Issue 6 OPERATOR GUIDE - de-di.gr · Citadel OPERATOR GUIDE 69810040 ENGLISH Issue 6 TISSUE...

69810040 Issue 6

Citadel

OPERATOR GUIDE

69810040

ENGLISHIssue 6

TISSUE PROCESSOR

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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, be copied, photocopied, reproduced, translated, or converted to any

electronic or machine readable form without prior written consent of Thermo.

The Citadel meets the following CE Mark requirements:In Vitro Diagnostic Directive 98/79/EC

Machinery Directive 2006/42/EC.

SYMBOLS

The following symbols and 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, ALWAYS REFER TO THIS OPERATOR GUIDE.

THIS SYMBOL WARNS YOU THAT SURFACES ARE HOT. IF THIS SYMBOL APPEARS ON THE INSTRUMENT, ALWAYS REFER TO THIS OPERATOR 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 LABORATORY PROCEDURES. TAKE SUITABLE PRECAUTIONS.

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

Note1 Notes give more information about a job or instruction but do not form part of the

instruction

Thermo Shandon Limited is an ISO 9001 and TickIT Accredited CompanyThermo 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.

WARNING

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LIST OF CONTENTS

WELCOME .............................................................................................................5

INTRODUCTION ....................................................................................................71.1 SAFETY FEATURES .............................................................................8

GENERAL DESCRIPTION ....................................................................................92.1 MAIN BODY ...........................................................................................92.2 OPERATING HEAD ASSEMBLY .........................................................102.3 HAND-HELD CONTROLLER ..............................................................102.4 OPTIONAL ACCESSORIES ...............................................................10

INSTALLATION ....................................................................................................12

CONTROLS AND INDICATIONS .........................................................................154.1 HAND-HELD CONTROLLER KEYS ..................................................154.2 HAND-HELD CONTROLLER DISPLAY ..............................................20

OPERATING CONDITIONS .................................................................................215.1 AUTO MODE .......................................................................................215.2 MANUAL MODE ..................................................................................215.3 ALARMS ..............................................................................................22

PREPARATION ....................................................................................................236.1 GENERAL ...........................................................................................236.2 REAGENTS .........................................................................................236.3 FILLING THE CONTAINERS ...............................................................24

PROGRAMMING .................................................................................................287.1 GENERAL ...........................................................................................287.2 PREPARING A PROGRAM TABLE .....................................................287.3 ENTERING A PROGRAM ...................................................................317.4 CHECKING AN ENTERED PROGRAM ..............................................337.5 ALTERING A PROGRAM ....................................................................347.6 ENTERING A PASS FACILITY INTO A PROGRAM ............................367.7 ENTERING A DELAY INTO A PROGRAM ..........................................387.8 OVERRIDING A PROGRAMMED DELAY ...........................................41

OPERATING PROCEDURE .................................................................................428.1 RUNNING A PROGRAM .....................................................................428.2 PROGRAM SEQUENCE .....................................................................448.3 LOADING THE TISSUE BASKETS .....................................................458.4 LOADING THE BASKETS INTO THE HANGER .................................468.5 LOADING THE BASKET HANGER INTO THE CITADEL ....................46

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MAINTENANCE ...................................................................................................479.1 CLEANING AND MACHINE CARE .....................................................479.2 WAX BATH TEMPERATURE ...............................................................499.3 DISPOSAL ...........................................................................................499.4 DECONTAMINATION ..........................................................................50

TECHNICAL DATA ...............................................................................................5210.1 ENVIRONMENTAL CONDITIONS ..........................................................53

ACCESSORIES....................................................................................................5411.1 CITADEL 1000 ........................................................................................5411.2 CITADEL 2000 ........................................................................................55Warranty Statement ........................................................................................56Declaration 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 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.

WARNING

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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 appro priate, 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 auto matically 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 - Operating Head Assembly2 - Basket Hanger3 - Evaporation Covers4 - Connection for Vacuum Tube5 - Wax Baths6 - Random Basket7 - Vacuum Unit

8 - Item no longer available 9 - Hand Held Controller10 - Electrical Tray11 - Auto Mode Indicator12 - Power On Indicator13 - Reagent Containers14 - 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:

• 64kgfortheCitadel1000(52kgdryweightplus12kgofreagents)

• 72kgfortheCitadel2000(48kgdryweightplus24kgofreagents)

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 touch-sensitive keys and the display indications are explained in the following tables.

4.1 HAND-HELD CONTROLLER KEYS

Resets the display step number to 1.

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)

STEP

+

_

PROG

RESET

Legend Function

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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.

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

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).

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)

ENTER

CLOCK

RAPID

AUTOSTART

MANUALSTOP

VAC

Legend Function

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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 DAYS DELAY held 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.

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.

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

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.

(Continued)

DAYSDELAY

ROTATE

RAISE

LOWER

GO TO 1

DELAYON

Legend Function

STARTTIME

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RESET

DELAYON

·DAYS

DELAYSTARTTIMECLOCK

AUTOSTART

MANUALSTOP ENTER

PROG VAC RAPID

STEP _ +

ROTATE RAISE

LOWER

GO TO 1 CHECK/FILL

EMERGENCY STOPCANCELALARM

·

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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 access to two groups of three reagent 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 reverts to Manual mode.

Clears the alarm condition, providing that the cause of the alarm has been removed. 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.

EMERGENCY STOP

CANCELALARM

Legend Function

CHECK/FILL

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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.

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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: 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:

a. Check that MANUAL is lit on the display.

b. If MANUAL is not displayed press MANUAL STOP.

2. Prepare to fill:

a. Press the CHECK/FILL key.

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:

1 2 3 4 5 6COL

AUTOSTART

MANUALSTOP

CHECK/FILL

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

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Two sample programs are provided:

• Routineovernightprocessingprogram

• Smallbiopsiesprogramfordaytimeprocessing

Example of Program for Routine Overnight Processing

Position/Step Reagent Immersion Period Period Entered Hrs Mins Hrs Mins

Position 1 Formalin 2.00 02.00 Position 2 Formalin 2.00 02.00 Position 3 Alcohol 70% 1.00 01.00 Position 4 Alcohol 90% 1.00 01.00 Position 5 Alcohol 100% 1.00 01.00 Position 6 Alcohol 100% 2.00 02.00 Position 7 Alcohol 100% 2.00 02.00 Position 8 Xylene 1.00 01.00 Position 9 Xylene 1.30 01.30 Position 10 Xylene 1.30 01.30 Wax Bath 1 (11) Wax 2.00 02.00 Wax Bath 2 (12) Wax 3.00 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 30

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 Immersion Period Period Entered Hrs Mins Hrs Mins

Position 1 Formal Saline 0.15 00.15 Position 2 Formal Saline 0.15 00.15 Position 3 Alcohol 70% 0.15 00.15 Position 4 Alcohol 90% 0.15 00.15 Position 5 Alcohol 100% 0.15 00.15 Position 6 Alcohol 100% 0.15 00.15 Position 7 Alcohol 100% 0.15 00.15 Position 8 Xylene 0.15 00.15 Position 9 Xylene 0.15 00.15 Position 10 Xylene 0.15 00.15 Wax Bath 1 (11) Wax 0.30 00.30 Wax Bath 2 (12) Wax 0.30 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.

69810040 Issue 6 31

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:


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

2. 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. Return to the start of the program:

a. Press the RESET key.

b. Check that Step 01 is displayed:

PROG

1 2 3 4 5 6COL

AUTOSTART

MANUALSTOP

1 2 3 4 5 6COL

RESET

1 2 3 4 5 6COL

69810040 Issue 6 32

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 +

once to increase the display time by one minute.

c. Press _ once to decrease the display time by one minute.

d. Press 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.

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

6. Proceed to Step 02:

a. Press the STEP key.


7. Repeat Steps 4 and 5.

ENTER

STEP

1 2 3 4 5 6COL

69810040 Issue 6 33

8. Enter the rest of the program:

a. Press the STEP key.

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.





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




1 2 3 4 5 6COL

AUTOSTART

MANUALSTOP

PROG

1 2 3 4 5 6COL

RESET

STEP

69810040 Issue 6 34

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

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

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:

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.

1 2 3 4 5 6COL

1 2 3 4 5 6COL

RESET

STEP

69810040 Issue 6 35







3. 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. Alter the step time as required:

Press keys +

or _

, and RAPID

if required, until the

desired time is displayed.

1 2 3 4 5 6COL

AUTOSTART

MANUALSTOP

PROG

1 2 3 4 5 6COL

1 2 3 4 5 6COL

STEP

69810040 Issue 6 36

5. Enter the altered value in the program memory:

Press the ENTER key.

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



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:






ENTER

RESET

1 2 3 4 5 6COL

AUTOSTART

MANUALSTOP

PROG

69810040 Issue 6 37


3. Proceed to the step in the program that you want to pass over:

a. Press the STEP key until the required step is displayed.

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

b. Press the Minus key , _

, until 00:00 is displayed:

4. Enter the PASS facility:

a. Press the - (Minus) key once more.

b. Check that PASS is displayed across the time:

5. Enter the PASS instruction into the program memory:

Press the ENTER key:

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

1 2 3 4 5 6COL

STEP

1 2 3 4 5 6COL

1 2 3 4 5 6COL

1 2 3 4 5 6COL

ENTER

69810040 Issue 6 38

7.7 ENTERING A DELAY INTO A PROGRAM

If you want a delay period before processing begins, proceed as follows:





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


3. Return to the start of the processing schedule:



4. Enter the required start time:

a. Hold down the START TIME key.

1 2 3 4 5 6COL

AUTOSTART

MANUALSTOP

PROG

1 2 3 4 5 6COL

RESET

1 2 3 4 5 6COL

STARTTIME

69810040 Issue 6 39

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 24-hour format. For example, 2.30pm would be displayed as:

5. Enter the required delay time (in days):

If no days delay is required, go to Step c.

a. Hold down the DAYS DELAY key.

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:

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

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.

DELAYON

1 2 3 4 5 6COL

1 2 3 4 5 6COL

DAYSDELAY

69810040 Issue 6 40

6. Return the head to position 1:

Press the GO TO 1 key.

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:

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

Friday Saturday Sunday Monday Work Weekend Weekend Work TIME 1600 1800 1800 1800 —> Processing (programmed) (start time) DAYS DELAY 2 1 0 0 displayed

∴ DAYS DELAY REQUIRED = 2

GO TO 1

LOWER

69810040 Issue 6 41

Example 2 Required processing start time is 1500 on Monday

Friday Saturday Sunday Monday Tuesday Work Weekend Weekend Holiday Work TIME 1600 1500 1500 1500 —> Processing (programmed) (start time)

DAYS DELAY 2 1 0 displayed

∴ 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.

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.

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

CLOCK

AUTOSTART

MANUALSTOP

69810040 Issue 6 42

OPERATING PROCEDURE

8.1 RUNNING A PROGRAM

Once you have selected a program manually, it can be initiated and is run automatically, as follows:









b. Check Step 01 is displayed:

1 2 3 4 5 6COL

AUTOSTART

MANUALSTOP

PROG

1 2 3 4 5 6COL

RESET

1 2 3 4 5 6COL

69810040 Issue 6 43

4. Return the operating head to the start position:

Press the GO TO 1 key.

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.

b. Check that AUTO is lit on the display:

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.

GO TO 1

AUTOSTART

MANUALSTOP

1 2 3 4 5 6COL

69810040 Issue 6 44

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.

69810040 Issue 6 45

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 46

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: • Citadel1000 2x25capacitybasket 1 x 10 capacity basket• Citadel2000 4x25capacitybasket 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 WHEN YOU OPEN THE LOAD DOOR.

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

69810040 Issue 6 47

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 48

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 1. Remove the excess wax using a flexible, deck 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 1. Dissolve wax using a suitable solvent. carrier 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 1. Remove wax using a flexible, non-metallic spatula. assembly and anti- evaporation covers 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.

69810040 Issue 6 49

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.

• Turnclockwisetodecreasethecontroltemperature.

9.3 DISPOSAL

DISPOSE OF EXHAUSTED REAGENTS IN ACCORDANCE WITH LOCAL PROCEDURES.

69810040 Issue 6 50

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, to protect yourself against the effects of chemicals.

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

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

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.

WARNING

WARNING

WARNING

WARNING

69810040 Issue 6 51

PRODUCT RETURN SAFETY DECLARATION

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

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 cleanedOR

· 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

69810040 Issue 6 52

TECHNICAL DATACitadel 1000 Citadel 2000

Supply voltage rangeMaximum supply voltage fluctuations not to exceed ±10% of the nominal voltageSupply frequency Power consumption Wax bath heater ratingWax bath temperature

Reagent container capacityWax bath capacityBasket cassette capacity - organiser - random Weight

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

Mains Plug Fuse(where applicable)

Instrument Fuse Sizes

110V -120V

220V - 240V

Transformer Fuses

Fuses must only be replaced by technically competent personnel.

110-120Vac or 220-240Vac

50Hz/60Hz (220-240Vac)50Hz/60Hz (110-120Vac)

500VA80W (max)

45-65°C

1000ml 1000ml 60Approx. 4052kg

2100ml1700ml110Approx. 7048kg

99hr 59mins1min

10mins1min

9 days-0.2 to -0.4 bar

5A 250V Approved to BS1362

Thermo part number

F1 F5A P11171 F2 T1.6A P11131

F1 F3.15A P11172 F2 T0.8A P11130

2 x T3.15A P05847

69810040 Issue 6 53

10.1 ENVIRONMENTAL CONDITIONS

General Indoor use only

Temperature (operation) +5°C to +40°CTemperature (transit/storage) -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 2 Installation category II

69810040 Issue 6 54

ACCESSORIES

11.1 CITADEL 1000

Description Catalogue No.

1-Litre Carousel Tissue Processor: UK English version 69800001 German version 69800002 USA version 69800003 European English version 69800008

Accessories sold as separate items

1 Random Basket 69810034

1 Organiser Basket (includes 2 x 25 69810029 baskets and 1 x 10 basket)

1 Basket Lid 69810031

1 Wax Bath (ratings as appropriate) 220-240V 69810050 110-120V 69810052

1 Reagent Container (plastic) 69810019

1 Reagent Container (stainless steel) 69810130

1 Vacuum Unit (ratings as appropriate) 220-240V (UK plug) 69810024 220-240V (European plug) A69810054 110-120 (USA) 69810025

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

1 English User Manual 69810040 1 German User Manual 69810040DE 1 French User Manual 69810040FR

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

69810040 Issue 6 55

11.2 CITADEL 2000

Description Catalogue No.

2-Litre Carousel Tissue Processor: UK English version 69800004 German version 69800005 USA version 69800006 European English Version 69800007

Accessories sold as separate items

1 Random Basket 69810035

1 Organiser Basket (includes 4 x 25 69810030 baskets and 1 x 10 basket)

1 Basket Lid 69810031

1 Wax Bath (ratings as appropriate) 220-240V 69810051 110-120V 69810053

1 Reagent Container (plastic) 69810018

1 Reagent Container (stainless steel) 69810131

1 Vacuum Unit (ratings as appropriate) 220-240V (UK plug) 69810024 220-240V (European plug) A69810054 110-120 (USA) 69810025

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

1 English User Manual 69810040 1 German User Manual 69810040DE 1 French User Manual 69810040FR

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

69810040 Issue 6 56

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.

69810040 Issue 6 57

Declaration of ConformityThis 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

Anatomical Pathology Division Tudor Road Cheshire +44 (0) 1928 534000 Manor Park WA7 1TA +44 (0) 1928 534001 fax Runcorn UK

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

Product Description: Tissue Processor

Product Designation: Citadel ®Part numbers: 69800001 – 69800008 (inclusive

including accessories supplied as standard

Year of Marking (CE): 1995

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

Safety: IEC 61010-2-010

Issued by: K. Waldron Quality Manager Thermo Fisher Scientific Anatomical Pathology Division

www.thermo.com

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.

69810040 Issue 6 58

INDEX

A

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

B

Baskets 11Cleaning 48Organiser 7

Capacities 46, 52Loading 45Loading into hanger 46

Random 7Capacities 52Loading 45Loading into hanger 46

Tissue 17, 19, 43Basket hanger 12

Cleaning 48Loading into Citadel 46

C

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

D

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

E

Electrical tray 9Amber indicator 44

Entering a delay into a program 38Entering a PASS facility 36ENTERING A PROGRAM 31Environmental conditions 53Evaporation covers 14, 25

Cleaning 48

F

Fuse sizes 52

H

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

I

Immersion times 28, 32, 34, 52Indicators

Amber 9, 10Green 9, 10

INSTALLATION 12

K

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

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L

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

M

MAINTENANCE 47Material Safety Data Sheets (MSDSs) 2, 25,

50Mode of operation

Manual 20

O

ON/OFF switch 13OPERATING CONDITIONS 21Operating head assembly 9, 10, 14, 31, 44

Cleaning 48Operating mode 20

Alarm 21, 22Auto 16, 20, 21Manual 16, 21

OPTIONAL ACCESSORIES 10Vacuum unit 10

Overriding program delays 41

P

Parts listCitadel 1000 54

Separate accessories 54Citadel 2000 55

Separate accessories 55PAT testing 48Plug

Fuses 52Rewiring 12

PREPARATION 23Product Return Safety Declaration 51Programmed delays 17

Examples 40–41Overriding 41

PROGRAMMING 28Programs (processing) 7

Altering 34Automatic 43

Sequence 44Automatic countdown 40Delays 38Entering 31Introduction 28Passing over a container 36

Reviewing 33Running 42

Program delays 38Program sequence 44Program tables 28

Examples 29–30Preparing 28

R

Reagents 23Clearing agents 23Dehydrants 23Disposal 49Fixatives 23Paraffin wax 23

Reagent containers 23Cleaning 48Filling 24Fill levels 24Inserting or removing 14

Illustration 14Passing over 36

Rewiring the plug 12Running a program 42

S

SAFETY FEATURES 8Safety precautions 5Safety testing

PAT 48Symbols and Conventions 2

T

TECHNICAL DATA 52Tissue processor

Cassettes 7Electrical tray 9Hand-held controller 7Illustration 11Introduction 7Main body 9Operating head assembly 9Size and weight 12, 52

Illustration 53Unpacking 12Wax baths 9

Tissue samples 7

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U

Unpacking 12

V

Vacuum unit 7, 10, 16, 20Voltages 5, 13, 52

W

Warranty Statement 56Wax baths 9, 23

Cleaning 48Connecting cables to 26Filling 26Fill levels 26Indicators 27Temperature 49

Wax baths temperature 49Increasing or decreasing 49

Issue 6 OPERATOR GUIDE - de-di.gr · Citadel OPERATOR GUIDE 69810040 ENGLISH Issue 6 TISSUE...

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Transcript of Issue 6 OPERATOR GUIDE - de-di.gr · Citadel OPERATOR GUIDE 69810040 ENGLISH Issue 6 TISSUE...