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Leica THERMOBRITE ELITE User Manual

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THERMOBRITE
ELITE
M O D E L N U M B E R S 6 0 0
USER MANUAL

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Summary of Contents for Leica THERMOBRITE ELITE

  • Page 1 ® THERMOBRITE ELITE M O D E L N U M B E R S 6 0 0 USER MANUAL...
  • Page 2 The ThermoBrite Interface on page 51 Network Requirements  on page Pause Step  on page 78 Assign Waste Bottles on page Module Manifold  on page 40 Reagent Step  on page 66 Flush on page 74 ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 3: Table Of Contents

    Use of Third Party Computer Products 2.13.4 Use of External USB device to Netbook Installation Unpacking Contents 3.2.1 ThermoBrite Elite System 3.2.2 Preventative Maintenance Kits Requirements 3.3.1 Electrical Requirements 3.3.2 Temperature Requirements 3.3.3 Space Requirements ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 4 Preparing the System for Run Reagents 5.1.1 Compatible Reagents 5.1.2 Reagent Preparation and Connection Slide Preparation System Ready Using the ThermoBrite Elite Software Before operating the instrument The ThermoBrite Interface Running a Protocol 6.3.1 Before running a protocol 6.3.2 Select a Protocol to Run 6.3.3...
  • Page 5 Instrument thread is either terminated or unresponsive within 20sec. Software will terminate 8.2.10 Modules did not reach target temperature(s) within 1 hour 8.2.11 Internal software error 8.2.12 Internal instrument error 8.2.13 Internal operation error ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 6 1. Table of Contents 8.2.14 Internal runner module error 8.2.15 No ThermoBrite Elite found 8.2.16 Reagent valve failed to switch to reagent line # 8.2.17 Self-test failed to communicate with Instrument 8.2.18 Sensors indicate a critical flow error 8.2.19 Sensors indicate reduced flow rate warning(s) 8.2.20...

  • Page 7: Introduction

    © Leica Biosystems Melbourne Pty Ltd, Melbourne, Australia, 2021 How to use the User Manual This document is the User Manual for the ThermoBrite Elite System. Read this manual carefully before operating the instrument, since the manual contains instructions for safe installation, operation, maintenance, and troubleshooting. A thorough knowledge of the system is recommended before any installation or use of the system.

  • Page 8: Notes, Precautions, And Warnings

    Highlights important facts, gives helpful information and tips, and clarifies procedures. 2.5.2 Cautions Electrical hazard! Unplug before handling. Important information on the proper operation of the ThermoBrite Elite System. This information is crucial for preventing instrument damage and maintaining the system. 2.5.3 Warnings Identifies potentially hazardous situations that could result in serious injury to laboratory personnel.

  • Page 9: Glossary Of Symbols

    2. Introduction Glossary of symbols 2.6.1 Regulatory symbols Explanation of the regulatory symbols used for Leica Biosystems products. Note: This glossary provides images of the symbols as presented in the relevant standards, however, some of the symbols may vary in color.

  • Page 10: Iso 7000

    Identifies the location where the handbook is stored or to identify information that relates to the servicing instructions for the equipment. To indicate that the service manual or handbook should be considered when servicing the device close to where the symbol is placed. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 11: Iec 60417

    IEC 60417 5134 Electrostatic Sensitive Devices Packages containing electrostatic sensitive devices, or a device or a connector that has not been tested for immunity to electrostatic discharge. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 12: Other Symbols And Markings

    Customers must understand and follow all laws regarding the correct decontamination and safe disposal of electrical equipment. AS/NZS 4417.1 Regulatory Compliance Mark (RCM) Indicates compliance with the Australian Communications Media Authority (ACMA) requirements (safety and EMC) for Australia and New Zealand. ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 13 Unconnected port This product has an unconnected port on the syringe pump. CLP Regulation GHS08 Serious health hazard (EC) No Health hazard. Potential serious longer term health hazards 1272/2008 such as carcinogenicity and respiratory sensitization. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 14: Safety Symbols

    2. Introduction 2.6.2 Safety symbols Explanation of the safety symbols used for Leica Biosystems products. 2.6.2.1 ISO 7010 Graphical symbols — Safety colours and safety signs — Registered safety signs. Symbol Standard/ Reference Description Regulation ISO 7010 W001 General warning...

  • Page 15: Warnings, Precautions, Limitations

    To maintain compliance, use only the cables supplied with the instrument. Any changes or modifications not expressly approved by Leica Biosystems could void the user’s authority to operate this equipment.

  • Page 16: Classification Of Equipment Under Cispr 11 (En 55011)

    Make certain that the power supply for the ThermoBrite Elite is from a dedicated line that provides power to no other instruments or appliances. If power is not clean and steady, a UPS and/or power conditioner is recommended.
  • Page 17 Fan blades do NOT stop immediately when the lid is open during operation. DO NOT touch the fan blades when the fan is running. For continued protection against risk of fire and hazard, replace only with the same type and rating fuse. Equipment requires connection to protective earth ground for safety reasons. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 18: Leica Biosystems Contact Information

    2.12.3 Important Information for All Users The term “Leica Biosystems” when used in text in this document refers to Leica Biosystems Melbourne Pty Ltd. Due to a policy of continuous improvement, Leica Biosystems reserves the right to change specifications without notice.

  • Page 19: Warranty

    The occurrence of any serious incident(s) that either has led to, or may lead to, death of a patient or user, or the temporary or permanent deterioration in the state of health of a patient or user must be reported to a local Leica Biosystems representative and the relevant local Regulatory Authority.

  • Page 20: Use Of External Usb Device To Netbook

    Installation of such third-party software, or non-approved electronic cards or other devices, without advance Leica Biosystems approval may affect the terms of or void any Leica Biosystems warranty otherwise in effect, covering Leica Biosystems supplied software and hardware on the computers and the overall performance and reliability of the entire Leica Biosystems instrument system.

  • Page 21: Installation

    Installation Unpacking Unpack the ThermoBrite Elite boxes and check the packaged items. If any of the items are damaged or missing, immediately notify Leica Biosystems or your distributor. If the ThermoBrite Elite unit, the Netbook, or the system accessories have been damaged during transport or are missing, notify your carrier immediately and contact customer service.

  • Page 22: Contents

    ThermoBrite Elite Instrument Netbook Kit: Netbook with Pre-Installed Software Power Cable Power Supply Mouse USB Cable ThermoBrite Elite Power Cable Fluid Management System: Bottle Rack 1L Bottle Assembly 2L Bottle Assembly TBE Wash Bottle Reagent Tube Kit Peristaltic Pump Tubing Kit 0.5L Bottle Assembly...

  • Page 23: Preventative Maintenance Kits

    1L Bottle Assembly 3800-007749-001 2L Bottle Assembly 3800-007750-001 TBE Wash Bottle Assembly 3800-007865-001 Slide Carrier Kit 3800-007744-001 Module Filter Kit 3800-007743-001 Fluid Management System 3800-007687-001 Fuse Kit 3801-007769-001 Waste Bottle Kit 3800-007684-001 Waste Tubing Kit 3800-007746-001 ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 24: Requirements

    Allow enough space to place the Netbook. Allow for enough space on either side of the ThermoBrite Elite Unit to place the Fluid Management System to the left and Waste Bottles to the right (if not placed underneath the instrument).

  • Page 25: Network Requirements

    3.3.5 Network Requirements ThermoBrite Elite does not require network access to function and perform its intended use. To prevent malicious or unauthorized access, install ThermoBrite Elite without any connection to your network / infrastructure. ThermoBrite Elite User Manual...

  • Page 26: Installation

    10 Amps or more and has an IEC320/CEE22 female connector to attach to the ThermoBrite Elite instrument. 1. Connect the electrical cable to the power port located on the back of the ThermoBrite Elite and to an electrical grounded outlet.
  • Page 27 Figure 3-4: Communication port located in the center of the back panel 4. Press the ThermoBrite Elite power switch, located on the rear panel, next to the power cable, to the On (I) position. Figure 3-5: Main power switch 5.
  • Page 28 Figure 3-7: Netbook Power switch 8. Enter Windows Password: Thermobrite. The ThermoBrite Elite System is shipped with a default password for ease of installation. Change this password in accordance with your organization’s password policy as part of the installation. To change the default password, press Ctrl + Alt + Del, select Change a password and follow the prompts.

  • Page 29: Fluid Management System

    2. Orient bottles such that the wire mesh filter is closest to the bottom-most edge for each respective bottle. Figure 3-9: Bottle positioning If the filter is not placed in the bottom-most edge of the bottle, flow errors might occur. ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 30 If the connector does not screw in easily, then unscrew and re-align it. Do NOT force a misaligned connector as this may damage the thread and lead to leakage. 4. Insert the fitting on the cap of each Reagent Bottle and then twist to lock. Figure 3-11: Reagent Bottle Cap Fitting ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 31 6. Connect the end of the Waste Tube to the appropriate Waste Port. Figure 3-13: Connect Waste Tube to Waste Port Waste Tubes are supplied in a 1.5m length. Tubing may be cut to desired length. ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 32 8. Label each Waste Bottle with a description of its intended content that is compliant and necessary for proper disposal; consult Material Safety Data Sheets for labeling requirements. Label the Waste Bottle that will receive the most toxic waste "C". Label the Waste Bottle that will receive the least toxic waste "A". ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 33 3. Installation 9. Connect the Emergency Waste Tube to the Emergency Waste Port. Figure 3-16: Connect the Emergency Waste Tube to the Emergency Waste Port 10. Installation is complete. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 34: End User License Agreement

    Biosystems product is conditional upon your assent to the terms of this agreement to the exclusion of all other terms. If you do not agree with all of the terms and conditions of this agreement, you may not use the Leica Biosystems product, or the computer programs contained in the Leica Biosystems product.
  • Page 35 Any indirect, special, consequential, exemplary or incidental damages; or Any amount in excess of two hundred fifty dollars (US$250.00). The limitations in this section 6 shall not limit Leica Biosystems’s liability for death or bodily injury solely resulting from Leica Biosystems’s negligence, willful misconduct or fraudulent misrepresentation.
  • Page 36 3. Installation Where Leica Biosystems has provided you with a translation of the English language version of this agreement, then you agree that the translation is provided for your convenience only and that the English language versions of the agreement will govern your relationship with Leica Biosystems, which language shall be controlling and any revision of this agreement in any other language shall not be binding.

  • Page 37: System Description

    Reagents are pumped into a sample chamber for deparaffinization, pretreatment, denaturation, hybridization, and post wash. Waste fluids are discarded into a Waste Bottle. The ThermoBrite Elite can process up to 12 slides per run. The user can denature and hybridize samples on-board. Components The main components of the system include:...

  • Page 38: Back

    4. System Description 4.2.2 Back Figure 4-2: ThermoBrite Elite Back View ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 39: Fluidic System

    Waste Bottles. The fourth port is the Emergency Waste Port. This serves as an overflow for any reagents that might accumulate in the base of the instrument. Figure 4-4: Waste ports located on the right side of the instrument ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 40: Pumps

    The Module Manifold is located between the peristaltic pumps. Six tubes located on top of the Module Manifold, are individually connected to each of the Sample Chambers of the three Thermal Modules. Figure 4-6: Module Manifold ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 41: Slide Carriers

    Slide Carriers Six Slide Carriers are provided with the ThermoBrite Elite System. Each Slide Carrier can hold up to two slides, allowing users to run up to 12 slides at one time. The Slide Carrier has a pivot that fits into grooves in the side of each Sample Chamber.

  • Page 42: Sample Chambers

    Three Thermal Modules are accessed by removing the instrument cover and opening the module lids. Each of the three Thermal Modules has two Sample Chambers, and has a temperature range from 25-95°C. Figure 4-9: Sample Chambers ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 43: Electrical And Communication Connections

    Figure 4-10: Power Switch - It includes the Fuse Box The instrument’s main power switch is used as the main disconnect device. 4.2.5.2 Netbook Communication Port Located in the middle on the back of the system. Figure 4-11: Netbook Communication Port ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 44: Software

    4. System Description 4.2.6 Software User control of the system is achieved via the Leica Biosystems custom software running on a Netbook supplied with the instrument. The intuitive easy-to-use software allows you to run standard protocols or configure and save custom protocols.

  • Page 45: Preparing The System For Run

    Preparing the System for Run Reagents 5.1.1 Compatible Reagents The following reagents may be used in the ThermoBrite Elite: Saline Sodium Citrate (SSC) Phosphate Buffered Saline (PBS) 2-(N-morpholino) Ethanesulfonic Acid (MES) Tris-HCL Citrate Based Buffers Proteases Sodium Thiocyanate 0.2N Hydrochloric Acid (and further dilutions)

  • Page 46: Reagent Preparation And Connection

    Figure 5-1: Dashboard—Select Protocol 2. Prepare the required reagents based on the Reagent List displayed on the screen. Reagent preparation instructions are provided in the ThermoBrite Elite Ancillaries document. Reagent Bottles should also be labeled with their contents. 3. Disconnect tubing from the appropriate Reagent Bottle caps by removing the tube fitting on the cap.
  • Page 47 6. Recap Reagent Bottles carefully; avoid damaging the bottle filter. 7. Insert then twist to lock the numbered Reagent Tube fitting to the cap of the appropriate Reagent Bottle. Figure 5-3: Lock Reagent Tube Fitting ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 48 If the bottle filter is not placed in the bottom-most edge of each reagent bottle, flow errors might occur. If harmful vapors are expected or are a concern, it may be appropriate to operate the ThermoBrite Elite under an appropriate ventilation hood.

  • Page 49: Slide Preparation

    Figure 5-5: Insert Slide Carrier into Sample Chamber System Ready 1. Make sure that the Netbook is connected to the ThermoBrite Elite instrument with a USB cable. 2. Make sure that the ThermoBrite Elite is powered up, and that the green LED is illuminated.
  • Page 50 5. Preparing the System for Run This page is intentionally left blank. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 51: Using The Thermobrite Elite Software

    Run. The ThermoBrite Interface All ThermoBrite Elite functions are performed on a series of screens, which are part of the software program installed on the provided Netbook. When you start ThermoBrite Elite, the Start screen is displayed. Figure 6-1: Start screen...

  • Page 52: Running A Protocol

    6. Using the ThermoBrite Elite Software The current software version is always displayed on the bottom left corner of the screen. Current software version The Start screen has six functional buttons: Click to run a protected protocol. Run/Create/Edit Click to run, create, or edit a protocol before protecting it.

  • Page 53: Select A Protocol To Run

    6. Using the ThermoBrite Elite Software 6.3.2 Select a Protocol to Run 1. On the Start screen click either: Run— to select a protected protocol. You cannot modify a protected protocol. Run/Create/Edit—to select a protected or unprotected protocol. Using this option, you can edit unprotected protocols before running them.

  • Page 54: Add Slides To Module

    6. Using the ThermoBrite Elite Software 6.3.3 Add Slides to Module The Protocol Dashboard is used to assign specimen slides to a Sample Chamber in one of three Thermal Modules. Figure 6-4: Protocol Dashboard—Empty Sample Chamber There are three Thermal Modules; each contains two Sample Chambers, A & B. Each chamber can hold two slides.
  • Page 55 6. Using the ThermoBrite Elite Software 2. Select a slide, and then enter any data concerning the patient: i.e. Name, ID number. You can also overwrite the Module and slide number or add specific data next to the Module/slide numbers (see image below).

  • Page 56: Start The Protocol

    6. Using the ThermoBrite Elite Software 6. Click Next. The Protocol Dashboard is displayed. 6.3.4 Start the Protocol 1. If you have not already done so, load the slides in the corresponding Module slide position(s). Figure 6-8: Protocol Dashboard —Start 2.
  • Page 57 6. Using the ThermoBrite Elite Software The Protocol Dashboard is redisplayed showing the status of the protocol run. Figure 6-10: Protocol Dashboard—Protocol Run 5. If a protocol contains a Pause step, click Resume to continue. Figure 6-11: Pause Protocol Message...

  • Page 58: Monitor The Protocol Run Status

    6. Using the ThermoBrite Elite Software 6.3.5 Monitor the Protocol Run Status 6.3.5.1 Slide Position When you run a protocol, the status of the run, fill, and waste activity in each Module is displayed in the footer section of the screen, below the temperature indicators.
  • Page 59 6. Using the ThermoBrite Elite Software Current temperatures displayed in green indicate that the Module has reached its target temperature. Figure 6-14: Protocol Dashboard—Temperature Status (Target Temperature) Current temperatures displayed in blue indicate that the Module is cooling. Figure 6-15: Protocol Dashboard—Temperature Status (Cooling)

  • Page 60: Review The Protocol Completion Summary

    6. Using the ThermoBrite Elite Software 6.3.6 Review the Protocol Completion Summary When a protocol run is completed, the Protocol Completion Summary screen is displayed. If required, you can add comments about the Run to the Notes field. Figure 6-16: Protocol Completion Summary This summary includes five (5) options: View Summary Log –...

  • Page 61: View Summary Log

    6. Using the ThermoBrite Elite Software 6.3.6.1 View Summary Log Click View Summary Log and select a specific summary log from the list. The log file is opened in Notepad. A summary option is also available from the Protocol Completed screen when a protocol finishes running.

  • Page 62: Drain Chambers

    6. Using the ThermoBrite Elite Software 6.3.6.3 Drain Chambers This option is used to drain any remaining liquid from the Module’s Sample Chambers. If a protocol is aborted, the Sample Chambers must be drained. Figure 6-18: Protocol Dashboard—Drain Chambers 6.3.6.4 Save and Run Line Wash This option is used to wash the Reagent Lines.

  • Page 63: Creating A New Protocol

    6. Using the ThermoBrite Elite Software Creating a New Protocol Creating a new protocol requires several steps: Add a name and description Add the protocol steps Assign the Reagent and Waste Bottles. This is an example of setting up a reagent and is not a recommended setup for Clearene.
  • Page 64 6. Using the ThermoBrite Elite Software 2. Under the Available Protocols field, click New. Figure 6-20: Add New Protocol 3. In the Protocol Name field, enter a meaningful name for the new protocol (up to 80 characters). The name must be unique.
  • Page 65 6. Using the ThermoBrite Elite Software 4. Enter a Description for the new protocol. 5. If you do not want the protocol to be editable in the future, click the Protected check box to protect the protocol. If you select the Protected check box, the protocol cannot be edited after you click Next.

  • Page 66: Add Protocol Steps

    6. Using the ThermoBrite Elite Software 6.4.1 Add Protocol Steps When you create a new protocol, a Drain and an empty Reagent step are automatically included. You can, however, add any number of the following steps: Reagent Prime Pause Drain 6.4.1.1 Reagent Step...
  • Page 67 6. Using the ThermoBrite Elite Software The Protocol Reagent Step window is displayed. By default, the Reagent steps are pre-populated with the following options: Fill (Required step) Rock Temp Incubate Drain Figure 6-23: Protocol Reagent Step screen 3. In the Reagent Step list, double-click Reagent. The Reagent and Bottle fields are displayed.
  • Page 68 6. Using the ThermoBrite Elite Software Make sure the assigned bottle number matches the current bottle setup. Selecting the option Auto automatically assigns the next available bottle number, which might not correspond with the appropriate reagent. Figure 6-24: Protocol Reagent Step—Assign Bottle...
  • Page 69 6. Using the ThermoBrite Elite Software 6. Click Update to add the selected reagent and bottle. The Reagent Step screen is displayed with the bottle number displayed in brackets next to the reagent’s name. For example, Clearene [1]. Figure 6-25: Protocol Reagent Step—Update...
  • Page 70 6. Using the ThermoBrite Elite Software Reagent Fill This option is used to define the reagent volume distributed inside the module chamber. The default is 100%, which corresponds to 30mL. The Fill step is required. 1. Double-click Fill. If necessary, adjust the Dispense volume to a percentage between 25 and 200. In general, 100% fill volume is recommended during pretreatment and post wash and a 50% fill volume is recommended during denaturation and hybridization.
  • Page 71 6. Using the ThermoBrite Elite Software Reagent Rock This option is used to define the cycle rate at which the ThermoBrite Elite will rock back and forth. The default is Medium speed – 12 cycles/minute. We recommend not using Fast as it might damage the sample.
  • Page 72 6. Using the ThermoBrite Elite Software Reagent Temp Use this option to define the temperature at which each chamber must be for the reagent step. The default is 37°C. 1. Double-click Temp. Enter a temperature between 25°C and 95°C. 2. Do not uncheck On. This will disable heating and cooling for the module.
  • Page 73 6. Using the ThermoBrite Elite Software Reagent Incubate This option is used to define the incubation time for the reagent step. The default is 5 minutes. This step is relevant only if the Wait for temp before continuing check box was selected in the Temp step.
  • Page 74 6. Using the ThermoBrite Elite Software Flush Use this option to add a Flush step. Use a Flush step to ensure previous reagents have been flushed out of the fluidic lines. This is particularly important when using reagents of high or low pH or solvents. Including a Flush step can increase the life of the peristaltic tubing.
  • Page 75 6. Using the ThermoBrite Elite Software 5. Click Update to validate the entry. The Reagent Step screen is displayed. New steps are added immediately after the currently highlighted step. Pause Use this option to add a specific instruction and to pause the protocol run for a manual user action.
  • Page 76 6. Using the ThermoBrite Elite Software Save and Close Use the following options to edit, or save the protocol steps: Save and Close Save the reagent steps and display them in the Protocol Steps field Delete Delete the selection Move the selection one step up...

  • Page 77: Prime Step

    6. Using the ThermoBrite Elite Software 6.4.1.2 Prime Step The Prime step: removes fluid from a previous protocol using another reagent, and fills the lines to avoid flow errors. You do not need to add a Prime step. The instrument automatically primes as it reaches each new step.

  • Page 78: Pause Step

    6. Using the ThermoBrite Elite Software 6.4.1.3 Pause Step Use this option to add a specific instruction and to pause the protocol run. This option is the same as the Pause sub-step. See Reagent Step Pause. 1. Click the Add drop-down list, then select Pause.

  • Page 79: Drain Step

    6. Using the ThermoBrite Elite Software 6.4.1.4 Drain Step This option will drain the contents of the chamber modules into the Waste Bottles. 1. In the Protocol Steps field, click Drain. No options are available for the Drain step. Figure 6-36: Drain Step 6.4.2...
  • Page 80 6. Using the ThermoBrite Elite Software Waste "C" is the default because it is assumed to receive the most toxic waste. Use Waste “C” for ethanol and Xylene substitutes (such as Clearene or Sub-X). Use Waste "A" for the least toxic waste such as water. Use Waste “B”...

  • Page 81: Check Alerts

    6. Using the ThermoBrite Elite Software 6.4.3 Check Alerts 6.4.3.1 Warning Protocol Issues This warning is displayed if there is a potential issue with one or more steps. It does not mean that the run will abort. Figure 6-39: Warning—Protocol Issue 1.
  • Page 82 6. Using the ThermoBrite Elite Software This page is intentionally left blank. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 83: Maintenance

    Maintenance Do NOT expose the ThermoBrite Elite Unit or its Netbook to strong or concentrated acids, bases or oxidizing agents, aromatic or halogenated hydrocarbons, esters, or ketones. Wear appropriate personal protective equipment to prevent exposure to pathogens. Discard contaminated materials according to applicable regulations.

  • Page 84: Cleaning And Maintenance Checklist

    7. Maintenance Cleaning and maintenance checklist Use the schedule below to clean and maintain your ThermoBrite Elite. Task Section Daily—Before each run Check reagent level volume 3.4.1 - Fluid Management System Check reagent bottle filter position 3.4.1 - Fluid Management System Check waste bottle volume 7.2.1 - Discarding Liquid Waste...

  • Page 85: Disposition

    Run the Line Wash: as part of a routine weekly maintenance, when recommended as a component of troubleshooting, just prior to not using the ThermoBrite Elite for a week. This procedure consists of two steps: 1. An ethanol flush: All reagents except Clearene—70% ethanol Clearene or other Xylene substitutes—100% ethanol...

  • Page 86: Run A Line Wash

    For Clearene and line washes, use 100% ethanol. 1. Insert then twist to lock up to 3 Reagent Line fittings onto the cap of the ThermoBrite Elite Wash Bottle (filled with deionized water, 70% ethanol, or 100% ethanol for Clearene lines).
  • Page 87 Dispose of waste product in compliance with applicable legal regulations. If unsure of the applicable legal requirements, contact the local authorities for information. 5. Click Start. 6. Add the appropriate amount of 70% ethanol (or equivalent) to the ThermoBrite Elite Wash Bottle, based on messaging that appears on screen. Figure 7-4: Confirm Setup 7.
  • Page 88 Elite Wash Bottle cap to allow for an air flush. Figure 7-5: Pause message—Remove Reagent Lines 9. Click Resume. 10. Click Save Notes and Close. Figure 7-6: Pause message—Line Wash Completed 11. Repeat steps 1-10 for remaining lines to be washed. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 89: Cleaning

    Periodic cleaning is recommended for all laboratory instruments and frequency depends on the working environment. Recommended procedures are given below. Unplug the ThermoBrite Elite Unit from the wall outlet and disconnect it from the Netbook before cleaning. Before using any cleaning or decontamination methods other than those recommended, check with Technical Support that the proposed method will not damage the equipment.

  • Page 90: Clean The Pepsin Bottle

    7.4.2.1 Clean Instrument Surfaces Items required: Mild detergent, lint-free tissue, distilled water, and appropriate personal protective equipment. 1. Clean the outside surfaces of the ThermoBrite Elite Unit with a water-dampened lint-free tissue and mild detergent to remove any deposits. 2. Wipe again using distilled water.

  • Page 91: Clean Reagent Bottles And Filters

    3. Clean waste containers using a 0.5% bleach solution (w/v) or industrial strength detergent. 4. Rinse thoroughly with deionized water. 5. Return waste containers to the instrument. 7.4.2.5 Clean the Netbook Follow the manufacturer’s recommendations for cleaning the Netbook. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 92: Back Up Data

    Log files are stored in a text files. 7.5.2 Back up Protocol Files on Netbook Copy all files in the following folder to a USB: C:\Users\Public\Public Documents\Leica\protocols Each protocol is stored in a comma-separated values (.csv) file. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 93: As Needed Maintenance

    1. Turn the main power switch located in the back panel to the Off (O) position. Make sure the power cable to the ThermoBrite Elite Unit is unplugged. 2. Place paper towel underneath the Module Manifold to catch any possible fluid leak (see image below).

  • Page 94: Replace The Peristaltic Pump Tubes

    Peristaltic Pump Cover. Never attempt to adjust or access the tube while the instrument is powered on. Dispose of contaminated material in compliance with applicable legal regulations. If unsure of the applicable legal requirements, contact the local authorities for information. ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 95 1. Turn the main power switch located in the back panel to the Off (0) position. Make sure the power cable to the ThermoBrite Elite Unit is unplugged. 2. Place some paper towels underneath the peristaltic pump to catch any possible fluid leak, see image below.
  • Page 96 8. Lower the Peristaltic Pump Cover to close the pump. This lowers the top part of the pump, securing the tube above the rollers. 9. Discard the old tube according to applicable regulations. 10. Repeat the procedure for the second peristaltic pump. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 97: Replace The Fuses

    7.6.3 Replace the Fuses Turn the main power switch located in the back panel to the Off (0) position. Unplug the ThermoBrite Elite Unit from the wall outlet and disconnect it from the Netbook before replacing the fuses. For continued protection against risk of fire and hazard, replace only with the same type and rating fuses.
  • Page 98 6. Reinstall the fuse holder in its compartment until it clicks into place. 7. Reconnect the Netbook to the unit. 8. Reconnect the power cable, and then press the power switch to the On (I) position. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 99: Troubleshooting

    Troubleshooting A self-test is automatically performed when the ThermoBrite Elite Unit is powered on. When the instrument successfully powers up, a two-beep ready signal sounds, and the green LED on the right side of the front panel illuminates. Figure 8-1: Peristaltic Pump...
  • Page 100 The Reagent Pump is not pumping reagent, Check if the rollers are turning on the left see image below. pump located on the front of the instrument. If not, call Technical Support or your distributor. ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 101 Clean the system; see 7.3 - Line Wash . Chamber may be obstructed. See image If the problem persists, call Technical below. Support or your distributor. Clogged Manifold Filters Replace the Manifold Filters; see 7.6.1 - Replace the Module Manifold Filters. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 102: Error Messages

    If the problem persists, contact Technical Support or your distributor. 8.2.4 Error loading Protocol Causes Remedies The software cannot load the selected protocol. Restart the Netbook. If the problem persists, contact Technical Support or your distributor. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 103: Exit Valve Failed To Switch To Bypass Position

    Instrument thread is either terminated or unresponsive within 20sec. Software will terminate Causes Remedies The instrument is not responding to a software command. Restart the Netbook. If the problem persists, contact Technical Support or your distributor. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 104: Modules Did Not Reach Target Temperature(S) Within 1 Hour

    8.2.10 Modules did not reach target temperature(s) within 1 hour Causes Remedies Firmware or Thermal Module issue. Restart the Netbook and ThermoBrite Elite. If the problem persists, contact Technical Support or your distributor. 8.2.11 Internal software error Causes Remedies The software stopped working.

  • Page 105: No Thermobrite Elite Found

    8. Troubleshooting 8.2.15 No ThermoBrite Elite found Causes Remedies The Netbook cannot connect to the ThermoBrite Elite. Check the USB connections between the instrument and the Netbook. Restart the Netbook and instrument. If the problem persists, contact Technical Support or your distributor.

  • Page 106: Sensors Indicate A Critical Flow Error

    Peristaltic Pump Tubes. Sensors indicate a reduced flow problem while draining. If the problem persists, contact Technical Support or your Causes: distributor. obstructed Chamber Port blocked Manifold Filter worn Peristaltic Tube full Waste Bottles ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 107: The Protocol Has Failed

    8.2.23 USB Communication interruption Causes Remedies The Netbook lost connection with the ThermoBrite Elite. Unplug the USB from the Netbook and then plug it in again. Restart the Netbook and instrument. If the problem persists, contact Technical Support or your distributor.

  • Page 108: Checking Usb Connections

    Figure 8-2: USB Connection between Netbook and Instrument Figure 8-3: Netbook Communication Port When the connection is established, the Main screen displays the USB connection icon. Connected     Not Connected ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 109: Specifications

    Product Name ThermoBrite Elite Product Number 3800-007000-001 Model Number S600 Computer Netbook with ThermoBrite Elite software preloaded Interface USB port Capacity (12) 2.54cm X 7.62cm (1” X 3”) slides Electrical Power Requirement 100 – 240 VAC, 50-60Hz, 10.0 A Dimensions Height: 38.1cm (15.0”)

  • Page 110: References

    3. CDC. Updated: US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Post Exposure Prophylaxis. Appendix A and B. MMWR 50 (RR-11): 1-42, June 29, 2001. ThermoBrite Elite User Manual 3855-7500-501 B02...

  • Page 111: Index

    Instrument thread is either terminated or unresponsive within 20sec Discarding Liquid Waste Intended Use Disclaimer of warranty Internal instrument error Drain Internal operation error Drain Chambers Internal runner module error Drain Side Low Flow ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 112 Reagents Monthly Maintenance References Replacing the Fuses Netbook Communication Port Replacing the Module Manifold Filters XE Network Requirements Restrictions No ThermoBrite Elite found Rock Notes Operator’s Manual Run Completion Summary How to use Run Slide Position Activity 58-59 Running a Protocol...
  • Page 113 U.S. government users Unhandled exception Unpacking USB Communication interruption USB Connections check Use of Third Party Computer Products Using the ThermoBrite Elite Software Warning Invalid Protocol Name Warning Protocol Issues Warnings Warnings, Precautions, Limitations ThermoBrite Elite User Manual 3855-7500-501 B02...
  • Page 114 Index This page is intentionally left blank. ThermoBrite Elite User Manual 3855-7500-501 B02...

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