Autostainer RSt User Manual Rev A02

Vision BioSystems

Intended use statement The Autostainer RSt™ is designed for the routine staining of Histology and Cytology specimens. The instrument has been designed to safeguard the operator and specimens, provided it is operated according to the instructions in the accompanying documentation. Installation and repairs must only be carried out by qualified service personnel authorized by Vision BioSystems.

Trademarks Vision BioSystems and logo design and Autostainer RSt logo design are trademarks of Vision Systems Limited and are used under license. Other trademarks are the property of their owners. Vision BioSystems Limited owns the copyright on this document and any associated software. Under law, our written permission is required before either the documentation or the software is copied, reproduced, translated, or converted to electronic or other machine-readable form, in whole or in part. © Vision BioSystems Limited 2005. Vision BioSystems Limited is ISO13485 certified. Vision BioSystems Limited, ABN 72 008 582 401, is a wholly owned subsidiary of Vision Systems Limited. *Authorized Representative: Vision BioSystems is a division of Vision Systems (Europe) Ltd.

Important information for all users The components of the Autostainer RSt system are supplied only for the purposes of the intended use specified. Do not connect or install equipment or software that is not approved by Vision BioSystems, or configure equipment or software in a manner that is not approved by Vision BioSystems. The Autostainer RSt has been designed to safeguard the operator and specimens, provided it is operated according to the instructions in the accompanying documentation. Autostainer RSt™ contains no user-serviceable components. Installation and repairs must only be carried out by qualified service personnel authorized by Vision BioSystems. Any device that is serviced using other than the authorized procedures will not be covered under the warranty and liability offered by the manufacturer. Warranty claims can be made only if the system has been used for the intended use and operated according to the user documentation provided. Vision BioSystems cannot assume liability for any damage or loss resulting from inappropriate handling, failure to protect the system, and/or misuse of the product, and any of these conditions will invalidate the warranty or service contract. Due to a policy of continuous improvement, Vision BioSystems reserves the right to change specifications without notice.

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Vision BioSystems

Contacting Vision BioSystems Asia Pacific

North America

Europe, Middle East, Africa

Vision BioSystems Ltd Private Bag 18 495 Blackburn Road Mount Waverley VIC 3149 Australia

Vision BioSystems Inc. 700 Longwater Drive Norwell MA 02061 United States of America

Vision BioSystems (Europe) Ltd Balliol Business Park West Benton Lane Newcastle Upon Tyne NE12 8EW United Kingdom

+1 781 616 1190 +1 781 616 1193 Customer Service: 1 800 753 7264

+61 3 9211 7400 +61 3 9211 7401 Customer Service: 1 800 246 797 (Aus) 0 800 400 589 (NZ)

+44 191 215 4242 +44 191 215 1152 Customer Service: 0 800 298 2344

Vision BioSystems e-mail: [email protected] for general inquiries [email protected] for support inquiries You can also visit the Vision BioSystems Web site at http://www.vision-bio.com

Revision record Rev.

Issued

Sections affected

Detail

A01

Oct 2004

All

First release

A02

Feb 2005

All

Cosmetic hardware changes; typos corrected

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Vision BioSystems

CE Marking and European Union Notice The CE mark on the equipment indicates compliance with the In Vitro Diagnostic Medical Devices Directive (98/79/EC) and the Electromagnetic Compatibility Directive (89/336/EEC). Marking of equipment in this manner denotes that the equipment meets the following technical standards: IEC 61010-1

“Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1 General requirements”

UL 1262

Standard Laboratory Equipment

EN 61326

“Electrical equipment for measurement, control and laboratory use – EMC requirements”

EN 55011

“Limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment” – Class B

EN 61000-3-2

“Limits for harmonic current emissions (equipment input current < 16A per phase)”

EN 61000-3-3

“Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current < 16A”

EN 61000-4-2

“Electrostatic discharge immunity test”

EN 61000-4-3

“Radiated, radio-frequency electromagnetic field immunity test”

EN 61000-4-5

“Surge Immunity Test”

EN 61000-4-6

“Conducted disturbances induced by radio frequency fields, immunity test”

EN 61000-4-8

“Power-frequency magnetic field immunity test”

EN 61000-4-11

“Voltage dips, short interruptions and voltage variations immunity test”

ISO 13485: 2003

“Medical Device-Quality management systems-Requirements for regulatory purposes”

A “Declaration of Conformity” in accordance with the preceding directives and standards has been made, and is on file at Vision BioSystems, 495 Blackburn Road, Mount Waverley, Victoria 3149, Australia, and Vision BioSystems (Europe) Ltd, Ballilol Business Park, West Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom.

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Safety Warning Read this document carefully before using the Autostainer.

Hazardous reagents Some reagents of a hazardous nature are employed for histochemistry. Laboratory staff and service personnel are advised to familiarize themselves with these hazards prior to using or servicing the Autostainer. In some instances external extraction systems may be needed to keep the vapors produced by these reagents to an acceptable level. In all cases the users should consult the particular reagent Material Safety Data Sheet (MSDS) prior to using the reagent in the Autostainer.

Electrical hazards Mains voltages are present in this instrument. Only qualified service personnel may access the internal components of the instrument. Mains voltages are present inside the heater control box and at the inside side of the ON/STOP switch of the instrument. The power jumper cable must never be removed by the user. The mains voltage selector is set at the factory and must not be altered. Severe damage may occur to the instrument if it is connected to a power supply other than that for which it was originally set.

Mechanical hazards If an external battery backup unit is installed the instrument will not stop immediately if mains power is disconnected or switched off. Wait for all movement to stop before accessing the instrument after switching it off.

Safety features A series relay protects the instrument in the case of malfunction of the heater circuits. Thermal fuses and cutouts prevent the heater elements attaining excessive temperatures. Separation of wet and dry areas of the instrument. Audible and visible alarms in case of malfunction. Liquid-impermeable membrane keypad. Internal error detection and logging. A machine with a serious malfunction can not be operated until serviced. Fume control system to absorb chemical vapours. Load and Exit drawers to further reduce exposure to vapors during routine instrument use.

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Contents Intended use statement... (ii) Trademarks... (ii) Important information for all users... (ii) Contacting Vision BioSystems... (iii) Revision record... (iii) CE Marking and European Union Notice... (iv)

1 Introduction... 1-1 2 Installation... 2-1 2.1...Site requirements

2-1

2.2... Contents list

2-3

2.3... Connection

2-3

2.3.1...Power 2.3.2... Water supply 2.3.3... Drain hose 2.3.4... Battery backup (optional) 2.3.5... Remote alarm (optional) 2.3.6... Fume control system 2.3.7... Remote exit drawer indicator

2-3 2-4 2-4 2-5 2-5 2-5 2-6

3 Operation... 3-1

Autostainer RSt User manual

3.1... Communication

3-1

3.1.1... Control panel 3.1.2... Display 3.1.3...Keypad 3.1.4... LED indicators 3.1.5... Load and Exit keys and indicators 3.1.6...Audible signals

3-1 3-1 3-2 3-2 3-2 3-2

3.2... Main menu

3-2

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Contents

3.3... Editing a program

3-3

3.3.1...Entering steps 3.3.2... Erasing Steps 3.3.3... Inserting a blank step into a program 3.3.4... Removing blank steps 3.3.5... Saving a program 3.3.6...Deleting a Program 3.3.7...Copying a Program 3.3.8... Viewing a Program 3.3.9... Checking program compatibility

3-3 3-4 3-4 3-5 3-5 3-5 3-6 3-6 3-6

3.4... General instrument setup parameters

3-7

3.4.1... Oven 3.4.2... Agitation (Dips) 3.4.3... Rack movement times

3-7 3-8 3-8

3.5... Staining

3-9

3.5.1...Reagent containers 3.5.2... Wash system 3.5.3...Water saving 3.5.4... Loading slide racks 3.5.5... Unloading Racks from the Exit Drawer 3.5.6... Unloading racks from other stations 3.5.7... Interrupting staining 3.5.8... Aborting a rack

3-9 3-9 3-9 3-10 3-10 3-10 3-11 3-11

3.6...Cleaning

3-12

3.6.1... Cleaning the instrument 3.6.2... Wash containers 3.6.3...Reagent containers 3.6.4... Slide racks 3.6.5... Oven

3-12 3-12 3-12 3-12 3-12

4 Errors and Troubleshooting... 4-1 4.1...Messages

4-1

4.2... Preventative maintenance checklist

4-3

A Compatible staining programs...A-1 B Specifications...B-1 C Spare parts...C-1 Glossary... Glossary-1

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1 Introduction Staining excellence through innovation The Autostainer RSt™ is the result of an extensive research program to provide an innovative stainer which meets the quality requirements of the modern laboratory, as well as: High throughput Flexibility Safety The Autostainer RSt achieves its high throughput by means of an innovative slide-rack transfer mechanism which allows continuous loading of up to 11 racks of 30 slides each. The flexibility of the Autostainer RSt also permits simultaneous processing of slide racks according to different staining protocols so that Papanicoleau and Haematoxylin/Eosin staining can be conveniently performed at the same time, without reprogramming or reagent changes. The Autostainer RSt incorporates all of the features which ensure high flexibility, convenience and above all, quality staining. A fan forced oven is available to quickly dry slides and optimized wash stations result in rapid removal of excess reagent. The minimum carryover design of the slide racks ensures that there are no drips and reagent life is extended. The Autostainer RSt is safe to use and has an integral fume control system. Rack loading and unloading is achieved by a unique two drawer system which means virtually no exposure to fumes. The outstanding flexibility, throughput, and quality staining capability of the Autostainer RSt has set a new standard in staining excellence.

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2 Installation Instructions on how to install the instrument are provided in this chapter. A diagram and description of components is also given. Finally, the procedure for replacement of the fume filter is outlined.

2.1 Site requirements The Autostainer RSt™ requires a solid bench of dimensions 1090 mm (43 inches) long and 670 mm (26 inches) deep. The instrument must be located within 3 metres (10 ft.) of a water supply and drain. The power requirements for the Autostainer RSt™ are: 8 amps: at 95-125 V AC 4 amps: at 180-250 V AC The oven voltage selector and other internal components are set by the manufacturer to suit the country of sale. Warning The oven voltage selector setting must not be altered by the user. The Autostainer RSt™ requires connection to a laboratory water supply with a ¾ inch BSP mains pressure fitting. A filter may be fitted to the mains water in areas of hard water.

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1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35.

Transfer mechanism Wash stations Oven Program pad Display screen Keypad LED indicators On/Stop switch Slide rack Lid Reagent container Load drawer Load LED and keypad Exit drawer Slotted lid Exit LED and keypad Container map on fume filter cover Lid support (gas strut) Drain outlet (reversible) Water inlet Lid Serial port Power supply Reserved Oven voltage selector and fuses Mains switch Mains inlet Feet (adjustable) Power outlet Power jumper cable Power supply inlet Rating and serial number plate Remote alarm socket, 50V 1A max Accessory port Exhaust air duct

Figure 2-1: Components of the Autostainer RSt

Installation

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2.2 Contents list The Autostainer RSt comes with a number of items. Check that they are all present:

Description

Quantity

Reagent Container c/w Lid

22

Slide Rack

5

Wash Container

5

Reagent Container Lid, Slotted

2

Alarm Plug

1

Carbon Filter

1

Collection Tray (Heater)

1

Elbow

1

Filter Cover

1

Hose Clamp

1

Hose Drain

1

Inlet Hose

1

Jumper Lead

1

Mains Power Lead

1

Program Pad

1

User Manual

1

2.3 Connection 2.3.1 Power There are two power modules at the rear of the unit: The mains inlet (mains input) The power supply (to the unit) Refer to Figure 2-1 on page 2-2. Connect the power jumper lead between the power outlet on the mains inlet and the power inlet on the power supply. Connect mains power to the mains inlet with the IEC power cable.

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Warning The instrument must never be operated without the power jumper cable. Warning The instrument must be connected to an earthed mains power outlet socket. To switch the Autostainer on: 1.

Switch power ON at mains wall socket.

2.

Set the ON/STOP switch at the front to STOP (See Figure 2-2 and Label 8 in Figure 2-1 on page 2-2).

3.

Set the ON/OFF switch at the rear of the unit to ON (see Label 26 in Figure 2-1 on page 2-2).

4.

Set the ON/STOP switch to ON.

The instrument will sound 3 short beeps and the Main Menu will be displayed.

Figure 2-2: ON/STOP switch

When the instrument is not in use set the ON/STOP switch to STOP. The ON/OFF switch at the rear of the instrument should be left ON.

2.3.2 Water supply Connect the water hose to the water inlet at the rear of the unit. Screw the other end of the hose to the cold water tap. The hose has a ¾ inch BSP fitting. Slowly turn the tap on fully. Warning Ensure that the water washer/filter is present when fitting the water inlet hose. Failure to do so may result in leakage of water.

2.3.3 Drain hose Connect the drain hose to the drain outlet on the rear of the unit. The drain outlet fitting may be rotated to point in the required direction by loosening the screw clamp, rotating the fitting and then securing the clamp again. The drain hose is an interference fit on the elbow fitting so that water does not leak at this joint. One end of the drain hose is supplied with an extra elbow already fitted. This elbow may be removed and the expanded drain hose easily fitted to the instrument. Ensure that the hose slopes towards a sink and place the end into the sink so it is below the level of the bottom of the stainer. Ensure there are no dips in the hose. Shorten the hose and secure if necessary. Extra elbows may be fitted for a tight bend in the hose or at the exit end of the hose to hook into the sink. Immerse the end of the hose in hot water to facilitate the insertion of the elbow fitting.

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2.3.4 Battery backup (optional) An uninterruptible power supply (UPS) can be used to permit staining of slides to continue during brief mains power failures. A small UPS can be connected using the power jumper lead, as shown in Figure 2-3.

Figure 2-3: Connecting the battery backup.

The UPS should be rated at 200 VA for 5 minutes. Heating in the oven will not be maintained by the UPS. The UPS must be rated for use with the local mains voltages. Your local supplier can recommend a suitable UPS.

2.3.5 Remote alarm (optional) The remote alarm option is a latched relay that is voltage-isolated from the rest of the instrument. When an alarm condition occurs (either a major failure of the instrument, or loss of mains power during a processing run whilst a battery backup unit is fitted) the alarm circuit closes, sounding the alarm. A battery-powered remote alarm must be used if you require the remote alarm to sound when the mains power fails. Ensure that the instrument is turned ON and press any key to reset the alarm. If mains power failed during a run, it may be necessary to put the ON/STOP switch to STOP, and then to ON again. The remote alarm will only operate during loss of mains power if a battery backup unit is fitted. Your distributor can provide connection details for the remote alarm. The remote alarm connected to the instrument must be rated at less than 1 A and a maximum of 50 V. Connect the remote alarm to the alarm socket at the rear of the unit, using a 6.25 mm phono jack.

2.3.6 Fume control system Fumes are exhausted through the activated carbon filter which must be changed every three months (with average usage). To remove a filter, lift out the plate covering the filter. Remove the filter, using the tabs. Replace with a new filter and fit the cover into place.

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2.3.7 Remote exit drawer indicator A louder exit drawer alarm is available as an optional accessory to the Autostainer RSt™. Two red ultra bright light emitting diodes (LED’s) mounted to the top of the indicator provide an extra indication of an alarm. The alarm plugs directly into the Autostainer RSt existing accessories port. The alarm may be placed on top of the Autostainer RSt™ or in the mounting bracket supplied with the indicator to mount to a wall or bench. Extension cables may be used up to 10 m total length (use standard 9-pin “D” range pin for pin extensions).

Figure 2-4: Connecting the exit drawer indicator.

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3 Operation This chapter describes how to operate the Autostainer RSt™. It includes sections on how to use the control panel functions and other indicators, how to create and edit programs and how to stain slides. Autostainer RSt offers some unique features not available in other stainers and these are explained in subsequent sections. Firstly, slide racks are loaded and unloaded by means of drawers, not by opening the lid. If the instrument is free to accept a rack for staining the Load LED will be on. After loading, the Load key must be pressed to inform the instrument to begin processing. Similarly, if a rack is finished staining in the Exit drawer the Exit LED will be on. The Exit key must be pressed to inform the instrument when the rack is removed. Programs can finish at any station. However, if the EXIT drawer is not the last step then the LCD will inform you of the station to unload from. In this case, the lid will have to be opened to remove the rack. The Autostainer RSt can accept racks whenever the Load LED is on and process up to 11 racks simultaneously. Each rack can be processed according to any of the 15 programs, provided that the reagents are available and the program chosen is compatible (no conflicting sequence) with programs already being used.

3.1 Communication Communication with the Autostainer RSt is via the control panel, load and unload keys, and associated indicators and audible signals.

3.1.1 Control panel The control panel consists of an LCD display, the keypad, and four LEDs - (see Figure 3-1).

3.1.2 Display The display is a four line LCD with backlighting. The fourth line is usually reserved for commands associated with the function keys [F1] to [F4]. A flashing cursor appears beneath userchangeable settings.

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Figure 3-1: Control panel

3-1

Operation

3.1.3 Keypad The membrane keypad incorporates 4 function keys and 4 arrow keys. The function keys perform the action indicated immediately above them on the fourth line of the display. The arrow keys move the cursor in the direction indicated. They are also used to select digits and other settings. Contact with solvents, use of sharp implements or excessive force may damage the keypad.

3.1.4 LED indicators The four LEDs are located below the arrow keys and have the following functions. The unload LED (yellow flashing) indicates that a rack has been completed and is ready to be removed from a station other than the exit drawer. The staining LED (yellow) is lit when staining is in progress. The alarm LED (red) indicates that an instrument error has occurred. The mains LED (green) signals that mains power is available (ON at ON/OFF switch, ON at ON/STOP switch).

3.1.5 Load and Exit keys and indicators The load and exit keys and associated LED indicators are located adjacent to the load and exit drawers.

3.1.6 Audible signals There are four types of audible signals given: Single Beep: Indicates key press Single Tone: Indicates unacceptable key press or error message Two Single Tones: Operator attention required to remove a completed rack Continuous Tone: Indicates unit failure

3.2 Main menu When the Autostainer is turned ON at the ON/STOP switch, the following Main Menu will be displayed and the instrument will give three beeps: The modes of operation of the instrument are:

Autostainer RSt™ V2.00 Main Menu Stain

Edit

SetUp

PC

Stain: To stain slides Edit: To create, view or change programs SetUp: To set, view or alter parameters such as oven temperature and the number of dips (amount of agitation) upon entering a reagent station PC: For service use only.

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3.3 Editing a program Autostainer RSt can store 15 programs numbered from 1 to 15 in permanent memory. Programming is performed using a simple, menu-driven system and all information is entered via the keypad. A program consists of 25 steps, some of which may be blank. A step consists of the following information: The step number The station The immersion time Whether the immersion time must be achieved exactly. The step number defines the order in which the stations are used. The immersion time is the time the rack is fully immersed in a station. As there is potential for timing clashes to occur when multiple racks are present in the instrument, steps which require precise timing are designated as ‘exact’ in the program. Immersion times at these steps are given priority and are achieved to within 1 second. Racks at steps not marked as ‘exact’ will receive attention as the head becomes available. Programs that are assigned to racks currently being stained cannot be altered or copied. For an overview of the programming structure, see Figure 3-2 on page 3-4.

3.3.1 Entering steps 1.

Press [F2] Edit from the Main Menu.

2.

Select the desired program number using the

3.

Press [F2] Edit

and

keys.

The first step of the program is then displayed under the following headings:

step: stn: time: exact:

step number station number or description immersion time, in minutes and seconds whether the immersion time is critical or not

4.

With the cursor under the step number, use the and keys to move between steps 1 to 25 of the program. Alternatively, press [F2] Next to move to the next step.

5.

To enter program information, use the and  keys to position the cursor beneath the appropriate heading. Scroll through the options or alter the digits using the and keys. Fill in the program details, using the and  keys to move to the next heading as each item in the step is completed.

An immersion time of 00:00 means that this step will be omitted. 6.

Repeat steps 4 and 5 until the program is complete.

To finish the rack in the EXIT drawer, insert this as the last step. 7.

To save the program, see section 3.3.5.

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Operation

SELECT PROGRAM LOAD MAIN MENU

EXIT

STAIN

UNLOAD

ABORT RACK

PAUSE

MAIN MENU

STAIN

SELECT PROGRAM COPY EDIT

SET STEP STATION TIME AND EXACT INCUBATION STATUS

EDIT VIEW

INSERT (Blank step)

MORE

MORE

DELETE (All steps)

NEXT (Step)

CHECK (Compatibility)

BLANK (Steps removed)

ERASE (Step) QUIT

Save Program

OVEN

SETUP

PC CONTROL

DIPS (Agitation)

DIP (Agitation)

MOVE (Rack movement times)

UP (Withdrawal) DOWN (Entry)

Figure 3-2: Menu map.

3.3.2 Erasing Steps Information contained in a step may be erased leaving a blank step. 1.

To select the program, see steps 1 to 3, section 3.3.1.

2.

To select the step to be deleted, see step 4, section 3.3.1.

3.

Press [F3] Erase. The step will be left blank.

4.

You may enter new step details, if desired.

5.

To save the program, see section 3.3.5.

3.3.3 Inserting a blank step into a program This function is used to insert an additional step into an existing program.

3-4

1.

Select the program (see steps 1 and 2, section 3.3.1).

2.

Press [F2] Edit.

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