How To Run A Pacemar Optima System On A Microsoft Powerbook 2.5 (Powerbook) With A Powerbook 1.5 And Powerbook 3.5 On A Pc Or Macbook 2 (Powerstation) With An

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Paceart Optima

®

System

TECHNICAL REqUIREMENTS

Workstation/Client Requirements Hardware (minimum)

Processor Intel® Pentium® Core™ 2 Duo CPU 2.40 GHz System Memory 4GB RAM

HDD Free Space 15GB

Data Input Connector Universal Serial Bus (USB) 2.0

Software

Operating System Client Configuration (No ECG Recording)

• Microsoft® Windows® 7 Professional Edition SP1 (32-bit) • Microsoft Windows 7 Professional Edition SP1 (64-bit)

Client Configuration with ECG Recording

• Microsoft Windows 7 Professional Edition SP1 (32-bit) Microsoft Components • Microsoft .NET Framework 3.5 SP1

• Windows Installer 4.5

Additional items required to use certain features

In-Clinic Surface ECGs • Isolation Transformer (contact Paceart Technical Support for isolation transformer specifications)

• Paceart ECG Module

Programmer Import • Universal Serial Bus (USB) port

• 3.5” floppy disk drive (contact your device clinic to determine what transport method their device programmers support)

TTM Acquisition • Paceart ECG Module • Analog or PBX phone line

Application Server Requirements Hardware (recommended minimum)

Processor Intel Pentium Core 2 Duo CPU 2.40 GHz System Memory 8GB RAM*

HDD Free Space 20GB**

Software

Operating System Server Configuration (Including Mainspring® Data Express)

• Microsoft Windows 7 Professional Edition SP1 (32-bit) • Microsoft Windows 7 Professional Edition SP1 (64-bit)

• Microsoft Windows Server® 2003 R2 Standard Edition SP2 (32-bit) • Microsoft Windows Server 2003 R2 Standard Edition SP2 (64-bit) • Microsoft Windows Server 2008 Standard Edition SP2 (32-bit) • Microsoft Windows Server 2008 Standard Edition SP2 (64-bit) • Microsoft Windows Server 2008 R2 Standard Edition SP1 (64-bit)

This document details the hardware and software requirements for the Paceart Optima System. Performance of the Paceart® System may be impacted if these requirements are not met. Technical requirements may vary depending on your system configuration (see below for distributed and stand-alone configurations). Please contact Paceart Technical Support at 1 (800) PACEART (United States and Canada) or your local representative for additional information.

Paceart Optima System Configuration #1: Distributed Model (no HL7®)

Multiple workstations connecting to a central database – Medtronic Mainspring® Data Express

installed not using HL7

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Microsoft Components • Microsoft .NET Framework 3.5 SP1 • Microsoft Core XML Services (MSXML) 4.0 SP2 • Windows Installer 4.5 • Microsoft Core XML Services (MSXML) 6.0 • Microsoft Message Queue component

• Microsoft IIS as specified in following table: Operating System IIS Version

Microsoft Windows 7 Professional Edition 7.5

Microsoft Windows Server 2003 R2 Standard Edition SP 2 6.0 Microsoft Windows Server 2008 Standard Edition SP 2 7.0 Microsoft Windows Server 2008 R2 Standard Edition SP 1 7.5

Email, Faxing, and Paging • Microsoft Windows Fax Services component • 56 KB Fax Modem

• Connectivity to a Simple Mail Transfer Protocol (SMTP) email server

Connectivity • Network connectivity to Remote Systems (e.g., Medtronic CareLink® Network)

Paceart Database Server Requirements

When installed on either the Application Server or Database Server the following requirements are needed in addition to the respective minimums.

HDD Free Space 5GB

Software

Operating System • Microsoft Windows 7 Professional Edition (64-bit) Microsoft Components Microsoft Windows PowerShell® 2.0

Microsoft SqL Server® from the following list:

• Microsoft SQL Server 2005 Express Edition SP4 (4GB max file size) • Microsoft SQL Server 2005 Standard Edition SP4

• Microsoft SQL Server 2008 R2 Express Edition SP1 (10GB max file size) • Microsoft SQL Server 2008 R2 Standard Edition SP1

• MS SQL Server Command Line Utilities • MS SQL Server Remote Management Objects • MS SQL Server Shared Management Objects • MS SQL Server System CLR Types

• MS SQL Server Native Client

Database Server Requirements Hardware (minimum)

Processor Intel Pentium Core 2 Duo 2.40 GHz System Memory 4GB RAM

Software

Operating System • Microsoft Windows 7 Professional Edition SP1 (32-bit) • Microsoft Windows 7 Professional Edition SP1 (64-bit)

• Microsoft Windows Server 2003 R2 Standard Edition SP 2 (32-bit) • Microsoft Windows Server 2003 R2 Standard Edition SP 2 (64-bit) • Microsoft Windows Server 2008 Standard Edition SP 2 (32-bit) • Microsoft Windows Server 2008 Standard Edition SP 2 (64-bit) • Microsoft Windows Server 2008 R2 Standard Edition SP1 (64-bit) Microsoft Components Microsoft SqL Server from the following list:

* See Memory Sizing For Application Server on Page 6 for more information.

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Processor Intel Pentium Core 2 Duo CPU 2.40 GHz System Memory 4GB RAM

HDD Free Space 15GB

Software

Operating System Client Configuration (No ECG Recording)

• Microsoft Windows 7 Professional Edition SP1 (32-bit) Microsoft Components • Microsoft .NET Framework 3.5 SP1

• Windows Installer 4.5

In-Clinic Surface ECGs • Isolation Transformer (contact Paceart Technical Support for isolation transformer specifications) • Paceart ECG Module

Programmer Import • Universal Serial Bus (USB) port • 3.5” floppy disk drive (contact your device clinic to determine what transport method their device programmers support)

Application Server Requirements Hardware (recommended minimum)

Processor Intel Pentium Core i3 CPU 2.40 GHz System Memory 8GB RAM*

Software

Operating System Server Configuration (Including Mainspring Data Express) • Microsoft Windows 7 Professional Edition SP1 (32-bit) • Microsoft Windows 7 Professional Edition SP1 (64-bit)

• Microsoft Windows Server 2003 R2 Standard Edition SP2 (32-bit) • Microsoft Windows Server 2003 R2 Standard Edition SP2 (64-bit) • Microsoft Windows Server 2008 Standard Edition SP2 (32-bit) • Microsoft Windows Server 2008 Standard Edition SP2 (64-bit) • Microsoft Windows Server 2008 R2 Standard Edition SP1 (64-bit)

Email, Faxing, and Paging • Microsoft Windows Fax Services component • 56 KB Fax Modem

• Connectivity to a Simple Mail Transfer Protocol (SMTP) email server Connectivity • Network connectivity to Remote Systems (e.g., CareLink® Network)

• Network connectivity to HL7 integrated system

Paceart Optima System Configuration #2: Distributed Model with HL7

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Paceart Database Manager Requirements

When installed on either the Application Server or Database Server the following requirements are needed in addition to the respective minimums.

HDD Free Space 5GB

Software

Operating System • Microsoft Windows 7 Professional Edition SP1 (64-bit) Microsoft Components Microsoft PowerShell 2.0

Microsoft SqL Server® from the following list:

• MS SQL Server Command Line Utilities • MS SQL Server Remote Management Objects • MS SQL Server Shared Management Objects • MS SQL Server System CLR Types • MS SQL Server Native Client

Database Server Requirements Hardware (minimum)

Processor Intel Pentium Core 2 Duo 2.40 GHz System Memory 4GB RAM*

Software

Operating System • Microsoft Windows 7 Professional Edition SP1 (32-bit) • Microsoft Windows 7 Professional Edition SP1 (64-bit)

• Microsoft Windows Server 2003 R2 Standard Edition SP2 (32-bit) • Microsoft Windows Server 2003 R2 Standard Edition SP2 (64-bit) • Microsoft Windows Server 2008 Standard Edition SP2 (32-bit) • Microsoft Windows Server 2008 Standard Edition SP2 (64-bit) • Microsoft Windows Server 2008 R2 Standard Edition SP1 (64-bit) Microsoft Components Microsoft SqL Server from the following list:

* See Memory Sizing For Application Server on Page 6 for more information.

** The amount of disk space needed will vary based on the amount of data that is kept and how much is added each month.

Processor Intel Pentium Core 2 Duo CPU 2.40 GHz System Memory 8GB RAM**

HDD Free Space 80GB***

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Processor Intel Pentium Core 2 Duo CPU 2.40 GHz System Memory 4GB RAM

HDD Free Space 15GB

Software

Operating System • Microsoft Windows 7 Professional Edition SP1 (32-bit)

Microsoft Components • Microsoft .NET Framework 3.5 SP1 • Windows Installer 4.5 • Eurovoice Objects 3.0

CardioVoice TTM Assistant Hardware • Intel Dialogic Voice Board (uses PCI Slot) • Analog phone line

Browser Support

• Microsoft Internet Explorer® 7 and above • Mozilla Firefox® 3.0 and above

• Adobe® Acrobat® browser plug-in for report viewing

CardioVoice® TTM

Paceart Optima Web Access Module

Workstation/Client Requirements (continued) Software

Operating System Client Configuration (No ECG Recording) (Including Mainspring Data Express)

• Microsoft Windows 7 Professional Edition SP1 (32-bit)

In-Clinic Surface ECGs • Isolation Transformer (contact Paceart Technical Support for isolation transformer specifications) • Paceart ECG Module

Programmer Import • Universal Serial Bus (USB) port • 3.5” floppy disk drive (contact your device clinic to determine what transport method their device programmers support)

* Mainspring Data Express with HL7 interface must be installed on an application server. ** See Memory Sizing For Application Server on Page 6 for more information.

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Network Recommendation

Replication over Wide Area Network (WAN)

Connection Bandwidth of 384 kbps or greater* Paceart Client Local Area Network (LAN)

Connection Bandwidth of 100 mbps or greater Paceart Application Server Local Area

Network (LAN) Connection Bandwidth of 100 mbps or greater Paceart Database Server Local Area Network

(LAN) Connection Bandwidth of 100 mbps or greater

Printer Requirements

Printable Area • 7.75” X 10.5” with 0.25” margins Supported Paper Size • 8.5” X 11”

• A4

* Bandwidth and amount of data will impact total replication time.

Virtual Environments

Workstation/Client, Application Server, Database Server Requirements

VMware® ESX or VMware ESXi versions 4.1

VMware ESX or VMware ESXi versions 4.1 with Citrix® Presentation Server version 4.5 or XenApp 6

Memory Sizing For Application Server

When deciding on how much memory to configure on the Application Server, 4 GB of RAM is the absolute minimum. Add 1 Gig of RAM to the Application Server for each 2 concurrent users of the system. Each Mainspring interface (specifically SessionSync®, Remote Monitoring Interfaces, HL7 Inbound, HL7 Outbound, One-Stop Scheduling and Report Export) should be considered a user for this purpose.

CPU Sizing For Application Server

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Web Access Server

Click Once Server

In clinic software In clinic software Mainspring Data Express

Database Manager Dialogic Board

Telephone

Paceart Database Paceart Database

CardioVoice Service ECG Module Client Application Web Browser Database Manager Application Server Web Client Client Client Application Server Database Server St. Jude Medical Boston Scientif ic Medtronic Medtronic CareLink Programmer (SessionSync) EHR Merlin.net® LATITUDE® CareLink® Database Server (Replicated) Legend: PSTN Publicly Switched Telephone Network PBX Private Branch Exchange MLLP Minimum Layer Level Protocol

HTTP HyperText Transport Protocol

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Technical Support Access (United States and Canada)

Contact Paceart Technical Support at paceart.support@medtronic.com or 1 (800) PACEART

(United States and Canada).

Microsoft, Microsoft Windows, Microsoft Vista, and Microsoft Server are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.

Mozilla Firefox is a trademark or registered trademark of Sun Microsystems, Inc. in the United States and other countries, used under license. Intel and Pentium are trademarks of Intel Corporation in the United States and/or other countries.

VMware is a registered trademark or trademark of VMware, Inc. in the United States and/or other jurisdictions.

Citrix is a trademark of Citrix Systems, Inc. and/or one or more of its subsidiaries, and may be registered in the United States Patent and Trademark Office and in other countries.

LATITUDE is a trademark of Boston Scientific, Inc. Merlin.net is a trademark of St. Jude Medical, Inc.

Brief Statement Paceart® System

Intended Use: The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators. Contraindications: There are no known contraindications for the Paceart System. Precautions: See the Paceart Manuals for more detailed information regarding precautions and use of the system. For further information regarding Paceart, please call Medtronic at 1 (800) 722-3278 and/or consult Medtronic’s website at www.paceart.com.

Medtronic CareLink® Monitor/CareLink® Network

Intended Use: The CareLink Monitor and the CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability may be unavailable at times due to maintenance or updates. Contraindications: There are no known contraindications for the CareLink Monitor. Warnings and Precautions: The CareLink Monitor must only be used for interrogating compatible Medtronic implantable devices. The CareLink Monitor is intended for use within the prescribing country.

See the device manuals for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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www.medtronic.com

World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN USA 55432-5604 Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals)

Distributor

Medtronic of Canada Ltd.

99 Hereford Street Brampton, Ontario L6Y 0R3 Canada

Tel: 1 (800) 268-5346 Fax: (905) 460-3998

Medtronic Australasia Pty. Ltd.

97 Waterloo Road, PO Box 945 North Ryde NSW 1670 Australia

Tel: (61-2) 9857-9000 Fax: (61-2) 9878-5100

Medtronic, Inc. Cardiac Rhythm Disease Management

8200 Coral Sea Street NE Mounds View, MN 55112 USA 1 (800) PACEART