Medtronic PASCV Instructions for Use

PACEART®SYSTEM
Get Connected III Edition
Paceart System Administrator's Guide
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician (or properly licensed practitioner).
The names of actual companies and products mentioned herein may be the trademarks of their respective owners. The following are trademarks of Medtronic: Medtronic, and Paceart

Contents

Chapter 1: Introduction to the Paceart System................................9
Chapter 2: Preparing for Paceart.....................................................15
Paceart System Administrator's Guide | Contents | i
Explanation of symbols...........................................................................................................10
Purpose...................................................................................................................................10
Intended Audience..................................................................................................................10
Indications...............................................................................................................................10
Precautions.............................................................................................................................11
Contraindications....................................................................................................................12
Paceart authorized users........................................................................................................12
Technical Support...................................................................................................................13
Minimum requirements............................................................................................................16
Database................................................................................................................................16
Replication...................................................................................................................16
SQL Server licensing ...................................................................................................17
Determining Database Size..........................................................................................17
Data migration..............................................................................................................18
Security........................................................................................................................18
Network bandwidth requirements............................................................................................18
Example.......................................................................................................................19
Estimating transmission time........................................................................................19
Configurations.........................................................................................................................19
Stand-alone Paceart workstation/server.......................................................................20
Master SQL server only, single database.....................................................................20
Master SQL server only, multiple databases................................................................21
Master and local SQL servers, single database, full publication...................................22
Master and local SQL servers, single database, filtered publication............................23
Master and local SQL servers, multiple databases......................................................25
Local SQL servers only, multiple databases.................................................................26
Chapter 3: Paceart System Installation...........................................29
AutoRun window.....................................................................................................................30
Paceart System server installation..........................................................................................30
Installation requirements..............................................................................................30
Notes for users of Paceart System 16-bit software.......................................................30
Installing the Paceart System server............................................................................31
Paceart System client installation............................................................................................32
Installation requirements..............................................................................................32
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Notes for users of Paceart System 16-bit software.......................................................32
Installing the Paceart System Client.............................................................................32
Starting the Paceart System client for the first time......................................................32
Global configuration options overview.....................................................................................33
Accessing the Global configuration options.................................................................34
Creating a new global configuration.............................................................................34
Local configuration options overview......................................................................................38
Accessing the Local Configuration options window......................................................38
Paceart Device Update CD.....................................................................................................45
Starting the Paceart System Device Update.................................................................45
Troubleshooting.......................................................................................................................46
Progress bar moves backward during server installations............................................46
Select device window appears during client installation...............................................47
Windows logo testing warning appears........................................................................47
Chapter 4: Paceart Database Manager............................................49
Starting the Paceart Database Manager.................................................................................50
Creating your first Paceart System Database..........................................................................50
Sample data.................................................................................................................50
Publications.............................................................................................................................51
Setting up a new publication.........................................................................................52
Maintaining existing publications..................................................................................54
Subscriptions..........................................................................................................................55
Creating and configuring a new subscription................................................................55
Maintaining existing subscriptions................................................................................56
Bulk copy................................................................................................................................57
Performing a bulk copy.................................................................................................57
BCP export...................................................................................................................58
BCP import...................................................................................................................58
MDB import.............................................................................................................................58
Performing an MDB import...........................................................................................59
Script schema.........................................................................................................................60
Creating a script schema..............................................................................................60
Changing the compatibility level for a SQL Server 2008 database...............................60
Delete strips............................................................................................................................61
Deleting strips..............................................................................................................61
Rename database...................................................................................................................61
Renaming a database..................................................................................................61
Run script................................................................................................................................62
Delete patients........................................................................................................................62
Deleting patients..........................................................................................................62
Users.......................................................................................................................................63
Changing the compatibility level for a SQL Server 2008 database...............................63
Creating a new user.....................................................................................................63
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Maintaining existing users............................................................................................64
Roles.......................................................................................................................................65
Changing the compatibility level for a SQL Server 2008 database...............................65
Creating a new role......................................................................................................65
Maintaining roles..........................................................................................................66
Enable or disable auditing.......................................................................................................66
Enabling auditing..........................................................................................................66
Disabling auditing.........................................................................................................67
Tools.......................................................................................................................................67
Server Active Connections Management Window.......................................................68
Database Active Connections Management................................................................69
Command Line Interface.........................................................................................................69
Command Line Switches.............................................................................................69
Running the Paceart Database Manager from Command Line....................................71
Creating Shortcuts to the Paceart Database Manager............................................................71
Troubleshooting.......................................................................................................................71
Chapter 5: Database Replication.....................................................73
When to use replication...........................................................................................................74
Replication topologies.............................................................................................................74
Central publisher..........................................................................................................74
Publishing subscriber...................................................................................................75
Central subscriber........................................................................................................75
Replication security.................................................................................................................76
SQLServerAgent service..............................................................................................76
Publisher/distributor security........................................................................................76
Subscriber security.......................................................................................................77
Setting up replication....................................................................................................77
SQL server synchronization....................................................................................................79
Synchronization using the Paceart Database Manager................................................79
Synchronization with SQL Server Enterprise Manager.................................................80
Synchronization with Windows Synchronization Manager...........................................80
Getting subscriptions to appear in Windows Sychronization Manager.........................80
Performing on-demand synchronization.......................................................................80
Configuring sychronization on log on/log off.................................................................81
Configuring scheduled synchronization........................................................................81
Synchronization management and replication conflicts..........................................................82
Microsoft Replication Conflict Viewer...........................................................................82
Troubleshooting.......................................................................................................................83
Chapter 6: Paceart System Security and Privacy...........................85
Paceart System security..........................................................................................................86
Paceart Login Profile Manager.....................................................................................87
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Setting up Paceart System security..............................................................................89
Paceart System privacy...........................................................................................................90
Access and authorization control.................................................................................90
Audit control.................................................................................................................91
Entity Authentication.....................................................................................................92
Data authentication......................................................................................................93
Performing a batch print of reports for a given patient..................................................93
HL7 export and PHI......................................................................................................93
BCP data export and PHI.............................................................................................93
Chapter 7: Paceart System Maintenance........................................95
System backup.......................................................................................................................96
Backup software...........................................................................................................97
Backup hardware.........................................................................................................97
Backup media..............................................................................................................98
Paceart SQL Server backup VB script........................................................................100
MSSQLServer service backup...................................................................................101
SQL Server backup....................................................................................................102
Checking the backup integrity....................................................................................102
System recovery...................................................................................................................102
Paceart recovery script...............................................................................................103
SQL Server restore....................................................................................................104
Database maintenance planner............................................................................................104
Accessing the Database Maintenance Planner Wizard..............................................105
Updates to the Paceart System.............................................................................................105
Paceart System software update................................................................................105
Paceart database structure updates...........................................................................105
Structure revision update type....................................................................................105
No structure revision change update..........................................................................106
Decimal update..........................................................................................................106
Integer update upgrade process................................................................................107
Updating the structure revision level...........................................................................107
Paceart Customer-Specific Configurations (PCSC)..............................................................108
Applying Microsoft Service Packs/Updates and other updates.............................................108
Chapter 8: Device Data Import/Export from the Programmer.....109
Biotronik Programmer...........................................................................................................110
Serial cable import.....................................................................................................110
CD or memory card Import.........................................................................................111
Supported devices.....................................................................................................111
Troubleshooting and known issues ............................................................................112
ELA Programmer..................................................................................................................112
Performing an import using removable media (such as floppy disks).........................112
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Supported devices.....................................................................................................113
Troubleshooting and known issues ............................................................................113
Guidant Programmer.............................................................................................................113
Performing an import using removable media (such as floppy disks).........................113
Supported devices.....................................................................................................114
Troubleshooting and known issues ............................................................................114
Intermedics Programmer.......................................................................................................114
Hardware connections...............................................................................................114
Configuring the Programmer......................................................................................115
Performing an import..................................................................................................115
Supported devices.....................................................................................................116
Troubleshooting and known issues ............................................................................116
Medtronic Programmer.........................................................................................................116
Saving device data to a floppy disk............................................................................116
Saving device data using SessionSync......................................................................117
Supported devices.....................................................................................................117
Troubleshooting and known issues............................................................................117
Pacesetter Programmer........................................................................................................118
Hardware connections...............................................................................................118
Performing an import..................................................................................................119
Supported devices.....................................................................................................119
Troubleshooting and known issues ............................................................................119
St. Jude Medical Programmer...............................................................................................119
Saving device data to a floppy from the Programmer.................................................120
Performing an import using removable media (such as floppy disks).........................120
Serial cable import.....................................................................................................120
Supported devices.....................................................................................................121
Troubleshooting and known issues ............................................................................121
Data export from Paceart to the Programmer........................................................................121
Saving the programming information to disk from a patient's Follow-Ups folder.........121
Chapter 9: Paceart System Printing...............................................123
Report Queue server.............................................................................................................124
Running multiple Report Queue servers.....................................................................124
Configuring Paceart clients to use the Report Queue sever.......................................124
Configuring the Report Queue server.........................................................................125
Starting and stopping the Report Queue server.........................................................128
Report Queue Server Maintenance............................................................................128
Patient Carry card lamination................................................................................................130
Laminating patient carry cards...................................................................................130
Troubleshooting Printing........................................................................................................130
Chapter 10: Paceart Web Access...................................................133
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Architecture...........................................................................................................................134
Configurations.......................................................................................................................135
Common Server Configuration...................................................................................135
Multiple Server Configuration.....................................................................................136
Multiple Server Configuration with Multiple Report Queue Servers............................137
Configuration file: Custom.dat....................................................................................137
Installation..................................................................................................................141
Paceart Web Access security................................................................................................143
Secured Sockets Layer (SSL)....................................................................................143
Automatic redirection.................................................................................................144
Custom error handling................................................................................................144
Account administration...............................................................................................145
SQL Server login........................................................................................................146
Requesting passwords...............................................................................................146
Changing user passwords..........................................................................................147
Monitoring services and limiting access to reports.....................................................147
Chapter 11: CardioVoice TTM Assistant........................................149
Installation requirements.......................................................................................................150
CardioVoice Installation.........................................................................................................150
Installing a new 32-bit system.....................................................................................150
Upgrading from a 16-bit system to a 32-bit system.....................................................152
CardioVoice Account Management.......................................................................................154
Patient CardioVoice IDs..............................................................................................154
Physician CardioVoice IDs.........................................................................................155
CardioVoice Configuration Options.......................................................................................155
Opening the CardioVoice Configuration Options Window..........................................155
Options Tab................................................................................................................155
Fax Options Tab.........................................................................................................156
Prompts Tab...............................................................................................................156
Call Script Tab............................................................................................................157
External Notifications............................................................................................................158
Faxing........................................................................................................................158
Paging........................................................................................................................158
Emailing.....................................................................................................................158
Patient and Physician Voice Messages.................................................................................159
Troubleshooting CardioVoice................................................................................................161
Chapter 12: Paceart Gateway Services.........................................163
Installation requirements.......................................................................................................164
Paceart Gateway Services application..................................................................................164
Paceart System Database tab....................................................................................164
Remote Acquisition Service tab.................................................................................165
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Local Acquisition Service tab.....................................................................................167
Services Configuration options.............................................................................................169
Enabling the Remote Acquisition service...................................................................169
Enabling the Local Acquisition service.......................................................................169
Services log on...........................................................................................................169
Administrative maintenance..................................................................................................170
Windows Event Viewer...............................................................................................170
Configuring the Event Log file size.............................................................................170
Data Exchange Log Viewer...................................................................................................171
Accessing the Data Exchange Log Viewer.................................................................171
Search criteria............................................................................................................171
Buttons.......................................................................................................................171
Results.......................................................................................................................172
Troubleshooting.....................................................................................................................172
Configuring Windows Vista for SessionSync..............................................................172
Configuring the Windows firewall...............................................................................173
"Host not Found" error message................................................................................173
Configuring the proxy server......................................................................................174
Configuring the HTTP SSL service.............................................................................174
System lockup accompanied by an error dialog from virus checker program.............174
Chapter 13: Paceart Export Module...............................................175
Installation.............................................................................................................................176
Installing the Export Module.......................................................................................176
Configuration.........................................................................................................................176
Configuring the Export Module global options............................................................176
Event data export..................................................................................................................179
Exporting event data..................................................................................................179
Paceart XML Schema Definition (XSD).................................................................................179
Troubleshooting.....................................................................................................................180
Chapter 14: Paceart Satellite Services Client...............................181
Installing the Paceart Satellite Services client on the terminal server....................................182
Installing Terminal Services client on workstations................................................................182
Starting a Satellite Services Client session...........................................................................182
Running Satellite Services in Administrative Mode...............................................................182
Logging off sessions.............................................................................................................183
Purchasing Satellite Services licenses..................................................................................183
Appendix A: Appendix A: HIPAA....................................................185
Product use and technical features.......................................................................................186
Potential security exposures.................................................................................................186
Paceart System security features..........................................................................................187
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Important notes.....................................................................................................................190
Additional information...........................................................................................................190
Appendix B: Appendix B: Unassisted Update Guide...................191
Unassisted Update Guide.....................................................................................................192
Before you begin...................................................................................................................192
Synchronizing local data with the network database..................................................193
Backing up the Paceart System database..................................................................193
Checking the MDAC version information....................................................................193
Uninstalling Paceart Gateway Services......................................................................194
Deleting Publications from the Server and Subscriptions from Workstations.............194
Installing the Paceart System - Get Connected III Edition Software......................................194
Installing the documentation CD................................................................................195
Installing the Paceart System Database Manager software.......................................195
Updating the structure revision level...........................................................................195
Configuring replication on the publishing server.........................................................196
Configuring replication on the subscribing workstation(s)..........................................196
Installing the Paceart System Client...........................................................................196
Installing Paceart Customer-Specific Configuration software.....................................196
Installing the Paceart Gateway Services software......................................................197
Installing the Connected Systems Gateway...............................................................197
Installing the CardioVoice TTM Assistant...................................................................198
Installing the Export Module.......................................................................................199
Installing the Paceart Satellite Services client on the terminal server.........................199
Completing the update..........................................................................................................200
Chapter
1

Introduction to the Paceart System

Topics:
Explanation of symbols
Purpose
Intended Audience
Indications
Precautions
Contraindications
Paceart authorized users
Technical Support
The Paceart System is a clinic management tool that organizes patient, device, and programmer information and provides access to trend analysis, aiding a physician or clinician in their evaluation of a patient’s condition. The Paceart System supports cardiac rhythm devices from most manufacturers.
You’ll find the Paceart System adaptable. You can configure it to meet your present needs, adding new devices, patients or physicians. It works within the processes of varied clinical environments.
The Paceart System supports most cardiac rhythm devices from most manufacturers. So whatever device or programmer you’re looking at, you’ll see the information presented in a similar way.
The Paceart System:
• Stores programmed device parameters
• Summarizes patient session data into concise reports
• Keeps a history of patient device tests
• Offers TTM technologies, such as CardioVoice, designed to work with pacemaker transmitters and cardiac event recorders
• Creates correspondence documents
• Schedules patient follow-up appointments
• Speeds records processing
• Assists in charge and billing management
• Offers integration with your hospital's or clinic's HL7-compatible system
• Provides import of data from pacemakers, programmers, and other storage media
If you have any questions about the contents of this manual or need assistance with your Paceart System, contact Paceart Technical Support.
10 | Paceart System Administrator's Guide | Introduction to the Paceart System

Explanation of symbols

Consult instructions for use
Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive MDD 93/42/EEC.
For US audiences only
Authorized Representative in the European Community
Manufacturer
Lot number
Reorder number
Date of Manufacture

Purpose

This manual, the Paceart System Administrator's Guide, is intended as a companion to the Paceart System Online Help. This guide deals with the technical aspects of deploying, managing, maintaining, and administrating your Paceart System.

Intended Audience

The information contained in this manual is intended for:
• New or advanced Paceart users who are tasked with maintaining their Paceart System.
• Hospital and clinic information technology staff responsible for administering and maintaining a Paceart System at their hospital or clinic.
• Medtronic Paceart technical support staff.

Indications

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.
Paceart System Administrator's Guide | Introduction to the Paceart System | 11

Precautions

Storage and installation
• Avoid moisture or contact with water.
• Avoid excessive or extreme air pressure.
• Avoid vibration and mechanical shock while moving.
• Place on a level floor.
• Use AC power that corresponds in frequency, voltage, and allowable current capacity.
• Use the isolation transformer as the source of AC power during in-clinic follow-ups.
• Use a grounded 3-wire AC power plug.
• The outside of the Paceart Module can be cleaned with a clean, dry cloth.
• Use the isolation transformer as the source of AC power and plug it directly into a grounded wall outlet.
• Use a grounded 3-wire AC power cable to connect the PC to the isolation transformer.
• Ensure there is no condensed moisture on the Paceart software CD-ROMs.
• Paceart software CD-ROMs must be stored within the following conditions:
Storage Environment
-20°C to +50°CTemperature
5% to 90%Relative Humidity
System operation
Before system operation:
• Check that the system components are working properly.
• Check that the cords are connected to the system correctly.
• Ensure that the system is not being used with other instruments that may result in misdiagnosis or other problems.
• Check to be sure that there is no damage to the circuitry that connects directly to the patient.
• Ensure there is no condensed moisture on the Paceart software CD-ROMs.
• Paceart software CD-ROMs must be operating in an environment within the following conditions:
Operating Environment
-25°C to +70°CTemperature
10% to 95%Relative Humiditiy
During system operation:
• Maintain constant observation of the patient to ensure that significant events are detected immediately.
• The system can be switched off when necessary to ensure the patient's safety.
After system operation:
• The system and all the accessories should be carefully cleaned after use to prepare them for the next session.
Additional precautions
• Do not modify the original system in any way. This includes adding any software product.
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• The system and its components should undergo regular maintenance inspections.
• If the system is stored for a long period of time without use, make sure that the system is in perfect condition prior to operation.
• Use only ECG disposable electrodes in proper working condition.
• Use electrode gel or electrolytic pads to ensure that good electrode contact is obtained.
• Ensure that the proper lead colors are connected to the correct electrode sets.
• Do not use the equipment in an explosive atmosphere.
• Do not use liquid on top of the equipment.
• Ensure that all patient records are updated and permanently stored before turning the PC power off.
• Do not use the instrument in an environment with excessive temperature and humidity.
• Double-check the data before typing the data into the system.
• Call customer service or your biomedical department for service and repairs.
• Ensure that the report to be printed reflects the proper leads. The operatorselects which leads will be shown in the printed report.
• The operator should not touch the computer and patient simultaneously when the patient is connected to the ECG electrodes.
• ECG electrodes should not contact other conductive parts, including earth.
• The Paceart ECG module is not suitable for direct cardiac applications.
Transmission and transmitter settings
• The transmitter transmission speed must match the transmit speed setting in Paceart.
• The transmitter transmit format must match the transmit format setting in Paceart.
• Discrepancies between the transmission speed or the transmission format will result in incorrect measurements that may lead to incorrect ECG interpretations.
• The Date Given field must have a date that is the same or prior to the date the transmission is recorded.
• A patient may only have one active transmitter.
• The Paceart operator is responsible for setting the speed and format settings.
ECG noise
The following may cause noise affecting artificial pacemaker spikes:
• Pacemaker programmers
• Poor electrode contact
• Electrical interference due to grounding problems
Caution: Make sure that the PC used to record pacemaker clinic ECGs is connected to AC power using an isolation transformer and a grounded three-wire power cable.

Contraindications

No known contraindications.

Paceart authorized users

Medtronic representatives provide the Paceart System orientation and training materials at the time of the installation. All users should be familiar with the Paceart documents, including the online Help, before using
Paceart System Administrator's Guide | Introduction to the Paceart System | 13
the Paceart System. The designated system administrator should also read the Paceart System Administrator's Guide for information on using the Paceart 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.

Technical Support

For technical support contact your local Medtronic office. In the US and Canada, call 1-800-PACEART.
Chapter
2

Preparing for Paceart

Topics:
Minimum requirements
Database
Network bandwidth requirements
Configurations
The intent of this chapter is to help you as a system administrator prepare for an installation of the Paceart System at your site. It should answer many of the questions you may have about how the Paceart System can utilize your existing network infrastructure. This chapter should also help you decide the preparations you will need to make for deploying the Paceart System.
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Minimum requirements

For information regarding the minimum hardware and software requirements, refer to the Paceart System Technical Requirements document included with your software documentation.
Power Distribution
An isolation transformer is required on all Paceart Systems on which you will be performing in-clinic ECG acquisitions. If you are using a laptop computer, an isolation transformer is needed if the laptop or any device connected to the laptop is acquiring power from a wall outlet.
Connect the Paceart computer, printer, monitor, Paceart modules (if using the external AC power adapter), and any additional AC-powered equipment that you have connected to the Paceart computer directly to the isolation transformer.
Contact Paceart Technical Support if you need to purchase isolation transformers.

Database

Which version of SQL server?
The Paceart System uses a Microsoft SQL Server database for the storage of data. Paceart will run against any of the 32-bit editions of SQL Server 2000, 2005, and 2008. This includes the MSDE Edition of SQL Server 2000 and the Express editions of SQL Server 2005 and 2008, provided the conditions listed under Full editions vs. Express are met. SQL Express and MSDE cannot be used as publishers in a replicated environment.
Full editions vs. Express
The express editions are a limited version of SQL Server. They are limited to 4 GB of data storage and are optimized for a low number of concurrent users. Because of these limitations, the Paceart System restricts the scenarios where Express editions can be deployed with the Paceart System.
If you meet all three of the following conditions, the Paceart System allows you to use an Express edition:
• You will store less than 4 GB of data.
• You will have no more than two client workstations.
• You will not be performing replication.
If you exceed any of the above conditions, a full edition of SQL Server is required.
Note: MSDE 2000 has a limit of 2 GB. If you have been using MSDE 2000, you may wish to upgrade to SQL Server 2008 Express to avoid hitting this limit. SQL Server 2008 Express is provided on the installation CD.
Note: The client and server do not need to be installed on separate computers.

Replication

If your deployment will utilize SQL Server replication, your publishing server must have either the Enterprise or Standard edition of SQL Server installed. Your Paceart System workstations that will be participating in database replication as subscribers also require their own local version of Microsoft SQL Server.
SQL Server Express and MSDE cannot be used as publishers in a replicated environment.
Paceart System Administrator's Guide | Preparing for Paceart | 17

SQL Server licensing

Depending on the configuration selected for your installation, the cost of SQL Server licenses will vary. SQL Server 2008 Express is provided on the installation CD, and can be used without the need to purchase a SQL Server license. Full editions of SQL Server require the purchase of a license or licenses. If you require SQL Server licenses, contact your Paceart Sales Representative.
If your computers will be configured by Medtronic Paceart staff, and you are not purchasing SQL Server through Medtronic Paceart, ensure that all licenses and installation media are available for the Paceart Technical Service Specialist performing your installation.

Determining Database Size

The majority of the database is composed of ECG data, programmer data transfers, and auditing. When determining the size of the database, you must estimate the number of patients that will be maintained in the database, the number of seconds of ECG stored per follow-up, and if you will be utilizing the programmer data import or auditing features.
Paceart estimates that the average transtelephonic recording requires 150 bytes / second. The average clinical ECG recording requires 250 to 300 bytes / second.
1. To compute an estimate of the average growth of your database size each year, complete the following:
a) Enter the average length of clinic follow-up ECG recordings:
a=___ Seconds
b) Enter the average length of Pacemaker TTM follow-up ECG recordings:
b=___ Seconds
c) Enter the average length of Arrhythmia TTM follow-up ECG recordings:
c=___ Seconds
d) Enter the average number of clinic follow-ups per day:
d=___ Follow-ups
e) Enter the average number of Pacemaker TTM follow-ups per day:
e=___ Follow-ups
f) Enter the average number of Arrhythmia TTM follow-ups per day:
f=___ Follow-ups
g) Enter the number of days follow-ups performed each year:
g=___ Days
h) Will you transfer data from programmers for clinic follow-ups?
If yes, h= 25000. If no, h=0
i) Will you utilize the Auditing feature of the Paceart database?
If yes, i=2 If no, i=1
2. Enter your numbers in the following formula and compute:
Bytes per year = G*I(275*A*D)+(H*D)+(150*B*E)+(150*C*F)
3. Use the formula's result to calculate the following estimates:
• Divide Bytes per year by 1,024 to find your estimated growth in kilobytes
• divide Bytes per year 1,048,576 to find your estimated growth in megabytes
• divide Bytes per year by 12 to find your estimated average monthly growth
• divide Bytes per year by 4 to find your estimated average quarterly growth.
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Note: These numbers should only be used as rough estimates as you determine your disk storage space
needs. As new features are released for the Paceart System, these features may require additional disk space that is not accounted for in this formula.
The Paceart Database Manager provides the option of deleting patients and ECG strips from your Paceart database to maintain the size of the database. You can delete patients based on their status code or affiliation code. You can delete ECG strips based on their recorded date, size, or type.
Note: The option to delete patients is only available in Paceart System Database Manager version 3.30 and greater.
If you have a license for the full edition (Enterprise or Standard) of SQL Server, you can maintain the size of your database by using tools in SQL Server Enterprise Manager. For more information, consult SQL Server Books Online or Paceart Technical Support.

Data migration

The Paceart System comes with utilities for migrating legacy data that is contained in 16-bit versions of the Paceart System. Paceart may also be able to migrate data from your existing computerized systems, including your legacy test data systems, scheduling systems, or billing systems. This data can include:
• Legacy arrhythmia monitoring data
• Legacy TTM data
• Legacy ICD and pacemaker follow-up data
• Patient demographic data
• Doctor demographic data
• Event recorder, pacemaker, ICD, or lead device data
Paceart may be able to migrate some or all of your legacy data, including migration from other competitor's data or third party electronic medical record systems. Contact your Paceart Sales Representative if you wish to have a data migration consultation.

Security

As you plan a Paceart System installation, you will also have to consider the type and level of security you wish to implement. The Paceart System builds upon existing Microsoft security models. You can choose to use Windows authentication or SQL Server authentication with your Paceart System.
Note: If your operating system is Windows Vista, then you must use Windows authentication.
Another feature of the Paceart System is the ability to add role-based access to your Paceart data. You can set up roles to grant or deny permissions to users or groups of users to different types of Paceart data.
Note: Role-based security is only available with Paceart Systems version 3.30 and greater.

Network bandwidth requirements

If you will be running your Paceart System in a client-server configuration on multiple machines, you must consider network bandwidth requirements. A minimum 384 Kbps link should be used for the Paceart System, running over a networked environment such as a WAN. This bandwidth will allow you to view ECG strips and achieve reasonable interactive synchronization times.
All bandwidth recommendations are based on past experience with other Paceart installations. You should estimate the amount of data that will need to be stored and maintained at any one time to help estimate bandwidth requirements for use with replication to ensure that initialization of subscriptions and ongoing replication can be performed in a reasonable amount of time.
Paceart System Administrator's Guide | Preparing for Paceart | 19
Determining reasonable response times can be very subjective. What may be acceptable for one user or for one type of application may not work for other users or applications.

Example

Replicating clinic follow-up ECG strips
The following example should give you a good method for determining the amount of bandwidth that your Paceart System will require.
You have just performed 10 clinic follow-ups at a remote clinic, and you want to synchronize your data with the central database at your central clinic. For each follow-up, you recorded an average of 30 seconds of ECG. This means that you have 5 minutes of ECG to transmit, or about 81 kilobytes (645 kilobits) of data. To send 645 kilobits of data at 384 Kbps, it would take you approximately 1.7 seconds. At 128 Kbps (Dual ISDN), it would take approximately 5 seconds. If you were to transmit over a 56 Kbps modem, it would take approximately 12 seconds.

Estimating transmission time

The following table can be used to estimate the transmission time for a given amount of in-clinic ECG across a particular network bandwidth, assuming you will be utilizing the entire bandwidth.
T310Base-T
0.001 sec0.006 sec0.04 sec0.17 sec0.52 sec1.2 sec30 sec
0.003 sec0.01 sec0.09 sec0.34 sec1 sec2.4 sec1 min
0.015 sec0.07 sec0.43 sec1.7 sec5.2 sec12 sec5 min
0.030 sec0.13 sec0.85 sec3.4 sec10 sec24 sec10 min
0.089 sec0.40 sec2.6 sec10 sec31 sec1.2 min30 min
0.17 sec0.80 sec5.1 sec21 sec62 sec2.4 min1 hr
Data
T1384 KbpsDual ISDN56k ModemAmount of
Ethernet

Configurations

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 clinical ECG-acquisition stations needed
• Number of TTM-acquisition stations needed
• 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 24/7 TTM-acquisition
• Need for remote, disconnected data access
Paceart System is scalable and configurable, providing a number of options to best suit your installation.
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Stand-alone Paceart workstation/server

This scenario is the most basic and most limited Paceart System configuration option. It involves a single computer, with no network connection, running both the Paceart server and client software.
Paceart Hardware, such as the 12-Lead ECG/TTMECG Module for in-clinic and transtelephonic ECG acquisition, or the Paceart Sound Card Interface for transtelephonic-onlyECG acquisition, is added to capture ECG signals.
This configuration most likely will not need a full version of SQL Server, because an Express edition will suffice. The only time a full version of SQL Server would be required is if the database would need to store more than 4 GB of data.

Master SQL server only, single database

Description
This scenario is the most typical Paceart System scenario in use today. In this scenario, there is one Paceart Server with a single SQL Server database containing the data from all of the workstations. These workstations could be all within the same facility, sending the data across a local area network (LAN) or in different geographies, sending data on a wide area network (WAN).
Complexity
This configuration has a low degree of complexity. There is only one database to maintain, and no replication is needed.
Pros
• Centralized security and maintenance at the master location, including a central repository for backups.
• For server software upgrades, only one database needs to be updated if the database structure changes during a Paceart System upgrade.
• All patient data is stored in one database and is accessible from any location on the LAN or WAN.
Cons
• No local copy of data at local locations if LAN or WAN fails.
• Higher bandwidth requirements as individual locations will be saving all data, including large ECG strips, across the LAN or WAN.
• Client software upgrades must be upgraded across multiple locations simultaneously if the database structure changes.
• Queries must contain extra criteria if remote locations only wish to see local patients.
• Lookup tables will contain information from all locations and will require special maintenance to ensure uniform data entry.
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Diagram
Figure 1: Master SQL Server and a single Paceart Database

Master SQL server only, multiple databases

Description
In this scenario, there is one Paceart Server running an instance of SQL Server that has multiple databases, one for each department or remote location. Each workstation can be configured to connect to any of the databases on the Paceart Server over the LAN or WAN.
This scenario is not typically used. The most common reason for implementing it is to segregate patient populations for confidentiality purposes. Often, monitoring services will use this scenario with their Paceart System to keep separate databases for separate clients.
Complexity
This configuration has a low degree of complexity. There are multiple databases to maintain, but all databases are located at a single site, meaning no replication. Users can set up shortcuts to access each database from each workstation.
Pros
• Centralized security and maintenance at the master location, including a central repository for backups.
• If the database structure changes during a Paceart System upgrade, individual workstations can update their client software at convenient times, and database structure changes can be applied separatelyto each database at convenient times.
• Autonomy of data entry at each location. Each location can maintain separate lookup tables. Extra filter criteria are not needed to generate queries and reports for one department or remote locations.
Cons
• No local copy of data on the workstation if LAN or WAN fails.
• Higher bandwidth requirements, as individual locations will be saving all data, including large ECG strips, across the LAN or WAN.
• If the database structure changes during a Paceart System upgrade, a workstation will not be able to access data in the other databases until all database structures have been upgraded to the same revision level.
• No ability to perform queries and reports across multiple databases.
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• If a patient moves from one remote location to another, their history will need to be manually re-entered into the new database.
Diagram
Figure 2: Master SQL Server and multiple databases

Master and local SQL servers, single database, full publication

Description
This is the first scenario where we introduce replication. In this scenario, there is a master Paceart Server running an instance of SQL Server with a single database. This database contains all of the data from all of the remote locations. Each remote location has its own local Paceart Server running an instance of SQL Server with a single database. This database contains a replicated copy of all of the data from the master database. Workstations at the remote locations would run against their local SQL Server database. The remote databases would synchronize with the master database on a scheduled basis.
This scenario is one that is commonly used by Paceart customers who wish to use replication. For example, a customer may have a satellite clinic with no high-speed WAN connection to the central clinic. They want to work off a local copy of the Paceart database and connect only occasionally to the master database to synchronize changes. They can do this by setting up replication between the satellite clinic(s) and the central office.
Complexity
This configuration introduces a high degree of complexity. Replication must be used, which increases the complexity of software upgrades when there is a database structure change. However, it is the simplest replication configuration as only one publication is created that serves all subscribers.
Pros
• Centralized maintenance at the master location, including a central repository for backups.
• Local copy of data at all remote locations in the event of WAN failure.
• Only one database needs to be updated at each location if the database structure changes during a Paceart System upgrade.
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• All patient data is stored in one database. If patients move from one remote location to another, they can be found automatically at the new location. Queries of data can be done easily across all locations.
Cons
• If security is desired, security information must be maintained at each location.
• Higher bandwidth requirements, as all remote locations must replicate their data, including large ECG strips, across the WAN.
• If the database structure changes during a Paceart System upgrade, all remote locations will need to update all software simultaneously to access the new database. If the change is a major structurechange, replication will need to be removed before the update is made and re-established after the update.
• Queries and reports for individual remote locations will need extra criteria to filter for patients only at that location.
• Lookup tables will be combined for all locations and will require special maintenance to ensure uniform data entry.
Diagram
Figure 3: Master and local SQL Servers, a single database, and full publication

Master and local SQL servers, single database, filtered publication

Description
In this scenario, there is a master Paceart Server running an instance of SQL Server with a single database. This database contains the data from all of the remote locations. Each remote location has its own local Paceart Server running an instance of SQL Server with a single database. However, instead of having a complete copy of all of the data on the master database, only a portion of the data is replicated to the remote location. With a copy of only its own patients from the single database on the master SQL Server. Workstations at the remote locations would run against their local SQL Server database. The remote databases would synchronize with the master database on a scheduled basis.
This scenario is very similar to the Master and Local SQL Servers, Single Database, Full Publication scenario. The difference is that separate publications for each remote location will be created on the master SQL Server. Separate publications are created to reduce the amount of data that needs to be transferred between sites. This reduces network bandwidth requirements while still giving the flexibility of having all patient data stored
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in the same database at a master location. Many filters can be created on the publication, including limiting the amount of ECG data that is published or filtering the patients that are published to each location.
Complexity
This configuration introduces a high degree of complexity. Replication must be used, which increases the complexity of software upgrades when the database structure changes. It also requires the creation and maintenance of multiple publications and subscriptions.
Pros
• Centralized maintenance at the master location, including a central repository for backups.
• Better delegates what data is published to meet your subscriber needs.
• Lower network bandwidth requirements since only a subset of the data is replicated across the WAN.
• Each remote site has a copy of their data in the event of WAN failure.
• Only one database needs to be updated at each location if the database structure changes during a Paceart System upgrade.
• All patient data is stored in a single, master database.
• If a patient moves from one location to another, the patient's affiliation code can be changed. After synchronizations are performed, the patient's data will be transferred to the new location.
• Queries of data can be done easily across all locations.
Cons
• If security is desired, security information must be maintained at each location.
• If the database structure changes for a particular software upgrade, all remote locations will need to update all software simultaneously to access the new database. If the change is a major structurechange, replication will need to be removed before the update is made and re-established after the update.
• Queries and reports for individual remote locations will need extra criteria to filter for patients only at that location, if run from the master database.
• Lookup tables will be combined for all locations and will require special maintenance to ensure uniform data entry.
Diagram
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Figure 4: Master and Local SQL Servers, a single database, and filtered publication

Master and local SQL servers, multiple databases

Description
This scenario is not used very often. In this scenario, there is a master Paceart Server running an instance of SQL Server with multiple databases, one for each remote location. Each remote location has its own local Paceart Server running an instance of SQL Server, which would contain a replicated copy of the database specific to that location. Workstations at the remote locations would run against their local SQL Server database. The remote databases would synchronize with their counterpart database on the master SQL Server on a scheduled basis. If a particular remote location needs to review data from another remote location, they can connect to the desired database on the master SQL Server using the WAN.
Complexity
This configuration presents the highest degree of complexity. Replication must be used, which increases the complexity of software upgrades when there is a database structure change. A publication is needed for each database on the master SQL Server, and a subscription is needed on each remote database. Users can create shortcuts to access either the local database or remote master databases on their workstations.
Pros
• Centralized maintenance at the master location, including a central repository for backups.
• Lower bandwidth requirement due to the fact that only patient data for a single site must be replicated across the WAN.
• Local copy of data at all remote locations in the event of WAN failure.
• If the database structure changes during a Paceart System upgrade, individual locations can update their database structure and client software as time allows.
• Autonomy of data at each location. Each location can maintain separate lookup tables and will not need extra filter criteria to generate queries and reports for their patients.
Cons
• If security is desired, security information must be maintained at each location.
• If the database structure changes during a Paceart System upgrade, a location will not be able to access other locations' data until all databases are brought to the same structure revision level. Multiple databases will need to be updated at the master location.
• No ability to perform queries and reports across databases from all locations. If a patient moves from one location to another, their data will need to be manually re-entered.
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Diagram
Figure 5: Master and Local SQL Servers and multiple databases

Local SQL servers only, multiple databases

Description
This scenario is not frequently used. In this scenario, there is a local Paceart Server running an instance of SQL Server at each individual remote location with one database. This database contains patient data only for that particular location. Workstations at each location would work against their local SQL Server. If a particular location needs to review data from another remote location, they would connect to the remote location's database on the remote location's SQL Server via the WAN.
Complexity
This configuration presents a medium degree of complexity. Multiple databases need to be maintained, but maintenance can be delegated to individual locations. No replication is used. Users will need shortcuts to access the database at all locations. Individual SQL Servers need to be addressable from all other SQL Servers to give access at all locations.
Pros
• Autonomy of maintenance at each location. Individual remote locations can determine backup and maintenance schedules.
• Low bandwidth requirement due to the fact that the majority of data access is performed locally, with only infrequent requests being sent over the WAN.
• Local copy of an individual remote location's data in the event of a WAN failure.
• If the database structure changes during a Paceart System upgrade, individual locations can update their database structure and client software as time allows.
• Autonomy of data entry at each location. Each location can maintain separate lookup tables and will not need extra filter criteria to generate queries and reports for their patients.
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