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CB-DOC Instruction Manual

Manual Version: 1.2 Date of Issue: 2011/06

© 2011 Siemens Healthcare Diagnostics Products GmbH. All rights reserved. Emil-von-Behring-Str. 76 35041 Marburg Germany

Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg Germany www.siemens.com/diagnostics

IDD and PP CB-Docs - Instruction Manual

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Introduction Note: This documents is valid only for products of Infectious Disease Diagnostics, Plasma Protein and Hemostasis.

This document describes how documents from PSOH are now organized in CB-DOCs. CB-DOC stands for Computer Based Documentation and is the new repository for all DX Service Documentation. CB-DOC is the publication medium of the Astoria CMS (Content Management System), which will be used in the future to create, store and distribute all service documentation content. The most important difference between PSOH and CB-DOCs is: • In PSOH the information is organized by manual types. • In CB-DOCs the information is organized by tasks or Info Classes. To find a document in a CB-DOC, the following has to be clarified: • What task is to be performed? Installation, Maintenance or Service? • Is this task related to the system or to a component? Note: The category System comprises all documents, which are relevant for the whole system (consisting of the analyzer, the supply unit (if applicable) and the System Software). A Component category comprises all documents, which are relevant for a certain peripheral (e.g., Monitor, Printer, PC. Also Software Tools and LIS are treated as components).

• What has to be done in detail? Troubleshooting, Configuration, Replacement of Parts etc.?

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IDD and PP CB-Docs - Instruction Manual

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Not migrated documents Since the CS intranet is strictly for service documentation, the following documents (containing customer information) have not been migrated to CB Docs: • Product Folder • MSDS • Application Sheets • CLSI Procedures • Connectivity Training (CA-7000Auto.) • Lot Data • Quick Reference Guide (BCS) • Customer Maintenance Logs They can still to be found in PSOH and recently also in the Document Library.

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Siemens Healthcare Diagnostics - GPS Documentation

IDD and PP CB-Docs – Instruction Manual – Version 1.0

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Documentation for Analyzers

PSOH

CB-DOC

1st level: System name

1st level: System name

2nd level: Manual type

3rd level: System/Component

4th level: Manual type

Analyzer Breakout

Function

System

Function description

Certificates

Function

Comp. Certificates

Function description

ECR

Updates

Comp. ECR

Update instructions

FAQ

Function

System

Function description

FCA

Updates

System/Component

Update instructions

Installation Guides

Installation

System/Component

Pre-Installation, Installation instruction, Installation and startup, Upgrade instruction, Software, Qualification Procedures, Tune Up, Report

Instrument Specifications

Function

System

Function description

Service Manuals (Hardware/Software)

Service

System

Adjustment

Circuit Diagrams

Service

System

Wiring diagrams

Data Interface Manuals

Installation

Comp. LIS

Software

Maintenance Manuals

Maintenance

System

Report

Tips and Tricks (Helpfile Service Guidebook)

System

Troubleshooting

Reference Manuals

Function

System

Function description

MacIntosh OS Specs

Installation

Comp. PC

Installation instruction

Maintenance Logs (PM Checklist)

Maintenance

System

Report

Part List

Service

System

Replacement of parts

Pre-installation Checklist

Installation

System

Pre-Installation

3 Table 1 Assignment of the manual types in PSOH to the Analyzer CB-DOC structure

IDD and PP CB-Docs - Instruction Manual

2nd level: Info class (task)

Manuals

3rd level: Manual subtype

CB-DOC

1st level: System name

1st level: System name

2nd level: Manual type

3rd level: Manual subtype

2nd level: Info class (task)

3rd level: System/Component

4th level: Manual type

Qualification Procedures

Installation

System

Quality Assurance

Research Use Only

Installation

Comp. Research Use Only

Software

Screen Simulator

Function

Comp. Screen Simulator

Function description

Service Settings Guide

Service

Component

Configuration

Software Documents

Installation

System

Software

Software Release Notes

Installation

System/Component

Software, Installation and startup

Function

Function description

Service

Report

IDD and PP CB-Docs – Instruction Manual – Version 1.0

STM for CA-7000 Specifications

Function

System

Function description

Support Bulletins (see Chapter 3.1 also)

Function, Installation, Maintenance, Service

System/Component

Different manual types

Sysmex Support Bulletin

Updates

Comp. Sysmex Support Update instructions Bulletin

Troubleshooting Guides

Service

System

Table 1 Assignment of the manual types in PSOH to the Analyzer CB-DOC structure (Continued)

Troubleshooting

IDD and PP CB-Docs - Instruction Manual

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PSOH

IDD and PP CB-Docs - Instruction Manual

3.1

Support Bulletins (SB) • SBs are also organized by tasks: If one attachment of a SB contains service content and another one contains installation content, they will be assigned to these different Info classes. • If a SB cannot be assigned with regard to content (as described above), it will be assigned to Updates. • In addition, all SBs are listed in a Linklist to all currently valid Support Bulletins, which can also be found under Updates. The links in this list open the respective documents. • Since in CB-DOCs the correlation between the title page of a SB and its attachments is not as clear as in PSOH, the title page of the SB is added to each attachment (if the attachment is a PDF). • If one or more attachments of a SB are no PDF, the title page is regarded as a document of its own and is - with regard to its content - assigned to an Info class. All non-PDF attachments are assigned to the same Info class.

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Documentation for reagents and consumables For the documentation for reagents and consumables there is an Application CB-DOC for PP and IDD. Table 2 shows the assignment of the manual types in PSOH to the Application CB-DOC structure. • MSDS and Product Folder have not been migrated (see Chapter 2). • As for the Analyzer CB-DOCs, a Linklist to all currently valid Support Bulletins is available under Updates.

PSOH

CB-DOC

Manual type

Info class

System/Component

FAQ

Function

FAQ

Application Sheets

Application Sheets

Calibrator Traceability

Calibrator Traceability

Method Performance Data

Method Performance Data

Open Channel Policy

Open Channel Policy

Support Bulletins

Updates

FCA

Support Bulletins FCA

Table 2 Assignment of the manual types in PSOH to the Application CB-DOC structure

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IDD and PP CB-Docs - Instruction Manual

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"Miscellaneous" Documentation • All documents which could be found in PSOH under Miscellaneous are assigned to the appropriate Analyzer CB-DOCs and their Info Classes. • RoHS-documents can be found in the appropriate Analyzer CB-DOCs under Function > Component RoHS.

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Siemens Healthcare Diagnostics - GPS Documentation