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.

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3855-004741-001 REV G Operator’s Manual
Section 2
Unpacking and Installation
Inspect Packaging
The ThermoBrite and its accessories are delivered in one carton. If the instrument or
accessories have suffered any damage in transport, please inform your carrier
immediately.
NOTE: Save original shipping carton and foam inserts. Original packaging is required
for returns and service to prevent damage during transport.
Verify Contents
Installation Instructions
1. Place the ThermoBrite on a level surface suitable for laboratory instrumentation.
2. The ThermoBrite has an intake fan located underneath the instrument; ensure
no obstruction exists on the intake fan.
3. Ensure the ThermoBrite is placed at least 12” (30 cm) from the wall to allow for
proper cooling.
4. Position the ThermoBrite away from direct sunlight and sources of heat or cold.
The package contains:
1
ThermoBrite
1
Line Cord
1
Operator’s Manual
2
Humidity Cards

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3855-004741-001 REV G Operator’s Manual
5. Verify voltage requirements located on serial number label on the rear of the
instrument.
6. Plug the instrument into a grounded outlet supplying the voltage and frequency
indicated on the serial number label.
7. The main power switch is located on the rear of the instrument, next to the line
cord power entry module.
8. Installation is complete.
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.

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3855-004741-001 REV G Operator’s Manual
Section 3
System Overview
Principle and Intended Use
For in vitro diagnostic use in denaturation/hybridization of slide-based FISH
procedures
The ThermoBrite is a microprocessor controlled small bench top hot plate with
lid. The ThermoBrite allows storage of 40 programs, three operating modes,
Fixed Temperature, Hybridization Only or Denaturation and Hybridization,
capacity for twelve slides and a maximum temperature of 99°C. The instrument
is UL/cUL listed and CE marked.
Keypad

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Keypad Symbols and Definitions
Up
Move cursor up; Enter character A-Z for program name
Down
Move cursor down; Enter character A-Z for program
name
Enter
Accept or Enter
Backspace
Move cursor back to previous screen
Stop
End a program in process
0-9
Enter numeric values for time and temperature or for
program name
8

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Display Abbreviations
Abbreviation
Expansion
PGM
Program
Denat & Hyb
Denaturation & Hybridization
Denat Temp
Denaturation Temperature
Denat Time
Denaturation Time
Hyb Temp
Hybridization Temperature
Hyb Time
Hybridization Time
Hyb Only
Hybridization Only
Fixed Temp/Fxd
Fixed Temperature
Audible Indicators - NORMAL
Single beep:
All legal keystrokes.
Two short beeps:
Upon accepting a field and cursor has moved to
next field.
Five beeps:
Completion of process.

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Section 4
Operating Instructions
Opening and Closing the Lid
WARNING: The plate may be hot. Use caution and check temperature on display
before handling slides. Improper precaution can cause a burn.
NOTE:Depressions located on either side of the lid allow user to simply lift lid into
position. The lid should offer some resistance when opening. To close, reverse process.
Assure front is completely down and no obstructions prevent the cover gasket from
sealing on housing base.
Turning Unit On
The ThermoBrite main power switch is located on the rear panel. Assure unit is
plugged into a grounded outlet. Move switch to ON (I) position. Instrument will beep
to announce power has been turned on. Main Menu will be displayed when the
instrument has reached the default temperature of 37°C.
Indicators on power switch: I=ON O=OFF
Run a PGM
Edit a PGM
Create a PGM
Present Temp: 37°C

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Enter PGM no.
or Scroll (arrows)
PGM 01 namexxxxxx
PGM 02 EBV
Add Slides –Close Lid
Start
Main Menu
PGM 01 HER2
Add Slides –Close Lid
Start
Main Menu
PGM 03 BAKE
Add Slides –Close Lid
Start
Main Menu
PGM 02 EBV
Hyb: 55°C 01:30
Run PGM
Main Menu
Run a Program
Turn unit on and wait for the Main Menu screen. Cursor highlights “Run a PGM” line.
Press “Enter” button to accept.
With the arrow keys, scroll through program numbers 1 to 40 / program names.
Alternately, use the keypad to enter desired program number. If no programs have
been saved advance to programming section of this handbook. To accept, press
“Enter” button.
Display will confirm PGM number, name, incubation time(s) and temperatures. Cursor
highlights “Run PGM” line. Press “Enter” button to accept.
The display prompts to “Add Slides and Close Lid”. Before adding slides, saturate two
Humidity Cards with distilled or deionized water, and insert into the inside lid. Now
place the slides to instrument. (see Humidity Cards). Move cursor to highlight “Start”
line. Press “Enter” button to run the program. To return to the Main Menu instead,
move the cursor to highlight “Main Menu” line and then press the “Enter” button.
PGM 01 HER2
82°C :05; 45°C 20:00
Run PGM
Main Menu
PGM 03 BAKE
FIXED: 65°C
Run PGM
Main Menu
Hyb Only Denat & Hyb Fixed Temp

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Denaturation and Hybridization:
Display indicates present temperature of the slides.
Once temperature reaches denaturation set point, the ThermoBrite will beep twice
and denaturation time will count down from the set time.
The ThermoBrite will automatically cool to hybridization set temperature once
denaturation is completed.
Hybridization time will count down from the set time once temperature reaches
hybridization set point.
Upon program completion the ThermoBrite will beep five times and the display will
show “PROCESS COMPLETE”. Hybridization temperature will be maintained until
“End PGM/Main Menu” is accepted by pressing “Enter” button. Before pressing
“Enter” button, remove slides for further processing. If “End PGM/Main Menu” is
not accepted within the first minute of program completion, the ThermoBrite will
add the time accrued since completion of the original hybridization program to the
time of the original hybridization program to give the Total Time at the hybridization
temperature.
PGM 01 HER2
Denat in Process
Denat: 82°C 02:28
Present Temp: 82°C
PGM 01 HER2
**Heating**
Denat: 82°C :05
Present Temp: 42°C
Please Wait
Cooling to Hyb 45°C
Present Temp: 58°C
PGM 01 HER2
PROCESS COMPLETE
Total Hyb Time 21:05
End PGM/Main Menu

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Hybridization Only:
Display indicates present temperature of the slides.
Once temperature reaches hybridization set point, the ThermoBrite will count down
from the set time.
Upon program completion the ThermoBrite will beep five times and the display will
show “PROCESS COMPLETE”. Hybridization temperature will be maintained until
“End PGM/Main Menu” is accepted by pressing “Enter” button. Before pressing
“Enter” button, remove slides from instrument for further processing. If “End
PGM/Main Menu” is not accepted within the first minute of program completion,
the ThermoBrite will add the time accrued since completion of the original
hybridization program to the time of the original hybridization program to give the
Total Time at the hybridization temperature.
PGM 02 EBV
PROCESS COMPLETE
Total Hyb Time 02:15
End PGM/Main Menu
PGM 02 EBV HYB
Hyb in Process
55°C 01:30
Present Temp: 55°C
Please Wait
Heating to Hyb 55°C
Present Temp: 45°C

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Fixed Temp:
Display indicates present temperature of slides.
Once temperature reaches target, timer counts elapsed time.
To end program, use the arrow keys to move to “End PGM/Main Menu”line and
press “Enter”button to accept.
NOTE: If ambient temperature is programmed the fan will continually cycle until the
program is aborted. The lowest temperature that may be programmed is ambient
+ 5°C or 30°C (whichever is higher).
NOTE: The temperature can be increased or decreased as the unit is running by using
the up/down arrows from the “Fixed Temp” line.
Abort Program in Process
To end a program in process press “STOP”button, three beeps will sound.
Use arrows to move cursor to “Yes”line and press “Enter”button to accept. The
program will continue to run until “Yes”or “No”has been accepted.
NOTE: The ThermoBrite prompts, “Are You Sure?” This measure is to prevent
accidental disruption of a program in process.
PGM 03 APPL FIXED
Fixed Temp: 65°C
Reset Timer 01:18:10
End PGM/Main Menu
Please Wait
Heating to Fxd: 65°C
Present Temp: 30°C