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Sartorius Stedim Biotech BioSealer TC User Manual

Sartorius Stedim Biotech BioSealer TC
49 pages
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2486866-000-00
Operating Manual
BioSealer
®
TC

Table of Contents

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Sartorius Stedim Biotech BioSealer TC Specifications

General IconGeneral
BrandSartorius Stedim Biotech
ModelBioSealer TC
CategoryLaboratory Equipment
LanguageEnglish

Summary

Technical Safety Information

Change Index

Lists document version history and changes.

About this Document

Symbols Used

Explains warning, caution, and notice symbols for hazard communication.

Hazard Information

Safety Warnings and Precautions

Covers hand injury, hot surfaces, power disconnect, and ESD hazards.

Operational Notices and Safety Guidelines

Provides notices on device usage, environment, power, and handling rules.

General Information

Disclaimer of Liability

States manufacturer's limitations on liability for improper use or accidents.

Introduction

Device Characteristics

Lists features like sealing range, area, portability, and design.

Safety in Operation

Warns about moving parts and the importance of safety features.

Usage Limitations

Specifies industrial use only, not medical applications, and testing requirements.

Device Functionality

Explains the sterile separation process and data logging.

Handling Blocked Devices

Explains error messages and troubleshooting for blocked devices.

Cleaning Instructions

Provides guidelines and warnings for cleaning the device.

Decontamination Procedures

Lists agents and responsibilities for decontamination.

Carrying and Handling Guidelines

Illustrates correct and incorrect ways to carry the device.

Start-up

Delivery Kit Contents

Lists all items included in the BioSealer TC package.

Equipment Familiarization

Identifies main device components via a diagram and table.

Assembly and Initial Power-up

Guides on connecting power and turning on the device.

User Login Process

Explains initial login, supervisor access, and user authentication.

Maintenance Requirements

Details periodic maintenance alerts and service needs.

Initializing the Axes

Describes the process of initializing device axes after startup or tubing change.

Sealing Process

Inserting Tubing and Closing Cover

Guides on correctly inserting tubing and closing the device cover.

Compression Phase Execution

Details starting the compression phase and verifying tubing.

Setting and Securing Clamps

Explains how to clamp tubing on both sides of the sealer.

Sealing Operation Phases

Covers the heating and cooling phases of the sealing process.

Seal Log Screen Display

Shows information logged after a successful sealing.

Removing Tubing After Sealing

Describes how to remove the sealed tubing once the process is complete.

Visual Inspection of Seals

Guides on visually checking seal quality using a template.

Removing Clamps

Details when and how to remove clamps after sealing.

User Interface

User Interface Mutual Exclusion

Explains that only one interface (touch or web) can be active at a time.

Touchscreen Interface

Introduces the touch screen as a primary control method.

Touchscreen Menu Structure

Shows the menu tree for the Supervisor user group.

Touchscreen Menu Options

Details various functions accessible via the touchscreen menus.

Touchscreen Symbol Guide

Explains common and menu-specific symbols used on the touchscreen.

Touchscreen Operating Elements

Describes buttons, spin boxes, text boxes, and input windows.

User Login and Logout Procedures

Explains how to log in, log out, and automatic logout.

Setting Date and Time

Guides on adjusting the device's date and time settings.

Selecting Interface Language

Explains how to change the device's display language.

Tubing Selection and Configuration

Details how to select the correct tubing type and size for sealing.

Network Parameter Reset

Explains how to reset network settings to factory defaults.

User Administration and Management

Covers adding, managing, and deleting users and their permissions.

Log Data Storage and Retrieval

Explains how log data is stored on the SD card and directory structure.

Device Information Display

Lists device status details like IP address, serial number, and wear.

Web Browser Interface

Connecting to the Web Interface

Guides on finding the IP address and accessing the device via browser.

Web Browser Menu Structure

Outlines the main menu items available in the web interface.

Web Browser Operating Elements

Describes buttons, spin boxes, and text boxes in the browser interface.

Web Browser Interface Appearance

Shows the layout and components of the web browser interface.

Web Browser General Parameters

Covers device settings like tubing, language, and network via the web interface.

Web Browser User Login/Logout

Explains user login and logout procedures within the web interface.

Web Browser User Management

Details managing users, passwords, and auto-login via the browser.

Web Browser Information Access

Explains how to download device state, logs, and sync date/time.

Web Browser Log Download

Describes how to download log files (raw, pdf, html, csv) via the browser.

Web Browser Date/Time Synchronization

Explains synchronizing device time with the host computer.

Runs and Automated Processes

Initializing Device Axes

Describes the process of initializing the device's axes.

Sealing Run Procedure

Refers to the sealing process and how to initiate a run.

Handling Power Failures During Runs

Explains device behavior and actions during power interruptions.

Temperature Validation Process

Guides on performing temperature validation using a separate tool.

Using Service Position

Explains how to access the service position for cleaning or removing tubing.

Log Recording and Content

Seal Log Data Fields

Details the content of the seal log table, including date, time, user, etc.

Seal Log Screen Functionality

Describes the seal log screen for GMP/FDA environments and its display conditions.

User Groups and Interface Authorizations

Operator vs. Supervisor Roles

Compares user groups, their controls, and interface support.

Troubleshooting Operating Problems

Device Power Off Issues

Explains when and how to safely switch off the device.

Foreign Objects and Blockages

Warns about foreign objects and their impact on device mechanics.

Incorrect Tubing Insertion

Discusses issues arising from using the wrong tubing and consequences.

Memory Card Recognition Issues

Lists potential causes for the device not recognizing the SD card.

Lost Password Recovery

Outlines methods for resetting lost passwords for users.

Manual Cover Opening Procedure

Provides instructions for manually opening the device cover if it fails to auto-open.

Error and Warning Message Guide

Troubleshooting Error Messages

Lists common error messages and their potential causes and solutions.

Interpreting Warning Messages

Explains warning messages, their causes, and recommended actions.

Device Disposal and Decontamination

Information on Decontamination

Discusses hazardous materials and operator responsibility for decontamination.

Disassembly Requirements and Procedure

Outlines steps before disassembly and warnings about sharp parts.

Disposing of Device and Parts

Covers proper disposal methods and battery disposal.

Technical Data Specifications

Device Specifications

Lists technical details like voltage, current, operating temp, and mass.

Power Supply Specifications

Details input voltage, frequency, current, and power cord requirements.

Device Dimensions

Provides physical dimensions of the BioSealer TC with diagrams.

Appendix and Contact Information

Copyright and Trademarks

Lists copyright notices and registered trademarks of relevant companies.

Technical Contact Details

Provides contact information for technical support.

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