Shandon Pathcentre Operator Guide Issue 2

Operator Guide

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Shandon Pathcentre

ENCLOSED TISSUE PROCESSOR

ENGLISH Issue 2

OPERATOR GUIDE 75210150

75210150 GB Issue 2

OPERATOR GUIDE LIST OF CONTENTS

CONTENTS

This Page

SAFETY SYMBOLS USED Other Symbols Used

WELCOME Introduction; Safety

DESCRIPTION 13 Introduction; Loading Specimens; Processing; Standard Flush; Extended Flush; To Rinse; Quality Control; Warnings; Reagent Sets; Accessories Drawer; Underfills; Wax Bath Rotation; Other Facilities CONTROLS AND SCREEN LAYOUT 34 Introduction; On/Off Switch; Unit Control Panel; Emergency Release; Vacuum Release; Wax/Paraffin Baths; The Reagent Store; The Console; Accessories Drawer INSTALLATION AND SETTING UP 43 Preparation; To Unpack; To Assemble; To Fit The Console; Electrical Connection; To Level The Shandon Pathcentre; Multi-Unit Installation; To Connect A Printer; To Connect A Remote Alarm; To Adjust The Display; To Switch On; To Load Wax/Paraffin; To Load Reagents; To Use The Console; Options Menus; To Complete Setting Up

Thermo Shandon Limited is an ISO 9001 and TickIT Accredited Company. Thermo Electron Corporation is the trading name of Thermo Shandon Limited. All information contained in this manual is proprietary and confidential, and the exclusive property of Thermo Electron Corporation. This manual is protected by copyright and any reproduction is prohibited. This manual is for use only by the individuals to which it has been made available by Thermo Electron Corporation.

PROGRAMMING 75 Introduction; To Select A Module; To Create A Program; To View A Program; To Copy A Program; To Edit A Program; To Stop Processing

Thermo Electron Corporation makes every endeavour to ensure that the information contained in its support documentation is correct and clearly stated but does not accept responsibility for any errors or omissions. The development of Thermo products and services is continuous. Make sure that any published information that you use for reference is up to date and relates to the status of the product. If necessary, check with Thermo or your local Thermo representative.

PROCESSING Introduction; To Start; To Delay A Start; To Self Start; To Stop Process; To Step Through; To Restart; To Abort Processing; Reagent Changeover; To Finish; To Flush; Rinse; Complete; Quality Control Checklist; Print

© 1996-2003 Thermo Electron Corporation. All rights reserved. This manual may not, in whole or in part, be copied, photocopied, reproduced, translated, or converted to any electronic or machine readable form without prior written consent of Thermo.

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CLEANING AND MAINTENANCE 93 Introduction; Reagent Bottles; To Drain A Heated Bath; To Clean A Bath; Rotate Wax Order; The Reaction Chamber; The Chamber Filter; Lid Seal; Command Console; The Air Bag; Vapour Trap Bottle; The Charcoal Filter; Spillages; Battery Replacement; Schedules 75210150 GB Issue 2

TROUBLE-SHOOTING Equipment Status Checks; Fuses

104

SAFETY SYMBOLS USED

SPECIFICATION AND ACCESSORIES Specification; Accessories

106

The following symbols and conventions are used throughout this manual and on the instrument.

WARRANTY STATEMENT Declaration of Conformity

110

APPENDIX A - TRANSPORTATION INSTRUCTIONS Introduction; Clean The Instrument; Package The Instrument

112

APPENDIX B - RECOMMENDED REAGENTS Compatible Reagents: Reagents Not Formally Tested

115

APPENDIX C - TYPICAL PROCESSING SCHEDULES

117

APPENDIX D - REFERENCE SHEETS To Load Tissues; To Start Processing; To Clear The Quality Control Checklist; To Stop Processing Or Flushing; To Flush; To Rotate Wax Bath Order

129

INDEX

136

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THIS SYMBOL APPEARS ON THE EQUIPMENT AND IN DOCUMENTS TO WARN YOU THAT YOU MUST FOLLOW INSTRUCTIONS FOR CORRECT AND SAFE OPERATION. REFER TO THIS USER GUIDE WHENEVER YOU SEE THIS SYMBOL

THIS SYMBOL ON EQUIPMENT AND IN DOCUMENTS WARNS YOU THAT TEMPERATURES MAY BE PRESENT THAT ARE HIGH OR LOW ENOUGH TO CAUSE DISTRESS.

THIS SYMBOL IS USED ON THE EQUIPMENT, OR IN A DOCUMENT, TO WARN THAT THERE MAY BE A BIOHAZARD ASSOCIATED WITH THE INSTRUMENT. ALWAYS ACT WITH COMMON SENSE AND BE AWARE OF THE SAMPLES USED. TAKE SUITABLE PRECAUTIONS

THIS SYMBOL IS USED ON THE EQUIPMENT, OR IN A DOCUMENT, TO WARN THAT HARMFUL CHEMICALS ARE USED WITH THE INSTRUMENT. REFER TO THE MATERIAL SAFETY DATA SHEETS FOR THE CHEMICALS USED. ALWAYS ACT WITH COMMON SENSE AND BE AWARE OF LOCAL LABORATORY PROCEDURES. TAKE SUITABLE PRECAUTIONS

WARNING

This symbol in the document tells you that there is a danger of personal injury or damage to samples or equipment.

Note 1 Notes give more information about a job or instruction but do not form part of the instruction.

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OTHER SYMBOLS USED Symbols that appear on the Electronics Box in the top righthand corner of the rear panel indicate as follows:

IOIOI ��

Each mains lead supplied with the instrument has an integral moulded plug. Make sure it is possible to interrupt the power supply to the instrument by using an isolating switch, or by removing the plug from the wall socket.

Only equipment that conforms to the requirements of IEC1010-1 and/or IEC950 may be connected to the outputs on the rear of the electronic box or the Command Console.

The remote alarm switch is rated for operation at 3A and 24Vdc. The remote alarm facility must only be connected into an external circuit that conforms to the requirements of IEC1010-1, and only by a technically competent person.

Only a Thermo trained service engineer may change the fuses in this instrument.

The Shandon Pathcentre is a Class 1 instrument as defined in IEC1010-1. It must be correctly connected to a protective earth/ground contact marked:

The adjacent connector is an RS2485 interface for use by service personnel only. It has no user function.

The adjacent female connector is an RS485 interface that accepts the male plug of an Extension Link. The adjacent male connector is an RS485 interface that accepts the female plug of an Extension Link.

The connector adjacent to this symbol is a socket that provides access to the Remote Alarm switching facility. Only a technically competent person should make connections to this socket.

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Notes 1 IEC approved type mains leads that are coloured white are for use with 220 to 240V instruments. Mains leads that are coloured black are for use with 120V instruments.

BATTERIES This instrument contains two AA size 1.5V sealed batteries.

FUSES Power supply fuse type BEL(3AG) 250V 5A F (UL, CSA) on 220 to 240V instruments. Mains inlet fuse is Cooper Bussman UL198 250V 10A Fast. Mains plug fuse, where applicable, is Cooper Bussman TDC180 250V 13A Fast [NAME]

This convention indicates a keystroke performed by the operator.

POWER

The power ON/OFF switch is annotated I for ON and O for OFF.

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WELCOME ��

1.1 INTRODUCTION Welcome to the Shandon Pathcentre® tissue processor, a fully automatic, enclosed tissue processor for use in pathology laboratories by appropriately trained medical laboratory technicians. Designed and made with care, the Shandon Pathcentre is safe to use, simple to operate, easy to maintain, and incorporates a safe storage area for all the processing reagents. This Operator Guide gives instructions for the correct operation and use of Shandon Pathcentre.

1.2 SAFETY THIS PARAGRAPH DETAILS IMPORTANT SAFETY INFORMATION. PLEASE READ THIS SECTION CAREFULLY. Thermo products are designed for convenient and reliable operation, and to accepted standards of safety. Using the Shandon Pathcentre does not entail any hazard if you operate it in accordance with the instructions given in this manual. However, incorrect actions may damage the equipment, or cause a hazard to health. It is important for you to obey the following safety precautions: i

You must read and understand the Operator Guide, and only operate the unit in accordance with the instructions. If you do not follow the instructions, the protection provided by the instrument may be impaired.

Be aware that potentially lethal voltages above 110V a.c. or 50V d.c. are present inside the instrument.

iii

The instrument must be properly connected to a good earth (ground) via the mains input supply.

The Shandon Pathcentre® Enclosed Tissue Processor

Shandon Pathcentre conforms with the International Safety Standard IEC 1010-1 and IEC1010-2-010. ®

Shandon Pathcentre® has also been tested to satisfy the following safety requirements: UL3101-1, and CSA 1010-1. Shandon Pathcentre® meets the requirements of the CE Mark; Directive 93/68/EEC.

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Do not remove any panels or covers. Shandon Pathcentre does not have any user serviceable parts inside the instrument.

Shandon Pathcentre, as supplied, conforms to IEC1010-1 and IEC10102-010. However, the addition of chemicals introduces potential hazards. You must follow good laboratory practice when dealing with these chemicals, and give consideration to the potential for hazard when dealing with particular chemicals. Be aware that many of the reagents used with Shandon Pathcentre are flammable. Do not introduce any source of ignition into, or near, the instrument once it has been loaded with reagents.

vi.

vii

Be aware that, although Shandon Pathcentre, as supplied, conforms to IEC1010-2-010, it may not do so fully until the end of the 2-hour warm-up period. The centre of gravity position for a fully laden instrument is shown below:

viii

It is important that you employ normal standards of safety and good laboratory practice. Always use common sense and the best known practice when operating the instrument.

Refer to your own laboratory procedures and material safety data sheets (MSDSs) when using reagents.

If the instrument has been used with materials that are toxic or contaminated with pathogenic micro-organisms, follow the cleaning instructions given in Chapter 7. You must complete the Product Return Certificate (Appendix A) if you want to return the instrument to Thermo.

The instrument must be regularly cleaned, as described in Chapter 7 of this Operator Guide.

xii

Use only factory approved accessories or replacement parts with Shandon Pathcentre.

xiii

Do not use in the instrument any flammable or explosive materials, or materials that react vigorously.

xiv.

Do not use any reagents that contain mercuric chloride, calcium chloride, mercuric salts or strong acids.

Shandon Pathcentre is a totally enclosed processor with a Charcoal Filter to protect against emergency venting of poisonous or injurious gases. Exposure to such gases is limited to the process reagents you use. Risk assessment and good laboratory practice ensure safety.

xvi.

Stand clear of the Shandon Pathcentre lid when you operate the emergency release. If the Reaction Chamber is pressurised, the sudden release of pressure blows the lid open vigorously, and gas or vapour might vent explosively towards you.

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viii

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Shandon Pathcentre weighs approximately 160 kilograms (352 lbs) when empty; get help to move or lift it. 75210150 GB Issue 2

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xvii.

The walls of the heated baths and the wax become hot (60°C). Wear protective rubber gloves to prevent injury.

DESCRIPTION 2.1 INTRODUCTION

xviii. Take Reagent Bottles to a fume cupboard or well-ventilated area before filling the bottles with reagent.

xix.

Pay particular attention to the handling and disposal of infectious or potentially infectious materials, as these can pose a serious risk to health, or even death.

xx.

Correct maintenance procedures are essential for consistent performance. It is recommended that you take out a maintenance contract with your supplier.

xxi.

xxii.

The instrument must be serviced annually by a Thermo trained engineer, in accordance with the instructions contained in the Shandon Pathcentre Service Manual (75210151).

The Shandon Pathcentre enclosed tissue processor is supplied as a Command Unit, or an Extension controlled from a Command Unit. Each Command Unit has a Command Console (1) which is the interface by which data and programs can be entered into the Electronics Box. The Electronics Box of the Command Unit directly controls its own processing routines, and communicates with the Electronics Box of each connected Extension to upload programs and control data.

Each Command contains:

Unit

and

Extension

A heated Reaction Chamber (1)

Four heated Wax Baths (2)

iii

A Reagent Bottle Store (3)

An Accessories Drawer (4)

The Electronics Box, behind the Reaction Chamber, is accessible from the rear. The Electronics Box of the Command Unit is not the same as an Electronics Box of an Extension - they are not interchangeable.

Refer any problems and queries to your supplier.

The Command Unit and each Extension have capacity for processing up to 306 cassettes as a single load. A multi-unit installation, comprising one Command Unit and up to three Extensions, increases processing capacity to a maximum of 1224 cassettes. Control of the Command Unit and each Extension is via the single Command Console of the Command Unit.

You must maintain the instrument in accordance with Thermo’s recommendations.

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Extensions are added with a link that connects between the new unit and an existing unit. The control system of the Command Unit automatically recognises the new unit, and gives it a number. Each installed unit operates independently of any other in a multi-unit installation. The only common component is the Command Console which enables you to communicate with each module.

Wax impregnation starts at program Step 11, after all the specified processing steps are completed. The procedure is similar to that for processing reagents but this time molten wax is transferred from one of the four Wax Baths - A, B, C or D - via a heated pipe and indexing valve, to the temperature controlled Reaction Chamber.

All units are programmed via touch-sensitive keys on the Console of the Command Unit. A context related help key ( i ) is available for guidance. You can enter up to nine programs, each of up to 14 steps, for each installed Shandon Pathcentre. The 14 programmable steps can comprise: i

Up to ten processing steps

Up to four wax impregnation steps

The eleventh and twelfth bottles in the reagent store (positions 15 and 16) hold flush reagents that are used to clean the Reaction Chamber and associated internal components after each processing cycle.

Note 1 If any wax is admitted into the Reaction Chamber at any time, a flush routine must run before a new processing cycle may start.

2.2 LOADING SPECIMENS BE AWARE THAT TISSUE SAMPLES MAY POSE A BIOHAZARD. TAKE SUITABLE PRECAUTIONS

Each of the ten processing steps of a program transfers reagent into the Reaction Chamber from one of ten Reagent Bottles. The time it is held there is set in the program, as is the temperature, pressure, and type of agitation applied, according to preference.

Each processing step of a program is associated with a store position (1 - 10). Wax for the impregnation steps is taken from the four Wax Baths. When no reagent or wax is required, that program step is set for zero time.

Specimens are placed in cassettes and loaded into tissue baskets specific to Shandon Pathcentre. Three types of basket are used, sometimes in conjunction with a Displacement Block, if there is less than a full load.

RANDOM LOAD BASKETS accept handfuls of cassettes inserted at random. They are quick and easy to load and unload.

Three Random Load Baskets comprise the set. Each loaded basket suspends from the centre column of the Reaction Chamber to occupy a third of the volume.

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ORGANISED LOAD Baskets hold six groups of nine cassettes, that is, a total of 51 cassettes. Retaining clips secure the cassettes in position.

A DISPLACEMENT BLOCK provides substitute volume to ensure that all specimens get immersed when very low numbers of specimens are processed. It fits into a spare Basket Carrier and is inserted into the Reaction Chamber as if it were a loaded basket.

The baskets fit into a Basket Carrier that suspends from the centre column of the Reaction Chamber. Each Basket Carrier holds two Organised Load Baskets, and a lid fits on the top basket. A total of three Basket Carriers comprise a full load and hence the maximum load for each module is 6 x 51 = 306 cassettes.

WARNING

It is your responsibility as the operator to ensure that the instrument does not overfill when the Displacement Block is used.

THE DISPLACEMENT BLOCK IS HEAVY AND COULD CAUSE INJURY IF MISHANDLED OR DROPPED. HANDLE AS GLASS.

Organised Load Baskets allow a high packing density, and easy identification of individual cassettes. Uniform spacing encourages superior processing. LARGE BLOCK neurological baskets fit into the same Basket Carrier as the Organised Load Baskets. Dividers provide spaces for six large block specimens in each basket. Each of the three Basket Carriers can hold up to six Large Block Baskets.

2.3 PROCESSING The lid (2) of the Reaction Chamber (3) must be closed and locked before processing can start. The top front panel (4) locks and secures the lid latch when it is fully pushed in and vertical.

Random Load, Organised Load, and Large Block Baskets can be loaded simultaneously if required. Note 1 DISTRIBUTE THE LOAD EVENLY BETWEEN ALL THE BASKETS. If only one basket is used there is a danger that the topmost cassettes do not get properly processed or impregnated with wax.

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When processing starts, the Reaction Chamber (3) is evacuated, and the air withdrawn transfers to the Reagent Bottle (7) that contains the specified reagent for that program step, via the indexing valve (5) and the air pump (6). The resultant imbalance of pressure causes reagent to transfer from the Reagent Bottle to the Reaction Chamber.

An emergency release is available to override the lid interlock if there is no power. Pull the tab firmly to the right to operate.

WARNING

Provided that there is sufficient fluid in each Reagent Bottle specified in the program, all the specimen cassettes are completely immersed in processing reagent at each step in the program. On completion of each program step, air is pumped out of the applicable Reagent Bottle and transferred back into the Reaction Chamber. The resultant pressure imbalance causes the reagent in the Reaction Chamber to transfer back into its original Reagent Bottle in the store. The indexing valve then activates under the control of the program to select the next reagent, so that the next program step can start.

The indexing valve mechanism is quite audible when it is operating. All other Shandon Pathcentre functions are inhibited until valve indexing is complete.

The mechanical lid release is for emergency use only. It provides a means of access into the Reaction Chamber during power failure, or if the lit [LID] push-button fails to release the lid. Press [STOP] on the Unit Control Panel for not less than three seconds to make sure processing stops, before you use the emergency release.

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Select the processing program from the menu in the on-screen display of the Command Console (1). Processing starts either immediately or after a programmed delay.

STAND CLEAR OF THE LID AREA OF THE SHANDON PATHCENTRE WHEN THE EMERGENCY RELEASE OPERATES. IF THE REACTION CHAMBER IS PRESSURISED AT THE TIME, THE LID IS BLOWN OPEN VIGOROUSLY BY THE SUDDEN RELEASE OF PRESSURE, AND CAN VENT GAS OR VAPOUR EXPLOSIVELY TOWARDS YOU.

If the lid is held shut by vacuum when power fails, a manually operated Vacuum Release tap is available to admit air into the sealed air system. Close the tap after use to seal the air system again, or the instrument will not function. The lid of the Reaction Chamber is locked shut during processing. An interlock prevents the lid’s being opened unless the [LID] push-button of the small Unit Control Panel is lit. Pressing [LID], when it is lit, releases the interlock. Pressing [LID] when it is not lit has no effect. [LID] is only lit when processing has stopped.

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Program steps are actioned one after the other to introduce up to ten reagents into the Reaction Chamber in turn, followed by up to four wax impregnation steps.

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The quality of processing depends on the integrity of the sealed air system and the quality of the reagents used. If the Accessories are not properly maintained, or if the Reagent Bottles are incorrectly capped or installed, an underfill might result which could adversely affect the quality of processing.

When the last program step ends, wax is held in the Reaction Chamber at the processing temperature. The display shows ‘Complete’, and a soft key offers a ‘Drain’ option.

2.4 STANDARD FLUSH A Standard Flush fills the Reaction Chamber with fluid from the Reagent Bottle in storage position 15 (A, Flush 1), and heats it for 20 minutes. The temperature does not exceed 60°C.

Selecting ‘Drain’ transfers the wax from the Reaction Chamber back into the appropriate Wax Bath. An alarm sounds at 30 second intervals after the drain is completed to remind you that specimens are ready for removal. The alarm cancels when the lid is opened, or a flush is started.

During the 20 minute Flush 1 cycle, the agitator of the centre column reciprocates the Basket Carrier gently back and forward through the Flush 1 fluid. Periodically, air in the totally closed system passes rapidly into the Reaction Chamber to create a stream of bubbles. The agitation that results cleans the higher reaches of the Reaction Chamber, and the lid.

Use the handle provided to unload the hot baskets, either before or after draining.

WARNING

Take care when removing hot tissue baskets from the Reaction Chamber. Splashes of hot wax (60°C) can be painful.

You can stop the processing from the small Unit Control Panel when the [STOP] pushbutton is lit, and restart using the [RESTART] push-button (when lit).

Ten bubble cycles occur during the 20 minute Flush 1 period of a Standard Flush. At the end of this time, the Flush 1 fluid returns to the Reagent Bottle in position 15 of the Reagent Bottle Store.

(A)

When all processing and wax steps are completed, you must flush the system to clear wax from the Reaction Chamber, indexing valve, and pipework, before the next processing cycle starts. This is mandatory. You have a choice of standard or Extended Flush, and an optional ‘Rinse’ cycle with warm soapy water, or similar, after flushing is completed.

(B)

When the first flush is complete, Flush 2 fluid (B) from the Reagent Bottle in storage position 16 is drawn into the Reaction Chamber, where it is heated for five minutes. The temperature does not exceed 35°C. Three bubble cycles take place and the tissue baskets are reciprocated during this time.

The total time for a Standard Flush is about 35 minutes, including fluid transfer times.

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2.5 EXTENDED FLUSH

2.6 TO RINSE

An Extended Flush fills the Reaction Chamber with fluid from the Reagent Bottle in storage position 15 (Flush 1), and heats it for 40 minutes. The temperature does not exceed 60°C. The Basket Carrier reciprocates for the whole of the time and twenty bubble cycles take place.

A rinse cycle is similar to a flush cycle but takes approximately five minutes in total, including fluid transfer times.

The second flush stage takes Flush 2 fluid from the Reagent Bottle in storage position 16, into the Reaction Chamber, and heats it for five minutes (maximum temperature 35°C). Reciprocation and three bubble cycles take place.

Before a rinse cycle is started, you must remove the Reagent Bottle in position 16 of the Reagent Bottle Store (Flush 2) and replace it with a Reagent Bottle that contains the preferred Rinse reagent (a). Typical rinse reagents are warm soapy water, or plain water.

You can stop any flush cycle at any time, except during a bubble cycle. If you stop Flush 1 and open the lid (to add components for example), the timer resets to the start of the first flush stage. The timer does not reset if you stop the flush during the second flush (Flush 2) stage, and flushing continues immediately the instrument is restarted.

Note 1 Make sure all traces of soap or detergent are washed away, or the tissue morphology might be affected.

If the instrument is not restarted within five minutes after it is stopped, an alarm sounder operates, and an on-screen error message is displayed.

When the bottle changeover is complete, press the [RINSE] soft key. Rinse reagent is drawn into the Reaction Chamber, where it is held for one minute and then expelled back into the Reagent Bottle in store position 16.

When the flush cycle is finished, you must select [COMPLETE] or [RINSE] to proceed. [COMPLETE] returns control to the main menu for the selected module; [RINSE] selects the rinse facility.

You may repeat rinse cycles as often as you want. When the final rinse is finished, press [COMPLETE]. Remove the Rinse Reagent Bottle from storage position 16, and replace it with the Flush 2 Reagent Bottle.

You cannot abort from a Flush cycle, and you must perform a flush cycle after any wax has been in the Reaction Chamber. This is mandatory.

Refer to the material safety data sheets (MSDSs) when handling the reagents listed in Appendix B.

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2.7 QUALITY CONTROL

iii

Vapour Trap Bottle emptying frequency

You can set up quality control criteria in Shandon Pathcentre for monitoring consumables used during processing. This enables you to keep a tally of the number of cassettes processed, or the number of times reagent or wax is used since the last renewal.

Battery replacement interval

Enter quality control criteria, which can be password protected, into the memory of the instrument via the Command Console.

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The frequency of hardware service is also monitored, and warnings are generated when materials or equipment are used beyond their intended life.

Shandon Pathcentre

If you select reagent usage for quality monitoring, the actual number of times a reagent may be used is entered into memory via the ‘Set Uses’ column of the ‘Set Reagents’ menu display, together with details of the reagents that comprise a particular ‘set’ or combination of reagents.

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Set up the monitoring option for reagent usage, or cassettes processed, via a ‘Quality Control’ options menu in the display. Other selectable options in this menu are for BACKUP or AUTO recovery from underfills, and for switching on or off the wax rotation facility.

Shandon Pathcentre

Air Bag replacement frequency

Charcoal Filter replacement frequency

Quality Control warnings that relate to processing reagents only show if the Quality Control warning option is enabled. A warning is generated when the set limits are reached or passed. You must then either attend to the subject of the warning, or override the warning, so that processing can proceed.

After quality criteria are set in memory, and quality monitoring is enabled, the ‘Quality Control Checklist’ display shows the number of times that each reagent, or wax in each bath, has been used. This data also appears in the ‘Set Reagents’ display, for reference only. A count of cassettes processed also shows in the Quality Control Checklist display if ‘Cassette Counting’ is enabled. Details of the hardware items are also provided

The Quality Control Checklist is not password protected and may be viewed at any time. It enables you to make checks on quality sensitive material, and to take remedial action if a warning is generated. When you have attended to the subject of the warning, the counters are reset with a soft key and quality monitoring continues for the replacement material.

Enter monitoring criteria for items of hardware via the ‘Maintenance’ menu of the display, where the criteria for each installed module are as follows: i

The desired temperature of the Wax Baths is also set via the Maintenance menu.

The Quality Control Checklist appears automatically before processing can start, if a quality warning exists. Warnings may be overridden, if necessary, to start processing immediately. Overridden warnings are displayed until the cause is rectified and the counters cleared. 75210150 GB Issue 2

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2.8 WARNINGS

‘Underfill’ appears in the display banner if an underfill occurs during processing, even if the automatic underfill recovery system operates successfully.

Warnings remove the ‘Shandon Pathcentre’ banner in the display and replace it with the relevant warning text. The number of the module responsible for the warning also shows. The cause of the warning is displayed when the relevant module is selected via the Module Select display.

‘Filling’ in the display banner shows that the instrument is active and not idle in the first stage of the processing sequence. ‘Quality Control’ appears in the centre of the display banner when one or more item of hardware, or a consumable, has reached the preset limit for attention. To see the cause of the warning select the Quality Control Checklist display.

2.9 REAGENT SETS The most frequently used combination of reagents for any Shandon Pathcentre Reagent Set 1 (a), occupies the Reagent Bottles in store positions 1 to 10.

All quality control functions operate for each of up to nine Reagent Sets associated with each installed module.

Sometimes it is convenient to change one or more of the reagents to suit a different processing requirement. The new combination of reagents becomes Reagent Set 2 (b). The differences between each set of reagents may be as little as a change of one bottle, or as much as a completely new combination of reagents.

Other warnings that appear in the banner of the display are as follows. The number of the module causing the warning appears in the top right corner of the display. ‘Held’ appears in the top left corner when a program is interrupted by operator intervention. A warning sounder operates after five minutes if no further action is taken. ‘Lid not locked’ appears on the left corner if the lid of the Reaction Chamber is not properly closed. Processing cannot proceed when this warning shows. ‘Drawer open’ shows if the Accessories Drawer of the module in the display is not fully closed. The Air Bag, Vapour Trap and Charcoal Filter within the Accessories Drawer all form part of the sealed air system. ‘A powerfail has occurred’ shows in the top centre of the banner if the power supply was interrupted during processing. The actual time that power failed, and the time it was restored, is shown in the top right hand corner of the banner.

a 26

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b 27

Each Shandon Pathcentre module (Command Unit or Extension) in a multi-unit installation has its own individual suite of Reagent Sets which might, or might not, be the same as the Reagent Sets in other modules. Do not interchange Reagent Sets between modules.

Up to nine different Reagent Sets can be accommodated for each Shandon Pathcentre module. The quality control system assumes that only bottles that are different from their predecessor are loaded in the store when a Reagent Set is changed. Consequently, a tally of usage for each bottle in each set is maintained. Quality control warnings are therefore generated as before for each Reagent Set.

2.10.2

CHARCOAL FILTER

The Charcoal Filter is part of the sealed air system and provides emergency protection if a blockage in the system causes the pressure relief valve to operate. The filter removes vapour fumes from the saturated air before the air is released to the atmosphere. The filter must be changed annually.

2.10.3

VAPOUR TRAP BOTTLE

The Vapour Trap Bottle receives condensed vapours from the sealed air system to prevent the build up of condensate in the air lines. It is a working part of the system and must be emptied at least weekly.

Note 1 Using highly volatile reagents, or operating the Shandon Pathcentre in low ambient temperatures, can cause the Vapour Trap Bottle to fill more quickly.

A ‘Reagent Set Changeover’ display prompts you to install the appropriate Reagent Bottles to suit the program selected.

WARNING

Check the contents of the Vapour Trap Bottle regularly.

2.10 ACCESSORIES DRAWER

2.10.4

The Accessories are contained in the pull-out Accessories Drawer (1) beneath each Shandon Pathcentre module. They comprise a Charcoal Filter (2), a Vapour Trap Bottle (3), a Spillage Container (4), and an Air Bag (5).

The Spillage Container is the only component in the Accessories Drawer that does not form part of the sealed air system. It has sufficient capacity to contain the loss of a full bottle of reagent or a Wax Bath. It must be checked monthly and emptied and cleaned as necessary.

2.10.5 2.10.1

TO OPEN THE DRAWER

AIR BAG

The Air Bag is an integral part of the sealed air system, and accommodates the small changes in the total air volume that take place as a result of changes in temperature or pressure during processing. The Air Bag must be changed every three months to ensure the integrity of the sealed air system.

Pull the front of the drawer outwards until it is stopped by the catches. To remove the drawer completely, press down on the two catches simultaneously and pull the drawer towards you until it is free of the slides. The drawer might be quite heavy if the Spillage Container is full.

SPILLAGE CONTAINER

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TO CLOSE THE DRAWER

Lift the drawer and engage it in the right and left hand slide runners. Push the drawer away from you until the catches operate. Push down on both catches simultaneously and push the drawer closed.

TAKE CARE NOT TO TRAP YOUR FINGERS.

If the underfilled reagent is the last of its type in the sequence, the program goes back one station and refills the Reaction Chamber using the last used similar reagent as the substitute (AUTO 2). Again, the program completes at the scheduled time.

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2.11 UNDERFILLS

If an underfill occurs while AUTO is selected, the instrument tries to continue the program and finish at the specified time. It does this by substituting the next similar reagent to the one that underfilled (AUTO 1) and uses it to complete that program step. The substituted reagent is then held in the Reaction Chamber for the duration of its own program step. The program thus completes at the scheduled time.

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2.10.6

An Underfill occurs if there is not enough reagent in a bottle, or wax in a bath, to fully immerse all the cassettes in the Reaction Chamber. It can also occur if a pipe is blocked or if there is a fault in the sealed air system.

Shandon Pathcentre automatically detects an underfill if it occurs. Two program selectable options are available for dealing with an underfill - Backup or Auto-Recovery. The factory set option is for Auto-Recovery.

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If an underfill occurs while BACKUP is selected, the last used reagent is returned to the Reaction Chamber and processing ceases. The banner in the display changes to show an UNDERFILL error message, and an alarm sounder operates. Specimens are held in the Reaction Chamber until an operator attends to the instrument.

If a second underfill occurs during an underfill recovery, the system defaults to the BACK UP state and processing ceases. If the instrument has already auto-recovered from a previous underfill, and another underfill occurs later on, then the instrument tries to auto-recover again.

Whenever an underfill occurs, the display shows an ‘Underfill’ message in place of the Shandon Pathcentre banner - even if auto-recovery is successful.

2.12 WAX BATH ROTATION Up to four wax impregnation steps are possible (program steps 11, 12, 13 and 14). When a number of wax impregnation cycles have been completed, the wax in the first Wax Bath tends to become contaminated, or diluted with processing reagent. When that happens, drain, clean, and fill that bath with fresh molten or pelletised wax, so that it is then suitable for use as the last wax step.

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Because it is not possible to move the physical position of a Wax Bath, the order in which the Wax Baths are used is rotated by use of a soft key in response to an onscreen prompt. Operation of the soft key changes the order in which the Wax Baths are called up in the program, and resets the counters of the quality control facility.

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Wax Bath rotation (R1) moves the original first Wax Bath (A) to become the fourth (final) wax step, and advances the original second Wax Bath (B) to become the first wax step. Similarly, the previous third Wax Bath (C) now becomes the second wax step and bath D supplies wax for the third wax step.

2.13 OTHER FACILITIES As an additional electrical safeguard for the Shandon Pathcentre installation, a proprietary ground fault interruption (earth leak detection) device can be fitted at the wall socket.

All actions performed by Shandon Pathcentre are logged, and are available for printing in hard copy form. You can use any dot matrix or inkjet line printer that typically connects to the LPT1 port of an IBM* compatible computer.

Remote access capability is built in to the Shandon Pathcentre to facilitate on-line fault analysis and recovery. This is a high-level application and not an operator selectable function.

An output is provided for operating an alarm sounder or annunciator remote from the Shandon Pathcentre.

(R1)

(R2)

Wax Bath rotation is a function of the Quality Control Checklist display. Each operation of the [CLEAR & ROTATE] soft key advances the Wax Bath order once (R2).

* IBM is a registered mark of International Business Machines.

Pelletised wax in a single Wax Bath normally attains operating temperature within approximately 150 minutes. Processing can continue while wax in the fourth wax position is melting.

Note 1 Shandon Pathcentre is designed to operate with Wax Bath rotation. Replenishing wax in two adjacent baths simultaneously might temporarily upset the temperature control system. Hot wax is held in the Reaction Chamber, at the end of the ‘last’ or ‘4th Wax’ step, until you drain the wax from the Reaction Chamber back into the ‘4th wax’ Wax Bath. You can drain either before or after the tissue baskets are removed.

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CONTROLS AND SCREEN LAYOUT Operator accessible components of the Shandon Pathcentre are as follows: The ON/OFF Switch

The Unit Control Panel

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The Wax Baths

The Bottle Store

The Console

The Accessories Drawer

3.3.2

STOP

Press [STOP] to interrupt processing at any step in a program. The push-button is only operative when lit, and must be held pressed for not less than 3 seconds to prevent accidental operation. A STOP command from the Unit Control Panel performs the same function as a STOP command from the Console.

3.3.3

RESTART

Press [RESTART] to resume processing after an interrupt. The push-button is only operative when lit and not flashing. A RESTART command from the Unit Control Panel performs the same function as a RESTART command from the Console. The instrument restarts processing at the same step in the program at which it was stopped.

3.2 ON/OFF SWITCH The ON/OFF ( l / O ) switch is at the rear of the instrument and is marked I for on, and O for off. Note 1 There is a delay of up to 10 seconds after the instrument is first switched on before there is a visible response.

3.3.4

LID

Press [LID] to release the Lid Latch interlock. The push-button is only effective when lit and not flashing. [LID] flashes for up to 20 seconds while the interlock clears.

3.3 UNIT CONTROL PANEL A miniature panel on the front of each unit contains a display annotated MODULE, with STOP, RESTART and LID illuminating push-buttons.

MODULE

The display shows the number allocated to a module in a multi-unit installation.

3.1 INTRODUCTION

3.3.1

The Lid Latch interlock mechanism holds the lid of the Reaction Chamber closed. It also acts as a safety cover over the Vacuum Release valve. The Lid Latch must be fully engaged before the instrument can operate.

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3.5 VACUUM RELEASE

Pull the plate of the Lid Latch towards you, after the interlock is released, to disengage the lid of the Reaction Chamber from the catch. Lift the Reaction Chamber lid from the front to open it. The Reaction Chamber lid self-supports in the open position and must be pushed down to close.

If vacuum in the Reaction Chamber prevents the lid from opening even after correct operation of the Lid Latch release, turn the knurled knob of the vacuum release tap anti-clockwise to open. The Vacuum Release Tap is located in the bottom left hand corner, under the lid latch plate.

To close the Reaction Chamber lid, push it down until it sits firmly on the seal, then push the plate of the Lid Latch inwards until it latches shut when vertical.

CLOSE THE TAP AFTER USE.

3.4 EMERGENCY RELEASE

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A manually operated EMERGENCY RELEASE for the Lid Latch interlock is accessed via the door next to the Lid Latch. If there is no power to energise the Lid Latch interlock, pull the metal tab firmly to the right. The Lid Latch will spring open to the released position.

WARNING

Only use the Emergency Release if the power supply fails, or if the lid fails to release after the lid latch interlock delay expires.

STAND CLEAR OF THE LID AREA OF THE SHANDON PATHCENTRE WHEN THE EMERGENCY RELEASE OPERATES. IF THE REACTION CHAMBER IS PRESSURISED AT THE TIME, THEN THE LID IS BLOWN OPEN VIGOROUSLY BY THE SUDDEN RELEASE OF PRESSURE, CAN VENT GAS OR VAPOUR EXPLOSIVELY TOWARDS YOU.

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3.6 WAX/PARAFFIN BATHS Operator functions with respect to the Wax (Paraffin) Baths are concerned only with maintenance. Access the Wax Baths by lifting the cover from the front. The Wax Baths Cover can be removed completely when at approximately 45°.

To remove a lid from a Wax Bath, pull up the centre knob until it ‘clicks’, then grip and twist the centre knob to release the seal. Lift the lid to remove it.

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THE WALLS OF THE WAX BATH AND VENT TUBES BECOME HOT (60°C). WEAR PROTECTIVE RUBBER GLOVES TO PREVENT INJURY.

Make sure that the Wax Baths are filled to the correct level. DO NOT OVER FILL THEM. The correct level is clearly indicated by a high/low marker on the back wall of each bath.

Shandon Pathcentre has storage positions for twelve identical bottles on two shelves. The top shelf holds six Reagent Bottles that correspond with program steps 1 to 6, numbered from the left, and the bottom shelf holds the four Reagent Bottles that correspond with program steps 7 to 10, again numbered from the left. The two bottle spaces that remain on the bottom shelf are for storing the flushing reagents.

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3.7 THE REAGENT STORE

Make sure that the vertical vent tubes in the Wax Baths are secure. The tubes unscrew from the bottom of the baths to facilitate cleaning, and must be replaced before new wax is added. Failure to replace the vent tubes can cause an expensive and time-consuming instrument malfunction.

1 Program steps 11, 12, 13, and 14 are for wax impregnation, so the two flush bottle storage positions are designated 15 and 16. Flush 1 reagent is in storage position 15 and Flush 2 reagent is in storage position 16.

2 3

5 6

Close the lid of a Wax Bath by pushing the lid firmly down until it is flush with the top deck. Press down the centre knob until it ‘clicks’. An up-and-over door covers each shelf. Note 1 You must reduce the level of wax (paraffin) in Wax Bath D by approximately 50mm (2ins) before the Shandon Pathcentre is moved for any reason.

WARNING

Each storage bottle holds 4.3 litres of reagent and has a graduated scale to simplify making up dilutions. A plastic screw cap seals the fill orifice of each bottle to the standards required by the sealed air system. It is important that the cap seals are maintained in good condition.

Wax (paraffin) levels are critical. Over-filling can force wax into the pneumatic system and cause blockages. Under-filling can result in poor processing.

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Thermo Electron Corp

Tissue Processors

Shandon Pathcentre Operator Guide Issue 2