SERVICE MANUAL
Galaxy™ and Galaxy™²
Intravascular Ultrasound Systems
One Boston Scientific Place
Natick, MA 01760 USA
Table of Contents
Table of Contents..............................................................................2
Table of Figures ..............................................................................10
Boston Scientific Equipment Service Business12
SERVICE PHILOSOPHY....................................................................................................12
SERVICE POLICY............................................................................................................12
Warranty Service.......................................................................................................12
Service Agreement....................................................................................................13
Non-Warranty / Non-Contract ..................................................................................13
TECHNICAL SUPPORT.....................................................................................................13
Chapter 1 About This Manual.....................................15
SERVICE MANUAL SCOPE AND PURPOSE .......................................................................15
GALAXY™ AND GALAXY™².........................................................................................15
OVERVIEW.....................................................................................................................18
WARRANTY INFORMATION............................................................................................18
Warranty Shipments, Returns, and Adjustments ......................................................18
Decontamination of Returned Equipment.................................................................19
Limitations ................................................................................................................19
ONVENTIONS AND SYMBOL DEFINITIONS....................................................................20
C
Symbol Definitions ...................................................................................................21
U
SAGE PRECAUTIONS AND WARNINGS..........................................................................22
Warnings ...................................................................................................................22
Cautions.....................................................................................................................24
MEDICAL ULTRASOUND SAFETY...................................................................................26
DISCLAIMERS ................................................................................................................27
Document ....................................................................................................................... ................................. 27
Application & Usage....................................................................................................................................... 27
Indemnification................................................................................................................................................27
SOFTWARE LICENSE ......................................................................................................27
REGULATORY INFORMATION.........................................................................................29
S
AFETY STANDARDS......................................................................................................30
Relevant Safety Standards............................................................................................................................... 30
2
Instrument Enclosure....................................................................................................................................... 30
System Inputs and Outputs..............................................................................................................................30
Patient Isolation............................................................................................................................................... 31
..............................................................................................................................................31
EGISTERED TRADEMARKS ...........................................................................................31
R
C
OPYRIGHT....................................................................................................................31
Chapter 2 Specifications................................................32
GALAXY™...........................................................................................................32
GALAXY™²...................................................................................................................34
Chapter 3 Introduction to the Galaxy™ System........35
OVERVIEW.....................................................................................................................35
KEY FEATURES AND FUNCTIONALITY ...........................................................................36
High Resolution Display...........................................................................................36
Multiple Image Display.............................................................................................37
IVUS Display .................................................................................................................................................. 37
Longitudinal View (LongView™) ..................................................................................................................37
X-Ray Display................................................................................................................................................. 37
Pre-Post Display.............................................................................................................................................. 38
Overhead Display Compatibility...............................................................................38
Control Panel.............................................................................................................39
Digital Image Storage and Retrieval.........................................................................39
Bookmarking.............................................................................................................39
Measurement Capabilities.........................................................................................40
TraceAssist™ .................................................................................................................................................. 41
Motordrive and Pullback Sled...................................................................................41
Printer........................................................................................................................42
VCR...........................................................................................................................42
Image Storage............................................................................................................43
DICOM 3 Storage Support........................................................................................43
USING THE SYSTEM TO ACQUIRE IMAGES......................................................................44
Initializing the Galaxy™ System..............................................................................44
Patient Data Entry .....................................................................................................44
Vessel and Run Data.................................................................................................45
Imaging......................................................................................................................46
Optimizing the Image................................................................................................46
TGC Sliders..................................................................................................................................................... 46
Gain Knob ...................................................................................................................... ................................. 46
Depth Knob .....................................................................................................................................................47
Rotate Knob..................................................................................................................................................... 47
DDP Knob.......................................................................................................................................................47
Reject Setting...................................................................................................................................................47
3
Gray Scale Map............................................................................................................................................... 47
Pullback.....................................................................................................................47
Pullback Sled................................................................................................................................................... 48
Audio.........................................................................................................................48
Saving Settings..........................................................................................................48
USING THE SYSTEM TO REVIEW IMAGES .......................................................................50
Image Review Source................................................................................................50
Reviewing Digitally-stored Images................................................................................................................. 50
Reviewing Videocassette Images .................................................................................................................... 50
Measurements............................................................................................................51
Computer Assistance....................................................................................................................................... 51
TraceAssist™ .................................................................................................................................................. 51
Annotate....................................................................................................................51
Procedure Reports.....................................................................................................51
Entries.............................................................................................................................................................. 52
Items Reported.................................................................................................................................................52
Archiving Images......................................................................................................53
Manual Archiving............................................................................................................................................ 53
DICOM............................................................................................................................................................ 53
Other................................................................................................................................................................54
IVUS Procedure Archiving.......................................................................................54
Entering File Mode..........................................................................................................................................54
Chapter 4 Functional Description............................55
PURPOSE........................................................................................................................55
SCOPE............................................................................................................................55
OVERVIEW.....................................................................................................................55
Detailed Description..................................................................................................55
Motor Drive 5 (MD5) assembly...................................................................................................................... 55
Image acquisition assembly .............................................................................................................................56
68000 computer............................................................................................................................................... 56
ACQ4...............................................................................................................................................................57
RF4............................................................................................................................ ...................................... 57
HV3.................................................................................................................................................................57
Interconnect................................................................................................................... .................................. 57
Windows NT computer assembly installed in Galaxy™................................................................................. 57
PBUF............................................................................................................................................................... 58
National Instruments A/D board...................................................................................................................... 58
Comtrol serial I/O board ....................................................................................................... ........................... 58
16 bit sound board ........................................................................................................................................... 58
10/100BaseT Ethernet board ........................................................................................................................... 58
Adaptec SCSI controllers ................................................................................................................................ 59
MO Drive.........................................................................................................................................................59
18GB HDD......................................................................................................................................................59
9GB HDD........................................................................................................................................................59
Windows NT computer assembly installed in Galaxy™²................................................................................ 59
Windows NT computer PCA’s common to both Galaxy™ and Galaxy™²..................................................... 60
1) PSC...........................................................................................................................................................60
2) Matrox graphics/frame grab..................................................................................................................60
3) Merlin VCF .............................................................................................................................................61
Control Panel................................................................................................................................................... 61
4
Keyboard ......................................................................................................................................................... 62
Monitor or LCD Display ................................................................................................................................. 62
Printer.............................................................................................................................................................. 62
VCR................................................................................................................................................................. 63
CD-R Drive .....................................................................................................................................................63
DVD+RW Drive.............................................................................................................................................. 63
PC UPS Assembly...........................................................................................................................................63
UPS Power Supply ..........................................................................................................................................63
PCA Power Distribution.................................................................................................................................. 63
PCA UPS Controller........................................................................................................................................ 64
Peripheral Equipment...................................................................................................................................... 64
Merlin VIF....................................................................................................................................................... 64
SXVGA to SVHS converter / Extron .............................................................................................................. 64
System Isolation Panel.....................................................................................................................................65
External Peripheral Equipment .................................................................................................. ...................... 65
X-ray Overhead Monitor Switchbox (OMS) ................................................................................................... 65
GALAXY™ HARDWARE BLOCK DIAGRAMS ..................................................................66
Chapter 5 Galaxy™ System Maintenance..................68
BASIC CARE...................................................................................................................68
Checking Galaxy™ System Performance................................................................68
Checking the UPS Battery ........................................................................................70
Battery Maintenance .................................................................................................71
Replacing a Fuse .......................................................................................................71
Cleaning ....................................................................................................................72
FUNCTIONALITY TEST ...................................................................................................73
Purpose......................................................................................................................73
Equipment & Materials.............................................................................................73
Prior to Testing..........................................................................................................73
Functional Test..........................................................................................................74
PROBLEM SOLVING........................................................................................................78
Motor Drive (MD5) problems...................................................................................78
Intermittent recognition of catheter(s).............................................................................................................78
“Catheter Motor Overload” (error message)....................................................................................................79
“Catheter motor speed out of tolerance” (error message) ................................................................................ 79
MD5 will not pullback..................................................................................................................................... 80
No image, catheter Id. is correct and stable, no error messages appear........................................................... 80
Dark images..................................................................................................................................................... 80
Galaxy™ System console problems.........................................................................81
No video on the display screen when powered up........................................................................................... 81
Error messages following boot process or during the application ................................................................... 81
Printer problems .............................................................................................................................................. 82
VCR problems................................................................................................................................................. 83
Assorted issues ................................................................................................................................................ 84
Chapter 6 DICOM..............................................................85
DICOM C
Overview...................................................................................................................85
ONFIGURATION .............................................................................................85
5
Pre-installation ..........................................................................................................85
Storage Server Considerations......................................................................................................................... 85
Viewing Station Considerations ...................................................................................................................... 86
Quick Reference Procedure.......................................................................................86
Detailed Procedure....................................................................................................89
GALAXY™ SYSTEM DICOM OPERATOR-
CONFIGURATION............................................................................................100
Settings....................................................................................................................100
DICOM Network Operation - Validation ...............................................................103
Networking Parameter Reference ...........................................................................104
DICOM Parameter Reference.................................................................................105
DICOM Information ...............................................................................................107
DICOM OPERATIONS..................................................................................................109
Overview.................................................................................................................109
DICOM Capabilities ...............................................................................................109
DICOM Limitations................................................................................................110
DICOM NETWORK OPERATIONS ................................................................................110
Standard DICOM Network Transfer.......................................................................111
Automated DICOM Network Transfer...................................................................111
Standard DICOM Network Transfers.....................................................................112
By Patient or Vessel ...................................................................................................................................... 112
By Run........................................................................................................................................................... 113
Automated DICOM Network Transfers..................................................................113
Selection........................................................................................................................................................113
Processing...................................................................................................................................................... 114
DICOM STORAGE ON GALAXY™ SYSTEM REMOVABLE DISK
MEDIA...................................................................................................................115
Capacities ...................................................................................................................................................... 115
Method...........................................................................................................................................................116
By Patient or Vessel ...................................................................................................................................... 116
By Run........................................................................................................................................................... 116
DICOM-
DICOM Folder........................................................................................................117
DICOMNET Folder ................................................................................................118
DICOM-specific DiskView Operations..................................................................119
Export Settings........................................................................................................119
Image Compression (Format)..................................................................................119
DICOM Modality....................................................................................................121
Automatic Conversion of Screenshots....................................................................121
Start Frame / End Frame .........................................................................................121
Q
UICK REFERENCE PROCEDURE..................................................................................121
Automated DICOM Network Transfers..................................................................122
Standard DICOM Network Transfers.....................................................................122
DICOM Transfer to Galaxy™ Disks .....................................................................123
ETAILED PROCEDURE................................................................................................123
D
Automated DICOM Network Transfers..................................................................124
RELATED DISKVIEW ITEMS...........................................................................117
Standard DICOM Network Transfers............................................................................................................128
6
Update the Database...................................................................................................................................... 132
DICOM Transfer to Galaxy™ Disks .....................................................................133
Formatting New Media.................................................................................................................................. 133
DICOM Transfers to Galaxy™ Removable Media....................................................................................... 134
Update the Database...................................................................................................................................... 138
Chapter 7 Overhead Monitor Switchbox (OMS)....139
Galaxy™ System
and the Overhead Monitor Switchbox ............................139
Overhead Monitor Switch Box - Basic Functionality.............................................140
Installation Options for the OMS............................................................................141
Materials Required to Install the OMS ...................................................................141
Galaxy™ System OMS Frequently Asked Questions.................................142
Installation at the x-ray monitor (Diagram 1)............................................................................................... 145
Installation in the x-ray card rack (Diagram 2)............................................................................................. 146
Chapter 8 Galaxy™ System Parts Replacement.............149
OVERVIEW...................................................................................................................149
PROCEDURES ...............................................................................................................149
Removal of Galaxy™ System covers......................................................................149
Front cover removal.......................................................................................................................................149
Back cover removal....................................................................................................................................... 149
Top Control Panel assembly removal............................................................................................................150
Side covers removal.......................................................................................................................................150
Back Panel removal (drawing 51236-000) .................................................................................................. 150
On/Off switch..........................................................................................................151
Internal VME Lemo® Cable...................................................................................151
Video Scan Converter .............................................................................................151
Isolation PCA..........................................................................................................151
Merlin VIF PCA......................................................................................................152
VME Power Supply ................................................................................................152
Low Voltage Power Supply Assembly ...................................................................152
Un-interruptable Power Supply (UPS)....................................................................153
UPS Controller PCA ...............................................................................................154
Trackball .................................................................................................................154
Jog Shuttle [Control Panel].....................................................................................154
Keyboard.................................................................................................................154
Keyboard Plunger....................................................................................................155
CD ROM drive (Galaxy™ only)............................................................................155
PC............................................................................................................................155
PC assembly replacement..............................................................................................................................156
Galaxy™ Hard Disk Drives (HDD)...............................................................................................................156
Galaxy™² Hard Disk Drives (HDD).......................................................................................................... 157
PC Printed Circuit Assemblies (PCA)........................................................................................................... 157
CR-RW/DVD +RW drive (Galaxy™² only) ................................................................................................. 158
7
PC Power Supply........................................................................................................................................... 158
Video Cassette Recorder (VCR).............................................................................158
Printer......................................................................................................................158
VME Card Cage......................................................................................................159
Monitor (Galaxy™)................................................................................................160
Monitor cover................................................................................................................................................160
Front Monitor bezel....................................................................................................................................... 160
LCD Display Unit (Galaxy™²)...............................................................................160
Video Splitter (Galaxy™²)......................................................................................160
Front Caster.............................................................................................................161
Chapter 9 Parts................................................................162
Galaxy™ System Parts............................................................................................162
Galaxy™ System Accessories ................................................................................165
Chapter 10 Diagrams...................................................166
Diagram Number Diagram Description
50374-001 Assy, Final, Galaxy™………………………………...
168
50374-001 Assy, Final, Galaxy™………………………………...
169
50374-001 Assy, Final, Galaxy™………………………………...
170
51237-XXX Assy, Final, Galaxy™²……………………………….. 171
51237-XXX Assy, Final, Galaxy™
51237-XXX Assy, Final, Galaxy™²….……………………………. 173
51237-XXX Assy, Final, Galaxy™²……………………………….. 174
51236-000 Assy, Electromechanical Galaxy™
175
51214-001 Assy, LCD Electromechanical Galaxy™
176
51236-000 Assy, Electromechanical Galaxy™
177
10798-003 Assy, Cables, PC, Galaxy™………………….……… 178
10798-002 Assy, Rear Panel, PC, Galaxy™…………………….. 179
10978-002 Assy, Rear Panel, PC, Galaxy™…………………….. 180
8
²……………………………….. 172
²……….………….
²…….………
²…………….…….
Galaxy™² PC photos ……………………………...… 181
11778-007 Assy, VME ……………………………………...…… 182
09531-149 Interconnect Power & Signal, Galaxy™………...…… 183
09531-149 Interconnect Power & Signal, Galaxy™…………..…..184
09531-149 Interconnect Power & Signal, Galaxy™…….….….… 185
09531-447 Interconnect Power & Signal, Galaxy™²………..……186
09531-447 Interconnect Power & Signal, Galaxy™²…..…………187
09531-447 Interconnect Power & Signal, Galaxy™²……………..188
9
Table of Figures
Figure 1 Viewing the software version in the Imaging menu.......................................16
Figure 2 On-screen controls – Graphic User Interface (GUI)......................................36
Figure 3 Cross sectional, LongView™, X-Ray image displayed.................................38
Figure 4 Control Panel..................................................................................................39
Figure 5 Scroll Bar showing Bookmarks......................................................................40
Figure 6 Measurement Example...................................................................................41
Figure 7 Pullback Sled with Catheter & MDU.............................................................42
Figure 8 Patient Data Entry Window............................................................................45
Figure 9 Vessel and Run Identification Tabs................................................................46
Figure 10 Preset Selection Window...............................................................................49
Figure 11 Report Example.............................................................................................52
Figure 12 Completed Report Example ..........................................................................53
Figure 13 MD5 Motor-Drive Unit................................................................................56
Figure 14 Control Panel Functions................................................................................62
Figure 15 Simulator .......................................................................................................68
Figure 16 Typical Simulator Image...............................................................................69
Figure 17 DICOM Network Connector Location..........................................................89
Figure 18 Main Menu access and Imaging Menu Button..............................................90
Figure 19 Viewing the installed software version.........................................................91
Figure 20 DICOM Network Window............................................................................92
Figure 21 Standard MS-Windows Networking Dialog Box..........................................93
Figure 23 DICOMIT Configuration Window................................................................95
Figure 25 DICOM Archives Window used for Testing.................................................98
Figure 26 Settings Window showing DICOM Parameters..........................................100
Figure 27 DICOM Network Window showing DICOM Parameters ..........................102
Figure 28 DiskView showing DICOMNET Pop-up Menu .........................................125
Figure 29 Auto Archival Settings Dialog Box.............................................................126
Figure 30 DICOM Export Dialog Box ........................................................................129
Figure 31 DICOM Storage Destinations Dialog Box..................................................132
Figure 32 The OMS is connected to the “live” fluoro and reference roadmap monitors
and mounted on the monitor yoke assembly................................................140
Figure 33 Galaxy™ input/output connectors located at the back of Galaxy™ .........143
Figure 34 Galaxy
Figure 35 OMS (partial) schematic .............................................................................148
™
² SVGA Connector Location........................................................143
10
11
Boston Scientific
Equipment Service Business
Service Philosophy
• Provide the customer with the highest quality service utilizing a team of dedicated,
competent, well trained and well supported personnel.
• Respond to all customer requests in the most expeditious manner, which is mutually
beneficial to the customer and Boston Scientific.
• Establish and maintain positive, long-term partnerships with all customers of Boston
Scientific Corporation.
Service Policy
• The primary objective of the Equipment Service Business is to provide customers
with a level of service and responsiveness that allows maximum system utilization.
• Products shall be serviced at the customer site or returned to Boston Scientific for
servicing as required. When necessary an exchange or replacement item/unit may be
provided to the customer, during (or instead of) factory repairs. Boston Scientific, or
properly trained personnel, shall perform all Services.
• Boston Scientific Equipment Service Business provides the training, tools, and
service necessary to achieve this result. The company provides support by the
following methods:
Warranty Service
Warranty service is generally provided for:
• One year, instrument – new
• Ninety (90) days, replacement items
Note: Please refer to specific Warranty information in your Galaxy™ or Galaxy™²
User’s Guide and/or your Boston Scientific Sales Agreement. Also reference
Warranty information described in Chapter 1 of this Service Manual.
12
Service Agreement
A Service Agreement can be purchased at any time subject to verification of current
system condition. This contract shall remain in effect for a minimum of one year and a
maximum of five years. Service Agreements will offer a range of services and support
levels.
Non-Warranty / Non-Contract
Boston Scientific will provide Non-Warranty / Non-Contract service to all domestic
customers at an hourly rate, plus travel expenses and replacement parts costs.
Technical Support
Boston Scientific Customer Support will provide telephone assistance, where technical
support is readily available; 5:30am to 5:00pm Pacific Time, Monday through Friday,
excluding all holidays observed by Boston Scientific.
Emergency technical support is always available 24 hours/day, 7 days/week.
EMAIL:
PHONE: AT&T (800) 949-6708
Note: Basic Biomedical Equipment Technician training may be available for the
Note: For clinical support (how to use your system), contact your local Boston
ivus.techsupport@bsci.com
Galaxy™ System. Contact Boston Scientific for more information.
Scientific Sales Representative.
13
14
Chapter 1 About This Manual
Service Manual Scope and Purpose
The Primary user of this documentation will be either a trained or untrained hospital
Biomedical Equipment Technician (BMET) or similarly qualified service personnel.
Please contact Boston Scientific for more information. A secondary user will be a
trained Boston Scientific Field Service Engineer (FSE). Boston Scientific FSE’s are
trained to specific internal procedures, which includes but is not limited to, the entire
contents of this manual.
This document is intended to provide information sufficient for a hospital BMET to
provide proper equipment care, configure pre-sets, and perform basic preventative &
corrective maintenance.
It is assumed the user of this manual can operate the System sufficiently to determine that
it is functioning properly. This manual is intended to provide limited operating
instructions for qualified operators, service personnel and technicians. This manual does
not replace the User’s Guide and is not meant to be a source of clinical information.
Galaxy™ and Galaxy™²
This manual includes information for both Galaxy™ and Galaxy™² Intravascular
Ultrasound Systems (IVUS).
Galaxy™ and Galaxy™
between the two instruments are hardware related. For example, Galaxy™ has a CRT
monitor and Galaxy™² has a LCD display. Galaxy™ has a CD-R and Galaxy™² has a
DVD+RW. Please refer to Chapter 2, Specifications and Chapter 4, Functional
Description for more specific details.
For the purposes of this service manual, these two instruments shall be defined and
referenced throughout as follows:
Galaxy™ pertains only to software version 1.03 and lower
Galaxy™
Galaxy™ System pertains to both Galaxy™ and Galaxy™² as defined herein
² pertains only to software versions 2.01 & 2.02
² instrument functions are virtually the same. Differences
15
The software version may be identified in the Imaging Menu.
Refer to the User’s Guide for more information.
software version
Figure 1 Viewing the software version in the Imaging menu
This manual covers the following areas:
Chapter 1: About This Manual - Provides warnings and general information regarding
the contents of this manual.
Chapter 2: Galaxy™ System Specifications - Provides electrical, connection, physical
and environmental specifications.
Chapter 3: Introduction to the Galaxy™ System - This chapter explains the
capabilities and uses of the Galaxy™ System. It includes important information on the
Galaxy™ System’s unique features. This chapter is introductory in nature and intended
to provide service technicians with a broad overview of the Galaxy™ System. Please
refer to the Galaxy™ or Galaxy™² User’s Guide for more specific details regarding
system operation.
Chapter 4: Functional Description - This chapter provides basic functional descriptions
of Galaxy™ and Galaxy™
principles may be understood.
² components and their interrelationship so that operating
16
Chapter 5: Galaxy™ System Maintenance - This chapter provides information on
maintenance activities that can be performed by the end-user or technical maintenance
personnel. It includes information on basic care of the Galaxy™ System, storage,
cleaning, replacing fuses, considerations when relocating the Galaxy™ System, and
problem solving.
Chapter 6: DICOM - This chapter is divided into two sections; DICOM configuration
and DICOM usage/operation.
• DICOM Configuration: This section provides instructions for configuring the
DICOM feature for Galaxy™ running software version 1.03, or any Galaxy™².
• DICOM settings and operation: These sections describe; 1) the user’s default
settings and manner in which the Galaxy™ System handles DICOM operations 2)
Galaxy™ System DICOM operation.
Chapter 7: Overhead Monitor Switchbox (OMS) - This chapter provides technical
information for understanding the operation and installation requirements for integrating
the Galaxy™ System IVUS Imaging Overhead Monitor Switchbox (OMS) with Cath
Lab x-ray systems. This chapter contains:
• description of OMS system operation
• overview of the installation process
• wiring diagrams and schematics
• frequently asked questions
Chapter 8: Galaxy™ System Parts Replacement - This chapter provides instruction
for removing and replacing the internal subassembly components of the Galaxy™
System. These procedures are intended for field service engineers and biomedical
equipment technicians.
Chapter 9: Parts - This chapter provides an itemized list of Galaxy™ System parts,
accessories and ordering information.
Chapter 10: Diagrams – This chapter provides mechanical breakdown schematics,
wiring and interconnection diagrams for troubleshooting purposes.
17
Overview
Most service support requirements that occur during the first year of ownership of the
Galaxy™ System are covered by the warranty, as explained in the following sections.
For support not covered under the terms of the warranty, Boston Scientific Corporation
offers support on a per-call basis. Please contact the Boston Scientific Equipment
Service Business at 1-800-949-6708 for equipment support for your Galaxy™ System, or
for information on available service support programs.
Warranty Information
Boston Scientific Corporation warrants that reasonable care has been used in the design
and manufacture of the Galaxy™ System. When maintained in such conditions as
specified by Boston Scientific Corporation, it will be free from defects in material and
workmanship at the buyer’s location for 12 months from the date of delivery (unless a
shorter period for a specific component is specified). This warranty is in lieu of and
excludes all other warranties not expressly set forth herein, whether expressed or implied
by operation of law, or otherwise including, but not limited to, any implied warranties of
merchantability or fitness for a particular purpose. Handling, storage, cleaning, and
sterilization of this instrument, as well as other factors relating to the patient, diagnosis,
treatment, surgical procedures, and other matters beyond Boston Scientific Corporation’s
control directly affect the instrument and the results obtained from its use. Boston
Scientific Corporation’s obligation under this warranty is limited to the repair or
replacement of this instrument, and Boston Scientific Corporation shall not be liable for
any incidental or consequential loss, damage, or expense directly or indirectly arising
from the use of this instrument. Boston Scientific Corporation neither assumes nor
authorizes any other person to assume for it, any other or additional liability or
responsibility in connection with this instrument.
Warranty Shipments, Returns, and Adjustments
A warranty claim must be made promptly and must be received by Boston Scientific
Corporation during the applicable warranty period. Should it become necessary to return
a product for repair and/or adjustment, a Return Authorization (RA) must be obtained
from the Boston Scientific Equipment Service Business (1-800-949-6708). Boston
Scientific Corporation will provide instructions as to how and where products should be
shipped. Any product or component returned for examination or for warranty repair shall
be sent insured and prepaid via the means of transportation specified by Boston Scientific
18
Corporation. Shipping charges for all products or components replaced or repaired under
warranty shall be the sole responsibility of the buyer. In all cases, Boston Scientific
Corporation has sole responsibility for determining the cause and nature of a product’s or
component’s failure, and Boston Scientific Corporation’s determination with regard
thereto will be final.
Decontamination of Returned Equipment
To comply with United States postal and transportation laws, equipment returned to
Boston Scientific Corporation must be properly decontaminated with a chemical
germicide that is approved for use as a hospital disinfectant. If equipment is received
without having been decontaminated, Boston Scientific Corporation will charge cleaning
costs to the customer.
Limitations
• This warranty does not cover the Imaging Catheter, Catheter Simulators, or OEM
equipment that is not included in the System Console.
• This warranty does not cover normal calibration, cleaning, or maintenance of the
system.
• Any product returned to Boston Scientific Corporation without prior authorization
shall be returned at sender’s expense.
• Boston Scientific Corporation reserves the right to change or discontinue this
product’s specifications without prior notice.
19
Conventions and Symbol Definitions
The following conventions are used throughout this manual:
Warning or Caution labels on the outside of the Galaxy™ System, or those listed in the
User’s Guide and Service Manual, represent potential hazards for the operator, service
personnel, and the patient.
WARNING
A WARNING indicates that PERSONAL INJURY OR DEATH may occur to patient
and/or user if the user does not observe the provided information.
CAUTION
A CAUTION indicates that DAMAGE TO EQUIPMENT may occur if the user does
not observe the provided information.
PRECAUTION
A PRECAUTION indicates that INCONVENIENCE TO THE USER (such as loss of text
entries or saved settings) may result if the user does not observe the provided information.
IMPORTANT
IMPRORTANT or NOTE: Indicates there is ADVISORY information that is
important for you to be aware of.
20
Symbol Definitions
This symbol is used to draw attention to information that may relate to
safety of the patient, the operator, or the equipment.
This symbol indicates that the equipment is not Category AP, and
therefore must not be used in the presence of flammable liquids or
gasses.
This symbol indicates that the equipment on which it appears is intended
for defibrillator-proof direct cardiac application (type CF), and includes
circuitry to limit the patient leakage current to the levels specified in UL
2601-1, EN 60601-1, and JIS-T-0601-1.
This symbol indicates that the equipment does not utilize a floating
double insulated isolation connection, and therefore must not be
connected to external equipment that is not protectively earthed (DO
NOT connect to class II equipment).
V
Hz
AC
VAC
A
Non-ionizing radiation may be produced by this device.
Voltage
Hertz, cycles per second
Alternating current
Voltage of an alternating current
Amperes (current)
21
mm
millimeters
ms
IPX4
milliseconds
Splash proof. When the sterile cover (Drape) is attached to the
Motordrive and an Imaging Catheter is inserted into the
Motordrive/sterile cover system, that combined unit is splash proof
(IPX4) per IEC 529.
This symbol indicates that the System may be affected by Electro-Static
Discharge (ESD) on or near the System's rear panel connectors when
power is applied. Avoid touching the rear panel connectors or making
connections when the System has power applied.
Usage Precautions and Warnings
Warnings
Inappropriate use of the Galaxy™ System may lead to patient injury or death.
Please read the Galaxy™ or Galaxy™² User’s Guide and the package inserts
for the imaging catheters carefully and completely before attempting to use the
System.
To achieve proper grounding reliability, the power plug must be fully inserted
into a receptacle marked 'Hospital Grade." If there is any question of power
outlet or power cord integrity, do not proceed. Obtain qualified technical
assistance.
To reduce the risk of electric shock, DO NOT connect the Galaxy™ System’s
input or output connections to equipment that is not protectively earthed -grounded (DO NOT connect to class II equipment).
22
For continued protection against fire hazard, replace fuses only with listed and
certified fuse of the specified type and rating indicated on this label located on
the Console rear panel:
NOTE: The box bisected with a line indicates a fuse, “T A” indicates the fuse type, and
“VAC” indicates the alternating current voltage rating. The values appropriate
for your System will be entered (e.g., T8A, 250 VAC, etc.)
The Power-on/Standby Switch on the rear panel does not immediately remove
AC power from the System internally. There may be lethal potentials within
the Galaxy™ System even when the power cord is disconnected due to the Un-
interruptable Power Supply operation. The only power indication is the
System Display Screen.
Possible explosion hazard if used in the presence of flammable anesthetics.
The Galaxy™ System employs a floating double insulated patient isolation
connection within the Galaxy™ System Motordrive Unit. This connection is
intended for defibrillator-proof direct cardiac application (type CF), and
includes circuitry to limit the patient leakage current to the levels specified in
UL 2601-1, IEC 60601-1, and JIS-T-1001.
Use only Imaging Catheters that are specifically approved for the Galaxy™
System. Refer to the Directions for Use supplied with the specific Imaging
Catheter to determine certification for use with the Galaxy™ System. If the
proper identification of a connected Imaging Catheter is not displayed on
screen, do not proceed with its use.
Prior to initiating and during automatic pullback, ensure that the
Motordrive/Sled combination is in a stable position and will not fall. Failure to
do so may jeopardize patient safety.
For instructions on proper disposal methods for the following consumable
items, please refer to the Directions for Use packaged with the item:
• Sled
• Motordrive Drape
• Imaging Catheter
These items may be contaminated and must be handled accordingly.
The Imaging Catheters used with the System are designed for single patient use
only. Do not reuse or re-sterilize catheters
. Previously used or re-sterilized
catheters may result in patient injury or death. Refer to the Catheter Directions
for Use, packaged with each catheter.
23
Instructions in the User’s Guide for Imaging Catheter preparation are provided
for general guidance only. Always follow the Directions for Use packaged with
each Imaging Catheter.
Cautions
If the System will be stored in a location where power cannot be applied (to
maintain the battery in a charged state) for over thirty days, contact Boston
Scientific Service; as the battery should be removed from the System to help
prevent potentially hazardous conditions as a result of the battery deteriorating.
If the hemostasis valve seal is tightened excessively, the rotating imaging core
within the Catheter may become pinched, which can damage it, or cause image
artifacts. (This is not a patient risk issue).
To prevent the Galaxy™ System from interfering with other sensitive
electronic equipment, and for full compliance with “IEC60601-1-2 Collateral
Standard: Electromagnetic Interference”, the System should only be used in an
X-ray shielded room.
Be aware of the potential hazards associated with the environment into which
the equipment will be installed. Boston Scientific cannot anticipate these for
you.
Incorrect connections to the Overhead Monitor Switchbox may cause loss of
video to external monitors. The external video capabilities require an initial
setup procedure prior to use. Boston Scientific’s Field Service personnel must
work in conjunction with your biomedical engineers to implement this
capability. Contact Boston Scientific for details, including a list of compatible
video formats.
The Overhead Monitor Switchbox is used to connect the Galaxy™ System
IVUS System to the overhead monitor. When connecting cables, match
symbols on cabling with symbols on the Overhead Monitor Switchbox.
Never remove the MO Disk Cartridge without using the Eject Button, or data
loss, or damage to the Drive and/or Disk may occur.
Galaxy™ System power must be in Snooze or Standby mode when connecting
or disconnecting external equipment, including the Motordrive and the Lemo®
Cable to the Overhead Monitor Switchbox. Never connect or disconnect the
Motordrive’s cable when the Galaxy™ System is operational.
24
The Galaxy™ System and/or the external equipment can be damaged if signal
levels are not appropriate. If equipment not specifically authorized by Boston
Scientific is to be connected, it must meet all applicable electrical safety
standards that apply to the Galaxy™ System in order to maintain the Galaxy™
System’s safety integrity. Any equipment not supplied by Boston Scientific
must be initially connected by Boston Scientific.
Ensure that the Imaging Catheter is carefully inserted through the opening in
the Imaging Catheter Drape, without catching any part of the Bag between the
Imaging Catheter and the Motordrive.
Never attempt to connect, or disconnect an Imaging Catheter to the Motordrive
while it is running, or damage to the Imaging Catheter or Motordrive may
occur.
If the Imaging Catheter currently connected to the Motordrive is not the same
type as the Procedure Catheter displayed, measurement results may be invalid.
Always connect an Imaging Catheter of the same type as displayed as
“Procedure Catheter” while making measurements.
Do not change types of Imaging Catheters during a Run or invalid measurement
results may result.
If an Imaging Catheter that has not been approved for use with the Galaxy™
System is connected, or if a Catheter is not properly connected, the
corresponding Imaging Catheter identification data and Displayed Depth will
not be displayed. Imaging will be disabled. Resolve this issue before
continuing use. The System and/or the Imaging Catheter could be damaged if a
Catheter is connected that is not approved for such use.
For best results, do not attempt to manually move the Motordrive once it is
installed in a Sled without the use of the Release Lever, or damage to the Sled
may occur.
Do not allow anything to obstruct the pathway of the Motordrive on the Sled, as
this will interfere with proper pullback motion.
Never attempt to re-use the disposable Sled for subsequent procedures. Its
internal movement mechanism was not designed for prolonged usage.
Repeated usage will result in wear that will degrade measurement accuracy.
25
A number of the components devices used with the Galaxy™ System (e.g., the
imaging catheter, disposable sled, motor drive cape) are for single patient use
only. Reuse, reprocessing, or re-sterilization of these devices may compromise
the structural integrity of such devices and lead to device failure which, in turn,
may result in inaccurate measurements, patient injury, illness, or death.
Carefully review the directions for use of each component used with the
Galaxy™ System for reuse precautions.
Boston Scientific Corporation assumes no liability with respect to single use
devices that are reused, reprocessed, or re-sterilized, and makes no warranties,
expressed or implied (including the warranties of merchantability or fitness for
a particular use), with respect to such devices.
Do not apply adhesive labels (other than circular labels designed specifically
for CD-R labeling) on the CD-R. Other labels may unbalance the CD-R; or
come loose, potentially damaging the Drive or CD-R.
Improper setting of the DDP or Reject selections may obscure diagnostically
valuable information in the display.
The default Gray Scale Map has been pre-selected as being appropriate for
most imaging circumstances. Improper setting of this selection may obscure
diagnostically valuable information in the display.
The Galaxy™ System is immune to in-band RF interference at field strengths
less than 32 mV/m. When imaging in the presence of in-band signals that are
greater than 32 mV/m, the interference may appear on the monitor as bright
speckles, snow, spokes, white background, or other forms. In extreme cases,
the interfering signal may render the image unreadable until the transgressing
signal is terminated.
Per IEC60601-1-2 Collateral Standard: Electromagnetic Interference for patient
connected systems, the immunity levels for external electromagnetic
interference is 10mV/m for the Galaxy™ System.
Medical Ultrasound Safety
Anyone using the Galaxy™ System for human procedures of any kind should
thoroughly understand the implications of such use. The AIUM (American Institute of
Ultrasound in Medicine) has published a document titled Medical Ultrasound Safety
(AIUM 1994). ALARA is an acronym for the principle of prudent use of diagnostic
ultrasound by obtaining the diagnostic information at a power output that is As Low As
Reasonably Achievable. To obtain a copy of this document, please contact the AIUM.
26
Disclaimers
Document
Boston Scientific makes no representations or warranties of any kind concerning the
contents of this publication. Under no circumstances will Boston Scientific be held liable
for any loss or other damages pertaining to the use of this publication.
This publication is general in nature. The information contained in this publication is
subject to change without notice. Boston Scientific reserves the right to make changes
and product improvements at any time and without prior notice. Consult Boston
Scientific for information regarding the current version of this publication.
Application & Usage
Boston Scientific warrants that its products possess the characteristics represented on the
product labeling and will perform as represented by Boston Scientific when used
according to the instructions for use supplied by Boston Scientific.
Indemnification
Since its products are used in circumstances beyond Boston Scientific’s control, the
buyer and user agree to assume all liability and to be solely responsible for, and to
defend, indemnify, and hold Boston Scientific harmless from any claims or damages
whether arising from warranty, contract, or otherwise (including negligence, strict
liability, and failure to warn) based on improper inspection, selection of patients,
application, operation, equipment service, or use of Boston Scientific products, including
multiple use of single-use items.
No agent, employee, or representative of Boston Scientific has the authority to change
any of the foregoing or assume or bind Boston Scientific to any additional liability or
responsibility in connection with this product.
Software License
You have acquired a device that includes software developed and owned by Boston
Scientific Corporation, as well as software licensed by Boston Scientific from various
software licensors ("Boston Scientific’s Software Suppliers"). Those installed software
products of Boston Scientific and Boston Scientific’s Software Suppliers, as well as all
associated media, printed materials, and "online" or electronic documentation
("SOFTWARE") are protected by copyright laws and international copyright treaties, as
well as other intellectual property laws and treaties. The SOFTWARE is licensed, not
sold.
27
IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT ("EULA"),
DO NOT USE THE DEVICE OR COPY THE SOFTWARE. INSTEAD, PROMPTLY
CONTACT BOSTON SCIENTIFIC FOR INSTRUCTIONS ON RETURN OF THE
UNUSED DEVICE(S) FOR A REFUND. ANY USE OF THE SOFTWARE,
INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE, WILL
CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR RATIFICATION OF
ANY PREVIOUS CONSENT).
GRANT OF LICENSE. The SOFTWARE is licensed, not sold. This EULA grants you
the following rights to the SOFTWARE:
• You may use the SOFTWARE only on the DEVICE. You may not: (1) copy
(other than for back-up purposes), distribute, rent, lease or sublicense all or
any portion of the SOFTWARE; (2) modify or prepare derivative works of the
SOFTWARE; (3) publicly display visual output of the SOFTWARE; or (4)
transmit the SOFTWARE over a network, by telephone, or electronically
using any other means. You agree to keep confidential and use your best
efforts to prevent and protect the contents of the SOFTWARE from
unauthorized disclosure or use.
• NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT
TOLERANT. BOSTON SCIENTIFIC HAS INDEPENDENTLY
DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE AND
BOSTON SCIENTIFIC’S SOFTWARE LICENSORS HAVE RELIED
UPON BOSTON SCIENTIFIC TO CONDUCT SUFFICIENT TESTING TO
DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE.
• NO WARRANTIES FOR THE SOFTWARE. THE SOFTWARE is provided
"AS IS" and with all faults. THE ENTIRE RISK AS TO
SATISFACTORY QUALITY, PERFORMANCE, ACCURACY, AND
EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU.
ALSO, THERE IS NO WARRANTY AGAINST INTERFERENCE
WITH YOUR ENJOYMENT OF THE SOFTWARE OR AGAINST
INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRANTIES
REGARDING THE DEVICE OR THE SOFTWARE, THOSE
WARRANTIES DO NOT ORIGINATE FROM, AND ARE NOT BINDING
ON, BOSTON SCIENTIFIC or BOSTON SCIENTIFIC’S SOFTWARE
LICENSORS.
• Note on Java Support. The SOFTWARE may contain support for programs
written in Java. Java technology is not fault tolerant and is not designed,
manufactured, or intended for use or resale as online control equipment in
hazardous environments requiring fail-safe performance, such as in the
operation of nuclear facilities, aircraft navigation or communication systems,
air traffic control, direct life support machines, or weapons systems, in which
the failure of Java technology could lead directly to death, personal injury, or
severe physical or environmental damage. Sun Microsystems, Inc. has
28
contractually obligated Boston Scientific and Boston Scientific’s Software
Licensors to make this disclaimer.
• No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW,
BOSTON SCIENTIFIC AND BOSTON SCIENTIFIC’S SOFTWARE
LICENSORS SHALL HAVE NO LIABILITY FOR ANY INDIRECT,
SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES
ARISING FROM OR IN CONNECTION WITH THE USE OR
PERFORMANCE OF THE SOFTWARE. THIS LIMITATION SHALL
APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL
PURPOSE. IN NO EVENT SHALL BOSTON SCIENTIFIC OR
BOSTON SCIENTIFIC’S SOFTWARE LICENSORS BE LIABLE FOR
ANY AMOUNT IN EXCESS OF U.S. TWO HUNDRED FIFTY
DOLLARS (U.S. $250.00).
• Limitations on Reverse Engineering, Decompilations, and Disassembly.
You may not reverse engineer, decompile, or disassemble the SOFTWARE,
except and only to the extent that such activity is expressly permitted by
applicable law notwithstanding this limitation.
• SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS.
You may permanently transfer rights under this EULA only as part of a
permanent sale or transfer of the Device, and only if the recipient agrees to
this EULA. If the SOFTWARE is an upgrade, any transfer must also include
all prior versions of the SOFTWARE.
• EXPORT RESTRICTIONS. You acknowledge that the SOFTWARE is of
US-origin. You agree to comply with all applicable international and national
laws that apply to the SOFTWARE, including the U.S. Export Administration
Regulations, as well as end-user, end-use and country destination restrictions
issued by the U.S. and other governments. For additional information on
exporting the SOFTWARE, see http://www.microsoft.com/exporting/.
Regulatory Information
United States Federal Law restricts this device to sale by or on the order of a physician,
licensed by the law of the jurisdiction in which they practice, to use or order the use of
this device.
Ultrasound scanning of human subjects for medical diagnostics should only be performed
by qualified medical professionals. Although there have been no confirmed adverse
effects produced by diagnostic levels of ultrasound, unnecessary exposure should be
avoided.
29
The Galaxy™ System meets the acoustic output emission guidelines established by the
Food and Drug Administration (FDA) and the International Electrotechnical Commission
(IEC). The total ultrasonic power emitted from the imaging catheter has been measured,
using a calibrated hydrophone and an automated drive system to scan the acoustic field
around the catheter tip when it is immersed in water. In order to maximize the measured
values, the intensity of the ultrasound beam was determined with the calibrated
hydrophone as near to the surface of the catheter as possible (the Galaxy™ System
drives the imaging catheters in B-mode only).
Guidelines for measurements and definitions of terms may be found in:
1) Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers issued by the FDA, U.S. Department of Health
and Human Services, Center for Devices and Radiological Health, Sept. 30, 1997.
2) IEC publication 60601-2-37, which establishes particular requirements for the safety
of ultrasonic diagnostic equipment and those aspects thereof which are directly
related to safety.
Safety Standards
Relevant Safety Standards
All Boston Scientific instruments, cables and diagnostic ultrasound imaging catheters
have been designed to meet all appropriate requirements contained within UL 2601-1
(Standard for Medical Electrical Equipment Part 1: General Requirements for Safety),
IEC 60601- (Medical Electrical Equipment Part 1: General Requirements for Safety),
and JIS-T-1001 (General Requirements of Medical Electrical Equipment), including
limits for current leakage and isolation from primary power line. Chapter 22 of Volume
2 of the Galaxy User’s Guide provides information pertaining to FCC and IEC
compliance.
Instrument Enclosure
The Galaxy™ System is a Class I protectively earthed (grounded) System. The main AC
inlet Isolation Transformer is certified to be in compliance with EN 60601-1, and limits
the enclosure leakage currents to non-patient connected levels in both normal and single
fault conditions. The System Enclosure leakage current is tested during production on all
Systems for various primary power and ground conductor faults.
System Inputs and Outputs
The System’s isolation panel and hi-line video connectors provide a 500V dielectric
withstand between the System’s I/O connectors and the System’s enclosure to prevent
30
unwanted voltages and/or currents from flowing to the System’s enclosure. Both isolation
barriers operate on safety extra low voltage (SELV) circuits only.
Patient Isolation
The Galaxy™ System employs a floating double insulated patient isolation connection
within the Galaxy™ System Motordrive Unit. This connection is intended for
defibrillator-proof direct cardiac application (type CF), and includes circuitry to limit the
patient leakage current to the levels specified in UL 2601-1, EN 60601-1, and JIS-T0601-1.
The CE marking in the labeling of Galaxy™
Medical Device Directive 93/42/EEC.
The CE marking in the labeling of Galaxy™ signifies that at the time of manufacture
Galaxy™ complied with the European Medical Device Directive 93/42/EEC. Galaxy™
is no longer manufactured, refurbished, or otherwise available for sale from Boston
Scientific.
² signifies compliance with the European
Registered T rademarks
Referenced throughout this manual:
• Cidex® & Cidex Plus® are registered trademarks of Johnson & Johnson Medical,
Inc., Arlington, TX
• Lemo® is a registered trademark if Interlemo Holding S.A., Ecublens, Switzerland
• APC® is a registered trademark of American Power Conversion Corporation,
W. Kingston, RI.
Copyright
Copyright © 2004 Boston Scientific Corporation. All rights are reserved. These
documents are the property of Boston Scientific Corporation and shall not be reproduced,
distributed, disclosed, or used for manufacture or sale of apparatus without the expressed
written consent of Boston Scientific Corporation.
31
Chapter 2 Specifications
This chapter provides electrical, connection, physical and environmental
specifications.
Galaxy™
Type Parameter Value
Electrical Power requirements 120 VAC, 60 Hz (U.S.)
220 VAC, 50/60 Hz
100 VAC, 50/60 Hz (Japan)
230 VAC, 50/60 Hz (Europe)
Power consumption Nominal 5 A @ 120 VAC
Nominal 6 A @ 100 VAC
Nominal 2.7 A @ 220/230 VAC
Maximum 650VA
Catheter frequency 9-40 MHz
Safety
Input/Output RF Output Analog RF Waveform
Connectors RF-I Output
RF-Q Output
RF Trigger Output Future use
ECG Input Signal +
P1, P2 Pressure Inputs Future use
LAN In/Out Future use
RS-232 In/Out Future use
Video In/Out RS-170 525-60
Impedance = 75 Ohm
Video Output NTSC (RS-170(A)) Compatible,
525 lines, 60 Hz, (U.S. and Japan)
Class I per IEC 60601-1, UL2601-1, JIS-T-1001
Applied part (Motordrive) Defibrillation-proof type CF
Future use
Future use
1.0 V max. swing (factory default setting)
PAL 625/50
Siemens 1023/60, 1249/50,
1023/120
GE 1023/60, 1249/50
Philips 1049/60, 1166/76
Shimadzu 1125/60
32
Type Parameter Value
Isolated S-video (Y - C),
Output Impedance = 75 Ohm
Physical System weight 445 lbs. / 202 Kg.
Shipping weight 705 lbs. / 320 Kg.
System dimensions 64” H, 30” D, 24” W
163 cm H, 76 cm D, 61 cm W
Crate dimensions 73” H, 47” D, 39” W
185 cm H, 119 cm D, 97 cm W
Environmental
(operating)
Relative humidity 30 to 70 %
Pressure (P) 700 to 1060 hPa
Environmental Temperature
(Storage/transit)
Relative humidity 10 to 85 %
Pressure (P) 500 to 1060 hPa
Temperature
+10 to +40 °C
-10 to +50 °C
33
Galaxy™²
Ordering Information
™
GALAXY
2
SYSTEM TECHNICAL SPECIFICATIONS
Processor: Pentium®4 2.4 GHz
Operating System: Windows NT
Database Structure: Microsoft Access
Digital Archiving: Hard Drive 120 GB
Dimensions: 64”H (LCD open) or
System Weight: 377 Lbs.
Shipping Weight: 695 Lbs.
Frequency of Operation: 9–40 MHz
Catheter Compatibility:........All Boston Scientific Ultrasound
Power Requirements: 100–240 VAC, 50/60 Hz
Monitor: 17” LCD Flat Panel Monitor (Foldable)
Monochrome Digital
Graphic Printer: Gray Scale, 256 Shades
VCR: NTSC
Input/Output: RS232, ECG Input, Pressure 1&2 Input,
Safety Standards: Class 1 per EN 60601-1,
Environmental: (Operating) Temperature +10 to +40˚C
MD5-Motordrive Unit: Handheld Imaging Controller
OMS-Overhead
Monitor Switchbox: (Not Included– Order) X-ray Integration
DVD+RW over 3.5 GB
CDR 650 MG
48” H (LCD closed),
30”D, 24”W
Imaging Catheters
RF Trigger Output, RF Output, Composite
Video Output, S-VHS Video Output, LAN
UL2601-1, JIS-T-0601-1
™
Galaxy
2
IVUS Imaging System
®
®
ORDERING INFORMATION
H749I51280 (120 V, NTSC): Galaxy
Hardware Accessories
H749A70200: Galaxy Disposable Pullback Sterile Sled
H749A70260: Galaxy Motordrive (MD5) Sterile Cover
H749019330010: Sony Printer Paper UPP-110HD
™
2
Disposable
Pullback Sled
34
Chapter 3 Introduction to the Galaxy™ System
This chapter explains the capabilities and uses of the Galaxy™ System. It includes
important information on the Galaxy™ System’s unique features.
This chapter is introductory in nature and intended to provide service technicians with a
broad overview of the Galaxy™ System. Please refer to the Galaxy™ or Galaxy™²
User’s Guide for more specific details regarding system operation.
Overview
The Galaxy™ System Intravascular Ultrasound System (IVUS) provides state-of-the-art
real-time viewing of internal vascular structures such as coronary and peripheral arteries,
and intra-cardiac applications.
The Galaxy™ System sets new standards in diagnostic capabilities and efficiency-of-use
in the Imaging Lab through its wide range of advanced features, such as:
• Integrated Automatic Pullback Subsystem offering quick preparation and
lightweight design.
• Longitudinal vessel view, to aid in interpretation and analysis.
• Enhanced display modes, including split screen views of IVUS, Longitudinal
view and angiographic views.
• IVUS image display on overhead monitors.
• Real-time digital procedure storage capability with ‘bookmark’ capability.
• Computer-aided linear and area measurements, including computation of Cross-
sectional Area (CSA) and Percent Stenosis.
• Luminal and vessel border detection using TraceAssist™.
• Image quality enhancements in gray scale, display quality, and blood speckle
reduction.
• Read/write DVD, CD-ROM and/or Magneto-optical (MO) disk drives for digital
archiving of procedures and reports.
• Real-time audio recording captures comments during procedures.
• Semi-automatic Report Generation.
• A Patient Database.
• Automated archiving to DICOM Network
35
• Familiar ‘windows-like’ user interface.
• A task-optimized ergonomic Control Panel.
• An integrated back-up power supply supports quick relocation.
Key Features and Functionality
The Galaxy™ System offers a wide range of important features to aid in intra-vascular
imaging.
High Resolution Display
A high resolution SXVGA (1280 x 1024) 17-inch color CRT-type monitor or LCD
display is provided, with an integrated microphone to record procedure-related
conversations.
Menu
buttons
Auto-hide
menu bar
Figure 2 On-screen controls – Graphic User Interface (GUI)
For ease of use, the on-screen controls utilize the familiar Windows point-and-click
interface. The auto-hide menu bar further simplifies the interface.
NOTE: Some images are shown in reversed grayscale for improved clarity when
printed.
36
Multiple Image Display
The Galaxy™ System can simultaneously display up to three modes at once, including:
IVUS Display
The IVUS image can be displayed full screen, or as a quarter screen when combined with
other display modes. The Galaxy™ System automatically switches the IVUS display to
quarter screen when the LongView™ imaging mode is selected.
Longitudinal View (LongView™)
The Galaxy™ System provides a fully integrated longitudinal view (LongView™)
display, where a sequence of tissue data frames are acquired during a System-controlled
transducer pullback, and displayed congruent to the blood flow. An adjustable “cutplane” indicator selects a two-dimensional slice through the imaged vessel, perpendicular
to the conventional cross-sectional IVUS image for the LongView™ display. The
Galaxy™ System can also use ECG gating for selection of IVUS frames used for the
LongView™ display. ECG gating helps minimize tissue border artifacts caused by the
cardiac cycle.
X-Ray Display
The Galaxy™ System can display an externally-sourced X-ray image full screen, or as a
quarter screen. Like the IVUS display, the X-ray Display is switched to the quarter
screen when the LongView™ display mode is selected.
37
Longitudinal
display area
Cross
sectional
display area
X-ray display
area
Figure 3 Cross sectional, LongView™, X-Ray image displayed
Pre-Post Display
The Galaxy™ System can also display simultaneous side-by-side viewing (not shown
here) of two procedures for comparison. The System divides the normal image viewing
area into two windows, and automatically displays the DiskView Window, which is used
to select the Bookmarked images to be displayed in these two windows.
Overhead Display Compatibility
The IVUS screen can be displayed on most imaging overhead monitors to aid in
visualization of the IVUS imaging by others in the lab. An Overhead Monitor Switchbox
(OMS) is placed in the lab, and provides connections between the Galaxy™ System and
the existing overhead imaging X-ray display. The module also identifies the specific lab
to the Galaxy™ System. This allows the System to automatically configure to the lab’s
38
video requirements (after initial setup has been done) when it is relocated. Your
biomedical engineers must work together with Boston Scientific personnel to implement
this capability. Please contact Boston Scientific for details, including a list of compatible
X-ray video formats.
Refer to Chapter 7 for more information regarding the Overhead Monitor Switchbox option.
Control Panel
Functions used during a normal IVUS procedure are provided via a task-efficient Control
Panel, optimized according to the flow of an IVUS procedure. Settings used less
frequently are provided via on-screen menus, to streamline operations. Controls are
back-lit to aid visualization in reduced light environments, and indicate when a control is
activated.
Figure 4 Control Panel
Digital Image Storage and Retrieval
The Galaxy™ System stores IVUS images in digital format to preserve image quality,
optimize review time, and enable computer-aided image enhancement and
measurement/analysis capabilities. Digital storage includes the internal Imaging Hard
Disk, magneto-optical (MO) disk, CD-R, or DVD+RW in either the Galaxy™ System or
DICOM format. DICOM (Digital Imaging and Communications in Medicine). Network
storage of Galaxy™ System studies is also supported. The System can retrieve and play
back locally stored IVUS images in real-time as a continuous loop, as if they were “live”.
Bookmarking
39
The Bookmarking feature is used to identify regions of interest during or after image
acquisition, providing easy review of key image data by clicking the Bookmark.
Bookmarks can be set either while recording or playing images. If an X-ray image is
displayed on the Galaxy™ System at the time the Bookmark is created, it will be stored
along with the IVUS record.
Other data that is stored with a Bookmark, in addition to the displayed IVUS and X-ray
images (as available), are:
• Frame (index) number
• Displayed measurement and annotation information
• The current display format (LongView™, etc.)
• Depth setting
• Imaging Catheter
Bookmarks can be used during review to quickly retrieve a single IVUS frame (or single
LongView™ sequence). Additional Bookmarks can be set during image review.
Bookmarks
Figure 5 Scroll Bar showing Bookmarks
Scroll Bar
Measurement Capabilities
Frame Indicator
The Galaxy™ System provides accurate and efficient measurements. The measurement
feature allows up to six linear cross-sectional measurements. As each linear
measurement is completed, that distance appears on screen. When an area is defined, the
Galaxy™ System can automatically determine the minimum and maximum diameter
within that area, and the Cross-sectional Area (CSA). The Galaxy™ System facilitates
measurements in the LongView™ display, which may help determine lesion length.
40
Figure 6 Measurement Example
TraceAssist™
The Galaxy™ System also offers a TraceAssist™ feature that uses computer image
analysis to automatically detect and identify the cross-sectional luminal and vessel
border. The computer-generated border is easily modified, if desired.
Motordrive and Pullback Sled
The Motordrive provides the rotation of the Imaging Catheter Core required for crosssectional imaging of a vessel. With the aid of the Sled, the Automatic Pullback function
provides a constant rate of longitudinal movement of the Imaging Catheter Core. This
allows the Galaxy™ System to provide longitudinal (LongView™) displays of the
pullback area. The disposable Sled is used for a single IVUS procedure, which can
consist of multiple pullbacks. The System displays pullback distance information on the
Motordrive’s integrated display, and on screen.
The Motordrive is placed in a sterile disposable drape (cover) during use. The disposable
Sled is sterile, eliminating the need for a second sterile cover for the Sled, which
simplifies setup.
41
Other Automatic Pullback features include:
• Selectable pullback rate: 0.5mm/sec or 1.0 mm/sec
• Pullback distance displayed on the Motordrive, on-screen, and (optionally)
overhead
• Optional synchronization to an external ECG input
• No external power (battery) requirements
The Motordrive and Automatic Pullback Subsystem are compatible with applicable
Boston Scientific Imaging Catheters.
Motordrive
Imaging
Catheter and
Anchor Post
Pullback
Sled
Figure 7 Pullback Sled with Catheter & MDU
Printer
A high-resolution graphics printer is incorporated into the Galaxy™ System Console.
The Printer is operated by pressing the Print Button on the Galaxy™ System Control
Panel, and provides high-resolution monochrome prints of the display. Print results are
also saved as a file on the System Imaging Hard Disk. These can be located in the File
Manager and are listed as “screenshots.” These screenshots are bitmap (*.BMP) files
that can then be copied to CD-R or DVD+RW and removed from the system for viewing
on any PC.
VCR
The Galaxy™ System includes an SVHS-format VCR integrated into the Console. The
VCR is operated using its built-in front panel controls. It can also be configured to
record automatically when the Record Button is pressed on the Galaxy™ System
Control Panel. VCR and digital image playback are independent of each other.
42
Image Storage
The Galaxy™ System offers two selections for how images are stored during
acquisition; 1) to the Imaging Hard Disk only 2) to the Imaging Hard Disk and the
VCR. By default, images are initially digitally stored on Galaxy™ System’s internal
Imaging Hard Disk to provide the digital cine-loop capability. The acquired images can
also be simultaneously recorded by the VCR for (analog) storage on videocassette.
DICOM 3 Storage Support
The Galaxy™ System provides conversion of IVUS procedures performed on the
System into DICOM (Digital Imaging and Communications in Medicine) formatted
multiple frame series of images, or single frame images. The Galaxy™ System’s
DICOM-formatted images are intended for viewing off the System at Viewing Stations
capable of displaying images in the DICOM 3 Ultrasound modality, or IVUS modality.
The System can store the images it converts to DICOM format on its internal disk drives
(System Hard Disk, MO, CD-R, DVD+RW). Additionally, if the System has been
configured into a DICOM network, it can also store DICOM-formatted images to Storage
Servers on that network, on either an immediate basis, or from a queue on a scheduled
basis.
43
Using the System to Acquire Images
The following sections describe how the Galaxy™ System features explained in the
previous sections are utilized to perform an IVUS procedure.
Note: This information is introductory in nature. Typical clinical implementation is not
described herein.
Initializing the Galaxy™ System
Normally the System is maintained in a power-on state, ready to begin imaging
immediately. The Galaxy™ System has an internal power supply that will allow the
System to enter a standby (Snooze) mode (without imaging) for several minutes,
allowing it to be unplugged and relocated without shutdown and start-up delays. This
feature also provides protection against loss of imaging data in the event that the System
is accidentally unplugged during a procedure.
If the System is powered off, a switch located on the Console initiates the power-up
sequence, and within a few moments it is ready for use without any further operator
intervention.
Patient Data Entry
The Patient Button (or menu selection) provides access to the Patient Window, and the
Patient Search function, which queries the Database for previous entries for a patient.
The System is also configured to allow initialization of a procedure without first entering
the patient data when an emergent situation arises, although pre-entry is recommended.
Patient data (and procedure-related) data entries include:
• Last Name
• MI (Middle Initial)
• First Name
• Patient ID
• Date-of-Birth
• Sex
• Physician
• Tape Number
• Disk Number
• Comments
44
Only the patient’s last name and ID (identification number) are required entries.
Access to
Patient
Database
Figure 8 Patient Data Entry Window
Vessel and Run Data
The Galaxy™ System facilitates identification of the vessel being imaged and of each
scan of the vessel (called a “Run”). Entry of this data facilitates computer-assisted
measurements, report generation, and image archival features. Each Run can last up to
five minutes (or longer, when using an ICE Imaging Catheter), and contain up to ten
centimeters of longitudinal information.
Some examples of Run identifications are:
• Pre – used to identify imaging done before
• Post – used to identify imaging done after a procedure.
• Stent – used to identify imaging of stent deployment.
Commonly used procedures and devices are provided in the selection list, with the
capability to add others
a procedure.
45
Run Name
-
Run Tab
(will be
named from
Run pick-list)
Vessel Tab
(will be
named from
Vessel picklist)
Figure 9 Vessel and Run Identification Tabs
Imaging
Imaging is started or stopped using either of two Image Buttons. One is located on the
Control Panel of the Console and the other is located on the Motordrive.
Optimizing the Image
Several controls and settings are available for optimization of the displayed image
(although this is not normally necessary). These are:
TGC Sliders
Time Gain Control (TGC), allows segmented changes in gain relative to the distance
from the Transducer.
Note: TGC settings are automatically set according to the (automatically detected)
characteristics of the Imaging Catheter currently connected. A button adjacent to
the (normally off) TGC controls can be pressed to activate these controls.
Gain Knob
The Gain setting controls the overall echo intensity.
46
Depth Knob
The Depth control provides a “zoom” (magnification), which can be used to obtain a
more detailed view of the region nearest the Transducer. Depth is not adjustable during
an automated controlled pullback using the disposable sled.
Rotate Knob
The Rotate control allows rotation (re-orientation) of the cross-sectional IVUS image for
convenient viewing.
DDP Knob
Data Dependent Processing (DDP) provides sophisticated image processing that can help
remove “blood speckle” in the image resulting from reflections from (moving) blood
cells.
Reject Setting
The Reject setting allows elimination of low-level signals that may result in noise clutter
in the image.
Gray Scale Map
Gray Scale Mapping allows selection of how echo intensities are translated into the
black-through-white image intensity display.
Note: The default values of all of these settings have been optimized for most imaging
situations. Improper alteration of these settings may degrade image quality or obscure
diagnostically significant information.
Pullback
The Automatic Pullback Subsystem consists of the Motordrive and the Sled. Use of the
Automatic Pullback Subsystem is required when the System’s LongView™ imaging
mode is utilized. If longitudinal movement is to be done while imaging, the Automatic
Pullback Subsystem offers a more uniform result than can normally be attained through
manual movement. There are two available pullback rates – 0.5 and 1.0 mm/second (0.5
is the recommended setting). The pullback motion can be started and stopped from the
Pullback Start/Stop Buttons located either on the Motordrive, or on the Control Panel.
Image acquisition can also be synchronized to an externally supplied ECG input, to
reduce the effects of heart motion on the images.
47
Pullback Sled
The Galaxy™ System uses a disposable pre-sterilized Sled to provide uniform
longitudinal movement. The Pullback Sled enhances the operation by reducing draping
and sterilization requirements. The Motordrive unit (required for all imaging) is draped
and then inserted into the corresponding receptacle (cup) in the Sled. The Imaging
Catheter is then connected to the Motordrive, and its Anchor Housing is inserted into the
Anchor Post at the nose of the Sled.
The Motordrive can be manually moved along the Sled when the Release Lever (at the
rear of the Motordrive) is pressed. The Motordrive also has a digital position readout,
and a button to zero the reading at the desired point. The pullback distance is displayed
both on the Motordrive’s display and on the Galaxy™ System screen.
Audio
The Galaxy™ System is equipped with a Microphone, which is built into the Display
housing. User comments are recorded whenever images are being recorded. (The
playback can be turned off if desired).
Saving Settings
The Galaxy™ System offers a wide range of settings to allow optimization of its
operation. The default values established by Boston Scientific for these settings are
optimized for most imaging situations based on inputs from experienced IVUS personnel.
Those default values are stored as the “Galaxy™ System Default” Preset.
After using the System, if you have changed any of the following parameters, those
changes (along with other un-altered settings) can be saved as a separate Preset. Storable
parameters include:
• Recording device(s) (e.g., VCR, MO Disk, etc.)
• Time and date format
• TGC settings
• TraceAssist™ settings
• Grid settings
• Reject level
• Gray Scale
• DDP setting
• Pullback speed
• Audio settings
• X-ray source
• Current Imaging Catheter type
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• Display Mode
• Parameter Display mode
• Depth Setting
• Grid off/on state
Multiple Presets with differing content can be saved, and can be named with intuitive
keywords (such as a procedure type or user’s name)
The Galaxy™ System default preset values are permanently stored in the System, and
can be applied at any time, allowing quick restoration of those settings. The default
preset values cannot be altered.
Figure 10 Preset Selection Window
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Using the System to Review Images
The following sections describe how the Galaxy™ System features explained in the
previous sections are utilized in reviewing IVUS images. Image Review is the “normal”
mode, and is automatically implemented when no other mode is selected.
Image Review Source
Most image review operations are performed immediately following acquisition. That
image data is normally stored on the Imaging Hard Disk. Other possible review sources
are the MO Drive, CD-R & DVD+RW Drive, and VCR. The Patient Database feature
can be used to quickly locate previous procedures.
Reviewing Digitally-stored Images
The Disk Review controls on the Control Panel mimic VCR control functions, allowing
Play, Jog, Shuttle, Pause, and Stop features. The current Run will play in a continuous
loop if desired. The Shuttle control can function as a variable speed fast-forward or
reverse, with rates from 12 to 120 frames per second (normal frame rate is 30 FPS).
Additionally, the controls provided on the Scroll Bar below the image, and the Frame
Counter display can be used to move through the selected Run.
During review, any previously saved image overlay features (e.g., Grid, Measurements,
Annotations) will be displayed, and the original Depth setting will be maintained. If a
Run is being reviewed in the LongView™ mode, the Cut Plane Indicator in the crosssectional area of the display can be re-located to any position (using the Trackball), and
the LongView™ display will be updated accordingly. The Trackball can also be used to
reposition the Current Frame Cursor in the LongView™ display, and the cross-sectional
area of the display will be updated accordingly.
Reviewing Videocassette Images
If the archive is on tape, once the appropriate videocassette is inserted, the VCR’s front
panel controls can be used to review the procedure. Most measurement functions are
also available for use in VCR review.
50
Measurements
The Galaxy™ System supports area-based (Cross Sectional Area, CSA) and distancebased analysis measurements on still cross-sectional IVUS images; and distance
measurements on still cross-sectional and LongView™ images. Up to six distance
measurements and four area measurements are supported on cross-sectional images; and
four additional vertical (size) and horizontal (length) measurements in the LongView™
section. Distance and area measurements are intended for lumens, vessels, and stents.
Computer Assistance
Computer-aided features make measurement operations more efficient. When two area
measurements are made, one within the other, the Galaxy™ System will automatically
identify the larger measurement as the vessel, and the smaller measurement as the lumen.
When three area measurements are made within each other, the Galaxy™ System will
automatically identify the larger measurement as the vessel, the mid-sized measurement
as the stent, and the smaller measurement as the lumen. When area measurements are
performed, the maximum and minimum cross-sectional distances are also calculated and
displayed.
TraceAssist™
Additional computer assistance is available to automatically identify the peripheral
borders of the vessel and the lumen. This feature is called “TraceAssist™”. If enabled,
the System detects the borders of the vessel and lumen and displays a graphical overlay
where they are detected. You can either accept the computer selection, or edit it (move
the border tracing).
Measurement results are displayed both in the image area and in the Measurement
Window. If a measurement is to be included in a System-generated Report, it must be
identified using a convenient pick-list.
Annotate
Text Annotations can be added to the image display. The Annotation function is
accessed from within the Measurement and Annotation Window. A pick-list of pre-set
annotations is available for selection. Free-form text can also be entered.
Procedure Reports
The Galaxy™ System provides a Patient Database and a powerful Report Generator,
which helps to streamline documentation of the IVUS procedure. Many entries in the
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Report are automatically transferred from patient and vessel information entered earlier
in the procedure, as well as measurement results. Other key information is easily
specified by selecting commonly used terms from pick-lists. Only a minimal amount of
information remains to be typed in (if desired).
Patient
information
Black fields
are Pick-lists
from Patient
Window entries
Figure 11 Report Example
Automatic entries
from the
Measurement
function
Entries
Once the patient and vessel have been selected, the Report Generator fills in the entries in
the Measurement section that correspond to those measurements made during the study
of that vessel.
Items Reported
Selectors are provided to expedite completion of the Report in the following areas:
• Procedure Device(s)
• Lesion Morphology
• Lesion Results
• Lesion Type
52
In addition to the pre-set selections, free-form text entry fields are also provided.
When the Report is complete, simply click the Save Button. To obtain a hard copy of the
Report, press the Print Button on the Control Panel while the Report is displayed.
Figure 12 Completed Report Example
Archiving Images
Manual Archiving
Patient’s images can be manually copied between any of the following digital storage
devices:
• Imaging Hard Disk
• MO disk
• CD-R or DVD+RW disk
This is accomplished using the DiskView Window in the Files Menu.
DICOM
The Galaxy™ System can store the images it converts to DICOM 3 IVUS or Ultrasound
format on its internal disk drives (System Hard Disk, MO, CD-R, DVD+RW).
Additionally, if the System has been configured into a DICOM network, it can also store
53
DICOM-formatted images to Storage Servers on that network, on an immediate basis or
from a queue on a scheduled basis.
Other
The VCR can also be used as an automatic archive (while performing the procedure),
although digital archiving is recommended.
IVUS Procedure Archiving
The Galaxy™ System provides internal storage for images and patient records, but these
must be archived to either a removable digital media such as DVD, CD-ROM or MO
disk, so that those images can be manually deleted from the Imaging Hard Disk to free up
storage space for future procedures. Saving patient studies on videocassette is also a
viable cost-effective alternative, although image quality will not be as good as digital
media options.
Entering File Mode
The Technologist accesses the File Menu, then selects the patient and their procedures,
and then indicates which storage device will be utilized to archive the data.
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Chapter 4 Functional Description
Purpose
This Chapter provides basic functional descriptions of Galaxy™ and Galaxy™²
components and their interrelationship so that operating principles may be understood.
Scope
This Chapter is not intended to provide a detailed theory of operation. The following
information is intended to provide Service Engineers and Technicians a broad and basic
understanding of Galaxy™ System components and their interrelationship.
Such information may aid the servicing of Galaxy™ Systems.
Overview
The Galaxy™ System is Boston Scientific Corporation’s Intravascular Ultrasound
system (IVUS). The system provides the same ultrasound imaging capabilities as Boston
Scientific’s earlier model, ClearView® Ultra™, with improvements to its display and
archival capabilities. The new display capabilities include, a color graphical user
interface (GUI), the ability to import x-ray hi-line and export IVUS hi-line video, and a
real time Longitudinal view. The new archival capabilities includes a digital cine loop,
and the ability to save to CD-R, DVD+RW, or Magneto Optical (MO) disks, depending
on the Galaxy™ System version. These new capabilities are achieved with proprietary
hardware & software and an Embedded Windows NT computer assembly.
Detailed Description
Motor Drive 5 (MD5) assembly
The major functions of the MD5 are:
• Transmit and receive the ultrasound pulses
• Identify the catheter type in use
• Rotate and locate the angle of the motor shaft (i.e., catheter)
• Pullback and locate the imaging core relative to the catheter sheath
The MD5 is a defibrillator proof type CF applied part. It contains the transmitter,
receiver, catheter drive motor, catheter optical encoder, catheter identification and patient
isolation circuits. In addition, it contains an embedded micro-controller, a numeric LCD
55
display, a sled optical encoder, and a sled motor to control and report the uniform linear
movement of the MD5 when mated to a sled. This linear movement enables the
acquisition of uniformly spaced image frames that are used to create the longitudinal
view.
Position Reset
LCD
Pullback
Start / Stop
Imaging Start / Stop
Figure 13 MD5 Motor-Drive Unit
Image acquisition assembly
This assembly is a VME-based embedded computer, with a 68000-based 6U VME board,
a fourth generation acquisition and control board (ACQ4), a fourth generation Radio
Frequency (RF4) processing board, a third generation high voltage (HV3) board, and an
interconnect board.
68000 computer
This 68000 computer executes a proprietary kernel that communicates with the Windows
NT assembly via an RS232 serial link. It controls and monitors all image acquisition
functions within the VME image acquisition assembly. It also executes a software
watchdog timer that must be pacified by the Windows NT (PC) assembly or the imaging
functions are disabled.
56
ACQ4
The ACQ4 board controls the catheter rotational motor and receives the catheter optical
encoder pulses from the MD5. The ACQ4 synchronizes all imaging acquisition functions
to the catheter encoder pulses. Imaging is initiated by starting the catheter motor
rotation. This causes encoder pulses to be generated which are used by the ACQ4 to
create the transmit signal to the transmitter board in the MD5. The ACQ4 board also
generates a Time Gain Control (TGC) signal. The TGC signal is sent to the RF4 board
where it controls the gain of the received ultrasound signal as a function of elapsed time
relative to the transmit signal. The ACQ4 board also digitizes the processed received
ultrasound signals and transmits R/Theta image data via a high-speed serial data stream
to the Windows NT computer using four LVDS (Low Voltage Differential Signal)
twisted pairs.
RF4
The RF4 board processes the received ultrasound signals from the MD5 receiver board.
The RF4 board varies the gain of the received ultrasound signal as a function of the TGC
control signal from the ACQ4 board. It then ‘band pass filters’ the received signal.
Finally, the signal is log compressed and detected prior to being transmitted to the ACQ4
board for digitization.
HV3
The HV3 board provides a low current selectable voltage to the transmitter output
amplifier. This voltage is used to set the transmitted ultrasound power level. The High
Voltage PCA (HV3-6U) generates a DC voltage in the range of 0 to 150 VDC which is
fed to the transmitter PCA in the Motor-drive unit (MDU).
Interconnect
The interconnect board provides noise filtering and connectivity between the acquisition
assembly and the other assemblies within the Galaxy™ System.
Windows NT computer assembly installed in Galaxy™
The Windows NT computer assembly contains a 300W power supply, a DEC passive
back plane, a Single Board Computer (SBC), a Matrox graphics/frame grabber video
board, a PCI Buffer (PBUF) board, a PCI Scan Converter (PSC) board, a Merlin Video
Conversion Function (VCF) board, a National Instruments AD board, a Comtrol serial
I/O board, a 16 bit sound board, a 10/100BaseT Ethernet board, two Adaptec SCSI
boards, a Magneto Optical (MO) drive, an 18GB cine-loop Hard Disk Drive (HDD), and
a 9GB System HDD.
DEC passive back plane
The DEC passive back plane provides 12 PCI slots, in 3 groups of 4, interconnected by 2
PCI to PCI bridge chips, and 3 ISA slots connected via an ISA bridge chip.
SBC
57
The SBC has two Pentium II 400MHz processors, 512Mbytes of SDRAM, an IDE
controller, two Ultra Wide SCSI controllers, a PS2 mouse port, a PS2 keyboard port, and
two RS232 serial ports. The operating system for the SBC is Windows NT embedded.
The SBC provides basic Windows NT services to Galaxy™ . The SBC also executes a 5
frame Finite Impulse Response (FIR) filter within software that is identical to the 5 frame
FIR filter used in ClearView®.
PBUF
The PBUF PCA resides between the PC PCI bus and the VME PESS ACQ4 R-Theta
output port. The PBUF buffers incoming R-Theta data from the ACQ4 PCA and makes
this data available to the PCI bus. The PBUF is a PCI based dual port frame buffer board
with a high-speed digital input port. The PBUF buffers each frame (256 8 bit samples
per vector times 256 vectors per frame) of sample values before transferring the data onto
the PCI bus.
National Instruments A/D board
The National S/D card is an ISA based data acquisition board having multiple digital I/O
and three analog inputs. The digital I/O is used to communicate the status of the system
power to the Windows NT computer assembly. The analog inputs are used to input an
analog ECG and two physiological inputs for digitization. All digitized outputs are
provided to the computer assembly via the ISA bus.
Comtrol serial I/O board
The serial I/O board provides 4 RS-232 serial I/O ports for communication. One RS-232
port is connected to the System Isolation Panel for external access. Another is used to
communicate and control the status of the embedded micro-controller within the MD5
that controls the linear movement of the MD5 on the sled. Another serial port is used to
control and communicate the status of the VCR within the system.
16 bit sound board
The sound card has an audio line input and output, a microphone input, and a speaker
output. The sound card is used to record and play back digital audio from the system
cine loop and analog audio from the VCR. The microphone is used to input audio into
the Galaxy™ for digital and analog recording. The speaker is used to playback both
analog and digital audio. The line output is used to provide analog audio to the VCR for
recording. The line input is used to playback analog audio from the VCR. The ISA bus
transfers all digital audio to and from the system.
10/100BaseT Ethernet board
The board is a PCI based Ethernet card having a digital I/O port that supports both
10BaseT and 100BaseT communication networks. The digital I/O port is connected to
the System Isolation Panel for external access.
58
Adaptec SCSI controllers
The Adaptec SCSI controllers are PCI based SCSI cards with high speed parallel digital
interfaces compliant with the SCSI3 specification. The SCSI card on the R-Theta PCI
bus is used to forward the R-Theta and digital audio data to the Cine-loop HDD. The
SCSI card on the Primary PCI bus is used to archive digital data to the CD-R or the MO
drive and to provide digital data to the SCSI page printer for printing.
MO Drive
The MO Drive has a SCSI2 bi-directional data port. The MO Drive provides the ability
to record digital case data onto and play back digital case data from MO media. The MO
Drive provides the ability to archive up to 30 minutes of IVUS digital data.
18GB HDD
The 18GB Hard Disk Drive provides up to 90 minutes digital cine-loop storage.
9GB HDD
The 9GB Hard Disk Drive maintains the operating system, Galaxy™ application, and the
patient database.
Windows NT computer assembly installed in Galaxy™²
The Galaxy™² PC Subsystem hardware contains the following components:
An active motherboard including the with the following:
• ATX V2.03 form factor
• A Pentium 4 2.4 GHz 400 MHz Front-side bus
• 1024 Mbytes of DDR266 SDRAM
• Two (2) IDE interface ports supporting the Ultra ATA/100 hard drive interface
standard capable of over 10 Mbytes/sec of sustained data transfer
• 100 Mbps Ethernet LAN connectivity
• Audio function capable of multimedia recording and playback
• Two (2) RS-232 serial ports
• One (1) parallel port
• One (1) PS/2 keyboard port
• One (1) PS/2 mouse port
• Audio output port for “Audio Line Out”
• Audio input ports for “Audio In” and "Microphone In"
• Six (6) 33 MHz 32-bit 5 volt PCI slots
PCI slots are populated with the following:
• PBuf PCA as described herein
• PSC PCA as described herein
• Matrox Graphics/Frame Grabber PCA as described herein
• Optionally, VCF PCA as described herein
59
• Four (4) Port Multi-serial PCA capable of sustaining serial transfer of 9600 Baud
Rate each
• General-purpose I/O PCA with at least four (4) digital input TTL-level channels, four
(4) digital output TTL-level channels, and three (3) 12-bit A/D channels
ATX P4 12VDC Power Supply with a minimum output of 400 Watts.
Mass Storage Devices:
• Two (2) internal-mount ATA-100 120 Gbyte 7200 RPM hard drives with minimum
sustained data transfer of 10 Mbytes/sec for each drive
• One (1) internal-mount IDE bus 4.7 Gbyte DVD+RW drive. The drive is capable of
writing to CD-R and DVD+RW media and reading from CD-ROM, CD-R, DVDROM, DVD+RW media
• One (1) internal-mount 3.5” floppy drive
Windows NT computer PCA’s common to both Galaxy™ and Galaxy™
1) PSC
²
The PSC is a PCI based scan converter board with a digital parallel input port and an
output port. The scan converter converts the 8 bit R-Theta (Polar) sample value into 8 bit
X-Y (Cartesian) pixel values. The data is converted based on a weighted four point
interpolator having 4 bit per point resolution (i.e. each X-Y pixel value is calculated
based on a 4 –bit relative weighting of the 4 nearest R-Theta sample values.)
2) Matrox graphics/frame grab
The Matrox graphics/frame grabber video board is a PCI based video board with two
digital parallel input ports, an analog frame grab input port, and an SXVGA output port.
The main video display simultaneously combines the following main overlays:
• Real Time Tissue Ball Input Digital Video
• Real Time X-ray Input Digital Video
• Post Processed or Archived Digital Video (from PCI Bus)
• Menu Graphics
The Tissue Ball data is able to be input from both the PCI bus and a dedicated digital
video bus.
The menu graphics input is from the PCI Bus.
The video board has two independent display memories. This allows for non-destructive
graphic overlay onto real time images. One of the digital parallel input ports is used to
input the scan converted real time IVUS data and the other is used for the real time x-ray
data.
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The Graphics/Frame Grab system provides input capture of video from a SVHS VCR
The analog frame grab port is used to input the VCR video output. This input captures
SVHS (Y/C) and transfers this to the Graphics/Frame Grab display memory.
3) Merlin VCF
The VCF is a PCI based video conversion board having an SXVGA input and two
passthrough output ports, a Main System Digital Video output port, an x-ray digital video
input and parallel output ports, and a VCF to VIF Input/Output (I/O) control port. The
VCF provides two SXVGA buffered outputs and converts the x-ray digital video from
the Merlin Video Isolation Function (VIF) board into the Galaxy™ System SXVGA
video format and the analog Galaxy™ System SXVGA video into a digital black and
white x-ray video format. The SXVGA passthrough output ports provide the Galaxy™
System video to the Galaxy™ System monitor for display and to the SXVGA to SVHS
video converter for recorded onto SVHS videotape. The Main System Digital Video
output port provides digital black and white Galaxy™ System video in the x-ray video
format to the Merlin VIF board for display on the overhead x-ray monitor. The x-ray
digital video input port provides digital black and white x-ray video to the VCF for
conversion to the Galaxy™ System video format. The digital video parallel output port
provides x-ray video in the Galaxy™ System video format to the Matrox video board for
display on the Galaxy™ System. The VCF to VIF control I/O port provides
communication and control data between the Merlin VCF and VIF boards.
Control Panel
The Control Panel has an RS232 bi-directional data part, a Trackball output port
(Microsoft 3 button mouse compatible), and user accessible buttons, knobs, and slide
pots. The control panel is used to control the basic imaging functions of the Galaxy™
System. Please refer to the Galaxy™ or Galaxy™² User’s Guide for specific details on
Control panel operation.
61
utto
g
Stop
Patient
PRINT
Pause
Jo
Shuttle
BOOKMARK
TRACE
ASSIST
Play
LongView
IVUS
Mid
IMAGE
RECORD
B
Trackbal
Trackball
Pull Back
Figure 14 Control Panel Functions
XRAY
Overhead
n
Trackball
DDP
Depth
TGC
Slide pots
Volume
TGC
Rotate
GAIN
Keyboard
The keyboard has a standard PS2 keyboard input port. The PC compatible keyboard is a
splash resistant US English style PC keyboard. The keyboard does not contain any
special or non-standard keys.
Monitor or LCD Display
The Galaxy™ monitor or Galaxy™² LCD display has a standard SXVGA input port.
The display is a color computer display at 1280 x 1024 resolution with a 72 Hz refresh
rate.
Printer
The printer will generate a black and white (B&W) print of the current image on the
monitor.
• The Galaxy™ printer (
Mitsubishi Digital CP-700DSU) has a SCSI2 bi-directional data
port. The printer is a SCSI color photo-realistic page printer, although only B&W is
enabled. The printer is configured (in Windows NT) to cut following each print.
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• The Galaxy™² printer is a standard PC-type B&W page printer (SONY Digital UP-D895)
connected to the parallel port (LPT1) of the computer.
VCR
The VCR utilizes the S-Video input, S-Video output, Video output, audio input and
output ports, and a bi-directional RS232 control port. The S-Video input is NTSC or
PAL compatible. The S-Video output port is the NTSC or PAL video output from the SVHS tape to the Matrox frame grabber. The VCR Video output provides NTSC or PAL
video output to the isolation panel. The Audio input receives case audio form the sound
card for recording to videotape. The Audio output provides audio from tape to the sound
card for playback from tape. The RS232 port provides command, control, and status
information to and from the VCR. The VCR is an S-VHS (Super VHS capable) VCR for
recording case audio and video onto tape.
CD-R Drive
The Galaxy™ CD-R Drive has a SCSI2 bi-directional data port. This drive is external to
the PC enclosure. The CD-R Drive provides the ability to record digital case data onto
and play back digital case data from CD-R media.
DVD+RW Drive
The Galaxy™² DVD drive has an IDE bi-directional port. This drive is internal to the
PC enclosure. The DVD drive provides the ability to record digital case data onto and
playback digital case data from CD-R, CD-RW, DVD+RW type media.
PC UPS Assembly
The PC UPS assembly contains a UPS Power Supply, a PCA Power Distribution board,
and a PCA PDS Control board. The PC UPS Assembly provides batteries based power to
the Windows NT computer assembly and the monitor in order to facilitate graceful
operating system shutdown in the event of power loss, and to allow for system
transportation between catheter laboratories without necessitating an operating system
shut down and reboot. All imaging modalities of the Galaxy™ System are disabled
when the Galaxy™ System is drawing power from its internal batteries.
UPS Power Supply
The UPS power supply receives isolated AC main power and provides AC mains battery
backed-up power to the PCA Power Distribution.
PCA Power Distribution
The PCA Power Distribution board receives isolated AC main power and battery backed
up power and distributes AC power to the Galaxy™ System.
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PCA UPS Controller
The PCA UPS Control board has multiple digital connections between the National
Instruments A/D card and the PCA power Distribution board. The PCA UPS Controller
board reports the status of AC power to the Windows NT computer assembly. The PCA
UPS Controller board also monitors the health of the operating system via a watch dog
timer. The PCA Power Distribution board commands the distribution of AC power
throughout the Galaxy™ System by controlling the PCA Power Distribution board.
Peripheral Equipment
The Galaxy™ System’s peripheral equipment includes a Merlin VIF, an Extron SXVGA
to SVHS converter, a CD-R drive (Galaxy™ only), and a system Isolation Panel. The
Galaxy™ System’s peripheral equipment is defined as assemblies located outside the
Motor Drive 5, Image acquisition, Windows NT computer assemblies, excluding the
User interface assemblies, and within the Galaxy™ System’s enclosure providing needed
functionality.
Merlin VIF
The Merlin VIF board has a Main System Digital Video input port, an x-ray digital video
output port, an analog Galaxy™ System video output port, an x-ray video input port, a
VCF control I/O control port, and a x-ray control output port. The VIF is the Signal
Input Part/Signal Output Part (SIP/SOP) for the Galaxy™ System hi-line (x-ray) video.
It provides a 500VAC dielectric boundary between the Galaxy™ System, x-ray video,
and the x-ray control signals and the two SXVGA buffered outputs and converts the xray digital video from the Merlin Video Isolation Function (VIF) board into the Galaxy™
System SXVGA video format and the analog Galaxy™ System SXVGA video into a
digital black and white x-ray video format. The SXVGA passthrough output ports
provide the Galaxy™ System video to the Galaxy™ System monitor for display and to
the SXVGA to SVHS video converter for recorded onto SVHS videotape. The Main
System Digital Video output port provides digital black and white Galaxy™ System
video in the x-ray video format to the Merlin VIF board for display on the overhead x-ray
monitor. The x-ray digital video input port provides digital black and white x-ray video
to the VCF for conversion to the Galaxy™ System video format. The digital video
parallel output port provides x-ray video in the Galaxy™ System video format to the
Matrox video board for display on the Galaxy™ System. The VCF to VIF control I/O
port provides communication and control data between the Merlin VCF and VIF boards.
SXVGA to SVHS converter / Extron
The SXVGA to SVHS converter has SXVGA video input and SVHS video output ports.
The SXVGA to SVHS converter converts Galaxy™ System SXVGA computer video
from the Merlin video pass through port into NTSC or PAL SVHS video for recording
onto videotape.
64
System Isolation Panel
The System isolation panel has the following isolated input ports: ECG, Pressure #1, and
Pressure #2. The System isolation panel has the following isolated output
ports: RF, RF
I, RF Q, RF Trigger, Galaxy™ System SVHS Out, and Galaxy™ System Video Out.
The System isolation panel has the following isolated bi-directional data ports: 10BaseT
and RS232. The system isolation panel is a separation device that isolates the Galaxy™
System from externally connected equipment. Please refer to the users manual for
specific details on provide signal inputs and outputs.
External Peripheral Equipment
The Galaxy™ System External Peripheral Equipment includes an x-ray Overhead
Monitor Switchbox (OMS). The External Peripheral Equipment is defined as equipment
that is located outside the Galaxy™ System console that provides Galaxy™ System
peripheral functionality to the console. The MD5 motor drive is not considered External
Peripheral Equipment because it is essential to the main function of Galaxy™ System.
X-ray Overhead Monitor Switchbox (OMS)
The x-ray OMS has a Galaxy™ System video input, a Roadmap video input, a fluoro
video input, an x-ray control input, an x-ray video output, and a Galaxy™ System/x-ray
Video Output. The Galaxy™ System Video Input is a black and white Galaxy™ System
video input to the OMS that has been scan converted to the x-ray monitor line rate. The
Roadmap video input is the Roadmap monitor video to the x-ray switch box. The fluoro
video input is the fluoro monitor video input to the x-ray switch box. The x-ray control
input provides the control signals that allow the Galaxy™ System to select either x-ray
or fluoro video input and either fluoro or Galaxy™ System video output. The x-ray
video output is either the Roadmap or the fluoro (depending on Galaxy™ System
settings) video input to the Galaxy™ System for display on the Galaxy™ System
monitor. The Galaxy™ System/x-ray video output is either the Roadmap or Galaxy™
System video for display on the Roadmap monitor. See Chapter 7 for more details.
65
Galaxy™ Hardware Block Diagrams
LAN
Physio
Isolation
RS-232
RF - I/Q
DAQ
Subsystem
TX
RF
HV
Control
MDU Subsystem
Galaxy
System
MDU
RS-232
PC/DAQ
RS-232
R/Theta
Data
MDU
RS-232
SVHS
Playback
PC Keyboard
Control
Panel
PC Subsystem
SXVGA
VCR SXVGA
SVHS
Live
to
SVHS
Trackball
Digital
X-ray
Video
Isolation
Printer
SXVGA
Digital
Galaxy
Video
SXVGA
Display
Power
Distribution
Subsystem
Fluoro Video
Roadmap Video
Roadmap Monitor
X-ray
Video
Switch
66
(R,θ)
(X,Y)
10BaseT
k
n
t
t
n
A
ECG
Pressure #1 & #2
RS-232
RF Out
RF I & RF Q (X2)
RF Trigger
Galaxy SVHS Out
Galaxy Video Out
RF, I, Q,
Data Acquisition Assy. (DAQ)
System
Isolation
Panel
AC mai
UPS Power
Supply
ECG/Pressure #1 &
SVHS Out
VCR SVHS
VCR Video
DAQ
RS-
Pwr. Dist. System (PDS)
PCA Power
Distribution
RSRSRS-
PCA PDS
Control
National
A/D
Comtrol
Serial I/O
Card
PC
Audio
In Out
Mic Spea
16 Bit
Sound
DAQ
RS-232
DRAM
IS
CPAN
RS-232
Pentium
Control
Track
Pentium
Host
PCI
IDE
SCSI
Bridge
Galaxy™ Block Diagram
Keyboard
CD-R
Floppy
9 Gb
System
SCSI
Bridge
(Adaptec)
SCSI2
(10BaseT
Printer
M. O.
Drive
LAN
PC
RF4
Interconnect PCA
Galaxy Video Out - RM
Roadmap
fluoro
HV3
P2 Bus
Motor Drive
(MD5) Assy.
ACQ4
Lemo®
Cable
Force6
68000
CPU
VME Bus
R/Thet
a
APD
Contro
x-ray
Video
Switch
Box
Galaxy
x-ray
x-ray
67
PCI BUS
PCI
Frame
Windows NT
Computer Assy.
VCR Control (RS-
Video
Isolation
Function
VIF
(Merlin)
Spare
(R,θ)
VCR SVHS Ou
VCR Video
DEC Passive
Backplane
SCSI
Bridge
Cine-loop
Disk Array
Audio I
Audio Ou
Main System Digital Video - B/W 1Kx1K
x-ray (Roadmap or Flouro) Digital - B/W 30Hz
VCF
PCI-PCI
Bridge
Future
(R,θ,T)
Future
Filtered
VCR
Scan
Convert
SVHS Out
SVHS
PRIMARY PCI BUS
PCI BUS
Tissue
Ball
SVHS
Playbac
Graphics/
Frame
SXVGA
SXVGA
to SVHS
PCI-PCI
Bridge
x-ray
SXVGA
Spare
(X,Y)
Video Conversion
Function
SXVGA
Console
Monitor
Chapter 5 Galaxy™ System Maintenance
Note: This chapter provides information on maintenance activities that can
be performed by the end-user or technical maintenance personnel.
It includes information on basic care of the System, storage, cleaning, replacing fuses,
considerations when relocating the System, and problem solving techniques.
Boston Scientific will also perform these tasks for you upon request, although some may
not be covered by warranty or service contract. Please feel free to contact Boston
Scientific for further information or support.
The following procedures assume you are familiar with the information in the Controls,
Settings, and Displays chapter in the Galaxy™ or Galaxy™
to that chapter for any needed clarifications.
² User’s Guide. Please refer
Basic Care
Checking Galaxy™ System Performance
Depending on your institution’s operational protocol, verification of proper Galaxy™
System functionality may be desirable. This can be accomplished using the Catheter
Simulator. The following steps can be used to verify that the Galaxy™ System will
generate images and give further assurance that the system is ready for use.
Figure 15 Simulator
1. Insert the Catheter Simulator into the end of the Motordrive, with the dot marking
on the Simulator aligned with the blue-green Image Button near the end of the
Motordrive. Press the Simulator firmly into the Motordrive.
68
Press the Image Button either on the front side of the Motordrive, or on the Galaxy™
System Control Panel. An image similar to that shown in Figure 16 should be displayed.
You may need to adjust the Gain control on the Control Panel to achieve a similar display
as Simulator results vary between Simulators
Figure 16 Typical Simulator Image
NOTE: The Catheter Simulator is not intended to detect subtle variations in system
performance. When temporarily substituted for the Imaging Catheter, it can be useful
in discerning whether an imaging problem is caused by the Galaxy™ System or the
Imaging Catheter.
69
Checking the UPS Battery
The Galaxy™ System contains an Un-interruptable Power Supply (UPS) powered by a
rechargeable battery. The charge on this battery is automatically maintained if the
system remains connected to an active power receptacle. The following procedure
explains how to verify proper operation of the battery:
WARNING
The Power-on/Standby Switch on the rear panel does not immediately remove
internal AC power from the Galaxy™ System. There may be lethal potentials
within the Galaxy™ System even when the power cord is disconnected due to the
Un-interruptable Power Supply operation. The only power indication is the
Galaxy™ System’s display screen.
Note: This procedure should be performed every ninety days, but only at a time when the
Galaxy™ System is not likely to be utilized for several hours (to allow time for the battery
to recharge after this test).
1. To verify that the battery is in a ready condition, first ensure that the Galaxy™
System has been connected to an active power receptacle for at least five hours
without the system being used.
2. Follow the instructions for “Applying Power” in the User’s Guide chapter titled
Preparing the Galaxy™ System for Use, then click the Snooze button and
disconnect the power cord from the wall receptacle.
3. The Galaxy™ System should automatically enter the Snooze Mode with a normal
display on the Monitor, and should remain in that state for at least seven minutes
(if the battery is fully charged and in good condition), after which it will
automatically shut down.
If you are certain that the battery was fully charged (as explained above) and the
Galaxy™ System does not perform accordingly, contact Boston Scientific Service for
assistance. There are no user remedies for UPS problems other than maintaining a full
charge, as explained earlier.
70
Battery Maintenance
The battery in the UPS is a spill-proof maintenance-free sealed lead-acid battery. There
are no user actions for battery maintenance other than maintaining it in a charged
condition. This is simply done by having the Galaxy™ System connected to an active
power receptacle as much as possible.
CAUTION
If the Galaxy™ System will be stored in a location where power cannot be applied
(to maintain the battery in a charged state) for over thirty days, the UPS battery
must be fully charged prior to storage. This can be accomplished by plugging
Galaxy™ System in to A/C power for a minimum of 24 continuos hours.
Typical battery life is three to five years when the battery is maintained in a charged
state. Leaving the battery in a discharged state reduces its life.
Replacing a Fuse
There are two fuses located at the lower rear of the Console. If the Galaxy™ System
fails to operate, a blown fuse may be the cause. To replace a fuse:
1. Unplug the Galaxy™ System. It is preferable to minimize the time that the system is
disconnected from power due to the internal Un-interruptable Power Supply.
WARNING
The Power-on/Standby Switch on the rear panel does not immediately remove
internal AC power from the Galaxy™ System. There may be lethal potentials
within the Galaxy™ System even when the power cord is disconnected due to the
Un-interruptable Power Supply operation. The only power indication is the
Galaxy™ System display screen.
71
2. To remove the Fuse Holder, pull the tab on the top of the face of the Fuse Holder
outward with a small screwdriver or other tool until the Fuse Holder pops outward.
The Fuse Holder can then be pulled completely out of the System.
3. Remove the fuse or fuses from the Fuse Holder and inspect. Replace any defective
fuse with a new fuse of the same type and rating as indicated on the adjacent
label.
4. Insert the Fuse Holder back into the Galaxy™ System in the reverse order of
removal.
5. Re-connect the power cord, and test the Galaxy™ System. If the fuse blows again,
contact your authorized service representative.
Cleaning
1. Use only a soft cloth dampened with isopropyl alcohol, Cidex®, or Cidex Plus® to
wipe the Console and its accessories. Do not use harsh chemicals to clean as they
may damage the finish.
2. The Trackball requires regular cleaning or poor movement response may result. Use
a soft cloth dampened with isopropyl alcohol, Cidex®, or Cidex Plus® and roll the
Trackball slowly while wiping it to access its entire surface.
3. Do not use disinfectants such as Gluteraldahyde or Hydrogen Peroxide to clean the
Console or the accessories. Do not use acetone.
4. Do not autoclave, immerse, or attempt to sterilize the Motordrive.
72
Functionality Test
Purpose
Provides Field Service personnel a standardized procedure for:
1. Testing and verifying the operation and functionality of the Galaxy™ System.
2. Performing basic preventative maintenance.
Equipment & Materials
See the table below for equipment and materials referenced in this procedure:
Description Part Number
Galaxy™ disposable sled
MO Disk H749A70310
VCR Tape 08803-001
CD-R Disk H749A70320
Field Service Report 07651-001
Printer Paper H749A70350
Catheter Simulator H749054080010
H749A70200
Prior to Testing
1. Log the serial numbers of the Galaxy™ System and MD5 on a Service Report or
checklist (data sheet follows this section).
2. Remove the Galaxy™ System covers and back panel screws. Drop the back panel.
Visually inspect all cables and connectors. Re-secure if necessary.
3. Dust & clean the PC as necessary using a vacuum and/or dry compressed air.
4. If the Overhead Monitor Switchbox (OMS) is utilized, connect the Galaxy™ System
to the OMS using the Lemo®-Lemo® cable. Used stored x-ray images for testing
purposes.
73
Functional Test
1. Power up Galaxy™ System and verify the system boots into the Galaxy™ System
application.
2. Press “Patient” button, enter fictitious information in the Last Name and Patient ID
fields, left click on “Enter”.
3. Place the Catheter Simulator in the Motor Drive Unit (MDU) and place the MDU in
a disposable sled.
4. Verify that the catheter simulator is identified properly.
5. Verify MDU LED display illuminates. Slide MDU forward and reset to zero.
6. Load the media; video tape, printer paper, blank CD-R (may use DVD+RW if
Galaxy™
7. Press “IMAGE” and “PULLBACK” buttons on the Galaxy™ System control
panel, press “LONGVIEW” button to switch to LongView™ display mode.
8. Verify Digital recording active.
9. Verify VCR recording active.
10. Verify fluoro test video is present next to the tissue ball in the LongView™ display
mode (if OMS utilized).
11. Verify simulator image is acceptable.
12. Verify MD5 pulls back in the sled.
13. Verify that when pressing the Overhead monitor button on Galaxy™ System the
OMS Roadmap video out toggles between the Galaxy™ System video and the
fluoro test video (if OMS utilized).
14. Press “IMAGE” button to stop pullback, recording, and imaging.
15. Create/Select “Run 2” and press “IMAGE” on the MDU only.
16. While imaging, press or turn every control knob / slide / button on the Top Deck
Control Panel.
17. Verify knobs and slides are secured to their posts.
18. Verify Galaxy™ System user functions and imaging parameters respond correctly to
controls when adjusted.
Note: There is no response for measurement functions, depth, digital playback
when imaging and pulling back.
19. Press “IMAGE” button on the MDU to stop.
20. Double click on the Run 1 tab to load the data previously recorded.
21. Use the ‘jog-shuttle’ and digital Play control on the Galaxy™ System control panel
to verify that the digital playback functions properly and that recorded audio can be
heard during playback.
22. With a still IVUS image displayed, left click on the image field, draw one distance
and one area, verify manual measurements can be performed (accuracy is not tested).
23. Press “Trace Assist” button on the Galaxy™ System control panel and verify a
TraceAssist™ border is detected.
24. Press the “Print” button and verify printer functionality.
²) and MO disk (if applicable).
74
25. Use the VCR ‘jog-shuttle’ to verify that VCR recording and playback function
properly; image is centered and audio is heard.
26. Open File Manager, verify the ‘test’ Patient name, Vessel and Run(s) appear in the
Disk View.
27. Select the MO drive (if applicable, otherwise skip), left click on “Format” to format
the MO disk. Verify successful “Galaxy” format.
28. Select the CD-ROM drive, left click on “Format” to format the CD-ROM. Verify
successful “Galaxy” format.
29. Select the ‘test’ file from the HDD, drag & drop to the MO drive (if applicable) and
again to the CD-ROM. Verify data transfers to media.
30. Remove MO disk and/or CD-ROM from Galaxy™ System.
31. Delete the ‘test’ patient from hard drive in the File Manager list.
32. Reboot the Galaxy™ System and install the MO disk and/or CD-ROM.
33. From the MO disk and/or CD-ROM, drag & drop the ‘test’ patient data to the hard
drive in the File Manager. Verify data transfers normally. Remove media and reboot
the Galaxy™ System.
34. Double click on the ‘test’ patient now listed in the File Manager. Data should load.
Verify cine drive playback is normal.
35. Test the UPS function, verify: the < 1 minute timer starts when system power cord is
unplugged and the < 1 minute timer stops when system power is restored.
36. Verify that “Snooze” functions normally: While in the ‘snoozed’ state, the 8 minute
timer begins when the system power cord is unplugged and the 8-minute timer stops
when system power is restored.
37. Shut down the system using the “Shutdown” button (via software application), left
click on “Yes” in the confirmation message box. Verify system shuts down
completely using software.
38. Document results on the Service Report or Data Sheet.
75
GALAXY™ SYSTEM FUNTIONAL TEST CHECKLIST
System S/N ____________MD-5 S/N _______________Date___________
Location
(Customer) _________________________ City, State ___________________________________
1. Dust & clean PC. DONE N/A
2. Simulator ID functional PASS FAIL
3. MDU LED display illuminates PASS FAIL
4. Digital record mode functional PASS
5. VCR record mode functional PASS
6. Fluoro test video is present N/A PASS FAIL
7. Simulator image acceptable PASS FAIL
8. MD5 pulls back in the sled PASS FAIL
9. Overhead button toggles x-ray monitor display PASS FAIL
10. Knobs and slides secured PASS FAIL
11. System and image respond properly to controls PASS FAIL
12. Digital playback functional PASS FAIL
13. Recorded digital audio heard during playback PASS FAIL
FAIL
FAIL
14. Manual measurements functional PASS FAIL
15. Trace Assist Functional PASS
16. Printer functions normally PASS FAIL
17. VCR record/playback functions OK PASS FAIL
18. Patient name, vessel & runs appear in file manager PASS FAIL
19. MO media can be Galaxy
20. CD-ROM media can be Galaxy formatted PASS FAIL
21. Data records to MO drive N/A
22. Data records to CD ROM drive PASS FAIL
23. Data transferred to cine HDD from remote media PASS
formatted N/A PASS FAIL
PASS FAIL
76
FAIL
FAIL
24. Transferred data plays back from cine HDD PASS FAIL
25. The 1 minute timer is functional PASS FAIL
26. 1 minute timer is disabled at restoration of power PASS FAIL
27. Snooze functions normally PASS FAIL
28. The 8 minute timer is functional PASS FAIL
29. 8 minute timer is disabled at restoration of power PASS FAIL
30. Galaxy™ System shuts down using software GUI PASS
TESTS PERFORMED BY _____________________________ Date ____________
(signature)
FAIL
77
Problem Solving
Motor Drive (MD5) problems
Intermittent recognition of catheter(s)
1. Is the catheter seated properly? Verify. Carefully pinch the tapered end of
catheter hub (beige colored piece) and pull outward slightly. The catheter
should not budge. It is very difficult to remove the catheter hub once fully
inserted into the MD5 and locked in place.
Problem Possibility:
Catheter will not seat properly into the MD5.
Possible Cause:
A. The catheter is not inserted fully or appropriately; e.g., dot to dot.
B. The MD5 shaft may not be mating properly with the catheter hub slot/receptacle.
Solution:
If the MD5/catheter mating problem is suspected, the user should remove the
catheter and press the Image button on the MD5 or Galaxy™ System. This will
spin the MD5 motor shaft. When imaging is stopped, the MD5 shaft should have
a different orientation. Reinsert the catheter and try again.
2. Is the catheter hub dry? Be careful during the prep. If wet, the wrong
catheter Id. may be displayed.
3. Has another catheter been tried? May be catheter problem.
4. Before replacing the MD5, test away from the patient table and out of the
clinical setting. Save the catheter from the case or use demo catheters to test.
A. Insert catheter into the MD5.
B. If the catheters cannot be identified consistently, replace the MD5.
C. If the catheters are identified correctly, there still may be an intermittent
problem. Gently press on the side of a catheter hub (like on the flush port
extension) in opposite directions and see if the Catheter ID. becomes
intermittent. The Cath ID. should be ‘rock solid;’ stable. If intermittent,
replace the MD5. Do not perform this test with the Simulator, which is
more stable and may not demonstrate a failure.
D. If the MD5 identifies all test catheters successfully, suspect clinical
application.
78
“Catheter Motor Overload” (error message)
1. This message may appear ‘once and awhile’ and is normal whenever the
catheter rotation is severely restricted (as with a NURD situation).
Nevertheless, the appearance of this message should be infrequent. Check for
application or catheter issues; e.g. catheter kink, tortuous calcified vessel,
Touhy-Borst valve too tight, catheter hub not seated properly in the MD5.
Problem Possibility:
Catheter is not seated properly into the MD5.
Possible Cause:
The MD5 shaft may not be mating properly with the catheter hub slot/receptacle.
Solution:
If the MD5/catheter mating problem is suspected, the user should remove
the catheter and press the Image button on the MD5 or Galaxy™ System.
This will spin the MD5 motor shaft. When imaging is stopped, the MD5
shaft should have a different orientation. Reinsert the catheter and try
again.
2. If the message appears very frequently there is a hardware problem that needs
to be resolved. Most likely the MD5 will need to be replaced. Following the
failure of replacement MD5’s to eliminate these error messages, a Field
Service visit may be required.
“Catheter motor speed out of tolerance” (error message)
1. When this message appears (usually) there is ‘no problem’ with the system’s
performance. Image quality is not affected and pullback performance is not
compromised. The MD5’s activity is monitored by software and based on
tolerance specifications that (in retrospect) were too stringent. As a result,
‘alarms’ (the error message) occasionally go off unnecessarily. This problem
has been resolved with a firmware update to the VME software. Field Service
is required to install the software. If unsure of your system’s version, email or
call Fremont Technical Support for information.
EMAIL: ivus.techsupport@bsci.com
PHONE: AT&T (800) 949-6708
2. If the message appears and the latest firmware has been installed, replacement
of the MD5 should conclusively resolve this issue.
79
MD5 will not pullback
1. The display may indicate a normal incremental (.5mm/sec) pullback as if it is
pulling back, but the MD5 will fail to pullback if the MD5 is not seated
properly in sled. Check both sides of the MD5/sled interface! Do not rely
on the lit (MD5) LED display alone to determine whether the MD5 is seated
properly.
2. Error message MDU Clutch Disengaged - Pullback Stopped. The clutch
lever that the user squeezes to allow the MD5 to slide back & forth in the sled
is physically stuck.
a. Try giving the clutch lever a few hard squeezes. Sometimes it will pop
out.
b. Otherwise, replace the MD5.
3. Error message MDU Pullback Motor Overload - Pullback Stopped
a. Most likely the sterile bag is caught up in the sled gear. Verify proper
bagging technique. Slide back and forth once following insertion of the
MD5 into the sled prior to pullback.
b. Defective sled is a possibility; try another.
c. Catheter restriction (Touhy-Borst too tight?) may also cause this message
to appear.
d. Replace MD5 if the problem is reoccurring and the aforementioned
suggestions have been ruled out.
No image, catheter Id. is correct and stable, no error messages appear
1. Try another catheter or check with Simulator. Still no image? Then . . .
2. Reboot the Galaxy™ System. Still no image? Then . . .
3. Replace the MD5.
Dark images
1. Insure catheter is seated fully in the MD5 and that the Cath Id. is stable.
2. Flush the catheter or try another.
3. Reboot the Galaxy™ System.
4. Replace the MD5 if the symptom is reproducible.
Note Galaxy™ instruments: If the MD5 is "started" within two seconds of the
catheter insertion, the result is a weak image for that catheter. This often happens
‘accidentally’ by the user who bumps the start button at the MD5 while inserting the
catheter. The solution is to stop imaging, then start again and full gain should be
restored. Galaxy™² instruments are not problem atic in this regard.
80
Galaxy™ System console problems
No video on the display screen when powered up
1. If everything else powers up (VCR, printer, fans) and the display screen is
blank, call Tech. Support @ (800) 949-6708.
2. If the system is completely powerless, check the fuses in the back and/or test
again at a different A/C outlet.
3. Be aware that some ‘brand new’ Galaxy™ System’s just out of the crate have
experienced a wide range of anomalous problems that have occurred when
initially powered up. Those ‘anomalous’ issues were resolved by plugging
the system in for a couple of hours prior to use again. Depleted U.P.S.
batteries are suspected as cause.
Problem Description:
Pre-mature failure of the UPS battery.
Cause:
User does not keep the Galaxy™ System plugged into A/C power at all times. If the
Galaxy™ System is unplugged or ‘stored’ at a time when the when the UPS battery is in
a ‘less than fully charged’ condition, battery damage may occur. The manufacturer of
the UPS, American Power Conversion, states this:
A discharged battery, needs to be recharged within 72 hours of the discharge to avoid
permanent battery damage. Storing a UPS with the battery connected can cause
permanent battery damage within a few days to a week. Allowing batteries to stand for
long time after a discharge without recharging will cause plate "sulfation." Sulfation is
the formation of large crystals or "hard" lead sulfate on the battery plates. Excessive
sulfation of this kind is difficult to reduce and may cause premature damage (i.e.
overheating or inability of the battery to retain charge). All APC
batteries against over-discharge, but, as implied above, the storage life of the battery will
be shortened relative to the amount of charge removed.
® UPS’s protect their
Solution:
Keep the Galaxy™ System plugged into A/C power at all times
instrument must be stored and away from A/C power, charge the Galaxy™
System (UPS) for at least 24 hours prior to storage.
. If the
Error messages following boot process or during the application
Examples: Internal sub-system failure, DAQ or NI-DAQ or VME Watch
Dog / Dog Bark
81
1. Insure the Galaxy™ System UPS is fully charged (see section above).
Minimally, leave plugged in for two hours prior to using the Galaxy™
System. Full battery charge usually takes 24 hours.
2. Insure MD5 Lemo® connector is plugged in all the way at the back of the
Galaxy™ System.
3. Reboot Galaxy™ System. Error messages still present?
a. Make sure that the UPS is OK and can hold a charge; test “snooze”
functionality for 8 minute timeout. Early shutdown indicates a defective
or uncharged UPS.
b. If Biomedical Technician help is available, ask them to reseat the VME
circuit boards. Check connections to the UPC Controller/A/C Distribution
boards.
c. Call Tech. Support @ (800) 949-6708 for assistance.
Printer problems
Description: Paper cuts one sheet at a time and falls on the floor.
Solution: This is the default setting for Galaxy™. Galaxy™² does not
automatically cut. If undesirable, notify Field Service (800) 949-6708 and a Field
Service Engineer (FSE) can reconfigure the Galaxy™ printer software to ‘paperfeed’ during his next visit to the account.
Description: When print is selected an error message appears saying “Printer not
found.”
Solution: Most likely, the Mitsubishi printer alarm light is on. This is usually
caused by Galaxy™ being placed in ‘snooze’ mode (or powered down) while the
printer is still trying to print. Once this occurs, rebooting Galaxy™ will not reset
the printer. To extinguish the alarm light: (1) take the printer off-line (2) press
the paper feed / cut button (which it will do, paper feed and cut), then (3) place
back on-line.
Description
Solution
1) Paper is installed incorrectly.
2) Paper is old/damaged.
3) Wrong paper is being used.
Note, use only: Mitsubishi K65HM in the Galaxy™
: Images are washed out and/or blurry.
:
Sony UPP-110S in the Galaxy™
Description
or print comes out crooked.
Solution
most likely the result of a previous paper jam. Clean away all paper from the
inside roller. Note: This is not an easy task. Using a small jeweler’s screwdriver
: Print starts to come out, then the alarm light comes on and stops /
: There is printer paper (usually small pieces) stuck on an inside roller,
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²
may help. All pieces of paper must be removed. Never use an alcohol solution
to clean the rollers.
Note: If the Mitsubishi printer power is shut down and then restored using the
on/off switch while Galaxy™ is booted, the entire system needs to be rebooted to
restore printer functionality. If Galaxy™ is not rebooted and the “Print” button is
pressed, an error message may appear saying; “Printer not connected.” The
printer should always be “on” when Galaxy™ boots up.
VCR problems
Description: VCR playback quality is poor.
Comment
: The Galaxy™ System takes hi-resolution computer video and
converts it to standard (VCR) video so it can be recorded. When played back
from the VCR, that standard, relatively ‘low-line rate’ S-Video is then up-scanned
back to computer video for display on the Galaxy™ System’s monitor. Quality is
lost in the process.
Note: Playing back the video tape on a remote VCR playback station (instead of
using the Galaxy™ System) looks very good in comparison.
Description
: Cannot read the alphanumeric from VCR playback.
Comment: Quality is too poor to read some of the small alpha-numeric. Try
using the jog-shuttle and advance to another frame to reduce jitter.
Description: No VCR playback video – can hear audio but the Galaxy™ System
display screen is blank (display may appear as a light shade of gray).
Solution:
1) Reboot the Galaxy™ System.
2) Check the VCR Video Input switch behind the hidden front door. Should be
set to “S-VIDEO.”
3) If Biomedical Technician help is available, check video cable plug at Extron
Scan Converter on the back panel – plug falls out or loosens sometimes during
shipment or aggressive instrument movement.
Description
: VCR playback video is not centered during playback.
Solution: Extron Scan Converter needs to be replaced or the firmware updated.
Field Service is required.
Description
: When ‘record’ is selected, error message appears: “Internal sub-
system not responding – VCR.”
Solution:
1) Most likely, the write-protect tab is removed from the videocassette.
2) Check to see that the videocassette is installed.
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Note: As with the printer, if the VCR is powered down (using the on/off switch)
while the Galaxy™ System is booted, the entire system must be rebooted to restore
VCR operation. The VCR should always be on when the Galaxy™ System boots.
Assorted issues
Issue: Message when loading data from CD or MO says “CD/MO cannot be
removed until this run is active.
Comment
: Should say “inactive.” CD/MO cannot be removed until this run is
INACTIVE. So, to remove the disk, select and load any other ‘run’ saved on the
hard drive and make that run active. Then remove the media.
Issue
: Audio and images become out of sync during digital playback, especially
at the end of the record.
Comment: The way audio is digitally recorded is somewhat different than the
way images are placed on the hard drive and the result is that they do not sync. up
perfectly. Mostly this is not discernible but noticed more commonly at the end of
long pullbacks.
Issue: While rotating the 2D ‘cut-plane’ line in LongView™ mode, when select
(left click) is entered, the 2d image seems to jump a few frames and is not exactly
where selected.
Comment: This is normal. The LongView™ information is displayed
differently than the 2D image where there may be several frames of 2D imaging
for only one line of LongView™ data. Thus, when the 2D slice is selected,
Galaxy™ System determines the nearest representative LongView™ line of data
and the 2D image may appear to ‘jump’ slightly.
Issue: When the Galaxy™ System boots up a DOS window appears with a
message saying; “The operation was completed successfully.”
Solution:
1. To remove the DOS window and use the Galaxy™ System normally, just
click “OK.”
2. The folders in the Galaxy™ System File Manager must always have at least
one file in the folder (which is why there is always a ‘Patient 1’). Often, when
the user ‘cleans up’ a File Manager folder, folders are often deleted entirely
(all at once, because it is easier to delete the folder rather than one file at a
time). When a folder exists without a file (e.g.; DICOM, Screenshots), this
symptom will appear. To resolve the above scenario, one needs to create a
file in the empty folder. Usually this problem occurs when the Screenshots
folder is erased. To resolve, just make a print. The next time the Galaxy™
System is booted the DOS window will be gone.
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Chapter 6 DICOM
DICOM Configuration
Overview
This guide provides instructions for configuring the DICOM feature for a Galaxy™
System running software version 1.03, 2.01or 2.02.
Note: The user of this document must be proficient in MS-Windows networking
configuration, and understand the requirements of the network utilized in the facility
where this Galaxy™ System is installed.
The procedure is also best performed with the assistance of someone familiar with
Galaxy™ System operation; otherwise, please refer to the Galaxy™ or Galaxy™²
User’s Guide for assistance with operation instructions.
Pre-installation
Before the Galaxy™ System DICOM installation is scheduled, we recommend that a
person from the IT (Information Technology) staff of that institution enter the appropriate
values in the “Assigned Entries” column of the “Networking Parameter Reference Chart”
on page 104, and the “DICOM Parameter Reference Chart” starting on page 105. That
information should then be forwarded to the BSC person in charge of the installation
prior to the site visit. This will aid in the installation process, which cannot be completed
without this information.
A DICOM Conformance Statement is available for Galaxy™ and Galaxy™², which
defines its compliance with applicable parts of ACR-NEMA Digital Imaging and
Communications in Medicine, DICOM V3.0. The Galaxy™ BSC document number is
90047601. The Galaxy™² BSC document number is 90060910. If you need this
document, please contact Boston Scientific.
Storage Server Considerations
The Galaxy™ System sends DICOM files up to 2 GB in size. When configuring the
System, ensure that any Storage Servers set to receive files from the Galaxy™ System
are capable of handling multiple files of this size.
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NOTE: The Galaxy™ System is intended for network use in a DICOM Network only, and
only to send DICOM files to a compatible Storage Server.
Viewing Station Considerations
Software used at DICOM Viewing Station can vary greatly in the ability to display IVUS
images; and the information and imaging parameters that the Galaxy™ System provides
in the DICOM files it exports. We recommend that the clinical users view sample
Galaxy™ System DICOM files at the various Viewing Stations before or during this
configuration process. Decisions on the settings for certain parameters such as image
compression (if any), DICOM modality, and Screenshot inclusion may be affected by the
results of such an evaluation.
The Galaxy™ System can also export DICOM files via its internal removable media
disk drives for this evaluation. Contact your Boston Scientific Sales representative if you
would like to obtain sample Galaxy™ System DICOM files on CD, MO or DVD media
for evaluation purposes.
The DICOM Viewing Station must be able to display images with the following
properties to display screenshots exported in the DICOM format from a Galaxy™
System:
• Photometric Interpretation: PALETTE_COLOR
• Size: 1280x1024
• Modality: Single-frame Ultrasound
• Image format: No compression
NOTE: The Galaxy™ System cannot display or import DICOM files.
Quick Reference Procedure
If you are not familiar with the topics in the following Quick Reference procedure, please
proceed to the Detailed Information section.
1. Ensure that the Galaxy™ System is on (i.e., normal display), no operations are
ongoing, all images have been archived, and that the archival media is removed.
2. Connect the Galaxy™ System to the network at the connector marked “LAN”.
3. Move the pointer to the right border of the screen to reveal the main Menu Bar,
select Imaging, then select the Params tab. Check that the Software Version
displayed is 1.03, 2.01 or 2.02. If lower than 1.03, contact Boston Scientific.
4. Select File on the main Menu Bar, then select the DICOM Network tab.
5. Click the TCP/IP button. Enter the password (GAL2002), then click OK.
6. The standard Windows NT Network dialog box will be displayed. Ensure that the
“(1) Intel 82557-based Ethernet PCI-Adapter” is selected where “Adapter” is
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shown. All other settings in the Windows Network dialog boxes are per the
requirements of the facility.
7. Once network settings have been completed, click OK in the Network dialog box.
8. Press the “Standby” position of switch on the rear panel to shut the System down,
then re-start the System.
9. Reveal the main Menu Bar, select File, then select the DICOM Network tab.
10. Click the DICOM Admin button. Enter the password (GAL2002), then click OK.
11. Select the DICOMIT Config tab.
12. Click in the desired entry field, then make entries for AE Title and (optional)
Station Name that are compatible with the network, then click the SAVE button.
Other entries in the upper section are not used.
13. Remove any existing entries that are not applicable by clearing the AE_TITLE
field, then clicking on the gray button on the left side of the DICOM Instruments
table. When the whole row is highlighted, press the Delete button on the
Keyboard.
14. See the “DICOMIT Configuration Reference” tables. A minimum of one Archive
Device must be entered in the DICOM Instruments section (maximum ten).
15. Complete all entries, then click on any other row. The pencil icon will disappear
and the entry is automatically saved.
16. Click on the DICOM Archives tab to bring that dialog box to the foreground.
17. Click the up-down arrows to set the correct number of Archive destinations.
18. Click in the AE Title field, delete existing entries if they are not applicable, then
enter the “AE TITLE” (and the “Description”) of the archive device(s).
19. Click the Save button.
20. Click the corresponding “Test” button. The Galaxy™ System will attempt to
verify each DICOM association. If an “Association Made” message appears, a
valid Association has been made with the DICOM device at that address.
If an Association was not made, verify that all entries are exactly correct,
observing case match as well. Also verify that related network cabling is correct,
and the remote devices are on-line.
21. Click the EXIT button below the DICOMIT window to return to normal System
operation. It is not necessary to re-start the Galaxy™ System for the DICOMIT
settings to be implemented.
22. Reveal the main Menu Bar, then select File.
23. Select the Settings tab, then select the default values for DICOM file
compression, modality, and Screenshot inclusion.
24. Select the DICOM Network tab, then highlight one or more DICOM Archival
Destination. Click to toggle between select (highlighted) and deselect.
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25. Place a check mark in the popup DICOM Archival Selection Dialog check box to
automatically display the DICOM Archival Selection dialog box.
26. Refer to “DICOM Operations” following this section and in the Galaxy™
System User’s Guide for instructions on performing DICOM network transfers,
to test for proper functioning of the System in the DICOM network.
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N
Detailed Procedure
1. See the Windows NT Network Settings Reference table on page 104 and the
“DICOMIT Configuration Reference” table on page 105. We recommend that
you complete the entries in the “Assigned Entry” columns of these tables before
continuing with this procedure. This information is usually provided by the
network administrator for the institution.
2. Ensure that the Galaxy™ System is on (i.e., normal display), and that no
operations are ongoing.
3. Ensure that all images have been archived, and that the archival media is
removed.
4. See Figure 17. Connect the Galaxy™ System to the facilities network using an
RJ-45 type connector inserted into the connector marked “LAN” on the
Connector Panel (located on the lower rear of the System Console).
DICOM
etwork
connection
Figure 17 DICOM Network Connector Location
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5. See Figure 18. Use the Trackball to move the pointer to the right border of the
screen to reveal the main Menu Bar, then select Imaging.
Use Trackball to
move cursor to
the right edge to
reveal the menu
Imaging Menu
access
Figure 18 Main Menu access and Imaging Menu Button
6. In the Imaging window, select the Params tab (if the Params window is not
already in the foreground).
7. See Figure 19. Check the Software Version displayed to the right of “Active
Preset Number”. The software version must be 1.03, 2.01 or 2.02 higher. If not,
discontinue this procedure and contact Boston Scientific for assistance.
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Software
version
(1.03, 2.01 or
2.02)
Figure 19 Viewing the installed software version
8. Use the Trackball to select File on the main Menu Bar, then select the DICOM
Network tab (if the DICOM Network window is not in the foreground).
9. See Figure 20. Click the TCP/IP button. The “Enter Password” dialog box will
be displayed. Enter the case-sensitive password GAL2002, then click OK.
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Click to access
Windows NT
network settings
used for DICOM
Click to access
DICOM
settings
Figure 20 DICOM Network Window
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10. See Figure 21. The standard Windows NT Network dialog box will be
displayed.
Click to access
TCP/IP settings
used for DICOM
Click to
change the
displayed
settings
Figure 21 Standard MS-Windows Networking Dialog Box
Ensure that the “(1) Intel 82557-based Ethernet PCI-Adapter” is selected in all
instances where “Adapter” is shown. This is the only setting that is Galaxy™
System dependent. All other settings in the Windows Network dialog boxes are
per the requirements of the facility where this Galaxy™ System is being
networked.
DICOM utilizes the TCP/IP protocol only. The following parameters are
normally specified when setting up the networking parameters for DICOM:
• Computer Name – in the Identification tab (must be unique, can be
changed from the default name provided)
• Workgroup – in the identification tab
• IP address – in Protocols - TCP/IP Properties, IP Address tab (or select
“Obtain IP address automatically” if your network supports that feature)
• Sublet mask - in Protocols - TCP/IP Properties, IP Address tab, if an IP
address is entered and your network requires this entry
• Gateway address - in Protocols - TCP/IP Properties, Gateway tab, if your
network requires this entry
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These entries are listed in the Windows NT Network Settings Reference table.
If you need further assistance in completing the settings in the Network dialog
boxes, please refer to MS-Windows Networking documentation, or your network
administrator.
11. Once the network settings have been completed, click OK in the Network dialog
box, then press the “0” (Standby) position of the Power On / Standby switch on
the rear panel to momentarily shut the System down.
12. Re-start the System using the “1” (Power On) position of the switch, then wait for
the System to complete normal initialization.
13. Use the Trackball to reveal the main Menu Bar, then select File.
14. Use the Trackball to select the DICOM Network tab (if the DICOM Network
window is not in the foreground).
15. See Figure 20. Click the DICOM Admin button. The “Enter Password” dialog
box will be displayed. Enter the case-sensitive password GAL2002, then click
OK.
See
16. Figure 22. Use the Trackball to select the DICOMIT Config tab (if the
DICOMIT Config window is not in the foreground).
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p
N
N
Click this tab to access
settings after clicking the
DICOM Admin button
shown in Figure 20
Ignore: The Modality
and Institution settings
are entered elsewhere
Used to
save upper
anel
settings
Figure 22 DICOMIT Configuration Window
ormally
ot used
NOTE: “DICOMIT” is an application used by the
Make entries for each DICOM Storage Server
to be used. These lower panel settings are
saved automatically.
Galaxy™ System for parts of its DICOM
communications capability.
17. There are two sections to this window. The upper section (labeled “DICOMIT
Machine”) determines how the Galaxy™ System will appear to other DICOM
devices on your network. The lower section (labeled “DICOM” Instruments)
determines how the Galaxy™ System will interact with other DICOM devices on
your network.
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18. In the upper DICOMIT machine section, use the Trackball to click in the desired
entry field, then make entries that are compatible with your network for the
following:
• AE Title
• Station Name (optional)
See the “DICOMIT Configuration Reference” table.
Note: Station Name is optional. Secondary Capture Device ID does not apply to
Galaxy™ System. The LMHOSTS button is not used, as the corresponding
entries are established in the “HOST” column in the following DICOMIT
Instruments section of this dialog box. Modality and Institution name are entered
at a different location later in this procedure. Those settings here are not used.
• Click the SAVE button to save the upper section entries.
At a minimum, one Archive Device should be set up in the DICOM Instruments
section. No more than ten items should be entered. Only Archive Devices should
be entered. The Galaxy™ System is not configured to communicate with any
other types of DICOM devices. The Archive Devices configured must be capable
or receiving multiple DICOM files of up to 2 GB. Due the slower processing
speed of the Galaxy™ (compared with Galaxy™²) when used with variable
archive devices (servers), anecdotally, the slower Galaxy™ instruments have
mixed results when transferring files greater than 1GB.
• In the DICOMIT Instruments section shown in the lower part of the DICOMIT
Config window, use the Trackball to remove any existing entries that are not
applicable by first clicking in the AE_ TITLE field and then using the Delete key to
remove that entry. Next, click the gray button on the left side of the DICOM
Instruments table. When the whole row is highlighted, press the Delete button on the
Keyboard.
• In the DICOMIT Instruments section, use the Trackball to click in the desired entry
field, then make all five entries for each DICOM device with which the Galaxy™
System shall communicate (archive units):
• AE Title
• Host (the DICOM device’s IP address)
• Port
• Alias
• Packet Size (PDU maximum)
See the “DICOMIT Configuration Reference” tables starting.
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To Remove Data
Single cell - click on the entry. When it is highlighted, press the Delete button on
the keyboard.
Entire row – First, click in the AE_TITLE field for that row, then press the
Delete button on the Keyboard to clear that field. Next, click on the gray box on
the left side of the AE_TITLE field. An arrow icon appears to the left and the
row is highlighted. Press the Delete button again to remove all the data in this
row.
Editing Entries
Click on the field to be edited, then type the desired entry.
Adding New Instruments
1. Click in the AE_TITLE field located next to the asterisk icon. Once you begin
typing the edit, the asterisk will change to a pencil icon indicating that the record
is being edited.
2. Click in each field to type the new value.
3. Complete all entries, then click on any other row. The pencil icon will disappear
and the entry is automatically saved.
NOTE: The asterisk symbol in the left margin of the table indicates the row available for a new
The DICOM Archives window provides setup and verification of a DICOM Association
with the configured destinations. Setting up an Association is the configuration
communication that takes place between sending and receiving devices. During this
configuration communication, the devices establish what they do and do not support,
thereby ensuring that neither attempts something the other does not support. A
successful Association verifies that the DICOM connection is established with the remote
system. This is much more comprehensive than a “ping” test.
NOTE: The following procedure can be also be used for testing communication with pre-
To test the ability for the DICOM-configured Galaxy™ System to communicate with an
existing DICOM Archive configured in the adjacent DICOM Instruments table, do the
following:
entry.
established DICOM archives on the network.
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22. See Figure 23. Click on the DICOM Archives tab to bring that dialog box to the
foreground.
Enter the AE Title assigned
to each Storage Server to be
configured
Click arrows to select
quantity of Storage
Figure 23 DICOM Archives Window used for Testing
Each Test button corresponds to
the Storage Server entry listed
on the left
23. Use the Trackball to click the up-down arrows to set the correct number of
destinations per number of Archive locations entered in step above (excluding the
entry for the Galaxy™ System).
24. Click in the AE Title field, delete any existing entries if they are not applicable, then
enter the exact AE TITLE (and optionally, the “Description”) of the archive
device(s).
25. Click the Save button to store your entries.
26. Click the corresponding “Test” button. The Galaxy™ System will verify each
DICOM association. If an “Association Made” message appears, a valid Association
has been made with the DICOM device at that address.
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If an association was not made:
1) Verify that all entries are exactly correct, observing case match as well.
2) Ping the Server.
3) Also verify that related network cabling is correct, and the remote devices are on-
line.
Click the EXIT button below the DICOMIT window to return to normal System
operation. It is not necessary to re-start the Galaxy™ System for the DICOMIT settings
to be implemented.
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p
y
Galaxy™ System DICOM
Operator-Configuration
Settings
The following settings establish the default manner in which the Galaxy™ System
handles DICOM operations. Although these settings can be changed by the user, they
should be set to an initial state that is appropriate for the protocol used by the institution
where this System is being set up.
NOTE: These settings establish the values used for most DICOM Network transfers,
and establish the default
values used for other DICOM conversions.
Set default image
compression
Items in the
DICOM section are
used to set System
default values for
these parameters.
Details for these
settings are
rovided in the
Systems Settings
chapter of the
User’s Guide.
Figure 24 Settings Window showing DICOM Parameters
1. Use the Trackball to reveal the main Menu Bar, then select File.
Set default
DICOM image
format modalit
Set default
handling of any
Screenshots
associated with a
Run
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