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Dolphin v4.5.1 - Installation and Service Manual (Rev 1.3)
Dolphin v4.5.1 - Installation and Service Manual (Rev 1.3)
Dolphin v4.5.1 - Installation and Service Manual (Rev 1.3)
Legal Notices
Attention
This document and its contents are subject to change without prior notice.
All information contained in this manual is believed to be correct. Viasonix assumes no responsibility for
any errors that may appear in this document. Viasonix shall not be liable for errors contained herein or for
incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Viasonix makes no commitment to update the information contained in this document.
Trademarks
Dolphin/4D, Dolphin/IQ, Dolphin/MAX and Dolphin/XF are trademarks of Viasonix Ltd.
Copyright
All Rights Reserved © Viasonix Ltd.
This manual and its contents are the sole property of Viasonix Ltd. Reproduction in any form of the manual
or its content, in whole or in part, whether in English or in any other language, is strictly prohibited without
the prior written consent of Viasonix Ltd.
The software program (“Software”) included with Dolphin system is a proprietary product of Viasonix Ltd.
and is protected by copyright laws and international treaty. You must treat the software like any other
copyrighted material.
Transferring a copy of the Dolphin software to unauthorized people or entities is strictly prohibited.
Installing a Dolphin software license key that was not provided by Viasonix Ltd. is strictly prohibited. A
Dolphin software license key shall be installed and used on one and only one computer at any single time.
Limited Warranty
Inspect the contents and the condition of the goods which are delivered within 14 days of receiving the goods,
and immediately notify your supplier in the event that the shipment is incomplete or if the goods arrived with
any damage.
Standard manufacturer warranty period for the Dolphin is 12 months, and for the probes and other accessories
is 90 days. This warranty covers only malfunctions encountered during appropriate and normal use of the
equipment. Damage caused by failure to follow instructions, misuse, improper maintenance, abuse or
mishandling of the equipment, including mechanical damage to the product housing, is not covered by the
warranty.
Warranty does not cover any damages, whether direct, consequential, incidental, financial or otherwise relating
to performance or service issues of the system, including damages, data loss or loss of business profit.
Immediately contact your local distributor or a Viasonix service representative upon encountering a service
problem. In the event that the product or any of its components should be returned to Viasonix, ensure that the
product is well packaged with its' original packaging elements.
Contact Information
Manufacturer: European Representative:
Viasonix Ltd. Arazy Group GmbH
10 Hamelacha St., Ra’anana, 4366105, Israel Squaire 12, Am Flughafen,
Tel: +972-9-7441692 60549 Frankfurt am Main
Fax: +972-9-7450621 Germany
E-mail: germany@arazygroup.com
Section 01 | Introduction
NOTE: Service to the Dolphin that requires opening the system is allowed only by authorized
Viasonix service personnel. Unauthorized service operations can affect system safety
and shall automatically void the warranty.
Service Personnel
This manual is intended for use by information technologies (“IT”) personnel, biomedical engineers or
technicians, Viasonix distributors and other individuals who are familiar with the routine service and
maintenance of medical devices.
The service personnel should also be proficient with the architecture, components and typical service
procedures for personal computers running the Microsoft Windows operating system.
Viasonix Ltd. understands the importance of feedback to continual quality improvement, and encourages
users and service personnel to provide any suggestions for improving the products and this manual.
The standard Dolphin/IQ system may include the A rear view of the Dolphin/IQ is shown below:
main console, Doppler probes, power supply, USB
cable, remote control, foot switch, monitoring
head gear and a user manual.
Dolphin/MAX Description
The Dolphin/MAX is similar to the Dolphin/4D
system in all aspects, except that the Dolphin/MAX
The Dolphin/4D front panel also includes a rechargeable internal battery for
operation.
The back panel of the Dolphin/MAX is slightly
different, and includes an inlet for the external
power supply of the system, and a battery door
located on the bottom panel that allows
replacement of the internal rechargeable battery.
Section 04 | Warnings
The Dolphin User Manual includes all warnings and cautions. This section includes warnings and cautions
relevant to this service manual. Please read carefully.
Take care to carefully read the following section. Use only medically approved computers, printers
Additional warnings and cautions also appear in and any other devices which may be used together
other parts of this manual and in the user manual. with the Dolphin. Otherwise, use an approved
isolation transformer to power up these devices.
Only authorized Information Technology (IT) personnel The Dolphin and all other external devices that are
may configure the system connectivity to the Institute’s used in conjunction with the system should be
network. IT personnel must follow the instructions in the placed out of reach of patients at a distance of at
Dolphin conformance statements, and validate proper least 1.5 meters from the patient.
network connectivity.
Any wireless devices that are used in conjunction
Do not use or connect to the Dolphin any probes or with the Dolphin must comply with FCC regulations,
other accessories that are not supplied by Viasonix and comply with EU Directive RTTE. Any battery
for the Dolphin. used with such device must comply with applicable
Immediately contact your local service device standards.
representative or Viasonix when encountering When connecting the system or the computer to any
problems with the Dolphin. Only trained and external accessory both must be off the mains
authorized personnel are permitted to service the power supply.
system or open the casing. Do not attempt to repair
the system or open the casing. Do not modify or Place the Dolphin only on a flat and hard surface.
make any changes to the Dolphin installation Ensure that the ventilation slots are free, and do not
directory unless instructed to do so by this manual. place the system on cloth, sponge or similar
material.
Electrical shock hazard. Do not remove casing cover.
For service, contact an authorized service Do not open the Dolphin casing. It does not contain
representative. parts that can be serviced by a technician. If the
device is opened then warranty will be void.
Do not attempt to repair the power supply, repair
cracked or broken cables, or to replace a fuse. For Disposal of the rechargeable battery of the
service, contact an authorized service Dolphin/MAX should be only to recycled bins per
representative. institute guidelines and in accordance with local,
state or applicable federal regulations.
Turn off the power before performing maintenance
activities. Do not clean the system with a wet cloth. If the Dolphin/MAX rechargeable battery case is
Do not immerse the probes in water or other liquids. broken, avoid direct contact with internal
components and do not use the rechargeable
Use only the power supply that is supplied with battery with Dolphin/MAX.
Dolphin. Before turning the power on, make sure
that all cables and connectors are properly Do not use the Dolphin/MAX rechargeable battery
connected. with Dolphin/MAX if it has been exposed to liquids,
especially saltwater.
Do not use the system near flammable conditions.
Keep away from water or other liquids. Do not Use only approved battery for the Dolphin/Max. The
operate the system under non-approved Dolphin/MAX rechargeable battery is directional,
environmental conditions. and can only be inserted in the correct direction. Do
not force it in.
Do not operate the system if the power cord or any
other cable or connector is damaged. When transporting the Dolphin/Max rechargeable
battery follow the transportation instructions in this
All external devices, including computers, printers, manual.
carts, or any other devices or components which
may connect directly to the Dolphin or the Remove the Dolphin/Max rechargeable battery
Dolphin/IQ computer, must comply with IEC/EN whenever the system is not likely to be used for
60601-1. It is the responsibility of the user to ensure some time.
compliance with patient isolation and IEC/EN 60601-
1 requirements if equipment that is not supplied by
Viasonix is used with the Dolphin.
Section 05 | Cautions
! Turn off the power before connecting or ! Do not install or run any other applications
disconnecting any probes or accessories. on the computer when operating the
When re-connecting system components, Dolphin. Make sure all other applications are
make sure that you connect them in their removed or turned off.
proper location.
! Never pull on the cables for disconnecting
! Turn off the power before cleaning. Clean the probes or accessories.
the system only with a soft cloth or brush.
! Connect the Dolphin/IQ system only to a
! Do not attempt to repair the system. Do not computer that meets the minimum
attempt to change or modify the Dolphin requirements.
software. Do not attempt to operate the
! Make sure that the system is checked and
system if you suspect that the system is not
serviced once a year on a routine basis by
functioning properly. Contact immediately
approved service personnel.
your local distributor.
! Whenever transporting the system,
! Routinely create back-ups of all of the patient
computer, and all accessories, make sure that
recordings. Ensure that the backup media is
all are secured in place without risk of falling.
kept in a safe place for possible future
Make sure that there are no loose cables that
restoration.
might get tangled during the transportation.
! Never drop the system or any of its
! If Ground Bond Safety Test is performed on a
components. Take special care to prevent
Dolphin system, the Dolphin system must be
the sensors and Doppler probes from
powered off during the test.
dropping or knocking on a hard surface in
order to prevent mechanical damage.
NOTE: This section is not relevant for Dolphin/4D and Dolphin/MAX, for review stations and
for presentations.
Using a computer with specifications below the minimum requirements may result in
performance problems.
The following minimum and recommended requirements are defined for a computer connected to Dolphin/IQ:
(1) Home Edition does NOT have a Network Domain support. If the institute requires a Network Domain
connection, it will be required to upgrade the Windows Home Edition to at least Windows Pro edition
using an online payment.
(2) Important if the institute requires network connection.
NOTE: This section is not relevant for Dolphin/4D and Dolphin/MAX, for review stations and
for presentations.
Using the Dolphin/IQ without preparing the computer per the instructions below may
result in performance problems.
NOTE: This warning is relevant only for the Dolphin/IQ and Dolphin/MAX models.
The Ground Bond Test can be performed only under specific conditions!
Connecting the ground bond lead to the ISO plug can damage
the Dolphin system and negate any warranty claims!
This section describes the process of assembling Connect the Ergotron stand to the Dolphin back
the optional Ergotron stand to the Dolphin/4D or panel by using the 4 unique M4 screws.
Dolphin/MAX back panel.
Fig. 1: Unscrew the 4 screws marked with red circles Fig. 5: The red line position
The following guidelines are important to assure 9. If Domain network connection is required,
Dolphin system functionality and safety with the Domain connection must be secured
regards to Cybersecurity threats: according to local institution protocols.
1. Local institution IT must be consulted 10. If domain network is not applicable, it is
regarding Cybersecurity requirements for advised to manually password protect the
Dolphin system. active user accounts on the Dolphin
computer. Strong passwords are preferable.
2. Unapproved additional 3rd party applications
Passwords must not be publicly exposed.
must not be installed. However, it is allowed
to use a corporate version antivirus or 11. It is advised to password protect the BIOS
firewall according to Section 15 | Windows component of the PC and configure the BIOS
Updates, Antiviruses and Firewalls. to prevent a USB boot. The password must
remain confidential.
3. On routine use, the system must not be
connected to the Internet. 12. It is advised to work in a restricted user
account on routine use.
4. Cybersecurity controls provided by Microsoft
Windows such as Windows Firewall, 13. Providers and institute IT are advised to have
Windows Defender, User Account Control, each end user aware of the following:
etc. must not be turned off.
a. Avoid leaving the computer unattended
5. When accessing the system using a USB without logging off first.
storage device (for example, to update
b. Avoid using an administrator account.
software), make sure the USB device was
scanned with an updated antivirus prior to c. The importance of using a relatively strong
plugging it into the system. login password.
6. Windows Updates on Dolphin computer must d. Avoid publicly exposing their login
follow Section 15 | Windows Updates, password
Antiviruses and Firewalls. e. The importance of periodically changing
7. If Dolphin system needs to be connected to their login password.
internal network for routine use, it must be f. Avoid installing third party software.
connected to a controlled network
supervised by local institution IT. g. Avoid changing critical system settings.
8. Wired network is preferable over wireless h. Avoid connecting the Dolphin computer to
network connection. Wireless network an unsecured wireless network.
connection should only be used if there is no
wired alternative and it that case, it must be
properly secured according to local
institution IT protocols.
NOTE: Carefully follow the instructions in this document to avoid possible performance problems.
NOTE: This document does NOT replace VS0533 Dolphin DICOM Conformance Statement.
NOTE: This document does NOT replace VS0533 Dolphin DICOM Conformance Statement.
NOTE: This document does NOT replace VS0533 Dolphin DICOM Conformance Statement.
From Viasonix software main screen, click New, 2. Exit Viasonix software and restart it.
then click GDT Get Next Patient. Once data is 3. With extended log files enabled, repeat the
received from server, the details of the patient verification section that was unsuccessful.
will automatically be filled.
4. Go back to Menu, then
ServiceAssistanceSend File to Viasonix
Querying Patient Details and follow instructions.
From Viasonix software main screen, click New,
then type a patient ID and click GDT Get Patient
Details. Once data is received from server, the
details of the patient will automatically be filled.
To setup a review station computer to receive automatic PDF reports, please follow the instructions below:
.3
1. The review station solution requires a shared 5. In File Name Template field, create a
folder that will be accessible by each work template that will be used to automatically
station and review station. generate the PDF file name.
2. If there are multiple Dolphin work station 6. You may use the Insert Tag list on the right
connected, they can either share the same hand side to insert <TAGS> that will be
folder or have a separate shared folder for replaced with actual data when generating a
each Dolphin work station in order to identify PDF file. For example, <PATIENTID> will be
on the review station from which Dolphin replaced with the patient ID of the examined
work station the examination belongs to. patient.
Network Share Preparation 4. In Network Shared Path field, enter full path
of the shared folder. This can be a mapped
1. The shared database solution requires a drive, for example, Z:\ or a shared folder UNC
shared folder that will be accessible by each path, for example,
work station and review station and it needs \\StorageComputer\DolphinStorageShare.
to reside on a storage server. 5. Click Test Connection to verify connectivity.
2. Request from IT to setup and provide: 6. Click Ok to confirm.
a. The storage computer name (for example Advanced Setup (SQL Database):
“StorageComputer”),
1. On the SQL server, create a database named
b. A shared folder on the storage computer “Viasonix” and assign a user and password
(for example “DolphinStorageShare”), (SQL authentication) that has full permissions
c. The login user and password to the on the “Viasonix” database.
review station computer with full 2. Open MENU > Database > Network > Shared
permissions for the shared folder Database
DolphinStorageShare.
3. Enter password itvia
d. Optionally, ask the local IT to prepare a
mapped drive on the local computer that 4. For Database Storage Mode, select Shared
automatically reconnects on login to the Database (SQL)
shared folder DolphinStorageShare (for 5. In Network Shared Path field, enter full path
example, “Z:\”) of the shared folder. This can be a mapped
3. If there is no local IT at the institution, please drive, for example, Z:\ or a shared folder UNC
refer to Appendix A below to create a shared path, for example,
folder. \\StorageComputer\DolphinStorageShare.
6. Type Server Address and Server Port of the
Dolphin Software Configuration SQL server. Alternatively, enter instance
name of the SQL server such as
The following configuration shall be performed Dolphin\SQLEXPRESS and leave the Server
on each Work Station and on each Review Port field blank.
Station.
7. Enter the assigned user name and password.
You can choose between easy setup using Access
database, or advanced setup using SQL database 8. Click Test Connection to verify connectivity
(a more difficult setup that requires Microsoft and finally, click Ok to confirm.
SQL server).
Easy Setup (Access Database):
1. Open MENU > Database > Network > Shared
Database
2. Enter password itvia
3. For Database Storage Mode, select Shared
Database (Access)
In general, the Dolphin does not require a 5. Windows and antivirus updates according
periodic preventive maintenance (“PM”). to Section 15 | Windows Updates,
However, a periodic PM can be performed by the Antiviruses and Firewalls.
institution IT/engineers or by a Viasonix
* S.M.A.R.T parameters - Every hard disk drive
distributor.
includes Self-Monitoring, Analysis, and Reporting
A typical periodic PM may include the following: Technology (abbreviated as SMART), which
reports internal information about the drive. It is
1. Diagnostics procedure and report according
possible to use these statistics as a prediction to
to Section 31 |Service - System Diagnostics
a following hard drive crash. It is recommended
2. Upgrade to the latest Dolphin software to replace a hard drive as soon as it shows
release. degradation in critical SMART parameters.
3. Checking Free Space from MENU > Help >
About to prevent running out of disk space.
4. Checking hard disk (“S.M.A.R.T.
Parameters”*) using a tool such as Acronis
ADM or similar. It is advised to consider hard
disk replacement following any sign of
degradation in hard disk performance, if any
is detected.
1. Make sure Dolphin software is closed. 3. Install the software upgrade. If asked for a
password, enter administrative account
2. It is advised to make a backup copy of the
password (default administrative account is
current installation prior to upgrade:
IT and default password is itvia)
a. Open Windows File Explorer.
b. Make a backup copy of Viasonix Dolphin
folder, which is located under
C:\Program Files (x86) folder to an
external hard drive. Prior to copying,
make sure that the external hard drive
has sufficient disk space to store the
entire copy of the folder.
The software automatically performs a backup of 4. Under Viasonix Dolphin folder, open Backup
all software settings, protocols, etc. on a weekly folder.
basis. This can be used as a restore point in case a
5. Each folder is a restore point. The name of
setting was changed or a problem appears.
the folder is in the date format YYYYMMDD.
Locate the most recent restore point and
To Reload Software Settings from a open its folder.
Restore Point 6. Right click on Recovery.bat batch file, select
Run as Administrator and confirm if asked.
1. Close Dolphin software on the computer that
needs to be replaced. 7. Read carefully the instruction on screen.
2. Open Windows File Explorer. 8. Enter password: itvia
3. Make a backup copy of Viasonix Dolphin 9. Verify that all files successfully restored.
folder, which is located under C:\Program
10. Open Dolphin software to see if the problem
Files (x86) folder to an external hard drive.
is resolved.
Prior to copying, make sure that the external
hard drive has sufficient disk space to store 11. If the problem is not resolved, you may
the entire copy of the folder. follow the steps above to use another earlier
restore point.
To perform a self-diagnostics procedure on Dolphin system, please follow the instructions below:
6. Once all tests are completed, click on Print Report on the right hand panel. Then, select Print.
Network
Database
Examination
Prior to resetting the software, it is advised to: 4. Try renaming Patients folder to something
o Reinstall software to the latest update else such as PatientsOld. This will force the
according to Section 28 |Service - software to automatically create a new
Upgrading a Software Version. patients database.
o Try the troubleshooting steps in Section 5. Run Dolphin software again and check if the
32 |Service - Troubleshooting. issue is resolved.
o Try using a restore point according 6. Move all *.ezd to files to another location. If
to Section 30 |Service - Using a Restore these files do not exist, the Dolphin software
Point. automatically restores all settings, protocols,
etc. to factory default.
The following steps will reset the software to
factory default: 7. Run Dolphin software again and check if the
issue is resolved. If the issue is not resolved,
1. Make sure Dolphin software is closed. please contact your local representative.
2. In the folder Dolphin Software Recovery
open Examinations Database and Settings.
3. Make a backup copy of all the data in this
folder to an external hard drive. Prior to
copying, make sure that the external hard
drive has sufficient disk space to store all the
data.
The external analog input channels allow Digital Inputs and Outputs
connecting other devices capable of
outputting analog data to Dolphin (for The external digital input and output
example, a Capnograph) in order to display channels are intended for research purposes,
their output signal on Dolphin screen. The for example, to generate a square wave
analog inputs can receive a signal of +/- 10V. signal for brain stimulation (Digital Output)
It is possible to setup each channel or to input a stimulus signal from another
separately including display color, calibration, device (Digital Input). It is not intended for
scale and units. complex communication and cannot be
connected to a computer. The square wave
signal is 0/3.3V.
38
Dolphin Installation and Service Manual
3. On the review station computer, set up a e. Make sure Reconnect at Sign In and
shared drive or folder: Connect using different credentials are
both checked. Click Finish.
a. Open Properties on that driver or folder
f. Type username and password and check
b. Open Sharing tab. Remember my Credentials. Click Ok.
c. Click on Advanced Sharing
d. Check Share this Folder
e. Type a Share Name of your choice for
example DolphinReviewShare
f. Click Permissions and set Full Control
g. Click Ok twice.
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