Instructions for Use ASP6025 - Advanced Smart Processor Vacuum tissue processor ASP6025 Tissue Processor V 2.4, English 12/2015 Order No.: 14 0495 80101 RevL Always keep this manual with the instrument. Read carefully before working with the instrument.
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Use periodically and on an ongoing basis according to the Leica reserves the right to change technical specifications as well latest technical developments, nor to provide our customers as manufacturing processes without prior notice. Only in this with additional copies, updates etc.
Table of Contents Important Information ......................7 Symbols in the text and their meanings ........................7 Instrument type ..............................10 Qualification of personnel ............................. 10 Intended use of instrument ........................... 11 Safety ............................. 12 Safety notes................................12 Warnings ................................12 Safety features on the instrument ......................... 17 Instrument Components and Specifications ................
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Running programs ............................... 127 5.5.1 User-defined programs ............................127 5.5.2 Favorites ................................128 5.5.3 Defining Favorite programs ..........................129 5.5.4 Starting a program .............................. 132 5.5.5 Ending a program ..............................136 Permanently installed infiltration programs ......................137 ASP6025 Tissue Processor...
“Environment-friendly Use Period” of the product Warning instructions on the dust cover of the in years. The symbol is used if a substance re- instrument. stricted in China is used in excess of the maximum permitted limit. ASP6025 Tissue Processor...
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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 Founda- tion International (NSF) and others.
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This causes the indicator tube to change color. The TILTWATCH checks in a simple, obvious and irreversible manner whether your product was transported upright and stored as prescribed. The indicator field becomes red if your tipping-endangered product was tilted more than 83 °. ASP6025 Tissue Processor...
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 ASP6025 Tissue Processor is available in two voltage variants, 120 V and 230 V. Nameplate for voltage 230 V variant.
The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use. The ASP6025 modular tissue processor can be operated only with the reagents listed in Chapter 3.3 - "Compatible reagents".
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. Safety notes These Instructions for Use include important instructions and...
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Severe damage may occur if the instrument is connected to a power supply voltage other than that to which it was originally set. • The installation location must be well ventilated, and must contain no sources of ignition of any kind. The chem- icals to be used in the ASP6025 Tissue Processor are easily inflammable and hazardous to health. • Do not operate the instrument in rooms with explosion hazard. • Exposure to extreme temperature changes between storage and installation locations and high air humidity may cause condensation inside the instrument.
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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.
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• 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. ASP6025 Tissue Processor...
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• Do not use solvents that contain acetone for cleaning. Liquid must not get into the instrument while operating or cleaning it. • When using cleaners, comply with the safety instructions of the manufacturer and the safety regulations of your laboratory! • Check the condensate container at least once a week and, if necessary, drain it. • System bottles and Leica RTU-bottles must not be cleaned in a dishwasher - the containers are NOT dishwasher- proof. Material safety data sheets can be obtained from the supplier of the chemicals. Alternatively, they can be downloaded from the following website: http://www.msdsonline.com...
Safety Safety features on the instrument The 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.
Standard delivery - packing list The ASP6025 Tissue Processor is available in two voltage variants, each of which have a different scope of delivery. Immediately after taking delivery, check the delivery against the packing list below to ensure that it is complete.
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1495.10253 You will find these as well as other accessories you may have ordered packed in a separate carton. Carefully check the delivery against the packing list and the delivery note. Should you find any discrepancies, please contact your Leica sales office without delay. ASP6025 Tissue Processor...
Instrument Components and Specifications Technical data Nominal supply voltages: Two factory-preset voltages (not user-adjustable): 120 V + 10 % 230 V + 10 % Nominal frequency: 50 to 60 Hz Main fuses: 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:...
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Reagent management system (RMS): Toggle between RMS and concentration measurement Software interlock: ON/OFF Network protocols used Remote Care uses the TCP/IP network protocol and, at the user level, https (128-bit encrypted). No other network protocols are used. ASP6025 Tissue Processor...
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Instrument Components and Specifications Technical data (continued) Hardware and software • Color LCD touchscreen. • User-friendly, intelligent software • Three USB ports • Alarm system with two remote connections • Password protection for instrument administrator • Built-in multiple specimen protection system Capacity • 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. 6 days • Up to 300 cassettes can be processed simultaneously • Three cleaning programs for the retort • 9 internal system bottles • 6 RTU-bottles in the drawer • 3 paraffin baths • 1 paraffin station for melting paraffin • 1 condensate bottle • Reagent temperature selectable from 35 °C to 60 °C...
Disinfectants based on aqua dest. (e.g. Incidin, Dextran 31, Eodisin) Use of the ASP6025 is permitted with the reagents specified only. Reagents and protocols must be vali- dated before use, i.e. tissue processing with patient tissue for diagnostics, by the laboratory itself ac- cording to the local or regional accreditation requirements.
Chapter 4.4.7, Fig. 44). The cassettes to be processed are stored in three baskets (21), each of which can hold up to 100 cassettes. If the baskets are used with inserts (spirals), each basket can hold 80 cassettes. ASP6025 Tissue Processor...
30 - Terminal for keyboard (K) 38 - Exhaust output Connecting a keyboard/mouse is reserved SOLELY for trained Leica employees. This also applies to the network connection, which is to be used only together with RemoteCare (service diagnostics). Instructions for Use V 2.4 RevL - 12/2015...
(100 %) ethanol. This means that time-consuming dilution and the errors that can occur during that process, as well as contact (inhalation!) with the solvents are entirely avoided. ASP6025 Tissue Processor...
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• Used paraffin is pumped out via the infiltration chamber by instrument-controlled draining, i.e. with a connected (paraffin) hose. • The internal, uninterruptible power supply of the ASP6025 prevents tissue specimens from drying out or suffering other possible damage, in the event of power failures for example, by automatically filling the retort with a safe reagent.
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• RemoteCare Internet connection between the ASP6025 and the Service Support Team enables optimized service through permanent monitoring of instrument functions. • Infiltration chamber with single-hand safety catch and locking device with a switch, so that it can be opened (during a program sequence) when the ambient pressure has been reached. • Multilingual user interface, graphic display of the program flow (= SMART SCREEN), and contextual online help are available for clarifying all menu steps. • Access to the instrument can be limited via a multilevel password protection system. • Two programs for cleaning the infiltration chamber can be supplemented with a water rinsing step. ASP6025 Tissue Processor...
1 m on the side and rear. On the front, the distance must be at least 3 m, ASP6025 as the ASP6025 is rolled from the pallet in this direction. The room height must be at least 2.5 m, as the packaging must be removed by pulling it upwards.
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(Fig. • Then, carefully remove the plastic dust cover (88) from the instrument. Before unpacking the instrument, be abso- lutely certain to read the unpacking instruc- tions. They are attached to the outside of the transport packaging. Fig. 7 ASP6025 Tissue Processor...
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Instrument Setup Unpacking the instrument ( Setting up the ramp continued • Pull out the two rails (91) for the ramp beneath the instrument by pulling them forwards (Fig. • 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...
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Unpacking the instrument ( Push the instrument from the pallet (Fig. 11.3) continued 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.
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Instrument Setup Unpacking the instrument ( continued 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.
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(108) on the rear side. • Tighten the screws (100) evenly but not too tightly using the No. 3 Allen key (104) supplied (Fig. 16). • Finally, remove the molded foam cushion (98) by lifting it off the monitor. Fig. 16 ASP6025 Tissue Processor...
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Instrument Setup Unpacking the instrument ( Removing the transport anchors continued • 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. Fig. 18 • Then, open the drawer (9) and remove all foam parts there (Fig.
After unpacking the instrument, the instrument must be handled only by the handles (26) on the rear side (Fig. 3) to move it to its final location. After- wards, the brakes must be applied to the instrument's castors. Fig. 20 ASP6025 Tissue Processor...
Instrument Setup 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 de- vice. 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.
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Fig. 23 • Now attach one end of the exhaust hose (74) to the upwards-pointing tube (79, Fig. 23) of the flange and push it down as far as it will go (Fig. 24). • Finally, connect the other end of the exhaust hose with the external exhaust station. Fig. 24 ASP6025 Tissue Processor...
Instrument Setup 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.
• To continue the process after opening the retort, move the handle back into the locking position (Fig. 28). Then press the CONTINUE button on the screen. The device is equipped with an emergency un- lock function. For details, see Chap. 7.4. Fig. 29 ASP6025 Tissue Processor...
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Instrument Setup The retort (continued) Insert the sieve (42) into the drain opening on Fill level sensors the floor of the retort. It is imperative to insert the mag- netic stirrer before an infiltration program is started! Attach the magnetic stirrer (41) to the axis on the floor of the retort with the little hole facing upwards.
4.4.2 Counter area • To the right of the retort in front of the screen, there is a stain- less steel counter area (45) for setting down the prepared specimens (Fig. 33). Baskets removed from the retort can also be set down there. • It is recommended that you cover the counter area with cellulose. Fig. 33 ASP6025 Tissue Processor...
Instrument Setup 4.4.3 Specimen baskets • 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.
Despite this, avoid contact between the two. A small plate (Detail, item 52) with the serial Immediately wipe up any reagent splashes! number of the instrument is attached to the console in which the USB port is located. ASP6025 Tissue Processor...
Instrument Setup 4.4.5 The paraffin station • The paraffin station (54) is located behind the left door (53) of the instru- ment, 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.
The handles and covers are also hot, therefore always wear gloves and proceed carefully. Fig. 41 • The baths can be filled with liquid paraffin manually or from the paraffin station. It is also possible to fill with pellets - the melting time then is approx. 720 min. ASP6025 Tissue Processor...
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Instrument Setup • 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.
Remove the unwanted RTU-bottle and replace with a new one (in the drawer!) • If you have removed an RTU-bottle, place the filler neck (61) in a hole (62) provided for this purpose in the grating on the floor of the drawer (Fig. 45). Fig. 45 ASP6025 Tissue Processor...
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- 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. Only RTU-bottles from Leica are approved for this instrument. However, if d ifferent bottles are used, the customer must INDEPENDENTLY check that they are suitable for such use. (For information about temperature and dimension requirements see page Fig.
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Fig. 48 If RTU-bottles other than those installed by Leica are used in the drawer, these must be resistant to the following reagents and temperatures and dimensionally stable. For cleaning solutions up to a temperature of 71 °C For progress reagents up to a temperature of 64 °C...
• When inserting a system bottle, always ensure that the retaining ring (35) is tightened and the connection port ONLY Leica system bottles can be used. (65) clicks into place correctly with the O-ring (65. Once the pressure point is exceeded, you can clearly feel it click into place, thus ensuring an optimum fit in the reagent cabinet.
To do so, pull the tray out by the handle (Fig. 53) and empty it if necessary. Dispose of waste solvents with care according to local regulations and the waste manage- ment policy of the company or institution. Fig. 53 ASP6025 Tissue Processor...
Instrument Setup 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. The labels for system bottles come in eight different colors.
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The station number can likewise be noted on the label as well as the date when the specified reagent was commissioned (Fig. 57). This must also be adjusted in the reagent status for a newly filled RTU-bottle. Fig. 57 ASP6025 Tissue Processor...
Instrument Setup Switching the instrument on 26) into the ‘POWER IN‘ socket on the rear side of the instrument. • Plug the power cable (39, Fig. • 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 on the rear panel of the instrument (item 37 in Fig. 26). • The instrument will take a few minutes to initialize after switching on.
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To exit this menu, the device must be restarted. To do so, press the RESTART APPLICATION button (8 in Fig. 60) and confirm the following prompt with YES. The initialization restarts as shown in Fig. 58 Fig. ASP6025 Tissue Processor...
Alarm functions In the ASP6025, states can occur that require the attention of, or a decision on the part of, the user. In the sim- plest case, these are confirmations for continuing in the infiltration program. In addition, however, during con- tinuous 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.
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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.
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This means that stereo jack. Depending on the configuration of the polarity, the the alarm is triggered even if the ASP6025 is de-energized (e. g. inner or the outer terminal of the stereo jack is switched through in the event of a power supply failure).
Instrument Setup Touchscreen functions The ASP6025 is operated via a color LCD touchscreen. This touchscreen is resistant to reagents and responds even if the operator is wear- ing laboratory gloves. Activating critical functions usually triggers a prompt that must be confirmed before the function is carried out.
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The graphic appearance of the button symbols in the ASP6025 changes depending on whether the allocated function is possible (enabled) or not possible (disabled). not active Disabled button symbols differ from those that are enabled by their thinner border.
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Important keys for switching: Shift: Switches to upper case letters and back. AltGr: Permits the entry of special characters. <-- : Deletes the previous character. Delete: Deletes the entire line. Takes over the entered term. Fig. 66 ASP6025 Tissue Processor...
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ASP6025. Fig. 67 Before starting an operation, you first have to select the stations (system bottles not active active and RTU-bottles) to be used.
The instrument must then be switched off using the ON/OFF switch on the rear panel of the instrument (Item 37 in Fig. 3 / Fig. 26). Caution! The ASP6025 is allowed to be switched off completely in this way only. Otherwise, severe damage to the instrument's hardware and loss of data can occur. After a complete shutdown, the paraffin cools down and becomes hard. You may no longer be able to remove the paraffin bath drawers from the instrument. Important! If the ASP6025 is to remain shut off for a long period or be transported, it is mandatory to carry out a SMART cleaning before it is switched off. (For more information, refer to Chap. 6.1.4) ASP6025 Tissue Processor...
The ENHANCEMENT button is enabled in supervisor mode only. This menu displays the parameters for the ASP6025 which are to be configured during installation. Fig. 71 5.1.1 The Installation menu The serial number of the instrument and the current software version are entered at the factory and cannot be edited.
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• Press OK and the selected language is set. Fig. 74 Service functions Buttons located on the right side of the menu: INSTALL HELP UPGRADE SOFTWARE CALIBRATE TOUCHSCREEN are service functions and are only visible in Supervisor mode. Fig. 75 ASP6025 Tissue Processor...
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Operation The INSTALLATION menu In order to be able to install the help file, the associated file must (continued) be present as a ZIP file on a USB stick. Installing help • Plug in the USB stick and press the INSTALL HELP button. • Then, follow the instructions on the screen and confirm ...
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. The SYSTEM SETUP window is divided into eight areas: • Program options • Basket mode • Measure concentration • Date/Time • Security • Alarm relay • Instrument • Acoustic instrument alarm ASP6025 Tissue Processor...
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Operation System settings The PROGRAM OPTIONS are used to define the settings with which (continued) programs are executed. By pressing a button you can modify the Program options corresponding value; the current setting is displayed next to the button (Fig. 80). STATION ALLOCATION: Here you can choose between two modes: Concentration and Auto by RMS In Auto by RMS mode, the order is controlled by the current RMS values, i.e.
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A warning message is also output at the end of an infiltration program if the threshold val- ues have been exceeded. DISABLED mode The number of cassettes inserted into the retort is not queried prior to the program start. ASP6025 Tissue Processor...
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Operation System settings (continued) Measuring the alcohol concentration The MEASURE CONC. field (Fig. 85) shows whether or not alcohol concentration measurement is enabled. In concentration mode (Fig. 79), alcohol concentration measure- ment is ALWAYS enabled. Alcohol concentration can also be measured in RMS mode. If this is not desired, it can be disabled.
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• You can select a paraffin bath temperature between 50 °C and 65 °C. The input value is paraffin-specific and depends on the melting temperature of the selected paraffin type. Fig. 89 • Enter the desired paraffin bath temperature and then press OK to confirm. You should always set the value to the highest permitted temperature for the paraffin used since there is a small temperature drop when the retort is being filled. Fig. 90 ASP6025 Tissue Processor...
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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 Setting the date • Pressing the DATE button opens the settings window (Fig.
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The report contains the following data on the program that has run: • The program name • The program number • The infiltration program that was executed • Run log events that occurred during the program execution. The program reports can be saved to a USB stick using the SAVE PDF PRINTOUTS in the ENTRIES menu. ASP6025 Tissue Processor...
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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) NOTE CRITICAL ERROR Fig. 95 If a sound has been selected for an event, its name is displayed beside the button (Fig.
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• In the POLARITY INV. each touch of the button toggles between "OPENING CONTACT" and "CLOSING CONTACT". Configure the buttons such that there is NO alarm sounding. • Set the associated TEST button to "ON". The alarm should now sound again. Changing the polarity • This setting is stored so that the alarm is actually forwarded as well. Fig. 99 ASP6025 Tissue Processor...
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. Operator access level The OPERATOR symbol is displayed in the top right corner of the screen.
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• Press UNLOCK and use the keyboard to enter the password to unlock the instru- ment. If Lock mode is activated while a program is running, the program will continue but an operator cannot intervene. Fig. 102 ASP6025 Tissue Processor...
The service maintenance symbol is displayed in the top left corner in all menus. Now, at the latest, maintenance by the Leica Technical Service is required in order to prevent any serious damage to the instrument.
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• If the set alarm threshold value is exceeded, a message is output on the screen to inform the user that the carbon filter age has been exceeded. • When this message appears, at the latest, the active carbon filter must be replaced in order to ensure that it functions and works efficiently. Fig. 104 ASP6025 Tissue Processor...
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.
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The status of the PDF printer is displayed here. It cannot be changed. "Printer ready" means that a PDF file can be generated and saved after a program has run, if this was specified in the run options (see also Chapter 5.1.2, Printer Fig. 94). ready Fig. 108 ASP6025 Tissue Processor...
The SYSTEM STATUS symbol appears in all menus of the ASP6025 software and is constantly being re-evaluated. If there is a system status change, then the corresponding new symbol is displayed.
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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). This message must also be confirmed with OK. Fig. 112 ASP6025 Tissue Processor...
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Operation The system status Display of the system status (continued) 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 cor- rected.
• Events that may have had an effect on running a program, e.g. power failure, pause or opening a lid while the program is running. The data can be sorted by: • Date • Event ID or • Level To do this, press the respective button in the table header. ASP6025 Tissue Processor...
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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 entries are sorted by number – the most recent entry is shown at the top of the table and visually highlighted. The following events are included in the RUN LOG: The data can be sorted by: • Error Number, • Number of Occurrences, • First Occurrence or • Most Recent Occurrence. To do this, press the respective button in the table header. ASP6025 Tissue Processor...
Operation 5.1.9 Saving or loading data Saving data to a USB stick 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.
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Operation Saving or loading data Loading data from a USB stick (continued) 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,...
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Operation Saving or loading data Save PDF printouts (continued) With this function, the PDF files from programs that have been run or lists stored in the instrument can be transferred to a USB stick. To save these PDF files to a USB stick, proceed as follows: • Press the ENTRIES and SAVE PDF PRINTOUTS buttons to call up the SAVING PDF PRINTOUTS window (Fig.
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Operation Saving the incident report to a USB stick To receive support from Leica when an instrument malfunction, decrease in specimen quality or destruction of a specimen oc- curs, the entire incident report must be saved and a routine save must be carried out (routine backup files, SAVE TO USB STICK button).
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Operation a folder named "ASP6025Exlog" has been created. In this 10. If the save operation fails, the following error message ap- folder, you should find files with the extension "CAB" that pears. Confirm it and check the specified information. Please are named according to the following pattern: note that the message also appears if no incidents occurred within the specified time frame.
When the maximum number of cycles is reached, a message indicating that it needs to be emptied appears. • If a bottle contains a reagent that has exceeded a warning value, this is shown with an exclamation mark on a yellow background. For this function to take effect, threshold values must have been set. ASP6025 Tissue Processor...
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Operation The smart screen Additional functions on the SMART SCREEN (continued) • The stirrer can be started and stopped again. Stirrer off Stirrer working When the button is colored orange, the stirrer is working (Fig. 131). Fig. 131 • 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.
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135). The paraffin station will remain locked while the melting process is taking place. Fig. 135 The ASP6025 has an extensive help system that can be started The online help from every main window. This help system includes the entire Instructions for Use in the corresponding local language.
Operation Reagents 5.2.1 Editing the reagent list 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.
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If a reagent is renamed, its allocation to a station will be deleted. • Highlight the reagent the name or group of which you wish to change. • Press the corresponding button symbol in the headline. • In the entry window (or via the keyboard), enter the new reagent group allocation / the new reagent name. • Press OK to save the new reagent group / reagent name. Fig. 139 ASP6025 Tissue Processor...
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. Please remember that a reagent which is already used in a program can- not be deleted.
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(after the cleaning) (Fig. 143). From there, you can press YES to go directly to the REAGENT STATUS window. Fig. 143 • The reagent status highlights the exceeded values in red in the table (Fig. 144). Displayed if: • The number of processed cassettes is exceeded. • The number of specified cycles is exceeded. • The days until changing the reagent are exceeded. Fig. 144 ASP6025 Tissue Processor...
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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.
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1500 cassettes or 5 cycles ParaLast after 2400 cassettes or 8 cycles 1 paraffin after 2400 cassettes or 8 cycles Cleaning xylene after 6 cycles Cleaning alcohol after 6 cycles Cleaning water after 6 cycles for a low throughput of approx. 100 cassettes daily ASP6025 Tissue Processor...
Operation 5.2.3 The reagent status The REAGENT STATUS window (Fig. 145) 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. The following is displayed: • The current age of each reagent • The current status of each station (full or empty)
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• Otherwise, switch to the SETTINGS menu and press the REAGENT STATUS button there. • Highlight the newly added reagent in the table (Fig. 146). • Press SET AS FULL to mark the station status as "full". If the RMS has been activated, all warning threshold values for the newly filled reagent are automatically reset to "0". ASP6025 Tissue Processor...
(Fig. 147) shows a list of all stations with the assigned reagents that have been defined for the respective station. Fig. 147 The ASP6025 includes the following stations for reagents: Adding/changing a reagent • In the table, highlight the station that is to be filled with a • 9 system bottles in the reagent cabinet, reagent (Fig.
gram display. Fig. 148 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. 148). • Select the color you want and confirm with OK. • The newly selected color will now be used on all stations to represent the highlighted reagent group. T he color will apply for all reagents in the group. • To exit the display without changing any colors, select CANCEL. ASP6025 Tissue Processor...
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.
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• 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. The software notifies the customer of the situation.
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Operation Functional description of ethanol rotation (continued) step In the following program (that is to say when another infiltra- tion 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.
Here, you can configure the threshold value for the ethanol concentration. Possible ethanol values range between 50 % and 60 % in 1 % increments. An ethanol threshold value of 55 % is set by default. Fig. 156 ASP6025 Tissue Processor...
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 replace- ment via a screen message (Fig.
The VIEW/EDIT USER PROGRAMS window (Fig. 158) 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.
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. 158) highlight a program as similar as pos- sible 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, "(2)"...
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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. 160 ASP6025 Tissue Processor...
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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.
Finally, pressurized air is used to clear the hose after each fill / drain so that no dirt remains. The hose must therefore not be taken out of the external station until this cleaning step is complete. Fig. 161 ASP6025 Tissue Processor...
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Operation Draining/filling reagents (continued) Press the SMART SCREEN button. The SMART SCREEN (Fig. 162) pops up. The smart screen is the initial screen for manual operation of the instrument. ATTENTION VERY IMPORTANT! During remote filling or draining, always se- lect ONLY the external station (79) and the bottle that is to be filled or drained in the SMART FUNCTIONS window.
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• The entire process is displayed graphically on the screen (SMART SCREEN view) (Fig. 166). Fig. 166 • A message window on the screen shows that the process has been completed (Fig. 167). To continue working, confirm this with OK. • If the same reagent will not be used in the next operating step, the retort may have to be cleaned with a cleaning program. Fig. 167 ASP6025 Tissue Processor...
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Operation Draining/filling reagents (continued) Remote filling Select station Press button 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.
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• Therefore leave the hose in the remote station until the process has ended, or insert it into another suitable container. Fig. 172 • After the rinsing has been completed, a message appears (Fig. 173), informing you that remote filling has been com- pleted. To end the process, press OK. Fig. 173 ASP6025 Tissue Processor...
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Operation Manually changing the reagents Caution! Never replace reagents or fill empty system bottles or RTU-bottles while a process is run- ning. This can result in severe damage to the instru- ment. • Remove the system bottle (15) from the reagent cabinet and unscrew the container cover (15. • Drain the used reagent into a bulk container and then refill the system bottle.
Fig. 177 • Confirm the prompt (Fig. 177) with YES. If the last reagent in the retort is not com- patible with paraffin, the retort must first be cleaned using a cleaning program (without water step!). • The liquid paraffin is then pumped from the paraffin station to the retort. • Then, the selected paraffin bath is filled from the retort. • Finally, the retort has to be cleaned. Fig. 178 ASP6025 Tissue Processor...
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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. 179) menu to activate heating and melting after being refilled with paraffin pellets. • T o do so, go to the reagent status, select the paraffin station and press the SET AS FULL button.
When drainage is finished, the hose is Fig. 180 cleaned automatically using air. Do not remove the hose from the external re- ceptacle until this cleaning step is complete. • Using the SMART SCREEN button, call up the SMART FUNCTIONS screen (Fig. 181). Fig. 181 ASP6025 Tissue Processor...
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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 (without water step!). • Select the paraffin tank to be emptied and the receptacle for the used paraffin (external station) (Fig. 182). • Then press STATION DRAIN. Fig. 182 • The following security prompt must be confirmed in order to continue (Fig. 184). Fig. 184 Fig. 183 • If necessary, the retort must be heated to the necessary temperature so that the paraffin remains fluid. Then, the paraffin is pumped from the selected paraffin bath into the retort.
This can also be done after the program has started. • In this case, the operator has to interrupt the program by pressing the PAUSE button. However, this action only affects the current program run and does not change the stored protocol. For more information, refer to Chapter 5.5.4. ASP6025 Tissue Processor...
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.
PROGRAM selection window appears (Fig. 189). This lists ALL programs that are stored in the instrument, including the user-defined programs. • Select the program you want and press OK to confirm. The name of the program is transferred to the empty line. Fig. 189 ASP6025 Tissue Processor...
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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. 190). 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.
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Deleting a Favorite program • Highlight the program you want to delete in the VIEW/EDIT FAVORITES window. • Touch the DELETE button. The highlighted program will be deleted without a security prompt. The Favorite program will only be removed from the FAVORITES list, the program itself will not be deleted. ASP6025 Tissue Processor...
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.
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PROGRAMS window, the START button must be Fig. 193 pressed to start the program. If the ASP6025's automatic pressure test fails, a pro- cessing program CANNOT be started and the retort CANNOT be filled manually via the SMART screen.
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Operation Starting a program Fig. 195 shows the SMART SCREEN while an infiltration (continued) program is running. The rotating green and white symbol in- dicates that a protocol is currently being processed. The number of cassettes that are being pro- cessed in the retort is displayed.
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197) 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 Fig.
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. 199 After fully draining the paraffin, an automatic dripping time of 2 minutes is implemented in order to optimize the use of cleaning reagents. Instructions for Use V 2.4 RevL - 12/2015...
50 and 60 %. • The ethanol concentrations shown are the initial concentrations that apply for installation of the tissue processor. Bottle Reagent 70 % ethanol 80 % ethanol 95 % ethanol 100 % ethanol 100 % ethanol 100 % ethanol Xylene Xylene Xylene Formalin Water Xylene exchange Ethanol exchange -> 100 % Cleaning xylene Cleaning alcohol ASP6025 Tissue Processor...
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Operation Standard tissue over night All specimen types that can fit into a standard cassette, tissue with a high fat content may require a longer protocol. Instructions for Use V 2.4 RevL - 12/2015...
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Operation 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. ASP6025 Tissue Processor...
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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. 202 Instructions for Use V 2.4 RevL - 12/2015...
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Operation Xylene protocol 1 h Endoscopic biopsies and needle biopsies from chest and prostate. Diameter up to 1.5 mm. Fig. 203 Instructions for Use V 2.4 RevL - 12/2015...
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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. 204 ASP6025 Tissue Processor...
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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. 205 Instructions for Use V 2.4 RevL - 12/2015...
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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. 206 ASP6025 Tissue Processor...
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Operation Xylene protocol 12 h All routine tissues with maximum dimensions of 20 x 10 x 5 mm (tissue with a high fat content may require a longer protocol). Fig. 207 Instructions for Use V 2.4 RevL - 12/2015...
To start a xylene-free program, it must have been saved in the list of "FAVORITES". See also Chapter 5.5.3. The isopropanol concentrations shown are the initial concentrations that apply for installation of the ASP6025 modular tissue processor. Reagent positioning/Replacement cycle for time-optimized xylene-free programs: System bottle S1 contains 70 % ethanol.
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Operation Xylene-free 1 h Endoscopic biopsies and needle biopsies from chest and prostate. Diameter up to 1.5 mm. Fig. 208 Instructions for Use V 2.4 RevL - 12/2015...
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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. 209 ASP6025 Tissue Processor...
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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. 210 Instructions for Use V 2.4 RevL - 12/2015...
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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. 211 ASP6025 Tissue Processor...
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Operation Xylene-free 12 h All routine tissues with maximum dimensions of 20 x 10 x 5 mm (tissue with a high fat content may require a longer protocol). Fig. 212 Instructions for Use V 2.4 RevL - 12/2015...
Cleaning and Maintenance It is mandatory to wear laboratory gloves for all cleaning tasks! 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).
After 6 cleaning cycles, both cleaning xylene and cleaning alcohol must be replaced. Furthermore, neither molds or other objects may be cleaned using any ASP6025 cleaning program! If the last reagent in the retort was either paraffin, ParaLast™...
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- no CANCEL key is present. Cleaning MUST be carried out! When cleaning with the water step, the retort is filled to the second level in the water step, Fig. 220 regardless of whether 3-basket or 2-basket mode has been selected. ASP6025 Tissue Processor...
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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 speci- mens 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.
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 thor- oughly cleaned using the extended cleaning mode and that there is no reagent in the retort.
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In the first phase, the fluid lines are all purged in sequence using a blast of compressed air. For this purpose, all system and RTU-bottles (in the reagent cab- inet and in the drawer) have to be in the instrument (Fig. 225). Fig. 225 ASP6025 Tissue Processor...
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Cleaning and Maintenance The SMART cleaning (continued) Step 2 The user is prompted to remove all reagent bottles from the instrument (Fig. 226). 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.
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When changing the software configuration, adjust the arrange- ment of the bottles and reagents according to the new configu- ration. The reagents can be reused as long as the specified limits regarding contamination have not been exceeded. ASP6025 Tissue Processor...
Caution! Do not use solvents on painted surfaces, warning labels or the touchscreen. Checking the drip tray CAUTION! ASP6025 Some of the reagents used in the are hazardous to health. Therefore always wear gloves and safety goggles when han- dling them.
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See also Chapter 5.1.4. When inserting the new filter, make sure that it is pushed all the way into the compartment and that the flap is closed. ASP6025 Tissue Processor...
(prior to this, melt the paraffin residue in a provided oven) Remove the paraffin from the outer surface of the ASP6025 and wipe the instrument Clean the glass window of the retort Remove the paraffin from the retort lid and the seal, and...
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Clean the RTU-bottles Check to see if the system bottle connections are perma- nently screwed into place Clean the outer surface of the ASP6025 Check the filter in the paraffin station and clean it if necessary Check and clean the lids of the paraffin baths...
Cleaning and Maintenance 6.3.1 Daily cleaning and maintenance Clean the retort lid and seals Use the provided paraffin scraper to scrape off the paraffin on the interior surfaces of the retort lid. Carefully remove the paraffin along the lid seal. 1.
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This will enable you to return to the standard display. This way, you will be able to touch and clean Fig. 236 the screen without inadvertently enabling a function. Only the following cleaners can be used to clean the screen: • Surface cleaner for plastic (Poliboy) • Paraguard by Polyscience • PC monitor cleaner (spray) ASP6025 Tissue Processor...
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Cleaning and Maintenance Cleaning the level sensors The level sensors must be cleaned of all resi- due (reagents and paraffin) after every clean- ing program. You will be prompted to clean the sensors by the instrument software at the end of each cleaning program (Fig. 237). Proceed as follows: • Remove the screen (40, Fig.
ALWAYS be inserted in the white system bottle. Tighten the retaining ring (35) so that the bottle is perfectly sealed. 65.1 65.1 Connection port with delivery hose Connection port Condensate bottle System bottle Fig. 241 Fig. 242 ASP6025 Tissue Processor...
The level can be identified by simply looking through the RTU-bottles if these are cleaned regularly to remove clinging contamination. Using a bottle brush and a laboratory detergent in warm water. Leica RTU-bottles must never be cleaned in a dishwasher. The reagent containers are NOT dishwasher-proof! Fig. 243...
Troubleshooting Troubleshooting When a problem occurs in the 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. If the failure oc- curred during a program run, check the Run Log for an indication of whether the failure oc- ...
Troubleshooting 7.1.2 Instrument procedure in case of power failure If the instrument detects a power failure, the heaters and the monitor are im- mediately switched off. If the power failure lasts longer than 10 s, the safety mechanism is initiated. 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.
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"decision" is made about how to proceed. Current step for power failure Protection in the safe reagent Formalin (fastening) Formalin Ethanol (Dehydration, diluted) Formalin Ethanol (absolute) Formalin Xylene (intermedium) Xylene (heating off) Isopropanol (intermedium) Formalin Paraffin Paraffin (heating off) ParaLast ParaLast ASP6025 Tissue Processor...
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After the actions described, the ASP6025 (and thus the specimens as well) is in a safe state. The tissue samples are in a safe reagent and the currently running program is modified such that when the power supply is restored, the processing can be resumed.
The safe specimen state of the instrument is indicated on the SMART screen with an icon (109) immediately to the left of the retort (Fig. 246). In addition, a corresponding entry in the Run Log is generated. Fig. 246 ASP6025 Tissue Processor...
Clean the retort in a cleaning program (see Chapter 6.1). If you cannot determine or eliminate the problem by carrying out the above listed steps, call Leica Technical Service before attempting to run any further programs. Instructions for Use V 2.4 RevL - 12/2015...
Then, the retort is filled with a safe reagent. 2. Wait until the unlock symbol (Fig. 247) lights up. If the unlock symbol does not light up after a maximum of 5 minutes, a mechanical emergency Fig. 247 unlock is necessary (see the following section). ASP6025 Tissue Processor...
Fig. 248 pressure, open the bolt handle very carefully and slowly. 3. Contact an authorized Leica service technician immediately and notify this person of the mechanical emergency unlock activation. If you fail to do this, any warranty becomes void. 4. Do not put the instrument back into operation until the inspection is complete.
Cleaning tools for prisms and level sensors ........................14 0495 47955 Microfiber cloth for prism ..............................14 0495 47736 Maintenance kit ................................14 0495 48279 Power cable for UK ............................... 14 0411 49619 Power cable for EU 230 V ...............................14 0411 32570 Power cable for Brasil ..............................14 0411 49615 ASP6025 Tissue Processor...
Service information If you are in need of technical customer support or spare parts, please contact your Leica representa- tive or the Leica dealer where you purchased the instrument. Please provide the following information: • Model name and serial number of the instrument.
The focal point of the installation, orientation and training was proper operation, with particular emphasis on risk prevention (laboratory person- nel, tissue, instrument functions). Installation, orientation and training were carried out on the ASP6025 vacuum tissue processor based on the instructions for use with version number ........, by a (by more than one) trained Leica employee(s)/product specialist(s).
Dear Customer, Any product that is to be returned to Leica Biosystems or serviced on site, must be cleaned and decontaminated in the appropriate manner. Since it is not possible to decontaminate for prion diseases, such as CJD, BSE, CWD etc., equipment exposed to specimens containing prion diseases cannot be returned to Leica Biosystems for repair.
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If no**, please indicate why not: Such equipment must not be returned without the written agreement of Leica Biosystems. Decontamination Certificate (Master) The equipment has been prepared to ensure safe handling/transportation. Whenever possible, please use the original transportation case/box. Important - to avoid refusal of shipment: Place one copy in the unit prior to packaging, or hand it over to the service engineer.
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Notes Instructions for Use V 2.4 RevL - 12/2015...
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Do you have a question about the asp6025 and is the answer not in the manual?
Questions and answers
after changing the paraffin, the retort light is red not green