Citadel Operator Guide

Citadel TISSUE PROCESSOR

ENGLISH Issue 6

OPERATOR GUIDE

69810040

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SYMBOLS The following symbols and conventions conventions are used throughout this manual and on the instrument. THIS SYMBOL WARNS YOU THAT YOU MUST FOLLOW INSTRUCTIONS FOR SAFE AND CORRECT OPERATION. IF THIS SYMBOL APPEARS ON THE INSTRUMENT INSTRUME NT,, ALWA ALWAYS REFER TO THIS OPERA OPERATOR TOR GUIDE. GUIDE. THIS SYMBOL WARNS YOU THAT SURFACES ARE HOT. IF THIS SYMBOL APPEARS APPEA RS ON THE INSTRUMEN INS TRUMENT T, ALWA ALWAYS REFER REFE R TO THIS OPERAT OP ERATOR OR GUIDE. THIS SYMBOL WARNS YOU THAT THERE MIGHT BE A BIOHAZARD ASSOCIATED WITH THE INSTRUMENT. ALWAYS ACT WITH COMMON SENSE AND BE AWARE OF THE SAMPLES USED. TAKE SUITABLE PRECAUTIONS. THIS SYMBOL WARNS YOU 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 LABORA LABORATOR TORY Y PROCEDURES. TAKE SUITABLE PRECAUTIONS. WARNING

A warning is given in the document if there is a danger of personal injury or damage to samples or equipment.

Note 1 Notes give more information about a job job or or instruction instruction but do not form part of the instruction Thermo Shandon Limited is an ISO 9001 and TickIT Accredited Company Thermo Fisher Scientific is the trading name of Thermo Shandon Limited All information contained in this manual is proprietary and confidential, and the exclusive property of Thermo Fisher Scientific. This manual is protected by copyright and reproduction is prohibited. This manual is for use only by the individuals to whom it has been made available by Thermo Fisher Scientific. The Citadel meets the follow following ing CE Mark requirements: In Vitro Diagnostic Directive 98/79/EC Machinery Directive 2006/42/EC 2006/42/EC..

Thermo Fisher Scientific 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.

© 2009 Thermo Fisher Scientific. All rights reserved. This manual may not, in whole or in part, par t, be copied, photocopied, reproduced, translated, or converted to any electronic or machine readable form without prior written consent of Thermo. Thermo.

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LIST OF CONTENTS WELCOME............................................................................................................. .............................................................................................................5 5 INTRODUCTION .................................................................................................... ....................................................................................................7 7 1.1 SAFETY FEA FEATURES TURES ........................................................ ............................................................................. .....................8 8 GENERAL DESCRIPTION .................................................................................... ....................................................................................9 9 2.1 MAIN BOD BODY Y ................................................... ...........................................................................................9 ........................................9 2.2 OPERATING OPERA TING HEAD ASSEMBL ASSEMBLY Y .........................................................10 2.3 HAND-HELD CONTROLLER ..................................................... .............................................................. .........10 10 2.4 OPTIONAL ACCESSO ACCESSORIES RIES ...................................................... ............................................................... .........10 10 INSTALLA INST ALLATION TION .................................................... ....................................................................................................12 ................................................12 CONTROLS AND INDICA INDICATIONS TIONS...................................................... ......................................................................... ...................15 15 4.1 HAND-HELD CONTROLLER KEYS ..................................................15 4.2 HAND-HELD CONTROLLER DISPLA DISPLAY Y ..............................................20 OPERATING CONDITIONS .................................................................................21 OPERATING .................................................................................21 5.1 AUTO MODE ........................................................... .......................................................................................21 ............................21 5.2 MANUAL MANUA L MODE ...................................................... ..................................................................................21 ............................21 5.3 ALARMS ........................................................ ..............................................................................................22 ......................................22 PREPARATION PREPARA TION .................................................... ....................................................................................................23 ................................................23 6.1 GENERAL ..................................................... ...........................................................................................23 ......................................23 6.2 REAGENTS REAGE NTS ................................................... .........................................................................................23 ......................................23 6.3 FILLING THE CONT CONTAINERS AINERS ...................................................... ............................................................... .........24 24 PROGRAMMING ................................................. PROGRAMMING .................................................................................................28 ................................................28 7.1 GENERAL ..................................................... ...........................................................................................28 ......................................28 7.2 PREPARING PREP ARING A PROGRAM TABLE .....................................................28 7.3 ENTERING A PROGRAM .......................................................... ................................................................... .........31 31 7.4 CHECKING AN ENTERED PROGRAM ..............................................33 7.5 ALTERING AL TERING A PROGRAM ................................................. .................................................................... ...................34 34 7.6 ENTERING A PASS FACILITY INTO A PROGRAM ...... ............. .............. ............. ........ ..36 36 7.7 ENTERING A DELA DELAY Y INTO A PROGRAM..........................................38 7.8 OVERRIDING A PROGRAMM PROGRAMMED ED DELA DELAY Y...........................................41 OPERATING PROCEDURE..................................................... OPERATING .................................................................................42 ............................42 8.1 RUNNING A PROGRAM .................................................. ..................................................................... ...................42 42 8.2 PROGRAM SEQUENCE .................................................. ..................................................................... ...................44 44 8.3 LOADING THE TISSUE BASKETS .....................................................45 8.4 LOADING THE BASKETS INTO THE HANGER .................................46 8.5 LOADING THE BASKET HANGER INTO THE CIT CITADEL ADEL....................46

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MAINTENANCE ...................................................................................................47 9.1 CLEANING AND MACHINE CARE .....................................................47 9.2 WAX BATH TEMPERATURE ...............................................................49 9.3 DISPOSAL...........................................................................................49 9.4 DECONTAMINATION ..........................................................................50 TECHNICAL DATA...............................................................................................52 10.1 ENVIRONMENTAL CONDITIONS ..........................................................53 ACCESSORIES....................................................................................................54 11.1 CITADEL 1000 ........................................................................................54 11.2 CITADEL 2000 ........................................................................................55 Warranty Statement ........................................................................................56 Declaration of Conformity ...............................................................................57

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WELCOME All Thermo Fisher equipment is designed to accepted standards of safety. Its use does not entail any hazard if operated in accordance with the instructions given in this guide. However, you must obey the following safety precautions:

WAX BATH SURFACES ARE HOT (60°C).

A BIOLOGICAL HAZARD IS ASSOCIATED WITH THE INSTRUMENT, BECAUSE OF THE PRESENCE OF TISSUES, AND OF SOLVENT VAPOURS.

Take care when loading and unloading baskets and reagent containers, to WARNING avoid trapping your fingers.

i

Potentially lethal voltages above 110Vac or 50Vdc are present inside the unit. Do not remove any access covers.

ii

If any aspect of the operation or care of the instrument is unclear, ask your Thermo supplier for advice. Incorrect use can introduce a hazard to health, or might damage the equipment.

iii

Disconnect the instrument from the mains supply before you carry out any maintenance or manual cleaning procedure.

iv

The Citadel is heavy. Seek assistance to lift or move the instrument.

v

It is important that you employ normal safety standards. Always use common sense and good housekeeping practices when operating the instrument.

vi

Wipe up any spills immediately. If fluid might have spilt inside the instrument, disconnect the instrument from the mains supply immediately by removing the plug from the mains supply socket. Do not reconnect to the mains supply until the instrument has been throroughly dried out and checked by a properly trained service engineer.

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v

Always comply with local regulations when handling chemicals or reagents. Observe the precautions recommended by the supplier of any material used with the instrument.

vi

Correct maintenance procedures are essential for consistent performance. It is important that the instrument be serviced by properly trained service personnel. You are strongly advised to take out a maintenance contract.

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INTRODUCTION

The Citadel is a programmable, carousel tissue processor intended for use in pathology laboratories by appropriately trained medical laboratory technicians. It is controlled by a hand-held controller unit connected to the processor through a coiled cable. If the processor is located within a fume or safety cabinet, the controller unit is kept outside.

You may use Hyperclean with the Citadel, to reduce exposure to solvent vapours.

Four 12-step processing programs can be programmed into the hand held controller, and an electronic timer with a maximum setting in each step of 99 hours and 59 minutes facilitates the running of extended programs (for example, weekend programs). A facility is also provided which allows you to introduce a delay before the processing schedule begins.

Tissue samples are placed into cassettes which are placed in a random or organiser tissue basket, with a lid, and then loaded on the processor. In the standard configuration, ten reagent containers and two independently heated wax baths are filled, as appropriate, and the processor is then programmed to rotate the operating head and lower the tissue basket into each of the containers for a pre-set length of time. You can apply a vacuum to the final wax bath, if a vacuum unit has been supplied with the processor.

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1.1 SAFETY FEATURES Various safety features are incorporated into the processor to safeguard both the operator and the tissue specimens.

i

The processing cycle stops automatically at position 12 to prevent double processing.

ii

The temperature of each wax bath is controlled electronically and can be adjusted over the range 45-65°C.

iii

A safety cut-out device prevents the wax overheating.

iv

You can raise manually the lift arm assembly from which tissue baskets are suspended, to remove any blockages or obstructions.

v

Electrical and mechanical safeguards are incorporated.

vi

When power is restored after a power failure during an automatic cycle, the processor resumes operation from the step and time of the interruption.

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GENERAL DESCRIPTION The Citadel Tissue Processor comprises two main sections: the main body, and the operating head assembly. Control is provided by a hand-held unit containing a keyboard and a display.

2.1 MAIN BODY Ten reagent containers and two wax baths are suspended by their rims from the deck at the top of the main body. An electrical tray slides into the base of the main body, which also houses the operating head drive motor, together with associated transformer and drive electronics.

Wax Baths Each wax bath is heated independently. The temperature is variable between 45°C and 65°C, adjustment being made by turning the recessed screw located in the lower half of the narrow face of the wax bath. A resettable thermal cut-out interrupts the power supply if the temperature rises to 80°C.

Green and amber indicators are provided. The green indicator is lit when power is applied to the bath and is extinguished if power is interrupted. The amber indicator illuminates when the heater is energised. The wax baths are plugged into shuttered mains power outlets on the electrical tray (see below).

Electrical Tray An electrical tray is located at the base of the main body, and incorporates the following items: i

Power switch, two mains fuses and a mains inlet cord.

ii

Mains power outlets for the wax baths.

iii

The connection to the hand-held controller.

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iv

Green and amber indicators. The green indicator is lit continuously while the machine is switched on. The amber indicator is lit in Auto mode to confirm that processing is in progress, and flashes when an alarm condition is detected. In the latter case, an audible alarm on the electrical tray is sounded.

v

A vacuum unit control link (supplied with the Vacuum Unit).

2.2 OPERATING HEAD ASSEMBLY The operating head assembly consists of a lift arm assembly enclosed by an operating head cover. The lift arm assembly raises and lowers the tissue basket into and out of the reagent. Access to the basket is by way of a door, in the operating head cover, which is secured by a catch. To provide optimum agitation, the tissue basket is raised clear of the reagent every ten minutes and then lowered again.

2.3 HAND-HELD CONTROLLER The controller consists of a keypad and a liquid crystal display, and is connected to the electrical tray by means of a coiled cable. The keypad controls programming, the mode of operation, and other functions; and the display provides program and other tissue processor status information.

The processor may be located in a fume cupboard or safety cabinet, and the hand-held controller placed outside the cabinet

2.4 OPTIONAL ACCESSORIES 2.4.1 Vacuum Unit You can apply a vacuum to the wax bath located at position 12. The vacuum unit is connected to, and controlled from, the mains tray, but is only applied when selected from the hand-held controller.

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2.4.2 Baskets Additional random tissue baskets and organiser tissue baskets are available.

Key: 1 2 3 4 5 6 7

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Operating Head Assembly Basket Hanger Evaporation Covers Connection for Vacuum Tube Wax Baths Random Basket Vacuum Unit

8 -

Item no longer available

9 10 11 12 13 14 -

Hand Held Controller Electrical Tray Auto Mode Indicator Power On Indicator Reagent Containers Organiser Baskets

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INSTALLATION The Citadel is a bench-mounted instrument which must be unpacked and installed with care. Ensure that the bench area is level, made of a non-flammable material, is large enough to take the instrument (which is 680mm in diameter), and is capable of taking the instrument’s weight:

•

64kg for the Citadel 1000 (52kg dry weight plus 12kg of reagents)

•

72kg for the Citadel 2000 (48kg dry weight plus 24kg of reagents)

Ensure that any unnecessary heating and cooling is avoided, as this could affect the evaporation of the reagents, or the temperature control of the wax baths.

Remove the top cover of the packing case and accessory packaging from the top of the instrument.

THE INSTRUMENT IS HEAVY, SO GET HELP TO LIFT OR MOVE IT, OR USE APPROPRIATE MECHANICAL HANDLING AIDS. WHEN MOVING OR LIFTING THE INSTRUMENT, GRIP IT FIRMLY ANYWHERE UNDERNEATH THE PLINTH.

Remove the instrument from the base of the packaging and place it carefully on the bench. Remove any packing from the operating head cover and check that the movement of the operating head is not obstructed. Check that the instrument is undamaged and complete. Contact your Thermo dealer if necessary.

Remove the basket hanger from the packing and fit it into the operating head by inserting the metal clip on the top of the lid into the corresponding connector on the head. Push the clip in until the basket hanger is fully home. Close the operating head cover.

The Citadel is supplied with a moulded mains connector. If this does not match your mains socket, remove the plug and rewire it as follows:

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Brown wire – Live (L or L2) terminal Blue wire – Neutral (N or L1) terminal Yellow/green wire – Earth (E or Ground) terminal

ONLY A COMPETENT ELECTRICIAN MAY REWIRE THE VACUUM UNIT PLUG.

Ensure that the mains voltage rating corresponds with the voltage rating on the specification plate of the instrument (situated at the rear of the base of the instrument).

The ‘~’ symbol on the rating plate indicates that the instrument operates on an alternating current (ac) supply. If possible, use a power supply with an emergency generator back-up.

Notes: 1

The Citadel is Class I equipment as defined in IEC1010, and as such it must be protectively earthed. Ensure that the instrument is properly connected to a good earth/ground contact, marked:

2

Make sure that it is possible to interrupt the power at a place away from the instrument. In an emergency, remove the plug from the mains supply socket. Do not use the instrument ON/OFF switch to disconnect the instrument.

Press O on the ON/OFF (I/O) switch on the electrical tray to ensure that the instrument is switched off. Plug the mains cable into the power supply.

Press I on the ON/OFF (I/O) switch to switch the instrument on. Check that the POWER indicator is lit and that the hand-held controller display is displaying STEP 1, PROG A, B, C, or D and MANUAL.

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To insert and remove the reagent containers Note: 1

Position 1 is adjacent to the hand-held control unit mounting position. Container positions are numbered clockwise.

Press the CHECK/FILL key on the hand-held unit. Each time this key is pressed, the operating head moves to position 2, 6 and 10, to allow access to all the containers. Remove the evaporation covers, and insert a reagent container into each space. Ensure that the handle of the container lies flat, to avoid fouling as the operating head rotates. Note that wax baths must be fitted into positions 11 and 12, which are situated to the right of the hand-held unit, above the wax bath power connections on the electrical tray.

Press the CHECK/FILL key again and repeat the procedure until there are containers in all 12 positions. Ensure that the evaporation covers are replaced.

The containers can be removed from the instrument in the same way.

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CONTROLS AND INDICATIONS The hand-held controller has been designed for easy use. The functions of the touchsensitive keys and the display indications are explained in the following tables.

4.1 HAND-HELD CONTROLLER KEYS Legend

Function Resets the display step number to 1.

RESET

STEP

_

+

PROG

Increases the display step number from 1 to 12 to 1 etc. Press once to increment the step number by 1. Press and hold to increase the step number quickly.

Decreases the display time. Press once to decrease the time by 1 minute. Press and hold to decrease the time quickly. Wraps round from 00.00 to PASS to 99.59.

Increases the display time. Press once to increase the time by 1 minute. Press and hold to increase the time quickly. Wraps around from 99.59 to 00.00.

Changes the displayed program in the sequence A-B-C-D-A-B etc., where A is the first program and D is the fourth. Press once to change the program by one step. Press and hold to change the program quickly.

(Continued)

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Legend

Function Selects the vacuum. VACUUM is displayed. Press once to enable the vacuum and press again to disable the vacuum. Vacuum is applied when the operating head is at position 12 and the tissue basket is lowered, when the processor is in Auto mode. Vacuum is independently selectable for each program and will be retained by each program unless cancelled.

VAC

Increases the rate of change of display time to 20 per second when pressed together with + (Plus) or - (Minus). RAPID

AUTO

MANUAL

START

STOP

Determines the mode of operation. When switched from Auto to Manual, any movements which are already in progress are completed. AUTO or MANUAL is displayed as appropriate.

In Manual mode, all the keys are active and a keypress is indicated by a short audible tone. The ENTER tone is slightly longer indicating that the time has been stored in the program displayed.

In Auto mode, only the AUTO/MANUAL, EMERGENCY STOP and Timing keys are active. In addition, CANCEL ALARM is active if an alarm condition exists.

For further Details refer to Mode Descriptions (Section 5, Operating Conditions ).

ENTER

CLOCK

Writes the displayed time into the currently displayed step of the current program.

When pressed and held down, displays real time. You can alter the setting by pressing the + (Plus) or - (Minus) key with the CLOCK key held down.

(Continued)

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Legend

START TIME

DAYS DELAY

DELAY ON

Function When pressed and held down, displays the start time of the program. You can alter the setting by pressing the + (Plus) or (Minus) key with the START TIME key held down.

If the indicator on the key is lit, a delay has been programmed. In this case, when the DAYS DELAY key is pressed and held down, the number of days delay, in 24-hour periods, is displayed. The setting can be altered by pressing the + (Plus) or - (Minus) key with DA DAYS YS DELA DE LAY Y held hel d down.

A programmed delay is activated when the key is pressed and is de-activated when the key is pressed a second time. When the delay is activated, the indicator on the key is lit.

ROTATE

When the tissue basket is raised, each press causes the head to advance one position. The switch has no effect if the basket is lowered.

RAISE

When the tissue basket is lowered, press once to raise the tissue basket. The key has no effect if the basket is already raised.

LOWER

GO TO 1

When the tissue basket is raised, press once to lower the tissue basket. The key has no effect if the basket is already lowered.

When the tissue basket is raised and the head is not at position 1, press once to rotate the head to position 1. Note that position 1 is directly above the connection point for the hand-held controller controller..

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RESET

STEP

PROG

VAC

AUTO START

_

+

R A P ID

MANUAL STOP

ENTER

·

CLOCK

START TIME

DAYS DELAY

·

DELAY ON

LOWER ROTATE

GO TO 1

RAISE

EMERGENCY STOP

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CHECK/FILL

CANCEL ALARM

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Legend

CHECK/FILL

EMERGENCY STOP

CANCEL ALARM

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Function When the tissue basket is raised, press to rotate the head to positions 2, 6,10, 2, 6 etc. Positioning the head at any of these positions facilitates facilitates access to two groups of three reagent r eagent vessels and wax baths via the anti-evaporation covers.

Stops the machine immediately. A continuous ‘beep’ audible alarm sounds and the AMBER PROCESSING indicator flashes. If the machine is operating in Auto mode, it rev reverts erts to Manual mode.

Clears the alarm condition, providing that the cause of the alarm has been removed. Press Press once to silence the alarm then press again after a 3-second delay to restore the machine to its selected operating mode and program step. If the alarm is caused by operator interference or a mechanical obstruction of the head, then, when you press the key the second time, the head moves to the nearest position and the tissue carrier lowers and raises. To resume operation, press the AUTO/MANUAL key.

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4.2 HAND-HELD CONTROLLER DISPLAY

Indication

Function

PROG A-B-C-D

Indicates which program is selected.

VACUUM

Indicates that vacuum is selected for the displayed program. The indicator flashes while the vacuum is applied.

AUTO/MANUAL

Indicates the mode in which the machine is operating.

Digits 1 and 2

Display the current program step in AUTO and MANUAL.

Digits 3, 4, 5, and 6

Display the time stored for the selected step. The time is counted down to 00:00 in Auto mode. Digits 3 and 4 display hours, and digits 5 and 6 display minutes.

In Manual mode, the colon is steady.

In Auto mode, the colon flashes when the time is being counted.

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OPERATING CONDITIONS The two main operating conditions which are set by the operator are: i

Auto mode

ii

Manual mode

A further condition, entered automatically is: Alarm – This is automatically activated when the processor detects an alarm condition.

5.1 AUTO MODE Auto mode is the processing mode of the machine. The tissue processor is programmed in Manual mode (see below) after which Auto mode is entered by pressing the AUTO START/MANUAL STOP key.

In this mode, only the AUTO START/MANUAL STOP, EMERGENCY STOP and Timing keys are active. You can re-enter Manual mode at any point in the program by pressing AUTO START/MANUAL STOP. If this key is pressed whilst the head or basket carrier is moving, the movement is completed before Manual mode is entered.

If the EMERGENCY STOP key is pressed while the basket carrier is moving, the carrier stops immediately, then completes its move when ALARM CANCEL is pressed. However, if EMERGENCY STOP is pressed while the operating head is rotating, rotation does not resume when ALARM CANCEL is pressed. In this case, press ROTATE after ALARM CANCEL to complete the movement.

For details of the automatic program sequence refer to Section 8.2, Program Sequence .

5.2 MANUAL MODE Manual mode is entered when the tissue processor is first switched on. This mode also enters automatically when an end of cycle or null run occurs, or when you press the EMERGENCY STOP key followed by the ALARM CANCEL key. If the processor is in Auto mode, enter Manual mode by pressing the AUTO START/MANUAL STOP key. 69810040 Issue 6

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Once in Manual mode, all the keys are active and a key press is indicated by a short ‘beep’. You can program the processor and execute individual motions (rotate, raise and lower) of the operating head and basket carrier. Resetting from an emergency stop as described in Section 5.1, Auto Mode .

5.3 ALARMS An alarm sounds automatically when an alarm situation occurs, or when you press the EMERGENCY STOP key. A continuous ‘beep’ sounds and an alarm code displays, unless the Alarm mode was entered via the EMERGENCY STOP key, in which case ES is displayed. Alarms AL 2, 4, 6 and 7 can be caused by obstructions to the head or basket lift carrier assembly. When these alarms occur, check for any obstruction to the head or basket lift carrier assembly. If this is not the case, the alarm might be due to mechanical or electronic wear or failure.

Use the ALARM CANCEL key to cancel the Alarm. Press the key twice, once to cancel the alarm and a second time, after a 3-second delay, to restore the processor to the previously selected operating mode and program step. If the cause of the alarm is not apparent, and pressing ALARM CANCEL twice does not clear the alarm, call your local Thermo service engineer.

Note that if the alarm was caused by operator interference or a mechanical obstruction of the head, pressing ALARM CANCEL the second time causes the operating head to move to the nearest position and the tissue carrier to lower and then raise. You must then press the AUTO START/MANUAL STOP button to resume operation.

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PREPARATION 6.1 GENERAL Once the processor has been installed, (refer to Section 3, Installation ), the containers can be filled as appropriate. A list of the approved reagents etc. is supplied below, followed by the filling procedure.

As cooled wax can take up to five hours to remelt, the usual procedure is to switch on the processor power supply and connect the wax baths already filled with molten wax. This also ensures that you can detect immediately any malfunction of the wax baths.

6.2 REAGENTS The following reagents are approved by Thermo for use with the Citadel processor. Contact your local Thermo dealer for advice before using any reagents that are not listed below.

i

Fixatives: Formalin Formol Saline Buffered Formalin Bouin’s Fluid

ii

Dehydrants:

Methanol (Methyl Alcohol) Ethanol (Ethyl Alcohol) Isopropyl Alcohol Acetone

iii

Clearing Agents: Xylene Toluene Chloroform Xylene Substitute

iv

Paraffin Wax:

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Histoplast You may use any good quality paraffin wax

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6.3 FILLING THE CONTAINERS Before filling the containers, refer to the written program table (Section 7.2, Preparing a Program Table) to ensure that the reagents are allocated appropriately.

6.3.1 Reagents

1.

Ensure that Manual mode is selected: 1

2

3

a. Check that MANUAL is lit on the display.

b. If MANUAL is not displayed press MANUAL STOP.

2.

4

5

6

COL

AUTO

MANUAL

START

STOP

Prepare to fill: a. Press the CHECK/FILL key. CHECK/FILL

b. Check that operating head moves to position 2, 6 or 10. Each of these positions allows access to a set of containers.

3.

Remove the appropriate anti-evaporation cover.

4.

Fill the containers with the selected reagents: Fill the containers to the maximum level marked on the container. If necessary, you can remove the reagent containers from the instrument to a fume cupboard or well-ventilated area for filling. Or you can fill the reagent containers with the containers fitted in the instrument. However, be aware of the following advice and precautions:

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FOR PLASTIC CONTAINERS, THE FILL LINE IS THE TOP OF THE ROUNDED FEATURES ON THE SIDE OF THE CONTAINER.

FOR NEWER METAL CONTAINERS, THE FILL LINE IS MARKED ON THE INSIDE OF THE CONTAINER. FOR OLDER METAL CONTAINERS, THAT DO NOT HAVE THIS INDICATOR, THE CORRECT FILL LEVEL IS 6.5cm FROM THE TOP OF THE CONTAINER.

PLASTIC CONTAINERS ARE FOR USE WITH FIXATIVES AND DEHYDRANTS. METAL CONTAINERS ARE FOR USE WITH CLEANING AGENTS. USING THE WRONG CONTAINER FOR THE REAGENT TYPE CAN DAMAGE THE CONTAINER, AND CAUSE INSTRUMENT ERROR.

ALWAYS REFER TO THE RELEVANT MSDS WHEN USING REAGENTS.

USE GOOD LABORATORY PRACTICE WHEN FILLING CONTAINERS.

TAKE CARE WHEN CARRYING FULL REAGENT CONTAINERS, AND WHEN FITTING FULL CONTAINERS IN THE INSTRUMENT.

DO NOT SPILL REAGENT INTO THE INSTRUMENT. NOTE THAT SOLVENT VAPOURS WILL BE PRESENT WHEN YOU ARE FILLING THE CONTAINERS.

TAKE CARE NOT TO TRAP YOUR FINGERS WHEN REFITTING THE CONTAINERS IN THE INSTRUMENT.

CHECK REAGENT CONTAINERS REGULARLY TO ENSURE THE FILL LEVEL IS CORRECT.

Refer to Section 7.2, Preparing a program Table . 5.

When you have filled the containers, replace the anti-evaporation covers.

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6.3.2 Wax YOU MAY USE SEMI-MOLTEN WAX, OR MOLTEN WAX AT A TEMPERATURE NOT GREATER THAN 60°C, TO FILL THE BATH TO THE DESIRED LEVEL, BUT POURING WAX HOTTER THAN 60°C INTO A COLD BATH CAN DAMAGE THE SENSITIVE THERMOSTAT. FOR THE SAME REASON, DO NOT ALLOW AN EMPTY BATH TO HEAT UP.

1.

Repeat Steps 1-3 of Section 6.3.1, Reagents . Ensure access to the wax baths is possible.

2.

Fill the wax baths: Citadel 1000: Fill the wax baths with molten wax to the bottom of the level indicated on the inside of the wax bath. Citadel 2000: Fill the wax baths with molten wax to the bottom of the lower level (1400ml) when using organiser baskets, or to the bottom of the upper level (1700ml), when using random baskets. You can fill the wax baths either off the instrument, or while the baths are fitted to the instrument.

TAKE CARE WHEN CARRYING AND FILLING THE WAX BATHS.

TAKE CARE NOT TO TRAP YOUR FINGERS WHEN FITTING THE WAX BATHS.

3.

Connect the wax bath cables: Plug the wax bath cables into the sockets located on the electrical tray at the base of the processor.

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4.

Check that the wax baths are on: Check that the indicators on each wax bath are lit.

Note that heating commences as soon as power is switched on.

TAKE CARE WHEN HANDLING THE WAX BATHS. THERE ARE ACCESSIBLE HOT SURFACES.

ONLY USE WAX IN THE WAX BATHS. IF YOU USE FLAMMABLE LIQUID, YOU MAY CAUSE A FIRE.

CHECK THE WAX BATH REGULARLY TO ENSURE THE FILL LEVEL IS CORRECT.

IF YOU USE A VACUUM UNIT, CHECK THAT THE TUBE IS CLEAR, AND THE TOP OF THE CONTAINER IS FREE FROM DEBRIS.

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PROGRAMMING 7.1 GENERAL The processor can store up to four (A, B, C, D) 12-step programs. It is essential that you create a written record of each processing cycle, for reference purposes. To this end, prepare a program table, similar to the examples below.

7.2 PREPARING A PROGRAM TABLE When preparing a program table, consider the following: i

The minimum immersion time in any position/step is one minute.

ii

The maximum immersion time in any position/step is 99 hours 59 minutes. This allows for extended programs (such as weekend programs).

iii

The programmed time indicates the end of an immersion period.

iv

The lift arm is raised and lowered automatically every ten minutes to provide mechanical agitation.

v

When transferring from position to position, the basket drains for approximately one minute. This minute is NOT included in program time.

vi

You can delay the programmed schedule up to nine days using the delay feature. Refer to Section 7.7, Entering a Delay Into a Program .

The steps involved in preparing a program table are summarised below. Step 1. List the reagents and then allocate them to a specific position/step. Step 2. Insert any critical immersion times. Step 3. Complete the table. Note: 1

28

It is not essential that all twelve steps be used in each program (refer to Section 7.6, Entering a Pass Facility).

69810040 Issue 6

Two sample programs are provided: •

Routine overnight processing program

•

Small biopsies program for daytime processing

Example of Program for Routine Overnight Processing Position/Step

Reagent

Position 1 Position 2 Position 3 Position 4 Position 5 Position 6 Position 7 Position 8 Position 9 Position 10 Wax Bath 1 (11) Wax Bath 2 (12)

Formalin Formalin Alcohol 70% Alcohol 90% Alcohol 100% Alcohol 100% Alcohol 100% Xylene Xylene Xylene Wax Wax

Immersion Period Hrs Mins 2.00 2.00 1.00 1.00 1.00 2.00 2.00 1.00 1.30 1.30 2.00 3.00

Period Entered Hrs Mins 02.00 02.00 01.00 01.00 01.00 02.00 02.00 01.00 01.30 01.30 02.00 03.00

END OF CYCLE Total processing time = 20hrs Full program time = 20hrs 11mins, allowing one minute for every change of position

THERMO HAS NOT VALIDATED THE PROTOCOL ILLUSTRATED HERE, AND TAKES NO RESPONSIBILITY FOR ITS USE. YOU MUST ALWAYS VALIDATE PROTOCOLS BEFORE PLACING ANY RELIANCE ON THEM.

69810040 Issue 6

29

Example of Day-time Program for Small Biopsies (Such As Needle Biopsies) Note: 1 This processing schedule is appropriate for needle biopsies of 2 mm in diameter and 10 mm in length.

Position/Step

Reagent

Position 1 Position 2 Position 3 Position 4 Position 5 Position 6 Position 7 Position 8 Position 9 Position 10 Wax Bath 1 (11) Wax Bath 2 (12)

Formal Saline Formal Saline Alcohol 70% Alcohol 90% Alcohol 100% Alcohol 100% Alcohol 100% Xylene Xylene Xylene Wax Wax

Immersion Period Hrs Mins 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.30 0.30

Period Entered Hrs Mins 00.15 00.15 00.15 00.15 00.15 00.15 00.15 00.15 00.15 00.15 00.30 00.30

END OF CYCLE Total processing time = 3hrs 30mins Full program time = 3hrs 41mins, allowing one minute for every change of position

THERMO HAS NOT VALIDATED THE PROTOCOL ILLUSTRATED HERE, AND TAKES NO RESPONSIBILITY FOR ITS USE. YOU MUST ALWAYS VALIDATE PROTOCOLS BEFORE PLACING ANY RELIANCE ON THEM.

30

69810040 Issue 6

7.3 ENTERING A PROGRAM Before you can enter a program into the memory, you must switch on the power supply (refer to Section 3, Installation ), and make sure the movement of the operating head is not obstructed in any way. All further operations are controlled via the hand-held controller. 1.

Select Manual mode: 1


b. If MANUAL is not displayed, press MANUAL STOP.

2.

2

3

4

6

AUTO

MANUAL

START

STOP

Select the appropriate program: a. Press the PROG key to select the A, B, C or D program as appropriate.

b. Check that A, B, C or D is lit on the display. If A is selected, the display shows:

3.

5 COL

1

2

PROG

3

4

5

6

COL

Return to the start of the program:

a. Press the RESET key. RESET

b. Check that Step 01 is displayed:

69810040 Issue 6

1

2

3

4

5

6

COL

31

4.

Set the required immersion time for Step 01: a. Using the + (Plus), - (Minus) and RAPID keys, as appropriate, set the required immersion time for Step 01.

b. Press

c. Press

d. Press

+

_

once to increase the display time by one minute.

once to decrease the display time by one minute.

RAPID

, and either

or +

_

to alter the displayed time rapidly, until the required immersion time is displayed.

5.

Enter the required immersion time into program memory:

Press the ENTER key. ENTER

A ‘beep’ sounds, verifying that the time has been entered into the program memory.

6.

Proceed to Step 02: a. Press the STEP key. STEP

1

2

3

4

5

6

COL


7.

32

Repeat Steps 4 and 5.

69810040 Issue 6

8.

Enter the rest of the program:

a. Press the STEP key. STEP

b. Repeat Steps 4 and 5 until you have entered the entire program. c. Check that 03 to 12 are displayed as each step in the program is selected. d. Adjust the time for each step as described in Step 4.

7.4 CHECKING AN ENTERED PROGRAM Follow this procedure when you want to review an entered program. 1.


2

3

4



2.

5

AUTO

MANUAL

START

STOP

Select the appropriate program: a. Press the PROG key to select the A, B, C or D program, as appropriate.


3.

6

COL

1

2

3

4

PROG

5

6

COL

Return to the start of the program: a. Press the RESET key. RESET

69810040 Issue 6

33

b. Check that Step 01 and the appropriate immersion time are displayed (for example, 1 hour).

1

2

3

4

5

6

COL

c. Go through the full program, pressing the STEP key to move from one step to another.

STEP

d. Check that the entered times displayed are correct throughout the program sequence.

For example, at Step 03 of program A, with an immersion time of 12 minutes, the display would show:

1

2

3

4

5

6

COL

4.

Check programs in other memory locations:


b. Proceed as in Steps 2a to 3d of Section 7.4, Checking an Entered Program .

7.5 ALTERING A PROGRAM Adjustments as small as ±1 minute can be made at any program step without affecting any other steps. These adjustments are often desirable in selected program steps, to compensate for conditions such as reagent dilution or aging.

34

69810040 Issue 6

1.

Select Manual mode: a. Check that MANUAL is lit on the display.


2.

1

2

3

4

5

6

COL

AUTO

MANUAL

START

STOP

Select the appropriate program:

a. Press the PROG key to select the A, B, C or D program as appropriate.


3.

1

2

3

PROG

4

5

6

COL

Proceed to the step requiring alteration: a. Press the STEP key the appropriate number of times to reach the correct place in the program

b. Check that the appropriate step number is displayed. For example, if Step 03 is selected, the display shows:

4.

1

2

3

4

5

STEP

6

COL

Alter the step time as required:

Press keys

or +

_

, and

if required, until the RAPID

desired time is displayed. 69810040 Issue 6

35

5.

Enter the altered value in the program memory:

Press the ENTER key. ENTER

A ‘beep’ sounds, verifying that the time has been entered into the program memory. 6.

Return to the start of the program: a. Press the RESET key. RESET

b. Check that Step 01 is displayed.

Note: 1 To completely change a program, follow Steps 1 to 6 for each step of the program to be amended.

7.6 ENTERING A PASS FACILITY INTO A PROGRAM If you want to ‘pass over’ individual reagent or wax containers without the specimen baskets entering the reagent containers, perform the following steps:

1.



2.

1

2

3

5

6

COL

AUTO

MANUAL

START

STOP


36

4

PROG

69810040 Issue 6


3.

1

2

3

4

5

6

COL

Proceed to the step in the program that you want to pass over: a. Press the STEP key until the required step is displayed. STEP

For example, if the step required is Step 03, the display shows:

b. Press the Minus key ,

_

1

2

3

4

5

6

COL

, until 00:00 is displayed:

1

2

3

4

5

6

COL

4.

Enter the PASS facility: a. Press the - (Minus) key once more.

1

2

4

5

6

COL

b. Check that PASS is displayed across the time:

5.

3

Enter the PASS instruction into the program memory: Press the ENTER key: ENTER

IF YOU ENTER 00:00 FOR ANY STEP, PROCESSING STOPS AT THAT STEP.

69810040 Issue 6

37

7.7 ENTERING A DELAY INTO A PROGRAM If you want a delay period before processing begins, proceed as follows: 1.



2.

1

2

3

4

5

AUTO

MANUAL

START

STOP

Select the appropriate program: a. Press the PROG key to select the A, B, C or D Program, as appropriate.


3.

6

COL

1

2

3

4

PROG

5

6

COL

Return to the start of the processing schedule: a. Press the RESET key. RESET

1


4.

2

3

4

5

6

COL

Enter the required start time: a. Hold down the START TIME key.

START TIME

38

69810040 Issue 6

b. Enter the required start time by pressing the + (Plus) and - (Minus) keys until the required start time is displayed.

The start time is displayed in 24hour format. For example, 2.30pm would be displayed as:

5.

1

2

3

4

5

6

COL

Enter the required delay time (in days): If no days delay is required, go to Step c. a. Hold down the DAYS DELAY key.

DAYS DELAY

b. Select the required number of days delay using the + (Plus) or - (Minus) keys. The display shows the number of days (24-hour periods) delayed, in the format 1 to 9 preceded by the letters ‘dd’. For example, a delay of six days is displayed as:

1

2

3

4

5

6

COL

c. Press the DELAY ON key to activate the delay.

DELAY ON

Check that the indicator in the key lights up, to show that a delay has been activated.

If a delay has been programmed in, the indicator in the DAYS DELAY key also lights up.

To cancel the delay press the DELAY ON key once more.

69810040 Issue 6

39

6.

Return the head to position 1: Press the GO TO 1 key. GO TO 1

7.

Load the tissue basket onto the processor Refer to Section 8.3, Loading the Tissue Baskets , to Section 8.5, Loading the Basket Hanger into the Citadel .

8.

Lower the basket into the fixative at position 1: LOWER

Press the LOWER key.

9.

Automatic countdown to processing: When the number of days delay has been counted down to 0, the light on the DAYS DELAY key goes out. When the days delay has counted down to 0 and the real time passes the programmed start time, the processor goes into Auto mode and begins processing at the step shown on the hand- held controller display. The light on the DELAY ON key goes out when processing begins.

On the day of programming, if you programme the number of days delay before the required start time (for example, the start time is 18:00 but you programme the days delay at 16:00), then you must add an extra day. See the following examples.

Example 1 Required processing start time is 1800 on Sunday

TIME DAYS DELAY displayed

Friday Work 1600 1800 (programmed) 2 1 ∴

40

Saturday Weekend 1800 0

Sunday Monday Weekend Work 1800 —> Processing (start time) 0

DAYS DELAY REQUIRED = 2

69810040 Issue 6

Example 2 Required processing start time is 1500 on Monday Friday Work 1600 (programmed)

TIME

DAYS DELAY displayed

Saturday Weekend 1500

2

Sunday Weekend 1500

1 ∴

Monday Tuesday Holiday Work 1500 —> Processing (start time)

0

DAYS DELAY REQUIRED = 2

IF POWER IS LOST DURING THE DELAY PERIOD, THE PROCESSING START TIME CANNOT BE GUARANTEED.

10.

Check that the real clock time is correct: a. If you need to change the time, hold down the CLOCK key. CLOCK

b. Press the + (Plus) and - (Minus) keys until the correct time is displayed. Hold down the RAPID key at the same time, for faster adjustment.

7.8 OVERRIDING A PROGRAMMED DELAY

Press the AUTO START key.

AUTO

MANUAL

START

STOP

The processing schedule begins immediately at whatever step is displayed on the hand-held controller.

69810040 Issue 6

41

OPERATING PROCEDURE 8.1 RUNNING A PROGRAM Once you have selected a program manually, it can be initiated and is run automatically, as follows:

1.


2

3

4



2.

5

AUTO

MANUAL

START

STOP



3.

6

COL

1

2

3

PROG

4

5

6

COL

Return to the start of the program:


1

b. Check Step 01 is displayed:

42

2

3

4

5

6

COL

69810040 Issue 6

4.

Return the operating head to the start position:

Press the GO TO 1 key. GO TO 1

5.

Load the tissue basket carrier: If you are using an organiser basket, load the most urgent samples in the topmost section for fast access. Refer to Section 8.5, Loading the Basket Hanger Into the Citadel .

6.

Start the Automatic program: a. Press the AUTO START key.

AUTO

MANUAL

START

STOP

1

b. Check that AUTO is lit on the display:

2

3

4

5

6

COL

c. The program continues to run to completion, unless you select MANUAL during a program—at which point the cycle stops.

d. When you reselect AUTO, the cycle recommences from the time and step of the interruption.

THE UNIT CARRIES OUT WHATEVER ACTION SHOWS ON THE DISPLAY. ALWAYS ENSURE YOU PRESS THE RESET KEY BEFORE STARTING THE PROGRAM.

69810040 Issue 6

43

8.2 PROGRAM SEQUENCE An automatic program performs the following sequence: i

The operating head moves to the position corresponding to the first step in the program, as displayed on the controller.

ii

The amber processing indicator on the electrical tray illuminates.

iii

The time selected for the current program step is displayed and counted down to 00:00. Note that the countdown does not begin until the basket carrier is completely lowered into the reagent vessel. The colon flashes continuously during processing.

The time display counts down from the selected time to 00:00. The time displayed at any time is the time remaining in that step.

iv

When the count reaches 00:00, the number of the next step is displayed, with its selected time. Any step displaying PASS instead of a time is omitted, and the basket will not be lowered into the reagent.

v

The operating head moves to the position corresponding to the next step displayed, and countdown begins again.

vi

Steps iv and v are repeated for each subsequent step in the program, until the final step in the program has been counted down to 00:00, or the time for the next step has been set to 00:00.

vii

When the program is complete, the processor automatically enters Manual mode and a series of ‘beeps’ is sounded.

viii

The amber processing indicator is extinguished.

ix

Press RAISE on the handset, open the load door, and remove the tissue baskets.

44

69810040 Issue 6

Note: 1 On completion of the final step (Step viii), the tissues remain immersed in the reagent until you remove them. It is impossible for the processor to transfer the tissues from Position 12 (End of Program) back to Position 1.

TAKE CARE, AS THE WAX IS HOT.

SOLVENT FUMES MIGHT BE PRESENT WHEN THE LOAD DOOR IS OPENED.

WHEN YOU USE THE VACUUM, ‘RAISE’ THE BASKET FROM THE CONTAINER WITH THE LOAD DOOR CLOSED. A VACUUM IN THE LAST STEP CAN CAUSE THE WAX BATH TO BE LIFTED WITH THE BASKET. IF THE WAX BATH FALLS, WAX MIGHT SPILL.

8.3 LOADING THE TISSUE BASKETS 8.3.1 Random Basket Place tissue cassettes loosely in these baskets.

8.3.2 Organiser Basket Each large section of the organiser basket holds five layers of five cassettes—that is, 25 cassettes in total. The small section holds two layers of five cassettes—that is, 10 cassettes in total. The tissue cassettes must be laid flat in the organiser baskets, as dictated by the basket shape.

ENSURE THAT YOU LOAD TISSUES CORRECTLY INTO THE CASSETTES, AND THAT THE LID OF THE CASSETTE IS SECURELY FASTENED. USE GOOD QUALITY TISSUE CASSETTES, SUCH AS THOSE SUPPLIED BY THERMO.

69810040 Issue 6

45

8.4 LOADING THE BASKETS INTO THE HANGER 8.4.1 Organiser Baskets Insert an organiser basket at the top of the basket hanger, with the narrow side of the basket towards the centre of the instrument.

Ensure the organiser basket is in as far as it can go, and that the flanges on the basket hanger line up with the slots in the horizontal flange on the basket. Allow the basket to slide down to the bottom of the head.

Repeat this with the other baskets. Capacities: •

Citadel 1000

•

Citadel 2000

2 x 25 capacity basket 1 x 10 capacity basket 4 x 25 capacity basket 1 x 10 capacity basket

Finally, place the organiser lid on top of the baskets.

8.4.2 Random Basket Fit the basket in the same way as the organiser baskets.

8.5 LOADING THE BASKET HANGER INTO THE CITADEL Fit the connector on top of the hanger into the slot in the lift arm, and slide the connector fully home.

REAGENT FUMES ARE PRESENT WHENYOU OPEN THE LOAD DOOR.

TAKE CARE NOT TO TRAP YOUR FINGERS IN THE LOAD DOOR.

46

69810040 Issue 6

MAINTENANCE If hazardous material is split on, or inside, the instrument, carry out the appropriate decontamination. Cleaning or decontamination methods, other than those recommended in the Operator Guide, must be checked with a Thermo agent to ensure that the proposed method will not damage the equipment.

9.1 CLEANING AND MACHINE CARE Always wipe up spills immediately. In the event of a major spillage, disconnect the machine from the mains supply IMMEDIATELY and do not reconnect it until the machine has been dried out thoroughly and checked by a service engineer.

Each of the main items, and their recommended cleaning method, are presented in the table on page 48 .

DURING ALL CLEANING PROCEDURES, THE EQUIPMENT MUST BE DISCONNECTED FROM THE MAINS SUPPLY.

69810040 Issue 6

47

Item

Recommended Cleaning Method

Reagent containers

Hot water and detergent (maximum temperature 60°C)

Wax baths

1. Pour the hot wax into a suitable container. 2. Allow the remaining wax to cool slightly and then peel away the wax while it is still warm.

Baseplate and top deck

1. Remove the excess wax using a flexible, non-metallic spatula or a dry cloth. 2. Remove stains using water and detergent.

Central housing

Wipe using a moist cloth and detergent.

Baskets and basket carrier

1. Dissolve wax using a suitable solvent. 2. Wash the basket and basket carrier in hot soapy water (60-70°C) using a mild detergent. Note: If necessary, you can melt the wax in an oven heated to 60°C.

Operating head assembly and antievaporation covers

1. Remove wax using a flexible, non-metallic spatula. 2. If necessary, wipe using a moist cloth and detergent.

Cleaning the instrument regularly, in accordance with the instructions contained within this Operator Guide, will ensure that the instrument continues to operate efficiently and safely in normal day-to-day use. Contact your Thermo agent if any part of the instrument appears to be damaged in any way.

Conduct portable appliance testing (PAT) annually.

48

69810040 Issue 6

9.2 WAX BATH TEMPERATURE The temperature at which the wax bath operates has been factory set to 60°C. Check the wax bath temperature regularly and, if necessary, adjust it by removing the protective plastic cap, and turning the recessed screws located in the lower half of the narrow face of the wax bath.

With the narrow face of the wax bath facing to the front;

•

Turn anti-clockwise to increase the control temperature.

•

Turn clockwise to decrease the control temperature.

9.3 DISPOSAL DISPOSE OF EXHAUSTED REAGENTS IN ACCORDANCE WITH LOCAL PROCEDURES.

69810040 Issue 6

49

9.4 DECONTAMINATION IF HAZARDOUS MATERIAL IS SPILT ON, OR INSIDE, THE INSTRUMENT, YOU MUST CARRY OUT THE APPROPRIATE DECONTAMINATION.

CLEANING OR DECONTAMINATION METHODS, OTHER THAN THOSE RECOMMENDED IN THE OPERATOR GUIDE, MUST BE CHECKED WITH A THERMO AGENT TO ENSURE THAT THE PROPOSED METHOD WILL NOT DAMAGE THE EQUIPMENT.

Always wear protective gloves when you clean or decontaminate the Citadel, WARNING to protect yourself against the effects of chemicals.

WARNING

Do not use any chemicals that might interact with materials of manufacture. If in doubt, check with the Thermo Service department.

WARNING

Phenol and Hypochlorites in strong solution will damage the instrument and its accessories.

WARNING

Do not use abrasive compounds or metal components to clean the Citadel or its components and accessories.

ALWAYS WIPE UP ANY SPILLS IMMEDIATELY. IN THE EVENT OF A MAJOR SPILLAGE, DISCONNECT THE INSTRUMENT FROM THE MAINS SUPPLY WITHOUT DELAY AND DO NOT RECONNECT AND SWITCH ON UNTIL THE INSTRUMENT HAS BEEN THOROUGHLY DRIED OUT AND CHECKED BY A SERVICE ENGINEER.

REFER TO THE MATERIAL SAFETY DATA SHEETS WHEN HANDLING REAGENTS.

50

69810040 Issue 6

PRODUCT RETURN SAFETY DECLARATION Part 1

DECONTAMINATION CERTIFICATE

Any instrument or part of any instrument must be clean before being returned, and where necessary accompanied by a completed Decontamination Certificate. Should the instrument or any part of it be received in an unclean condition, or Thermo Fisher Scientific consider it to be a hazard, the instrument or part will be returned unrepaired at the expense of the customer. It is important that the certificate is forwarded by post or fax, and a copy attached to the exterior of the container. Containers will not be opened until the company is in possession of the required certificate. This form MUST be completed by the customer and NOT a Thermo or distributor employee. If an instrument or part is to be returned to THERMO, please note the following:1 If the instrument or any part of it has been exposed to, or been in contact with potential pathogenic or radioactive material, it is essential that it is decontaminated. 2 Set procedures are laid down in the European Health and Safety Directives for decontamination. To avoid any misunderstanding, we request that all instruments or parts returned to us must be accompanied by a certificate stating the following: We certify that this (Model) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Serial No

· has not been exposed to pathogenic, radioactive or other hazardous material and has been cleaned OR · has been decontaminated and cleaned (if exposed to the above) according to approved procedures, following exposure to: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . .

Signed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Position . . . . . . . . . . . . . . . . . . . . . . . . .

Name (Block Capitals) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Company or Organisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Full address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...................................................................................... Part 2

Guidelines for Returning Instruments

Please use the checklist below to ensure that the instrument being returned is ready for collection. · All reagents / wax removed from instrument, including vapour traps (if applicable) . . . . . . . . . . . . . . . . . · Accessories are secured / itemised . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . · Instrument has had transit clamps fitted as per operator guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . · Instrument is packed in original packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . YES / NO RMA NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CARRIER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FOR ATTENTION OF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Thermo Fisher Scientific, Tudor Road, Manor Park, Runcorn, WA7 1TA, United Kingdom Tel: +44 (0) 1928 534050; Fax: +44 (0) 1928 534049; www.thermoscientific.com/pathology 69810040 Issue 6

51

TECHNICAL DATA Citadel 1000

Supply voltage range Maximum supply voltage fluctuations not to exceed ±10% of the nominal voltage Supply frequency

110-120Vac or 220-240Vac

50Hz/60Hz (220-240Vac) 50Hz/60Hz (110-120Vac) 500VA 80W (max) 45-65°C

Power consumption Wax bath heater rating Wax bath temperature

Reagent container capacity Wax bath capacity Basket cassette capacity - organiser - random Weight

1000ml 1000ml 60 Approx. 40 52kg

2100ml 1700ml 110 Approx. 70 48kg

99hr 59mins 1min 10mins 1min 9 days -0.2 to -0.4 bar

Maximum immersion time per step Minimum immersion time per step Agitation interval Interval between steps Maximum programmed delay time Vacuum pressure range

5A 250V

Mains Plug Fuse (where applicable) Instrument Fuse Sizes

Citadel 2000

Approved to BS1362

Thermo part number

110V -120V F1 F2

F5A T1.6A

P11171 P11131

F1 F2

F3.15A T0.8A

P11172 P11130

2x

T3.15A

P05847

220V - 240V

Transformer Fuses Fuses must only be replaced by technically competent personnel.

52

69810040 Issue 6

10.1 ENVIRONMENTAL CONDITIONS General

Indoor use only

Temperature (operation) Temperature (transit/storage)

+5°C to +40°C -25°C to +55°C (+70°C for short exposure)

Humidity

80% max for temperatures < 31°C 50% max for temperatures > 31°C but < 40°C (non-condensing environment)

Altitude

up to 2000m

Pollution degree Installation category

2 II

69810040 Issue 6

53

ACCESSORIES 11.1 CITADEL 1000 Description

Catalogue No.

1-Litre Carousel Tissue Processor: UK English version German version USA version European English version

69800001 69800002 69800003 69800008

Accessories sold as separate items 1 Random Basket

69810034

1 Organiser Basket (includes 2 x 25 baskets and 1 x 10 basket)

69810029

1 Basket Lid

69810031

1 Wax Bath (ratings as appropriate) 220-240V 110-120V

69810050 69810052

1 Reagent Container (plastic)

69810019

1 Reagent Container (stainless steel)

69810130

1 Vacuum Unit (ratings as appropriate) 220-240V (UK plug) 220-240V (European plug) 110-120 (USA)

69810024 A69810054 69810025

Hyperclean 2 Workstation with Blower Unit (ratings as appropriate) 220-240V 64850602 110-120V 99900602

1 English User Manual 1 German User Manual 1 French User Manual

69810040 69810040DE 69810040FR

To order any of these items, contact your local Thermo dealer.

54

69810040 Issue 6

11.2 CITADEL 2000 Description 2-Litre Carousel Tissue Processor: UK English version German version USA version European English Version

Catalogue No.

69800004 69800005 69800006 69800007

Accessories sold as separate items 1 Random Basket

69810035

1 Organiser Basket (includes 4 x 25 baskets and 1 x 10 basket)

69810030

1 Basket Lid

69810031

1 Wax Bath (ratings as appropriate) 220-240V 110-120V

69810051 69810053

1 Reagent Container (plastic)

69810018

1 Reagent Container (stainless steel)

69810131

1 Vacuum Unit (ratings as appropriate) 220-240V (UK plug) 220-240V (European plug) 110-120 (USA)

69810024 A69810054 69810025

Hyperclean 2 Workstation with Blower Unit (ratings as appropriate) 220-240V 64850602 110-120V 99900602

1 English User Manual 1 German User Manual 1 French User Manual

69810040 69810040DE 69810040FR

To order any of these items, contact your local Thermo dealer.

69810040 Issue 6

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WARRANTY STATEMENT We are proud of our quality and reliability, and of our after-sales service. We continuously strive to improve our service to our customers.

Please ask your distributor or representative about Service Contracts which can keep your purchase in peak condition for many years to come.

Warranty provisions necessarily vary to comply with differences in national and regional legislation, and you can find details in your delivery documents or from your dealer or representative.

Please note that your warranty may be invalidated if: - the instrument is modified in any way, - accessories and reagents are used that are not approved by Thermo, or - the instrument is not operated or maintained in accordance with the instructions in this Operator Guide.

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69810040 Issue 6

Declaration of Conformity This Declaration of Conformity, issued under our sole responsibility, is only valid when the instrument is used in accordance with the instructions for use.

Manufacturer’s Name:

Thermo Shandon Limited (Trading as Thermo Fisher Scientific)

Manufacturer’s Address:

Tudor Road, Manor Park, Runcorn, Cheshire, WA7 1TA UNITED KINGDOM

Product Description:

Tissue Processor

Product Designation:

Citadel 69800001 – 69800008 (inclusive including accessories supplied as standard

®

Part numbers:

1995

Year of Marking (CE):

This product conforms to the essential requirements of the following directives: In Vitro Diagnostics Directive

98/79/EC

Machinery Directive

2006/42/EC

This product complies with the following International Standards: EMC:

EN 61326 EN 61000-3-2 EN 61000-3-3

IEC 61010-2-010

Safety:

Issued by:

K. Waldron Quality Manager Thermo Fisher Scientific Anatomical Pathology Division

Date: 20 April 2010

Optional accessories considered subject to the In Vitro Diagnostic Medical Devices Directive (IVDD) are specifically identified on this Declaration of Conformity. Further supplies of standard accessories are treated as spares. Convenience aids offered as accessories are not subject to the IVDD.

Anatomical Pathology Division

Tudor Road

Cheshire

+44 (0) 1928 534000

Manor Park

WA7 1TA

+44 (0) 1928 534001 fax

Runcorn

UK

www.thermo.com

Thermo Shandon Limited Registered Office: 19 Mercers Row, Cambridge CB5 8BZ, UK. Registered in England and W ales – No. 330973

69810040 Issue 6

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INDEX A Altering a program 34 Automatic countdown to processing 40 Automatic program 43

F

B

H

Baskets 11 Cleaning 48 Organiser 7 Capacities 46, 52 Loading 45 Loading into hanger 46 Random 7 Capacities 52 Loading 45 Loading into hanger 46 Tissue 17, 19, 43 Basket hanger 12 Cleaning 48 Loading into Citadel 46

Hand-held controller 7, 9, 10, 15 Display 20 Illustration 18

C Checking an entered program 33 Cleaning and machine care 47 Cleaning methods 48 Connecting wax bath cables 26 CONTROLS AND INDICATIONS 15

D DECLARATION OF CONFORMITY 57 Decontamination 47, 50 Disposal of reagents 49

E Electrical tray 9 Amber indicator 44 Entering a delay into a program 38 Entering a PASS facility 36 ENTERING A PROGRAM 31 Environmental conditions 53 Evaporation covers 14, 25 Cleaning 48

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Fuse sizes 52

I Immersion times 28, 32, 34, 52 Indicators Amber 9, 10 Green 9, 10 INSTALLATION 12

K Keys ALARM CANCEL 22 AUTO/MANUAL STOP 16 CANCEL ALARM 19 CHECK/FILL 14, 19 CLOCK 16 DAYS DELAY 17 DELAY ON 17 EMERGENCY STOP 19, 21 ENTER 16 GO TO 1 17 LOWER 17 MINUS 15 PLUS 15 PROG 15 RAISE 17, 44 RAPID 16 RESET 15 ROTATE 17 START TIME 17 STEP 15 VAC 16

69810040 Issue 6

L Lift arm assembly 10 Loading baskets into the hanger 46 Loading the hanger into the instrument 46 Loading the tissue baskets 45

M MAINTENANCE 47 Material Safety Data Sheets (MSDSs) 2, 25, 50 Mode of operation Manual 20

O ON/OFF switch 13 OPERATING CONDITIONS 21 Operating head assembly 9, 10, 14, 31, 44 Cleaning 48 Operating mode 20 Alarm 21, 22 Auto 16, 20, 21 Manual 16, 21 OPTIONAL ACCESSORIES 10 Vacuum unit 10 Overriding program delays 41

P Parts list Citadel 1000 54 Separate accessories 54 Citadel 2000 55 Separate accessories 55 PAT testing 48 Plug Fuses 52 Rewiring 12 PREPARATION 23 Product Return Safety Declaration 51 Programmed delays 17 Examples 40–41 Overriding 41 PROGRAMMING 28 Programs (processing) 7 Altering 34 Automatic 43 Sequence 44 Automatic countdown 40 Delays 38 Entering 31 Introduction 28 Passing over a container 36 69810040 Issue 6

Reviewing 33 Running 42 Program delays 38 Program sequence 44 Program tables 28 Examples 29–30 Preparing 28

R Reagents 23 Clearing agents 23 Dehydrants 23 Disposal 49 Fixatives 23 Parafﬁn wax 23 Reagent containers 23 Cleaning 48 Filling 24 Fill levels 24 Inserting or removing 14 Illustration 14 Passing over 36 Rewiring the plug 12 Running a program 42

S SAFETY FEATURES 8 Safety precautions 5 Safety testing PAT 48 Symbols and Conventions 2

T TECHNICAL DATA 52 Tissue processor Cassettes 7 Electrical tray 9 Hand-held controller 7 Illustration 11 Introduction 7 Main body 9 Operating head assembly 9 Size and weight 12, 52 Illustration 53 Unpacking 12 Wax baths 9 Tissue samples 7

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Citadel Operator Guide

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