Medtronic POS12D0110 Installation Instructions

Paceart Optima System™
POS12D Version 1.11 Software Installation and Configuration Instructions
Installation Manual
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
CareLink™, Export™, Integrity™, Medtronic CareLink™, Paceart Optima™, Paceart™, SessionSync™

Contents

2 Paceart System Installation and Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Paceart System Installation and Configuration Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Components of the Paceart Optima System System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Paceart System configuration options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.4 Recommended Windows settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.5 Configuring Internet Information Services (IIS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.6 Installing the Paceart Optima System Database Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.7 Configuring the Windows Fax and Scan and the Message Queuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.8 Installing the Paceart Optima System Application Server, Messaging Service, and Data Transformation Engine . . . . . . . . . 15
2.9 Installing TLS Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.10 Installing the MSI Client . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.11 Installing Paceart Web . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.12 Installing the ClickOnce Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.13 Installing the Paceart Optima System Client on Citrix Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.14 Uninstalling Paceart Optima System Customizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
2.15 Uninstalling the Paceart Optima System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
2.16 Paceart System Database Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
2.17 Database Replication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3

1 Introduction to the Paceart Optima™ System

1.1 About the Paceart Optima™ System

The Paceart Optima System is a clinic management tool that organizes patient, device, and programmer information. It also provides access to trend analysis, aiding a physician or clinician in their daily workflow and management of patient and cardiac data. The Paceart System supports cardiac rhythm devices from most manufacturers.
The Paceart System:
• Stores programmed device parameters
• Summarizes patient data into concise reports
• Keeps a history of patient encounters
• Creates correspondence documents
• Schedules patient follow-up appointments
• Assists with records processing
• Assists in charge and billing management
• Offers integration with a hospital’s or clinic’s HL7-compatible system
• Provides task management to streamline clinic workflow
• Provides automatic import of data from pacemakers, programmers, and other storage media

1.2 Explanation of symbols

Consult instructions for use
Manufacturer
Lot number
Re-order number
Date of Manufacture
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product.
Storage temperature limit
Transit temperature limit
Humidity Limitation
Software
Model number
Manufactured in
Authorized Representative in the European Community

1.3 Indications

The Paceart Optima System is intended for use as a database to follow cardiac patients with or without cardiac implantable devices.

1.4 Precautions

Storage and installation – Ensure there is no condensed moisture on the Paceart System software USBs.
Paceart System software USBs must be stored within the following conditions:
Storage Environment
Temperature -20°C (-4°F) to +70°C (158°F) Relative Humidity 20% to 75%
4
System operation – Ensure that the system is not being used with other instruments that may result in misdiagnosis or other problems.
Ensure there is no condensed moisture on the Paceart System software USBs. The Paceart System software USBs must be operating in an environment within the following conditions:
Operating Environment
Temperature 0°C (32°F) to +65°C (149°F) Relative Humidity 20% to 75%
Additional precautions – Do not modify the original system in any way. This includes adding any software product. Ensure that all patient records are updated and permanently stored before turning the PC power off. Double-check the data before typing the data into the system.

1.5 Contraindications

No known contraindications.

1.6 Authorized users

Medtronic representatives provide the Paceart Optima System orientation and training materials at the time of the installation. All users should be familiar with the Paceart System documents, including the online help, before using the Paceart Optima System. The designated system administrator should also read the Paceart System documentation for information on using the Paceart Optima System software user interface for function and control.
An authorized person, preferably a physician, must verify the implantable device and electrode specifications entered into the database or modified in the database. An authorized person, preferably a physician, must verify the test results that are automatically entered into the database by the instrument. The data obtained from this device must be interpreted in conjunction with other clinical data and the results of other independent tests.

1.7 Technical Support

For technical support contact your local Medtronic office. In the US and Canada, Paceart Technical Services can be contacted via phone or email.
• Phone: 1-800-PACEART
• Email: paceart.support@medtronic.com
• Web: Visit the Paceart Community website at MedtronicAcademy.com/Paceart.
If you encounter a serious incident with the software, contact your Medtronic representative and the competent medical regulatory authority for your region or country.

1.8 Manuals supplied with your system

Electronic versions of Paceart Optima System manuals are supplied on the documentation USB supplied with your software. You can also download or request printed copies of these manuals from www.medtronic.com/manuals.
There are two manuals installed for use with the Paceart Optima System software, the Paceart Optima SystemSoftware Installation
and Configuration Instructions and the Paceart Optima System Software User Manual. The Paceart Optima System Software Installation and Configuration Instructions provide you with the information you need to install and configure your Paceart Optima System software. This includes optional configurations and optional software components. The Paceart Optima System Software User Manual provides you with information on how to use your Paceart Optima System software. Contact Medtronic if you find any
errors in these manuals.
All patient and clinical data displayed in Paceart Optima System software documentation are fictitious and for demonstration purposes only.

1.9 Accessing the online help

The online help provides additional information about the features and functionality of the Paceart Optima System.
There are 6 ways to access the online help.
• Clicking Help > Table of Contents to open the full online help, with search, table of contents, and other navigation features.
• Clicking Help > Help from the menu bar opens the appropriate help topic for where you are in the application.
• Clicking the Help button in a dialog box opens the appropriate help topic for the dialog box.
• In any add or edit dialog box, clicking the "?" and selecting an active field opens the field level help for that field.
5
• Pressing the F1 key while a field is selected opens the field level help for that field.
• Pressing the F1 key while no fields are selected opens the appropriate help topic for where you are in the application.
If your version of the Paceart System has been customized, you can view your customer build number by clicking Help > About.

2 Paceart System Installation and Configuration

2.1 Paceart System Installation and Configuration Introduction

The intent of this information is to help you as a system administrator prepare for an installation of the Paceart Optima System at your site. It will answer many of the questions you may have about how the Paceart Optima System can use your existing network infrastructure.
This manual describes each of the Paceart Optima System components and provides detailed instructions for installing them. This information will help you decide which Paceart System configuration is the best fit for your site by providing details on each type of configuration.

2.2 Components of the Paceart Optima System System

You can install different components of the Paceart Optima System depending on your configuration.
You must have administrative rights on the computer to install Paceart Optima System components. If you have User Account Control (UAC) turned on, UAC might notify you before changes are made to your computer that require administrator-level permission. In the User Account Control dialog box, click Yes to confirm and start the installation.
Ensure that you are installing the components on a supported operating system. For a list of supported operating systems for each component, see the Technical Requirements for Paceart Optima System document.
The Paceart Database Manager
The Mainspring Data Express Database Manager is a tool for performing the most common tasks of creating and managing your Mainspring databases. This tool makes it easy to complete advanced database administration tasks by using wizards.
Some of the tasks performed by the Mainspring Data Express Database Manager could also be performed through other database management software such as Microsoft®* SQL Server®* Management Studio.
The Application Server
The Application Server allows you to centralize security and maintenance in one location. Only one database needs updating if the database structure changes during a Mainspring upgrade.
The Client
The Paceart Optima System System client is how most users interact with the Mainspring. The client is the user interface for the Paceart Optima System System. You enter and view information in the Mainspring user interface. That information is then sent to the Mainspring database via the Application Server.
The client connects to the application server and the Mainspring database. In a standalone configuration, you can have the client, the application server, and the database all on one workstation. Or in a distributed system you can have multiple clients running on different workstations that all connect into an application server and a Mainspring database.
ClickOnce Server
The ClickOnce server is an optional Mainspring server configuration that enables Mainspring users to install and run the Paceart Optima System System by clicking a link in a Web page instead of running the installation on individual workstations. ClickOnce ensures that users are always running the latest version of the Mainspring by automatically downloading any updates from the Application Server each time users run the Mainspring.
Medtronic Mainspring Data Express
Mainspring Data Express is a comprehensive solution for your cardiac patients, bringing together device and patient data from the Paceart System, the Medtronic CareLink Network, the CareLink Programmer, the Boston Scientific LATITUDE®* Patient Management system, the Abbott Merlin.net®* Patient Care Network, your EHR System, and local network. For installation and configuration instructions, refer to the Medtronic Mainspring Data Express Connectivity Guide.
Paceart System Web Access
Paceart System Web Access is an optional add-on package for use with the Paceart System. Adding Paceart System Web Access to your Paceart System allows you to access Paceart System reports through an easy-to-use Web interface.
6
Paceart System Web Access can be configured to work on either an intranet or on the Internet. Depending onyour access requirements, you can restrict Paceart System Web Access availability to your internal intranet, or you can access your Paceart System reports from any Internet connection in the world.

2.3 Paceart System configuration options

The Paceart System can be configured in multiple ways to support the needs of each installation.
When deciding on the configuration most appropriate for your installation, you must take the following items into consideration:
• Number of data entry terminals needed
• Availability of a local area network (LAN) and support
• Availability of a wide area network (WAN) and support
• Need for multiple geographic locations
• Number of places and locations for report retrieval
• Need for remote, disconnected data access
Paceart Optima System is scalable and configurable, providing options to best suit your installation.
Standalone Configuration
The Paceart Optima System standalone configuration is the most basic Paceart Optima System configuration option. It involves a single workstation running the following software with no network connection required:
• Microsoft SQL Server
• The Paceart Optima Database Manager
• The Paceart Optima Application Server
• The Paceart Optima MSI Client
• Medtronic Mainspring Data Express (optional)
This configuration most likely does not need a full version of SQL Server; in most cases, an Express edition of SQL Server suffices. An example of when a full version of SQL Server would be required is when the database would need to store more than 4 GB of data.
While the standalone configuration is the most straight forward to install, it is not practical if you want to run the Paceart System on multiple workstations.
Network Configuration
Pros of network configuration:
• This configuration has a low degree of complexity. There is only one database to maintain and no replicationis needed.
• Centralized security and maintenance at the Application Server location, including a central repository forbackups.
• Only one database needs updating if the database structure changes during a Paceart System upgrade.
• All patient data is stored in one database and is accessible from any client workstation on the LAN or WAN.
Cons of network configuration:
• No local copy of data if LAN or WAN fails.
• Higher bandwidth requirements as individual client workstations are saving all data, including large encounterswith multiple episodes, EGMs, and ECG strips, across the LAN or WAN.
• If you are not using ClickOnce, client software upgrades must be upgraded across multiple client workstations simultaneously.
• Queries must contain extra criteria if client workstations only want to see local patients instead of all patientson the network.
While you can connect multiple instances of the Paceart System client to the same Paceart System Application Server, you must have a separate database for each instance of an Application Server. The following diagram shows a typical Paceart System network configuration including which components can be installed on the application server. The Application Server and SQL Server Database can be hosted on the same workstation.
7
Figure 1.
Network
Application Server
Required: Database Manager
Optional: Mainspring Data Express,
ClickOnce, Paceart Web
SQL Server
Database
Paceart
Workstation 1
Paceart
Workstation 2
Paceart
Workstation 3
Paceart
Workstation 4
If you implement a network configuration then you should routinely assess your IT network and software configurations to determine if there are any risks that could affect patients, users, or third parties. Whenever a change is introduced into the network, such as new equipment or software, you should assess the change to determine if any new risks have been introduced into the network that must be mitigated.
Multiple Database Configuration
This configuration is for clinic settings that run the Paceart System on multiple databases. For example, your clinic could have separate databases for arrhythmia and pacemaker patients or adult and pediatric patients. Your clinic could also want a separate database for testing purposes. If you want to connect to multiple databases from a Paceart System workstation, install a separate Application Server for each database.
Use the ClickOnce installation method to connect to multiple databases on a single client workstation. You can be logged in to only one instance of the Application Server and one database at a time from a workstation.
8
Database Replication
This configuration is for clinic settings that run the Paceart System on a single, distributed database. Using replication, you can distribute data to remote or mobile users over a local area network, dial-up connection, or the Internet. Replication also allows you to enhance application performance, physically separate data basedon how it is used, or distribute database processing across multiple servers. For example, your clinic could have users that want to use replication as a means of backup to an alternate computer.

2.4 Recommended Windows settings

Use the recommended Windows display resolution for the best view of the Paceart Optima System user interface.
The Paceart Optima System user interface is best viewed using text scaling of 100%.
If you are not viewing the Paceart Optima System user interface in a maximized window, some areas of the user interface may not be accessible if you reduce the window size below 1366 x 768 pixels.

2.5 Configuring Internet Information Services (IIS)

Internet Information Services (IIS) is a Web server application and set of feature extension modules created by Microsoft for use with Microsoft Windows. IIS must be configured before installing the Paceart System.
The version of IIS installed on your workstation varies depending on which Windows operating system your workstation is running. You must have administrative rights on the computer to configure IIS. There are unique instructions to configure IIS for each version of Windows.

2.5.1 Configuring Internet Information Services (IIS) for Windows Server 2012 and Windows Server 2012 R2

Before you install the Paceart System, configure Internet Information Services (IIS).
1. Open Server Manager. The Server Manager window is displayed.
2. In the Quick Start box on the dashboard, click Add roles and features.
3. On the Select installation type page, select Role-based or feature-based installation and click Next.
4. On the Select destination server page, choose Select a server from the server pool, then select the server name from the Server Pool list and click Next.
5. On the Select Server Roles page, select Application Server.
6. Click Next.
7. On the Select features page, select the following options and then click Next.
• Under .NET Framework 3.5 Features, select .NET Framework 3.5 and HTTP Activation.
• Under .NET Framework 4.5 Features, select .NET Framework 4.5 and all options for WCF Services.
• Under Windows Process Activation Service, select all options.
8. Click Next.
9. On the Select role services page, select the following role services for the Application Server:
.NET Framework 4.5
Web Server (IIS) Support
• Under Windows Process Activation Service Support, select HTTP Activation, Named Pipes Activation, and TCP
Activation.
Note: Accept any additional items that are suggested when you select the server role options.
10. Click Next.
11. On the Confirm installation selections page, click Install.
12. Click Close when the installation completes successfully.

2.5.2 Configuring Internet Information Services (IIS) for Windows Server 2016

Before you install the Paceart System, configure Internet Information Services (IIS).
1. Open Server Manager. The Server Manager window is displayed.
2. In the Quick Start box on the dashboard, click Add roles and features.
3. On the Select installation type page, select Role-based or feature-based installation and click Next.
4. On the Select destination server page, choose Select a server from the server pool, then select the server name from the Server Pool list and click Next.
5. On the Select server roles page, select Web Server (IIS).
9
Figure 2.
6. Click Next.
7. On the Select features page, select the following options and then click Next. Under .NET Framework 4.6 Features, select .NET Framework 4.6 and the following options for WCF Services.
HTTP Activation
Named Pipe Activation
Figure 3.
8. Click Next.
9. On the Confirm installation selections page, click Install.
10. Click Close when the installation completes successfully.

2.5.3 Configuring Internet Information Services (IIS) for Windows Server 2019

Before you install the Paceart System, configure Internet Information Services (IIS).
1. Open Server Manager. The Server Manager window is displayed.
2. In the Quick Start box on the dashboard, click Add roles and features.
3. On the Select installation type page, select Role-based or feature-based installation and click Next.
10
4. On the Select destination server page, choose Select a server from the server pool, then select the server name from the Server Pool list and click Next.
5. On the Select Server Roles page, select Web Server (IIS).
Figure 4.
6. Click Next.
7. On the Select features page, select the following options and then click Next. Under .NET Framework 4.7 Features, select .NET Framework 4.7 and the following options for WCF Services.
HTTP Activation
Named Pipe Activation
Figure 5.
8. Click Next.
9. On the Web Server Role (IIS) page, click Next.
10. On the Select role services page, click Next.
11. On the Confirm installation selections page, click Install.
12. Click Close when the installation completes successfully.
11

2.5.4 Configuring Internet Information Services (IIS) for Windows 8.1

Before you install the Paceart System, configure Internet Information Services (IIS). During this process, Windows may prompt you for a Windows setup disk.
1. Select Settings > Control Panel
2. Click Programs > Programs and Features
3. Click Turn Windows features on or off
4. On the Windows Features window, expand .NET Framework 4.5 Advanced Services > WCF Services and select HTTP
Activation and Named Pipe Activation. Figure 6.
5. Expand Internet Information Services > World Wide Web Services > Application Development Features and then select ASP.NET 3.5.
6. Click OK

2.5.5 Configuring Internet Information Services (IIS) for Windows 10

1. Open the Control Panel.
2. Click Programs > Programs and Features
3. Click Turn Windows features on or off
4. On the Windows Features window, expand .NET Framework 4.6 Advanced Services > WCF Services and select HTTP Activation and Named Pipe Activation.
12
Figure 7.
5. Expand Internet Information Services and select Web Management Tools.
6. Expand Internet Information Services > World Wide Web Services > Application Development Features and then select .NET Extensibility 4.6.
7. Click OK.

2.6 Installing the Paceart Optima System Database Manager

Install the Paceart Optima System Database Manager to control the creation, maintenance, and use of your Paceart System databases.
If you have a Paceart Optima System customization installed, uninstall it before installing a new version of the Paceart Optima System Database Manager software. For more information on uninstalling customizations, refer to Uninstalling Paceart Optima Customizations.
If you plan to use Database Manager for replication and publications, you must have a standard or full version of SQL Server installed on your system before installing Database Manager. Systems containing subscriptions to the publishing system can still use express versions of SQL Server, but only with like versions. For example, a system using SQL Server 2014 with Express Service Pack 1 can only subscribe to a publication hosted on SQL Server 2014 Standard Edition with Service Pack 1, not SQL Server 2012 Standard Edition. If you plan to use Database Manager to manage replication functionality, SQL Server Express or Standard 2014, 2016, or 2017 must be installed on the same system as Database Manager.
If the Database Manager installer does not detect a supported version of SQL Server installed on your system, you will be given the option to install a supported version of SQL Server Express. The version depends on your operating system. Also, you are given the option to install the SQL Server Management Objects for your SQL Server version.
1. Insert the Paceart System installation USB drive to start the installation wizard. If your workstation has the Autorun feature disabled, navigate to the USB and then double-click setup.exe.
2. If there are any prerequisites that must be installed they are displayed in a list. Select and then click Installfor each of the prerequisites. You may need to restart your computer depending on which prerequisites are installed.
3. On the License Agreement window, read the license terms, then click I accept the terms of the license agreement if you agree to the terms.
13
4. Click Next.
5. Click Next.
6. On the Paceart Installer Configuration window, select Database Manager and click Next. The Paceart Database Manager - Install Shield Wizard window is displayed.
7. Click Next.
8. If you have a supported version of SQL server installed, you will be asked to install the SQL Server Managements Objects for that version. If you don’t have a version supported version of SQL Server installed, you will be asked to install SQL Server Express. Click Install to install.
9. Select a destination folder. Click Change to change from the default location.
10. Click Next.
11. Click Install.
12. Click Finish to exit the Paceart System Database Manager installer.
Paceart Optima System Database Manager is installed on your computer.

2.7 Configuring the Windows Fax and Scan and the Message Queuing

Windows Fax and Scan and Message Queuing need to be configured before installing the Paceart System Messaging Service. Windows may prompt you for a Windows setup disk during this process.
1. Click Start.
2. Click Control Panel.
3. Double-click Add or Remove Programs.
4. Click Add/Remove Windows Components.
5. On the Windows Component Wizard window, check if the Windows Fax and Scan and Message Queuing check boxes are selected.
• If both check boxes are selected, Windows Fax and Scan and Message Queuing are already configured. Click Cancel and continue the Paceart System installation.
• If one or both of the check boxes are not selected, select them and click Next.
Figure 8.
Figure 9.
6. Click Finish.
Windows Fax and Scan and Message Queuing are configured on your computer.
14

2.8 Installing the Paceart Optima System Application Server, Messaging Service, and Data Transformation Engine

Install the Paceart Optima System Application Server to centralize security and maintenance for the Paceart System in one location. The Messaging Service is used by the Paceart System to send email, fax, and pager messages. The Data Transformation Engine is used to transform data from various device data formats into Paceart XML format.
If you have a Paceart Optima System customization installed, uninstall it before installing a new version of the Paceart Optima System Application Server software. For more information on uninstalling customizations, refer to Uninstalling Paceart Optima Customizations.
You must also have the following features installed and configured before installing the Application Server.
• Windows Installer 4.5
• .Net Framework version 4.8
• Internet Information Services (IIS) 8.0 or greater
• Visual C++ 2015 Redistributable
1. Insert the Paceart System installation USB drive to start the installation wizard. If your workstation has the Autorun feature disabled, navigate to the USB and then double-click setup.exe.
2. If there are any prerequisites that must be installed they are displayed in a list. Select and then click Install for each of the prerequisites. You may need to restart your computer depending on which prerequisites are installed.
3. On the License Agreement window, read the license terms, then selectI accept the terms of the license agreement if you agree to the terms.
4. Click Next. The Paceart Installer - InstallShield Wizard opens.
5. On the Paceart Installer Configuration window, select Application Server and click Next. The Paceart Application Server wizard opens.
6. Click Next.
7. Select a destination folder. Click Change to change from the default location.
Figure 10.
8. Click Next.
9. Select the database server you are installing to.
15
Loading...
+ 35 hidden pages