fig. 119
135HistoCore SPECTRA STInstrument Components and Specifications 99. Instrument Components and Specifications9.1 Optional instrument componentsFig. 121 Transfer module for racksFor use in the HistoCore SPECTRA ST, for transferring samples to a connected robotic coverslipper HistoCore SPECTRA CV.This module is required when integrating a robotic coverslipper HistoCore SPECTRA CV to a workstation. It transfers the specimen slide automatically from the HistoCore SPECTRA ST staining machine into the HistoCore SPECTRA CV robotic coverslipper.Order No. 14 0512 473959.2 Optional accessoriesDesignation Order No.Exhaust hose, 2 m 14 0512 54365Active carbon filter set (2 pcs.) 14 0512 53772Replacement filter for oven air filter (3 pieces) 14 0512 54943Outlet hose, 2 m 14 0512 55279Supply hose 14 0474 32325Reagent vessel, assembly, including reagent vessel cover 14 0512 47086Water connection kit with filter, consisting of:2 pc. supply hoses, 10 mm, 2.5 m1 pc. pressure hose 3, 1.5 m extension1 pc. Y-piece G3/41 pc. double nipple G3/4 G3/81 pc. filter housing1 pc. filter cartridge1 pc. bushing G3/41 pc. blind cap G3/41 pc. gasket1 pc. single-head wrench SW30 DIN89414 0512 4932414 0474 3232514 0512 4933414 3000 0035114 3000 0035014 0512 4933114 0512 4933214 3000 0036014 3000 0043414 0512 5477214 0330 54755Transfer module for racks 14 0512 47395Insert for special dyes 14 0512 49261Rinsing water vessel, blue, assembly 14 0512 47087Molykote 111 grease, 100 g 14 0336 35460
136 Version 1.3, Revision J Instrument Components and Specifications9Designation Order No.Set of label covers for the input and output drawers (10 blank, 5 each of "H2O"=water, "A"=alcohol and "S"=solvent, e.g. xylene)14 0512 55161O-rings 7x2, for rinsing water vessel connecting piece (12 pcs. per package) 14 0253 54716Rack for 30 specimen slides* (3 pcs. per package) 14 0512 52473Rack 5 specimen slides* (3 pcs. per package) 14 0512 52475Handle for rack for 30 specimen slides* (yellow, 3 pcs. per package) 14 0512 52476Handle for rack for 30 specimen slides* (light blue, 3 pcs. per package) 14 0512 52477Handle for rack for 30 specimen slides* (dark blue, 3 pcs. per package) 14 0512 52478Handle for rack for 30 specimen slides* (pink, 3 pcs. per package) 14 0512 52479Handle for rack for 30 specimen slides* (red, 3 pcs. per package) 14 0512 52480Handle for rack for 30 specimen slides* (light green, 3 pcs. per package) 14 0512 52481Handle for rack for 30 specimen slides* (black, 3 pcs. per package) 14 0512 52482Handle for rack for 30 specimen slides* (gray, 3 pcs. per package) 14 0512 52483Handle for rack for 30 specimen slides* (white, 3 pcs. per package) 14 0512 52484Handle for rack 5 specimen slides* (yellow, 3 pcs. per package) 14 0512 52494Handle for rack 5 specimen slides* (light blue, 3 pcs. per package) 14 0512 52495Handle for rack 5 specimen slides* (dark blue, 3 pcs. per package) 14 0512 52496Handle for rack 5 specimen slides* (pink, 3 pcs. per package) 14 0512 52497Handle for rack 5 specimen slides* (red, 3 pcs. per package) 14 0512 52498Handle for rack 5 specimen slides* (light green, 3 pcs. per package) 14 0512 52499Handle for rack 5 specimen slides* (black, 3 pcs. per package) 14 0512 52500Handle for rack 5 specimen slides* (gray, 3 pcs. per package) 14 0512 52501Handle for rack 5 specimen slides* (white, 3 pcs. per package) 14 0512 52502Note • Information about the available Leica reagent kits and validated Leica programs can be requested from the responsible Leica sales organization.• Furthermore, instructions for use is provided with each Leica reagents kit, in which a supply source is specified for the import of validated Leica programs.Fig. 122 Outlet hoseLength: 2 mOrder No. 14 0512 55279
137HistoCore SPECTRA STInstrument Components and Specifications 9Fig. 123 Supply hose for rinsing waterLength: 2.50 m assembly with 3/4" connection for water tap, incl. replacement sealOrder No. 14 0474 32325Fig. 124 Water connection kit with filterOrder No. 14 0512 49324Consisting of:Supply hose, 10 mm, 2.5 m 14 0474 32325Extension hose, 1.5 m 14 0512 49334Y-piece G3/4 14 3000 003512x G3/4 G3/8 double nipple 14 3000 00350Water filter housing 14 0512 49331Filter cartridge 14 0512 49332Bushing G3/4 14 3000 00360Blind cap G3/4 14 3000 00434Gasket 14 0512 54772Single-head wrench SW30 DIN894 14 0330 54755Fig. 125 Exhaust hoseLength: 2 mOrder No. 14 0512 54365
138 Version 1.3, Revision J Instrument Components and Specifications9Fig. 126 Active carbon filter1 set, consisting of 2 pcs.Order No. 14 0512 53772Fig. 127 Reagent vesselAssembly, incl. reagent vessel coverOrder No. 14 0512 47086Fig. 128 Rinsing water vesselassemblyOrder No. 14 0512 47087
139HistoCore SPECTRA STInstrument Components and Specifications 9Fig. 129 Insert for special dyes(only for racks designed for up to 5 specimen slides)Order No. 14 0512 49261Fig. 130 Racks30 specimen slides, (3 pcs. per package)Order No. 14 0512 52473Fig. 131 Handle for rack30 specimen slides, (3 pcs. per package)Color Order No.:yellow 14 0512 52476light blue 14 0512 52477dark blue 14 0512 52478pink 14 0512 52479red 14 0512 52480light green 14 0512 52481black 14 0512 52482gray 14 0512 52483white 14 0512 52484
140 Version 1.3, Revision J Instrument Components and Specifications9Fig. 132 Racks5 specimen slides, (3 pcs. per package)Order No. 14 0512 52475Fig. 133 Handle for rack5 specimen slides, (3 pcs. per package)Color Order No.:yellow 14 0512 52494light blue 14 0512 52495dark blue 14 0512 52496pink 14 0512 52497red 14 0512 52498light green 14 0512 52499black 14 0512 52500gray 14 0512 52501white 14 0512 52502
141HistoCore SPECTRA STWarranty and Service 1010. Warranty and ServiceWarrantyLeica Biosystems Nussloch GmbH guarantees that the contractual product delivered has been subjected to a comprehensive quality control procedure based on the Leica in-house testing standards, and that the product is faultless and reflects all technical specifications and/or agreed characteristics. The scope of the warranty is based on the content of the concluded agreement. The warranty terms of your Leica sales organization or the organization from which you have purchased the contractual product shall apply exclusively. Service information If you are in need of technical customer support or spare parts, please contact your Leica representative or the Leica dealer where you purchased the instrument.Please provide the following information on the instrument: • Model name and serial number of the instrument. • Location of the instrument and name of a contact person. • Reason for the service call. • The delivery date of the instrument.
142 Version 1.3, Revision J Decommissioning and disposal1111. Decommissioning and disposalCaution The instrument or parts of the instrument must be disposed of according to existing applicable, local regulations. All objects contaminated with spilled reagents must be disinfected immediately with a suitable disinfectant to prevent spreading to other areas of the lab or to lab personnel.Please refer to the (→ p. 108 – 7. Cleaning and Maintenance) Chapter as well as the Decontamination Confirmation (→ p. 143 – 12. Decontamination Confirmation) Chapter at the end of these Instructions for Use in order to find information about cleaning the HistoCore SPECTRA ST stainer.The instrument can be contaminated when using biohazardous specimens. Thorough disinfecting is required before re-commissioning or disposal (e.g. multiple cleaning steps, disinfection or sterilization). Dispose of the instrument in compliance with the applicable laboratory specifications.Contact your Leica representative for more information.Instrument components such as the computer, monitor, etc. that are labeled with the crossed-out dust bin are affected by the European Directive 2002/96/EC for Waste Electrical and Electronic Equipment (WEEE) of the European Parliament and the Council of January 27, 2003.These objects must be disposed of via the collection points in accordance with the local regulations. More information on disposal of the instrument can be obtained from your local disposal company or your local Leica support staff.
143HistoCore SPECTRA STDecontamination Confirmation 12 12. Decontamination ConfirmationEvery product that is returned to Leica Biosystems or that requires on-site maintenance must be properly cleaned and decontaminated. You can find the dedicated template of the decontamination confirmation on our website www.LeicaBiosystems.com within the product menu. This template has to be used for gathering all required data.When returning a product, a copy of the filled and signed confirmation has to be enclosed or passed on to the service technician. The responsibility for products that are sent back without this confirmation or with an incomplete confirmation lies with the sender. Returned goods that are considered to be a potential source of danger by the company will be sent back at the expense and risk of the sender.
144 Version 1.3, Revision J AppendixAppendix 1 - Compatible reagentsCaution • Using non-listed reagents (e.g. acetone or solutions containing phenol) or reagents and acids in higher concentration than described can cause specimens to be destroyed, operators to be injured or the instrument to be damaged. Use the instrument in this way at your own risk. Leica Biosystems or affiliated sales and service organizations shall not assume any warranty claims or liability.• Flammable reagents and solvents must not be heated for fire and explosion protection reasons. Keep away all ignition sources when handling flammable solvents and reagents.Note All Leica reagents for preinstalled Leica programs have been tested with the instrument for staining quality and compatibility of materials.Staining method or reagent group Reagent name NotesH&E kit Leica Infinity ST HemalastST HematoxylinST DifferentiatorST BluingST EosinLeica SelecTech Hemotoxylin 560Hemotoxylin 560MXDefine MX-aqBlue Buffer-8Y515 Alcoholic EosinY515LT Alcoholic Eosin515 Eosin TrichromeEosin PhloxineOther H&E reagentsLeica Gill II HematoxylinGill III HematoxylinHarris HematoxylinMayer's HemalaunLeica Alcoholic EosinAqueous Eosin (1 %)Leica Scott's Tap Water SolutionLeica Acid Alcohol 0.5 %Leica Acid Alcohol 1.0 %User-defined Hydrochloric Acid 2 %PAS Leica Periodic Acid 0.5 %User-defined Periodic Acid (up to 10 %)Leica Schiff's ReagentDiastase-PAS Leica Diastase solution (37 °C)
145HistoCore SPECTRA STAppendixStaining method or reagent group Reagent name NotesAlcian Blue-PAS Leica Alcian Blue-SolutionAlcian Blue LeicaAlcian Blue and other Staining MethodsLeica Nuclear fast RedGomori Trichrome Blue and Green Collagen StainingLeica Weigert Hematoxylin (A+B Solution)Gomori Trichrome Blue Stain1 % Acetic AcidLight greenPerl's Iron StainingLeica Potassium ferrocyanide solutionHydrochloride Acid Solution• Must not come into contact with metal ions• Only for use with coated 5 series rack handlesGiemsa Leica Methanol Solution AStain 1 Solution BStain 2 Solution CBuffer Solution DCongo Red Amyloid StainLeica Congo Red SolutionLeica 1 % Potassium Hydroxide SolutionUser-defined Saturated Lithium Carbonate SolutionAlcian Yellow for Helicobacter PyloriLeica Alcian Yellow-Solution (0.25 % Alcian Yellow)5 % Periodic Acid5 % Sodium Metabisulfite6.8 pH Sorensen BufferToluidin Blue SolutionElastic Stain/Verhoeff's van GiesonLeica 5 % Alcoholic Hematoxylin10 % Ferric ChlorideLugol's Iodin Solution2 % Ferric ChlorideVerhoeff's Staining SolutionVan Gieson's Stain
146 Version 1.3, Revision J AppendixStaining method or reagent group Reagent name NotesGomori Methenamine Silver StainLeica Modified Chromic Acid (up to 5 %)Methenamine Borax0.5 % Silver Nitrate1 % Sodium Bisulfate1 % Gold Chloride2 % Sodium ThiosulfateLight green•• Must not come into contact with metal ions• Only for use with coated 5 series rack handlesPapanicolaou (PAP)Leica EA-50Leica Orange G-6Leica EA-65 (Secondary Counter Stain)Schmorl's ReductionSchmorl's Solution • Only for use with coated 5 series rack handles(Müller) Colloidal IronColloidal Iron SolutionFerrocyanide-Hydrochloric Acid Solution• Only for use with coated 5 series rack handlesOther reagents User-defined Anilin BlueUser-defined Methylene BlueUser-defined Fast GreenUser-defined CarminUser-defined Southgate or Mayer's MicicarmineUser-defined Neutral RedUser-defined Safranin
147HistoCore SPECTRA STAppendixStaining method or reagent group Reagent name NotesSolvent Leica/user-defined Xylene, TolueneLeica Leica Ultra ST Xylene Substitute based on Alipahtic HydrocarbonsLeica Leica Clearene Limonene based Xylene SubstituteMerck Merck Neo-Clear Xylene Substitute based on Alipahtic HydrocarbonsCarl Roth Roti®-Histol Limonene based Xylene SubstituteRichard-Allen Scientific/Thermo ScientificClear-Rite 3 Xylene Substitute based on Alipahtic HydrocarbonsRichard-Allen Scientific/Thermo ScientificCitrus Clearing Solvent Limonene based Xylene SubstituteAlcohol Leica/user-defined 2-Propanol (Isopropanol)Leica/user-defined EthanolMethanolRichard-Allen Scientific/Thermo ScientificDehydrant Ethyl Alcohol, Methyl AlcoholRichard-Allen Scientific/Thermo ScientificFlex Isopropyl, Alcohol, Methyl AlcoholUsual Acids (Max. Concentration)User-defined Acetic Acid (up to 15 %)Hydrochloric Acid (up to 5 %)Piric Acid (up to 3 %)
148 Version 1.3, Revision J Notes
www.LeicaBiosystems.comVersion 1.3, Revision J - 01.2017Leica Biosystems Nussloch GmbHHeidelberger Str. 17 - 19D-69226 Nussloch, GermanyGermanyPhone: +49 - (0) 6224 - 143 0Fax: +49 - (0) 6224 - 143 268Web: www.LeicaBiosystems.com

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