Table of Contents
Advertisement
Advertisement
Table of Contents
Related Manuals for Sartorius Stedim Biotech BioSealer TC
Summary of Contents for Sartorius Stedim Biotech BioSealer TC
- Page 1 Operating Manual ® BioSealer 2486866-000-00...
- Page 2 Technical Safety Information for the User This description contains the necessary information for the designated use of the product described herein. It is intended for technically qualified personnel. Qualified personnel are persons who, because of their education, experience and training as well as their knowledge of relevant standards, specifications, accident- prevention regulations and operating conditions, have been authorized by persons responsible for system safety to execute the necessary activities, and can recognize and avoid possible dangers in such activities.
-
Page 3: Table Of Contents
Contents Contents 1 About this Document....... 4 7.3 Web browser........30 7.3.1 Connecting . -
Page 4: About This Document
About this Document About this Document This document is intended for users of BioSealer ® TC from the user group “Supervisor” and “Operator”. Symbols Used WARNING Denotes a danger with risk that death or severe injury may result if it is not avoided. CAUTION Denotes a danger with risk that moderate or minor injury may result if it is not avoided. -
Page 5: Hazard Information
Hazard Information Hazard Information The following information is for the personal safety of operating personnel as well as the safety of the described product. Hand injury warning Never grab hold of anything inside openings during operation. Noncompliance can lead to serious injury. Warning of hot surface Inside the device, the surface can be hot and cause burns | injury. - Page 6 Hazard Information NOTICE ® As the BioSealer TC is intended to use as a handheld device, the operator must use safety shoes to prevent harm from a falling device. Be aware that microscopic or macroscopic particles | fluids of the tubing inner may be released into the environment during the sealing process or after separation.
-
Page 7: General Information
Disclaimer of liability Sartorius Stedim Biotech SA cannot accept any liability for errors and damages that occur caused by improper handling and by improper use of the device. Improper handling arises if the operating instructions, in particular the instructions for start-up, are not followed. -
Page 8: Introduction
Introduction Introduction The inserted dry or liquid filled tubing is compressed between two heating elements. The heat and the compression force generate a homogeneous sealing of the tubing section. The resulting sealing can be cut through the embedded guideline using scissors. -
Page 9: Function
Introduction Function The BioSealer ® TC is used for the sterile separation of tubing. For this purpose, tubing is inserted, the cover is closed and a run is initiated with the start button. During the run, the tubing is automatically squeezed and heated. Subsequently, the tubing is cooled, the tubing is released again and the cover is opened. -
Page 10: Decontamination
NOTICE The customer is responsible for correct decontamination! After correct decontamination, the customer must fill out the “Decontamination form” that the device is free from biological, chemical or radioactive contaminants. This form can be obtained from the local Sartorius Stedim Biotech SA representative. ® Operating Manual BioSealer... -
Page 11: Carrying Information
Introduction Carrying Information CAUTION Carry | Hold the BioSealer ® TC only the way shown in the picture below. Not following these instructions may lead in to unreliability, hazardous situations and disturbances of safety. ✔ CAUTION Do not carry | hold the BioSealer ®... -
Page 12: Start-Up
Start-up Start-up This chapter is a step by step guide for the start-up of the BioSealer ® Delivery kit − BioSealer ® TC device − Power supply − Power cord − SD memory card inserted into slot − Quick starting guide and operating manual ®... -
Page 13: Log In
Start-up Log in On delivery, the device is set so that a user with the name “Supervisor” is automati- cally logged in by the “Supervisor” user group. In this case, the instructions which are necessary to carry out an initialization are displayed on the touch screen. If no user has the automatic login attribute, the user must login with the user name and password. -
Page 14: Sealing Process
Sealing process Sealing process To perform a sealing, follow the instructions on the touch screen. If the device has not previously been initialised, no sealing can be performed at this status. Proceed as follows: NOTICE Verify that tubing is available and the correct tubing is set in the device. See chapter „7.2.7 Tubing“, page 26. -
Page 15: Compression Phase
Sealing process NOTICE Check on the user interface whether the selected tubing matches the inserted tubing. Internal and external diameters must also be checked. If all details match, press the start button to start the compression phase. Compression phase ® Operating Manual BioSealer... -
Page 16: Set Clamps
Sealing process Set clamps On both sides of the sealer, the tubing must be clamped. NOTICE The distance between the clamp and the sealer should be around 4 cm | 1.6 in. Sealing process ® Operating Manual BioSealer... -
Page 17: Seal Log Screen (Optional)
Sealing process Seal log screen (optional) Remove tubing Sealing process is completed when the cover opens automatically. ® Operating Manual BioSealer... -
Page 18: Sealing Visual Inspection
Sealing process Sealing visual inspection The operator must visually check the sealing. He bears the responsibility. In order to help the operator to assess the sealing quality there is a verification template (see picture left) included into the delivery box that can be used. If the sealing reopening crosses the limit, a new sealing must be performed. -
Page 19: User Interface
User interface User interface The BioSealer ® TC is delivered with two user interfaces which partially cover common functionalities. On one hand, the device can be operated via the touch screen integrated in the device, on the other hand via Ethernet over a web browser. NOTICE As far as possible, the user should operate the device with the local touch screen. -
Page 20: Touchscreen
User interface Rules for activating | switching a user interface: The touch screen can always be instantly activated by touching it. The web browser can only be activated if no user is logged into the device or after restarting. If you want to activate the web browser user interface, logout on the touchscreen is mandatory. - Page 21 User interface 1 11 ® Operating Manual BioSealer...
-
Page 22: Summary Of Symbols
User interface 7.2.2 Summary of symbols The following tables show the meaning of the symbols displayed on the touch screen. Common symbols Symbol Meaning Cancel, the current screen is exited. Changes are discarded. OK, changes are accepted and saved by the user or messages are acknowledged. -
Page 23: Operating Elements
User interface 7.2.3 Operating elements The touch screen has only a few standardized controls which are also common in other user interfaces. Element Example Importance Button Start: Start the process Button Stop: Terminate the process Button Buttons with icon. See chapter „7.2.2 Summary of symbols“, page 22. Spin box A “Spin box”... -
Page 24: User Login | Logout
User interface 7.2.4 User Login | Logout Login If no user has the “auto login” attribute, the user must login with the user name and password. Enter the user name and the corresponding password in the “User login” dialogue. Confirm your entries by pressing the OK button. If a user has the “auto login”... -
Page 25: Date And Time
User interface 7.2.5 Date and time The date and time is used as a time stamp for log. The setting is different on the touch screen and web browser. Date The day, month or year can be adjusted using the arrow key. By pressing once, the number is increased by one counter. -
Page 26: Tubing
User interface 7.2.7 Tubing The user has the option to select the tubing to be sealed. Depending on the choice, tubing parameters are selected (e.g. seal temperatures, closing motor positions, etc.). The user selects: − Tubing type: This property corresponds to the material of the tubing (e.g. TuFlux ®... -
Page 27: User Administration
User interface 7.2.9 User administration User administration includes all users. A user can edit his user data or those from the same or deeper user group. A user from the group “Operator” can only change his own password. User management is divided into three different screens on the touchscreen. Please read the chapter „7.3.3 Operating elements“, page 31 for further information. -
Page 28: Log
User interface Parameter Meaning All users allowed to be deleted are listed up here. Screen 3 On this screen the auto login can be assigned | removed to an existing user. Next screen with arrow down … All users allowed to be assigned are listed here. 7.2.10 Log For general information about log please read the chapter „9 Log“, page 38. -
Page 29: Info
User interface Directory name Log files in the directory BSTC-166 Raw.log Seal.pdf Seal.csv Seal.html State.xml As you can see, the contents of the directories are different in this example. Reason: The user did not always make the same download selection. The user has the following selection options. -
Page 30: Web Browser
User interface Web browser Working in the web browser: − No additional software needs to be installed on the computer. ® − At the same time several BioSealer TC can be operated via one web browser. − Operation via mobile devices such as laptops, smartphones, tablet PCs etc. possible. -
Page 31: Operating Elements
User interface 7.3.3 Operating elements Element Example Description Button OK: accept changes Button Cancel: decline changes Button Login: login user Button Logout: logout user Button Start: start the run Button Stop: stop the run Spin box A „Spin box“ offers a choice of entries Spin box with With a “Spin box with input”... -
Page 32: General Parameters
User interface 7.3.5 General parameters General parameter is used for basic settings of the device, such as tubing selection, language or network settings. NOTICE It is very important that the user selects the tubing that he actually wants to seal. The sealing may fail if the selected tubing and the actually sealed tubing have different properties (geometry, temperatures, etc.). -
Page 33: User Login | -Out
User interface Parameter Description MAC address This address must only be changed if 2 devices in the same network have the same MAC address. The MAC addresses are assigned by the manufacturer, each device has its own address. Static IP address If DHCP is unchecked, this IP address will be used. -
Page 34: User Management
User interface Automatic logout: If “auto login” is not selected, the system automatically logs out after a set time. This time always begins to count when the device has finished a run or when a user interaction has been performed. This time can only be changed via the Web Interface (General Parameters, Auto logout time) and is set up to 10 minutes by manufacturing configuration. -
Page 35: Log
User interface 7.3.9 For general information about log please refer to chapter „9 Log“, page 38. Under the menu “Info” the logs can be downloaded to the computer. Selection Description Please, always send this file with a problem report | complaint. (Used for debugging or failure analysis). -
Page 36: Runs
Runs Runs Runs are fully automated processes, which are carried out as soon as the cover is closed. A run is terminated when the cover opens. At the user interface, only processes are provided for which the user has the authorisation and which he can execute with the current device status. -
Page 37: Temperature Validation
Runs Temperature validation A separate validation tool needs to be bought for validating the temperature. The BioSealer ® TC must be initialized to use this function. User steps: 1. Press the “Temperature validation” symbol 2. Remove anything from the squeeze axis and close cover 3. -
Page 38: Log
® BioSealer TC records runs for its on-going operation and saves them. A circular buffer is provided for this purpose. If the memory is full (capacity of around 50,000 sealings) and a new log appears, the oldest log is deleted permanently and the new log is saved. -
Page 39: Seal Log Screen
Content Raw log Please, always send this file with a problem report | complaint (used for debugging or failure analysis). Status Please, always send this file with a problem report | complaint (used for debugging or failure analysis). The seal log is always output in the language that is currently chosen. Seal Log Screen The seal log screen shows all relevant information about the sealing just finished. -
Page 40: User Groups And User Interfaces
User groups and user interfaces 10 User groups and user interfaces The following table shows the authorizations of user groups and the user interfaces. User group Operator control Function Comments Group or menu item Detail Operator Touch screen and Web Initialize axis browser Seal... -
Page 41: Operating Problems
Operating problems 11 Operating problems 11.1 Switch off the device The BioSealer ® TC cannot be switched off during a run. After the run has finished, the device can be switched off by pressing the power button for a few seconds. NOTICE Before the device is switched off by the user, wait until the current run has ended. -
Page 42: Manual Cover Opening
Operating problems 11.6 Manual cover opening If the cover does not open after several attempts, it might be necessary to open it manually. For this purpose, a small hole was created on the bottom of the stainless steel case. Insert a small needle or similar and proceed as shown in the pictures below. -
Page 43: Error Reports And Warning Messages
Error reports and Warning messages 12 Error reports and Warning messages The following tables list error reports and warning messages which can appear in the operator control. Error message Remark All runs blocked (0) The source of this error is the cover unit. First try to reboot the device. If this does not solve the problem, try to manually open the cover. -
Page 44: Disposal
Disposal 13 Disposal 13.1 Information on Decontamination The device does not contain any hazardous materials that would necessitate special disposal measures. The cultures and media (e.g. acids, bases) used during the sealing process are potentially hazardous materials that could cause biological or chemical hazards. -
Page 45: Disposing Of Device And Parts
Disposal 13.3 Disposing of Device and Parts 13.3.1 Information on Disposal The device and the accessory must be disposed of properly by disposal facilities. A battery is installed inside the device. Batteries must be disposed of properly by disposal facilities. The packaging is made of environmentally friendly materials that can be used as secondary raw materials. -
Page 46: Technical Data
Technical data 14 Technical data 14.1 Device Type designation BioSealer ® Input voltage 24 VDC Supply current 6.25 A In and out connections Device plug XLR max. 24 VDC Ethernet jack type RJ45 Operating temperature +5°C - +40°C Place of use Indoor (Laboratory) Pollution degree Humidity... -
Page 47: Dimensions
Technical data 14.3 Dimensions ® Operating Manual BioSealer... -
Page 48: Appendix
Appendix 15 Appendix 15.1 Copyright C-Flex ® , SaniPure™ and PharMed ® are registered trademarks of Saint-Gobain Perfor- mance Plastics Corporation. Parts of the device are patented. No part of this device may be reproduced, distributed, translated or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or storing, in an information storage and retrieval system, without the prior written consent of Reed Electronics AG. - Page 49 Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen, Germany Phone: +49.551.308.0 www.sartorius.com The information and figures contained in these instructions correspond to the version date specified below. Sartorius reserves the right to make changes to the technology, features, specifications and design of the equipment without notice.
Need help?
Do you have a question about the BioSealer TC and is the answer not in the manual?
Questions and answers