Leica ThermoBrite S500 User manual

ThermoBrite®
Slide Denaturation/Hybridization System
Operator’s Manual

Operator’s Manual
ThermoBrite®
Model Number S500
For in-vitro diagnostic use
REF 3800-004852-001 - ThermoBrite Slide Denaturation/Hybridization System 120V
REF 3800-004852-002 - ThermoBrite Slide Denaturation/Hybridization System 240V
REF 3800-004970-001 - Humidity Card, 10pk
REF 3800-006418-001 - ThermoBrite Temperature Verification Kit
ThermoBrite is a registered trademark.
Copyright 2013 Leica Biosystems - All Rights Reserved

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3855-004741-001 REV G Operator’s Manual
Table of Contents
How to use this manual ______________________________________________________________3
Cautions and Warnings ________________________________________________________3
Symbols and Definitions _______________________________________________________5
Leica Biosystems Contact Information ____________________________________________________6
Authorized European Representative _____________________________________________________6
Manufacturer________________________________________________________________________6
Section 1 ___________________________________________________________________________7
Warranty ___________________________________________________________________________7
Section 2 ___________________________________________________________________________9
Unpacking and Installation ___________________________________________________________9
Inspect Packaging ____________________________________________________________9
Verify Contents ______________________________________________________________9
Installation Instructions ________________________________________________________9
Section 3 __________________________________________________________________________11
System Overview___________________________________________________________________11
Principle and Intended Use ____________________________________________________11
Keypad ___________________________________________________________________11
Keypad Symbols and Definitions_________________________________________________12
Display Abbreviations ________________________________________________________13
Audible Indicators - NORMAL___________________________________________________13
Section 4 __________________________________________________________________________14
Operating Instructions ______________________________________________________________14
Opening and Closing the Lid____________________________________________________14
Turning Unit On ____________________________________________________________14
Run a Program _____________________________________________________________15
Abort Program in Process _____________________________________________________18
Slide Installation ____________________________________________________________19
Humidity Cards _____________________________________________________________19

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3855-004741-001 REV G Operator’s Manual
Section 5 _________________________________________________________________________ 21
Programming_____________________________________________________________________ 21
Overview _________________________________________________________________21
Predefined Limits ___________________________________________________________22
Creating a Denaturation and Hybridization Program (Denat & Hyb) _______________________22
Creating a Hybridization Only Program (Hyb Only) ___________________________________23
Creating a Fixed Temperature Program (Fixed Temp) _________________________________24
Editing a Program ___________________________________________________________25
Section 6 __________________________________________________________________________26
Maintenance ______________________________________________________________________26
Overview _________________________________________________________________26
Cleaning __________________________________________________________________26
Temperature Verification______________________________________________________27
Service ___________________________________________________________________28
Troubleshooting Guide _______________________________________________________30
Audible Indicators - ERROR ____________________________________________________31
Error Messages _____________________________________________________________31
Section 7 __________________________________________________________________________35
Specifications _______________________________________________________________________35
References ________________________________________________________________36

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3855-004741-001 REV G Operator’s Manual
How to use this manual
This manual along with information contained on product labels should provide you
with all the information you need to operate and maintain the ThermoBrite.
Cautions and Warnings appear in boxes with symbols to the left of the text. Notes
also appear in boxes to highlight information.
Cautions and Warnings
A WARNING is a statement that alerts the user to the possibility of injury, death, or
other serious adverse reactions associated with the use or misuse of the instrument.
A CAUTION is a statement that alerts the user to the possibility of a problem with
the instrument associated with its use or misuse. Such problems include instrument
malfunction, instrument failure, damage to the instrument or damage to other
property. The CAUTION statement includes the precaution that should be taken to
avoid the hazard.
Please pay close attention to the instructions that accompany the notes and symbols
as well as the standard laboratory practices outlined by your facility and local
regulatory agencies. The table below lists all the CAUTIONS and WARNINGS for the
ThermoBrite.
CAUTION: Plug the instrument into a properly grounded outlet supplying the
voltage and frequency indicated on the serial number label.
CAUTION: Outside of North America: Inspect that the supplied Line Cord has local
electrical compatibility. Installation outside of the USA: Use power cord with an
IEC320/CEE22 female connector and male connector suitable for the power outlet
to be used. Cord must meet standards.
WARNING: Unplug the ThermoBrite from the wall outlet before performing
maintenance.

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3855-004741-001 REV G Operator’s Manual
CAUTION: Do NOT expose the ThermoBrite to strong or concentrated acids, bases,
esters, aromatic or halogenated hydrocarbons, ketones or strong oxidizing agents.
BIOLOGICAL HAZARDS: Universal precautions should be followed on all specimens,
regardless of whether a specimen is known to contain an infectious agent (see
Biohazard references).
WARNING: Risk of electric shock: The instrument contains no user serviceable parts
other than fuse and cover gasket replacement. Removal of housing will expose
potentially lethal voltage. Refer service to qualified service personnel.
WARNING: Hot Surface: The interior surface of the instrument may be HOT, use
caution to avoid potential burn.
CAUTION: Do NOT use paper towels or any other filter card in card positions. This
may change the humidity and may decrease the intensity of the probe, potentially
causing assay failure.
CAUTION: Please use the system as intended. Improper use of the ThermoBrite may
cause damage to the system, inaccurate results, or potentially nullify warranties.

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3855-004741-001 REV G Operator’s Manual
Symbol
Meaning
Definition
Catalog
Number
Indicates the product/catalog number
Warning/Caution
Statement of caution/warning, read instruction
carefully
Biological Hazards
Statement of caution/warning, read instruction
carefully
Caution, risk of electric
shock
Statement of caution/warning, read instruction
carefully
Warning, hot surface
Statement of caution/warning, read instruction
carefully
EC Representative
European Community Authorized Representative
For in vitro diagnostic
use
Clarifies for use as in vitro diagnostic only
SN
Serial Number
Indicates instrument serial number code
Manufacturer
Indicates manufacturer of the instrument
CE marking of
conformity
Indicates conformance to CE

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3855-004741-001 REV G Operator’s Manual
Leica Biosystems Contact Information
Customer opinion and input is extremely important to us.
Comments on this manual should be directed to:
Leica Biosystems Richmond, Inc.
5205 Route 12
Richmond, IL 60071
USA
Website: www.LeicaBiosystems.com
North America Phone Contacts:
Customer Service: 1-800-248-0123
Technical Support: 1-800-248-0123
Outside of North America, contact your local Leica representative.
Authorized European Representative
CEpartner4U
Esdoornlaan 13
3951 DB Maarn
The Netherlands
[phone]
Manufacturer
Leica Biosystems Richmond, Inc.
5205 Route 12
Richmond, IL 60071
USA
1-815-678-2000

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3855-004741-001 REV G Operator’s Manual
Section 1
Warranty
Leica Biosystems Warranty
Leica Biosystems, warrants that the instruments shall be free from defects in
material and/or workmanship, under normal use and service, for the period expiring
twelve (12) months from the date of installation. Leica Biosystems will, at its
discretion, repair or replace any unit covered under this warranty returned to Leica
Biosystems with shipping costs prepaid. Repaired or replaced instruments supplied
under this warranty carry only the remaining portion of the original warranty and
repairs shall not interrupt or prolong this warranty. For warranty terms and
conditions outside the United States, contact your Authorized Leica Biosystems
Distributor.
No warranty extended by Leica Biosystems shall apply to any instrument that has
been damaged due to misuse, negligence, accident, or damage resulting from
unauthorized repairs, alterations, or improper installation.
Leica Biosystems makes no warranty other than the one set forth herein. This
warranty is given expressly in lieu of all other warranties, expressed or implied. The
purchaser agrees that there is no warranty of merchantability or of fitness for any
intended purpose and that there are no other remedies or warranties, expressed or
implied, which extend beyond the description on the face of the agreement. No
agent or employee of Leica Biosystems is authorized to extend any other warranty or
assume for Leica Biosystems any liability except as set forth above. This warranty is
only applicable to the original purchaser.

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3855-004741-001 REV G Operator’s Manual
Limitation of Liability
Leica Biosystems shall not be liable for any loss of use, revenue or anticipated
profits, or for any consequential or incidental damages resulting from the sale or use
of the products. The purchaser shall be deemed liable for any and all claims, losses,
or damages incurred by the use or misuse of the Leica Biosystems instrument by the
purchaser, its employees or others, following receipt of the instrument or other
items.