HistoStar Tissue Embedding Sytem Operator Guide Issue 2

Legal Information Copyright 2009 . Thermo Fisher Scientific . All rights reserved. Thermo Shandon Limited is an ISO 9001, ISO 13485 and TickIT Accredited Company . Thermo Fisher Scientific is the trading name of Thermo Shandon Limited . All other trademarks are the property of Thermo Fisher Scientific and its subsidiaries 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 Fisher Scientific 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 Fisher Scientific or your local Thermo Fisher Scientific representative. This manual may not, in whole or in part, be copied, photocopied, reproduced, translated, or converted to any other electronic or machine readable form without prior written consent of Thermo Fisher Scientific . 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 any reproduction is prohibited. This manual is for use only by the individuals to whom it has been made available by Thermo Fisher Scientific . Contact Addresses: Anatomical Pathology Int., Tudor Road, Manor Park, Runcorn, WA7 1TA, UK Tel: +44 (0) 1928 534 050; Fax: +44 (0) 1928 534 049; Web: www.thermo.com/pathology Anatomical Pathology USA, 4481 Campus Drive, Kalamazoo, MI 49008, USA Tel: 1-800-522-7270; Fax: +1 269-372-2674; Web: www.thermo.com/pathology Standards The Thermo Scientific HistoStar meets the following CE Mark requirements: In Vitro Diagnostic Directive 98/79/EC Low Voltage Directive 2006/95/EC This IVD equipment complies with the emissions and immunity requirements of IEC 61326-2-6:2006. This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case it may be necessary to take measures to mitigate the interference. The electromagnetic environment should be evaluated prior to operation of the device. Do not use this device in close proximity to sources of strong electromagnetic radiation (eg: unshielded intentional RF sources) as these may interfere with the proper operation. The Thermo Scientific HistoStar™ is referred to throughout this, and other supporting documents as the HistoStar . Para Trimmer® is a registered trademark of Thermo Fisher Scientific. Refrigerant Warning The Cold Module contains fluorinated greenhouse gas covered by the Kyoto Protocol and is hermetically sealed. The refrigerant used is 100 grams of R134a (220-240V units); this has a global warning potential of 1300. The refrigerant used is 100 grams of R134a (100-120V units); this has a global warning potential of 1300.

Symbols The following symbols and conventions may be used throughout this document and on the instrument: This symbol is used on the equipment, or in a document, to indicate that instructions must be followed for safe and correct operation. If this symbol appears on the instrument, always refer to the operator guide. This symbol is used on the equipment, or in a document, to indicate that there may be a biohazard associated with the instrument. Always act with common sense and be aware of the samples used. Take suitable precautions. This symbol indicates that a surface is hot. If this symbol appears on the instrument or in the documentation, always refer to the operator guide. Take suitable precautions. This symbol indicates that a surface is cold. If this symbol appears in the documentation, always refer to the operator guide. Take suitable precautions. This symbol is used on the equipment, or in a document, to indicate that harmful chemicals are used. 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 DOCUMENTATION IF THERE IS A DANGER OF PERSONAL INJURY OR

DAMAGE TO THE EQUIPMENT OR SAMPLES.

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

Table of Contents Safety Information... 1 How To Use This Guide ... 5 Chapter 1 - Introducing HistoStar... 7 Introduction to HistoStar... 7 Compatibility... 8 Identification of Parts... 9 System Interfacing... 13 System Specification... 15 Chapter 2 - Basic Operation ... 17 Safety ... 17 Switching On HistoStar ... 18 Operating Method ... 20 Using the Para Trimmer ... 24 Switching Off HistoStar ... 25 Chapter 3 - Setup ... 27 Unpacking HistoStar ... 27 Connections ... 34 Setup and Location ... 37 Setting Workflow Direction ... 40 Filling with Wax ... 42 Dispense Lever Adjustment and Wax Flow Control ... 44 System Settings ... 47 Time and Date ... 49 Temperature Units ... 51 Temperature Set Points ... 52 Timer Settings ... 55 Display and Audio ... 58 Instrument Lighting ... 60 Forceps Block Power Settings ... 65 Language Selection ... 67 Touchscreen Calibration ... 69 Electric (Heated) Forceps ... 71 Chapter 4 - Troubleshooting ... 77 Troubleshooting Tables ... 77 vii

HistoStar Operator Guide A81010100 Issue 2 Touch Screen Display ... 77 Wax Tank and Dispense ... 78 Forceps Block ... 80 Hot Spot ... 81 Tissue Storage Tank... 82 Temperature Sensors... 83 Base Mould Storage ... 84 Cold Spot ... 85 Cold Plate... 86 Electric Forceps ... 87 Poor Sectioning ... 88 Heater System Check ... 89 Chapter 5 - Cleaning and Maintenance ... 91 Safety ... 91 General Instrument Cleaning ... 92 Daily Tasks ... 93 Weekly Cleaning ... 94 Fuse Replacement ... 95 Emptying the Waste Wax Drawer ... 97 Using the Wax Draining Assembly... 99 Draining the Tissue Storage Tank ... 103 Draining the Wax Tank ... 106 Appendices ... 111 Appendix A - Spares and Accessories ... 111 Appendix B - Packing Instructions, Removal from Use and Disposal ... 113 Appendix C - Screen maps ... 114 Appendix D - Approved Reagent List ... 115 Index ... 117

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Safety Information Introduction Thermo Fisher Scientific products are designed for convenient and reliable service; however, incorrect actions by a user may damage the equipment, or cause a hazard to health. The following sections contain important information for the safe setup and use of the instrument. All users must read and understand the following sections before using the instrument.

General Safety This instrument, as supplied, conforms with IEC61010-1, IEC 61010-2-010 and IEC61010-2-101; however, the addition of chemical introduces potential hazards. As with all scientific equipment, due care and good laboratory practice must be employed when dealing with these chemicals, and consideration must be given to the potential for hazard when dealing with particular chemicals. Be aware that many of the reagents used with this instrument may be flammable. Do not introduce any source of ignition into, or near, the instrument once it has been loaded with reagents. Do not remove any panels or covers. The instrument does not have any user serviceable parts. The instrument must be properly connected to a good earth (ground) via the Mains input supply. Position the instrument such that it is possible to interrupt the Mains supply at the source by removing the plug from the socket. If the equipment is used in a manner not specified by Thermo Fisher Scientific , the protection offered by the equipment may be impaired. Make sure that there is at least 100mm (4in) clearance around any fan inlets on the instrument. In compliance with statutory requirements all our equipment is designed to accepted standards of safety. Its use does not entail any hazard if operated in accordance with the instructions given in the documentation. However, the following safety precautions must be obeyed: •

All users must have read and understood the Operator Guide and these safety instructions; and only operate the unit in accordance with the instructions.

•

Potentially lethal voltages above 110V a.c. or 50V d.c. are present inside the instrument. Do not remove any access covers unless specifically instructed to do so.

•

It is important that normal standards of safety and good laboratory practices are employed. Always use common sense when operating the instrument.

•

Any problems and queries should be referred to your Thermo Fisher Scientific supplier.

•

Correct maintenance procedures are essential for consistent performance. It is recommended that a Maintenance Contract is taken out with our Service Department.

•

Use only factory approved accessories or replacement parts with this instrument.

•

Only use reagents recommended in the Operator Guide.

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HistoStar Operator Guide A81010100 Issue 2 Chemical Safety

THE INTRODUCTION OF CHEMICALS CREATES POTENTIAL HAZARDS AND THERMO FISHER SCIENTIFIC HAS ADOPTED THE FOLLOWING POSITION WITH REGARD TO THE SUBJECT OF VOLATILE CHEMICALS USED IN MEDICAL LABORATORIES: •

Non-specified chemicals are used in the instrument at the customers own risk.

•

All the chemicals recommended by Thermo Fisher Scientific have auto-ignition temperatures considerably above any surface temperature that can be reached during a single fault failure on the instrument. The paraffin wax present will not reach a temperature that will produce flammable vapour.

•

The instrument contains no source of ignition in any areas of the instrument where chemicals are stored, or are likely to leak into in a single fault condition.

•

The operator is fully aware of the contents of the specification documents detailing the properties of the chemicals they are using.

•

The operator has carried out any legally required assessment of chemicals used and is using good laboratory practice. Some chemicals which may be used during operation are flammable - do not use sources of ignition in the vicinity of the instrument when it is loaded with reagents. Harmful chemical vapours such as xylene and toluene may be emitted during the normal operation of some instruments, and the operator should be aware of suitable precautions and safety measures.

Environment This product is required to comply with the European Union's Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC. It is marked with the following symbol:

Thermo Fisher Scientific has contracted with one or more recycling / disposal companies in each EU Member State, and this product should be disposed of or recycled through them. Further information on Thermo Fisher Scientific 's compliance with these Directives, the recyclers in your country, and information on Thermo Fisher Scientific products which may assist the detection of substances subject to the RoHS Directive are available at: www.thermo.com/WEEERoHS

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Safety Information Warranty Statement We at Thermo Fisher Scientific are proud of our quality, reliability and of our after-sales service. We continuously strive to improve our service to our customers. Please ask your distributor or Thermo Fisher Scientific 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. Specific details can be found in the delivery documentation or from your dealer or representative. Please note that your warranty may be invalidated if: •

This instrument is modified in any way.

•

Accessories and reagents which have not been approved by Thermo Fisher Scientific are used.

•

The instrument is not operated or maintained in accordance with the instructions in the Operator Guide.

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HistoStar Operator Guide A81010100 Issue 2 Product Return Safety Declaration

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How To Use This Guide Introduction The Thermo Scientific HistoStar is an ergonomically designed tissue embedding system for use in laboratories by appropriately trained medical laboratory technicians familiar with tissue embedding techniques and laboratory equipment. Before operating this instrument the user should have read and understood the contents of this manual, paying particular attention to any safety information. Chapter Summary Chapter 1 - Introducing HistoStar This chapter gives a tour of the instrument and its features. It describes the different parts of the instrument and gives general information with regards to interfacing with the system. Chapter 2 - Basic Operation This chapter explains how to use the HistoStar on a day-to-day basis. Chapter 3 - Setup This chapter explains the procedures used to set-up the HistoStar . The information contained in this chapter also explains how users can set their own preferences to help HistoStar to fit into their workflow more efficiently. Chapter 4 - Troubleshooting This chapter is intended to help operators identify and cure commonly encountered issues. Chapter 5 - Cleaning and Maintenance This chapter describes the day-to-day cleaning schedule for HistoStar . It also explains any operator maintenance tasks which may be required, either as part of the cleaning schedule, or as a remedy to a problem listed in the troubleshooting section of this document.

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Chapter 1 - Introducing HistoStar Introduction to HistoStar The HistoStar is an ergonomically designed, precision engineered, tissue embedding system, comprising two temperature controlled modules. The Embedding Module includes a base mould storage compartment, a wax reservoir, a tissue storage tank, a wax dispenser and a Para Trimmer. HistoStar can be used with either heated or un-heated forceps. The temperature of various elements can be set using the built-in touchscreen user interface. Fixed LED lighting is incorporated into the unit in order to illuminate the main working areas. The Cold Module consists of a temperature regulated cold plate, which can be linked to the Embedding Module or used independently.

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HistoStar Operator Guide A81010100 Issue 2

Compatibility The HistoStar is designed to be compatible with most tissue cassettes and moulds, including Super Mega Cassettes and SecureSette. It is also designed to be compatible with most brands of histology grade paraffin wax - see Appendix D Approved Reagent List

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Chapter 1 - Introducing HistoStar

Identification of Parts Embedding Module

Heated Module - Front View 1 - Wax Tank Cover 2 - Base Mould Storage Compartment (Serial Number Label is inside) 3 - Tissue Storage Tank 4 - Cassette Lid Storage Dish 5 - Waste Wax Drawer 6 - Hot Spot

7 - Cold Spot 8 - Dispense Lever 9 - Wax Dispense Flow Control 10 - Forceps Block / Removable Cover 11 - Para Trimmer™ 12 - Touchscreen

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HistoStar Operator Guide A81010100 Issue 2

Heated Module - Rear View 13 - Footswitch Connector 14 - Cold Plate Timer Connector 15 - Fuse Drawer

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16 - Power Switch 17 - Mains Power Connector 18 - Rating Plate

Chapter 1 - Introducing HistoStar

Heated Module - Underside View 19 - Dispense Lever Position Adjustment Knob 20 - Heated Forceps Connector

21 - Tissue Storage Tank Drain Valve Lever 22 - Tissue Storage Tank Drain

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HistoStar Operator Guide A81010100 Issue 2 Cold Module

Cold Module - Rear View 23 - Cold Plate 24 - Timer Control Switch 25 - Cold Plate Timer Connector 26 - Fuse Drawer 27 - Power Switch

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28 - Mains Power Connector 29 - Rating Plate 30 - Serial Number Label 31 - Refrigeration Label

Chapter 1 - Introducing HistoStar

System Interfacing Using the Touchscreen The HistoStar has an embedded touchscreen user interface which is used to set all preferences and timer functions. Note Avoid using sharp or pointed objects to press buttons on the touchscreen. It is recommended that a clean finger is used to operate the touchscreen. However, if you require a stylus, the eraser-tipped end of a pencil (or similar) is suitable.

The touchscreen is used to alter all the user preferences and setup features - see System Settings.

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HistoStar Operator Guide A81010100 Issue 2 Buttons The following image buttons occur throughout in the user interface. Button Image

Description Return

and

and

Action(s) Returns the user to the previous screen

Left and Right

Used to scroll through lists

Up and Down

Used to increase or decrease values and scroll through lists

Sleep Timer Off

Used to enter 'Sleep Mode' Used to disable the timer function

Note There are many text buttons throughout the user interface which perform specific actions depending on the screen. These are explained in the relevant sections of this document.

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Chapter 1 - Introducing HistoStar

System Specification Embedding Module Physical Specification Height (doors closed)

430 mm

17 in

Height (doors open)

670 mm

26½ in

Width

650 mm

25½ in

Depth

587 mm

23 in

Weight (without wax)

25 kg

55 lbs

Weight (with wax)

35 kg

77 lbs

Electrical Specification Voltage

100 - 120V~ / 220 - 240V~

Frequency

50 / 60 Hz

Power

700VA

Fuses

2 x T10AH

Environmental Specification Temperature (Operating Limits)

+5°C to +40°C (+41°F to +104°F)

Temperature (Recommended Operation)

+17°C to +27°C (+63°F to +80°F) Note: Performance may deteriorate when operated outside of this temperature range.

Temperature (Transport / Storage)

-25°C to +55°C (-13°F to +131°F) +70°C (+158°F) for short exposure

Relative Humidity

Max. 80% RH up to 31°C Decreasing linearly to 50% RH at 40°C

Altitude

Up to 2,000 m (6,500 ft)

Pollution Degree

2

Over Voltage Category

II

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HistoStar Operator Guide A81010100 Issue 2 Cold Module Physical Specification Height

365 mm

14½ in

Width

430 mm

17in

Depth

585 mm

23 in

Weight

20kg

44lbs

Electrical Specification Voltage

220V~ - 240V~

100 - 120V~

Frequency

50 / 60 Hz

50 / 60 Hz

Power

230VA

230VA

Fuses

2 x T4AH

2 x T10AH

Environmental Specification

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Temperature (Operating Limits)

+5°C to +40°C (+41°F to +104°F)

Temperature (Recommended Operation)

+17°C to +27°C (+63°F to +80°F) Note: Performance may deteriorate when operated outside of this temperature range.

Temperature (Transport / Storage)

-25°C to +55°C (-13°F to +131°F) +70°C (+158°F) for short exposure

Relative Humidity

Max. 80% RH up to 31°C Decreasing linearly to 50% RH at 40°C

Altitude

Up to 2,000 m (6,500 ft)

Pollution Degree

2

Over Voltage Category

II