ASP300 S Operating Manual V1.2 Jan 2008

NOTE 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 manual according to the latest technical developments, nor to provide our customers with additional copies, updates etc. of this manual. For erroneous statements, drawings, technical illustrations etc. contained in this manual we exclude liability as far as permissible according to the national legal system applicable in each individual case. In particular, no liability whatsoever is accepted for any financial loss or consequential damage caused by or related to compliance with statements or other information in this manual. Statements, drawings, illustrations and other information as regards contents or technical details of the present manual are not to be considered as warranted characteristics of our products.

These are determined only by the contract provisions agreed between ourselves and our customers. Leica reserves the right to change technical specifications as well as manufacturing processes without prior notice. Only in this way is it possible to continuously improve the technology and manufacturing techniques used in our products. This document is protected under copyright laws. Any copyrights of this document are retained by Leica Biosystems Nussloch GmbH. Any reproduction of text and illustrations (or of any parts thereof) by means of print, photocopy, microfiche, web cam or other methods – including any electronic systems and media – requires express prior permission in writing by Leica Biosystems Nussloch GmbH. For the instrument serial number and year of manufacture, please refer to the name plate at the back of the instrument.

© Leica Biosystems Nussloch GmbH

Published by: Leica Microsystems Nussloch GmbH Heidelberger Str. 17 - 19 D-69226 Nussloch Germany Telephone: +49 (0)6224 143-0 Fax: +49 (0)6224 143-200 Internet: http://www.histo-solutions.de Leica ASP300 S

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Table of Contents 1.

Important information ... 6

2.

Safety ... 7

2.1 2.2 2.3

Safety instructions ... 7 Warnings ... 7 Integrated safety devices ... 11

3.

Instrument components and specifications ... 12

3.1 3.2 3.3 3.4 3.5

Overview - instrument components ... 12 Specific instrument options ... 14 Standard delivery - packing list ... 15 Technical Data ... 16 Compatible reagents ... 19

4.

Setting up the instrument ... 20

4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8

Site requirements ... 20 Electrical connection ... 20 Installing the accessories ... 22 Setting up the data connections ... 23 Alarm functions ... 24 Switching the instrument on ... 25 Touchscreen functions ... 27 Checklist for first operation ... 28

5.

Operation ... 29

5.1 Setting up the instrument parameters ... 29 5.1.1 System setup ... 29 5.1.2 Access levels ... 32 5.1.3 INSTALLATION menu ... 34 5.1.4 Editing the reagent list ... 37 5.1.5 Viewing the program list ... 40 5.1.6 Adding and/or modifying programs ... 41 5.1.7 Favorites ... 44 5.1.8 Editing the stations ... 46 5.1.9 Reagent groups ... 47 5.2 Reagent handling ... 48 5.2.1 Fill/drain reagents (other than wax) ... 48 5.2.2 Changing the wax ... 50

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Operating Manual V 1.2 – 01/2008

Table of Contents 5.3 Running programs ... 53 5.3.1 Editing a selected program ... 54 5.3.2 Starting a program ... 56 5.4 Reagent status ... 57 5.5 System Monitor ... 58 5.6 On-line help ... 59

6.

Solutions ... 60

6.1 6.2 6.3 6.4

General ... 60 Power failure ... 60 Troubleshooting ... 61 Typical fill or drain problems ... 62

7.

Cleaning and Maintenance ... 63

7.1 Clean programs ... 63 7.1.1 Retort clean programs ... 63 7.1.2 Wax clean program ... 65 7.1.3 Smart Clean ... 66 7.2 General cleaning steps ... 67 7.2.1 Daily cleaning and maintenance ... 69 7.2.2 Periodic cleaning and maintenance ... 71 7.3 Preventative maintenance schedule ... 72

8.

Warranty and Service ... 74

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1.

Important information

Symbols used in this manual

Designated use

Warnings appear in a gray box and are marked by a warning triangle . Notes, i.e. important user information appear in a gray box and are marked by an information symbol

.

Flammable solvents and reagents are marked with this symbol.

Instrument surfaces which become hot during operation are marked with this symbol. Avoid direct contact with these surfaces - they may cause burns.

(5)

Figures in brackets refer to item nos. in drawings.

ENTER

Function keys to be pressed on the instrument touch screen are written in bold-print capital letters.

Qualification of personnel • The Leica ASP300 S may be operated only by trained laboratory personnel. • The instrument may be operated only according to the instructions contained in this manual.

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The instrument has been designed so that it is safe to use by the operator as well as for processing specimens – provided that it is operated according to the present instruction manual. The Leica ASP300 S is a modular automated tissue processor designed for the following laboratory applications: • fixation, • dehydration • paraffin wax infiltration of histological tissue specimens. The Leica ASP300 S must be operated exclusively with the reagents listed in chapter 3.5 - "Compatible reagents" .

Any other use of the instrument is considered improper! Failure to adhere to these instructions may result in an accident, personal injury, damage to the instrument or accessory equipment.

Instrument type All information provided in this manual applies only to the instrument type indicated on the title page. A name plate indicating the instrument serial number is attached to the back of the instrument. Fig. 1 Operating Manual V 1.2 – 01/2008

2.

Safety

Make sure to comply with the safety instructions and warnings in this chapter. Make sure to read these instructions, even if you are already familiar with the operation and use of other Leica products.

2.1 Safety instructions This instruction manual includes important information related to the operating safety and maintenance of the instrument and it is an important part of the product.

This instrument has been built and tested in accordance with the safety regulations on electrical measuring, control, regulating and laboratory devices. In order to maintain this condition and to ensure safe operation the operator must comply with the instructions and warning contained in this instruction manual.

If additional requirements on accident prevention and environmental protection exist in the country of operation, this instruction manual must be supplemented by appropriate instructions to ensure compliance with such requirements.

For current information on applicable standards, please refer to the instrument’s CE declaration and visit: http://www.histo-solutions.com

The protective devices on both instrument and accessories may neither be removed nor modified. Only authorized and qualified service personnel may repair the instrument and access the instrument’s internal components.

2.2 Warnings The safety devices installed in this instrument by the manufacturer only constitute the basis for accident prevention. Primarily responsible for accident-free operation is above all the institution which owns the instrument and, in addition, the designated personnel who operates, services or repairs the instrument. To ensure trouble-free operation of the instrument, make sure to comply with the following instructions and warnings.

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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 this manual) must be followed when operating or replacing the item marked. Failure to adhere to these instructions may result in an accident, personal injury, damage to the instrument or accessory equipment. Some instrument surfaces become hot during operation. They are marked with this warning label. Touching these surfaces may cause burns.

Transport and Installation The instrument may only be transported in an upright position. Follow the unpacking instructions carefully to avoid damage to the instrument! A cleaning must be performed prior to each transport, during which the instrument may be shaken, tilted or lifted. Severe internal damage may otherwise occur. The instrument MUST be connected to an earthed mains power outlet socket. The instrument must not be connected to an extension cord without protective earth conductor. Ensure uniform current supply according the to set voltage! The set voltage CANNOT be changed by the user. Severe damage may occur if the instrument is connected to a power supply voltage other than that to which it was originally set. The instrument must be set up in a well ventilated area, free from any ignition sources. The chemicals to be used in the Leica ASP300 S are both flammable and noxious. Do not operate the instrument in rooms with explosion hazard. If there is a significant difference in temperature between the warehousing and the installation site of the instrument and if at the same time there is a high air humidity level, condensation water may form. In this case, a waiting period of at least two hours must be observed before the instrument is switched on. Failure to adhere to this waiting period may result in damage to the instrument. Failure to adhere to this waiting period may result in damage to the instrument.

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Operating Manual V 1.2 – 01/2008

2.

Safety

Warnings - Operating the instrument The Leica ASP300 S may only be operated by trained laboratory personnel, according to its designated use and per the present instruction manual. The ON/STOP switch at the side of the instrument may be used in an emergency to stop the instrument during operation. Always press PAUSE before opening the retort lid during processing to allow the retort to vent. Do not remove the wax drain hose or the remote fill/drain hose until the fill or drain has been completed, as pressurized air is used to clear the hose after each fill / drain. After refilling / replacing the reagent bottles ensure that the lids are tight. The bottles must be properly pushed home into the connection manifolds at the rear inner wall of the reagent module. Failure to correctly plug the reagent bottles into the manifold will cause an interruption to the processing run and may result in spilling of reagents. Fixatives containing mercuric salts, acetic or picric acid will corrode metallic components in the instrument. After each paraffin step a retort clean cycle must be run.

Material safety data sheets can be obtained from the supplier of the chemicals. They are also available on the Internet: http://www.msdsonline.com

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2.

Safety

Warnings -handling reagents Be careful when handling solvents! Always wear rubber gloves and safety goggles when handling the chemicals used in this instrument. Reagents used for tissue infiltration can be both toxic and/or flammable. To avoid damaging the instrument only use those reagents that are listed in chapter 3.5! Do not use acetone, benzene or trichlorethane in the instrument! Use caution when handling paraffin wax or removing baskets – molten paraffin is hot and may cause burns. Also, avoid personal contact with paraffin stations and retort walls – they can be very hot as well. Dispose of waste solvents with care according to local regulations and the waste management policy of the company or institution. Do not clean reagent bottles in an automatic dishwasher – they are NOT dishwasherproof.

Warnings - Cleaning and maintenance Prior to each maintenance and/or cleaning, switch the instrument off and disconnect mains power. Do not clean the instrument with solvents containing acetone or xylene. No liquid may be spilled into the internal components of the instrument – neither during operation nor during cleaning. When working with cleaning detergents, comply with all safety instructions by the manufacturer of the product and the laboratory management policy. The condensate bottle should be inspected at least once every week and, if necessary, emptied.

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Operating Manual V 1.2 – 01/2008

2.

Safety

2.3 Integrated safety devices In the case of power failures or other processing problems the Leica ASP300 S incorporates specimen protection features such as a fluid level sensor and sophisticated software controls which ensure that processing can be completed successfully without damage to the tissue specimens. Overpressure protection • When power is off the air pump and air valves default to a safe condition (retort vented, no pressure generation). • If the microprocessor control fails to stop the air pump at the right moment during retort pressurizing, a separate electronic hardware circuit will cut pump power. • In addition, there is a safety relief valve that vents all excess air pump output to atmosphere. Overcurrent protection • Overcurrent conditions are protected against by both the mains fuse and the separate heating power fuses. Overheating protection An error is indicated and all heating is stopped by the microprocessor control if the instrument detects any of the following conditions: • abnormally high temperature (>75 °C) • contradictory results of the temperature sensors • failure of one or more heating power control components • If the microprocessor fails to interrupt heating power, independent temperature limiting hardware circuits limit the temperature rise to a safe level. • If the temperature limiting circuits malfunction, an independent hardware thermal fuse circuit cuts power to the heating elements. Over vacuum protection • The vacuum system is not capable of generating a dangerous vacuum condition. Overcurrent protection • Overcurrent conditions are protected against by both the mains fuse and the separate heating power fuses.

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3.

Instrument components and specifications

3.1 Overview - instrument components 4

3

1

23

6

22 7

5

10

9

21

20 12 11 13

8

19 17

18 2

15

14 16

12

Fig. 2

Operating Manual V 1.2 – 01/2008

3.

Instrument components and specifications

Overview - instrument components

Instrument components and accessories

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 -

The processor module contains three paraffin wax baths, a processing retort, and also a touch screen with integrated key symbols as well as the electronic components. The cassettes are held in three baskets (21), each of which has a capacity of up to 100 cassettes. All processing occurs in the stainless steel retort under the pressure, vacuum and temperature conditions selected. The quick-connect reagent bottles are stored in the reagent cabinet.

Basic instrument - processor module Basic instrument - reagent module Wax bath lids Retort lid Touch screen Cover flap of the instrument console Instrument console comprising: Printer port Local alarm connection Remote alarm connection Floppy disk drive Serial port Activated carbon filter Condensate bottle Reagent bottle (13 units) Drip tray Wax drain connection Remote drain connection Retort Wax baths Specimen basket Lid for specimen basket Splash protection

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3.

Instrument components and specifications

3.2 Specific instrument options • Reagent Management System option (RMS) that displays the usage (length and frequency of use) of each reagent and also allows automatic ordering of reagent sequence, thus eliminating the need to physically move reagent bottles. After renewal of one or more reagents in a sequence, the RMS automatically uses the reagents in order of increasing cleanliness. • In-process fluid recirculation ("tidal agitation") for continuous and efficient mixing of fluids. • Remote fill/drain system – can drain and refill reagent bottles from bulk containers via the retort and a hose plugged into the processor module while the user is fully protected against coming into contact with reagents. • Remote wax bath fill/drain feature. • Optical fluid level sensor. • Active paraffin wax solvent removal feature that increases the life of the wax by extracting and condensing contaminating solvents. • Magnetic stirrer – to gently circulate reagents, ensuring uniform reagent temperature. • Programmable finish time for processing programs. • Three-step retort drain feature (adjustable) minimizes reagent carryover. • Specimen processing under pressure, vacuum, alternating pressure / vacuum cycles or under ambient pressure. • Four user-programmable clean programs. The clean programs automatically skip any steps not required to complete the clean.

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Operating Manual V 1.2 – 01/2008

3.

Instrument components and specifications

3.3 Standard delivery - packing list The basic version of the Leica ASP300 S includes the following parts: 1 Leica ASP300 Basic Instrument 1 Set of power cords 230-240 V version: 1 Mains cable "D" 1 Mains cable "UK" ST-BU F-5A 100-120 V version: 1 Mains cable "USA-C-J" 1 Jumper cable - mains 1 Basket hook 3 Specimen baskets, assy. including lid,dividers, springs and handle 1 Remote fill/drain hose 1 Paraffin drain hose 1 Funnel 1 Lubricant, Molykote 111, for valves and O-rings 2 Activated carbon filters, assy. 1 Magnetic stirrer, complete 1 Paraffin wax scraper 14 Reagent bottles, plastic (13 in instrument) 1 Condensate collector, plastic (in instrument) 1 Drip tray (in instrument) 1 Splash protection 1 Maintenance kit (2 replacement lids, 9 o-rings) 1 Maintenance kit for pump (in instrument) 2 Sets of labels for reagent bottles, set of 15 each 1 Remote alarm plug 1 Operating manual for Leica ASP300 S, multi-language 1 3,5" HD-diskette, blank, DOS-formatted, (on rear of console cover) 1 Demo-Program, CD-ROM

Part no.

0411 13558 0411 27822 0411 13559 0411 34604 0476 34713 0476 34193 0476 34716 0476 34721 0476 43631 0336 35460 0476 34150 0476 34202 0476 35923 0476 34274 0476 34278 0476 34145 0476 34770 0476 35921 0476 35922 0476 35792 6844 01005 0476 34712

Please check all delivered parts against the packing list and against your order to verify whether the delivery is complete! If there is any difference, please contact your local Leica Sales Office immediately.

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3.

Instrument components and specifications

3.4 Technical Data Nominal voltage:

Nominal frequency: Main fuses:

Nominal power: Dimensions, (W x D x H), in mm: Dry weight, unpacked: Weight, packed: Operating temperature range: Relative humidity: IEC 1010 classifications:

Altitude: Local / remote alarm relays:

Paraffin wax baths Number of baths: Volume (liters): Melt time: Temperature: Temperature accuracy:

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Two factory-preset voltages (not user-adjustable): 100 to 120 V or 230 to 240 V 50 to 60 Hz Two fast-blowing melting fuses, 20 x 5 mm, UL-approved • for 100 to 120 V ; F 10 A 250 VAC • or 230 to 240 V ; F 5 A 250 VAC 1000 VA 595 x 680 x 1,325 approx. 160 kg 220 kg 15 °C to 35 °C 10 % to 80 %, non-condensing Protective class 1 Pollution degree 2 Overvoltage installation category II: • 800 V impulse (120 V systems) • 1500 V impulse (240 V systems) 2500 m maximum 30 V DC, maximum 2 A 2 connections: Both single voltage-free, changeover contacts (both Normally-Open and Normally-Closed connections available)

3 4.3 l per bath approx. 10 hrs 40 to 65 °C +1K

Operating Manual V 1.2 – 01/2008

3.

Instrument components and specifications

Retort Capacity: Reagent volume: Temperature (paraffin): Temperature (processing reagents): Temperature (cleaning reagents): Temperature accuracy: Filling time: approx. Drain time: approx. Impregnation vacuum: Impregnation pressure: Fill vacuum: Drain pressure:

max. 300 cassettes 4.3 l 40 to 65 °C ambient or 35 to 55 °C 50 to 65 °C +1K 90 sec 80, 120, 140 sec (adjustable) -70 kPa (g) 35 kPa (g) -70 kPa (g) 35 kPa (g)

General Reagent bottles: Cleaning solution bottles: Maximum bottle volume: Printer: Pretest check: Fluid level sensor: Recirculation (pump in/out): (a) Time before 1st cycle: (b) Time between cycles:

10 3 5.0 l Optional accessory ON/OFF ON/OFF ON/OFF 16 min 20 min

System setup Password status: Type of password: Reagent Management Status: Software access control (lock mode):

Supervisor / User alphanumeric, freely selectable ON/OFF ON/OFF

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3.

Instrument components and specifications

3.4 Technical Data (continued) Hardware and Software: • Large color Liquid Crystal Display (LCD) and touchscreen. • User-friendly, intelligent software. • 3,5" floppy drive and printer port. • Alarm system with two remote alarm sockets. • Password-protected instrument supervisor mode. • Multiple specimen protection system.

Capacities: • 15 programs that consist of up to 10 reagent and 3 paraffin wax steps. • Time per program step: 0 to 99 hours, 59 minutes. • Delay time: max. 7 days. • Up to 300 cassettes can be processed simultaneously. • Four user-programmable retort clean programs. • Wax clean program. • 10 reagent bottles. • 3 wax baths. • 3 cleaning solution bottles. • 1 condensate bottle. • Reagent temperature adjustable from 35 °C to 55 °C or ambient. • Paraffin temperature adjustable from 40 °C to 65 °C. • Choice of three retort drain rates of 80, 120 and 140 seconds. • Up to 100 reagent names in memory.

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Operating Manual V 1.2 – 01/2008

3.

Instrument components and specifications

3.5 Compatible reagents The following reagents may be used in the Leica ASP300 S: Fixatives 1. Formalin, buffered or unbuffered 2. Formalin saline Dehydration 1. Ethanol 2. Isopropanol 3. Methanol

4. Butanol 5. Industrial Methylated Spirits

Clearing 1. Xylene 2. Toluol * 3. Chloroform *

* Prior to using these reagents, contact your Leica representative or Leica directly for information on necessary protective measures.

Paraffin wax 1. Paraffin

Caution: Reagents other than those listed here may damage some components of the instrument. Do not use acetone, benzene or trichlorethane in the instrument.

Fixatives containing mercuric salts, acetic or picric acid will corrode metallic components in the instrument and shorten instrument life. If you choose to work with such fixatives, it is essential to perform a clean cycle which contains multiple water rinses each time after use, to minimize damage. In addition, we recommend frequent and regular preventive maintenance by the Leica Technical Service.

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4.

Setting up the instrument

4.1 Site requirements • The instrument needs approx. 650 x 700 mm floor space. • Practically vibration-free floor. • Room temperature constantly between +10 °C and +35 °C. • Relative humidity maximum 80%, non-condensing. • Avoid vibrations, direct sunlight and heavy variation in temperature.

Moving the instrument

The chemicals to be used in the Leica ASP300S are both flammable and noxious. The Leica ASP300S must be set up in a well ventilated area free from any ignition sources. Do not operate the instrument in rooms with explosion hazard.

After the instrument has been unpacked (see unpacking instructions attached to outside of transport crate) it must be touched only at the points marked with dots ‘ ‘ for transport to its final site of installation. Once the instrument has been installed there, the brakes on the instrument rollers (24) must be locked. The instrument must be installed such that the mains switch at the rear of the instrument (item no. 42 in Fig. 4) can easily be accessed at any time.

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4.2 Electrical connection Attention! Follow the instructions below carefully to avoid damage to the instrument.

• Check the voltage label (Fig. 3) on the rear of the instrument to ensure that the instrument delivered is set to the correct voltage range. Caution! Severe damage may occur if the instrument is connected to a power supply voltage other than that to which it was originally set. The power supply voltage for the instrument is factory preset, and CANNOT be altered by the user.

Fig. 3

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Operating Manual V 1.2 – 01/2008

4.

Setting up the instrument

Connecting the instrument to mains Once the instrument has been switched on, the mains switch (ON/ OFF) (41) should always remain in position ON.

The instrument MUST be connected to an earthed mains power outlet socket. It is recommended that the ASP300 S be plugged into a wall socket that has Ground Fault Circuit Interruption (GFCI) protection - as an additional electrical safeguard. Make sure to use the appropriate mains cable for the local voltage supply (wall outlet).

Important:! Specification for connection (40) is as follows: 100 - 120 V or 230 - 240 V, max. 200VA.

• Connect the mains cable (37) to the mains power supply socket (41). • The jumper cable (38) which is supplied as part of standard delivery connects the mains power supply output (43) to the electronics module input (40).

41 37 42

40 43 38

Left: Electrical connections at the rear panel of the instrument. Right: Correct connection of the cables

Fig. 4

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