ASP300 S Instructions for Use V1.5 Rev D March 2013

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 manual periodically and on an ongoing basis according to the latest technical developments, nor to provide our customers with additional copies, updates etc. of this manual. 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 Instructions for Use 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 documentation is protected under copyright laws. All copyrights to this documentation are held by Leica Biosystems Nussloch GmbH. Any reproduction of text and illustrations (or of any parts thereof) by means of print, photocopy, microfiche, web cam or other methods – ­including any electronic systems and media requires express prior permission in writing by Leica Biosystems Nussloch GmbH. For the instrument serial number and year of manufacture, please refer to the name plate at the back of the instrument. © Leica Biosystems Nussloch GmbH

Leica Biosystems Nussloch GmbH Heidelberger Str. 17 - 19 D-69226 Nussloch Germany Phone: +49 (0) 6224 143-0 Fax: +49 6224 143-268 Internet: http://www.LeicaBiosystems.com Leica ASP300 S

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Contents 1.

Important Information... 7

2.

Safety... 10

3.

Instrument Components and Specifications... 15

4.

Initial Operation... 24

5.

Operation... 37

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Instructions for Use, V 1.5 RevD – 03/2013

1.1 1.2 1.3 1.4 2.1 2.2 2.3

3.1 3.2 3.3 3.4 3.5 3.6 3.6.1 4.1 4.1.1 4.2 4.2.1 4.2.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 5.1 5.1.1 5.1.2 5.1.3

Symbols and their meanings... 7 Qualification of personnel... 9 Intended use of instrument... 9 Instrument type... 9 Safety notes... 10 Warnings... 10 Safety features on the instrument... 14 Overview – instrument components... 15 Specific instrument options... 17 Standard delivery – packing list... 17 Technical Data... 19 Compatible reagents... 21 Recommended reagent handling... 22 Cycle for changing reagents... 23 Installation site requirements... 24 Moving the instrument... 24 Electrical connection... 25 Connecting the power supply... 25 Connecting an uninterruptible power supply (UPS)... 26 Installing accessories... 27 Making the data connections... 29 Anti-reflection clip – Function... 30 Alarm functions... 31 Switching the instrument on... 32 Touchscreen functions... 34 Checklist for initial operation... 35 Switching off the instrument... 36 Setting up the instrument parameters... 37 System setup... 37 Access levels... 40 INSTALLATION menu... 42

Contents 5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 5.1.9 5.2 5.2.1 5.2.2 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.4 5.5 5.6

Editing the reagent list... 45 Viewing the program list... 48 Adding and/or modifying programs... 49 Favorites... 52 Configuring the stations... 54 Reagent groups... 55 Reagent handling... 56 Draining/filling reagents (other than paraffin)... 56 Replacing the paraffin... 58 Running programs... 61 Editing a program that has been called up... 62 Starting a program... 64 Opening the retort... 65 Retort emergency release... 65 Reagent status... 67 System monitor... 68 The online help... 69

6.

Troubleshooting... 70

7.

Cleaning and maintenance... 73

6.1 6.2 6.3 6.4

7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1 7.2.2 7.3

General... 70 Power failure... 70 Troubleshooting... 71 Typical fill or drain problems... 72 Clean programs... 73 Retort cleaning programs... 73 Paraffin cleaning... 75 Smart clean... 76 General cleaning steps... 77 Daily cleaning and maintenance... 79 Periodic cleaning and maintenance... 81 Checklist for preventive maintenance... 83

8. Warranty and Service... 85 Appendix 1... 86 Notes on Specimen Preparation... 86

Leica ASP300 S

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1.

Important Information

1.1 Symbols and their meanings 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 .

Inflammable 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)

Numbers in parentheses refer to item numbers in illustrations.

ENTER

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

In vitro diagnostics (IVD) medical device This product fulfills the requirements of the Council's Directive 98/79/EC concerning in vitro diagnostics (IVD) medical devices. Environmental protection symbol of the China RoHS directive. The number in the symbol indicates the "Environmentfriendly Use Period" of the product. The symbol is used if a substance restricted in China is used in excess of the maximum permitted limit. Symbol for labeling electrical and electronic equipment in accordance with Section 7 of the German Electrical and Electronic Equipment Act (ElektroG). ElektroG is the law regarding the sale, return and environmentally sound disposal of electrical and electronic equipment.

Manufacturer

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Instructions for Use, V 1.5 RevD – 03/2013

1.   Important Information 1.1 Symbols and their meanings (continued) SN

Serial number

REF

Order No. Observe the Instructions for Use The package contents are fragile and must be handled with care. Indicates the correct upright position of the package. The package must be kept in a dry environment. Indicates the temperature range to which the medical device can be safely exposed. Minimum –29 °C Maximum +50 °C Indicates the air humidity range to which the medical can be safely exposed. Minimum 10 % Maximum 85 %

Leica ASP300 S

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). Tip-n-Tell indicator to monitor whether the shipment has been transported and stored in upright position according to your requirements. With a pitch of 60 ° or more, the blue quartz sand flows into the arrow-shaped indicator window and sticks there permanently. Improper handling of the shipment is immediately detectable and can be proven definitively.

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1.

Important Information

1.2 Qualification of personnel

1.4 Instrument type

• The Leica ASP300 S may be operated by trained laboratory personnel only. • All laboratory personnel designated to operate this instrument must read these Instructions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it.

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 serial number is also displayed above the loading door on the front side of the instrument.)

1.3 Intended use of instrument 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 Operating Manual. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. The Leica ASP300 S must be operated exclusively with the reagents listed in Chap. 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. Proper and intended use includes compliance with all inspection and maintenance instructions, along with the observance of all instructions in the Instructions for Use.

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Fig. 1

Fig. 1 is provided as an example only and shows a valid nameplate for this instrument with the necessary information about instrument type and power requirement. The precise data for the various versions is specified in Chap. 3.2 "Technical data".

Instructions for Use, V 1.5 RevD – 03/2013

2.   Safety 2.1 Safety notes • The safety and caution notes in this chapter must be observed at all times. • Be sure to read these notes even if you are already familiar with the operation and use of other Leica products. • The protective devices located on the instrument and the accessories must not be removed or modified. Only qualified service personnel authorized by Leica may repair the instrument and access its internal components. Residual risks • The instrument has been designed and constructed with the latest state-of-the-art technology and according to recognized standards and regulations with regard to safety technology. Operating or handling the instrument incorrectly can place the user or other personnel at risk of injury or can cause damage to the instrument or other property. The instrument may be used only as intended and only if all of its safety features are in proper working condition. Malfunctions which could impede safety must be remedied immediately. • Only original spare parts and permitted original accessories may be used.

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.

This instrument has been built and tested in accordance with the safety requirements for electrical equipment for measurement, control, and laboratory use. To maintain this condition and ensure safe operation, the user must observe all notes and warnings contained in these Instructions for Use.

These Instructions for Use must be appropriately supplemented as required by the existing regulations on accident prevention and environmental safety in the operator‘s country.

For current information about applicable standards, please refer to the CE declaration for the instrument and to our Internet site: http://www.LeicaBiosystems.com

2.2 Warnings The safety devices installed in this instrument by the manufacturer only constitute the basis for accident prevention. Operating the instrument safely is, above all, the responsibility of the owner, as well as the designated personnel who operate, service or repair the instrument. To ensure trouble-free operation of the instrument, be sure to comply with the following instructions and warnings. Leica ASP300 S

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2.

Safety

2.2 Warnings (continued) 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 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 Once unpacked, the instrument may be transported only in an upright position. Follow the unpacking instructions carefully to avoid damage to the instrument! Prior to every transport in which it is possible for the instrument to be shaken, tilted, or lifted, it must be cleaned for transport – otherwise the interior of the instrument can be severely damaged. Plug the instrument only into a grounded power socket. Do not interfere with the grounding function by using an extension cord without a ground wire. Make sure to observe the voltage settings! 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 installation location must be well-ventilated; there should be no ignition sources there of any kind. 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. Extreme temperature fluctuations between storage facility and setup site as well as high humidity may cause condensation to form. If this is the case, wait at least two hours before switching on the instrument. Failure to comply with this may cause damage to the instrument.

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Instructions for Use, V 1.5 RevD – 03/2013

2.   Safety 2.2 Warnings (continued) Warnings – Operating the instrument The instrument may only be operated by trained laboratory personnel. It must only be operated for the purpose of its designated use and according to the instructions contained in these ­Instructions for Use. In an emergency, the instrument can be switched off while working with specimens via the ON/STOP switch located on the side of the instrument. Before opening the retort when an infiltration process is in progress, always press the PAUSE button so that the retort is ventilated or vented. The paraffin drain hose and the hose for remote filling/draining are cleaned with compressed air after the filling or draining process. Therefore, never remove the hoses before a filling or draining process has been completed. After refilling/replacing reagent containers, close the container covers again tightly. The reagent containers must be properly pushed home into the connection manifolds at the rear inner wall of the reagent module. Failure to plug the reagent containers into the manifold correctly will interrupt the infiltration process and may also result in spilling of reagents. Fixing solutions that contain mercury salts, acetic acid, or picric acid can cause corrosion on metal components. After each paraffin step a retort clean cycle must be run. 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

Leica ASP300 S

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2.

Safety

2.2 Warnings (continued) Warnings – Handling reagents Take care 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 prevent damage to the instrument, use only the reagents listed in Chap. 3.5! Do not use acetone, benzene or trichlorethane! Use caution when handling paraffin wax or removing baskets – molten paraffin is hot and may cause burns. Also, avoid personal contact with paraffin reservoirs and retort walls – they can be very hot as well. When disposing of spent reagents, observe the applicable local regulations and the waste ­disposal regulations of the company/institution in which the instrument is being operated. Do not clean reagent containers (bottles) in a dishwasher; the containers are NOT dishwasherproof.

Warnings – Cleaning and maintenance Switch off the instrument each time before servicing and pull out the power plug. 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 using cleaners, please comply with the safety instructions of the manufacturer and the laboratory safety regulations. Check the condensate container at least once a week and, if necessary, drain it.

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Instructions for Use, V 1.5 RevD – 03/2013

2.   Safety 2.3 Safety features on the instrument

Overpressure protection

Overcurrent protection Overheating protection

Over vacuum protection Overcurrent protection

Leica ASP300 S

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. • When power is off the air pump and air valves default to a safe condition (retort vented, no pressure generation). • If the pump is not stopped at the correct moment during the pressurization, the power supply is interrupted by a separate electronic circuit. • In addition, there is a safety relief valve that vents all excess air pump output to atmosphere. • Overcurrent conditions are protected against by both the main fuse and the separate heating power fuses. 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. • The vacuum system is not capable of generating a dangerous vacuum condition. • Overcurrent conditions are protected against by both the main 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

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Fig. 2

Instructions for Use, V 1.5 RevD – 03/2013

3.   Instrument Components and Specifications Overview – instrument components

Instrument Components and Accessories

1 – Basic instrument – processor module 2 – Basic instrument – reagent module 3 – Wax bath lids 4 – Retort lid 5 – Monitor 6 – Cover flap of the instrument console 7 – Instrument console with: 8 – Printer port 9 – Local alarm connection 10 – Remote alarm connection 11 – Disk drive 12 – Serial port 13 – Active carbon filter 14 – Condensate container 15 – Reagent containers (13 units) 16 – Collecting tray 17 – Paraffin drain spout 18 – Remote drain connection 19 – Retort 20 – Wax baths 21 – Cassette basket 22 – Lid for cassette basket 23 – Baffle plate

Three wax baths and the retort comprise the infiltration module. The touchscreen and the electronic components are there. The cassettes to be processed are stored in three baskets (21), each of which can hold up to 100 cassettes. The specimens are processed in the stainless steel retort at the preselected pressure, vacuum, and temperature conditions. The reagent containers are located in the ­reagent cabinet.

Leica ASP300 S

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3.

Instrument Components and Specifications

3.2 Specific instrument options • Optionally usable Reagent Management System (RMS), displays service life and usage frequency of the individual reagents and enables automatic definition of the reagent sequence – there is no more need to rearrange reagent containers. If one or more reagents within a sequence are replaced, the RMS automatically uses the reagents in the correct sequence, organized in ascending order of cleanliness. • Liquid movement ("wave motion") during the process for better and continuous mixture of the reagents. • System for non-contact filling/draining of reagents – drains and fills the reagent container using a hose connected to the infiltration module without the operator being exposed to reagents in the process. • Non-contact wax bath drainage. • Optical level meter. • Active paraffin cleaning program – removes solvent residue from the paraffin, lengthening its service life. • Magnetic stirrer – for gentle circulation of the reagents, thus ensuring a uniform reagent temperature. • Programmable end time for infiltration programs. • 3-step drainage of the retort (adjustable) for reducing reagent displacement. • Infiltration process at ambient pressure, or with pressure, vacuum or a combination of both. • Four programmable cleaning programs. The cleaning programs automatically omit all steps that are not necessary to complete the cleaning procedure.

3.3 Standard delivery – packing list To prevent damage to the instrument or specimens, only accessories and spare parts authorized by Leica may be used. The standard equipment of the Leica ASP300 S includes the following parts: 1 Leica ASP300 S basic instrument 13 Reagent bottles, plastic (in the instrument) 1 Condensate container, plastic (in the instrument) 1 Collecting tray (in the instrument) 1 3.5 " diskette, empty (affixed to the rear side of the console cover)

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Part No. 14 0476 34274 14 0476 34278 14 0476 37350 14 0476 35915

Instructions for Use, V 1.5 RevD – 03/2013

3.   Instrument Components and Specifications 3.3 Standard delivery – packing list (continued) 1

1 1 1 1 1 1

Accessory kit, consisting of: 1 Basket handle 3 Specimen basket assemblies (lid, handle, separating walls and spiral inserts) 1 Stirrer 1 Reagent bottle, plastic 2 Set of adhesive bottle labels, 24 pcs. each 1 Funnel 2 Active carbon filter assembly 1 Filling/draining hose assembly 1 Paraffin drain hose 1 Paraffin scraper, plastic 1 Lubricant for valves and O-rings (Molykote 111, 100 gr) 1 Connecting cable – power supply 1 Maintenance kit (2 spare covers, 9 O-rings) 1 Baffle plate 1 Single-head wrench, size 27 1 Allen key, size 3.0 1 Remote alarm connection, 6.3 mm 1 Cleaning tools for prism 1 Microfiber cloth for prism Power cable for Germany Power cable for UK ST-BU F-5 A Power cable for Brazil 10 A, straight Power cable for the USA/Canada/Japan (for voltage variant 100-120 V) ASP300 S German/English Instructions for Use (+ language CD) Language CD, with ASP300 S demo program

14 0476 43727 14 0476 34713 14 0476 34193 14 0476 43630 14 0476 34274 14 0200 43464 14 0476 43631 14 0476 34150 14 0476 34716 14 0476 34721 14 0476 35923 14 0336 35460 14 0411 34604 14 0476 35921 14 0476 34770 14 0330 50891 14 0222 04138 14 6844 01005 14 0495 47955 14 0495 47736 14 0411 13558 14 0411 27822 14 0411 47869 14 0411 13559 14 0476 80001 14 0476 80200

Please check all delivered parts against the packing list and against your order to verify whether the delivery is complete! Should you find any discrepancies, please contact your ­Leica sales office without delay.

Leica ASP300 S

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3.

Instrument Components and Specifications

3.4 Technical Data Nominal supply voltages:

Two factory-preset voltages (not user-adjustable): 100 to 120 V or 230 to 240 V Nominal frequency: 50 to 60 Hz Main fuses: 2 melting fuses, 20 x 5 mm, UL-approved • for 100 to 120 V F 10 A 250 VAC • for 230 to 240 V F 5 A 250 VAC Nominal power: 1000 VA Dimensions, (L x W x H), in mm: 595 x 680 x 1325 mm Empty weight, unpacked: approx. 160 kg Weight, packed: 220 kg Operating temperature range: 15 °C to 35 °C Relative humidity: 10 % to 80 % non-condensing IEC 1010 classification: Protection class 1 Pollution degree 2 Overvoltage installation category II: • 800 V impulse (120 V systems) • 1500 V impulse (240 V systems) Altitude: 2500 m maximum Local/remote alarm relay: 30 V DC, maximum 2 A 2 terminals: Each with isolated switching contact (operable both as normally open and normally closed circuit)

Paraffin reservoirs Number of containers: Capacity: Melting time: Temperature: Temperature accuracy:

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3 4.3 l per container approx. 10 h 40 to 65 °C +1K

Instructions for Use, V 1.5 RevD – 03/2013

3.   Instrument Components and Specifications Retort Capacity: max. 300 cassettes Reagent volume: 4.3 l Temperature (paraffin): 40 to 65 °C Temperature (processing reagents): Ambient temperature or 35 to 55 °C Temperature (cleaning reagents): 50 to 65 °C Temperature accuracy: +1K Filling time: approx. 90 sec Drain time: approx. 80, 120, 140 sec (selectable) Impregnation vacuum: -70 kPa (g) Infiltration pressure: 35 kPa (g) Filling vacuum: -70 kPa (g) Draining pressure: 35 kPa (g) General Reagent container: 10 Cleaning solution bottles: 3 Maximum bottle volume: 5.0 l Printer: Optional Accessories Pretest check: ON/OFF Fluid level sensor: ON/OFF Recirculation (pump in/out): ON/OFF (a) Time before 1st cycle: 16 min (b) Time between cycles: 20 min System setup Password status: Type of password: Reagent Management System: Software interlock:

Leica ASP300 S

Supervisor/Operator 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 LCD touchscreen. • User-friendly, intelligent software. • 3.5" disk drive and printer port. • Alarm system with two remote alarm sockets. • Password-protected instrument supervisor mode. • Built-in multiple specimen protection system. Capacities: • 15 programs that consist of up to 10 reagent and 3 paraffin processing steps each. • 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. • Paraffin cleaning program • 10 reagent containers. • 3 paraffin containers. • 3 cleaning solution bottles. • 1 condensate container. • Reagent temperature selectable from 35 °C to 55 °C or room temperature. • Paraffin temperature selectable 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.

3.5 Compatible reagents Use of the ASP300 S is permitted with the reagents specified in Chap. 3.5 only. These reagents must 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. Reagents other than those listed here may cause severe damage to the components of the instrument. Acetone, benzene, chloroform and trichlorethane must NOT be used!

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Instructions for Use, V 1.5 RevD – 03/2013

3.   Instrument Components and Specifications 3.5 Compatible reagents (continued) The following reagents may be used in the Leica ASP300 S: Fixatives

Dehydration

Formalin

1st

(buffered or

2nd Isopropanol

unbuffered)

3.

Methanol

2nd Formalin replacement

4.

Butyl alcohol

5.

Industrial methylated spirits

1st

Ethanol

Clearing 1st

Xylene

Paraffinizing 1st

Wax

2nd Toluene* 3.

Chloroform*

* Before using these reagents, please obtain information from Leica or the supplier about required preventive measures.

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

3.6 Recommended reagent handling • The reagents used should be replaced after 1200 to 1800 specimens have been processed or after 6 cycles of 200 to 300 specimens each. • For formalin, process alcohol and process xylene reagents, ambient temperature is recommended. • The recommended temperature for cleaning reagents in the cleaning cycle is 65 °C. • Only zinc formalin based on zinc sulfates may be used in the ASP200 S/ASP300 S. If zinc formalin is used, the cleaning program must include an additional cleaning water step. • The use of formalin reagents containing zinc chloride can cause corrosion in and on the instrument. Leica ASP300 S

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