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Toshiba TOSDIC-CIE DS Instruction Manual

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OIS-DS Part11 Package
Instruction Manual
6F8C1115

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Summary of Contents for Toshiba TOSDIC-CIE DS

  • Page 1 OIS-DS Part11 Package Instruction Manual 6F8C1115...
  • Page 2 Third Edition 21 February, 2014 The contents of this manual may be revised without notice.  Copyright 2004 – 2014 by Toshiba Corporation. All rights reserved. No part of this manual may be reproduced in any form without permission.

  • Page 3: Safety Precautions

    Safety Precautions Safety Precautions The instruction manual and the labels affixed to the products or equipment give important information for using products safely. It helps prevent damage to properties and hazard to people who use them or work with them. Make yourself familiar with the signal words and signs in this page, then read the safety precautions that follow and always follow the instructions to avoid hazards.
  • Page 4 Safety Precautions Caution While FDD lamp on the floppy disk drive is lit, data is  being recorded or read. • If the following are executed during this period, the content of the Operation prohibited while floppy disk may be destroyed: FDD lamp lights •...
  • Page 5 • To use this product in a system where equipment such as the one human safety is involved and affecting the maintenance of public function(Note 2), special consideration (Note 3) regarding the system’s operation, maintenance and control is required. Contact Toshiba’s sales department.
  • Page 6 • Toshiba is not liable for any incidental damage from use or non use of this product (loss of business profit, discontinuation of business, change or loss of the memorized content and so on).

  • Page 7: Introduction

    This package is a software product to apply FDA 21CFR Part11 standard on the monitor of TOSDIC-CIE DS system. This helps you to identify an operator by setting up an operator name and its password before logging on. It also enables you to electronically record and display the operator, data before/after the change and operational reason by means of the function of entering a reason for the setup operation and saving the history.
  • Page 8 Introduction  Organization of this manual This manual consists of the following contents. Chapter 1 Part11 Application Package This chapter describes the software organization, usage condition and functions of Part11 application package. Chapter 2 Operation of OIS This chapter describes the operation of OIS for which Part11 application package has been installed.

  • Page 9: Table Of Contents

    Contents Contents Safety Precautions Introduction 1. Part11 Application Package                                 1 Overview ...
  • Page 10 Contents viii...

  • Page 11: Part11 Application Package

    1. Part 11 Application Package 1. Part11 Application Package Overview Part 11 Application Package consists of the following software. (1) Part11 Engineering Tool This helps you set up information required for Part11 processing on OIS. (2) OIS Part11 package software This makes OIS available for Part11 processing.

  • Page 12: Composition

    1. Part 11 Application Package Composition Software Composition Part11 Application Package consists of the software listed in the Table 1.1. Table1.1 Package software Package Format Media Part 11 Engineering Tool SCP11TDA 1 CD OIS Part11 package software SCPHP1DA 1 CD Package Contents OIS Part11 application package includes the following contents.

  • Page 13: Part11 Engineering Tool

    1. Part 11 Application Package Part 11 Engineering Tool Set up information required for OIS Part11 processing using Part11 Engineering Tool. Set up conventional information using OIS-DS engineering tool. Reference: The system configuration, hardware and software specifications are the same as those of OIS-DS Engineering Tool.

  • Page 14: Function

    1. Part 11 Application Package Function Part11 Engineering Tool are classified by the registration function and the utility function. The registration function includes following information. • Control registration Register control information required for Part11 processing. (1) User Information for Part11 (2) Operator Information •...

  • Page 15: User Information For Part11

    1. Part 11 Application Package User Information for Part11 Enter Windows login users for Part11 processing. Figure 1.4 Entry of User Information for Part11 Enter the following information. (1) User’s name Enter the Windows login user set up by [Monitoring Function] - [User Group] of OIS-DS Engineering tool (Up to 20 characters).

  • Page 16: Operator Information

    1. Part 11 Application Package Operator Information Enter operable operator information in Part11 mode. Figure 1.5 Entry of Operator Information Enter the following information. (1) Operator’s name You can enter up to 50 operators (up to 20 characters). (2) Ope-mode Select an operation mode to login from “Operator/administrator/engineer”...

  • Page 17: Reason For Operations

    1. Part 11 Application Package Note: Only initial password is required for setup from Part11 Engineering Tool. Formal password change and administration is made by OIS. The following utility functions are not available in the “Initialize Password” information.  Import/Export ...

  • Page 18: Ois Part11 Package Software

    1. Part 11 Application Package OIS Part11 Package Software “OIS Part11 package software” may be installed to OIS-DS53, OIS-DS/LIGHT (OIS-DS63) or OIS-DS/SMART. OIS will be able to operate in Part 11 mode according to the setting of Part 11 Engineering Tool after installation.
  • Page 19 1. Part 11 Application Package <2> Select [Install] from action types and click [Next] button. An action confirmation message will be displayed. <3> Click [Yes] button to proceed. If the OS is not Windows2000 or later, an error message will be displayed. <4>...

  • Page 20: Operation Of Ois

    2. Operation of OIS 2. Operation of OIS Overview When you log in OIS with a registered “User Information for Part11”, it operates in Part11 mode. Part11 mode operates as follows. (1) The operating mode at OIS startup is lock mode (logoff status). (2) Change the operating mode to logon status for setup operation.

  • Page 21: Operating Mode Change

    2. Operation of OIS Operating Mode Change Change operating mode to logon status to perform setup operation. To change operating mode, press [OpeMode] button on the top of the OIS window. Figure 2.2 Set Operator - 1 (logoff status) Select a registered operator name from the list and enter the password. An effective password ranges from 4 to 14 characters.

  • Page 22: Initial Password Change

    2. Operation of OIS Initial Password Change When you have set up an initial password and downloaded it from the tool, enter the initial password. Then, the change request dialog will be displayed. Press [Change] button and change the password to the formal one (See “Change Password ” on the next page for the operation).

  • Page 23: Operation In Logon Status

    2. Operation of OIS Operation in Logon Status Press [OpeMode] button in logon status to display the operator setup dialog again. Then, the following operation will be available. Figure 2.6 Set Operator (logon status) (1) Operator change Select a new operator name and enter its password. Pressing [Log On] button turns to the operating mode specified for the new operator.

  • Page 24: Operational Reason Entry

    2. Operation of OIS Operational Reason Entry Enter an operational reason for the user that requires reason entry for the following operations. (1) Process tag parameter change (2) Parameter tag parameter change (3) Control mode change (4) SV operation/MV operation/AO operation (5) Operation execution (Operation output of press buttons) (6) Accumulated status operation (7) Timer operation/counter operation...
  • Page 25 2. Operation of OIS Figure 2.8 Operation Reason setup You can display the soft keyboard by pressing [KeyBoard]. Enter an operational reason in the operational reason input area. You can enter up to 256 characters including a line feed code. You can enter necessary information (words and sentences) in the cursor position from the operational reason selection list.

  • Page 26: Operation History

    2. Operation of OIS Operation History History Display Screen Operator names will be displayed in the operation history instead of users names. Operator names will be displayed in button when they have their operational reasons. Figure 2.9 Operation History in Part11 mode Pressing [Operator name] button displays the operational reason dialog.

  • Page 27: Password Entry Error Messages

    2. Operation of OIS Password Entry Error Messages Operating Mode Change (Logon) Operation (1) Initial password error When you have set up an initial password and downloaded it from the tool, enter the initial password. Inputted password does not match with the initial password.
  • Page 28 2. Operation of OIS (4) Password change prompt The message will be displayed when the password has been correctly entered but it is valid for 5 days or less. Press [Change] button to change the password before the expiration date. The period display changes as shown below, depending on the date and time you log on.

  • Page 29: Password Change Operation

    2. Operation of OIS Password Change Operation (1) Current password error When changing from the initial password request, the current password is set as initial password. After changing the password, enter the formal password. The current password does not match with the initial password or the formal password.

  • Page 30: Appendix 1. Guidance Messages

    Appendix 1. Guidance Messages Appendix 1. Guidance Messages Table A1.1 Error guidance for data setup Item Description Guidance New password and Confirm Password is unmatch. Again, Input New Password. Cause The initial password you entered does not match with the confirmation password.
  • Page 32 Social Infrastructure Systems Company Security & Automation Systems Division 72-34, Horikawa-Cho, Saiwai-Ku, Kawasaki 212-8585, Japan...

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