Philips HD11 XE Getting Started Manual
Getting Started
4535 612 62651 Rev A
September 2006
HD11 XE Ultrasound System
Copyright © 2006 Koninklijke Philips Electronics N.V. All rights reserved Printed in USA
Manufactured by Philips Ultrasound
22100 Bothell-Everett Highway
Bothell, WA 98021-8431
USA
Telephone: +1 425-487-7000 or 800-426-2670
Fax: +1 425-485-6080
www.medical.philips.com
This Medical Device meets the provisions of the transposition of the Medical
Device Directive 93/42/EEC within the country of origin of the Notified Body
concerned with the device.
European Union Representative
Philips Medical Systems Nederland B.V.
PMS Quality and Regulatory Affairs Europe
Veenpluis 4-6
5684 PC Best
The Netherlands
CAUTION
United States federal law restricts this device to sale by or on the order of a
physician.
This document and the information contained in it is proprietary and confidential information of Philips Medical Systems
("Philips") and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated
without the prior written permission of the Philips Legal Department. This document is intended to be used by customers
and is licensed to them as part of their Philips equipment purchase. Use of this document by unauthorized persons is strictly
prohibited.
Philips provides this document without warranty of any kind, implied or expres sed, inc luding, but not limited to, the implied
warranties of merchantability and fitness for a particular purpose.
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Philips has taken care to ensure the accuracy of this document. However, Philips assumes no liability for errors or omissions
and reserves the right to make changes without further notice to any products herein to improve reliability, function, or
design. Philips may make improvements or changes in the products or programs described in this document at any time.
This product may contain remanufactured parts equivalent to new in performance, or parts that have had incidental use.
“Color Power Angio,” “HD11,” “High Q,” “OmniPlane,” “QLAB,” “SonoCT,” “Ultraband,” and “XRES” are trademarks of
Koninklijke Philips Electronics N.V.
Non-Philips product names may be trademarks of their respective owners.
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Contents
1 Read This First . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Warning Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
About Your User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
About Your Compact Disc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
User Information Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Upgrades and Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Customer Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Ordering Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Customer Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
2 Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Dangerous Voltages Symbol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Electrical Shock Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Explosion Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Radio Frequency Communications Equipment Hazard. . . . . . . . . . . . . . . . . . . . .24
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
ECG Signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Electrostatic Discharge Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Biological Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
ALARA Education Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Output Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Control Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
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Related Guidance Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Acoustic Output and Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Acoustic Output Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Acoustic Measurement Precision and Uncertainty . . . . . . . . . . . . . . . . . . . . . . . .43
Symbols Used on the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Ultrasound Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Thermal Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Electrical Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Installation Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
AC Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Defibrillators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Explosive Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Philips Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Latex Materials and Patient Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
FDA Medical Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Transmissible Spongiform Encephalopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Peripherals Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Operator Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Repetitive Strain Injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Foot Switch Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Philips Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Electrical Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Explosive Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Glutaraldehyde Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
3 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
About the HD11 XE Ultrasound System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
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Intended Uses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Abdominal Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Cardiac Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Gynecological Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Intraoperative Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Neonatal Head Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Obstetrical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Pediatric Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Small Parts Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Transcranial Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Vascular Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Ultrasound System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
System Control Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
About Standard Features, Clinical Options, and Purchasable Options. . . . . . . . . . . .73
Standard Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Clinical Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Purchasable Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
4 Using the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Turning the System On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Positioning the Control Panel and Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Adjusting the Monitor Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Locking and Unlocking the Monitor Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Adjusting the Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Raising, Lowering, and Swiveling the System Control Panel . . . . . . . . . . . . . . . . .82
Using the System Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Soft Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
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Select and Enter Keys and the Trackball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Changing the Current Input Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Customizing Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
About Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Changing and Saving System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Installing, Removing, and Disabling Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Assigning Option Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Making Backups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Backing Up Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Backing Up System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Backing Up Patient Folders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Managing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Managing Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Configuring Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
Configuring the System’s Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
Adding a DICOM Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
Associating DICOM Servers with Roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
Checking the DICOM Job Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Connecting Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
Connecting a Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Connecting a VCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Assigning Keys to Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Connecting and Configuring the Foot Switch . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Configuring and Using the Data Transfer Feature. . . . . . . . . . . . . . . . . . . . . . . . . . .105
Assigning a Record Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
Transferring Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
Moving and Transporting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
Taking Precautions When Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . .107
Using the Wheel Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108
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Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Transporting the System in a Vehicle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Getting Help and Troubleshooting Your System . . . . . . . . . . . . . . . . . . . . . . . . . . .111
Using the Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111
Getting Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113
5Cleaning and Maintaining the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Cleaning and Disinfecting System Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Cleaning the Cables and the Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118
Recommended Frequency of Maintenance Procedures . . . . . . . . . . . . . . . . . . .118
Service Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Electrostatic Discharge Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
Maintaining the System Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121
Cleaning the Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121
Cleaning the Trackball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Cleaning and Maintaining Peripherals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
VCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Video Printers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Replacing the System Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124
Disposing of Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124
6Device Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Model Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Storage Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
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Standards and Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Audible Acoustic Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Approved Cables, Transducers, and Accessories for EMC . . . . . . . . . . . . . . . .128
Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
Recommended Separation Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
Avoiding Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137
Restrictions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138
Immunity Level Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138
Electrosurgical Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
Input/Output Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
System Input/Output Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
ECG/Physio Input Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142
7 Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Supported Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145
Specialty Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149
Connecting Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
Activating Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154
Transducer Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154
8 Transducer Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Handling Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Inspecting Transducers for Damage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Installing and Cleaning the Ergonomic Grip. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Storing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157
Storage for Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157
Daily and Long-Term Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158
Safety Considerations When Using Disinfectants and Gels . . . . . . . . . . . . . . . . . . .159
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Latex Product Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Transmissible Spongiform Encephalopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Acoustic Coupling Medium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
Cleaning, Disinfecting, and Sterilizing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . .161
Choosing a Disinfectant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
General Cleaning Procedures for All Transducers . . . . . . . . . . . . . . . . . . . . . . .162
Disinfecting Transducers with Wipes and Sprays
(Low to Intermediate-Level Disinfection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163
Cleaning and Disinfecting Cables and Connectors with Wipes and Sprays . . . .164
Disinfecting Transducers by Immersion (High-Level Disinfection). . . . . . . . . . .167
Sterilizing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .173
Disinfectants Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176
Disinfectant Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177
Factors Affecting Disinfectant Efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177
Disinfectants Compatibility Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178
Gels Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .192
9 Endocavity Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193
Operator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193
Equipment Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195
Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195
Description and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195
C8-4v Endocavity Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .196
3D9-3v Endocavity Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .197
C9-5ec Endocavity Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .198
The Endocavity Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .199
Preparing the Endocavity Transducer for an Exam . . . . . . . . . . . . . . . . . . . . . . .199
Preparing a Patient for an Endocavity Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
Endocavity Examination Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
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Contents
Accessories for Endocavity Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .202
10 TEE Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Operator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .203
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .204
Equipment Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .207
Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .208
Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209
Electrosurgical Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209
Pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209
Defibrillators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210
Accident Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210
OmniPlane III Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210
Basic Transducer Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211
Deflection Control Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212
Temperature Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213
Description and Use: OmniPlane III Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . .214
Manipulating the OmniPlane III Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .215
Rotating the OmniPlane Array. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .216
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217
Checking the TEE Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .218
Inspecting the Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .218
Verifying Operation of the Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219
S7-3t TEE Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219
Selecting Patients for the S7-3t Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . .221
Deflection and Scan Plane Rotation Control. . . . . . . . . . . . . . . . . . . . . . . . . . . .221
Tip Deflection Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .221
Lock Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .222
Transducer Scan Plane Rotation Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .222
Special Considerations for TEE Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .224
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Preparing Patients for a TEE Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .224
Examination Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225
Tip Fold-Over. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .227
Recognizing Tip Fold-Over. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .228
Correcting Tip Fold-Over . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .228
Ensuring Accurate Temperature Sensing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .228
TEE Manual Auto-Cool Safety Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .229
Entering the Patient Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .230
Monitoring the Distal Tip Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .231
Resuming Imaging After an Auto-Cool Interruption. . . . . . . . . . . . . . . . . . . . . .233
Changing Temperature Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .234
Checking the Patient After a TEE Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . .234
TEE Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .235
Bite Guards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .235
Tip Protector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .235
Transducer Covers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .236
Disposable Drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .236
Electrical Safety Check Procedure for TEE Transducers . . . . . . . . . . . . . . . . . . . . .236
Test Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .236
Equipment and Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .238
11 Biopsy-Capable Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .241
Transducers Supporting Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .241
Biopsy Guide Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .242
Using the Biopsy Needle Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .243
Biopsy Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .243
12 Intraoperative Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .245
Operator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .245
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .246
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Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .246
Patient Contact Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .247
Equipment Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .247
Description and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .249
Preparing a Transducer for Intraoperative Imaging. . . . . . . . . . . . . . . . . . . . . . . . . .250
Disposable Drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .252
Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .252
Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .252
Defibrillators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .252
Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .252
Testing Leakage Current on Intraoperative Transducers . . . . . . . . . . . . . . . . . . . . .253
Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .253
Leakage Current Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .253
Appendix A HD11 XE System Supplies, Peripherals, and Accessories. . . . 259
Ordering Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .259
Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .259
Physio Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .259
Printer Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .261
VCR Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .262
Removable Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .262
Transducer Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .263
Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .265
Printers and Printer Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .265
VCRs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .266
Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .266
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
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1 Read This First
W
This section contains important information about the user information for your
system and about contacting Philips Ultrasound.
Intended Audience
Before you use your user information, you need to be familiar with ultrasound
techniques. Sonography training and clinical procedures are not included here.
This manual is intended for sonographers, physicians, and biomedical engineers
who operate and maintain the ultrasound system.
Warnings
Before using the system, read these warnings and the “Safety” section of this manual.
ARNINGS
• Do not remove system covers; hazardous voltages are present inside the sys-
tem. To avoid electrical shock, use only supplied power cords and connect
only to properly grounded wall (wall/mains) outlets.
• Do not operate the system in the presence of flammable anesthetics. Explo-
sion can result.
• Medical equipment needs to be installed and put into service according to the
special electromagnetic compatibility (EMC) guidelines provided in “Electro-
magnetic Compatibility” on page 24.
• The use of portable and mobile radio-frequency (RF) communications equip-
ment can affect the operation of medical equipment.
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Read This First
1
Warning Symbols
The system uses the following warning symbols (Table 1-1). For additional sym-
bols used on the system, see “Symbols Used on the System” on page 45.
Symbol Description
Documentation: The product is marked with this symbol
when it is necessary to refer to the user information.
Dangerous voltages: This symbol appears adjacent to
high-voltage terminals. It indicates the presence of voltages
greater than 1,000 Vac (600 Vac in the United States).
ESD (electrostatic discharge): The product is marked with this
symbol to warn the user not to touch exposed pins. Touching
exposed pins can cause electrostatic discharge, which can
damage the product.
Ta b l e 1 - 1 W a r n i n g S y m b o l s
About Your User Information
The user information provided with your system includes the following components:
• Compact Disc (CD): Includes all of the user information, except the Operat-
ing Notes.
• Getting Started: Introduces you to system features and concepts, and helps
you set up your ultrasound system. This manual also includes procedures for
basic operation. For detailed operating instructions, refer to Help or the User
Reference.
• Help: Help is available on the system in some languages and the information
in Help is also included in the User Reference on the CD. Help contains comprehensive instructions for using the system. Press Help on the system control panel to display Help. It includes a glossary containing descriptions of all
controls and display elements.
• Quick Guide: The Quick Guide is provided with the system and is also
included on the CD. It contains procedures, imaging tips, and information on
system controls.
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• Acoustic Output Tables: Included on the CD, it contains information about
mechanical index (MI) and thermal index (TI) precision and accuracy, the
acoustic output default tables, and the acoustic output tables.
• Medical Ultrasound Safety: Included on the CD, it contains information on
bioeffects and biophysics, prudent use, and implementing ALARA (as low as
reasonably achievable).
• Operating Notes: Contains information that clarifies certain system
responses that might be misunderstood or cause user difficulty.
• Shared Roles for System and Data Security: Contains guidelines to help
you understand how the security of your ultrasound system could be compromised and information on Philips efforts to help you prevent security
breaches.
About Your Compact Disc
The CD contains all of the user information, except the Operating Notes. The
instructions for using the CD are included with the CD.
Read This First
1
Conventions
The system uses certain conventions throughout the interface to make it easy for
you to learn and use. The accompanying user information also uses typographical
conventions to assist you in finding and understanding information.
System Conventions
These conventions are used in the system:
• The trackball, the Enter key, and the Select key work together somewhat
like a computer mouse. Moving the trackball is like moving the mouse. Pressing the Enter key is like pressing the left mouse button. In Image Review,
pressing the Select key is like pressing the right mouse button.
• To enter text into a field, click in the field and use the keyboard.
•To display a list, click the down arrow. To scroll through a list, click the arrows
at either end of the scroll bar or drag the scroll bar up or down.
• Controls on the control panel include buttons, soft keys, hard keys, option
and record keys, knobs, slide controls, and a trackball. Press a button to acti-
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vate or deactivate its function. Turn a knob to change the selected setting.
Move a slide control to change its setting. Roll the trackball in the direction
that you want to move a caliper or object.
•The Point er control has multiple functions, depending on the mode: Press it
to show or hide the system pointer, to exit an active application, to start a
function from an icon on the Report and Review pages, or to select and view
thumbnails on the display.
User Information Conventions
The user information follows these conventions:
• Hypertext links appear in blue.
• All procedures are numbered, and all subprocedures are lettered. You must
complete steps in the sequence they are presented to ensure success.
• Bulleted lists indicate general information about a particular function or procedure. They do not imply a sequential procedure.
• Control names and menu items or titles are spelled as they are on the system,
and they appear in bold text.
• Symbols appear as they appear on the system.
• The left side of the system is to your left as you stand in front of the system,
• Transducers and pencil probes both are referred to as transducers, unless the
• Click means to move the pointer to an object and press the Enter key.
• Double-click means to quickly click twice to select an object or text.
• Select means to move the pointer to an object and press the Select key.
• Drag means to place the pointer over an object and then press and hold the
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facing the system. The front of the system is nearest you as you operate it.
distinction is important to the meaning of the text.
Enter key while moving the trackball. Use this method to move an object on
the display.
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Information that is essential for the safe and effective use of the ultrasound system
appears throughout your system user information as follows:
1
NOTE
Notes bring your attention to important information that will help you operate
the ultrasound system more effectively.
CAUTION
Cautions highlight ways that you could damage your ultrasound system and consequently void your warranty or service contract.
WARNING
Warnings highlight information vital to the safety of you, the operator, and the
patient.
Upgrades and Updates
Philips Ultrasound is committed to innovation and continued improvement.
When upgrades that consist of hardware or software improvements are released,
updated user information sets will accompany those system upgrades.
Customer Comments
If you have questions about the user information set, or to report an error in the
user information set
• For U.S. customers, call Philips Ultrasound Customer Service at
800-722-9377.
• For customers outside the USA, call your local customer service representative or contact one of the offices under “Customer Service” on page 20.
You can also send e-mail to Philips Ultrasound Technical Communications at the
following address:
bothell.techpubs@philips.com
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Ordering Supplies and Accessories
You can order transducer covers, biopsy guides, and other supplies and accessories from CIVCO Medical Instruments:
CIVCO Medical Instruments
102 First St. South
Kalona, IA 52247-9589
Telephone: 800-445-6741, Ext. 1 for Customer Service (USA)
+1 319-656-4447 (International)
Fax: 877-329-2482 (USA)
+1 319-656-4451 (International)
E-mail: info@civcomedical.com
Internet: civco.com
For more information on ordering supplies and accessories, see “HD11 XE Sys-
tem Supplies, Peripherals, and Accessories” on page 259.
Customer Service
Customer service representatives are available worldwide to answer questions
and to provide maintenance and service. Please contact your local Philips Ultrasound representative for assistance. You can also contact one of the following
offices for referral to a customer service representative, or visit the Philips Ultrasound Web site:
www.medical.philips.com
Corporate and North American Headquarters
22100 Bothell-Everett Highway
Bothell, WA 98021-8431
USA
800-722-9377
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Asia Pacific Headquarters
Level 9, Three Pacific Place
1 Queen’s Road East
Wanchai
Hong Kong
+852 2821 5888
European Headquarters (also serves Africa and the Middle East)
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Str. 2
71034 Böblingen
Germany
+49 40 5078 4532
Latin American Headquarters
1550 Sawgrass Corporate Parkway, Suite 300
Sunrise, FL 33323
USA
1
+1 954-628-1000
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2Safety
Read this section before you use the ultrasound system. Also refer to the Quick
Guide and the Help.
Before you use any transducer for the first time, be sure to read all applicable
usage, patient-safety, operator-safety, and electrical-safety guidelines in this manual.
If you have any comments or questions about safety, contact your Philips representative.
This section includes critical information about the intended uses of the ultrasound system.
Dangerous Voltages Symbol
The dangerous voltages symbol appears adjacent to high-voltage terminals.
It indicates the presence of voltages greater than 1,000 Vac (600 Vac in the United
States).
Warnings
Before using the system, read the following warnings and this “Safety” section:
Electrical Shock Hazard
WARNING
Do not remove system covers. To avoid electrical shock, use only supplied power
cords and connect only to properly grounded wall (wall/mains) outlets. For more
information regarding operator and patient safety, see “Electrical Warnings” on
page 48.
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Safety
2
Explosion Hazard
WARNING
Do not operate the system in the presence of flammable anesthetics. For more
information regarding operator and patient safety, see “Explosive Hazards” on
page 52.
Radio Frequency Communications Equipment Hazard
WARNING
The use of portable and mobile RF communications equipment can affect the
operation of medical equipment.
Electromagnetic Compatibility
Electromagnetic compatibility (EMC) is defined as the ability of a product, a device,
or a system to function satisfactorily in the presence of the electromagnetic phenomena that exists in the location of the product, the device, or the system being
used; and, in addition, to not introduce intolerable electromagnetic disturbances
to anything in that same environment.
Electromagnetic immunity is the ability of a product, a device, or a system to function satisfactorily in the presence of electromagnetic interference (EMI).
Electromagnetic emissions is the ability of a product, a device, or a system to introduce intolerable electromagnetic disturbances into the use environment.
The ultrasound system has been manufactured in compliance with existing electromagnetic compatibility requirements. Use of this system in the presence of an
electromagnetic field can cause momentary degradation of the ultrasound image.
If this occurs often, review the environment in which the system is being used to
identify possible sources of radiated emissions. These emissions could be from
other electrical devices used within the same room or an adjacent room, or from
portable and mobile RF communications equipment such as cellular phones and
pagers, or from the existence of radio, TV, or microwave transmission equipment
located nearby. In cases where electromagnetic interference (EMI) is causing disturbances, it may be necessary to relocate your system.
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The system complies with International Standard CISPR 11 for radiated and conducted electromagnetic disturbances. Compliance with this standard allows the
system to be used in all establishments, including domestic establishments and
those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
CAUTION
Medical equipment has special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the
system’s accompanying documents.
“Electromagnetic Compatibility” on page 127 includes information on electro-
magnetic emissions and immunity as it applies to the system. Ensure that the
operating environment of your system meets the conditions specified in the referenced information. Operating the system in an environment that does not meet
these conditions may degrade system performance.
The information and warnings contained in this and other sections should be
observed when installing and using the ultrasound system to ensure its EMC.
Safety
2
The ultrasound system will remain safe and will provide the following essential
performance if it is operated within the electromagnetic environment listed in
Table 6-6 on page 131:
• Imaging (See “Electromagnetic Compatibility” on page 127 for conducted
immunity limitations and rationale.)
• Doppler audio and spectral display
•Measurements
• Acoustic output
• ECG triggering
• VCR recording and playback
• Printing using the system printers
• Patient information
• Date/time information
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WARNING
Using cables, transducers, or accessories with the system other than those specified for use with the system may result in increased emissions or decreased
immunity of the system.
ECG Signal
The amplitude of the electrocardiogram (ECG) signal is critical for reliable frame
triggering. Frame triggering should only be used when a clean, noise-free ECG
waveform is observed on the ECG display.
The ECG signal should be at least 0.25 mV to ensure reliable triggering when the
system is used in the presence of the electromagnetic phenomena described in
this manual.
WARNING
Operation of your system below 0.25 mV may cause inaccurate results. See
“ECG/Physio Input Connections” on page 142 for more information.
Electrostatic Discharge Precautions
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low
humidity, which can be caused by heating or air-conditioning. During low humidity
conditions, electrical charges naturally build up on individuals and objects and can
create static discharges.
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The following cautions can help to reduce ESD effect:
W
CAUTIONS
• Do not touch transducer connector pins or the system’s transducer recepta-
cle.
• Handle the transducer by the metal connector shell.
• Make contact with a metal surface of the system before connecting a trans-
ducer to the system.
• On connectors that display the ESD sensitivity symbol , do not touch the
connector pins, and always observe the preceding ESD precautions when handling or connecting transducers. For more information, see “Electrostatic Dis-
charge Guidelines” on page 120.
Biological Safety
This section contains information about biological safety and a discussion of the
prudent use of the system.
A list of precautions related to biological safety follows; observe these precautions when using the system. For more information refer to Medical Ultrasound
Safety on your user information CD.
Safety
2
ARNINGS
• Do not use the system if an error message appears on the video display indi-
cating that a hazardous condition exists. Note the error code, turn off power
to the system, and call your customer service representative.
• Do not use a system that exhibits erratic or inconsistent image updating. Dis-
continuities in the scanning sequence are indicative of a hardware failure that
must be corrected before use.
• Perform ultrasound procedures prudently. Use the ALARA (as low as reason-
ably achievable) principle.
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2
ARNINGS
• Use only acoustic standoffs that have been approved by Philips Ultrasound.
• Transducer covers may contain natural rubber latex. Those covers may cause
allergic reactions in some individuals. Refer to the FDA Medical Alert on Latex
Products, dated March 29, 1991.
• In contrast studies using a high-MI acoustic field, capillary rupture, due to
microbubble expansion within a capillary in an acoustic field, can cause
extravasation.
• Preventricular contractions can be caused by the oscillations of microbubbles
when a high-MI acoustic field is triggered in the heart at the end of systole. In
a very sick patient with certain risk factors, theoretically, this could lead to
ventricular fibrillation. References: 1. Skyba DM, Price RJ, Linka AZ, Skalak
TC, Kaul S. Direct in vivo visualization of intravascular destruction of microbubbles
by ultrasound and its local effects on tissue. Circulation 1998;98:290-293. 2. van
Der Wouw PA, Brauns AC, Bailey SE, Powers JE, Wilde AA. Premature ventric-
ular contractions during triggered imaging with ultrasound contrast. J Am Soc
Echocardiogr 2000;13(4):288-94.
• If the sterile transducer cover becomes compromised during an intraopera-
tive application involving a patient with Creutzfeldt-Jakob disease, follow the
recommendations described in “Transmissible Spongiform Encephalopathy”
on page 54.
• If the system becomes contaminated internally with bodily fluids carrying
• The backlight lamps in the system displays contain mercury and must be recy-
ALARA Education Program
The guiding principle for the use of diagnostic ultrasound is defined by the “as low
as reasonably achievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgement and insight of qualified personnel. No set of
rules can be formulated that would be sufficiently complete to dictate the correct
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pathogens, you must immediately notify your Philips Ultrasound service representative. The system’s internal components cannot be disinfected. In this
case, the system must be disposed of as biohazardous material in accordance
with local or federal laws.
cled or disposed of according to local, state, or federal laws.
Safety
response to every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the
sonographer’s responsibility to control total energy transmitted into the patient.
The sonographer must reconcile exposure time with diagnostic image quality. To
ensure diagnostic image quality and limit exposure time, an ultrasound system
provides controls that can be manipulated during the exam to optimize the
results of the exam.
The ability of the user to abide by the ALARA principle is important. Advances in
diagnostic ultrasound not only in the technology but in the applications of that
technology, have resulted in the need for more and better information to guide
the user. The output display indices are designed to provide that important information.
There are a number of variables which affect the way in which the output display
indices can be used to implement the ALARA principle. These variables include
index values, body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially
useful variable, because it is controlled by the user. The ability to limit the index
values over time supports the ALARA principle.
2
Applying ALARA
The system imaging mode used depends upon the information needed. 2D and
M-mode imaging provide anatomical information, while Doppler, Philips Color
Power Angio (CPA), and Color imaging provide information about blood flow. A
scanned mode, like 2D, CPA, or Color, disperses or scatters the ultrasonic energy
over an area, while an unscanned mode, like M-mode or Doppler, concentrates
ultrasonic energy. Understanding the nature of the imaging mode being used
allows the sonographer to apply the ALARA principle with informed judgement.
Additionally, the transducer frequency, system setup values, scanning techniques,
and operator experience allow the sonographer to meet the definition of the
ALARA principle.
Special care must be taken to enter the correct application when conducting an
exam, and to remain in that application throughout the course of that examination. In the future, HD11 XE may add some applications, such as ophthalmic appli-
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Safety
2
cations, dealing with delicate parts of the body which require lower limits for
acoustic output.
The decision as to the amount of acoustic output is, in the final analysis, up to the
system operator. This decision must be based on the following factors: type of
patient, type of exam, patient history, ease or difficulty of obtaining diagnostically
useful information, and the potential localized heating of the patient due to transducer surface temperatures. Prudent use of the system occurs when patient
exposure is limited to the lowest index reading for the shortest amount of time
necessary to achieve acceptable diagnostic results.
Although a high index reading does not mean that a bioeffect is actually occurring,
a high index reading should be taken seriously. Every effort should be made to
reduce the possible effects of a high index reading. Limiting exposure time is an
effective way to accomplish this goal.
There are several system controls that the operator can use to adjust the image
quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA. These controls can be
divided into three categories: direct, indirect, and receiver controls.
Direct Controls
Application selection and the Power control directly affect acoustic intensity.
There are different ranges of allowable intensity or output based on your selection. Selecting the correct range of acoustic intensity for the application is one of
the first things that occurs in any exam. For example, peripheral vascular intensity
levels are not recommended for fetal exams. Some systems automatically select
the proper range for a particular application, while others require manual selection. Ultimately, the user has the responsibility for proper clinical use. The ultrasound system provides both automatic (default) settings and manual
(user-selectable) settings.
Power has direct impact on acoustic intensity. Once the application has been
established, the Power control can be used to increase or decrease the intensity
output. The Power control allows you to select intensity levels less than the
established maximum. Prudent use dictates that you select the lowest output
intensity that is consistent with good image quality.
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