Leica ThermoBrite S500 Operator's Manual
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Leica ThermoBrite S500 Operator's Manual

Slide denaturation/hybridization system
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Slide Denaturation/Hybridization System
Operator's Manual

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Summary of Contents for Leica ThermoBrite S500

  • Page 1 ® ThermoBrite Slide Denaturation/Hybridization System Operator’s Manual...
  • Page 2 For in-vitro diagnostic use 3800-004852-001 - ThermoBrite Slide Denaturation/Hybridization System 120V 3800-004852-002 - ThermoBrite Slide Denaturation/Hybridization System 240V 3800-004970-001 - Humidity Card, 10pk 3800-006418-001 - ThermoBrite Temperature Verification Kit ThermoBrite is a registered trademark. Copyright 2013 Leica Biosystems - All Rights Reserved...

  • Page 3: Table Of Contents

    How to use this manual ______________________________________________________________ 3 ________________________________________________________ 3 Cautions and Warnings _______________________________________________________ 5 Symbols and Definitions Leica Biosystems Contact Information ____________________________________________________ 6 Authorized European Representative _____________________________________________________ 6 Manufacturer ________________________________________________________________________ 6 Section 1 ___________________________________________________________________________ 7 Warranty ___________________________________________________________________________ 7 Section 2...
  • Page 4 Section 5 _________________________________________________________________________ Programming _____________________________________________________________________ _________________________________________________________________ 21 Overview ___________________________________________________________ 22 Predefined Limits _______________________ 22 Creating a Denaturation and Hybridization Program (Denat & Hyb) ___________________________________ 23 Creating a Hybridization Only Program (Hyb Only) _________________________________ 24 Creating a Fixed Temperature Program (Fixed Temp) ___________________________________________________________ 25 Editing a Program Section 6...

  • Page 5: How To Use This 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.
  • Page 6 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).

  • Page 7: Symbols And Definitions

    Symbol Meaning Definition Catalog Indicates the product/catalog number Number Statement of caution/warning, read instruction Warning/Caution carefully Statement of caution/warning, read instruction Biological Hazards carefully Caution, risk of electric Statement of caution/warning, read instruction shock carefully Statement of caution/warning, read instruction Warning, hot surface carefully EC Representative...

  • Page 8: Leica Biosystems Contact Information

    5205 Route 12 Richmond, IL 60071 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 +31 (0) 6516536 26 Manufacturer Leica Biosystems Richmond, Inc.

  • Page 9: Warranty

    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.
  • Page 10 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.

  • Page 11: Unpacking And Installation

    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.
  • Page 12 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.

  • Page 13: System Overview

    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.

  • Page 14: Keypad Symbols And Definitions

    Keypad Symbols and Definitions Move cursor up; Enter character A-Z for program name Move cursor down; Enter character A-Z for program Down name Enter Accept or Enter Backspace Move cursor back to previous screen Stop End a program in process Enter numeric values for time and temperature or for program name 3855-004741-001 REV G...

  • Page 15: Display Abbreviations

    Display Abbreviations Abbreviation Expansion 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.

  • Page 16: Operating Instructions

    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.

  • Page 17: Run A Program

    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.
  • Page 18 Denaturation and Hybridization: Display indicates present temperature of the slides. PGM 01 HER2 **Heating** Denat: 82°C :05 Present Temp: 42°C Once temperature reaches denaturation set point, the ThermoBrite will beep twice and denaturation time will count down from the set time. PGM 01 HER2 Denat in Process Denat: 82°C 02:28...
  • Page 19 Hybridization Only: Display indicates present temperature of the slides. Please Wait Heating to Hyb 55°C Present Temp: 45°C Once temperature reaches hybridization set point, the ThermoBrite will count down from the set time. PGM 02 EBV HYB Hyb in Process 55°C 01:30 Present Temp: 55°C Upon program completion the ThermoBrite will beep five times and the display will...

  • Page 20: Abort Program In Process

    Fixed Temp: Display indicates present temperature of slides. Please Wait Heating to Fxd: 65°C Present Temp: 30°C Once temperature reaches target, timer counts elapsed time. PGM 03 APPL FIXED Fixed Temp: 65°C Reset Timer 01:18:10 End PGM/Main Menu To end program, use the arrow keys to move to “End PGM/Main Menu” line and press “Enter”...

  • Page 21: Slide Installation

    ABORTING! Are You Sure? Yes – Main Menu Fan will turn on. If the slide temperature is above 37°C, the fan will cool to 37°C. Slide Installation Temperature uniformity across the heater is within 1°C of set point across all slide positions.
  • Page 22 Instructions for re-use:  After the run has ended, keep the lid closed between runs to avoid drying out of the cards.  Do not reuse cards that have been dried out after initial saturation.  Resaturate the cards before starting a new run. ...

  • Page 23: Programming

    Section 5 Programming Overview The ThermoBrite is capable of storing 40 different programs. Each program can be one of three program types:  Denaturation and Hybridization (Denat & Hyb),  Hybridization Only (Hyb Only) or  Fixed Temperature (Fixed Temp). Programming is simple.

  • Page 24: Predefined Limits

    Predefined Limits Program Mode Temperature Range Timer Limits Denature 50°C to 99°C 00:00-00:30 minutes Hybridization Room temp: 30°C to 70°C 00:00 - 99:59 hours and minutes Fixed Temp Room temp: 30°C to 99°C 00:00 - 99:59 hours and minutes Creating a Denaturation and Hybridization Program (Denat & Hyb) From the Main Screen, use the arrow keys to move cursor to “Create a PGM”...

  • Page 25: Creating A Hybridization Only Program (Hyb Only)

    For room temperature hybridization (ambient temp +5°C) enter the two-digit value The cursor advances to “Hyb Time”. With the numeric keypad enter a two-digit time value in hours (0 – 99) followed by a two-digit value in minutes (0-59). The Display will now show entered program values. The cursor highlights “Enter to Accept”...

  • Page 26: Creating A Fixed Temperature Program (Fixed Temp)

    The cursor advances to “Hyb Time”. With the numeric keypad, enter a two-digit time value in hours (0 – 99) followed by a two-digit value in minutes (0-59). The display will now show entered program values. The cursor highlights “Enter to Accept”...

  • Page 27: Editing A Program

    The display will now show entered program values. Cursor highlights “Enter to Accept” line. PGM 03 APPL Fixed: 65°C ENTER to Accept STOP to Abort Press “Enter” button to accept the program values; or press “Backspace” button to return to previous screen to modify program values; or press “Stop” button to abort.

  • Page 28: Maintenance

    Overview Leica Biosystems recommends that instrument operators perform periodic inspections and maintenance on all Leica Biosystems instruments. Contact Leica Biosystems’s technical support department or distributor if, at any time, the instrument is not functioning properly. Contact Leica Biosystems’s technical support or distributor for more information.

  • Page 29: Temperature Verification

    ThermoBrite. Temperature Verification Leica Biosystems recommends users verify temperature of the ThermoBrite with the ThermoBrite Temperature Verification Kit. The ThermoBrite Temperature Verification Kit is available as an accessory to the ThermoBrite, and is purchased separately.

  • Page 30: Service

    Service There are no user-serviceable parts except for fuses and the cover gasket. Refer all other service to technical support. Reference the Leica Biosystems Warranty for further instruction. Decontamination is required before returning instrument for service...
  • Page 31 Fuses: REF 3801-004915-001 Fuse 3.0 A (120V) REF 3801-004915-002 Fuse 1.6A (240V) Fuses are located in the rear of the ThermoBrite between the main power plug and the On/Off switch. Fuse(s) Fuse Drawer Fuse Replacement Instructions: Unplug the ThermoBrite. Use a small flat screwdriver to carefully disengage the two snap-locks securing the fuse holder.

  • Page 32: Troubleshooting Guide

    Cover Gasket Replacement Instructions: Remove the existing cover gasket from the groove in the lid underside. Insert the new cover gasket with fingers. Be sure it is properly seated in the groove. Troubleshooting Guide Issue Possible Cause/Remedy Check both cord ends are plugged in Check fuses located on rear panel next to On/Off switch Unit does not turn on or no power If necessary, replace with same type and value (see label...

  • Page 33: Audible Indicators - Error

    Issue Possible Cause/Remedy Verify the program mode, you cannot exceed preset limits Denature Limits: 50-99°C, 00:00-00:30 minutes Cannot set temp above Hybridization Limits: 30-70°C, 00:00-99:59 hours and minutes 70ºC (Note: hotplate will hold 37°C after protocol end) Fixed Temp Limits: 30-99°C, 00:00-99:59 hours and minutes Can’t find “Create a If the maximum of 40 programs have been stored, only an Program”...
  • Page 34 If the instrument cannot measure the temperature, the software will automatically turn off the heating. An error message will appear to inform the user to turn off the unit and call service. A constant beep will sound. High ambient temperature condition: The instrument will attempt to achieve process set temperatures.
  • Page 35 If the ambient temperature changes during a process and causes the instrument process set temperature to change beyond the +/- 1°C specification for more than two minutes, a message will appear to inform the user that the ambient temperature is high. A constant beep will sound. The counter will continue to count. The present temperature will be displayed.
  • Page 36 If the ambient temperature changes after a process is completed, but before the user removes the slides and causes the instrument process set temperature to change beyond the +/- 1°C specification for more than two minutes a message will appear to inform the user that the ambient temperature is high. A constant beep will sound.

  • Page 37: Specifications

    Section 7 Specifications Product No. 3800-004852-002 3800-004852-001 Model No. S500-12 S500-24 Capacity Up to 12 slides 30°C -99°C Temperature Range Lowest programmable temperature is 30°C or ambient temperature+5°C (whichever is higher) Processing Time 00:00 - 99:59 hr:min Number of Programs Ramp Time 37-95°C in less than 3 minutes Cooling Time...

  • Page 38: References

    Biohazard References 1. NCCLS. “Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline-Second Edition.” NCCLS document M29- A2 [ISBN 1-56238-453-8]. NCCLS, 940 West Valley Rd, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001. 2. CDC. Recommendations for prevention of HIV transmission in health care settings.
  • Page 39 Incubate Audible indicators ERROR Inspect packaging Audible indicators NORMAL Installation Authorized European representative Installation instructions Biological warnings 4, 5 Leica Biosystems contact information Leica Biosystems warranty Cautions Cleaning Maintenance overview Cleaning instrument surfaces Manufacturer Closing the lid 14, 19 Contact information Leica Biosystems...
  • Page 40 Troubleshooting by symptoms Turning unit on Unpacking Verify contents W-X-Y-Z Warnings Warranty CEpartner4U Manufacturer Esdoornlaan 13 Leica Biosystems Richmond, Inc. 3951 DB Maarn 5205 Route 12 The Netherlands Richmond, IL 60071 31 (0) 6516536 26 3855-004741-001 REV G Operator’s Manual...

This manual is also suitable for:

Thermobrite s500-12Thermobrite s500-243800-004852-0013800-004852-002

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