Leica EG1150 H Instructions For Use V 2.5 RevF
Instructions for UseLeica EG1150 HParaffin Embedding StationLeica EG1150 H V 2.6, English 07/2016Order No.: 14 0388 81101 RevIAlways keep this manual with the instrument.Read carefully before working with the instrument.
IMPORTANT NOTEThe information, numerical data, notes and valuejudgments contained in this manual representthe current state of scientific knowledge andstate-of-the-art technology as we understand itfollowing 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 withthe national legal system as applicable in eachindividual case, we shall not be held liable forerroneous statements, drawings, technical illustrations etc. contained in this manual. In particular, no liability whatsoever is accepted for anyfinancial loss or consequential damage causedby or related to compliance with statements orother information in this manual.Statements, drawings, illustrations and otherinformation regarding the contents or technicaldetails of the present Instructions for Use arenot to be considered warranted characteristicsof our products.These are determined only by the contractprovisions agreed between ourselves and ourcustomers.Leica reserves the right to change technicalspecifications as well as manufacturing processes without prior notice. Only in this way is it possible to continuously improve the technology andmanufacturing techniques used in our products.This document is protected under copyright laws.All copyrights to this documentation are held byLeica Biosystems Nussloch GmbH.Any reproduction of text and illustrations (or ofany parts thereof) by means of print, photocopy,microfiche, web cam or other methods – including any electronic systems and media – requiresexpress prior permission in writing by Leica Biosystems Nussloch GmbH.For the instrument serial number and year ofmanufacture, please refer to the nameplate onthe back of the instrument. Leica Biosystems Nussloch GmbHIssued by:Leica Biosystems Nussloch GmbHHeidelberger Str. 17 - 19D-69226 NusslochGermanyPhone: 49 (0)62 24 143-0Fax: 49 (0)6224 143-268Internet: http://www.LeicaBiosystems.comAssembly contracted to Leica Microsystems Ltd. ShanghaiLeica EG1150 H – Paraffin Embedding Station3
Table of contents1. Important Information. 51.11.21.31.4Symbols in the text and their meanings. 5Intended use of instrument. 6Qualification of personnel. 6Instrument type. 62. Safety. 72.12.22.33.Safety notes. 7Warnings. 8Integrated safety devices. 9Instrument Components and Specifications. 103.13.23.3Technical data. 10Overview — instrument components. 11Instrument specifications. 124. Instrument Setup. 134.14.24.34.44.54.6Unpacking and installation. 13Location conditions. 14Delivery range. 15Necessary assembly work. 16Optional accessories. 18Electrical connection. 195.Operation. 206.Maintenance and Cleaning. 327.Troubleshooting. 345.15.25.35.45.55.66.16.27.17.2Instrument parts/functions. 20Switching the instrument on. 25Control panel functions. 26Operating modes. 27Time-program control. 28Instrument heater. 30Cleaning the instrument. 32Maintenance instructions. 33Possible faults. 34Changing a fuse. 378. Warranty and Service. 399.Decontamination Certificate (Master). 404Instructions for Use V 2.6 RevI – 07/2016
1. Important Information1.1 Symbols in the text and their meaningsWarningsappear in a gray box and are markedby a warning triangle .Notes,i.e. important user information appearin a gray box and are marked by an information symbol.Solvents and reagents that are inflammable are marked with this symbol.This warning symbol indicates the surfaces on the instrument that are hotduring operation.Avoid direct contact to prevent risk ofburning.(5)ENTERFigures in brackets refer to item numbers in figures.Function keys that have to be pressedon the input screen, are displayed inbold type and capital letters.ManufacturerObserve the Instructions for UseDate of manufactureThis product fulfills the requirementsof the Council's Directive 98/79/ECconcerning in vitro diagnostics (IVD)medical devices.Leica EG1150 H – Paraffin Embedding StationREF SNEnvironmental protection symbol of theChina RoHS directive. The number inthe symbol indicates the "Environmentfriendly Use Period" of the product. Thesymbol is used if a substance restrictedin China is used in excess of the maximum permitted limit.Symbol for labeling electrical and electronic equipment in accordance with Section 7 of the German Electrical and Electronic Equipment Act (ElektroG). ElektroGis the law regarding the sale, return andenvironmentally sound disposal of electrical and electronic equipment.Order No.Serial numberSymbol for alternating currentTip-n-Tell indicator to monitor whether the shipment has been transportedand stored in upright position according to your requirements. With a pitchof 60 or more, the blue quartz sandflows into the arrow-shaped indicatorwindow and sticks there permanently. Improper handling of the shipmentis immediately detectable and can beproven definitively.In the Shockwatch system, a precisionglass tube shows shocks or impactsthat are above a specified intensitythrough red coloration. Exceeding adefined acceleration (g value) destroysthe surface tension of the liquid in theinterior of the tube. This causes theindicator tube to change color.5
1.Important Information1.2 Intended use of instrumentThe Leica EG1150 H is a modern paraffin embedding station with microprocessor control system.It is designed for embedding histological tissue specimens in molten paraffin for use in pathology laboratories and only for the following tasks: Melt solid paraffin for sample embedding and maintain the molten paraffin at the requiredtemperature. Pour paraffin into embedding molds where the specimens are placed. Heat and maintain the temperatures of embedding cassettes with specimens and molds aswell as the required forceps.Any other use of the instrument will be considered as improper use!1.3 Qualification of personnel The Leica EG1150 H may be operated by trained laboratory personnel only. All laboratory personnel designated to operate this instrument must read these Instructionsfor Use carefully and must be familiar with all technical features of the instrument beforeattempting to operate it.1.4 Instrument typeAll information provided in these Instructions for Use applies only to the instrumenttype indicated on the cover page.A name plate with the serial number is attached to the back of the instrument.Fig. 1 is provided as an example onlyand shows a valid nameplate for thisinstrument with the necessary information about instrument type andpower requirement. The precise datafor the various versions is specified inChapter 3.1, "Technical data".6Fig. 1Instructions for Use V 2.6 RevI – 07/2016
2. SafetyThe 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 otherLeica products.2.1 Safety notesThese Instructions for Use include importantinstructions and information related to the operating safety and maintenance of the instrument.The Instructions for Use are an important part ofthe product, and must be read carefully prior tostartup and use and must always be kept nearthe instrument.This instrument has been built and tested inaccordance with the safety requirements forelectrical equipment for measurement, control,and laboratory use.To maintain this condition and ensure safeoperation, the user must observe all notes andwarnings contained in these Instructions for Use.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 protective devices on the instrument and its accessories must not be removed or modified.Only service personnel qualified by Leica may repair the instrument and access the instrument's internal components.Use only the provided power cable - this must not be replaced with a different power cable.If the power plug does not fit in your socket, contact our service.Residual risksThe instrument has been designed and constructed with the latest state-of-the-art technologyand 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 can cause damage to the instrument or other property. The instrument may be used onlyas intended and only if all of its safety features are in proper working condition. Malfunctionsthat impede safety must be remedied immediately.For current information about applicable guidelines, please refer to the CE declaration of conformity and on our Internet site at:http://www.LeicaBiosystems.comLeica EG1150 H – Paraffin Embedding Station7
2.Safety2.2 WarningsThe safety devices installed in this instrument by the manufacturer only constitute the basis foraccident 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 followinginstructions and warnings.Warnings – Safety notes on the instrument itselfSafety notes on the instrument itself, which are marked with a warning triangle, indicate thatthe correct operating instructions (as defined in these Instructions for Use) must be followedwhen operating or replacing the item marked. Nonobservance can cause accidents, injuriesand/or damage to the instrument/accessories.Certain surfaces of the instrument are hot during operation under normal conditions.They are marked with this warning sign. Touching these surfaces can cause burns.Safety instructions - transport and installation After unpacking the instrument it may only be transported in an upright position. Place the instrument on a laboratory table and adjust it to a horizontal position. The instrument must not be exposed to direct sunlight (window)! Plug the instrument only into a grounded power socket. The protective effect may not beeliminated by an extension cable without a protective grounding conductor. The instrument automatically recognizes the applied voltage/frequency. The installation location must be well-ventilated; there should be no ignition sources thereof any kind. The instrument may not be operated in hazardous locations. Extreme temperature fluctuations between storage facility and setup site as well as high humidity may cause condensation to form. In this case, wait at least two hours beforeswitching on.8Instructions for Use V 2.6 RevI – 07/2016
2. SafetySafety instructions - working with the instrumentParaffin is flammable and should therefore be handled with due care. Do not use sharp tools toremove solidified paraffin from the work areas, as this may destroy the coating on the surface.Use the plastic spatula supplied with the instrument.During operation, the paraffin reservoir, embedding mold tray, cassette tray, work area as wellas the forceps holder are hot.Risk of burning!Do not store any combustible and flammable substances near the instrument. There is a firehazard if work with an exposed flame (e.g. Bunsen burner) is carried out in the direct vicinityof the instrument (solvent vapors). Therefore, keep all ignition sources at least 2 meters awayfrom the instrument!Hazards - servicing and cleaningSwitch off the instrument each time before servicing and pull out the power plug.When using cleaners, please comply with the safety instructions of the manufacturer and thelaboratory safety regulations.Before changing defective fuses, the instrument has to be disconnected from the power supply.Only fuses that are easily accessible may be replaced by the user.Liquid must not get into the instrument while operating or cleaning it.2.3 Integrated safety devicesThe instrument is equipped with the following safety features and devices:Fuses in the heating elementsAll of the instrument's heating elements are equipped with overheating fuses, which trip if aheating element overheats and switch the element off.Automatic circuit breaker in standby switchAn automatic circuit breaker is located in the standby switch. This circuit breaker separates thepower electronics from the power supply in the event of a short-circuit.In this case, the standby switch jumps to the position "0" Off.Note that the only way the user has for complete disconnection from the power supply is disconnection of the power plug.Leica EG1150 H – Paraffin Embedding Station9
3.Instrument Components and Specifications3.1 Technical dataGeneral dataApprovals: The instrument-specific approval marks are located onthe rear panel of the instrument next to the type plate.Voltage of power supply:100-120 V, 50/60 Hz230-240 V, 50/60 HzPower consumption:1100 VAProtection class1:I1Pollution degree :2Overvoltage category:IIOperating temperature range: 18 C to 40 COperating temperatures:55 C to 70 C, adjustable in 5 K increments.Relative humidity:Max. 60 % non-condensing.1)according to IEC-1010, UL 3101, EN 61010FusesStandby switch: Circuit breaker manufactured by ETA, model3120-F421-P7T1-W01D-5AFine-wire fuses 6.3 x 32 mm:2x T2.0 A; 2x T4.0 A; 4x T5.0 A; 2x T6.25 AFuse type:Schurter: Type FstDimensions and tiesParaffin reservoir:Cassette tray:Embedding mold tray:Programmable parametersTemperature:Time:10360 mm500 mm640 mmApprox. 22 kgApprox. 3 lApprox. 100 cassettesApprox. 50 embedding moldsParaffin reservoir/dispenser(heating-up time 4 h)Embedding mold tray, cassette tray, work topWorking day, current weekdayWorking times (start, end), current timeInstructions for Use V 2.6 RevI – 07/2016
3. Instrument Components and Specifications3.2 Overview — instrument componentsStandbyswitchParaffin reservoirwith lidControl panelWork area illuminationDispenserLidCassette trayCassette trayForceps holderWork areaLidEmbeddingmold trayEmbeddingmold trayCooling spotParaffin collection trayleftParaffincollection trayrightFig. 2Leica EG1150 H – Paraffin Embedding Station11
3.Instrument Components and SpecificationsInstrument rear viewSecondary fusesF1-F3SecondaryfusesF4-F5Heat sinkPort for power cordPort forfoot switchSliding elementsFig. 33.3 Instrument specifications Paraffin reservoir with a capacity of 3 liters. The paraffin flow is activated by means of a height-adjustable, pivotable clip - activated eithermanually by the mold or a foot switch (optional). Controllable flow rate. Removable, heatable (indirectly, via the work surface) paraffin collection trays. Spacious, easy-to-clean, heated work area, with integrated cooling spot, also for extra large cassettes ("Super Mega Cassettes") with paraffin drain system. Trays for cassettes and/or molds with sliding lid, removable and interchangeable. Removable, heated forceps holder for 6 forceps, accessible from both sides. Optimum illumination of the work surface by the individual adjustable LED lamp. Temperature range of cassette and embedding mold tray, work area and paraffin reservoir adjustable from 55 C to 70 C. Permanent temperature display for all the work areas. The beginning and end of the work time and work days can be programmed.12Instructions for Use V 2.6 RevI – 07/2016
4. Instrument Setup4.1 Unpacking and installationWhen the instrument is delivered, check the tilt indicators on the packaging.If the arrowhead is blue, the shipment was transported laying flat, was tilted attoo great an angle or fell over during transport.Note this on the shipping documents and check the shipment for possible damage.1243These unpacking instructions onlyapply if the box is placed with the symbolsfacing upwards for unpacking.1. Remove the packing strap and the adhesivetape (1).2. Remove the carton lid (2).3. Lift up and remove the accessories (3) andinside cover (4).4. Remove the outer carton wall (5).53Fig. 4Leica EG1150 H – Paraffin Embedding Station13
4.Instrument Setup8676Fig. 55. In order to lift the instrument (6) take hold ofit only at the lower housing base in the frontand rear (arrow in the detail for Fig. 5) and liftit off of the bottom pad and out.Important!Lifting the instrument by the dispenser(7) or paraffin reservoir (8) can causeserious damage.The packaging must be retained for the duration of the warranty period. To return the instrument, follow the instructions above in reverse order.4.2 Location conditions Stable, vibration-free laboratory table withhorizontal, flat table top, as far as possiblevibration-free ground. The instrument must not be placed in thevicinity of the air outlet of an air conditionerand must be shielded from strong sunlight(window). To ensure a fully functional heat sink, theremust be gap of at least 15 cm behind the instrument. The vicinity of the work area must be free ofoil and chemical vapors.The installation location must be well-ventilated and free of ignition sources of any kind. Theinstrument should not be operated in hazardous locations.14Instructions for Use V 2.6 RevI – 07/2016
4. Instrument Setup4.3 Delivery rangeThe standard equipment for the Leica EG1150 H contains the following components:1 basic unit Leica EG1150 H2211112cassette or embedding mold trays, removablelids for cassette or embedding mold trayslid for paraffin reservoirparaffin scraperforceps holder, removablefilter screen with holderparaffin drip trays14 0388 3252214 0388 3248014 0388 3314814 0388 3313314 0388 3249714 0388 3220814 0388 381381 set of spare fuses:14 0388 463352 fuses T 2.0 A2 fuses T 4.0 A, 6 x 324 fuses T 5.0 A, 6 x 322 fuses T 6.25 A, 6 x 321 Instructions for Use bundle Leica EG1150 H (Instructions for Use & language CD)14 6000 0147914 6000 0148014 6000 0148114 6000 0148214 0388 81001The country specific power cord needs to be ordered separately. Please find a list of all powercords available for your device on our website www.LeicaBiosystems.com within the productsection.Please compare the delivered components against the packing list, delivery note, and your order. Should there be any discrepancy, please contact the Leica distributor handling your order.Leica EG1150 H – Paraffin Embedding Station15
4.Instrument Setup4.4 Necessary assembly workInstall the following accessories and make the appropriate adjustments tomake the instrument ready for use: Install accessories.Adjust instrument feet if necessary.Install magnifier (optional).Connect foot switch (optional).Connect to the power supply.Install accessories Install embedding mold tray (2) and cassette tray (3).Depending on the preferred working direction, the two heated trays (11)can be used for molds or cassettes as required. Close mold/cassette tray with the corresponding lids (4), (5). Push the paraffin collection tray (6) into the respective guide u nderneaththe work top. Insert the forceps holder (1). Insert the filtering screen (7) in the paraffin outlet hole (8) inside theparaffin reservoir so that the black O-ring seals the hole. Place the lid (9) on the paraffin reservoir.Adjustable instrument feetThe four feet are height-adjustable to allow the instrument to be adjustedto match the height of other devices or to compensate slight depressionson the surface.Lift the instrument slightly and turn the instrument foot (10 in Fig. 6) to adjustit to the proper height.To ensure a safe stand, all of the four feet must be adjusted to the same height.16Instructions for Use V 2.6 RevI – 07/2016
4. Instrument SetupInstalling the accessories 987 45 231111 10 16 6Fig. 6Leica EG1150 H – Paraffin Embedding Station17
4.Instrument Setup4.5 Optional accessoriesMagnifying glassThe magnifying glass provides a magnified view of the work area. Whenproperly adjusted, an enlarged view of the dispenser and cooling spot isavailable.511234543Fig. 7Installing the magnifying glass On the dispenser (5) a tap hole (1) is provided, which is closed with a nylonscrew (2). Remove the screw (2) with a screwdriver and store it in a safe place. Thenscrew the knurled screw (3) of the stand (4) firmly into the tap hole and alignthe magnifier.Foot switchThe foot switch can be used to actuate the dispenservalve, leaving the operator's hands free. To connect and use the foot switch, see Chapter 4.6and 5.1.Fig. 818Instructions for Use V 2.6 RevI – 07/2016
4. Instrument Setup4.6 Electrical connectionThe instrument MUST be connected to a grounded power socket.The instrument is supplied with a set of different power cords. Only the power cord intendedfor the local power supply (socket) may be used.Do not use an extension cord.146235Fig. 9Before connecting the power cord to the foot switch, ensure that the standby switch (1) (control panel, front) is set to "O" ("O" OFF).Connecting the power cord Connect the plug (2) of the power cord to theconnection socket (3) on the rear of the instrument.Connecting the foot switch (optional) Insert the plug (4) of the foot switch into theconnecting port (5) on the rear of the instrument. Plug the power cord into the wall outlet. Tighten the screws (6) of the plug.Leica EG1150 H – Paraffin Embedding Station19
5.Operation5.1 Instrument parts/functions1211Recycled paraffin may NOT be used inthe Leica EG1150 H due to the dangerof contamination.1141313212Fig. 10The flow cannot be stopped completely with the metering screw (11). It mustnot be turned while cold!20Paraffin reservoir (1)The paraffin reservoir has a capacity of approx.3 liters. The paraffin temperature can be set between 55 C and 70 C in 5 K increments. The lidshould always be in place otherwise the adjustedtemperature cannot be maintained.An overtemperature cutout is provided to preventoverheating the paraffin if temperature controlfails.A built-in filtering screen prevents any particlescontained in the paraffin from getting in the paraffin block.Dispenser (2)The dispenser is heated separately. The temperature setting of the dispenser and paraffinreservoir is coupled.The quantity of paraffin released from the fillertube (14) can be adjusted continuously with themetering screw (11).The dispenser handle (12) is used for manuallyoperating the paraffin flow. It is provided witha pressure clip (13). The pressure clip is heightadjustable and can be shifted to the side (left orright) depending whether the dispenser handle isreleased with the mold or the finger .The dispenser handle can be operated by simplypushing the mold (or the finger) against the pressure clip. Slightly pushing the handle backwardswill open the dispenser valve . Once released,the handle flips back in the original position andthe valve shuts.Instructions for Use V 2.6 RevI – 07/2016
5. OperationWork top (3)The temperature of the work top can be adjusted between 55 C and 70 C in 5 K increments.This includes the embedding area, forcepsholder (5) and the cooling spot (4).The working area has a groove around it andseveral drain holes (15), through which excessparaffin rapidly drains.5343Cooling spot (4)The cooling spot is an integral part of the workarea. Its position directly in front of the embedding area enables convenient working inergonomically most favorable conditions.To orientate the samples, the mold is filledabout one third with liquid paraffin. The liquidparaffin begins to solidify rapidly on the cooling spot.While the paraffin is semi-liquid, the samplecan be oriented as required. Finally, the moldcan rapidly be filled up with paraffin.154While orienting the tissue, the paraffin should not become too solid, asthis may cause different phases inthe finished block, including fissuresinside, as a result of which the blockmay break during sectioning.5Fig. 11Forceps holder (5)The removable forceps holder under the dispenser can accommodate up to 6 forceps.The forceps holder is constantly heatedto approximately 70 C.Risk of burning!Leica EG1150 H – Paraffin Embedding Station21
5.OperationParaffin collection tray (8)Two indirectly-heated paraffin collection traysfor excess paraffin are located under the worksurface.76The paraffin collection tray must beemptied daily. To prevent contamination, do not reuse paraffin collected in this tray.If the instrument is operated withoutthe paraffin collection trays there isrisk of burning.881716Fig. 12When working with half-open lids (17),raise the temperature one level to ensurethat the paraffin remains molten.22Embedding mold tray and cassette tray (16)Depending on the preferred working direction, the two heated instrument trays (6, 7)can be used for embedding molds or cassettes. The temperature is adjustable between55 C and 70 C.A removable tray (16) for cassettes or embedding molds can be placed in each instrumenttray.Each receptacle can hold approx. 100 cassettes or approx. 50 molds.A lid (17) is provided for each of the trays (16)to prevent loss of heat and contamination inside the tray. For easy access, the lid can beslid back and folded up.Only operate the cassette and embedding mold tray and paraffin reservoir with lid; otherwise the settemperature cannot be maintained.Instructions for Use V 2.6 RevI – 07/2016
5. OperationStandby switch (
The Leica EG1150 H is a modern paraffin embedding station with microprocessor control system. It is designed for embedding histological tissue specimens in molten paraffin for use in pathol-ogy laboratories and only for the following tasks: Melt solid paraffin for sample embedding and maintain the molten paraffin at the required temperature.
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