iLab Technical manual

Technical Manual

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iLab™ Ultrasound Imaging System Technical Manual

90233961-01 Rev. B

Boston Scientific

iLab™ Ultrasound Imaging System: Technical Manual Copyright Notice © 2006 Boston Scientific Corporation or its affiliates. All rights 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 express written consent of Boston Scientific Corporation. Trademarks Microsoft and Windows are trademarks of Microsoft Corporation.

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Contents Preface ... 7 Standard Legal and Regulatory Matter ... 8 Product Labeling ... 15 Conventions ... 23 Symbols ... 24 Warnings, Cautions, and Precautions Lists ... 26 Disclaimers ... 35 Indications and Contraindications ... 36 Safety Standards ... 39 1. Introduction to the iLab System ... 41 iLab System Configuration ... 42 Acquisition and Imaging Processors ... 46 Touch Screen Control Panel ... 47 Imaging Display ... 50 iLab System and User Profiles ... 55 Image Optimization Features ... 56 Equipment, Attachments, and Accessories ... 57 Catheters Supported by the iLab System ... 62 2. iLab System Administration ... 63 Logging In ... 64 Setting System Date and Time ... 69 Setting Up TCP/IP ... 70 Archiving Images ... 72 Configuring DICOM Preliminaries ... 74 Verifying a DICOM SCP AE ... 81 Performing Other Advanced Diagnostics ... 83 Editing the System Profile ... 92 Updating iLab System Software ... 99 Updating Catheter Profiles ... 100 3. Confirming System Functionality ... 101 Getting Ready to Confirm System Functionality ... 102 Performing a Test Case ... 104 4. Basic Troubleshooting ... 109 Introduction to Troubleshooting ... 110 Troubleshooting Methods ... 111 Message Types and Formats ... 112 Imaging Display Messages ... 113 Control Panel Messages ... 119 Control Panel Calibration ... 142 Contact Information ... 144 5. Basic Maintenance and Servicing ... 147 Basic Care ... 148 Printer Care ... 154 Shipping, Storage, and Disposal ... 158 BSC Equipment Service ... 159 Parts ... 161 Accessories ... 162 A. Related Publications ... 163 Translated Versions ... 164 B. Specifications ... 165 Specifications for iLab ... 166 C. Warranty ... 169

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iLab™ Ultrasound Imaging System

Warranty Information ... 170 Glossary ... 173 Index ... 177

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List of Figures 1. Location of System Label on iLab Installed System ... 16 2. Location of System Label on iLab Cart System ... 16 1–1. iLab Cart System features ... 42 1–2. iLab Cart System’s AC main power switch ... 43 1–3. iLab Installed System’s AC main power switch ... 43 1–4. iLab Installed System configuration ... 44 1–5. Typical control room configuration for iLab Installed System ... 44 1–6. Imaging Display in the imaging lab (ceiling mount shown) ... 45 1–7. Touch Screen Control Panel features ... 47 1–8. Control Panel button types ... 48 1–9. Control Panel INFO feature ... 49 1–10. “Screen Locked” feature ... 49 1–11. The iLab Cart System’s workspace ... 50 1–12. Full-sized cross-sectional display (LongView™ Feature layout disabled) ... 51 1–13. Imaging Display with LONGVIEW™ LAYOUT Feature enabled ... 52 1–14. Bookmarking in the longitudinal display (detail) ... 53 1–15. Trace Assist™ Feature ... 54 1–16. MDU controls ... 57 1–17. TSC with holder shown in orientation for use ... 58 1–18. AC Power Isolation Transformer ... 58 1–19. High-Resolution Printer ... 58 1–20. CD/DVD and removable hard drive access ... 59 1–21. Location of printer and Imaging Processor ... 60 2–1. LOGIN screen ... 64 2–2. Main Menu ... 65 2–3. UTILITIES screen ... 65 2–4. CHANGE PASSWORD screen ... 65 2–5. USER MANAGEMENT screen ... 66 2–6. CREATE/EDIT USER screen ... 67 2–7. USER MANAGEMENT screen ... 67 2–8. Warning message – Confirm password change ... 68 2–9. SYSTEM DATE AND TIME screen ... 69 2–10. Hospital LAN connection ... 70 2–11. TCP/IP PROPERTIES screen ... 70 2–12. SYSTEM PROFILE screen ... 75 2–13. ADVANCED SYSTEM PROFILE screen ... 75 2–14. DICOM AE MANAGEMENT screen ... 76 2–15. CREATE/EDIT DICOM AE screen – With entries ... 76 2–16. CREATE/EDIT DICOM AE screen ... 77 2–17. DICOM AE MANAGEMENT screen ... 77 2–18. CREATE/EDIT DICOM AE screen ... 78 2–19. CREATE/EDIT DICOM AE screen ... 78 2–20. CREATE/EDIT DICOM AE screen ... 79 2–21. ADVANCED SYSTEM PROFILE screen ... 80 2–22. DICOM AE MANAGEMENT screen ... 80 2–23. DICOM AE MANAGEMENT screen ... 81 2–24. ADVANCED DIAGNOSTICS screen ... 82 2–25. CREATE/EDIT DICOM AE screen ... 82 2–26. ADVANCED DIAGNOSTICS screen ... 83 2–27. ADVANCED DIAGNOSTICS screen ... 84 2–28. RECONNECTING... screen ... 85 2–29. ADVANCED DIAGNOSTICS screen ... 86

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iLab™ Ultrasound Imaging System

2–30. EVENT VIEWER screen ... 86 2–31. EVENT VIEWER screen ... 87 2–32. EXPORT AND BACKUP screen ... 87 2–33. EXPORT AND BACKUP screen – Browse for folder ... 88 2–34. Event log in plain text file ... 88 2–35. SYSTEM INFORMATION screen ... 89 2–36. SYSTEM INFORMATION screen – With details expanded ... 89 2–37. ADVANCED DIAGNOSTICS screen with warning message ... 90 2–38. MANAGE CASES screen ... 90 2–39. REVIEW DEMO CASES screen ... 91 2–40. UTILITIES screen ... 92 2–41. SYSTEM PROFILE screen ... 92 2–42. ADVANCED SYSTEM PROFILE screen ... 93 2–43. EXPORT AND BACKUP screen – Select Folder ... 94 2–44. ADVANCED DIAGNOSTICS screen ... 94 2–45. EXPORT AND BACKUP screen ... 95 2–46. EXPORT AND BACKUP screen – Browse for Folder ... 95 2–47. UTILITIES screen ... 96 2–48. ADVANCED DIAGNOSTICS screen ... 96 2–49. EXPORT AND BACKUP screen – Browse for Folder ... 97 2–50. SYSTEM PROFILE screen ... 97 2–51. ADVANCED SYSTEM PROFILE screen ... 98 2–52. SOFTWARE UPDATE screen ... 99 4–1. Information icon ... 110 4–2. On-line contextual help pop-up ... 110 4–3. STARTUP TEST Screen ... 142 4–4. Calibration Screen ... 142 4–5. Targets screen ... 143 4–6. Confirm Calibration screen ... 143 4–7. Location of Serial Number on Installed System (on top) ... 145 4–8. Location of Serial Number on Cart System (on rear) ... 145 5–1. Main fuse replacement: remove iLab Cart lower rear panel ... 149 5–2. AC Power Isolation Transformer (rear view) ... 150 5–3. Insert screwdriver under tab ... 150 5–4. Pull out the Fuse Holder (side view) ... 151 5–5. Fuse ... 151 5–6. “Screen Locked” message ... 152 5–7. Preparing to Load Paper ... 154 5–8. Set PAPER TYPE Switch to Match Paper ... 155 5–9. Loading a new roll of paper ... 155 5–10. Inserting the Cleaning Sheet into the Printer ... 156

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Preface Contents Standard Legal and Regulatory Matter ... 8 Product Labeling ... 15 Conventions ... 23 Symbols ... 24 Warnings, Cautions, and Precautions Lists ... 26 Disclaimers ... 35 Indications and Contraindications ... 36 Safety Standards ... 39

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Standard Legal and Regulatory Matter

Preface

STANDARD LEGAL AND REGULATORY MATTER Copyright © 2006 Boston Scientific Corporation or its affiliates. All rights 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 express written consent of Boston Scientific Corporation. Trademarks Windows, Windows XP, and DirectX are trademarks of Microsoft Corporation. MergeCOM-3 is a trademark of Merge eFilm. Nero is a trademark of Nero AG. Catalyst is a trademark of ATI Technologies, Inc. Iomega and REV are trademarks of Iomega Corporation. Intel is a trademark of Intel Corporation. Allen is a trademark of Industrial Fasteners, Inc. CPT is a trademark of the American Medical Association.

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Preface

Standard Legal and Regulatory Matter

BSC Addresses

Legal Manufacturer Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 USA USA Customer Service: 888-272-1001 Made in U.S.A.: 47900 Bayside Parkway Fremont, CA 94538-6515 USA

EC REP

EU Authorized Representative

Boston Scientific International S.A. 55 Avenue des Champ Pierreux TSA 51101 92729 NANTERRE CEDEX FRANCE

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Standard Legal and Regulatory Matter

Preface

Model Numbers This User's Guide applies to units with the following model/part numbers: Cart System Description

Model Number

iLab Cart System 100V

iLab100CART

iLab Cart System 120V

iLab120CART

iLab Cart System 220V

iLab220CART

iLab Cart System 240V

iLab240CART

iLab Cart System 100V (EPT)

EPiL100CART

iLab Cart System 120V (EPT)

EPiL120CART

iLab Cart System 220V (EPT)

EPiL220CART

iLab Cart System 240V (EPT)

EPiL240CART

Installed System Description

Model Number

iLab Installed Basic System 100V

iLab100INS

iLab Installed Basic System 120V

iLab120INS

iLab Installed Basic System 220V

iLab220INS

iLab Installed Basic System 240V

iLab240INS

iLab Installed Basic System 100V (EPT)

EPiL100INS

iLab Installed Basic System 120V (EPT)

EPiL120INS

iLab Installed Basic System 220V (EPT)

EPiL220INS

iLab Installed Basic System 240V (EPT)

EPiL240INS

Installed System Options Description

Part Number

MOUNT CEILING OSP 850MM iLab

H749PVCMTOSP850MM0

MOUNT CEILING OSP 600MM iLab

H749PVCMTOSP600MM0

MOUNT CEILING OSP 450MM iLab

H749PVCMTOSP450MM0

Bearing Wall OSP iLab

H749PVWLBRGOSP010

Ceiling Column 850MM PV

H74990141235010

CEILING COLUMN 570mm TROLLEY MAVIG

H74990141235050

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Preface

Standard Legal and Regulatory Matter

This System is a Medical Device Carefully read all instructions prior to use. Observe all contraindications, warnings, cautions, and precautions noted in these directions. Failure to do so may result in patient illness, injury, or death. The iLab System is a medical device for use by or on the order of a physician. The System and this documentation are intended for in-vivo use only by medical professionals fully qualified to perform invasive ultrasound procedures; however, other personnel properly trained in System usage may use the System and this documentation when patient contact is not involved. It is assumed that all users are fully qualified in proper laboratory procedures and protocols. Medical Ultrasound Safety Statement Anyone using the iLab 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. Software License You have acquired an item ("device") that includes software developed and owned by Boston Scientific Corporation (hereinafter referred to as “Boston Scientific” or “BSC”), 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 to you, not sold. For other software used on the iLab System, the following applies: 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 to you, not sold. This EULA and the EULAs listed in Table 1 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.

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Preface

- 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. - 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 (250.00 USD). - 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 United States (U.S.) 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: www.microsoft.com.

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Standard Legal and Regulatory Matter

Required Application Software and Drivers for the iLab System When applicable, the URL from where the EULA is retrieved is provided. Agreement to each EULA listed in this table is required to install the driver items. If you do not agree to the listed EULAs, 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. Manufacturer Software package name

Version number

ATI

ATI Catalyst™ Bundle (wxp-w2k-catalyst 8-09-041221m020455c.exe)

Bundle version: 5.1 (posted 01/17/2005) Display Driver: 6.14.10.6505; Control Panel: 6.14.10.5137; WDM Capture Driver: 6.14.10.6246 V3

Broadcom

NIC driver

3.60.0.0

Elo Elo Touch screen Touchsystems Universal Driver (sw500930.exe)

4.20

Intel

Intel™ NIC driver (pro2kxp.exe)

8.4.21.0

Intel

Intel Chipset Software 6.0.1.1002 Installation Utility (setup.exe)

Intel

Display driver

Iomega

Iomega™ REV™ Driver 2.0.2 (rev_system_softwarew32-x86-202.exe)

Marvell

NIC driver

EULA

6.14.10.3847

6.32.0.0

Merge eFilm MergeCOM-3™ Release 3.4.0 IB11 Advanced Integrator’s Toolkit Microsoft

Windows XP™ Professional SP1a

Windows XP Professional SP1a

www.microsoft.com

Microsoft

DirectX™ Runtime

9.0b - Managed

microsoft.com

Microsoft

.NET Framework Runtime

1.1 SP1

msdn.microsoft.com

Nero

Nero™ OEM

6.6.0.5

www.nero.com

Realtek

Audio driver 5.10.0.5583 (Acquisition Processor)

Realtek

Audio driver

Sony

Thermal printer driver UP-D895

5.10.0.5580

Table 1. Required Application Software and Drivers

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Standard Legal and Regulatory Matter

Preface

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. The iLab System meets the acoustic output emission guidelines established by the Food and Drug Administration (FDA). The total ultrasonic power emitted from the applicable imaging catheters 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 iLab System drives the imaging catheters in B-mode only). United States guidelines for measurements, definitions of terms, and acoustic output reporting requirements may be found in the guidance entitled Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued by the Food and Drug Administration of the U.S. Department of Health and Human Services, Center for Devices and Radiological Health, September 30, 1997. Additionally, European Union requirements for measurements, and definitions of terms may be found in EN 60601-2-37:2001 entitled Medical Electrical Equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

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Preface

Product Labeling

PRODUCT LABELING This section shows the labeling required by various regulatory authorities and describes their location. Please contact Boston Scientific if any of these labels are missing or damaged beyond legibility: ■ iLab System labels ■ iLab component labels ■ Motordrive Unit (MDU) labels System Label The System Label is the primary System label and contains the top-level product ID information, such as Catalog and Serial Number of your iLab System, the date of manufacture, as well as other information pertaining to applicable regulatory and compliance standards. The following examples are for reference only, and are not shown to scale. System Label - Catalog/Serial No.

NOTE: “Hz” indicates cycles per second, “V” indicates voltage, and the “~” symbol indicates alternating current. The System Label is located in different places depending on whether you have the Installed System or the Cart System. For the Installed System, the System Label is located on top of the AC Power Isolation Transformer.

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Product Labeling

Preface

1 1

Location of System Label for the Installed System configuration (top of AC Power Isolation Transformer).

Figure 1. Location of System Label on iLab Installed System For the iLab Cart System, the System Label is located on the rear panel adjacent to where the AC power cord exits the console. 1

Location of System Label for the Cart System (rear panel next to AC power cord).

Figure 2. Location of System Label on iLab Cart System System AC Power Cord (100/120 Volt Only)

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Preface

Product Labeling

AC Power Isolation Transformer Labels There are three labels associated with the AC Power Isolation Transformer. Transformer Bottom Label The transformer bottom label is located on the bottom of the AC Power Isolation Transformer.

Output Voltage Setting The output voltage setting label is located on the top of the AC Power Isolation Transformer.

System Equipotential Post Label

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Product Labeling

Preface

Acquisition Processor Labels There are six labels associated with the Acquisition Processor. Acquisition Processor Voltage Label Acquisition Processor iLab Ultrasound Imaging System

120V~

50/60Hz

150VA~ P/N 94-00148-01A

Input Voltage Setting The input voltage setting label is located on the top of the Acquisition Processor.

Rear Panel Connectors Label

Reset

ECG

TSC 94-00146-01A

■ Reset – Forces Acquisition Processor to restart. Used for troubleshooting only. ■ ECG Input Cable Connection – Displays ECG on Imaging Display. ■ TSC – Tableside Controller cable connection. ■ Hospital LAN Connection – Used for connecting to DICOM Network.

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Preface

Product Labeling

Acquisition Processor Side Label NOTE: This label can only be seen on the iLab Installed configuration.

94-00147-01A

MIC

■ MIC – Microphone input connection from monitor. ■ LAN Connection (private). ■ LAN Connection (private). System Equipotential Post Label

Motordrive Unit Connection Label

94-00145-01A

NOTE: The long horizontal symbol indicates the Motordrive; the circle with arrows indicates a combination input/output connector, which is located on the Acquisition Processor on the Installed System configuration and on the left side of the top-left rear of the Cart for Cart System configuration. The hand symbol indicates this connector is sensitive to electrostatic discharge. Imaging Processor Labels There are two labels associated with the Imaging Processor.

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Product Labeling

Preface

Imaging Processor Voltage Label Imaging Processor iLab Ultrasound Imaging System

100-120V~/220-240V~

50/60Hz 200VA P/N VOLB01A

Imaging Processor Video, USB, Data, Audio, and AC connectors labels SPKR

IPLS01A

From left: ■ DVI Video Outputs (Image Display & Control Panel) ■ USB Connections (2) ■ LAN Connections (Private & DICOM Network) ■ Speaker Output Connection ■ AC Power Input (for Processor only) Touch Screen Control Panel Labels There are two labels associated with the Touch Screen Control Panel. NOTE: Neither of the Control Panel labels will be visible on the iLab Cart System in normal use. Control Panel Voltage Label Control Panel iLab Ultrasound Imaging System

P/N 94-00144-01A

Control Panel Rear Connector and Brightness Control Label (with cutouts)

12 V

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