FORUM Archive and Viewer Sw ver 3.2 Instructions for Use Aug 2013

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FORUM Instructions for Use Software version 3.2 [G-30-1724-en, Version 5.1, 05.08.2013]

Release Notes for FORUM Software version 3.2 [RN-30-9026-en, Version 5.0]

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^ééÉåÇáñ Briefing Report for FORUM [G-30-1737-en, Issue 2.2, 04/2012]

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FORUM Instructions for Use Software version 3.2 [G-30-1724-en, Version 5.1, 05.08.2013]

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FORUM Software version 3.2 FORUM® Archive FORUM® Archive & Viewer

Instructions for Use

G-30-1724-en Version 5.1 05.08.2013

About these Instructions

These Instructions for Use form part of the delivery package. •

Please read carefully before using the product.

•

Keep them at the same location as the software.

•

Retain them throughout the service life of the software.

•

Pass them on to any subsequent owner or user of the software.

The example patient data shown is fictitious. Any similarity to living persons is therefore purely coincidental. Guidance

Scope

Information about the manufacturer

–

The list of chapters at the beginning of the instructions for use provides an overview of all topics.

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You will also find a detailed table of contents at the beginning of each chapter.

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The index at the end helps you find specific terms.

These Instructions for Use apply to FORUM Archive and FORUM Archive & Viewer, Version 3.2. Carl Zeiss Meditec AG Göschwitzer Str. 51-52 07745 Jena Germany

E-Mail: [email protected] Internet: www.meditec.zeiss.com

Subject to change in design and scope of delivery and as a result of ongoing technical development. Printed in Germany. © Carl Zeiss Meditec AG 2013

FORUM

Chapter overview

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Introduction

7

Symbols

8

Definition of terms

9

Trademark notices

9

CE conformity

9

Software description

10

Product variants

14

Safety measures

17

Hazard symbols in these Instructions for Use

18

Security measures for IT systems and networks

18

Data protection and information security

19

Connection to data networks

20

Notes on the hardware platform

20

Usage information

21

Calibrated recording devices and monitors

22

Limitations of the archiving system

23

Intended Use / Indications for Use

23

Contraindication

23

Normal Use

24

Software installation

25

General notes

26

Hardware and software configuration

26

License files

29

Installing the FORUM client application

34

Teleservice software

42

Uninstalling the FORUM client application

43

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FORUM

Page 4

Basic configuration

45

Starting the FORUM client application

46

Setting the language

48

Creating a new user

49

Changing the password of the default user

51

Connecting FORUM with other systems

52

First steps

59

Starting FORUM

60

Creating a patient

62

Scheduling procedures

65

Viewing results

67

Stopping work

73

Managing data

75

Patient Directory

76

Worklist

84

Patient Administration

94

Extended Search

107

Remote Data

109

Importing documents

116

Importing patient data records ("DICOM Import")

119

Combined reports

121

FORUM Glaucoma Workplace

124

Viewing and editing documents

125

Preview window

126

Document Display

134

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FORUM

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System configuration

165

User Administration

166

Storage Locations

175

AET Administration

178

Forward documents

185

Messages

190

Procedure codes

193

Show icons for particular data types (e.g. OCT Scans)

196

Rights administration for Workplaces

196

Configuration Administration

197

Configuring the Patient ID

198

Accession No. configuration

200

HIS Interface Configuration

201

EMR Interface Configuration

202

Utilities

205

General Information

206

TrayIcon

207

Starting/stopping the FORUM server

210

Service Tool

213

General Information

214

Setting the language

215

Data backup

216

Tools

225

Settings

230

Help

234

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FORUM

Page 6

Troubleshooting

235

General information

236

Malfunctions

237

Error messages

241

Menu structure

243

Application

244

Patient

244

System

245

Help

246

Other shortcuts

247

Index of technical terms

249

Index

253

Clinical Displays: Parameter assignment for document types

261

Backing up the FORUM database during continuous operation

265

Backup

266

Restoring

277

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FORUM

Introduction

Introduction Symbols ... 8 Definition of terms... 9 Trademark notices ... 9 CE conformity ... 9 Software description... 10 General ... 10 Overview of functions ... 11 Interfaces ... 13 Additional accessories ... 14 Product variants... 14

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Introduction

FORUM

Symbols The following information symbols are used in these Instructions for Use: –

Listing

 Prerequisites for an action •

Prompt for action

 Result of an action  The term following this symbol is explained in the list of technical terms (page 249) Additional information and tips.

Functions which are only provided by the "FORUM Archive & Viewer" product variant and require additional licensing are shown by a bar: FORUM Archive & Viewer Option

The product variant required for the respective function is highlighted (blue typeface on a white background). If a described function requires additional license, the "Option" field is also highlighted.

The following symbols are used on the DVD label: Please follow the instructions for use.

Manufacturing date

Manufacturer

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FORUM

Introduction

Definition of terms The following term is used in these Instructions for Use with the meaning given here: –

Plug-in: A plug-in is an optional software application for FORUM.

Trademark notices The following trademarks are used in these Instructions for Use: –

"VMware" is a registered trademark or brandname of VMware, Inc. in the USA and/or other countries.

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"Windows" is a registered trademark or a brandname of the Microsoft Corporation in the USA and/or other countries.

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iPad®, Mac® and Macintosh® are registered trademarks of Apple Inc. in the USA and other countries.

CE conformity The product meets the essential requirements stipulated in Annex I of the 93/42/EEC Directive governing medical devices. The product is marked with: 0297

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Introduction

FORUM

Software description General FORUM is software for managing and archiving patient data, particularly in the fields of ophthalmology and neurosurgery. FORUM enables you to archive patient master data and data relating to a patient, e.g. images, videos, reports and raw data. FORUM features an excellent document viewer that enables comprehensive viewing of stored documents. FORUM offers a clinically relevant display of the data. Different documents, and also several Modality(ies) can be flexibly arranged side by side and so easily compared with each other. FORUM enables users connected to the FORUM server via a local network to access and view stored data from any computer via a FORUM client application. Patient master data can be synchronized between FORUM and connected examination devices or applications to achieve a unified database. Furthermore, FORUM supports the workflow in practices and clinics. FORUM enables you to centrally schedule patient examinations and forward these to connected devices as orders. The examination data together with the patient master data can be called up on the respective devices, so no patient master data needs to be entered and all the required information on the examination to be performed is available. Once the examination results are transmitted they are automatically imported and assigned to the patient by FORUM. This provides immediate access to all diagnostic data for all users. FORUM manages DICOM files. A DICOM file contains both image data and patient master data, e.g., name, date of birth, etc. FORUM reads the patient master data in from the DICOM files and saves this, along with a reference to the image data ("Documents") in the FORUM database. The complete DICOM files are saved to the active storage location in the file system. FORUM works with all devices and software products that support the DICOM standard and are compatible with FORUM in compliance with our DICOM Conformance Statement. FORUM can be used as the primary image and report management system, but can also be integrated into an existing system via interfaces. Patient master data is then imported by the primary system.

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FORUM

Introduction

Overview of functions FORUM offers the following functions (depending on product variant or installed additional licenses):

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User Administration: an unlimited number of users can be configured. The number of users that can access the FORUM database at the same time is limited by the product variant and number of installed user licenses.

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There is the option of connection with other systems (ZEISS devices and third party devices) that support the DICOM standard. The number of configurable systems and their type is set by the product variant and additional licenses installed. AutoConnect™ configuration: Devices supporting this function are automatically connected to FORUM.

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"MultiSiteQuery": option to access other FORUM systems on the local network. This function can be used to load or import data and preview images from other FORUM systems on the local network.

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Patient Administration: processing of patient master data and organizing stored documents.

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Patient Directory: patient list with preview window for all documents stored for the patient.

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Document Display: comprehensive functions for displaying or comparing documents such as test findings (e.g. "Clinical Displays", see page 145).

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Order Management: option for creating examination orders, sending these to connected systems and re-importing the results (DICOM Modality Worklist). Devices can be defined as "Modality Worklist User" for the creation of standard orders.

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Automatic forwarding of documents: option for automatic forwarding to connected devices or software products of DICOM files incoming to FORUM (immediate forwarding). Forwarding can also be time-controlled.

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Saving image and report data and video data.

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Import: option to import DICOM data from connected systems and assign this to a patient.

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Introduction

FORUM

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Combined reports: option to create combined reports from individual reports stored in FORUM.

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Accession No.: option to change the accession number.

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Measurements: option to perform simple measurements1 in fundus images.

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Comments: the option to add comments to documents.

1) Measurements performed in FORUM are based on the scaling information made available from the DICOM Header of the corresponding fundus image.

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FORUM

Introduction

Interfaces FORUM enables you to exchange patient data, medical image data, raw data, videos and reports between devices that support the "DICOM PS 3-2011" standard. FORUM conforms to DICOM in accordance with our DICOM Conformance Statements. The DICOM Conformance Statement is available on request. The following interfaces are provided: –

DICOM interface to connected devices and software products (see page 178)

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DICOM import (see page 119)

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Document import (see page 116)

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HL7 interface for HL7 patients and order management (see page 233)

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HIS interface for the use of FORUM connected to a patient management system (see page 201)

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EMR interface for the use of FORUM connected to an EMR system (see page 202) If a license for this interface is installed, maximum storage space for DICOM data can be limited to 100 MB. Data storage is in accordance with FIFO principle.

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Opening the FORUM client application from an EMR system

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Opening the review software from FORUM Viewer (see page 128)

Using an Ethernet interface a PC on which the FORUM software is installed can be integrated into the hospital or practice network and can thus be networked with other DICOM-compliant devices and HIS/EMR systems.

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Introduction

FORUM

Additional accessories The following optional software applications are available for FORUM: –

FORUM ASSIST match: for software-based comparison of data sets for large FORUM databases.

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FORUM Glaucoma Workplace: for software-based analysis and display of glaucoma data based on data available in FORUM regarding field of view.

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FORUM Viewer App: for mobile access to the FORUM database (on an iPad). Documents stored in FORUM can be called up on the iPad for viewing.

These FORUM software applications are offered separately and have their own Instructions for Use.

Product variants FORUM is available in two product variants:

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FORUM Archive (incl. Archive Manager as client application) This product variant is appropriate when FORUM is primarily used for archiving data and/or as a central database for two or more ZEISS devices.

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FORUM Archive & Viewer (incl. FORUM Viewer as client application) This product variant can be extended for all additional licenses and all accessories. The central element is the FORUM Viewer with its comprehensive options for viewing and comparing documents. There are two basic licenses for the FORUM Archive & Viewer product variant: The first basic license is intended as a starter pack, by which the number of simultaneous users and number of configurable ZEISS devices is always limited to three. For the second basic license the number of simultaneous users and configurable devices is dependent only upon the number of relevant optional licenses for users and device connections. The constraints on the first basic license can also be lifted using an upgrade license, allowing it to behave in the same way as the second basic license.

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FORUM

Introduction

Both the functionality and extension capability of FORUM Archive and FORUM Archive & Viewer differ. The table below shows which functions are included in which product variant and which are optional, and what interfaces and additional accessories can be added to each variant. Explanation of symbols:  = included  = optionally included –

= not available FORUM Archive

FORUM Archive & Viewer

One user





More than one user simultaneously (max. 50)

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a)

One ZEISS device

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

Two ZEISS devices



Additional ZEISS devices



a)

Third party devices

–

a)

MultiSiteQuery (FORUM systems)

–



Patient Administration





Patient Directory

–



Immediate





Timed





Videos up to 10 minutes long





Videos of unlimited length

–



–



Functions Access to the FORUM database:

Connection to systems:

Automatic forwarding of documents:

Saving image and report data and video data:

Document Display a) Only possible for the second basic license.

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Introduction

FORUM

FORUM Archive

FORUM Archive & Viewer

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

From ZEISS devices

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

From third party devices

–



Generation of combined reports

–



Accession No. configuration

–



Measurements on fundus images

–



Comments

–



EMR interface





HIS-interface for the use of FORUM connected to a patient management system





HL7-patient administration





HL7 order management

–



FORUM ASSIST match





FORUM Glaucoma Workplace

–



FORUM Viewer App

–



Order management Import (DICOM data):

Interfaces

Additional accessories

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FORUM

Safety measures

Safety measures Hazard symbols in these Instructions for Use ... 18 Security measures for IT systems and networks... 18 Data protection and information security ... 19 Connection to data networks ... 20 Notes on the hardware platform ... 20 Usage information ... 21 Calibrated recording devices and monitors ... 22 Limitations of the archiving system ... 23 Intended Use / Indications for Use ... 23 Contraindication ... 23 Normal Use ... 24

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