Instructions for Use Leica ASP6025 - Advanced Smart Processor Vacuum Tissue Processor Leica ASP6025 V 2.2 English - 08/2013 Order No. 14 0495 80101 RevI Always keep this manual with the instrument. Read carefully before working with the instrument.
WARNING The 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 Instructions for Use periodically and on an ongoing basis according to the latest technical developments, nor to provide our customers with additional copies, updates etc. of these Instructions for Use.
Contents 1. Important Information...............................................................................................................5 1.1 1.2 1.3 1.4 2. Safety...................................................................................................................................... 10 2.1 2.2 2.3 3. Standard delivery - packing list.............................................................................................................................. 16 Technical Data.......
Contents 4.6 4.7 4.8 5. Alarm functions...................................................................................................................................................... 56 Touchscreen functions............................................................................................................................................ 59 Switching off the instrument correctly..................................................................................................................
Contents 5.5.5 5.6 5.6.1 5.6.2 5.6.3 6. Cleaning and Maintenance...................................................................................................... 149 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.2 6.2.1 6.2.2 7. 4 Cleaning programs............................................................................................................................................... 149 View cleaning programs....................................................................................................
1. Important Information 1.1 Symbols in the text and their meanings Dangers, warnings and cautions appear in a gray box and are marked by a warning triangle . Notes, i.e. important information for the user, are highlighted in gray and marked by the symbol. Inflammable solvents and reagents are identified using this symbol. Warning instructions on transport packaging. ON position of a key with click stop OFF position of a key with click stop Manufacturer.
1. Important Information Symbols in the text and their meanings The CSA test mark means that a product has been tested and fulfills the applicable safety and/or performance standards, including the relevant standards defined or administered by the American National Standards Institute (ANSI), Underwriters Laboratories (UL), the Canadian Standards Association (CSA), the National Sanitation Foundation International (NSF) and others.
1. Important Information Example of labeling in accordance with IPPC IPPC symbol Country code in accordance with ISO 3166, e.g. DE for Germany Regional identifier, e.g. HE for Hessen Producer/treatment provider code, unique assigned number starting with 49 Treatment code, e.g. HT (heat treatment), MB (methyl bromide), and possibly DB (debarked) Indicates the temperature range permitted for storing and handling the package.
1. Important Information 1.2 Instrument type All information provided in these Instructions for Use applies only to the instrument type indicated on the cover page. A nameplate indicating the instrument serial number is attached to the rear side of the instrument. The Leica ASP6025 is available in two voltage variants, 120 V and 230 V. Nameplate for voltage variant 230 V. Fig.
1. Important Information 1.4 Intended use of instrument The Leica ASP6025 is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens.
2. Safety 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. 2.1 Safety notes These Instructions for Use includes important 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.
2. Safety Warnings – Markings on the instrument itself Markings on the instrument 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. Some instrument surfaces become hot during operation.
2. Safety Warnings – Operating the instrument • 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. • In an emergency, the instrument can be switched off via the ON/OFF switch located on the rear of the instrument.
2. Safety Warnings – Operating the instrument (continued) • In exceptional situations (e.g. accidental reagent spills), it may be necessary to wear a respirator. This depends on the specific local ambient temperature, room volume, additional load, ventilation rate etc. In case of doubt, the laboratory owner/operator must carry out a local measurement to prove that applicable maximum workplace concentrations are not exceeded.
2. Safety Warnings – Cleaning and maintenance • Before any maintenance, switch off the instrument and unplug it from power supply. • Do not use solvents that contain acetone for cleaning. No liquid may be spilled into the internal components of the instrument – neither during operation nor during cleaning.
2. Safety 2.3 Safety features on the instrument Overpressure protection The Leica ASP6025 tissue processor is equipped with numerous safety functions and with sophisticated software control mechanisms. These ensure that the specimens remain undamaged in the event of a power failure or other malfunction during the infiltration process and that the infiltration is completed successfully.
3. Instrument Components and Specifications 3.1 Standard delivery - packing list The Leica ASP6025 is available in two voltage variants, each of which have a different scope of delivery. 230 V variant 1 Leica ASP6025 basic instrument 230 V. Order No.
3. Instrument Components and Specifications Standard delivery - packing list (continued) Order No.
3. Instrument Components and Specifications 3.2 Technical Data Nominal supply voltages: Nominal frequency: Main fuses: Two factory-preset voltages (not user-adjustable): 120 V + 10 % or 230 V + 10 % 50 to 60 Hz 2 melting fuses, 32 x 6.3 mm, UL-approved • for 120 V; T 15 A 125 VAC • for 230 V; T 10 A 250 VAC Nominal power: 1700 VA for both versions Dimensions, (L x W x H), in mm: 680 x 750 x 1500 Empty weight, unpacked: max. 210 kg Weight, packed: max.
3. Instrument Components and Specifications 3.2 Technical data (continued) Retort Capacity: max. 300 cassettes Reagent volume: 4.
3. Instrument Components and Specifications 3.2 Technical data (continued) Hardware and Software: • Color LCD touchscreen. • User-friendly, intelligent software. • Three USB ports. • Alarm system with two remote alarm sockets. • Password-protected instrument supervisor mode. • Multiple specimen protection system. Capacities: • 20 freely configurable programs, each consisting of up to 12 reagent and 3 paraffin processing steps. • Time per program step: 0 to 23 hours, 59 minutes. • Delay time: max.
3. Instrument Components and Specifications 3.3 Compatible reagents The following reagents may be used in the Leica ASP6025: Fixation Formalin 3.
3. Instrument Components and Specifications 3.4 Overview 24 13 22 7 5 4 21 18.1 18.2 8.2 8.1 5 6 19 11 1 10 3 2 23 25 9 16 9 15 23 12 14 17 12 3 20 Fig. 2 22 Instructions for Use V 2.
3. Instrument Components and Specifications Instrument components 1 2 3 4 5 6 7 8.1 8.
3. Instrument Components and Specifications 3.4.2 Instrument rear panel - terminals 5 31 27 38 26 28 29 30 32 33 36 37 26 Fig.
3. Instrument Components and Specifications 3.4.3 Instrument specifications • • • • • • • Leica ASP6025 The Leica ASP6025 is a modular tissue processor with a Reagent Management System optimized by an integrated measurement sensor (ethanol concentration) that supports consistently high specimen quality and helps to reduce reagent consumption. The concentrations of all ethanols and isopropanols located in the processor are measured and displayed in the REAGENT STATUS submenu.
3. Instrument Components and Specifications Instrument specifications (continued) • • • • • • • • • • • 26 Alternatively, the number of cassettes, number of protocols and days since the last change and the reagents to be replaced can be displayed according to standard laboratory replacement schedule. Reagents are changed by pulling out a drawer with six RTU-bottles. The bottles can then be replaced simply, quickly and without bending down, which is ergonomically more comfortable.
3. Instrument Components and Specifications Instrument specifications (continued) • • • • • • • • • • • Leica ASP6025 Harmful reagent vapors are continuously suctioned back from the infiltration chamber into the instrument and filtered even after the chamber is opened, e.g. to reload cassettes or baskets. All solvent vapors are transferred to the external vacuum extractor via a separate port on the rear of the instrument.
4. Initial Operation 4.1 Unpacking the instrument • Important! • At least TWO persons are required when lifting or carrying the instrument. • The packaging has two indicators (83, 84, Fig. 5) that indicate improper transport. When the instrument is delivered, check this first. If one of the indicators is colored red, the package was not handled as prescribed.
4. Instrument Setup Unpacking the instrument (continued) Removing the transport anchors 85 86 10 • First, remove the additional RTU-bottle (10) out of the transport anchor. • Take out the two transport anchors (86) made of foam (Fig. 6). • Afterwards, the outer sleeve of the packaging (85) must be removed from the pallet (87) by pulling it upwards. Fig. 6 88 89 90 Unpacking and removing the accessories • The carton (89) contains the accessories that are not yet installed in the instrument.
4. Initial Operation Unpacking the instrument (continued) • • • Pull out the two rails (91) for the ramp beneath the instrument by pulling them forwards (Fig. 8). Setting up the ramp 91 Hook these rails on the left and right with the panel (92) into the groove (93) of the pallet so that they are flush with the wooden board (94) that holds the instrument (Fig. 9). 91 91 Fig. 8 While doing so, make sure that the plate (92) is between the two screws (95) in the groove.
4. Instrument Setup Unpacking the instrument (continued) Push the instrument from the pallet (Fig. 11.3) Caution! The instrument castors move very easily. The empty weight of the ASP6025 is 210 kg! Therefore, it is mandatory to have at least TWO persons hold the instrument when it is rolled off the pallet via the ramp. The left and right illustrations show how the instrument must be held when rolled off the pallet via the ramp. 26 26 Fig. 11.2 Fig. 11.
4. Initial Operation Unpacking the instrument (continued) 109 5 98 Installing the monitor • The monitor (5) is wrapped in a plastic dust cover (109) and is placed with the screen facing downwards in a molded foam cushion (98) next to the retort (Fig. 12). • First, take out the two foam parts (107) next to the bracket (Fig. 12). Then you remove the dust cover.
4. Instrument Setup Unpacking the instrument (continued) Installing the monitor • 103 • To do so, lift the monitor out of the foam cushion and insert it with the notch (103) on the rear side into the matching bracket (101) (Fig. 15) and hold it securely in this position. Now remove the screws (100) and washers from the plastic bag. These screws are used to fasten the monitor to the bracket (101). 101 Fig.
4. Initial Operation Unpacking the instrument (continued) Removing the transport anchors • 19 105 • After installing the monitor, you have to remove all transport anchors (adhesive tape and foam parts). First, carefully remove all blue strips of adhesive tape (105) that secure the doors and the drawer of the instrument. 9 9 105 106 Fig. 18 • Fig. 17 • Remove the adhesive tape (105) from the lid of the retort (19) (Fig. 17).
4. Instrument Setup 4.2 Basic instrument/hardware CAUTION! The chemicals used in the Leica ASP6025 are easily inflammable and hazardous to health. Therefore the installation location must be well ventilated, and must contain no open flames. The room in which the instrument is located must not be used as a permanent station for people. Otherwise the room must be equipped with an exhaust device. The installation location must be protected against electrostatic discharge.
4. Initial Operation 4.3 Installing the tube for external exhaust air (optional) The instrument has been designed by the manufacturer so that it can be connected to an external exhaust device. The standard delivery includes the "Flange kit for external ventilation" for this purpose. To do so, set up the instrument so that it is possible to connect the exhaust hose to the external exhaust device.
4. Instrument Setup Installing the tube for external exhaust air (continued) 77 79 77 • Attach the exhaust flange (75) to the fan plate (78 in Fig. 22) and fasten it using the screws that held the plate. • First, screw in all four screws (77) loosely, then tighten them diagonally using the size 3 Allen key (76) to a tightening torque of 0.5 Nm (Figs. 22, 23). Make sure that the fan plate and the flange are flush against each other.
4. Initial Operation 4.4 Connecting the power supply Caution! Observe the following instructions carefully to prevent damage to the instrument: The 120 V voltage version of the instrument (REF 14 0495 43268) requires an electrical power supply with fuse protection of at least 20 A. The instrument MUST be connected to a grounded power socket. The power plug must be easily accessible so that it can be pulled out. The instrument is supplied with a set of different power cords.
4. Instrument Setup 4.4.1 The retort Retort locking • The retort locks automatically when a program is started. • Unlock it by pressing on the unlocking mechanism switch (8.2) below the screen (Fig. 29). • A message box appears on the screen; YES must be entered here to confirm unlocking of the retort while a process is in progress. • When the YES button is pressed (Fig. 29), the reagent vapors are removed by suction, filtered and the fluid level in the retort is lowered.
4. Initial Operation The retort (continued) Fill level sensors Insert the sieve (42) into the drain opening on the floor of the retort. 40 40.4 40.3 42 It is imperative to insert the magnetic stirrer before an infiltration program is started! 40.2 41 40.1 Attach the magnetic stirrer (41) to the axis on the floor of the retort with the little hole facing upwards. Fig. 30 Level sensors (at left in Fig. 31) Every time a program is started (except in CONCENTRATION mode, see Chapter 5.1.
4. Instrument Setup Active carbon filter • 24 To insert/replace the active carbon filter (13), open the flap (24) behind the retort lid. • Push the filter in as far as it will go with the handle facing forwards in the direction of the arrow, as shown in Fig. 32. • The date on which the filter has been inserted can be marked on the label (13.1) on the front side. 13 13.1 Filter label with order No.
4. Initial Operation 4.4.3 Specimen baskets 48 46 • Fig. 34 shows the standard stainless steel basket (48) filled with specimen cassettes. • The dividing spiral (46) is used to align the cassettes in the basket accurately. The dividing spiral is shown in the bottom part of Fig. 34 with the bar for inserting it into the metal basket. • As shown with the dividing spiral, the standard basket can be filled with up to 80 specimen cassettes.
4. Instrument Setup 4.4.4 The monitor • The Leica ASP6025 is programmed and operated via a color LCD touchscreen. • A screen saver will turn off the screen display if no key has been pressed for 30 minutes. Press any part of the touchscreen to restore the screen. After having been restored, the on-screen functions will be nonoperational for a few seconds to avoid accidental activation of any keys.
4. Initial Operation 4.4.5 The paraffin station • • 55 The paraffin station (54) is located behind the left door (53) of the instrument, below the retort (Fig. 37). It ensures that sufficient fresh, liquid paraffin is always available for the paraffin baths. The capacity is 5.0 l of liquid paraffin. There are two marks in the interior of the station that display the minimum fill level when filled with pellets or liquid paraffin (Fig. 38). The level must not fall below these marks.
4. Instrument Setup 4.4.6 The paraffin baths 58 • The instrument has three heated paraffin baths (58), each with a max. capacity of 4.9 l of liquid paraffin. • They are located behind a flap (57) over the reagent compartment with the system bottles (15). To access the flap, open the two lower Plexiglas doors (11, 12). • The individual paraffin baths can be pulled out for filling (Fig. 41) and can also be removed from the compartment for cleaning.
4. Initial Operation • If a paraffin bath has been pulled out, this is indicated by a red border (Fig. 42) and the signal light next to the bath turns red. Each signal light also turns red if the configured temperature is not reached or the melting time has not yet ended. • All paraffin baths have two handles (59) for pulling out and carrying. Two movable covers (60.1 and 60.2) provide for better thermal insulation and prevent the liquid paraffin from sloshing out when being pulled out (Fig. 43). Fig.
4. Instrument Setup 4.4.7 Drawer with RTU-bottles • 61 The drawer (9) with up to six RTU-bottles (10) must be pulled out completely by pulling it forwards, so that it does not slide back - otherwise there is a risk of injury! When fully loaded, the drawer is very heavy. Therefore, always open and close it carefully. NEVER lean on the drawer when it is pulled out. The instrument could tilt forwards and lead to personal injury or damage to the instrument. 9 10 Fig. 44 Detail, Fig.
4. Initial Operation Pull-out drawer with RTU-bottles (continued) • 10 • Seven RTU-bottles (10) are supplied for the drawer with the instrument (Fig. 46) - 6x for tissue infiltration, - 1x for the cleaning process (extended cleaning program by detergent). Each container has a screw plug. Each container has a max. capacity of 5 l. Fig. 46 Only RTU-bottles from Leica are approved for this instrument.
4. Instrument Setup Pull-out drawer with RTU-bottles (continued) • The RTU-bottles are displayed in the SMART SCREEN in a separate area on the screen. They are designated "D1" to "D6" (Fig. 48). • Additionally, the RTU-bottles can be emptied using the remote drain system. • The hose for the remote fill and drain system can also be stored in the drawer. Fig.
4. Initial Operation 4.4.8 Reagent cabinet with system bottles 14 The nine white plastic system bottles (15) are located together with the blue condensate bottle (14) in the reagent cabinet under the three paraffin baths (Fig. 49). • To access the system bottles, open the two lower Plexiglas doors (11, 12). The system bottles are designated "S1" to "S9" and are combined in a separate area on the screen (Fig. 50). The condensate bottle, designated "C", is on the left. • 15 12 11 • Fig. 49 Fig.
4. Instrument Setup Reagent cabinet with system bottles (continued) Condensate bottle • The condensate bottle (14, Fig. 52) has the exact same shape and connection design as the system bottle. The difference is that it is made of blue plastic. • It captures and collects condensate that forms in the system. A mark for the maximum level is on the front side. • Regularly check and empty the condensate bottle (once a week) (see Chapter 6.2.2). • The drip tray (16) is located below the reagent cabinet.
4. Initial Operation 4.4.10 Adhesive labels for system bottles and RTU-bottles The standard delivery of the ASP6025 includes two sets of adhesive labels. This includes: • 20 x labels for the system bottles in the reagent cabinet. • 10 x labels for the RTU-bottles in the drawer. Labels for system bottles (Fig. 54) Fig. 54 The labels for system bottles come in eight different colors. The colors are adapted to the selectable color palette for the individual reagent groups in the instrument.
4. Instrument Setup Labels for RTU-bottles (Fig. 56) The labels for the RTU-bottles in the drawer come in the same eight colors as for the system bottles. The label has filling level marks for the RTU-bottles printed on it, therefore it must be applied with particular care. Caution! The specified filling level marks (5.0 l and 3.8 l) are valid only for the RTU-bottles included in the delivery package. If other containers are used, the specified fill volumes on the label will not agree. Fig.
4. Initial Operation 4.5 Switching the instrument on • Plug the power cable (39, Fig. 26) into the "POWER IN" socket on the rear side of the instrument. • Then, connect the cable to the power socket. If applicable, switch on the switch for the power socket. • To switch on the instrument, press in the ON/OFF switch an on the rear panel of the instrument (item 37 in Fig. 26). • The instrument will take a few minutes to initialize after switching on.
4. Instrument Setup The SYSTEM DIAGNOSTICS menu 1 2 3 4 5 6 7 8 Touch the button that reads TOUCH HERE TO ENTER . . . in the lower right hand corner during initialization (Fig. 58). This takes you to the SYSTEM DIAGNOSTICS menu (Fig. 60). This menu provides access to basic instrument settings. Fig. 60 Caution! Only experienced operators may adjust the settings in this menu, since incorrect use of the functions can result in serious malfunctions.
4. Initial Operation 4.6 Alarm functions In the ASP6025, states can occur that require the attention of, or a decision on the part of, the user. In the simplest case, these are confirmations for continuing in the infiltration program. In addition, however, during continuous monitoring of the hardware, errors can be identified that must be eliminated as soon as possible for a running infiltration program to be finished successfully. Correspondingly, all messages are classified according to their severity.
4. Instrument Setup Alarm functions (continued) Local alarm This alarm is external to the Leica ASP6025, e.g. in the office of an instrument operator. The local alarm is used when the instrument cannot continue with the current program or operation because of a problem. If the instrument alarm is ignored for a programmed time (YES button not pressed), the ASP6025 also triggers a local alarm. An output is wired for the local alarm. The polarity of the output wiring is configurable in the SYSTEM SETUP menu.
4. Initial Operation Connecting the local and remote alarm system Connection of an external alarm system (local or remote alarm) is absolutely necessary for preventing damage to or loss of tissue samples in the event of a malfunction. The alarm systems for the local alarm and the remote alarm are connected via a 3-pole stereo jack. Connect the local or remote alarm system to the appropriate sockets (32, 33 in Fig. 3) using the 3-pole stereo jack provided (66) (Ø 6.3 mm).
4. Instrument Setup 4.7 Touchscreen functions 34 The Leica ASP6025 is operated via a color LCD touchscreen. This touchscreen is resistant to reagents and responds even if the operator is wearing laboratory gloves. Activating critical functions usually triggers a prompt that must be confirmed before the function is carried out. This allows the operator to undo changes caused by accidental key strokes. Fig. 64 Status Bar The blue bar at the top of the screen is called the status bar (34).
4. Initial Operation Functions of the touchscreen (continued) Button symbols Examples: Press the corresponding button symbol to enable functions on the touchscreen. Button symbols may contain graphical icons or text labels. Stop Stirrer Start Stirrer Some button symbols change color from blue to orange to indicate that a certain function is active. See example to the left.
4. Instrument Setup Functions of the touchscreen (continued) Selecting multiple items (Multiselect) in tables Multiselect active not active In the following tables, it must be possible to select multiple table rows simultaneously. Here, the listed functions for the following selected rows are to be executed: Table Function View/ edit user programs Clear, Reagent name Reagent status View/ edit user programs 0 %, 100 %, set to zero Duration, P/V Reagents Fig. 65 The keyboard The keyboard (Fig.
4. Initial Operation Functions of the touchscreen (continued) The SMART FUNCTIONS menu To switch to the SMART FUNCTIONS window, press the SMART SCREEN button. The stations (system bottles and RTUbottles) are displayed in the order in which they are positioned in the reagent cabinet and in the drawer of the ASP6025. Fig. 67 not active active Fig. 68 Before starting an operation, you first have to select the stations (system bottles and RTU-bottles) to be used.
4. Instrument Setup 4.8 Switching off the instrument correctly If the instrument must be completely switched off or disconnected from the power supply, please proceed as follows: • Press the BACK button to switch to a window that contains the EXIT button. • A prompt appears asking if you really want to shut down the system (exit) (Fig. 70). Pressing the NO button leads back to the original program window. Pressing YES saves all current data and shuts down the instrument. Fig.
5. Operation 5.1 System configuration - configuring the instrument parameters From the start screen, press ENHANCEMENT on the right-hand side to go to the window of the same name. In the ENHANCEMENT window (Fig. 71), first select the INSTALLATION button and move to the window of the same name. The E NHANCEMENT button is enabled in supervisor mode only. This menu displays the parameters for the ASP6025 which are to be configured during installation. Fig. 71 5.1.
5. Operation The INSTALLATION menu (continued) Assigning an instrument name Touch the INSTRUMENT NAME button and enter an instrument name, which may not exceed 20 characters, using the keyboard. The instrument name is also displayed on the start screen (FAVORITES). The instrument name also appears on all logs so that the source of the log can always be clearly identified. • Fig.
5. Operation The INSTALLATION menu (continued) In order to be able to install the help file, the associated file must be present as a ZIP file on a USB stick. • Plug in the USB stick and press the INSTALL HELP button. • Then, follow the instructions on the screen and confirm them as necessary. The system will automatically unpack and install the files. Installing help Fig. 76 Upgrading software There are two possible ways to update the software: 1.
5. Operation 5.1.2 System settings Fig. 79 To switch to the system settings, select the SYSTEM SETUP button in the ENHANCEMENT window (Fig. 71) and select the window with the same name.
5. Operation System settings (continued) The PROGRAM OPTIONS are used to define the settings with which programs are executed. By pressing a button you can modify the corresponding value; the current setting is displayed next to the button (Fig. 80). Program options Fig. 80 STATION SEQUENCE: Here you can choose between two modes for controlling the sequence of ethanol bottles: Concentration and Auto by RMS In Auto by RMS mode, the order is controlled by the current RMS values, i.e.
5. Operation System settings (continued) PROMPT FOR NUM CASSETTES: Here, too, there are two options: "Enabled" or "Disabled" The current setting is likewise displayed next to the button. Fig. 83 • In order to disable the PROMPT FOR NUM CASSETTES function, press the button of the same name. If values for a reagent that is used in a program are entered in the CASSETTES UNTIL CHANGE column in the SET UP REAGENTS AND WARNING THRESHOLDS, the mode is automatically set to ENABLED.
5. Operation System settings (continued) Measuring the alcohol concentration Fig. 85 The MEASURE CONC. field (Fig. 85) shows whether or not alcohol concentration measurement is enabled or not. In concentration mode (Fig. 79), alcohol concentration measurement is ALWAYS enabled. Alcohol concentration can also be measured in RMS mode. If this is not desired, it can be disabled. Press the button for the setting desired in the MEASURE CONC. field (Fig. 85/86). A green check appears for the selected option.
5. Operation System settings (continued) Select BASKET MODE Here you can select the maximum number of baskets with which the retort can be loaded. Depending on this selection, the retort is filled with the respective number of reagents during the program flow. The load options that can be selected are: • 2 baskets (corresponds to 3.8 l filling) or • Fig. 88 3 baskets (corresponds to 5.0 l filling). The corresponding symbol is displayed in the status bar.
5. Operation System settings (continued) Setting DATE and TIME You must ensure that the date and time are always current. Furthermore, it is important for the documentation that the parameters are always current. Fig. 91 Up Setting the date • Pressing the DATE button opens the settings window (Fig. 92). Use the MOVE UP and MOVE DOWN buttons to make the necessary settings and adjustments. Down Fig.
5. Operation System settings (continued) The RUN OPTIONS function displays the options with which a program is started. The green check mark indicates that the function has been enabled. Select RUN OPTIONS Pre-test: • If this option is enabled, a retort filling and draining test is carried out with the first reagent in the program before the program is started. This is to ensure that the system is functioning properly.
5. Operation System settings (continued) ACOUSTIC INSTRUMENT ALARM In this field, you can make the following selections: • • Which alarm sound should be emitted. Whether the acoustic instrument alarm should be repeated. Events to which this can be assigned: USER INTERACTION (required) WARNING CRITICAL ERROR Fig. 95 If a sound has been selected for an event, its name is displayed beside the button (Fig. 95). The green check mark beside the button indicates that the alarm sound will be repeated.
5. Operation System settings (continued) ALARM SOUND Volume up Volume down Periodic repetition of the alarm Touching TIME under SOUND PERIOD TIME opens a window in which you can configure the cycles in which the selected alarm sound should be repeated for the event (Fig. 97). The set time is shown to the right of the button. BUZZER VOLUME You can adjust the volume of the alarm sound by touching the corresponding button. "1" = quiet, "10" = loud The set volume is the same for all alarms selected. Fig.
5. Operation 5.1.3 User profiles SECURITY The access rights to the instrument are configured in this field in the form of user profiles. There are three access levels: • Operator mode • Supervisor mode • Service mode Fig. 100 The OPERATOR and SUPERVISOR modes have different levels of access and are used to operate the instrument. Service mode is intended for Leica service personnel only. A special password is required for this mode.
5. Operation Access levels (continued) For supervisor mode, there are two different settings: "Enabled" or "Disabled" The supervisor mode Supervisor mode is disabled in factory condition. Operator and Supervisor are distinguished by the fact that a password must be entered to activate Supervisor mode. When a password has been assigned, Operator mode will be activated when the instrument is started.
5. Operation 5.1.4 The System monitor menu The SYSTEM MONITOR menu (Fig. 103) displays data relating to the instrument functions. The current values for the respective process are displayed next to the individual buttons. Warning and alarm threshold values are stored for each process. Fig. 103 The warning or alarm threshold values can only be reset by Leica Service technicians. The alarm and warning threshold values cannot be accessed in supervisor mode.
5. Operation The System monitor menu (continued) Active carbon filter Also in Supervisor mode, only the runtime of the activated charcoal filter can be reset in the SYSTEM MONITOR menu (Figs. 103/104). If the ACTIVE CARBON FILTER button is touched, a field appears which displays the programmed warning and alarm threshold values. Even in supervisor mode, neither of these values can be changed. • If the stored warning value is exceeded, a warning message regarding the age of the carbon filter is output.
5. Operation 5.1.5 The Service functions menu Certain settings and processes in the ASP6025 can be changed using the service functions. Caution! The functions that can be accessed in this menu should only be used by experienced users since incorrect use of these options can lead to malfunctions or an impairment of the process in the instrument. Fig. 105 Paraffin bath melting times • There is a button for each paraffin bath and for the paraffin station.
5. Operation The Service functions menu (continued) Reagent status of the retort • The ASP6025 software continuously records which reagent was the last reagent in the retort. The last reagent in the retort is displayed next to the button. This way, it is ensured that incompatible reagents do not come into contact with one another. • If a filling process was canceled, it is possible that two reagents are displayed here.
5. Operation 5.1.6 System status System status Fig. 109 In the top right corner in the status bar, the general SYSTEM STATUS is displayed via a small symbol. Touching this symbol will lead you into the menu window of the same name (Fig. 113). The status of the instrument is continuously monitored while the ASP6025 is in operation. The messages of all sensors and active moving parts (pumps, valves, etc.) are evaluated and used to determine the system status.
5. Operation The System status (continued) Type and output of messages • • • Each message (warning or error) is output as a message on the screen as shown in the example on the left (Fig. 111). This message must be confirmed with OK. If an error occurs, it will remain present in the system status until the problem has been corrected. Fig. 111 • Depending on the nature of the problem, another message box may appear informing the user of the measures the system has taken to correct it (Fig. 112).
5. Operation The System status (continued) Display of the system status When the symbol for the general status is touched, the SYSTEM STATUS window (Fig. 113), which contains the detailed list, is called up. This list contains all of the messages that have been received and are not yet corrected. If there is at least one entry in this list, the general status is WARNING or ERROR and the corresponding symbol is displayed.
5. Operation 5.1.7 The Run log The RUN LOG (Fig. 114) displays all of the events that occurred while the program was running. To display a desired area, use the Up/ Down and/or double arrow (Fast Scroll) buttons. Fig. 114 After it has opened, you can view all of the entries that have been recorded in the run log during the entire application. The entries are sorted by date, the most recent entry being shown at the top.
5. Operation The Run log (continued) A priority level is assigned to each event. There are three different levels: Level 1: High priority events Level 2: Medium priority events Level 3: Low priority events When the DETAIL LEVEL button is pressed, the messages with the given detail level are displayed. If the button is pressed repeatedly, the display in the table can be filtered according to the individual levels. The display on the button changes correspondingly.
5. Operation 5.1.8 Long-term error log While a program is running, its progress is monitored. Events that occurred in during the program run are entered and counted in the Long-term error log. To display a desired area, use the Up/Down and/or double arrow (Fast Scroll) buttons. Fig. 115 After it is opened, all entries that have been recorded by the Long-term error log throughout the entire application can be viewed.
Operation 5.1.9 Saving or loading data Saving data to a USB stick 5. Fig. 116 With this function, all data relating to the instrument can be transferred to a USB stick. The following data is saved: • all programs, • the reagent list, • the instrument status, • the instrument configuration, • all log files, • the instrument installation parameters. To save the instrument data to a USB stick, proceed as follows: • Press the ENTRIES and SAVE TO USB buttons to open the window of the same name.
5. Operation Saving or loading data (continued) Loading data from a USB stick This function is used to transfer instrument data from a USB stick into an ASP6025. The following data is saved: • all programs, • the reagent list, • the instrument status, • the instrument configuration, • all log files, • the instrument installation parameters. Fig.
Operation Saving or loading data (continued) Saving PDF printouts 5. With this function, the PDF files from programs or that have been run or lists stored in the instrument can be transferred to a USB stick. Fig. 121 Fig. 122 To save these PDF files to a USB stick, proceed as follows: • Press the ENTRIES and SAVE PDF PRINTOUTS button to call up the SAVING PDF PRINTOUTS window (Fig. 121). • Insert a USB stick in one of the USB ports on the instrument and press the COPY FILES button.
5. Operation 5.1.10 The Smart Screen Pressing the SMART SCREEN button in the main menu opens the SMART FUNCTIONS window (Fig. 124). In this window, the entire instrument is represented graphically. The representation of bottle positions and colors on the screen corresponds to the geometrical arrangement and color coding of the bottles in the instrument. Fig.
5. Operation The Smart Screen (continued) Stop Stirrer Additional functions on the SMART SCREEN Start Stirrer • The stirrer can be started and stopped again. When the button is colored orange, the stirrer is working (Fig. 125). • The retort temperature can be set on the Smart Screen. To do this, press the SET TEMPERATURE button and call up the SELECT THE RETORT TEMPERATURE entry window (Fig. 126). The temperature of the retort can be entered here. The possible temperature range is from 35 - 65 °C.
5. Operation The SMART SCREEN (continued) Additional functions on the SMART SCREEN If the retort has been contaminated with xylene or ParaLast™, the retort can be flushed instead of running a cleaning program. When the RETORT RINSE button is pressed, a prompt will appear and must be confirmed with YES to start flushing (Fig. 128). Fig. 128 If the paraffin station has been refilled with solid paraffin, press the PARAFFIN MELTING button. A message will appear indicating the current melting time (Fig.
5. Operation 5.2 Reagents 5.2.1 Editing the reagent list The Leica ASP6025 is shipped together with a standard reagent list and predefined infiltration programs. The reagent list is adapted to these programs. If the operator writes his own programs, new reagents may have to be entered. Entering reagent names This is done via the REAGENTS menu option in the SETTINGS menu. You must be logged on at supervisor access level to proceed.
5. Operation Configuring the reagent list (continued) Allocation of reagents to the correct reagent group is the basis for compatibility monitoring. Allocation to the wrong reagent group can lead to reagent cross contamination. Changeable parameters Entering / modifying reagent thresholds If warning thresholds are required for a certain reagent, enter them as follows: • Highlight the reagent to be modified, either by pressing the reagent name or using the UP/DOWN buttons.
5. Operation Configuring the reagent list (continued) Deleting reagents from the list • Highlight the reagent to be deleted in the SET UP REAGENTS AND WARNING THRESHOLDS screen. • Press DELETE. • Press YES in the screen to confirm the reagent is deleted. Fig. 134 Please remember that a reagent which is already used in a program cannot be deleted. 5.2.
5. Operation The RMS system – adjusting warning threshold values (continued) Fig. 135 Reagent warning messages If the RMS is active, warning messages are output if reagents are used for too long. The following indicates that the warning threshold values have been exceeded: • Exclamation mark on the station system or RTU-bottle in the SMART screen (Fig. 135). • A warning message when starting a protocol (Fig. 136).
5. Operation The RMS system – adjusting warning threshold values (continued) Tables with warning threshold values The tables in this section list the recommended limits/warning threshold values for common reagents approved for the ASP6025. The warning threshold values recommended here must be used only in combination with the preinstalled processing protocols. For other processing protocols created by the user, corresponding threshold values have to be determined by the lab itself.
5.
5. Operation 5.2.3 The reagent status The REAGENT STATUS window (Fig. 139) is used to display and update the current reagent status of the individual stations. In addition, reagent stations can be marked as full or empty here.
5. Operation The reagent status (continued) Adding new reagents to stations Use the SMART FUNCTIONS menu to remote-fill the respective system bottle from an external station, or fill the system bottle manually. After filling a bottle manually the bottle must be defined as full. • To do this, open the REAGENT STATUS window; this can be done directly by pressing the REAGENT STATUS button on the SMART SCREEN. Fig.
5. Operation 5.2.4 Configuring the stations The View/edit STATIONS window (Fig. 141) shows a list of all stations with the assigned reagents that have been defined for the respective station. Fig. 141 The ASP6025 includes the following stations for reagents: • • • • 9 system bottles in the reagent cabinet, 6 RTU-bottles in the drawer, 3 paraffin baths, 1 paraffin station. The three paraffin baths and the paraffin s tation must only be used for paraffin.
5. Operation 5.2.5 The Reagent groups menu In the EDIT REAGENT GROUPS window (Fig. 142) you can s elect the colors to be used for each reagent group in the program display. Fig. 142 Changing the color of a reagent group • • • • • In the table, highlight the row containing the reagent group whose color you want to change. Press the COLOR button in the table header; the SELECT COLOR window appears (Fig. 142). Select the color you want and confirm with OK.
5. Operation 5.2.6 Ethanol rotation Functional description Ethanol has to be replaced while a program is running. For this to be carried out, CONCENTRATION mode must be turned on the PROGRAM OPTIONS field in the SYSTEM SETUP window, see Chapter 5.1.2. In this case, the system bottles for ethanol (S1-S6) must be filled according to the pattern shown in Fig. 141. In addition, all six ethanol stations must be defined in the program. The program checks this when it is started.
5. Operation Functional description of ethanol rotation (continued) Ethanol rotation is performed in two steps: • In the first step, used ethanol is ejected and the position of the ethanol in the system bottles is changed. • In the second step, fresh ethanol is added. The ASP6025 checks the level status of the reagent bottles being replaced in both steps during the process. In the event of incorrect operation due to incorrect filling or draining, the corresponding step cannot be carried out.
5. Operation Functional description of ethanol rotation (continued) 2. step In the following program (that is to say when another infiltration program is started in Concentration mode), the ethanol is replaced. For this purpose, fresh ethanol must be added manually to RTU-bottle D4 in the drawer prior to the start of the program. The operator is prompted to do this by a corresponding screen instruction (Fig. 146). This must be confirmed with YES before the program is started.
5. Operation 5.2.7 Adjusting the threshold value for ethanol rotation From the start screen, press ENHANCEMENT on the right-hand side to go to the window of the same name. In the INSTRUMENT CONTROL field (Fig. 149), touch the THRESHOLD / CONCENTRATION button - the input field for the threshold value (Fig. 150) appears. Fig. 149 Here, you can configure the threshold value for the ethanol concentration. Possible ethanol values range between 50 % and 60 % in 1 % increments.
5. Operation 5.2.8 Replacing xylene The order of xylene stations while the program is running is determined by the RMS system. If the threshold value for xylene is exceeded, the operator is informed that xylene is due for replacement via a screen message (Fig. 151) the next time a program is started. The operator must confirm the screen message with YES so that the replacement process described below can be carried out.
5. Operation 5.3 Infiltration programs 5.3.1 Display of the program list The VIEW/EDIT USER PROGRAMS window (Fig. 152) displays a list of all freely editable programs currently defined in the ASP6025. A maximum of 20 programs, each with up to 12 reagent steps and three paraffin processing steps, can be defined. At supervisor access level: • The program names for the infiltration programs can be edited. • New infiltration programs can be added and existing ones can be deleted. Fig.
5. Operation 5.3.2 Adding and modifying programs Creating a new program • Make sure you are logged on at supervisor level. • In the VIEW/EDIT USER PROGRAMS menu (Fig. 152) highlight a program as similar as possible to the program you wish to create - this minimizes the number of steps that are then necessary to create it). • Press COPY to copy the selected program. The new program will have the same name as the program copied, however, the figure "(2)" will be added to indicate the change.
5. Operation Editing program steps (continued) • To edit a step, highlight the corresponding line and press the respective headline. • In the entry windows that pop up enter / select the program step settings. Fig.
5. Operation Editing program steps (continued) Setting a delay step The delay step is the step that is prolonged to ensure that a program will finish at a specified time. • Highlight the program step you wish to define as delay step. • Touch the DELAY button. The delay symbol is moved to the selected step, thus defining the step as delay step. A delay step is permitted in fixing, intermedium or paraffin. The DELAY button is disabled for other reagents.
5. Operation 5.4 Reagent handling 5.4.1 Filling/draining reagents Remote replacement of reagents 70 • 18 71 The remote draining or filling function is possible in 3.8 and 5 liter mode. - Both system bottles and RTU-bottles can be filled or drained. The following steps should only be carried out by trained laboratory personnel, experienced in handling reagents. Always wear rubber gloves and safety goggles when handling the reagents used in this instrument.
5. Operation Draining/filling reagents (continued) Press the SMART SCREEN button. 79 The SMART SCREEN (Fig. 156) pops up. The smart screen is the initial screen for manual operation of the instrument. ATTENTION VERY IMPORTANT! Fig. 156 During remote filling or draining, always select ONLY the external station (79) and the bottle that is to be filled or drained in the SMART FUNCTIONS window. The retort cannot be filled in the meantime for this procedure.
5. Operation Draining/filling reagents (continued) Select station • On the screen (Fig. 156), select the system bottle or RTU-bottle that is to be drained and then select the receptacle (external station). Then press STATION DRAIN. • A prompt appears for carrying out the necessary preparations (Fig. 159). This must be confirmed with YES. The reagent is pumped out of the RTU-bottle into the retort. Once this task has been completed, the retort is drained into the external station (79 in Figs.
5. Operation Draining/filling reagents (continued) Select station Remote filling Press button Remote filling is only possible for system bottles. RTU-bottles in the drawer must be filled manually. + Fig. 162 Remote filling of system bottles takes place in exactly the same way as remote draining of RTU-bottles, but in the reverse order of course. • • • On the screen, select an empty system bottle (e.g. S6) and the external receptacle (Remote Station, Fig. 162). Then press the STATION REFILL button.
5. Operation Draining/filling reagents (continued) • The reagent is pumped out of the external container and initially into the retort. Then, the selected system bottle is filled. • The entire operation is displayed graphically on the screen (SMART FUNCTIONS view) (Fig. 165). • When the selected station is filled with reagent, a message window appears (Fig. 166), with a message to the effect that the hose for remote filling/draining is being blown out with air.
5. Operation Manually changing the reagents 15 Caution! Never replace reagents or fill empty system bottles or RTU-bottles while a process is running. This can result in severe damage to the instrument. 35 • 15.1 65 • Fig. 168 • • • • Fig. 169 118 Remove the system bottle (15) from the reagent cabinet and unscrew the container cover (15.1). Drain the used reagent into a bulk container and then refill the system bottle. The fill levels for filling with 3.8 l and 5.
5. Operation 5.4.2 Refilling paraffin The initial filling of all three paraffin baths should have used paraffin that has been melted earlier, e.g. using an external paraffin oven or other processor, so that the instrument can be started up as quickly as possible. Then, use the paraffin station for filling. The paraffin station There are two marks in the interior of the station that display the minimum fill level when filled with pellets or liquid paraffin respectively (Fig. 170).
5. Operation Filling a paraffin bath (continued) If the paraffin has been transferred out of the paraffin station and into a paraffin bath using the SMART SCREEN menu, the paraffin station is automatically set to "Empty" in the Reagent Status. • Therefore, the paraffin station must be set to "Full" in the reagent status (Fig. 173) menu to activate heating and melting after being refilled with paraffin pellets.
5. Operation 5.4.3 Draining a paraffin bath Always drain a paraffin bath using the Remote Drain function only. When doing so, you should use a suitable vessel with a capacity of at least 10 liters to drain a 5-liter paraffin bath to the outside (danger of splashing!). 57 • Connect the paraffin drain hose (36) to the spout (57) of the paraffin drain on the front of the instrument and guide it into a catch tank (Fig. 174).
5. Operation Draining a paraffin bath (continued) If the last reagent in the retort is not compatible with paraffin, the retort must first be cleaned using a cleaning program. • + • Select the paraffin tank to be emptied and the receptacle for the used paraffin (external station) (Fig. 176). Then press STATION DRAIN. Fig. 176 • Fig. 177 The following security prompt must be confirmed in order to continue (Fig. 178). Fig.
5. Operation 5.5 Running programs There are two different windows from which a program can be started: PROGRAMS and FAVORITES. 5.5.1 User-defined programs In the Start screen, press the PROGRAMS button. This window shows all the infiltration programs that have been created by the operator himself. Fig. 180 • • • • Leica ASP6025 To call up a program, touch the button that is labeled with the program name.
5. Operation 5.5.2 Favorites FAVORITES Up to 10 programs can be configured as FAVORITES in the ASP6025. A Favorite program is an infiltration program that is used frequently and has therefore been assigned to the FAVORITES list. All settings have already been programmed and only the number of cassettes needs to be entered, if this function has been activated.
5. Operation 5.5.3 Defining Favorite programs Before a program appears with a Start button in the FAVORITES window, it must be defined as a Favorite program. To do so, proceed as follows: Press the SETTINGS button to switch to the window with that name. Press the FAVORITE PROGRAMS button there. The VIEW/EDIT FAVORITES window opens (Fig. 182). This shows all infiltration programs that have been defined as Favorites. Fig. 182 Adding a program to Favorites • • • Select an empty program line.
5. Operation Defining Favorite programs (continued) Setting the end time • Press the FINISH TIME button to call up the entry window for the end time (Fig. 184). There are three options for setting the end time: • Enter the end time at which the program is to terminate using 24-hour notation. • Select NOW if the program is to be terminated without a waiting time. • Select TIME REQUEST if the system is not to prompt for input of a desired end time until the program is started.
5. Operation Defining Favorite programs (continued) Assigning a symbol to the program • • Press the ICON button; a selection window showing various symbols will appear (Fig. 186). Highlight the symbol you want there and press OK to confirm. The selected symbol will be assigned to the program and will also appear on the Start button in the FAVORITES window (Fig. 181). The first position in the list is empty. This option can be selected if you do not want a symbol any more. Fig.
5. Operation 5.5.4 Starting a program Before an infiltration program can be started, a number of conditions must be met. The following steps are essential in order to be able to start a program: All infiltration programs have to be validated before use, i.e. tissue processing with patient tissue for diagnostics, by the laboratory itself according to the local or regional accreditation requirements. 1.
5. Operation Only completely cleaned cassette baskets may be used for tissue processing! 6. When a program starts, a screen message (Fig. 187) indicates when the program is expected to end and reminds the operator to check the levels of all reagents and close the retort. Fig. 187 If the program was called up from the FAVORITES window, it starts automatically when all prompts have been confirmed.
5. Operation Starting a program (continued) Fig. 189 shows the SMART SCREEN while an infiltration program is running. The rotating green and white symbol indicates that a protocol is currently being processed. The number of cassettes that are being processed in the retort is displayed. The work step currently running and the time until it ends are displayed in the field below that. Fig. 189 The FINISH TIME button displays the time when the currently running program will end.
5. Operation Starting a program (continued) If you start a program for which TIME REQUEST was selected as the end time, an entry window (Fig. 191) opens in which you can select the end time. To ensure that the program ends on the specified date and time, the ASP6025 extends the duration of the programmed delay step correspondingly. When working with fixed end times, you should always check that the instrument time and date are current. Fig. 191 RUN OPTIONS This function (Fig.
5. Operation 5.5.5 Ending a program Once an infiltration program has ended, the retort can be drained basket by basket so that the cassette baskets can be removed without coming into contact with hot paraffin. Fig. 193 After fully draining the paraffin, an automatic drain time of 2 minutes is implemented in order to optimize the use of cleaning reagents. 132 Instructions for Use V 2.
5. Operation 5.6 Permanently installed infiltration programs All of the permanently installed infiltration protocols described in this chapter have to be validated before use, i.e. tissue processing using patient tissue for diagnostics, by the laboratory itself based on tissues that are not intended for diagnostics and in accordance with local or regional accreditation requirements. 5.6.1 Programs with automatic ethanol rotation Autorotation programs cannot be renamed, edited or deleted by the user.
5. Operation Standard tissue over night Fig. 194 All specimen types that can fit into a standard cassette, tissue with a high fat content may require a longer protocol. 134 Instructions for Use V 2.
5. Operation Fig. 195 Standard biopsy All biopsies up to 3 mm diameter. Gastrointestinal biopsies, tissue cores from kidneys, prostate, liver and chest, punch biopsies from skin tissue, small intestinal polyps.
5. Operation Small Specimen All kind of small specimen to maximum dimensions of approx. 10 x 15 x 2,5 mm (w x d x h). Fig. 196 136 Instructions for Use V 2.
5. Operation 5.6.2 Preinstalled xylene infiltration programs Pre-installed xylene infiltration programs cannot be renamed, edited or deleted by the user. To start a xylene program, it must have been saved in the list of "FAVORITES". See also Chapter 5.5.3. The ethanol concentrations shown are the initial concentrations that apply for installation of the tissue processor. Reagent positioning for time-optimized xylene programs.
5. Operation Xylene protocol 1 h Endoscopic biopsies and needle biopsies from chest and prostate. Diameter up to 1.5 mm. Fig. 197 138 Instructions for Use V 2.
5. Operation Xylene protocol 2 h All biopsies up to 3 mm diameter. Gastrointestinal biopsies, tissue cores from kidneys, prostate, liver and chest, punch biopsies from skin tissue, small intestinal polyps. Fig.
5. Operation Xylene protocol 4 h Small specimens from non-dense tissue (intestine, kidneys, liver etc.) with a thickness of up to 3 mm, excision and incision biopsies of the skin, ellipses. Fig. 199 140 Instructions for Use V 2.
5. Operation Xylene protocol 6 h All routine tissues with maximum dimensions of 15 x 10 x 4 mm (except specimens of brain tissue and pure adipose tissue). Fig.
5. Operation Xylene protocol 12 h All routine tissues with maximum dimensions of 20 x 10 x 5 mm (extremely adipose tissue may require a longer protocol). Fig. 201 142 Instructions for Use V 2.
5. Operation 5.6.3 Xylene-free infiltration programs Xylene-free infiltration programs cannot be renamed, edited or deleted by the user. To start a xylene-free program, it must have been saved in the list of "FAVORITES". See also Chapter 5.5.3. The specified isopropanol concentrations are the starting concentrations that apply for the installation of the ASP6025 modular tissue processor. Reagent positioning/Replacement cycle for time-optimized xylene-free programs: System bottle S1 contains 70 % ethanol.
5. Operation Xylene-free 1 h Endoscopic biopsies and needle biopsies from chest and prostate. Diameter up to 1.5 mm. Fig. 202 144 Instructions for Use V 2.
5. Operation Xylene-free 2 h All biopsies up to 3 mm diameter. Gastrointestinal biopsies, tissue cores from kidneys, prostate, liver and chest, punch biopsies from skin tissue, small intestinal polyps. Fig.
5. Operation Xylene-free 4 h Small specimens from low-density tissue (intestine, kidneys, liver etc.) with a thickness of up to 3 mm, excision and incision biopsies of the skin, ellipses. Fig. 204 146 Instructions for Use V 2.
5. Operation Xylene-free 6 h All routine tissues with maximum dimensions of 15 x 10 x 4 mm (except specimens of brain tissue and pure adipose tissue). Fig.
5. Operation Xylene-free 12 h All routine tissues with maximum dimensions of 20 x 10 x 5 mm (extremely adipose tissue may require a longer protocol). Fig. 206 148 Instructions for Use V 2.
6. Cleaning and Maintenance It is mandatory to wear laboratory gloves for all cleaning tasks! 6.1 Cleaning programs Three retort cleaning programs are defined in the ASP6025. Cleaning programs cannot be copied or deleted - but a water step can be added (see below). 6.1.1 View cleaning programs To select a retort cleaning program, call up the SETTINGS menu. In this menu, you can view and start the defined cleaning programs (1 - Fig. 207).
6. Cleaning and Maintenance 6.1.2 Running cleaning programs The cleaning program skips any steps not required to complete the cleaning of the retort. Which steps are carried out depends on which reagent was last in the retort. If cassette baskets are cleaned together in a retort by means of a cleaning program of clinging paraffin, the standard (cleaning) program has to be used, because ONLY completely cleaned cassette baskets can be used for tissue processing.
6. Cleaning and Maintenance Running cleaning programs (continued) Cleaning after completion of an infiltration program If desired, you can select an additional water step for each retort cleaning program (EXCEPT the full cleaning with detergents). (See also Chapter 6.1.3). Fig. 212 • Fig. 213 To select the water step, press the WATER YES/NO button so that a green check mark appears (Fig. 212/213).
6. Cleaning and Maintenance Running cleaning programs (continued) • • After you touch the corresponding button, a message appears indicating that before the cleaning is started the retort must be empty and all specimens have to be removed from it. When all necessary conditions have been satisfied, press the YES button to start the cleaning program. The procedure is displayed graphically on the SMART SCREEN. Fig.
6. Cleaning and Maintenance 6.1.3 Cleaning protocols I. Rapid cleaning program Step: Reagent: 1 Cleaning xylene 2 Cleaning alcohol Dry step: Empty retort 3 Vacuum step 4 Ventilation step Optional step instead of "Dry step": 5 Cleaning water II. Temp. (°C): 67 62 Pressure/Vacuum: Ambient Ambient 10 2 67 Ambient Vacuum Ambient 1 65 Ambient Time (min): 12 6 Temp. (°C): 67 62 Pressure/Vacuum: Ambient Ambient 10 2 67 Ambient Vacuum Ambient 1 65 Ambient Temp.
6. Cleaning and Maintenance 6.1.4 SMART cleaning The objective of the SMART cleaning is to clear reagent residue from all lines. The prerequisite for the start of SMART cleaning is that the retort has been thoroughly cleaned using the extended cleaning mode and that there is no reagent in the retort. Only in this way is it possible to ensure that no residue from other reagents gets into the newly defined stations. A SMART cleaning is necessary in the following cases: • At regular intervals (approx.
6. Cleaning and Maintenance The SMART cleaning (continued) The SMART clean process The actual cleaning takes place in four steps, which are run automatically in sequence. Ensure that all system and RTU bottles (and the condensate bottle) have been completely emptied before starting. Make sure that the retort has drained completely. This instrument function is active if the status of the retort is "full" or "partially full". The user is informed of the progress of cleaning at all times.
6. Cleaning and Maintenance The SMART cleaning (continued) Fig. 220 Step 2 The user is prompted to remove all reagent bottles from the instrument (Fig. 220). When the prompt has been confirmed by the operator, a vacuum is generated at each reagent position and then any remaining reagent in the hose is drawn into the retort.
6. Cleaning and Maintenance The SMART cleaning (continued) Step 3 (continued) Afterwards, several pressure cycles are generated in the retort. When the target pressure is reached, it is released via the (cleaning xylene) RTU-bottle (in this example: D5). Once the message that SMART Clean has been successfully completed is displayed on-screen, all bottles must be returned to the instrument. Fig. 222 Step 4 The last step in the SMART cleaning process is then to flush the retort with ethanol (100 %).
6. Cleaning and Maintenance 6.2 General instrument cleaning Paraffin containers Work carefully and wear gloves! Be careful as the walls of the paraffin baths are very hot and may cause burns! • • • Wipe the paraffin baths and lids clean. The lid can be removed for cleaning purposes. Wipe the paraffin station and lid clean. If they are very dirty, remove the wax sieves from the wax baths and the paraffin station. Clean, dry, and reinsert them.
6. Cleaning and Maintenance Emptying the condensate bottle • 14 The blue condensate bottle must be taken out, emptied and reinserted at regular intervals (weekly). This should be done sooner if a prompt to that effect is issued by the software (Fig. 225). Fig. 225 Replacing the active carbon filter Fig. 226 Dispose of waste solvents with care according to local regulations and the waste management policy of the company or institution. 13 Filter label Fig.
6. Cleaning and Maintenance 6.2.1 Daily cleaning and maintenance Cleaning the retort lid • Remove the paraffin on the inside of the retort lid and from around the retort lid seal with the plastic scraper provided. Thoroughly remove all paraffin deposits from around the lid seal. • The lid can be opened up to make cleaning easier. Clean the retort lid and seal carefully and only with the plastic scraper provided to avoid damaging the seal and/or the PTFE coating on the retort lid.
6. Cleaning and Maintenance Cleaning the retort sieve • The filter sieve in the base of the retort (Fig. 229) must be cleaned with ethanol or xylene. For convenience, the sieve may be taken out to remove all solid dirt. Fig. 229 Checking the retort lid seal • Regularly check the seal for damage after cleaning. If the seal is damaged, it must replaced without delay. Cleaning the touchscreen • • Call up CLEAN TOUCHSCREEN under PROGRAM PROTOCOLS on the SETTINGS MENU screen. Clean the touchscreen.
6. Cleaning and Maintenance Cleaning the level sensors The level sensors must be cleaned of all residues (reagents and paraffin) after every cleaning program. You will be prompted to clean the sensors by the instrument software at the end of each cleaning program (Fig. 231). Proceed as follows: • Remove the sieve (40, Fig. 232) in front of the sensors. Fig.
6. Cleaning and Maintenance 6.2.2 Periodic cleaning and maintenance Cleaning the system bottles • Empty and clean the system bottles. The level can be identified by simply looking through the system bottles if these are cleaned regularly to remove clinging contamination. Using a bottle brush and a laboratory detergent in warm water. Never clean system bottles in an automatic dishwasher.
6. Cleaning and Maintenance • Refill and reconnect the bottles once cleaned. Make sure the bottle lids are tight and the bottles are properly seated in their home position at the rear of the reagent module. The system bottles must be properly engaged in the home position in the connection manifolds at the rear inner wall of the reagent module. Failure to correctly plug reagent containers into the manifold will cause an interruption to the processing run and may result in spilling of reagents.
7. Troubleshooting 7.1 Troubleshooting When a problem occurs in the Leica ASP6025, take the following steps to diagnose the problem: • • • Check for error messages indicating the nature of the problem. If an error message is displayed, press the Help button on the message for any information relating to the cause. Check the Run Log for any messages that indicate the nature of the failure.
7. Troubleshooting 7.1.2 Instrument procedure in case of power failure If the instrument detects a power failure, the heaters and the monitor are immediately switched off. If the power failure lasts longer than 10 s, the safety mechanism is initiated. 44 The objective in case of power failure is to secure the tissue samples in a currently running program so that they can continue to be processed without hesitation after the power supply is restored.
7. Troubleshooting If no infiltration program is running when a power failure is detected, no further actions / backup measures are taken the instrument shuts down automatically. When a program is running: • The program that is running is stopped, regardless of the current status of processing. • To conserve the battery, all heaters, the agitator and the monitor are switched off directly. • • Fig.
7. Troubleshooting Instrument procedure in case of power failure (continued) First, the current status of processing the program that is running is determined. This includes: • Determining the step number. • Reagent of the step (reagent in the retort). • Safe reagent for this step. • Status of the step (filling, processing, draining). • Whether the safe reagent has already been used in the program. • Reagent of the next step.
7. Troubleshooting 7.2 Malfunctions in the program sequence Maintaining the specimen in a safe state is the primary concern during a malfunction. A safe specimen state is initiated following any power outage or malfunction where the infiltration protocol cannot be automatically finished. An infiltration protocol that has been started cannot be finished automatically leads to a safe specimen state being initiated. Example: a reagent station is under filled and no alternative reagent is available.
7. Troubleshooting 7.3 Typical fill or drain problems Fill and drain problems may be due to several causes: 1st There is insufficient reagent • Verify that the fill level in the system bottles, RTU-bottles and paraffin containers is sufficient. 2. Insufficient pressure or vacuum The instrument is unable to create sufficient vacuum (for a fill) or pressure (for a drain) in the retort. • Check whether the system bottles and RTU-bottles concerned have been inserted correctly.
8. Optional Accessories Basket handle.................................................................................................................................................................140476 34713 Cassette basket, complete...............................................................................................................................................140476 34193 RTU-bottle with cover.................................................................................................
9. Warranty and Service Warranty Leica 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 complies with all technical specifications and/or agreed characteristics warranted. The scope of the warranty is based on the content of the concluded agreement.
10. Log for Instrument Status Log for orientation to specifications and operation of the Leica ASP6025 Installation, orientation and training for the ASP6025 vacuum tissue processor with serial number: ........................................... , was carried out successfully in the following department / practice: Place, Date ................................................
Notes 174 Instructions for Use V 2.
www.LeicaBiosystems.com Leica Biosystems Nussloch GmbH Heidelberger Straße 17-19 D- 69226 Nussloch Tel.: +49 - (0) 62 24 - 143 0 Fax: +49 - (0) 62 24 - 143 268 Web: www.LeicaBiosystems.
