Cardiac Navigator

1.6

Software Installation Guide

Date of issue: 1.9.2023

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BITTIUM CARDIAC NAVIGATOR SOFTWARE

Software Installation Guide

IMPORTANT
Refer to this guide for the proper use, warnings, and cautions associated with the installation and upgrade
of Bittium Cardiac Navigator software manufactured by Bittium Biosignals Ltd. Please contact your sales
representative for any questions associated with installing and configuring Bittium software.

Please read this entire guide before using Bittium Cardiac Navigator software. Please also read the latest
Release Notes before using Bittium Cardiac Navigator software.

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Table of Contents

1 Conventions................................................................................................................................................. 6
2 About this document................................................................................................................................... 7
2.1 Terminology ....................................................................................................................................... 7
2.2 Related documents............................................................................................................................ 8
3 General Warnings and Cautions to review before use ............................................................................... 9
4 Introduction............................................................................................................................................... 10
4.1 Bittium Cardiac Navigator software ................................................................................................ 10
4.2 Bittium Faros – 4-in-1 ambulatory ECG sensor ............................................................................... 11
5 Installing the Cardiac Navigator Client ...................................................................................................... 13
5.1 What are the system requirements?............................................................................................... 13
5.1.1 Hardware requirements .............................................................................................................. 13
5.1.2 Operating system......................................................................................................................... 13
5.1.3 Recommended third party applications ...................................................................................... 14
5.1.4 Supported barcode formats ........................................................................................................ 14
5.2 What are the options for ECG database? ........................................................................................ 14
5.2.1 Local database ............................................................................................................................. 15
5.2.2 Server database ........................................................................................................................... 15
5.3 User roles and privileges ................................................................................................................. 16
5.4 How does licensing work? ............................................................................................................... 16
5.4.1 Single user licensing..................................................................................................................... 16
5.4.2 Server licensing ............................................................................................................................ 17
5.4.3 License types................................................................................................................................ 17
5.5 Installing the application ................................................................................................................. 18
5.5.1 Data structure after the standard client installation................................................................... 20
5.6 Setting up Cardiac Navigator software ............................................................................................ 20
5.6.1 Activating a license for local database installation ..................................................................... 23
5.6.2 Logging into server database ....................................................................................................... 25
6 Installing and configuring Cardiac Navigator Server ................................................................................. 26
6.1 System architecture......................................................................................................................... 26
6.2 What are the system requirements?............................................................................................... 27

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6.2.1 Hardware requirements: ............................................................................................................. 27

6.2.2 Operating system: ....................................................................................................................... 27
6.2.3 Required Port settings ................................................................................................................. 27
6.3 Installing the server application ...................................................................................................... 28
6.4 Creating a new server instance ....................................................................................................... 30
6.4.1 Launch the NavigatorDB Configuration Tool ............................................................................... 30
6.4.2 Create a new server Instance ...................................................................................................... 30
6.4.3 Configure Server Instance ........................................................................................................... 31
6.4.4 Handle certificates ....................................................................................................................... 35
6.4.4.1 Setup server certificate ........................................................................................................... 36
6.4.4.1.1 Create self-signed server certificate.............................................................................. 37
6.4.4.1.2 Import server certificate................................................................................................ 41
6.4.4.2 Handle trusted certificates ...................................................................................................... 43
6.4.4.2.1 Require client certificates .............................................................................................. 44
6.4.4.2.2 Create client certificates................................................................................................ 45
6.4.4.2.3 Import external trusted certificates .............................................................................. 47
6.4.4.2.4 Delete trusted certificates ............................................................................................. 49
6.4.4.2.5 Install certificates on client side .................................................................................... 50
6.4.5 Create a Firewall rule for Windows firewall ................................................................................ 56
6.4.6 Register and start Service ............................................................................................................ 57
6.4.7 Accessing Server log files ............................................................................................................. 59
6.5 Database setup and configuration .................................................................................................. 60
6.5.1 Adding licenses to the server ...................................................................................................... 62
6.5.2 Create a new database ................................................................................................................ 66
6.5.3 Create new users ......................................................................................................................... 67
6.5.4 Set the password for a new user ................................................................................................. 71
6.5.5 Auto-Login Grants........................................................................................................................ 71
6.5.6 Active Directory configuration .................................................................................................... 73
6.6 Database Maintenance.................................................................................................................... 77
6.6.1 Server mode ................................................................................................................................ 78
6.6.2 Shutting down the server ............................................................................................................ 80
6.6.3 Session list, access logs, and server logs ..................................................................................... 80

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6.7 Upgrading the database version...................................................................................................... 83

7 Troubleshooting ........................................................................................................................................ 86
7.1 System Logs ..................................................................................................................................... 86
7.2 Configuration file ............................................................................................................................. 87
8 Regulatory information ............................................................................................................................. 88
8.1 MDD Classification ........................................................................................................................... 88
8.2 Intended use .................................................................................................................................... 88
8.3 Indications for use ........................................................................................................................... 88
8.4 Contraindications ............................................................................................................................ 89
Manufacturer .................................................................................................................................................. 90

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1 CONVENTIONS
The following conventions are used in this user guide:

WARNING: Warning statements describe the conditions or actions that can result in per-
sonal injury or loss of life.

CAUTION: Caution statements describe conditions or actions that can result in damage to
the equipment or loss of data. Caution statements alert the user that the clinician has the
responsibility of determining the significance of the results due to actions and varying fac-
tors present with each case.

NOTE Notes contain additional information on using this product.

The CE Mark and Notified Body Registration Number signify that the product meets all the
essential requirements of European Medical Device Directive 93/42/EEC.

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2 ABOUT THIS DOCUMENT

Please read this entire user manual before using Bittium Cardiac Navigator software.

The information in this user guide applies to the Bittium Cardiac Navigator software version 1.6 or later. It is
assumed that the reader is familiar with Windows operating system functionality in the server and work-
station environment. The goal of this user guide is to provide an understanding of the installation and con-
figurations processes of Bittium Cardiac Navigator software.

The information is subject to change without notice. All changes will be in compliance with regulations gov-
erning manufacture of medical equipment. Bittium Biosignals Ltd. shall not be liable for any errors con-
tained herein or for incidental or consequential damages in connection with the furnishing, performance,
or use of this material. The publisher, authors, and translator accept no legal responsibilities or any other
kind of liability for incorrect data and their consequences.

CAUTION: Failing to follow the operation instructions in this manual may result in the im-
proper analysis of the data. The manufacturer accepts no liability for damages resulting
from improper use.

COPYRIGHTS

Bittium Biosignals Ltd, 2023. All rights reserved. This document may not be photocopied, reproduced, or
translated to another language without the prior written consent of Bittium Biosignals Ltd.

TRADEMARKS

Bittium is a registered trademark of Bittium Corporation. Windows is a registered trademark of Microsoft

Corporation. Intel® Core™ is a trademark of Intel Corporation. Adobe® Acrobat® is a trademark of Adobe
Inc. Any other company or product names or equivalent emblems depicted or referenced on the document
are either trademarks or trade names of Bittium, or they may be trademarks or trade names of third par-
ties. Your use of this document shall not be construed as granting, by implication or otherwise, any license
or right to use any marks, emblems, or trade names appearing on the site without the prior written consent
of Bittium or the third-party rights holder.

2.1 Terminology
This manual is written for IT professionals with a working knowledge of computer equipment and terminol-
ogy as required for operating them.

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2.2 Related documents

The user of Bittium Cardiac Navigator software is advised to consult the following Bittium product docu-
ments in order to obtain an adequate overview of working with Bittium Cardiac Products.

Bittium Cardiac Navigator 1.6 User Guide

Document code: 800946-4.0.0 Bittium Cardiac Navigator 1.6 User Guide

Detailed instructions for using Bittium Cardiac Navigator software for analyze ECG data.

Bittium Faros Manual

Document code: 800953-6.0.0 Bittium Faros Manual

Bittium Cardiac Navigator software is primarily used to analyze the ECG data recorded by Bittium Faros ECG
sensors. The 800953-6.0.0 Bittium Faros Manual describes the main operating principles and operating
methods of the Faros sensor and, therefore, helps to understand the principles related to the production of
the data that are to be analyzed.

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3 GENERAL WARNINGS AND CAUTIONS TO REVIEW BEFORE USE

Do not operate the Bittium Cardiac Navigator software without first reviewing the following notices.

WARNING: Bittium Cardiac Navigator software analyses are not intended for pediatric pa-
tients weighing less than 10 Kg (22 lbs.).

WARNING: Bittium Cardiac Navigator software does not provide diagnoses.

WARNING: Bittium Cardiac Navigator software is intended as a decision support system for
persons who have received appropriate medical training, and it should not be used as a sole
basis for making clinical decisions pertaining to patient diagnosis, care, or management. Any
application of medical information from the program, other than the original design or in-
tended use thereof, is not advised and is considered a misuse of the software product.

WARNING: As in all Holter systems, noise and artifacts may produce false positive ECG
events. Therefore, patient data MUST be reviewed and edited by a qualified technician or a
physician. Bittium Biosignals Ltd. and its staff cannot be held liable for patient data edited
by a non-qualified person nor for data edited by a qualified person.

CAUTION: The numerical and graphical results and any interpretation given must be exam-
ined with respect to the overall clinical condition of the patient and the general recorded
data quality.

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4 INTRODUCTION
Welcome to the Bittium Cardiac Navigator System. In this system, Bittium Cardiac Navigator software is
used for analyzing and editing the ECG data generated by Bittium Faros sensors into a reportable format.

4.1 Bittium Cardiac Navigator software

Bittium Cardiac Navigator software is a flexible and versatile solution for performing clinical Holter ECG
analysis when analyzing recordings with multiple days of ECG data efficiently, thereby speeding up the di-
agnosis. Recommended maximum length of recording is 21 days, analyzing longer recordings is not fully
supported.

Simple user interface and intuitive ECG navigations make the software fast to learn and support the easy
and efficient use of the software. Bittium Cardiac Navigator software provides views and dashboards that
present all the important ECG data and analytics to the user at a glance. Summary views, categorized strips
view, and arrhythmia tools support easier data interpretation and quicker data editing, along with a Full
Disclosure view that maintains the overall picture of the measurement being analyzed.

One of the main design principles of Bittium Cardiac Navigator software is arrhythmia centric analyzing
where the user focus is on analyzing and reannotation rhythms instead of beats. Software has Self-learning
templates that will reduce the need for traditional time-consuming template editing, allowing user to re-
classify and delete beats much easier. If needed the software allows template editing either with a pur-
pose-designed templates tool or from any view with ECG data.

The versatile P-wave and AV block detection, PQ and QTc time distribution by severity, novel De-
/Repolarization surface map visualization as well as information on the effects of the changing heart rate to
PQ and QT times provide valuable information on all the critical atrial and QT events.

Available ready-made narrative phrases with editing possibilities and the visual presentation of data pro-
vide everything that is needed for comprehensive and informative reporting. You can choose which pages
and analyses to include in the final report.

The summarized key benefits of Bittium Cardiac Navigator software are:

- Unique and simple dashboards and user interface for faster editing and analyzing
- Arrhythmia analysis with overview and event strips
- Precise and detailed atrial analysis
- Patient event analysis tool
- QRS templates
- QT analysis
- ST analysis
- Heart rate variability (HRV) analysis
- Pacemaker analysis
- Automatic noise detection
- Informative and graphical reporting

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- Automated narrative in reporting

- Custom reporting and customized report templates
- Local and network operation
- Options for local and network database
- Multiple licensing models

NOTE Some features described in this section are enabled by the software license agreement.
Your license might not enable all of these features.

4.2 Bittium Faros – 4-in-1 ambulatory ECG sensor

Faros ECG sensors provide signal acquisition for one channel (Bittium Faros 180, Bittium Faros 180L) or up
to three channels (Bittium Faros 360) of patient ECG waveforms through skin surface electrodes adhered to
the body.

Bittium Faros is a wearable, portable, externally applied electrocardiograph (ECG) recorder and wireless
transmitter for ECG data acquisition, R-R interval data acquisition, and patient motion capturing. Bittium
Faros is used for monitoring patient ECG and can be set to generate event markers using the built-in ar-
rhythmia detection algorithms. The data recorded by the device can be extracted by either a USB connec-
tion or via a Bluetooth connection to a wireless device.

There are several different options for sensor attachment to human body. ECG and RR can be recorded by
using Bittium Faros Sensor with Bittium OmegaSnap ECG electrode, or a cable set and commercially availa-
ble single-use snap on ECG electrodes.

Bittium Faros 180TM Bittium Faros 180LTM Bittium Faros 360TM

9404302 9404659 9404300

Figure 1 Bittium Faros 360 (gray) and Faros 180 and 180L (light blue) sensors.

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Figure 2 Recommended electrode connections for Faros sensors (1-ch lead set, 1-ch patch, 3-ch lead set)

NOTE Before using Bittium Faros sensors, read the instructions for use of the Faros sensors care-
fully and keep them for future reference.

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5 INSTALLING THE CARDIAC NAVIGATOR CLIENT

This chapter provides the information necessary to install Bittium Cardiac Navigator software.

CAUTION: Before you start the installation, please read the following instructions carefully
in order to avoid any data loss related to existing ECG databases.

NOTE Illustrations and screen representations are for illustrative purposes only and may vary from
the actual software. Your computer’s display settings may affect screen representations.

5.1 What are the system requirements?

Bittium Cardiac Navigator software has been developed and tested using the hardware components and
software application versions described below. To ensure support, the minimum hardware configurations
listed below must be met. If you plan to use hardware of a lower specification, please bear in mind that this
can affect the function of the software and as a result it may run slower or in worst case get instable.

5.1.1 Hardware requirements

• Processor: Minimum Intel Core i3; Recommended Core i7 or better
• Memory (RAM): Minimum 4 GB; Recommended 8 GB or above
• Hard Drive: Minimum 256 GB; Recommended 512 GB or more
• Internet connection (LAN or Wi-Fi)
• USB Port 2.0 or better (for accessing Bittium Faros devices)
• OPTIONAL: Bluetooth support for setting up wireless connection for Live ECG monitoring feature

NOTE Most laptops and desktops meet the minimum hardware requirements

NOTE When analyzing long-term measurements (> 3 days), it is recommended to use a computer
that matches at least the recommended settings.

5.1.2 Operating system

• Microsoft Windows 10

NOTE Bittium Cardiac Navigator software can also be used in computer running Microsoft Win-
dows Server 2016, or newer.

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NOTE Bittium Ltd. takes no responsibility for the configuration of Microsoft Windows used for
running Bittium Cardiac Navigator software.

5.1.3 Recommended third party applications

• Adobe® Acrobat® Reader DC or better
• Antivirus Software, such as F-Secure

5.1.4 Supported barcode formats

Bittium Cardiac Navigator software supports following barcode formats. Barcodes are read by utilizing
computers’ webcam interface.

Table 1 Supported bar code formats

1D product 1D industrial 2D
UPC-A Code 39 QR Code
UPC-E Code 93 Data Matrix
EAN-8 Code 128 Aztec
EAN-13 Codabar PDF 417
UPC/EAN Extension 2/5 ITF MaxiCode
RSS-14
RSS-Expanded

5.2 What are the options for ECG database?

Cardiac Navigator ECG database can be set up either on the client computer's local hard drive or the server.

The database on the client computer's hard disk is only available to a single user, whereas the server data-
base can be joined by multiple concurrent users.

When establishing an ECG database, it is necessary to take into account, for example, the estimated total
number of measurements to be stored in the database. For example, a three-day single-channel 250 Hz
ECG recording takes up about 100 MB of disk space. Whereas a corresponding measurement implemented
on three channels 250 Hz recording requires 300 MB.

The following table shows the approximate required disk space relative to the number of patient recordings
per a business day (bd) over the period of one year (average of 220 days per year).

Table 2 Table 2 Disk space requirements

Device settings 1 patient / bd / year 5 patients / bd / year 10 patients/ bd / year

1 ch, 250 Hz, 1 day 7 GB 35 GB 70 GB
3 ch, 250 Hz, 1 day 21 GB 105 GB 201 GB
1 ch, 250 Hz, 3 days 21 GB 105 GB 201 GB
3 ch, 250 Hz, 3 days 64 GB 320 GB 640 GB
1 ch, 250 Hz, 7 days 49 GB 245 GB 490 GB

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3 ch, 250 Hz, 7 days 147 GB 735 GB 1,43 TB

5.2.1 Local database

The ECG database for Bittium Cardiac Navigator software can be installed locally. This means creating a
database on the client computer's hard drive.

In this case, the database uses the space on the client computer's hard disk to store and process ECG meas-
urement data. Therefore, it is important to make sure that the hard disk of the computer used is large
enough and meets, for example, the space requirement caused by the average number of measurements
to be analyzed each year.

When using a local database, it should also be noted that the database can only be used with one license.
User of the local database must, therefore, be able to log on to the same client computer and account that
was used to create the database.

5.2.2 Server database

The use of a server database is highly recommended if the same database and the recordings it contains
are to be processed from several different client computers and/or by several users.

The server database is used for the unified storage and management of ECG measurements. Recordings are
processed and analyzed (calculated) on each user's own workstation with the Cardiac Navigator application
installed.

Several different databases can be created on the same server. A user may have access to more than one
database on the server. Access rights can be managed on a per-user basis.

NOTE Each individual database requires a license.

The server database can be accessed using the licenses attached to it. Licenses can be floating licenses that
can be used by several different users. There is no limit to the total number of users of floating licenses, but
the number of server sessions open at one time is limited to the number of licenses.

Users accessing the server database are identified when they log in to Cardiac Navigator with their own
user IDs. User IDs define the user's individual rights to process recordings and make changes. User IDs also
determine which ECG databases each user has access to. Cardiac Navigator Server supports Active Directo-
ry (AD) integration for Microsoft Windows domain that provides authentication and authorization mecha-
nisms to control the user database access.

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CAUTION: It is not possible to use Network-attached Storage (NAS) as the database location
for Cardiac Navigator software.

5.3 User roles and privileges

Using Bittium Cardiac Navigator software requires certain permissions on the client computer's folder ac-
cess and computer network resources. The following points should be considered if the Bittium Cardiac
Navigator is installed on a computer that is managed centrally by the system administrator.

The system administrator must perform the following procedures in order to enable users to access and
use the application:

• Installation of the software

• Add user accounts and set up user privileges
• If needed, to modify the antivirus and firewall settings to make sure the software is on the list of
trusted systems.

Including when a server database is used:

• Set up the server instance and database(s)

• Add user accounts and set up user privileges or alternatively enable Active Directory integration
• Define which type of software license each user is allowed to use (if there is more than one type
available)
• Define which ECG databases a user is allowed to access

NOTE Using Bittium Cardiac Navigator software does not require system administrator rights.

5.4 How does licensing work?

Use of Bittium Cardiac Navigator software requires a valid license. The license can be either:

- Standalone: Single user with a local database

- Server: Multiple users with shared database(s)

5.4.1 Single user licensing

When using a single user licensing, the ECG database will be installed locally on the user’s computer. With a
single user license, accessing the database is only possible through the software client installed on the
same computer with the database. With local installations, the software licenses are connected to the user
that has installed the software and activated the license. The license and database will not be available if
one will log on to the computer with another user's credentials.

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NOTE Single user license is only available for one particular user

5.4.2 Server licensing

When using a server database, the Cardiac Navigator software clients are connected to a remote database
located on a server.

In order to operate Bittium Cardiac Navigator, the server must have two types of licenses. A Database li-
cense for each separate database and floating user license(s) for use by the client software.

The database license allows a single database to run on the server. Use of the server requires the existence
of at least one such license.

All client licenses on a server database installation are so-called floating licenses, meaning that the license
is not connected to a particular PC or user, but licenses are taken into use from the pool of available licens-
es on the server when users log in with their Cardiac Navigator client. The number of available licenses in a
server setup defines the maximum number of concurrent users. Logging in will be done either automatical-
ly via Active Directory integration or by manually typing in the user credentials to the software log-in
screen.

NOTE Server licensing is managed by the credentials or by Active Directory linking used for logging
in to the Cardiac Navigator Client software.

5.4.3 License types

There are different types of licenses available for Bittium Cardiac Navigator software.

Table 3 License types

License type Properties

PRO A Full license for Holter ECG analysis with variety of data processing tools.
Event A license for Event recording analysis that includes simple dashboard view, patient
events, and listing of following arrhythmias:
- Pauses and AV blocks
- Bradycardia
- Tachycardia
- Atrial Fibrillation
- Supraventricular tachycardia
- Atrial Bigeminy/Trigeminy rhythms
- Idioventricular Rhythm
- Ventricular Bigeminy/Trigeminy rhythms
- Ventricular Couplets

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- Ventricular Salvos (triplets)

- Ventricular tachycardia.

Upload An operator type of license available only for server database installations that is
used for:
Adding new patients to the database
Setting up the ECG device and recordings
Importing measurement data.
Viewer A Viewer license provides device and patient management, import functions, and
ECG full disclosure viewer. The default license, if user continues without activating
other licenses.
MedicalSuite Pro features and a subset of user interface to be used with MedicalSuite web portal.
Database license Each server database requires a server license.

5.5 Installing the application

The installation of Bittium Cardiac Navigator software is very easy and runs almost automatically without
any interaction. The installation can be performed by a person with basic computer knowledge and skills.

Starting the installation:

1. Close all other applications so that the resources available to them do not slow down or interfere
with the installation process of Bittium Cardiac Navigator software.
2. Launch the Bittium Cardiac Navigator software installer by double-clicking the installer file.
3. Follow the instructions on the screen and, if asked to do so, reboot your computer system to finish
the installation.

The next page shows a series of screenshots of the installation progress.

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1. Setup Wizard opens. Click Next to continue. 4. Click Install to begin the installation.

2. Read the End User License Agreement. Accept 5. Please wait while the Setup Wizard installs the
the agreement and click Next to continue. Cardiac Navigator software

3. Select the components that you want to install 6. Click Finish to complete the installation.
and click Next to continue.

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5.5.1 Data structure after the standard client installation

The default path for the application:

“C:\Program Files\Cardiac Navigator”

The settings and setup parameters for the application, such as selected language, database path, and acti-
vated license type are stored in the .faros file that is located in “C:\Users\{current username}\”.

NOTE If the .faros file is not visible, please check your Windows folder settings to make sure that
the hidden items are displayed.

The default path for ECG data as well as analysis results and software log files is:

“C:\Users\{current username}\faros”

5.6 Setting up Cardiac Navigator software

This chapter provides the information necessary to set up Bittium Cardiac Navigator software for the first
run after the installation.

1. Launch software by double-clicking the Cardiac Navigator icon on your desktop or select it from the
Windows program list (Press Windows + S to open the “Search” box, type “Cardiac Navigator”,” and
then click Enter.

2. After the program starts, select the language version.

Figure 3: Select language version to be installed

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3. Next, select the database type based on your license configuration:

- Create/connect to local database (Local database)
- Connect to remote database (Server database)

Figure 4: Select database type to be installed

4. Entering database information

Skip this part if the remote database option was selected.

Figure 5: Enter the folder path for local database

Enter the folder path for the local database. The path can point to an already existing database. If there
is no existing database, a new folder structure for the database is created.

NOTE It is recommended to install the database to a folder that has no special characters or spac-
es in the folder name.

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Database encryption

Personal data is typically stored as clear text in a Cardiac Navigator database. As long as the data is
stored in a user folder (default), your operating system’s user management ensures that the data can
only be viewed by authorized persons. The system’s authentication must be activated.

If these measures do not suffice for your IT security policy, Cardiac Navigator offers the ability to store
personal data on your PC in an encrypted database.

In the same window where the location for the database is defined, you will also find the option to en-
crypt the database. Here, "no encryption" is selected by default. To encrypt the database, select an ap-
propriate encryption algorithm from the list.

CAUTION: if the database encryption option is not used, unauthorized viewing of patient
data must be prevented by other data security measures.

Skip this part if the local database option was selected.

Enter the host IP address and management port (default value 1528) for the remote database and a
path for local folder that is used for the temporary storage of files to be processed.

Figure 6: Enter details for network database

NOTE It is recommended to use a local folder that has no special characters or spaces in the folder
name.

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5.6.1 Activating a license for local database installation

When using a local database, Cardiac Navigator asks you to activate a license when it is launched for the
first time after installation. When connecting a client installation to a remote database, there is no need to
validate a license.

1. To access the Add license to account dialog, it is necessary to select the “License manager” option from
the pop-up window.

Figure 7 License activation

2. Enter your license key in the Add license to account dialog and click Check.

Figure 8 Adding a license

The activation of the license will be completed automatically if your computer is connected to the In-
ternet in order to access the Bittium Cardiac Navigator license server.

Figure 9 License registration

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Skip this part if the license was activated automatically.

In case the computer cannot validate the license automatically due to no Internet connection or a con-
flict with the firewall rules, a dialog will open wherein a QR code and website URL are available to navi-
gate to the Bittium license server for manual validation of the license. In this way, a mobile phone or
another computer may be used for activating the license.

Figure 10 License validation

When the QR code is read or the URL from the dialog screen is entered in a web browser. A website
with a readily filled out text field and a “Validate” button opens up.

Figure 11 Register license dialog

Click Register license and you will get your license validation key.

Figure 12 Validation key

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Copy or type in this validation key below the QR code on the Cardiac Navigator license validation dialog
and click “Check” to finalize the process.

Figure 13 Entering the license validation key

5.6.2 Logging into server database

When using a server database, the software will ask you to log in using your username and password. In
case the system is connected to the organization’s Active Directory, the users will automatically log in to
the system using the AD credentials. When using a local database, no login is required.

Figure 14 Entering user credentials during database login

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6 INSTALLING AND CONFIGURING CARDIAC NAVIGATOR SERVER

This chapter provides the information necessary to install Bittium Cardiac Navigator Server.

CAUTION: Before you start the installation, please read the following instructions carefully
to avoid any data loss related to the existing ECG databases.

NOTE Illustrations and screen representations are for illustrative purposes only and may vary from
the actual software. Your computer’s display settings may affect screen representations.

6.1 System architecture

The following diagram illustrates the system architecture for Bittium Cardiac Navigator system at high level.

Figure 15 Cardiac Navigator system architecture

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6.2 What are the system requirements?

Bittium Cardiac Navigator Server has been developed and tested using the hardware components and
software application versions described below. To ensure support, the minimum hardware configurations
listed below must be met. If you plan to use hardware of a lower specification, please bear in mind that this
can affect the function of the software and as a result it may run slower or in worst case become unstable.

6.2.1 Hardware requirements:

• Processor: Minimum Intel Xeon bronze series; Recommended Intel Xeon gold series or better
• Memory (RAM): Minimum 8 GB; Recommended 16 GB or above
• Hard Drive: Minimum 500 GB; Recommended 1 TB or more
• Internet connection (LAN or Wi-Fi)
• Static IP address
• Redundant power supply
• Hard Drive Backup capability

6.2.2 Operating system:

• Microsoft Windows Server 2016, or newer
• Adobe® Acrobat® Reader DC or newer

NOTE Bittium Ltd. takes no responsibility for the configuration of Microsoft Windows used for
running Bittium Cardia Navigator software.

6.2.3 Required Port settings

Windows Server firewall rules for incoming SSL TCP traffic through the following (default) ports:

• 1528 (server port)

• 443 (only if using WebAPI)
• 1527 (if you must expose the raw database port; NOT recommended)

NOTE These ports should not be accessible from public internet without a third-party security
solution such as a VPN tunnel.

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6.3 Installing the server application

The installation of Bittium Cardiac Navigator Server is very easy and runs almost automatically without any
interaction.

The person performing the installation must have adequate knowledge and skills in Windows server man-
agement and security.

Starting the installation:

1. Close all other applications so that the resources available to them do not slow down or interfere
with the installation process of Bittium Cardiac Navigator Server.
2. Launch the Bittium Cardiac Navigator Server installer by Double-Clicking the installer file
3. Follow the instructions on screen and if asked to do so, reboot your computer system to finish the
installation.

The next page shows a series of screenshots of the installation progress.

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1. Setup Wizard opens. Click Next to continue. 4. Click Install to begin installation.

2. Read the End User License Agreement. Accept 5. Please wait while the Setup Wizard installs the
the agreement and click Next to continue. Cardiac Navigator software

3. Select the components you want to install and 6. Click Finish to complete the installation.
click Next to continue.

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6.4 Creating a new server instance

A server instance is a collection of server databases that are run by a solitary server service or instance.

A server instance must be created and defined in order to create database(s) to Cardiac Navigator server.
Server instances are created with Navigator Database Configuration tool that is included in Cardiac Naviga-
tor server. The server instances are not linked with each other and can be controlled or managed separate-
ly. The details of each server instance can be viewed on the Navigator Database Configuration tool.

Please follow the routine below while creating and configuring your Cardiac Navigator server instances.

6.4.1 Launch the NavigatorDB Configuration Tool

Double Click the icon on Computer Desktop or search for the Navigator DB Configuration application

Figure 16 NavigatorDB Configuration Tool desktop icon

6.4.2 Create a new server Instance

Select Services and click New server instance

Figure 17 Creating a new server instance

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Enter the name for server Instance and click Apply

Figure 18 Entering a server instance name

6.4.3 Configure Server Instance

Open the newly created server Instance by clicking the round icon with the instance name on NavigatorDB
Configuration Tool

Figure 19 Server instance icon

On instance view, click the DB Config icon and select Change Configuration

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Figure 20 Database configuration – Change configuration

Fill out your database server details

- Service description
- ECG Database location by clicking the field Database location field
- Folder for server log files by clicking the Log folder field
- Folder for Temporary files by clicking the Temporary folder field
- Set the Server IP address
- Management port (1528) is defined by default, and should not be changed

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Figure 21 Server configuration - Server

NOTE It is recommended to install the database to a folder that has no special characters in the
folder name.

Define a database name, administrator, and specify the database password. If you use an automatically
generated password for the database, make sure that the password is kept for possible future reference.

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Figure 22 Server configuration - Database

Configure email settings for sending automatic emails. The fields can be left blank if you do not want e-
mails about the operation of the server

Figure 23 Server configuration - Mail

Click OK to save the configuration for server instance.

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6.4.4 Handle certificates

TLS (Transport Layer Security) is a cryptographic protocol that authenticates data transfer between
servers, systems, applications, and users. TLS certificates serve two purposes – they encrypt infor-
mation that is sent over the Internet and they provide identity assurance to identify and trust web ser-
vices that are safe to transact with.

In instance view, click the Certificates icon and select Handle certificates.

Figure 244 Handling certificates

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6.4.4.1 Setup server certificate

On Server certificate tab, select Server key store and Server key store password. Please use file exten-
sion .p12 for the key store. If the file doesn’t exist, it will be created.

Figure 255 Certificates

You have two options:

• Click Create button to create a self-signed server certificate. It can later be imported as the
server’s certificate using the Import button.
• Click Import button to import a key store as the server’s key store.

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6.4.4.1.1 Create self-signed server certificate

Click Create button in Certificates dialog to create a self-signed server certificate.

Fill in certificate details and click Create.

Figure 266 New certificate details

Click OK in the notification.

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Select a file for the private server key store. This file can be later imported as the server’s key store. The
file contains the servers private key and must not be distributed to clients.

You may get a notification to overwrite the key store if it already exists.

Then you get prompted for the private key store password. Take note of the password.

Click OK in the notification.

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Select a file for the public server key store.

If the key store already exists, you get prompted to overwrite the existing key store.

Then you get prompted for a password for the public key store. Please take note of the password.

Click OK in the notification.

At this point you can distribute the public key store and the password to the clients to be installed in
Windows’ key store. The key store only contains the server’s certificate (and public key), so it’s safe to
distribute. It’s recommended that the key store and password are delivered through separate and se-
cure channels.

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If this is the first time you are setting up the server, you can import the private key store immediately
using the Import button in the Certificates dialog.

If, on the other hand, you are renewing the server certificate, you should

• first distribute the public key store to the clients,

• let the clients import the key store to Windows’ key store and then, when all the clients have
imported the key store,
• import the private key store using the Import button in Certificates dialog.

This ensures that there are no breaks in the service.

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6.4.4.1.2 Import server certificate

You can import a server key store with Import button in Certificates dialog (figure 25). The imported
certificates can be generated with external tools or with the Create button. The certificates can be ei-
ther self-signed or be signed by a CA (certificate authority).

To import a key store click Import button.

You get prompted to proceed. Press OK in the notification.

Then select the private server key store.

You get prompted for the key store password.

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Click OK in the notification.

Close Certificates dialog.

Restart the server to activate the new certificate.

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6.4.4.2 Handle trusted certificates

In Certificates dialog, Trusted certificates tab, you can handle server’s trusted certificates. These can be
client certificates or LDAP/AD server certificates.

If the server requires client certificates, all applications connecting to the server need them. These include
Cardiac Navigator, the server admin tool and WebAPI services.

Select Trust store and Trust store password. Please use .p12 file extension for the trust store. If the file does
not exist it will be created.

Figure 27 Trusted certificates

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6.4.4.2.1 Require client certificates

To require client certificates, check Require client certificates.

Certificates for server administration tool and WebAPI services will be created automatically. The corre-
sponding private key stores will be created in <server installation folder>\cert\internal folder. They will be
used automatically when you open the admin tool or start services.

Click Yes, OK in the notifications.

If WebAPI is running, it must be restarted.

You can see two new certificates in the trusted certificates list: cndb service and cndb administrator.

You can also create/renew these certificates any time by clicking Create internal certificates button.

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6.4.4.2.2 Create client certificates

To create a self-signed client certificate, click Create client certificate button.

Fill in the certificate details and click Create button.

Pick an alias for the certificate.

Click OK in the notification.

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Select a folder and file name for the private client key store.

Choose a password for the file.

Click OK in the notification.

The private key store file and password should be delivered to the client and be installed in Windows’ key
store. It’s recommended that the key store and password are delivered through separate and secure chan-
nels.

You should see the newly created certificate in the trusted certificates list.

It is not required to restart the server after creating or importing client certificates as the server will auto-
matically reload them.

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6.4.4.2.3 Import external trusted certificates

You can import trusted certificates by clicking the Import button. These certificates can be client certificates
created by external tools or LDAP/AD server certificates.

NOTE: If you import LDAP/AD server certificates, the server must be restarted after the import. If you im-
port client certificates, it’s not required to restart the server as the server will automatically reload them.

Click Import button.

Select a key store to import.

Type the password for the key store.

Select an alias for the certificate. The default alias is the same alias as in the imported key store. If there’s
more than one certificate in the store, you must give aliases for all certificates.

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Click OK in the notification.

You can see the imported certificates in the trusted certificates list.

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6.4.4.2.4 Delete trusted certificates

To delete a certificate from the server’s trust store (and to revoke/remove trust to it), select a certificate in
the trusted certificates list and click Delete button. Click YES in the notification.

NOTE: If you deleted an LDAP/AD server certificate, the server must be restarted. If you deleted a client
certificate, it is not required to restart the server as the server will automatically reload the client certifi-
cates.

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6.4.4.2.5 Install certificates on client side

If you try to connect with Cardiac Navigator to a remote database and you don’t have correct certificates in
Windows’ key store, the connection will fail.

If the server uses a certificate that is signed by a public CA (certificate authority), it’s usually not needed to
import a server certificate on client side. But if the certificate is self-signed, the certificate must be import-
ed.

If the server requires client certificates, the client certificates must be installed on client computers.

Double click the key store (public server key store or private client key store).

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Depending on whether you want to install the certificate only for the current user or all computer’s users,
select Current user or Local Machine. Click Next.

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Click Next.

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Type the key store password.

If you need to able to export the certificate later from Windows’ key store, check Mark this key as exporta-
ble.

Click Next.

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Click Next.

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Click Finish.

To view and handle current user’s certificates, open certmgr.msc. To view local machine’s certificates, open
certlm.msc. Client certificates are under Personal -> Certificates and server certificates are under Trusted
Root Certification Authorities -> Certificates.

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6.4.5 Create a Firewall rule for Windows firewall

Skip this part if you ARE NOT using Windows firewall

In the instance view, click the DB Firewall and select Create firewall rule.

Figure 27 Create firewall rule

1. Disable Firewall rule for non-Windows firewall

Skip this part if you ARE using Windows firewall

In the instance view, click the DB Firewall and select Don’t handle firewall.

Figure 28 Don’t handle firewall selection

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6.4.6 Register and start Service

In instance view, click the DB Service icon and select Register service

Figure 29 Register service

Then, in instance view after the Service has been registered, click the DB Service icon again and select
Start Service.

Figure 30 Start service

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2. Server instance good to go!

The server instance is up and running when you have all the icons in green.

Figure 31 Server instance OK

NOTE If the Windows firewall rule is not used, the DB Firewall icon will remain gray.

Figure 32 Windows firewall rule not in use

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6.4.7 Accessing Server log files

Cardiac Navigator server log files can be accessed by using the NavigatorDB Configuration tool.

1. Open the instance view for the selected database.

In instance view, click the DB Config icon and select Open logs.

Figure 33 Open logs

The log files are shown on the left side of the Server Logs screen. Once a log is selected, its content is
shown on the right side of the screen.

Figure 34 Log file contents

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NOTE The actual log files are stored to the log folder that was defined during instance configura-
tion.

6.5 Database setup and configuration

The Navigator Database Administration Tool is a configuration tool for managing the databases contained
in a server instance.

A server must be configured in order to run Cardiac Navigator Client software using server licenses and
server databases. Server setup and configuration is done with Navigator Database Administration tool that
is included in Cardiac Navigator server.

Please follow the routine below while creating and configuring your Cardiac Navigator server databases,
adding users and activating licenses.

1. Launch the NavigatorDB Administration Tool

Double click the icon on your computer desktop or search for the NavigatorDB Administration Tool.

Figure 35 NavigatorDB Administration Tool desktop icon

Log in

- Fill out the IP address of your Database server (Database Management Host)
- If you are logging in for the first time, please use “sysadmin” as the default username and pass-
word.

Figure 36 Database server IP address and user credentials

NOTE The system administrator password should be changed after your first login.

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NOTE If the password for the database administrator tool is forgotten, it can be changed by using
the Database Configuration Tool’s Reset system password feature.

2. Changing the system administrator’s password

On the main screen, select Worksheets and click Change password.

Figure 37 Change password

You can set the desired password. Click Random to create a randomly generated password.

Figure 38 Generate password

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6.5.1 Adding licenses to the server

1. Adding a single license

Skip this part if you want to add multiple licenses at once.

On the main screen, select Licenses and click Register a single license.

Figure 39 Register a single license

Enter the license code and click Check.

Figure 40 Enter license code

2. Adding multiple licenses at once

Skip this part if you are adding just a single license.

On the main screen, select Licenses and click Register multiple licenses.

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Figure 41 Register multiple licenses

Copy – paste the license codes that you want to register to the window and click Validate.

Figure 42 Validate licenses

3. License activation

The activation of the license will be completed automatically if your server is connected to the Internet
and the necessary rules have been added to the firewall to be able to access the Bittium Cardiac Navi-
gator license server.

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Figure 43 License details dialog

Skip this part if the license was activated automatically.

In case the computer cannot validate the license automatically due to no Internet connection or a con-
flict with the firewall rules, a dialog will open where a QR code and website URL are available to navi-
gate to the Bittium license server for the manual validation of the license. In this way, a mobile phone
or another computer may be used for activating the license.

Figure 44 License validation

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When the QR code is read or URL from the dialog screen is entered in a web browser. A web page with
a pre-filled text field and “Validate” button opens up.

Figure 45 Register license

Click Register license and you will get your license validation key.

Figure 46 Validation key

Copy or type in this validation key below the QR code in the Cardiac Navigator license validation dialog
and click “Check” to finalize the process.

Figure 47 License validation and registration successful

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6.5.2 Create a new database

On the main screen, select Worksheets and click Database management.

Figure 48 Database management

NOTE In order to create a new database, you need to have a valid Server license.

A list of all the existing databases on the server is opened. Click New to create a new database.

Figure 49 Create new database

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Fill out the database details:

- Database name (without spaces)

- Readable name
- Language for the database
- OPTIONAL: email for sending server notifications

Click Create to Create a new database.

Figure 50 Database details

6.5.3 Create new users

On the main screen, select Worksheets and click User management

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Figure 51 user management

On a list of all created users, click New.

Figure 52 User management edit – Details tab

On the General tab: Fill out the details for a new user:

- Username
- Name
- Details:
- Email for notification messages
- Language

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- User account expiration date.

Figure 53 User management edit – General details for a user

On Access tab:

Select a database that the user should have access to and a license type that the user is able to use with the
database. Click Add to add the database and license to the user information.

Figure 54 User management edit – User database access

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NOTE The user can have access to multiple databases with the same or a different license type
(Professional, Basic, Event, and Upload).

On Options tab: Define the user profile and privileges for a new user:

In most cases, the Standard User should be selected as the user profile. If the user needs to have rights to
use the database administration tools, select System Administrator instead.

NOTE Privileged User (system configuration), Standard User (VDI), and Privileged User (VDI) pro-
files are not applicable for server database installations and should not be used.

A user profile must have one of the following configuration privileges to change the configuration settings
used in the Cardiac Navigator software:

- All + defaults management

The user has full privileges to change global default settings (i.e. for all users in the same database)
- All/no defaults management
The user has full privileges to change local settings (only settings for user profile)
- Cardio & Analysis configuration
The user has privileges to change local cardio & analysis settings
- Cardio configuration only
The user has privileges to change local cardio settings
- Local configuration only
The user has privileges to change local non-analysis-based settings

The user profile settings specified by the checkboxes:

- General access granted allows user to log in. User login can be prevented without the need to de-
lete all user data by unchecking General access granted.
- Multi-Session allows the user to log-in more than once and reserve more than one license.
- Auto-login must be enabled when using auto-login grants for this user profile.
- Can issue request is not needed for normal server installations.

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Figure 55 User management edit – Options

Click Create to create a new user.

6.5.4 Set the password for a new user

On a list of all the created users, select the user that you want to set/change the password for.

On a list of all the created users, click Password.

Set the password as desired or use the random password generator.

Figure 56 Set the user password

6.5.5 Auto-Login Grants

On the main screen, select Worksheets and click Auto-Login grants.

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Figure 57 Auto-Login grants

Click New to create a new set of auto-login grants.

Figure 58 New Auto-Login grant

Fill out the details of the IP range used for Auto-Login grants:

- Domain name
Set Domain BIOS name, OR * -character for ignoring the domain name
- IP address range start
First IP address of the trusted IP range within the network
- IP address range end
Last IP address of the trusted IP range within the network
- Authentication mode

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Set authentication mode as the User if you have several different devices accessing the software.
Set authentication mode as Device if you have one shared workstation for all users to access the
software.
- Database
Select the database for Auto-Login grants.

Figure 59 Auto-Login IP range

6.5.6 Active Directory configuration

On the main screen, select Worksheets and click Active Directory.

Figure 60 Active Directory

Click New to create a new Active Directory connection.

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Figure 61 New Active Directory connection

Fill out the details for the Active Directory configuration

On Domain tab: Fill out the details for Active Directory domain

- Domain BIOS name

- Domain name
- Search bases
- Search policy
- Default language
- Force default language

NOTE If you have no preferences on the search policy, you can use “Find user/group from bind-
ing”.

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Figure 62 Active Directory Configuration - Domain

On Connection tab: Fill out the details for LDAP settings:

- LDAP server URL

- LDAP server port
- Secure communications (SLDAP)
- Authentication
- Principal (r/o admin)
- Principal password

Click OK to test the connection.

NOTE Changes are only effective if the connection can be established.

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Figure 63 Active Directory Configuration - Connection

On Binding tab: Fill out the group license bindings:

- AD group name
- AD group domain name
- Database (when there are multiple databases)
- License for AD group
- User profile for the logical group

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Figure 64 Active Directory Configuration - Binding

Figure 65 Active Directory Binding

Click OK to finish Active Directory configuration.

6.6 Database Maintenance

CAUTION: We highly recommend for you to regularly back up and purge your database. A
database can grow to a large size that will affect the performance of your Bittium Cardiac
Navigator system.

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NOTE It is your organization’s responsibility to assure a safe, validated, and functioning environ-
ment. This includes providing proper training of staff, protecting systems, controlling medi-
cal devices from cyber-security threats, and performing maintenance on hardware. Your IT
department should also provide physical security for PCs and server hosts.

6.6.1 Server mode

Maintenance mode

On the main screen, select Maintenance and click Set server in maintenance mode in order to disable the
access to the database so that users are not able to log in to the database.

In maintenance mode, the service is still running and the database files remain locked on the server.

Figure 66 Set server in maintenance mode

Click Yes to confirm entering Maintenance mode.

Figure 67 Configuration dialog

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Figure 68 Database server in maintenance mode

Working mode

On the main screen, select Maintenance and click Set server in working mode in order to resume the serv-
er from maintenance mode and enable access to the database.

Figure 69 Set server in working mode

Click Yes to confirm entering Working mode.

Figure 70 Configuration dialog

Figure 71 Database server in working mode

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6.6.2 Shutting down the server

On the main screen, select Maintenance and click Shutdown server.

When the server is shutting down, the service is terminated and the database files are released.

Figure 72 Shutdown server

Click Yes to confirm the server shutdown.

Figure 73 Configuration dialog

6.6.3 Session list, access logs, and server logs

Session list

On the main screen, select Activity and click Session list to view:

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Figure 74 Session list

- a list of currently active users

- how many recordings each user has opened for editing (Locks tab)
- which licenses are consumed by a user
- which database a user is currently logged in to.

If necessary, the user session can be forced to terminate by selecting the session and clicking Terminate.

Figure 75 Sessions

Access Logs

On the main screen, select Activity and click Access logs to view user access logs for the selected database
and/or user during a defined time period. It is also possible to filter out the activities of one particular user
or all users on the selected database.

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Figure 76 Access logs

Figure 77 Access logs details

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6.7 Upgrading the database version

The following instructions should be followed when upgrading the server software version of an existing
database(s).

CAUTION: The size of a database will be doubled during the updates process!

If more than one version interval is being updated at the same run, the needed free space
may be three times the size of the biggest database.

NOTE The server must have at least the amount of free space that equals the size of the existing
database, or the biggest database if there are multiple databases, to update one version
interval (e.g. from version 1.2.xxx to 1.3.xxx).

1. Stop DB service

In the Navigator DB Configuration tool, open the instance view for the selected database.

On instance view, click the DB Service icon and select Stop service

NOTE If the server is running more than one instances, repeat this step for ALL the active database
services on the server.

Figure 78 Stop database service

Close the DB Configuration tool

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2. Run the installer for new database as explained in chapter 6.3

3. Start DB service

In the NavigatorDB Configuration tool, open the instance view for the selected database.

In instance view, click the DB Service icon and select Start service.

Figure 79 Start service

4. Wait for the database to upgrade

The database will be upgraded after the DB service has started.

NOTE The time required for updating a database depends on its size and may take several hours.

The progress of the database upgrade can be monitored via server log files. The log files can be accessed as
explained in chapter 6.4.7. The following are the log entries that are relevant when following the progress
of the database upgrade.

Example of the log entry for initializing the database for upgrade:
191126:094445.950 Initialize Database:TESTDB V:103

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Example of log entries for the database version being upgraded:

191126:094445.950 Update database:TESTDB V:103 >> V:104
191126:094445.997 Update database:TESTDB V:104 >> V:105

Example of log entries for confirmation of database version upgrade and defragmentation:
191126:094446.012 Database update successful:TESTDB V:105
191126:094446.215 Database defragmentation successful:TESTDB

Example of log entries when the database is successfully upgraded and can be accessed by Bittium Cardi-
ac Navigator clients:
191126:094446.965 Management database read into memory
191126:094446.965 EventScheduler: starting at tick 668 in 14s.
191126:094446.965 DB Maintenance Manager started.
191126:094446.965 EventScheduler: registered@hourly: DatabaseNotification
191126:094446.965 EventScheduler: registered@daily: SysManagement
191126:094446.965 Encryption enabled on management port - enabled protocols are
SSLv2Hello, TLSv1, TLSv1.1, TLSv1.2
191126:094446.965 Navigator database server listening on interface
/12.3456.78.910 on port 1528

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7 TROUBLESHOOTING
If you encounter any issues with Bittium Cardiac Navigator software, please contact our technical support
at [email protected].

NOTE It is important to know the release version of your software when troubleshooting any diffi-
culties with the system. To find the release version, click the Settings icon on the Home
Screen, and then click Configuration. The version and build date can be found under Soft-
ware License (Home screen -> Settings -> Configuration -> Software-License).

7.1 System Logs

Bittium Cardiac Navigator software system logs are very useful when troubleshooting more complex issues
with the software.

The log files for the Bittium Cardiac Navigator client are located in the database or cache data folder loca-
tion that the user has set up during the installation.

The default paths for the log files folder are:

- C:\Users\{username}\faros\log
- C:\Users\{username}\faros-cache\log

NOTE Bittium Cardiac Navigator software version number as well as the database location might
be different from what is specified above, depending on how Bittium Cardiac Navigator
software is installed and set up.

Please consult 801008-1.0.0 Bittium Cardiac Navigator 1.6 Software Installation Guide for accessing the
Bittium Cardiac Navigator server log files.

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7.2 Configuration file

Bittium Cardiac Navigator client stores all the configuration settings in the .faros file that is located in the
C:\Users\{username}\ folder of the PC running the client software.

The data in configuration file is presented in following format:

{"cfgs":[{database1 description}, {database2 description}, ... ,{databaseN descrip-
tion}], "active":X, "stupm":true}

Where:

Variable Description

N Number of databases (local or remote) currently available for user.

database description Local path for logs and data, server URL and port (for remote db server), id, lo-
cale (language code), and optional db encryption flag ("db.encrypt":true)

active = X Index number of the database previously used, 0...(N - 1).

stupm Start-up flag to display db selection list

- true = show db selection list

- false = open the active database.

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8 REGULATORY INFORMATION
8.1 MDD Classification
In accordance with MDD 93/42/EEC: Class IIa product

8.2 Intended use

Bittium Cardiac Navigator software is intended for the analysis of data pre-recorded on Bittium Faros series
ambulatory ECG devices. In addition, Cardiac Navigator software can display and analyze rest and stress
ECG data.

Bittium Cardiac Navigator software is intended for the analyzing, editing, reviewing, reporting, and storing
pre-recorded ambulatory EGG and accelerometer data on Bittium Faros series ambulatory ECG devices. The
results of the automated analysis are intended to assist the physician in the interpretation of the recorded
data. This information is not intended to serve as a substitute for the physician overread of the recorded
EGG data. Cardiac Navigator software is intended to be used by trained operators and licensed health care
practitioner in a hospital or clinic environment.

Cardiac Navigator software is intended for use under the supervision of a physician or those knowledgeable
in all aspects of ECG morphology, rhythm, and arrhythmia. This procedure is known as a Holter procedure
and captures infrequent or activity provoked ECG rhythm abnormalities inside or outside the hospital or
clinical environment.

Bittium Cardiac Navigator Software analyses are not intended for pediatric patients weighing less than 10
kg (22 lbs.).

Bittium Cardiac Navigator comprises Bittium Faros ambulatory ECG sensors and Bittium Cardiac Navigator
software. While the patient wears the ambulatory ECG sensor, it records the ECG data. The Cardiac Naviga-
tor software analyzes the recorded data.

Bittium Faros series sensors provide signal acquisition of patient ECG waveforms through skin surface elec-
trodes adhered to the body. In addition to patient ECG waveforms, Bittium Faros devices allow measuring
physical activity with the device’s in-built 3-axis accelerometer.

8.3 Indications for use

Bittium Cardiac Navigator software is indicated for analyzing, displaying, editing, and reporting the genera-
tion of ambulatory ECG data as part of the assessment of cardiac rhythm disturbance and myocardial is-
chemia.

Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities,

which must be confirmed by a physician with other relevant clinical information.

Bittium Cardiac Navigator software can be used on patients without any limitation on patient age or gen-
der. Indications for conducting Holter recording, and analysis are:

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• Evaluation of patients with symptoms related to rhythm disturbance or symptoms suggesting arrhyth-
mia
• Evaluation of patients with symptoms that may be due to myocardial ischemia
• Evaluation of patients for ST segment changes
• Evaluation of patients with a pacemaker
• Evaluating patients’ rest and stress ECG
• Reporting heart rate variability analysis

8.4 Contraindications
Computer assisted ECG data acquisition and interpretation is a valuable tool when used properly. However,
no automated interpretation is completely reliable, and interpretations should be reviewed by a qualified
physician before treatment, or non-treatment, of any patient.

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MANUFACTURER

Bittium Cardiac Navigator software complies with the requirements of the Medical Device Directive
93/42/EEC and carries the CE 0537 mark accordingly.

Manufactured for: MDD marketing authorization holder in Europe:

Bittium Biosignals Ltd. Bittium Biosignals Ltd.

Pioneerinkatu 6 Pioneerinkatu 6
70800 Kuopio 70800 Kuopio
Finland Finland

Email: [email protected] Email: [email protected]

Web: https://www.bittium.com Web: https://www.bittium.com

WEBSITE

You can find up-to-date product information, documents, and updates by visiting the Bittium website at
www.bittium.com

SALES

Please contact your sales representative for any questions that you may have about Bittium products.

Bittium Biosignals Ltd.

Pioneerinkatu 6 Email: [email protected]
70800 Kuopio Web: https://www.bittium.com
Finland

SERVICE DESK

If you encounter any issues with Bittium medical products, please contact our technical support at medi-
[email protected].

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