Thermo Scientific Shandon Excelsior ES Manual

Shandon Excelsior ES®
Operator Guide - English
A78410120 Issue 3

2 Shandon Excelsior ES Operator Guide
© 2006 Thermo Fisher Scientific. All rights reserved.
Thermo Shandon Limited is an ISO 9001 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 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 or your local Thermo representative. s
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
Fisher.
All information contained in this manual is proprietary and confidential, and the exclusive property
of ermo Fisher Scientific. is manual is protected by copyright and any reproduction is
prohibited. is manual is for use only by the individuals to whom it has been made available by
ermo Fisher Scientific.
Contact addresses
Anatomical Pathology
93-96 Chadwick Road
Astmoor, Runcorn,
Cheshire. WA7 1PR, UK
Tel: [phone]
Fax: [phone]
www.thermo.com/pathology
Anatomical Pathology
4481 Campus Drive
Kalamazoo
MI 49008, USA
Tel: [phone]
Fax: [phone]
www.thermo.com/pathology
The Shandon Excelsior ES meets the following CE Mark requirements:
In Vitro Diagnostic Directive 98/79/EC
Low Voltage Directive 73/23/EEC, as amended by 93/68/EEC.
®
C US

3
Shandon Excelsior ES Operator Guide
Contents
How to Use This Guide 7
Safety Information 8
1 Introducing Excelsior ES 13
Overview; Excelsior ES Instrument Tour; Systems
Monitoring; How You Process With Excelsior ES;
About the Excelsior ES Interface; Menus and Options;
2Daily Operations Mode 23
Introduction; Option Keys; Loading Specimens;
Level Key; Starting the Current Process; Starting a
Different Process; Removing Specimens; e Quality
Control Screen; Replacing Reagents, Reagent Rotation;
Daily Options Menu.
3Instrument Setup Menu 39
Introduction; Set Clock; Define Reagent Groups;
Load Reagent Groups; Colour Coded Reagent Tubes;
Edit Program; Changing Program Title; Defining
Programs, Program Step Parameters; Customisation;
Process Start Selection Options; Rotation Management;
Concept Demonstration; Daily Operations,
Unload Reagent Groups; Daily Options Menu.
4Menu Mode 63
Introduction; Set Clock; Processing in Menu Mode;
Loading Specimens; Starting the Current Process;
Starting a Different Process; Removing Specimens;
e Quality Control Screen; Replacing Reagents,
Reagent Rotation; Options.

4 Shandon Excelsior ES Operator Guide
5 Installing Excelsior ES 85
Introduction; Unpacking, Moving, Levelling;
Connecting Monitor, Printer; Fitting Filters;
Connecting to Mains Power; Powering ON
and OFF; Standby.
6 Troubleshooting 95
Introduction; Alert Icons; e Fault Status
Screen; Underfill Recovery; Problem / Cause
/ RemedyTables and Frequently Asked Questions.
7 Cleaning and Maintenance 105
Specification and Accessories 113
Specification; Accessories, Part Numbers;
Ordering Reagents; Declaration of Conformity.
Approved Reagent List 119
Introduction; Fixatives; Dehydrants;
Clearants; Infiltrants; Flush Reagents;
Cleaning Agents.
Program Examples 121
Routine Overnight Program; Rapid Biopsy
Program; Standard Flush Program;
Extended Flush Program; Rinse Program.
Transportation Instructions 123
Packaging the Instrument; Product Return
Safety Declaration; Warranty Statement.
Index 128
Appendix A
Appendix B
Appendix C
Appendix D

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Shandon Excelsior ES Operator Guide

6 Shandon Excelsior ES Operator Guide
e following symbols and conventions are used throughout this
manual and on the instrument.
THIS SYMBOL IS USED ON THE EQUIPMENT, OR IN A DOCUMENT, TO
WARN THAT INSTRUCTIONS MUST BE FOLLOWED FOR SAFE AND
CORRECT OPERATION. IF THIS SYMBOL APPEARS ON THE INSTRUMENT,
ALWAYS REFER TO THIS OPERATOR GUIDE. s
THIS SYMBOL IS USED ON THE EQUIPMENT, OR IN A DOCUMENT, TO
WARN THAT THERE MAY BE A BIOHAZARD ASSOCIATED WITH THE
INSTRUMENT. ALWAYS ACT WITH COMMON SENSE AND BE AWARE OF
THE SAMPLES USED. TAKE SUITABLE PRECAUTIONS. s
THIS SYMBOL WARNS YOU THAT SURFACES ARE HOT. IF THIS SYMBOL
APPEARS ON THE INSTRUMENT, ALWAYS REFER TO THIS OPERATOR
GUIDE. s
THIS SYMBOL IS USED ON THE EQUIPMENT, OR IN A DOCUMENT, TO
WARN THAT HARMFUL CHEMICALS ARE USED WITH THE INSTRUMENT.
REFER TO THE MATERIAL SAFETY DATA SHEETS FOR THE CHEMICALS
USED. ALWAYS ACT WITH COMMON SENSE AND BE AWARE OF LOCAL
LABORATORY PROCEDURES. TAKE SUITABLE PRECAUTIONS. s
A warning is given in the document if there is a danger of
personal injury or damage to samples or equipment. s
Note
Notes give more information about a job or instruction but do not
form part of the instructions. s
Symbols
!
WARNING

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Shandon Excelsior ES Operator Guide
How to Use This Guide
e Shandon Excelsior ES is intended for use in pathology
laboratories by operators familiar with tissue processing
techniques and laboratory equipment.
Before operating the instrument, you should read the section
Safety Information on page 8.
is Operator Guide is structured to let you start processing
quickly and safely with Excelsior ES.
Chapter 1 Introducing Excelsior ES gives you a tour of
the instrument, explaining general principles of processing
with Excelsior ES. You should now be ready to operate the
instrument in Daily Operations mode. You can learn later
about reagent management, programming and customising
Excelsior ES.
Chapter 2 Daily Operations Mode shows you how to run
defined processs programs, replace and rotate reagents. ese
are with current settings.
Chapter 3 Instrument Setup Menu gives details of Excelsior
ES programming, reagent loading and customisation.
Chapter 4 Menu Mode explains using Excelsior ES with all
options available.
Chapter 5 Installing Excelsior ES shows you how to install
the instrument on site, and correctly connect to an electrical
supply.
Chapter 6 Troubleshooting explains alert symbols and gives
instructions to clear them, using the Fault Status screen. e
reference lists suggest solutions to common processing issues.

8 Shandon Excelsior ES Operator Guide
Safety Information
THIS SECTION DETAILS IMPORTANT SAFETY INFORMATION.
PLEASE READ ALL OF THIS SECTION CAREFULLY.
ermo products are designed for convenient and reliable
operation and to accepted standards of safety. eir use does not
entail any hazard if operated in accordance with the instructions
given in this manual. However, incorrect actions by user may
damage this equipment, or cause a hazard to health. It is
important for you to obey the following safety precautions:
• AllusersmustreadandunderstandtheOperatorGuideand
only operate the unit in accordance with the instructions.
If the instructions are not followed, then the protection
provided by the instrument may be impaired.
• Donotmodifytheinstrument-ifunauthorisedmodications
are carried out, the instrument may be made unsafe and the
warranty may be invalidated.
• Potentiallylethalvoltagesabove110VACor50VDCare
present inside the instrument. e instrument must be
properly connected to a good earth (Ground) via the mains
input supply.
• Donotremoveanypanelsorcovers.erearenouser
serviceable parts inside the instrument.
• Itisimportanttomaintainnormalstandardsofsafetyand
Good Laboratory Practices. Always use common sense and
the best known practice when operating the instrument.

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Shandon Excelsior ES Operator Guide
• ExcelsiorES,assupplied,conformswiththeinternational
safety standards, IEC 61010-2-010. However, adding
chemical reagents introduces potential hazards. Good
Laboratory Practice must be followed when dealing with
these chemicals, and operators must consider the potential
for hazard when dealing with particular chemicals.
• BEFOREusingreagents,ALWAYSrefertoyourown
laboratory procedures and manufacturer safety data sheets
(MSDS).
• ManyofthereagentsusedwithExcelsiorareammable.
Do not introduce any source of ignition into, or near, the
instrument once it has been loaded with reagents.
Sources of ignition include electrostatic discharge,
resulting from a build-up of static electricity. is can,
under certain conditions, result in ignition of fumes from
any reagent used with Excelsior ES. Good Laboratory
Practice must be followed and ALL necessary precautions
taken.
• Whereseismicregulationsrequiretheinstrumentto
be secured, use the handle locations at the rear of the
instrument (2 x M8 female threads). e Centre of
Gravity position for a fully laden instrument is shown in
the diagram:
• ExcelsiorESweighs approximately 112 kilograms (246
lbs) when empty. Do not try to move Excelsior on
your own - at least two people are needed to move an
instrument.
335mm
Centre of Gravity
260mm
362mm

10 Shandon Excelsior ES Operator Guide
• Iftheinstrumenthasbeenusedwithmaterialsthataretoxic
or contaminated with pathogenic micro-organisms, follow the
cleaning instructions given. Before returning the instrument
to ermo, the Product Return Certificate (see Appendix D)
must be completed.
• AllreagentsandltersusedwithExcelsiorESmaybecome
contaminated. Personnel disposing of ALL reagents and
filters used with Excelsior ES must follow local regulations for
hazardous waste disposal.
• einstrumentshouldberegularlycleanedasdescribedin
Chapter 7 of this Operator Guide.
• Useonlyfactoryapprovedaccessoriesorreplacementparts
with Excelsior ES.
• Correctmaintenanceproceduresareessentialforconsistent
performance. It is recommended that a Maintenance Contract
is taken out with your supplier.
• einstrumentmustbeservicedannuallybyaermo-
trained engineer in accordance with the instructions
contained in the Shandon Excelsior ES Service Manual
(A78410101).
• Anyproblemsandqueriesshouldbereferredtoyoursupplier.

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Shandon Excelsior ES Operator Guide
e Sealed Lead Acid batteries within Excelsior ES need to be
replaced every two years.
Note
If Excelsior ES has been operated in very low temperatures
for much of the time, or has been exposed to frequent mains
failures, the batteries should be replaced every year. Batteries
must only be replaced in pairs.
e battery manufacturers (Yuasa Battery Sale (UK) Ltd)
advise their customers to comply with the relevant regulations
within their particular country regarding disposal of this type
of battery.
e batteries used in Excelsior ES are:
NP12-12, 12V, 12Ah, valve regulated sealed lead-acid type
rechargeable battery.
ese batteries are classified as, “Class 8, Group III UN
No. 2800 Batteries, wet, non-spillable, electric storage,
special provision A67”, and meet all requirements of the
International Air transport Association (I.A.T.A. Dangerous
Goods Regulations).
Disposal of Sealed
Lead Acid Batteries

12 Shandon Excelsior ES Operator Guide

13
Shandon Excelsior ES Operator Guide
Chapter 1 - Introducing Excelsior ES
e Shandon Excelsior ES is an enclosed automated tissue
processor, combining custom programming with simple
operation and reagent management.
Overview
Screen
Keypad
Reaction Chamber
Reagents

14 Shandon Excelsior ES Operator Guide
Excelsior ES
Instrument Tour
THERMOSHANDON
Astmoor,Runcorn,Cheshire,WA71PR,UK
NominalRatings: 100-120V a.c.
50/60Hz
950VA
FuseRating: 2xT10A
MADEINUK
Screen
Keypad
Disc Drive
Extraction Filters
Emergency Vacuum
Release
Switches
FLUSH
Reagent Bottles
Reaction Chamber
Waste Wax Tray
INFILTRANT Wax Baths
FIXATIVE
Reagent Bottles
Exchange Bottles
Downdraft Filter
DEHYDRANT and CLEARANT
Bottles
Electrical Connections

15
Shandon Excelsior ES Operator Guide
The Reaction Chamber is where processing of tissue specimens
takes place, according to defined programs. When the lid is open,
fumes are extracted through the Downdraft Filter.
The Screen has a menu window and a real time graphic display,
and the Keypad is used to operate Excelsior ES. Five keys select
menu options, with number and arrow keys for other controls.
The Disc DriveusesstandardoppydiscsforExcelsiorESdata
transfer options.
Two Extraction Filters clean the cabinet air - this helps to
contain fumes within the instrument. Behind the baffle plate,
the Vacuum Release Knob is for emergency situations only.
Switches inside the cabinet let you test and reset the heater, and
isolate the battery.
The Wax Baths store the infiltrant reagent, which is discarded
into the Waste Wax Tray after reaching the usage limit.
Fixative and Flush Reagent Bottles are in the front of the
cabinet. Two Exchange Bottles are stored empty, ready for
reagent exchange operations involving the concealed bottles.
e concealed Dehydrant and Clearant Reagent Bottles fixed
within are NOT accessible to operators.
The Electrical Connections panel is for mains power
and monitor, optional printer and remote alarms, data
communications, and the instrument POWER ON / OFF
switch.

16 Shandon Excelsior ES Operator Guide
To assure processing quality and specimen security, Excelsior ES
constantly monitors its systems and continuously updates the
displayed status.
When you see the ermo logo displayed at the top of the screen,
this means all systems are OK. If Excelsior ES detects that part
of the system is not OK, the ermo logo is replaced by one or
more alert icons.
e icons can indicate the need for reagent management and
maintenance tasks, hardware issues and instrument faults. See
Chapter 6 - Troubleshooting, for more information.
Systems Monitoring
Systems OK
ALERT

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Shandon Excelsior ES Operator Guide
You can put specimen cassettes into organised baskets
arranged in pairs.
How You Process
With Excelsior ES
Basket Lid
Specimen Cassette - 37 per half basket
Organised Basket

18 Shandon Excelsior ES Operator Guide
You can process up to three Levels of• organised baskets
arranged in pairs. For larger specimens, use a random
basket.
You put the baskets into the reaction chamber, covering•
the specimens with a basket lid.
37 Cassettes per half basket
74 Cassettes per basket Level
3 basket Levels
Up to 3 Levels of
organised baskets
Random basket
Knob
Lid Seal
Level Sensor
Agitator Drive Pins

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Shandon Excelsior ES Operator Guide
• Youselectastartoptiononthekeypad.
When you start a program, Excelsior ES moves through
the process steps, drawing in reagents in turn and
agitating the baskets to stir reagent around the specimens.
e instrument can be set up to heat the chamber and
put the chamber under constant or cycled vacuum
conditions for process steps. is is described in Chapter
3 - Instrument Setup.
Excelsior ES presents a uniquely compact, efficient and highly
informative operator interface, showing:
• Reactionchamberstatus
• Programdetailsandmenutext
• Optionkeys
• Animatedgraphicsshowingprocessingandreagent
movement in real time
• On-screenhelpinformation
*
About the
Excelsior ES
Interface
Customer Information
Alters, Logo
Reaction Chamber
Alcohol Quality
Wax
Reagents
Text
Options

20 Shandon Excelsior ES Operator Guide
You press one of the five keys to select an option. e•
options are grouped according to the instrument mode
and
displayed menu. e interface lets you perform tasks
intuitively, efficeintly, and consistently.
Press• to close a menu and return to a previous
menu
• Using a menu is summarised below;
Press a number key, OR highlight one of the sub-menus•
with the arrow keys
Select one of the five options displayed•
Press•
i
to show instructions or more information.
EXIT
Menus, Keys
and Options
<>
< >
i
12345
67890
ENTER
CANCEL
EXIT
*
Main Action
Sub-Menu
Press key
to select option
Press number keys
to enter values
Highlight item in list
Standby
Help information
Silence alarm
Multi-functions
Exit from menu