Lowenstein Medical prismaTS User manual

EN Installation instructions
prismaTS
prismaTSlab
Version 5.13

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Table of contents
Table of contents
1 Introduction 4
1.1 Intended use ................................................................................. 4
1.2 Operator and user qualification ..................................................... 5
1.3 Function ........................................................................................ 5
1.4 Supported devices ......................................................................... 6
2 Safety 9
2.1 Safety information ......................................................................... 9
2.2 General information .................................................................... 11
2.3 Data protection and data security ................................................ 12
2.4 Warnings in this document .......................................................... 13
3 Installation 15
3.1 System requirements ................................................................... 15
3.2 Network settings ......................................................................... 16
3.3 Installation .................................................................................. 18
3.4 Setting up an access check .......................................................... 25
3.5 Setting a new password .............................................................. 26
3.6 Changing the server address and data directory ........................... 27
3.7 Installing the Weinmann USB converter cable driver ..................... 28
3.8 Calling up the license agreement ................................................. 33
3.9 Performing uninstallation ............................................................ 34
3.10 Performing update ...................................................................... 35
4 Function check 37
4.1 Checking prismaTS ...................................................................... 37
4.2 Checking prismaTSlab ................................................................. 38
5 Faults 39
5.1 Faults during installation ............................................................. 39
5.2 Faults during connection to the therapy device ............................. 40
5.3 Faults during connection to SOMNO therapy devices .................... 42
5.4 Faults in case of 1:1 connection ................................................... 43
5.5 Faults when importing therapy data ............................................ 44

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5.6 Setting up remote maintenance via TeamViewer .......................... 45
6 Appendix 46
6.1 Technical data ............................................................................. 46
6.2 Declaration of conformity ............................................................ 46

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1 Introduction
1 Introduction
These installation instructions provide general information
concerning both the software program prismaTS and the program
prismaTSlab.
• Intended use, operator and user qualification, function
• General safety information
• System requirements, installation, uninstallation, updating
• Function check
• Faults
• Technical data, declaration of conformity
1.1 Intended use
prismaTSlab and prismaTS are supplementary PC software
programs for Löwenstein Medical Technology therapy devices.
prismaTS is used for starting the therapy, controlling the therapy
and performing the settings for service and maintenance. The
program allows the centralized administration of patient and
therapy monitoring data. Therapy data can be exported from
therapy devices and device configurations transferred to therapy
devices.
prismaTSlab allows the display and remote setting of the devices'
therapy parameters.
The software should only be employed and used by the physician,
specialist personnel authorized by the physician and specialist
personnel employed by the authorized dealer.
It can be used in inpatient and outpatient examinations in sleep
laboratories as well as outpatient examinations outside of clinics in
the area of sleep medicine.

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1.2 Operator and user qualification
As the operator or user, you must be fully familiar with the correct
operation of this medical device. Observe the statutory
requirements for operation and use (in Germany, particularly the
German regulations governing owners/operators of medical
devices (MPBetreibV)). General recommendation: You should seek
instruction on the correct handling, use and operation of this
medical device from a person authorized by the manufacturer.
1.3 Function
prismaTS
prismaTS offers the following functions:
• Centralized administration of patients and their therapy data
• Display of devices currently available locally and via the
network
• Reading out therapy devices
• Display of therapy data (different views are available
depending on the device version)
• Statistics view:
Statistical display of therapy settings, compliance, therapy
quality and leaks for a specified therapy period.
• Therapy calendar:
Display of usage time, day of use, time of use, compliance,
therapy quality and leaks by day
• Annual view of therapy calendar:
Display of usage time, day of use, time of use, compliance,
therapy quality and leaks by week
• Signal view:
Graphic representation of signals and events
• Therapy analysis
Tabular overview of the relevant ventilation parameters,
respiratory disorders and leaks depending on the respective
pressure over the course of a therapy night

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• Creation, saving, printing and sending of reports
• Configuration of therapy devices via a USB cable or SD card
depending on device type.
prismaTSlab
prismaTSlab offers the following functions:
• Centralized administration of patients
• Remote setting of therapy devices
*If a LAN connection is used, configuration is only possible in
prismaTSlab.
1.4 Supported devices
prismaTS and prismaTSlab support the following therapy devices:
Type WM150TD
• LUISA
Type WM090TD
•prisma SMART
• prisma SMART plus
• prisma SMART max
Options for connecting therapy device and PC depending on type of device and
intended use
WM150TD WM120TD WM110TD WM100TD WM090TD SOMNO
devices
Importing
therapy data USB-C LAN
SD card
LAN
SD card
LAN
USB
SD card
LAN
SD card
USB
SD card
Configuring
therapy device - LAN* LAN*
LAN*
USB
SD card
LAN*
SD card
USB
SD card

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• prisma SOFT
• prisma SOFT plus
•prisma SOFT max
Type WM100TD
• prismaLAB
• prisma20C
• prisma20A
• prismaCR
• prisma25S-C
• prisma25ST
• prisma25S
• prisma30ST-C
• prisma30ST
• prisma30ST-HFT
• TIVAN
Type WM110TD
• prisma VENT30
• prisma VENT30-C
• prisma VENT40
• prisma VENT40-C
• TIVAN 30
• TIVAN 30-C
• TIVAN 40
• Prisma Comfort40
Type WM120TD
• prisma VENT50
• prisma VENT50-C

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• TIVAN 50
Devices in the SOMNObalance / SOMNOsoft 2 range with
SD card option
(referred to in the following text as "SOMNO devices")
• SOMNObalance
• SOMNObalance e
• SOMNOsoft 2
• SOMNOsoft 2 e
• WEINMANNbalance JP
• WEINMANNsoft 2 JP
prismaTS and prismaTSlab support SOMNO devices as of firmware
version 10.0.
For further information on compatibility, please contact your
local authorized dealer or the Löwenstein Medical Technology
hotline for diagnostics and medical electronics,
tel.: [phone] - 204 (only possible within Germany).

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2 Safety
2 Safety
2.1 Safety information
2.1.1 Use of the software and therapy device
Risk of injury if software is used to monitor the therapy!
The software is not an online monitoring system.
The software must not be used to monitor a life-sustaining
therapy.
Incorrect therapy if the connection to the therapy device is
interrupted when performing the therapy settings!
Interrupting the connection to the therapy device when
performing the therapy settings may result in incomplete or
incorrect therapy settings and could injure the patient.
Do not interrupt network or USB connection between the
therapy device and the PC during data communication.
Do not disconnect the therapy device from the power supply
during data communication.
Do not remove the SD card during data communication.
If necessary, check the therapy parameters set in the therapy
device.
Impaired or incorrect therapy due to confusion of the therapy
device!
If the therapy device is changed when using the software or if
prismaTS is run multiple times on one PC, this may result in
confusion of data and incorrect settings in the therapy device.
Compare the serial number of the therapy device with the
display in the software.
When using the software, either operate one therapy device or
read the SD card from the device.

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Therapy data lost through manual deletion of the data on the
SD card!
If the data are manually deleted via a file explorer program, they
can be irretrievably lost.
Always import the data into prismaTSlab immediately.
Delete the data from the SD card while the SD card is inserted
in the therapy device.
2.1.2 Using the server and network
Impaired therapy due to server or network crash or
instabilities!
When running the software in a network, a server or network
crash or instabilities can result in data loss or incorrect settings in
the therapy device.
Ensure the network is constantly available.
If required, check the therapy parameters set in the therapy
device.
Delayed therapy due to shared use of the data cables in a
network!
The shared use of data cables in a network (e.g., LAN) can lead to
delays in the data communication and the display of the current
device values.
Pay attention to possible peak loads as a result of the parallel
operation of multiple therapy devices or other systems in a
network.
Treatment prevented due to data loss!
Deleting the database and the imported therapy data in the
prismaServerFiles folder leads to data loss.
The folder is only called prismaServerFiles if it was not renamed
during the installation.
Only use one server installation in the network.
Back-up the database regularly. You can do this using the
backup tool which you can find on the prismaTS DVD in the
/Tools subfolder. Consult the user manual before using the
tool.
Back-up the imported therapy data regularly.
Do not move the prismaServerFiles folder.

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Risk of material damage from malware, computer viruses and
unauthorized access!
Malware and viruses can damage the PC and network and affect
how they function.
Ensure that the external storage medium is not infected with
viruses.
Scan the system for viruses regularly.
Update firewalls regularly.
To protect personal data, secure your PC, network and
personal data against unauthorized access.
2.2 General information
Those who integrate medical devices or medical software in an IT
network or install it on a PC or integrate devices and software in a
medical IT network or install it on a PC are responsible for the
compliance with IEC 80001-1. If you have any questions, please
contact your local IT risk manager or the manufacturer's customer
services ([e-mail], German and
English) or the Löwenstein Medical Technology hotline for
diagnostics and medical electronics,
tel.: [phone] - 204 (only possible within Germany).
• The software is a medical device. The installation or
uninstallation of software products and the running of
programs can have reciprocal effects. According to
IEC 80001-1, the owner is responsible for the risk management
of any reciprocal effects in the medical IT networks. Please note
that the manufacturer does not offer any guarantee or liability
for reciprocal effects between the system components in an IT
network.
• Do not falsify or exchange any recorded data and do not
interfere with the program files manually.
• Only have modifications to the software carried out by the
manufacturer or by a technician expressly authorized by the
manufacturer.

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• Also observe the respective instructions for use of the device,
the components and the accessories.
• In the EU: As a user and/or patient, you must report any serious
incidents occurring in conjunction with the product to the
manufacturer and to the responsible authority.
2.3 Data protection and data security
The operator is responsible for compliance with the European Data
Protection Regulation (GDPR) in Europe. In accordance with the
GDPR, prismaTSlab attaches great importance to the protection of
personal data and assists you in achieving GDPR compliance by
• password-protecting the SQL database used;
• logging access to personal data.
In addition, prismaTSlab offers you the following optional
measures for GDPR implementation:
• Configurable access restrictions for certain users (see "Setting
up an access check")
• Manual deletion of patient data (see prismaTSlab user manual)
• Automatic deletion of data imports after a defined period of
time (see prismaTSlab user manual)
• Possibility of exporting patient data, statistics and reports (see
prismaTSlab user manual)
It is the operator’s responsibility to ensure an overall high level of
data protection and data security within the IT environment.
Widely accepted measures for raising the level of protection
include:
• Protection of the network, computer and server against
unauthorized access;
• Exclusive use of personalized user accounts;
• Regular backup of personal data;
• Passwords of sufficient complexity and careful guarding of said
passwords;

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• Up-to-date protection of all systems against malware (e.g., virus
scanners).
Additional measures for compliance with the GDPR provisions
include:
• Procurement of consent to data storage from the patient prior
to data processing
• Transfer of data only after legalization, e.g., via consent or
anonymization
• Compliance with data backup storage periods
• Assessment of residual risks with regard to data protection and
data security
2.4 Warnings in this document
Warnings are used to flag up safety-relevant information. You will
find a warning preceding any action that entails a hazard for
persons or equipment.
Warnings consist of
• the warning symbol (pictogram),
• a signal word designating the hazard level,
• information about the hazard,
• instructions for avoiding the hazard.
The warnings appear in three hazard levels, depending on the
degree of danger:
Designates an extremely dangerous situation. Failure to
observe this warning may lead to serious, irreversible, or fatal
injury.
Designates a dangerous situation. Failure to observe this
warning may lead to minor or moderately serious injury.

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Indicates a harmful situation. Failure to observe this warning
may lead to damage to equipment.
Designates useful information relating to a particular action.

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3 Installation
3.1 System requirements
Specification Value
Processor Intel®CoreTM 2 Duo
Free storage space on
hard disk
• Standalone installaion (prismaTS, prismaTSlab and database): Minimum 2 GB
• Server installation (prismaTS, prismaTSlab and database): Minimum 2 GB
• Client installation (only prismaTS and prismaTSlab without database):
Minimum 1 GB
• Additional storage space both for the installation of Microsoft®.NET 4.0 for
the client and the server installation and for the installation of Microsoft® SQL
Server 2014 SP2 Express or SQLite, depending on the installation version and
usage.
Memory
Standalone installation : At least 2 GB of free memory
Client installation: At least 1 GB of free memory
Server installation: At least 2 GB of free memory
Connection 1 free USB port 2.0 or 3.0, network minimum 100 Mbit
Screen resolution Minimum resolution 1,200 x 800 pixels
Color depth at least 32-bit
Graphics memory Minimum 512 MB
Printer Supported by Microsoft® Windows®
Input Keyboard and mouse or other similar pointing device
Supported operating
systems
Windows® Server 2012 R2 (for operation of the server only)
Windows® Server 2016 (for operation of the server only)
Windows® Server 2019 (for operation of the server only)
Windows® 8/8.1 32 bit and 64 bit
Windows®10 32 bit and 64 bit
Windows®10 LTSC (Version 1809)

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For further information on compatibility, please contact your local
authorized dealer or the Löwenstein Medical Technology hotline
for diagnostics and medical electronics,
tel.: [phone] - 204 (only possible within Germany).
3.2 Network settings
For it to be possible to run a prismaTS client/server installation and
establish connections to therapy devices via a local network, the
network must offer the following properties:
• Multicast/broadcast responses to UDP must be permitted on
the network.
• The use of a proxy server in the local network may lead to
communication problems or problems when importing data.
• Do not use a proxy server for local networks. Deselect the
Use proxy server for LAN check box (see Control
panel> Internet options, Connections tab, LAN
settings, proxy server).
or
Operating system
languages
Deutsch
English
French
Italian
Dutch
Spanish
Portuguese (Brazil)
Turkish
Russian
Japanese
Chinese
Danish
Finnish
Norwegian
Swedish
Required software Internet Explorer® Version 6.0 SP1 or higher
Adobe® Acrobat® Reader® Version 7.0 or higher
Specification Value

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• Specify an exception for the IP address of the PC with the
server installation. Select the Use proxy server for LAN
check box (see Control panel > Internet options,
Connections tab, LAN settings, proxy server). Click
Advanced and enter the IP address of the server in the
Exceptions field.
Firewall settings
The following ports and services are required for the
communication with the therapy devices and must be opened on
all PCs with prismaTS (client and server installation) and not
blocked by a firewall:
• 51338 UDP/TCP
• 51337 UDP/TCP
• Prisma FileService service (“prismaServer” service)
• Prisma SQLExpressWTSService
(“MSSQL$SQLEXPRESSWTS” service)
The following ports must also be opened for the PC with server
installation:
• 1434 UDP/TCP
• 1433, 80, 4022, 443, 2782 TCP
Check the settings of your firewall.
It is recommended to use the therapy devices in a network in
which the IP addresses are assigned by a DHCP server.
When using a manual network configuration, the therapy devices
and PCs with prismaTS installations must belong to the same
network/subnetwork. Set the IP addresses and subnet masks
accordingly.

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3.3 Installation
3.3.1 System requirements
Microsoft®.NET Framework 4.0, Microsoft® Windows® Installer
3.1 and Microsoft® SQL Server 2014 SP2 Express are required for
the installation and running of prismaTS. If this software is not yet
installed on your PC, it will be installed automatically. If you are
prompted to do so, restart your PC once the installation is
complete. You require administrator rights to run the installation
and at least main user rights to run the software.
You can choose between server installation and client installation
(see "Installation versions").
3.3.2 Installation versions
prismaTS can be used in the following scenarios:
• Standalone installation: Use on a single PC
Select this version if you only want to use prismaTS on one
workstation.
During installation or updates, all the prisma HUB modules in the
network are installed. Therefore, all the prisma HUB modules in
the laboratory must be connected and powered up before
installation begins.
A database is required for the running of prismaTS and
prismaTSlab. It must only be available once in the local network.
A USB converter cable driver is required for the running of
prismaTS and prismaTSlab with SOMNO devices (see "Setting up
an access check").

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• Server/client installation: Use on several workstations with
prismaTS via a network
Select this version if you want to use prismaTS on several
workstations in a local network.
Advantages:
• Centralized patient management
• Centralized storage of therapy data: Imported therapy data
can be reached from any workstation.
• Devices connected to the network can be operated from
every workstation (remote control, data import).
To operate several workstations in one network, install the server
installation on one of the PCs (see "Running standalone
installation"). This workstation PC then acts as a server for the
remaining PCs. Only install the client versions on all the other
workstations (see "Running client installation").
All prismaTS installations on the client PCs are updated
automatically as soon as a server installation update is carried out.
Running standalone installation
1. Start Windows® and exit all running programs.
There must only be one server installation available in a local
network!
To ensure the proper running of prismaTS on client
workstations in the same local network, the PC with the server
installation must be switched on! The IP address of the server
must remain the same. Should it prove necessary to change the
IP address of the server, change all of the client installations over
to the server's new IP address (see "Setting up an access
check").
Changing from standalone installation to client/server
installation is not possible.

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2. Insert the DVD in the drive.
The installation wizard starts automatically. If this doesn’t
happen, start the prismaTS-Setup.exe program manually from
the DVD.
3. Select the Install prismaTS standalone option during the
installation process.
4. Follow the instructions of the installation wizard.
Running server installation
A PC with a server installation can be used to provide its services to
other clients in the network.
1. Observe the hardware requirements (see "System
requirements").
2. Start Windows® and exit all running programs.
3. Insert the DVD in the drive.
The installation wizard starts automatically. If this doesn’t
happen, start the prismaTS-Setup.exe program manually from
the DVD.