Anda di halaman 1dari 278

HD11 XE Ultrasound System

Getting Started
4535 612 62651 Rev A
September 2006

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 expressed, including, 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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Contents

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 Systems 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
5 Cleaning 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

6 Device 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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Contents

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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Contents

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
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 man-
ual.

WARNINGS
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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15
1 Read This First

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.
Table 1-1 Warning Symbols
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.

About Your User Information


The user information provided with your system includes the following compo-
nents:
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 com-
prehensive instructions for using the system. Press Help on the system con-
trol 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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16 4535 612 62651
Read This First 1
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 compro-
mised 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.

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. Press-
ing 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 Pointer 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 pro-
cedure. 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,
facing the system. The front of the system is nearest you as you operate it.
Transducers and pencil probes both are referred to as transducers, unless the
distinction is important to the meaning of the text.
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
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:
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 con-
sequently 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 representa-
tive 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 accesso-
ries 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 Ultra-
sound representative for assistance. You can also contact one of the following
offices for referral to a customer service representative, or visit the Philips Ultra-
sound 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 Queens Road East
Wanchai
Hong Kong
+852 2821 5888

European Headquarters (also serves Africa and the Middle East)


Philips Medizin Systeme Bblingen GmbH
Hewlett-Packard-Str. 2
71034 Bblingen
Germany
+49 40 5078 4532

Latin American Headquarters


1550 Sawgrass Corporate Parkway, Suite 300
Sunrise, FL 33323
USA
+1 954-628-1000

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2 Safety
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 man-
ual.
If you have any comments or questions about safety, contact your Philips repre-
sentative.
This section includes critical information about the intended uses of the ultra-
sound 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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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 phe-
nomena 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 func-
tion satisfactorily in the presence of electromagnetic interference (EMI).
Electromagnetic emissions is the ability of a product, a device, or a system to intro-
duce intolerable electromagnetic disturbances into the use environment.
The ultrasound system has been manufactured in compliance with existing elec-
tromagnetic 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 dis-
turbances, it may be necessary to relocate your system.

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The system complies with International Standard CISPR 11 for radiated and con-
ducted 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
systems 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 refer-
enced 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.
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 speci-
fied 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 natu-
rally 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:
CAUTIONS
Do not touch transducer connector pins or the systems 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 han-
dling 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 precau-
tions when using the system. For more information refer to Medical Ultrasound
Safety on your user information CD.

WARNINGS
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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WARNINGS
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
pathogens, you must immediately notify your Philips Ultrasound service repre-
sentative. The systems internal components cannot be disinfected. In this
case, the system must be disposed of as biohazardous material in accordance
with local or federal laws.
The backlight lamps in the system displays contain mercury and must be recy-
cled or disposed of according to local, state, or federal laws.

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 reason-
able 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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response to every circumstance. By keeping ultrasound exposure as low as possi-
ble, while obtaining diagnostic images, users can minimize ultrasonic bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the
sonographers 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 infor-
mation.
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, attenua-
tion 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.

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 examina-
tion. In the future, HD11 XE may add some applications, such as ophthalmic appli-

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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 trans-
ducer 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 tech-
niques 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 selec-
tion. 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 selec-
tion. Ultimately, the user has the responsibility for proper clinical use. The ultra-
sound 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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Indirect Controls
The indirect controls are those that have an indirect effect on acoustic intensity.
These controls affect imaging mode, pulse repetition frequency, focus depth, pulse
length, and transducer selection.
The choice of imaging mode determines the nature of the ultrasound beam. 2D is
a scanning mode, Doppler is a stationary or unscanned mode. A stationary ultra-
sound beam concentrates energy in a single location. A moving or scanned ultra-
sound beam disperses the energy over an area and the beam is concentrated on
the same area for a fraction of the time as that of an unscanned mode.
Pulse repetition frequency or rate refers to the number of ultrasound bursts of
energy over a specific period of time. The higher the pulse repetition frequency,
the more pulses of energy in a period of time. Several controls affect pulse repeti-
tion frequency: focal depth, display depth, gate depth, scale, number of focal
zones, and sector width controls.
Focus of the ultrasound beam affects the image resolution. To maintain or
increase resolution at a different focus requires a variation in output over the
focal zone. This variation of output is a function of system optimization. Different
exams require different focal depths. Setting the focus at the proper depth
improves the resolution of the structure of interest.
Pulse length is the time during which the ultrasonic burst is turned on. The longer
the pulse, the greater the time-average intensity value. The greater the time-aver-
age intensity, the greater the likelihood of temperature increase and cavitation.
Pulse length or burst length or pulse duration is the output pulse duration in
pulsed Doppler. Increasing the Doppler gate length increases the pulse length.
Transducer selection indirectly affects intensity. Tissue attenuation changes with
frequency. The higher the transducer operating frequency, the greater the attenu-
ation of the ultrasonic energy. A higher transducer operating frequency requires
more output intensity to scan at a deeper depth. To scan deeper at the same out-
put intensity, a lower transducer frequency is required. Using more gain and out-
put beyond a point, without corresponding increases in image quality, can mean
that a lower frequency transducer is needed.

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Receiver Controls
Receiver controls are used by the operator to improve image quality. These con-
trols have no effect on output. Receiver controls only affect how the ultrasound
echo is received. These controls include gain, TGC, dynamic range, and image
processing. The important thing to remember, relative to output, is that receiver
controls should be optimized before output is increased. For example: before
increasing output, optimize gain to improve image quality.

An Example of Applying ALARA


An ultrasound scan of a patients liver begins with selecting the appropriate trans-
ducer frequency. After selecting the transducer and the application, which are
based on patient anatomy, adjustments to output power should be made to
ensure that the lowest possible setting is used to acquire an image. After the
image is acquired, adjusting the focus of the transducer, and then increasing the
receiver gain to produce a uniform representation of the tissue follows. If an ade-
quate image can be obtained with the increase in gain, then a decrease in output
should be made. Only after making these adjustments should you increase output
to the next level.
Having acquired the 2D display of the liver, Color can be used to localize blood
flow. As with the 2D image display, gain and image processing controls must be
optimized before increasing output.
Having localized the blood flow, use the Doppler controls to position the gate
over the vessel. Before increasing output, adjust velocity range or scale and Dop-
pler gain to obtain an optimal Doppler trace. Only if maximum Doppler gain does
not create an acceptable image do you increase output.
In summary: select the correct transducer frequency and application for the job;
start with a low output level; optimize the image using focus, receiver gain, and
other imaging controls; if the image is not diagnostically useful at this point, then
increase output.

Additional Considerations
Ensure that scanning time is kept to a minimum, and ensure that only medically
required scanning is performed. Never compromise quality by rushing through an
exam. A poor exam may require a follow-up, which ultimately increases exposure

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time. Diagnostic ultrasound is an important tool in medicine, and, like any tool, it
should be used efficiently and effectively.

Output Display
The system output display comprises two basic indices: a mechanical index and a
thermal index. The thermal index further consists of the following indices: soft
tissue (TIS), bone (TIB), and cranial bone (TIC). One of these three thermal indi-
ces will be displayed at all times. Which one depends upon the system preset or
user choice, depending upon the application at hand.
The mechanical index (MI) is continuously displayed over the range of 0.0 to max-
imum output (see the HD11 XE Acoustic Output Tables), in increments of 0.1 for all
applications except contrast, where the minimum increment is 0.01.
The thermal index consists of the three indices, and only one of these is displayed
at any one time. Each transducer application has a default selection that is appro-
priate for that combination. The TIB, TIS, or TIC is continuously displayed over
the range of 0.0 to maximum output, based on the transducer and application, in
increments of 0.1.
The decision as to which of the three thermal indices to display should be based
on the following criteria:
Appropriate index for the application: TIS is used for imaging soft tissue, TIB
for a focus at or near bone, and TIC for imaging through bone near the sur-
face, as in a cranial exam.
Mitigating factors that might create artificially high or low thermal index read-
ings: location of fluid or bone, or blood flow. For example, is there a highly
attenuating tissue path so that the actual potential for local zone heating is less
than the thermal index displays.
Scanned modes versus unscanned modes of operation affect the thermal
index. For scanned modes, heating tends to be near the surface; for
unscanned modes, the potential for heating tends to be deeper in the focal
zone.
Always limit ultrasound exposure time. Do not rush the exam. Ensure that
the indices are kept to a minimum and that exposure time is limited without
compromising diagnostic sensitivity.

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Mechanical Index (MI) Display


Mechanical bioeffects are threshold phenomena that occur when a certain level of
output is exceeded. The threshold level varies, however, with the type of tissue.
The potential for mechanical bioeffects varies with peak rarefactional pressure
and ultrasound frequency. The MI accounts for these two factors. The higher the
MI value, the greater the likelihood of mechanical bioeffects occurring. There is
no specific MI value that means that a mechanical effect is actually occurring. The
MI should be used as a guide for implementing the ALARA principle.

Thermal Index (TI) Displays


The TI informs the user about the conditions that exist that might lead to an
increase in temperature at the surface of the body, within the body tissue, or at
the point of focus of the ultrasound beam on bone. That is, the TI informs the
user of the potential for temperature rise in body tissue. It is an estimate of tem-
perature increase in body tissue with specific properties. The actual amount of
any temperature rise is influenced by factors such as tissue type, vascularity, mode
of operation and others. The TI should be used as a guide for implementing the
ALARA principle.
The bone thermal index (TIB) informs the user about potential heating at or near
the focus after the ultrasound beam has passed through soft tissue or fluid, for
example, at or near second or third trimester fetal bone.
The cranial bone thermal index (TIC) informs the user about the potential heating
of bone at or near the surface, for example, cranial bone.
The soft tissue thermal index (TIS) informs the user about the potential for heat-
ing within soft homogeneous tissue.

To display TIS, TIC, or TIB


1. Press Setup.
2. In the System widow, click the System tab.
3. Under Thermal Index, select the appropriate index.
4. Click Close.
TIC is displayed when you select a transcranial application.

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Mechanical and Thermal Indices Display Precision and Accuracy


The MI and TI precision is 0.1 unit on the system.
For system MI and TI display accuracy estimates, see the HD11 XE Acoustic Output
Tables. These accuracy estimates are based on the variability range of transducers
and systems, inherent acoustic output modeling errors and measurement variabil-
ity, as discussed below.
The displayed values should be interpreted as relative information to help the sys-
tem operator achieve the ALARA principle through prudent use of the system.
The values should not be interpreted as actual physical values in interrogated tis-
sue or organs. The initial data that is used to support the output display is derived
from laboratory measurements based on the American Institute of Ultrasound in
Medicine (AIUM) measurement standard. The measurements are then put into
algorithms for calculating the displayed output values.
Many of the assumptions used in the process of measurement and calculation are
conservative in nature. Over-estimation of actual in situ intensity exposure, for
the vast majority of tissue paths, is built into the measurement and calculation
process. For example:
The measured water tank values are derated using a conservative, industry
standard, attenuation coefficient of 0.3 dB/cm-MHz.
Conservative values for tissue characteristics were selected for use in the TI
models. Conservative values for tissue or bone absorption rates, blood perfu-
sion rates, blood heat capacity, and tissue thermal conductivity were selected.
Steady State temperature rise is assumed in the industry standard TI models,
and the assumption is made that the ultrasound transducer is held steady in
one position long enough for steady state to be reached.
A number of factors are considered when estimating the accuracy of the displayed
values: hardware variations, estimation algorithm accuracy, and measurement
variability. Variability among transducers and systems is a significant factor. Trans-
ducer variability results from piezoelectric crystal efficiencies, process-related
impedance differences, and sensitive lens focusing parameter variations. Differ-
ences in system pulser voltage control and efficiencies is also a contributor to
variability. There are inherent uncertainties in the algorithms used to estimate
acoustic output values over the range of possible system operating conditions and
pulser voltages. Inaccuracies in laboratory measurements are related to, among
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others, differences in hydrophone calibration and performance, positioning, align-


ment, and digitization tolerances, and variability among test operators.
The conservative assumptions of the output estimation algorithms of linear prop-
agation, at all depths, through a 0.3 dB/cm-MHz attenuative medium is not consid-
ered in the accuracy estimate for the display. Neither linear propagation, nor
uniform attenuation at the 0.3 dB/cm-MHz rate, occur in water tank measure-
ments or in most tissue paths in the body. In the body, different tissues and organs
have dissimilar attenuation characteristics. In water, there is almost no attenua-
tion. In the body, and in particular, in water tank measurements, non-linear propa-
gation and saturation losses occur as pulser voltages increase.
Therefore, the display accuracy estimates are based on the variability range of
transducers and systems, inherent acoustic output modeling errors, and measure-
ment variability. Display accuracy estimates are not based on errors in, or caused
by measuring according to, the AIUM measurement standards, or the effects of
non-linear loss on the measured values.

Control Effects
Controls Affecting the Indices
As various system controls are adjusted, the TI and MI values may change. This
will be most apparent as the Power control is adjusted; however, other system
controls will affect the on-screen output values.

Power
Power controls the system acoustic output. Two real-time output values are on
the screen: a TI and MI. They change as the system responds to Power adjust-
ments.
In combined modes, such as Triplex (simultaneous Color, 2D, and pulsed-wave
Doppler), the individual modes each add to the total TI. One mode will be the
dominant contributor to this total. The displayed MI will be from the mode with
the largest MI value.

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2D Controls
Sector Width
Narrowing the sector angle may increase frame rate. This action will increase the
TI. Pulser voltage may be automatically adjusted down with software controls to
keep the TI below the system maximums. A decrease in pulser voltage will
decrease MI.

Zoom
Increasing the zoom magnification by pressing Zoom may increase frame rate.
This action will increase the TI. The number of focal zones may also increase
automatically to improve resolution. This action may change MI since a different
focal zone may now produce the largest MI value.

Number of Focal Zones


More focal zones may change both the TI and MI by changing frame rate or focal
depth automatically. Lower frame rates decrease the TI. MI displayed will corre-
spond to the zone with the largest MI value.

Focus
Changing the focal depth will change MI. Generally, higher MI values will occur
when the focal depth is near the natural focus of the transducer.

Color and Power Controls


Color Sector Width
Narrower color sector width will increase color frame rate and the TI will
increase. The system may automatically decrease pulser voltage to stay below the
system maximum. A decrease in pulser voltage will decrease the MI. If pulsed
Doppler is also enabled then pulsed Doppler will remain the dominant mode and
the TI change will be small.

Color Sector Depth


Deeper color sector depth may automatically decrease color frame rate or select
a new color focal zone or color pulse length. The TI will change due to the com-
bination of these effects. Generally, the TI will decrease with increased color sec-
tor depth. MI will correspond to the peak MI value of the dominant pulse type
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which is a color pulse. However, if pulsed Doppler is also enabled then pulsed
Doppler will remain the dominant mode and the TI change will be small.

Scale
Using the scale control to increase the color velocity range may increase the TI.
The system may automatically adjust pulser voltage to stay below the system max-
imums. A decrease in pulser voltage will also decrease MI.

Sector Width
A narrower 2D sector width in Color imaging will increase color frame rate. The
TI will increase. MI will not change. If pulsed Doppler is also enabled, then pulsed
Doppler will remain the dominant mode and the TI change will be small.

M-mode and Doppler Controls


Combination Modes
Use of combination modes affects both the TI and MI through the combination of
pulse types. During duplex, the TI will display the dominant pulse type. The dis-
played MI will be from the mode with the largest MI value.

Gate Depth
When Doppler gate depth is increased the Doppler PRF may automatically
decrease. An increase in PRF will increase the TI. The system may also automati-
cally decrease the pulser voltage to remain below the system maximum. A
decrease in pulser voltage will decrease MI.

Other
2D, Color, M-mode, CPA, PW, and CW
When a new imaging mode is selected, both the TI and MI may change to default
settings. Each mode has a corresponding pulse repetition frequency and maximum
intensity point. In combined or simultaneous modes, the TI is the sum of the con-
tribution from the modes enabled and the displayed MI is the largest of the MI val-
ues associated with each mode and focal zone enabled. The system will return to
the previously selected state if a mode is turned off and then reselected.

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Transducer
Each transducer type has unique specifications for contact area, beam shape, and
center frequency. Presets are initialized in 2D mode when you select a transducer.
Factory presets vary with transducer and selected mode. With each new trans-
ducer selected, the MI and TI displayed values are likely to change.

Depth
An increase in 2D depth will automatically decrease the 2D frame rate. This
would decrease the TI. The system may also automatically choose a deeper 2D
focal depth. A change of focal depth may change the MI. The MI displayed is that
of the zone with the largest MI value.

Preset
Factory presets vary with transducer and selected mode. A change in preset
while a transducer is active will change some of the controls listed above, which
can change the MI and TI values in the ways indicated for each relevant control.

Related Guidance Documents


For more information about ultrasonic bioeffects and related topics, see the fol-
lowing:
1. AIUM Report, January 28, 1993, Bioeffects and Safety of Diagnostic Ultra-
sound
2. Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound
Med., Sept. 1988: Vol. 7, No. 9 Supplement
3. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equip-
ment. (AIUM, NEMA. 1998)
4. Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment
(AIUM, 1998)
5. Second Edition of the AIUM Output Display Standard Brochure, Dated March
10, 1994. (A copy of this document is provided with each system.)
6. Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers. FDA. September 1997. FDA.

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7. Standard for Real-Time Display of Thermal and Mechanical Acoustic Output


Indices on Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA.
1998)
8. WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and
Recommendations on Thermal and Non-Thermal Mechanisms for Biological
Effects of Ultrasound, Ultrasound in Medicine and Biology, 1998: Vol. 24, Supple-
ment 1.

Acoustic Output and Measurement


Since the initial use of diagnostic ultrasound, the possible human biological effects
(bioeffects) from ultrasound exposure have been studied by various scientific and
medical institutions. In October 1987, the American Institute of Ultrasound in
Medicine (AIUM) ratified a report prepared by its Bioeffects Committee (Bioef-
fects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med.,
Sept. 1988: Vol. 7, No. 9 Supplement), sometimes referred to as the Stowe
Report, which reviewed available data on possible effects of ultrasound exposure.
Another report Bioeffects and Safety of Diagnostic Ultrasound, dated January
28, 1993, provides more current information.
The acoustic output for this system has been measured and calculated in accor-
dance with the Acoustic Output Measurement Standard for Diagnostic Ultra-
sound Equipment (AIUM, NEMA 1998), the Standard for Real-Time Display of
Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment (Revision 1, AIUM, NEMA 1998), and the September, 1997 FDA doc-
ument Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers.

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In Situ, Derated, and Water Value Intensities


All intensity parameters are measured in water. Since water absorbs very little
acoustic energy, these water measurements represent a worst case value. Biolog-
ical tissue does absorb acoustic energy. The true value of the intensity at any
point depends on the amount and type of tissue and the frequency of the ultra-
sound that passes through the tissue. The intensity value in the tissue, In Situ, has
been estimated by using the following formula:
In Situ = Water [e-0.23alf]

Where: In Situ = In Situ Intensity Value


Water = Water Value Intensity
e = 2.7183
a = Attenuation Factor
Tissue = a(dB/cm-MHz)
Amniotic = 0.006
Fluid
Brain = 0.53
Heart = 0.66
Kidney = 0.79
Liver = 0.43
Muscle = 0.55
l = Skin line to measurement depth (cm)
f = Center frequency of the transducer/system/mode
combination (MHz)

Since the ultrasonic path during an examination is likely to pass through varying
lengths and types of tissue, it is difficult to estimate the true In Situ intensity. An
attenuation factor of 0.3 is used for general reporting purposes; therefore, the In
Situ value which is commonly reported uses the formula:
In Situ derated = Water [e-0.069lf]
Since this value is not the true In Situ intensity, the term derated is used.

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Mathematical derating of water based measurements using the 0.3 dB/cm-MHz


coefficient, may yield lower acoustic exposure values than would be measured in a
homogenous 0.3 dB/cm-MHz tissue. This is true because non-linearly propagating
acoustic energy waveforms experience more distortion, saturation, and absorp-
tion in water than in tissue, where attenuation present all along the tissue path
will dampen the buildup of non-linear effects.
The maximum derated and the maximum water values do not always occur at the
same operating conditions; therefore, the reported maximum water and derated
values may not be related by the In Situ (derated) formula. For example: a
multi-zone array transducer that has maximum water value intensities in its deep-
est zone may have its largest derated intensity in one of its shallowest focal zones.

Conclusions Regarding Tissue Models and Equipment Survey


Tissue models are necessary to estimate attenuation and acoustic exposure levels
In Situ from measurements of acoustic output made in water. Presently, available
models may be limited in their accuracy because of varying tissue paths during
diagnostic ultrasound exposures and uncertainties in acoustical properties of soft
tissues. No single tissue model is adequate for predicting exposures in all situa-
tions from measurements made in water, and continued improvement and verifi-
cation of these models is necessary for making exposure assessments for specific
applications.
A homogeneous tissue model with an attenuation coefficient of 0.3 dB/cm-MHz
throughout the beam path is commonly used when estimating exposure levels.
The model is conservative in that it overestimates the In Situ acoustic exposure
when the path between the transducer and the site of interest is composed
entirely of soft tissue, because the attenuation coefficient of soft tissue is generally
higher than 0.3 dB/cm-MHz. When the path contains significant amounts of fluid,
as in many first and second-trimester pregnancies scanned transabdominally, this
model may underestimate the In Situ acoustical exposure. The amount of under-
estimation depends on each specific situation. For example, when the beam path
is longer than 3 cm and the propagation medium is predominantly fluid (condi-
tions that may exist during transabdominal OB scans), a more accurate value for
the derating term is 0.1 dB/cm-MHz.
Fixed-path tissue models, in which soft tissue thickness is held constant, some-
times are used to estimate In Situ acoustical exposures when the beam path is

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longer than 3 cm and consists largely of fluid. When this model is used to esti-
mate maximum exposure to the fetus during transabdominal scans, a value of
1 dB/MHz may be used during all trimesters.
The maximum acoustic output levels of diagnostic ultrasound devices extend over
a broad range of values:
A survey of 1990-equipment models yielded mechanical index (MI) values
between 0.1 and 1 at their highest output settings. Maximum MI values of
approximately 2 are known to occur for currently available equipment. Maxi-
mum MI values are similar for real-time 2D, M-mode, pulsed Doppler, and
Color flow imaging.
Computed estimates of upper limits to temperature elevations during trans-
abdominal scans were obtained in a survey of 1988 and 1990 pulsed Doppler
equipment. The vast majority of models yielded upper limits less than
1 degree C and 4 degrees C for exposures of first-trimester fetal tissue and
second-trimester fetal bone, respectively. The largest values obtained were
approximately 1.5 degrees C for first-trimester fetal tissue and 7 degrees C
for second-trimester fetal bone. Estimated maximum temperature elevations
given here are for a fixed-path tissue model and are for devices having ISPTA
values greater than 500 mW/cm2. The temperature elevations for fetal bone
and tissue were computed based on calculation procedures given in Sections
4.3.2.1-4.3.2.6 in Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993).

Acoustic Output Tables


Acoustic output tables are in the HD11 XE Acoustic Output Tables manual.

Acoustic Measurement Precision and Uncertainty


All table entries have been obtained at the same operating conditions that give
rise to the maximum index value in the first column of the tables. Measurement
precision and uncertainty for power, pressure, intensity, and center frequency are
shown in Table 2-1 and Table 2-2.

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Table 2-1 Acoustic Measurement Precision


NOTE
Per Section 6.4 of the Output Display Standard, measurement precision on the
following quantities is determined by making repeated measurements and stating
the standard deviation as a percentage.

Precision
Quantity (Percentage Standard Deviation)
Pr is the underated peak rarefactional Pr: 5.4%
pressure measured in MegaPascals.
Wo is the ultrasonic power in 6.2%
milliWatts.
fc is the center frequency in MHz <1%
(NEMA UD-2 definition).
PII.3 is the derated spatial-peak pulse PII.3: 3.2%
intensity integral in Joules/cm2.

Table 2-2 Acoustic Measurement Uncertainty


Measurement Uncertainty
(percentage, 95% confidence
Quantity value)
Pr is the underated peak rarefactional Pr 11.3%
pressure measured in MegaPascals.
Wo is the ultrasonic power in 10%
milliWatts.
fc is the center frequency in MHz 4.7%
(NEMA UD-2 definition).
PII.3 is the derated spatial-peak pulse PII.3: +18% to -23%
intensity integral in Joules/cm2.

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Symbols Used on the System


Table 2-3 lists the symbols used on the ultrasound system and their meanings.
Table 2-3 Symbols Used on the System
Symbol Meaning Description
Type BF The patient-applied part provides a degree of protection
from electrical shock. Suitable for external and internal
application to the patient, excluding direct cardiac
application. The patient-applied part is floating (isolated)
from earth ground.
Type CF The patient-applied part provides a degree of protection
from electrical shock. Suitable for all patient-applied
applications including direct cardiac applications. The
patient-applied part is floating (isolated) from earth ground.
Type CF The patient-applied part provides a degree of protection
Defibrillator from electrical shock. This symbol indicates that the
Proof patient-applied part is defibrillator proof. The patient-applied
part is suitable for all patient applications including direct
cardiac applications.
Attention See the accompanying documentation.

Dangerous This symbol appears adjacent to high-voltage terminals. It


voltages indicates the presence of voltages greater than 1,000 Vac
(600 Vac in the United States).

Input The connector near either of these symbols receives an


incoming signal.

Output The connector near this symbol sends an outgoing signal.


Alternating The connector near this symbol receives alternating
current voltages.
Ground Protective earth ground.

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Table 2-3 Symbols Used on the System (Continued)


Symbol Meaning Description
Equipotential Used post for establishing common ground between
grounding instruments.
post
Electrostatic Warns the user not to touch exposed pins. Touching
discharge exposed pins can cause electrostatic discharge, which can
damage the product.
Mercury This symbol indicates that the system display contains
content and mercury. Dispose of properly in accordance with local, state,
proper or federal laws.
disposal This symbol also indicates separate collection for electrical
and electronic equipment in compliance with the Waste
Electrical and Electronic Equipment (WEEE) Directive.
Recycle Dispose of properly in accordance with local, state, or
federal laws.

Global Indicates the symbol for the Global Medical Device


Medical Nomenclature Code.
Device
Nomencla-
ture
The following symbols may appear on the optional foot switch:
Record Press this pedal to record the display image.
pedal
Print pedal Press this pedal to print the display image.
Freeze pedal Press this pedal to freeze the display image.
size
x

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Table 2-3 Symbols Used on the System (Continued)
Symbol Meaning Description
The following symbols appear on the product packaging to indicate environmental
considerations:
Atmospheric Atmospheric pressure range of 572 to 1,013 hPa for
pressure transport and storage.
Relative Relative humidity range of 20% to 90% (noncondensing) for
humidity transport and storage.
Ambient Ambient temperature range 20C to +60C (4F to
temperature +140F) (noncondensing) for transport and storage. (Does
not apply to media.)

Patient Safety
This section describes issues and situations that can affect patient safety when you
are using the ultrasound system.

Ultrasound Exposure
Although no harmful effects have been demonstrated for the ultrasound frequen-
cies, intensities, and exposure times used in examinations with Philips ultrasound
systems, Philips recommends that you select the lowest ultrasound exposure that
produces diagnostically acceptable information.
Follow these guidelines to reduce ultrasound exposure:
Use diagnostic ultrasound only when there is a good medical reason.
Reset controls at the start of every examination.
Reduce exposure time, independent of the acoustic index value.
Use techniques that enable you to both collect clinical data and end the exam-
ination quickly.
Use a transducer that provides the best possible resolution and penetration.
For more detailed information on ultrasound exposure, see the Output Display
Standards and ODS Acoustic Tables booklet.

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Information regarding the concept of ALARA (As Low As Reasonably Achievable)


and possible ultrasound bioeffects is described in the brochure, Medical Ultrasound
Safety, developed by the American Institute of Ultrasound in Medicine (AIUM).

Thermal Exposure
Some transducers, such as transesophageal echocardiography (TEE) transducers,
use Auto-Cool software to prevent overheating. The system software issues
on-screen warning messages and (if necessary) terminates the imaging session to
prevent transducer overheating. For more information about Auto-Cool thermal
controls, see TEE Manual Auto-Cool Safety Feature on page 229.
WARNING
Your system automatically turns off the transmit power if the device malfunctions.
If this occurs, turn off the system, remove any transducer from the patient, and
contact your Philips service representative.

Electrical Warnings
Follow these warnings to ensure patient and operator safety. Failure to follow
these warnings can affect both patient and operator safety.

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WARNINGS
Do not remove the system covers.
Do not attempt to service the system yourself. Only qualified personnel
should service the system.
Do not touch accessible connector pins and the patient simultaneously.
Be very careful not to touch internal electrical circuits. Accidently contacting
internal electrical circuits could cause serious injury.
To avoid electrical shock, use only the supplied power cords and connect
them only to properly grounded wall outlets.
Connect all equipment supplied with the system only into the 115-Vac outlets
provided. Connecting equipment supplied with the system to a wall outlet can
cause excessive enclosure leakage current.
Do not connect items to the ultrasound system that are not specified by Phil-
ips as part of the system. See Explosive Hazards on page 52.
Do not connect additional multiple-socket outlets or extension cords to the
system.

Installation Requirements
The system is designed to be installed by qualified service personnel. Installation
of the system by a Philips service representative is included in the purchase price
of all new systems purchased from Philips.

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AC Power Requirements
Plug your system only into an AC outlet that satisfies the following criteria:
The AC outlet must be capable of handling up to 1,440 VA to compensate for
surges and fluctuations.
The AC outlet must be able to handle intermittent currents of up to 15 A (for
100/120 Vac) or 10 A (for 200/240 Vac).
The AC outlet must have a circuit that can accommodate this additional load.
An equipotential terminal is provided on the rear panel of the system. Use this
when redundant earth ground is necessary according to IEC 60601-1-1.
WARNING
No life-support devices should be connected to the same circuit as the ultra-
sound system.

The AC power to the system must be capable of delivering 1,000 VA sustained


and 1,450 VA intermittent, and meet all of the minimum requirements specified in
IEC 60601-1, second edition. This means, for example, that transients on the
power line should not be any greater than the following:
AC drops down to 70% of nominal voltage for up to 25 AC cycles.
AC drops down to 40% of nominal voltages for up to 5 AC cycles.
Complete AC dropout for one complete AC cycle.
If your AC power does not meet these requirements, you should use a power line
conditioner, or an uninterruptible power supply (UPS).

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Defibrillators
Use defibrillators that do not have grounded patient circuits. To determine
whether or not a defibrillator patient circuit is grounded, see the defibrillator ser-
vice guide, or consult a biomedical engineer.
Observe the following precautions when using a transducer when a defibrillation
is required.

WARNINGS
Before defibrillation, always remove the transducer from the patient.
Before defibrillation, always disconnected the transducer from the system.
Consider that a disposale transducer cover provides no protective electrical
insulation against defibrillation.
A small hole in the outer layer of the transducer opens a conductive path to
grounded metal parts of the transducer. The secondary arcing that could
occur during defibrillation could cause patient burns. The risk of burns is
reduced, but not eliminated, by using an ungrounded defibrillator.

Pacemakers
Philips ultrasound equipment in normal operation, as with other medical elec-
tronic diagnostic equipment, uses high-frequency electrical signals that can inter-
fere with pacemaker operation. Though the possibility of interference is slight, be
alert to this potential hazard and stop system operation immediately if you note
interference with a pacemaker.

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Explosive Hazards
Failure to follow these warnings can affect both patient and operator safety.

WARNINGS
Do not operate the system in the presence of flammable anesthetics. Doing
so could lead to an explosioni.
Do not use the foot switch in the operating room. IEC 60601-1-1 specifies
that foot-operated control devices used in the operating room must be of
watertight construction. The foot switch supplied with the ultrasound system
meets only IPX1 drip-proof construction requirements.

Philips Transducers
Use only transducers that are approved by Philips for use with your ultrasound
system. For a list of transducers that are compatible with the system and for
information on caring for your transducers, see Transducers on page 145.

Latex Materials and Patient Contact


The ultrasound system and transducers do not contain natural rubber latex that
contacts humans. Natural rubber latex is not used on any ultrasound transducer,
including transthoracic, intraoperative, and transesophageal echocardiography
(TEE) transducers. It also is not used on Philips ECG cables for the products in
this manual.
WARNING
Latex is commonly used in sheaths (transducer covers) marketed to help with
infection control in transesophageal, endocavity, and intraoperative imaging appli-
cations and during biopsies. Examine the packaging to confirm latex content.
Studies have shown that patients can experience allergic reactions with natural
rubber latex. The U.S. Food and Drug Administration published a medical alert on
latex products dated March 29, 1991.

FDA Medical Alert


The U.S. Food and Drug Administration published the following medical alert on
latex products, dated March 29, 1991:

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Allergic Reactions to Latex-Containing Medical Devices
Because of reports of severe allergic reactions to medical devices containing
latex (natural rubber), the FDA is advising health care professionals to identify
their latex sensitive patients and be prepared to treat allergic reactions
promptly. Patient reactions to latex have ranged from contact urticaria to sys-
temic anaphylaxis. Latex is a component of many medical devices, including
surgical and examination gloves, catheters, intubation tubes, anesthesia masks,
and dental dams.
Reports to the FDA of allergic reactions to latex-containing medical devices
have increased lately. One brand of latex cuffed enema tips was recently
recalled after several patients died as a result of anaphylactoid reactions during
barium enema procedures. More reports of latex sensitivity have also been
found in the medical literature. Repeated exposure to latex both in medical
devices and in other consumer products may be part of the reason that the
prevalence of latex sensitivity appears to be increasing. For example, it has
been reported that 6% to 7% of surgical personnel and 18% to 40% of spina
bifida patients are latex sensitive.
Proteins in the latex itself appear to be the primary source of the allergic reac-
tions. Although it is not now known how much protein is likely to cause
severe reactions, the FDA is working with manufacturers of latex-containing
medical devices to make protein levels in their products as low as possible.
FDAs recommendations to health professionals in regard to this problem are
as follows:
When taking general histories of patients, include questions about latex sensi-
tivity. For surgical and radiology patients, spina bifida patients and health care
workers, this recommendation is especially important. Questions about itch-
ing, rash, or wheezing after wearing latex gloves or inflating a toy balloon may
be useful. Patients with positive histories should have their charts flagged.
If latex sensitivity is suspected, consider using devices made with alternative
materials, such as plastic. For example, a health professional could wear a
non-latex glove over the latex glove if the patient is sensitive. If both the
health professional and the patient are sensitive, a latex middle glove could be
used. (Latex gloves labeled Hypoallergenic may not always prevent adverse
reactions.)

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Whenever latex-containing medical devices are used, especially when


the latex comes in contact with mucous membranes, be alert to the
possibility of an allergic reaction.
If an allergic reaction does occur and latex is suspected, advise the
patient of a possible latex sensitivity and consider an immunologic
evaluation.
Advise the patient to tell health professionals and emergency person-
nel about any known latex sensitivity before undergoing medical pro-
cedures. Consider advising patients with severe latex sensitivity to
wear a medical identification bracelet.
The FDA is asking health professionals to report incidents of adverse reac-
tions to latex or other materials used in medical devices. (See the October
1990 FDA Drug Bulletin.) To report an incident, call the FDA Problem
Reporting Program, operated through the U.S. Pharmacopeia toll-free num-
ber: 800-638-6725. (In Maryland, call collect 301-881-0256.)
For a single copy of a reference list on latex sensitivity, write to: LATEX DA,
HFZ-220, Rockville, MD 20857.

Transmissible Spongiform Encephalopathy


WARNING
If a sterile transducer cover becomes compromised during an intraoperative
application involving a patient with transmissible spongiform encephalopathy, such
as Creutzfeldt-Jakob disease, follow the guidelines of the Centers for Disease
Control and Prevention (CDC) and the World Heath Organization (WHO). The
WHO provides infection control guidelines for transmissible spongiform enceph-
alopathies. The transducers for your system cannot be decontaminated using a
heat process.

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Peripherals Connections
Do not connect AC power cords for peripherals to the AC power outlets on the
system unless the peripherals are specified by Philips as part of the system. The
risks associated with connecting such equipment to the outlets provided include
Excessive power draw, resulting in possible fire or electrical shock hazards
High-impedance ground connection
Electromagnetic interference with other system devices
The outlets installed on this system are rated 115 V~60 Hz 500 VA maximum
total load. Use the outlets only for supplying power to equipment that is intended
to be part of the system. Do not connect additional multiple socket outlets or
extension cords to the system.

WARNINGS
If you use peripheral equipment powered from an electrical source other than
the ultrasound system, the combination of the peripheral equipment and the
ultrasound system is considered to be a medical system. It is your responsibil-
ity to comply with IEC 60601-1-1 and to test the medical system according to
the requirements. If you have questions, contact your Philips representative.
Do not use nonmedical peripherals, such as report printers, within 1.5 m
(6 ft) of a patient, unless the nonmedical peripherals receive power from an
isolated power outlet on the Philips ultrasound system, or from an isolation
transformer that meets medical safety standards, as defined by standard IEC
60601-1-1.

Philips ultrasound systems are tested to the requirements of IEC 60601-1 and IEC
60601-1-1, with system peripherals that are powered by the built-in isolation
transformer. The system peripherals meet general electrical safety usage require-
ments, but not necessarily medical device standards.
Devices connecting to the network interface of the ultrasound system must com-
ply with the applicable IEC or national standards. In addition, the device must be
certified to IEC 60950 or equivalent.

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WARNING
The use of cables, transducers, or accessories not supplied with the HD11 XE
system can result in increased electromagnetic emissions or decreased electro-
magnetic immunity of the system. For more information on electromagnetic
immunity, see Electromagnetic Immunity on page 131.

Operator Safety
This section describes issues and situations that can affect operator safety when
you are using an ultrasound system.

Repetitive Strain Injury


Repetitive ultrasound scanning has been associated with carpal tunnel syndrome
(CTS) and related musculoskeletal problems. Some investigators1 have looked at a
large population of sonographers with different types of equipment. An article2,
with feedback from a smaller geographical area, makes the following recommen-
dations:
Maintain your joints in optimum positions with a balanced posture while scan-
ning.
Allow frequent breaks to give soft tissue a chance to recuperate from awk-
ward positions and repetitive movement.
Avoid gripping the transducer with excessive force.
NOTE
The S3-1, S4-2, and S8-3 transducers are shipped with an ergonomic grip. To
order additional ergonomic grips, contact your Philips representative. To learn
how to install and clean the ergonomic grip, see Installing and Cleaning the Ergo-
nomic Grip on page 156.

1. Pike, Ian et al. Prevalence of Musculoskeletal Disorders and Related Work and Personal Fac-
tors Among Diagnostic Medical Sonographers. Journal of Diagnostic Medical Sonographers.
Vol. 13, No. 5: 219-227, September 1997.
2. Necas, Martin. Musculoskeletal Symptomatology and Repetitive Strain Injuries in Diagnostic
Medical Sonographer. Journal of Diagnostic Medical Sonographers, 266-273, November/Decem-
ber 1996.

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Foot Switch Warning


WARNING
Do not use the foot switch in the operating room. IEC 60601-1-1 specifies that
foot-operated control devices used in the operating room must be of watertight
construction. The foot switch supplied with the ultrasound system meets only
IPX1 drip-proof construction requirements.

Philips Transducers
Use only transducers that are approved by Philips for use with your Philips ultra-
sound system. The transducers that are compatible with the system are listed in
the Supported Transducers on page 145.

Electrical Warnings
To learn about electrical warnings associated with the system, see Electrical
Warnings on page 57.

Explosive Hazards
To learn about explosive hazards associated with the system, see Explosive Haz-
ards on page 57.

Glutaraldehyde Exposure
The United States Occupational Safety and Health Administration (OSHA) has
issued a regulation dealing with levels of acceptable glutaraldehyde exposure in
the working environment. Philips does not sell glutaraldehyde-based disinfectants
with its products. This type of disinfectant is, however, recommended for the dis-
infection of transducers used in TEE, intraoperative, endocavity, and biopsy proce-
dures.
To reduce the presence of glutaraldehyde fumes in the air, be sure to use a cov-
ered or ventilated soaking basin. Such systems are commercially available. The
most current information about such products can be found on the following
Philips Web site:
www.medical.philips.com/transducercare

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Infection Control
There are issues related to infection control for you, as well as for the patient.
You should follow the infection control procedures established in your clinic or
hospital for both the protection of the staff and the patient.

Transducers
The major area of concern is the handling of transducers that have come into
contact with infected patients. You should always wear gloves when you handle
transducers used in TEE, endocavity, intraoperative, and biopsy procedures that
have not been previously disinfected.
For information on cleaning and disinfecting transducers, see Cleaning, Disinfect-
ing, and Sterilizing Transducers on page 161.

Removing Blood and Infectious Material from the System


Use a gauze pad moistened with soap and water to remove blood on the system
and the transducer connectors and cables. Then dry the equipment with a soft
cloth to prevent corrosion. You can use a 70% solution of isopropyl alcohol (rub-
bing alcohol) on the system and only on certain parts of some transducers. Addi-
tional cleaning agents are also available for transducers. For more detailed
information, see Cleaning, Disinfecting, and Sterilizing Transducers on page 161.
To learn more about removing blood and other infectious material from the sys-
tem, see Cleaning and Disinfecting System Surfaces on page 115.
CAUTION
Do not wipe the transducer strain relief/housing joint, the strain relief, or the
cable with isopropyl alcohol. Isopropyl alcohol can damage these parts of the
transducer. This damage is not covered by the warranty or your service contract.
Also, do not use isopropyl alcohol on TEE transducers (except for their handles).

ECG Cables and Lead Sets


For cleaning and disinfection information for ECG cables and lead sets, see the
instructions provided with the ECG cables and lead sets.

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Safety 2

Disposable Drape
If you believe contamination of the imaging system might occur during an exam,
Philips recommends that you take universal precautions and cover the ultrasound
system with a disposable drape. Consult your hospitals rules regarding equipment
use in the presence of infectious disease.
CAUTION
Be sure to position the drape so that you do not block the vents on the ultra-
sound system, the monitors, or the peripherals.

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2 Safety

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3 System Overview
This section provides information to help you get started using the Ultrasound
System.

About the HD11 XE Ultrasound System


The system is a powerful ultrasound imaging and image review tool. Use the sys-
tem to perform the following tasks:
Image in a variety of modes, including 3D mode and 4D mode.
Store, manage, and review images.
Perform measurements and calculations by using the comprehensive analysis
package.
Create, edit, and add images to reports.
Print images to one of the printers.
Export data in PC formats to removable media.
Export DICOM data to removable media (requires a DICOM option).
Generate and store DICOM structured reporting (SR) across network PACS
and DICOM media for OB/GYN and cardiac studies (requires the DICOM
Networking option).
Archive data to removable media (if your system does not have a DICOM
option).
Send images and patient information over a network to a DICOM picture
archiving and communication system (PACS).
Use QLAB Advanced Quantification software to analyze stored images by
using quantification tools referred to as plug-ins.
Use Anatomical M-mode to orient the M-mode cursor to the anatomy of
interest instead of the transducer.

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NOTE
Some features are options and are not available on all systems. For more informa-
tion about the standard features, the clinical options, and the options available,
see About Standard Features, Clinical Options, and Purchasable Options on
page 73.

For more information and detailed instructions, see the Help.


A copy of the DICOM Conformance Statement is available on the following Phil-
ips Web site:
www.medical.philips.com/main/company/connectivity/us/

Intended Uses
The ultrasound system is useful in a variety of diagnostic ultrasound applications,
as outlined in Table 3-1. The patient population includes adults, pregnant females,
children and adolescents, and neonates.
Table 3-1 Intended Uses

Color Power Angio

Calcs Analysis
CW Doppler
PW Doppler

Color Flow
2D Mode

M-mode

3D/4D

Imaging
Application
Abdominal X X X X X X
Cardiac X X X X X X X
Gynecological X X X X X X
Intraoperative X X X X X
Musculoskeletal X X
Neonatal Head X X X X X
Obstetrical X X X X X X X
Pediatric X X X X X X X
Small Parts X X X X X
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Table 3-1 Intended Uses (Continued)

Color Power Angio

Calcs Analysis
CW Doppler
PW Doppler

Color Flow
2D Mode

M-mode

3D/4D
Imaging
Application
Transcranial X X X X X X
Transesophageal X X X X X X
Vascular X X X X X X

Studies
The following sections provide information about the imaging applications listed in
Table 3-1.

Abdominal Studies
Abdominal studies are performed with fundamental imaging or Tissue Harmonic
Imaging (THI) to obtain images that can be used for
Detecting abdominal organ abnormalities
Evaluating organ size and texture
Determining size, contour, and patency of vessels
Characterizing obstructions
Determining blood flow patterns and velocities
Guiding a biopsy needle
Table 3-2 lists important information about abdominal studies.
Table 3-2 Abdominal Studies
Target Approach Patients
Abdominal organs, arteries, Transabdominal Adult, pediatric, and neonatal
and veins

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Cardiac Studies
Cardiac studies are performed with fundamental imaging or Tissue Harmonic
Imaging to obtain images that can be used for
Detecting abnormalities in heart anatomy and blood flow
Determining the blood flow patterns and velocities in the heart and associated
vessels
Imaging and measuring anatomic parameters of the heart and associated ves-
sels
Table 3-3 lists important information about cardiac studies.
Table 3-3 Cardiac Studies
Target Approach Patients
Heart and vessels Transthoracic Adult, pediatric, and neonatal
Heart and vessels Transesophageal Adult and pediatric (recommended
echocardiography (TEE) weight: at least 25 kg (55 lb))
Heart and vessels Transabdominal Fetal heart

Gynecological Studies
Gynecological studies are performed with fundamental imaging or Tissue Har-
monic Imaging to obtain images that can be used for
Visualizing female reproductive organs
Determining blood flow patterns and velocities
Guiding a biopsy needle
Detecting structural abnormalities
Table 3-4 lists important information about gynecological studies.

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Table 3-4 Gynecological Studies


Target Approach Patients
Female organs Abdominal and endovaginal Adult females
Female organs Abdominal Pediatric females
Arteries and veins Abdominal and endovaginal Adult females

Intraoperative Studies
Intraoperative studies are performed during surgery to obtain images that can be
used to help the surgeon
Locate and visualize anatomical structures.
Visualize blood flow patterns and quantify velocities.
Image and measure anatomical and physiological parameters of interest.
Table 3-5 lists important information about intraoperative studies.
Table 3-5 Intraoperative Studies
Target Approach Patients
Internal organs and vessels Intraoperative Adult and pediatric

Musculoskeletal Studies
Musculoskeletal studies are performed to obtain images that can be used for
Evaluating tendon, ligament, and muscle size and contour
Detecting pathology and other abnormalities
Evaluating integrity of tendons and ligaments
Table 3-6 lists important information about musculoskeletal studies.

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Table 3-6 Musculoskeletal Studies


Target Approach Patients
Tendons and ligaments Shoulder Adult and pediatric
Wrist/hand
Knee
Ankle/foot
Muscles Extremities Adult and pediatric

Neonatal Head Studies


Neonatal head studies are performed to obtain an image of brain structures that
can be used to detect abnormalities, such as abnormal ventricle size or a shift in
the midline or flow abnormalities. In addition, neonatal head studies are often
performed to detect bleeding.
WARNING
Do not aim the ultrasound beam toward the posterior orbit, because acoustic
output is greater than that recommended for ophthalmic use.

Table 3-7 lists important information about neonatal head studies.


Table 3-7 Neonatal Head Studies
Target Approach Patients
Brain structure Intact fontanelles Infants

Obstetrical Studies
Obstetrical studies are performed with fundamental imaging or Tissue Harmonic
Imaging to obtain images of the fetus that can be used for
Detecting maternal or fetal structural abnormalities
Imaging and measuring anatomic parameters of the fetus
Determining blood flow patterns and velocities
Table 3-8 lists important information about obstetrical studies.

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Table 3-8 Obstetrical Studies


Target Approach Patients
Fetus Transabdominal Pregnant women and fetuses
Fetus Endovaginal Pregnant women and fetuses

The American Institute of Ultrasound in Medicine (AIUM) has issued the follow-
ing statement regarding obstetrical ultrasound studies:
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM
strongly discourages the non-medical use of ultrasound for psychosocial or
entertainment purposes. The use of either two-dimensional (2D) or
three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of
the fetus or determine the fetal gender without a medical indication is inap-
propriate and contrary to responsible medical practice. Although there are no
confirmed biological effects on patients caused by exposures from present
diagnostic ultrasound instruments, the possibility exists that such biological
effects may be identified in the future. Thus ultrasound should be used in a
prudent manner to provide medical benefit to the patient.

Pediatric Studies
For information about pediatric studies, see the following sections:
Abdominal Studies on page 63
Cardiac Studies on page 64
Gynecological Studies on page 64
Intraoperative Studies on page 65
Neonatal Head Studies on page 66

Small Parts Studies


Small parts studies are performed to obtain images that can be used for
Detecting structural abnormalities
Determining blood flow patterns and velocities
Guiding a biopsy needle

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Table 3-9 lists important information about small parts studies.


Table 3-9 Small Parts Studies
Target Approach Patients
Thyroid Neck Adult, pediatric, and neonatal
Scrotum Scrotal sac Adult and pediatric males
Breast Breast Adult and pediatric

NOTE
Breast imaging is intended for adjunctive evaluation.

Transcranial Studies
For information about transcranial studies, see Vascular Studies on page 68.

Transesophageal Echocardiography (TEE) Studies


For information about transesophageal echocardiography (TEE) studies, see Car-
diac Studies on page 64.

Vascular Studies
Vascular studies are performed to obtain images that can be used for
Detecting vessel size, contour, and patency
Characterizing obstructions and abnormalities
Determining blood flow patterns and velocities
Imaging and measuring anatomic parameters of vessels
Detecting structural irregularities
Table 3-10 lists important information about vascular studies.

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Table 3-10 Vascular Studies


Target Approach Patients
Cerebrovascular arteries and Neck Adult, pediatric, and neonatal
veins Transcranial Adult
Upper extremity arteries and Arms Adult, pediatric, and neonatal
veins
Lower extremity arteries and Legs Adult, pediatric, and neonatal
veins
Abdominal vessels Abdominal Adult and pediatric
Superficial Vessels Intraoperative and Adult and pediatric
surface

Ultrasound System Components


The system consists of a monitor, a system control panel, and a cart, as shown in
Figure 3-1.

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Figure 3-1 HD11 XE System

Microphone
Monitor

Transducer and
gel holders Soft key panel

Control panel

Handle
Transducer
Printer connector
CD-RW panel
drive

Physio panel
MOD drive
Storage bin

Wheels

NOTE
The headphone jack on the CD drive is not active on this system.

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System Control Panel Components


The system control panel, as shown in Figure 3-2, is the horizontal surface that
contains keys that you press, knobs that you turn and push, and slide controls that
you move left and right or up and down.
The Help describes all of the controls on the system control panel.
Figure 3-2 System Control Panel

Soft key On/Off


panel
Keyboard Help

Option keys
Slide controls

Control
panel keys

Record keys

Knobs Trackball

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Display
The display looks somewhat different depending on the mode, application, preset,
and transducer. The imaging area is in the center of the display. The imaging area,
soft key labels, image data, and patient and study information, and thumbnail area,
however, always remain in the same location, as shown in Figure 3-3.
Figure 3-3 Display

Patient and study data area

Image data
area

Thumbnail
area

Icon area

Soft key
labels Select menu
and prompts

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System Overview 3

About Standard Features, Clinical Options, and Purchasable


Options
This section lists the standard features on the system, the clinical options that are
available, and options that you can purchase and install.

Standard Features
Each system includes the following standard features:
iSCAN Intelligent Optimization
High Q Automatic Doppler Analysis
SonoCT Real-time Compound Imaging
XRES Adaptive Image Processing
Anatomical M-mode
Multi-session CD-RW drive
Freehand 3D with multiplanar reformatting (MPR) capability for linear and
curved array transducers
Onboard patient reporting with embedded images
Support for up to three onboard peripherals

Clinical Options
Each system includes one of the four standard clinical software applications. You
must purchase the clinical application package for each exam type that you want
to perform.
Optionally, you can purchase the Shared Service Clinical package which combines
all of the applications and presets listed in Table 3-11 and includes physio (ECG),
exam-specific calculations and analysis, configurable reporting, and biopsy capabil-
ities.

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Table 3-11 lists and describes the application packages that you can purchase for
use with the ultrasound system. For instructions on installing, removing, and dis-
abling options, see Installing, Removing, and Disabling Options on page 85.

Table 3-11 Clinical Option Packages


Name Description
Cardiac Provides adult and pediatric presets. Also includes physio
(ECG), cardiac calculations and analysis, and reporting
capabilities.
General Imaging Provides adult and pediatric presets for abdominal
(including renal), small parts, musculoskeletal, and prostate
exams. This application also includes biopsy capabilities,
exam-specific calculations and analysis, and reporting
capability.
OB/GYN Provides presets for obstetrical, gynecological,
endovaginal, and fetal echo. This option also includes
biopsy capabilities, OB/GYN calculations and analysis, OB
trending, and reporting capability.
Vascular Provides presets for carotid, transcranial Doppler (TCD),
and bilateral lower and upper extremities. Also includes
physio (ECG), vascular calculations and analysis, and
reporting capability.
ICE Imaging Provides cardiac-catheterization (Cath) lab and
electrophysiology (EP) lab presets for intracardiac echo
(ICE) imaging. The ICE Imaging option allows use of the
EPMedSystems FlexMate ICE catheter transducer. This
option uses the cardiac/adult calculations and analysis
package.

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Purchasable Options
In addition to the standard features available on the system, other features are
available as purchasable options.
You need to install options before you can use them. Use the Options setup win-
dow to install the options. For more information, see Installing, Removing, and
Disabling Options on page 85.
For information on purchasing options, contact your Philips representative.
Table 3-12 lists and describes the performance and image management options.
Table 3-12 Performance and Image Management Options
Name Description Requirements
Advanced Clinical Features SonoCT Real-time Compound --
Performance Package Imaging with up to 9 beam-steered lines of
sight. This option also includes XRES
Adaptive Image Processing for reducing
noise and artifacts to improve tissue
conspicuity.
Contrast Package Provides low mechanical index (MI) One of the
contrast with Pulse Inversion Harmonics following clinical
for left ventricular opacification (LVO) options: Cardiac
evaluation in cardiac and vascularity of the or General
abdominal area in general imaging. This Imaging
option is optimized to work with the C5-2
and S3-1 transducers.
Note: The use of contrast is limited to
specific options in some countries.
DICOM Networking Provides an MOD drive plus connectivity to --
an RIS/CIS or PACS, and supplies DICOM
Modality Worklist, Modality Performed
Procedure Step, Print and Store, and
Structured Reporting (OB, Cardiac).

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Table 3-12 Performance and Image Management Options (Continued)


Name Description Requirements
DICOM Networking Provides connectivity to an enterprise data MOD drive
Software Upgrade management system or PACS, and supplies installed on the
DICOM Modality Worklist, Modality system
Performed Procedure Step, Print and Store,
and Structured Reporting (OB, Cardiac).
Panoramic Imaging This option provides a more complete view --
of vasculature, musculature, and enlarged
organs and masses for more natural views
of structures and relationships. Includes
zoom, pan, and image rotation of
panoramic images.
Stress Echo This option provides for efficient stress Cardiac
echo exams. It includes the ability to define application
protocols with up to eight stages and views,
and three factory default protocols. It also
provides wall motion scoring and the ability
to pause the protocol to acquire images.
This option also includes the foot switch
and an MOD drive, and the software
needed to save studies in DICOM format
to an MOD.

Table 3-13 lists and describes the advanced 3D/4D option packages.
NOTE
Each 4D option package requires the installation of 4D hardware. A 4D option is
not a software-configurable optionit is a hardware option that requires the pur-
chase and installation of the motor controller board. The Fetal STIC option will
only function if you have installed the 4D Imaging option.

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Table 3-13 Advanced 3D/4D Option Packages


Name Description Requirements
4D Imaging Automated, quantitative 3D volume acquisition --
that is supported on the following transducers:
3D8-4, 3D6-2, and 3D9-3v.
This option provides the ability to acquire and
display in 4D mode, depending on the transducer.
This package also includes 3D Color Power Angio
Imaging and 3D color Doppler.
Presents the fetal heart beating in a multiplanar --
Fetal STIC
display, preserving spatial and temporal
relationships to aid in detecting anomalies during
routine obstetrical exams.
4D Vaginal This package includes the 4D Imaging option and You must
Package the 3D9-3v transducer. purchase the
Fetal STIC
option
separately.
4D Abdominal Includes the 4D Imaging option, and one curved You must
Package array transducer (choose from either 3D6-2 or purchase the
3D8-4). Fetal STIC
option
separately.
4D Combo Includes the 4D Imaging option, the 3D9-3v You must
Package transducer for endovaginal applications, and one purchase the
curved array 3D volume transducer (choose from Fetal STIC
either 3D6-2 or 3D8-4). option
separately.
4D Complete Includes the 4D Imaging option, the 3D9-3v You must
Package transducer for endovaginal applications, and two purchase the
curved array 3D volume transducers (3D6-2 and Fetal STIC
3D8-4). option
separately.

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Table 3-14 lists each of the software options that are available for the system.
Table 3-14 Software Options
Software Option Application Package
Resident Self Test --
Stress Stress Echo
QLABGI 3DQ OB/GYN Clinical
Application Package
QLAB2DQ Cardiac Clinical Application
Package
QLABSQ Cardiac Clinical Application
Package
QLABROI Cardiac Clinical and
General Imaging Application
Packages
QLABIMT Vascular Clinical
Application Package
DICOM Networking DICOM Networking
Panoramic Panoramic Imaging
Color for 4D Imaging 4D Imaging
3D Fetal Echo STIC Fetal STIC
Contrast Contrast Package
Vascular Vascular Clinical
Application Package
OB/GYN OB/GYN Clinical
Application Package
General Imaging General Imaging Clinical
Application Package
Cardiac Cardiac Clinical Application
Package

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4 Using the System
This section describes how to begin using your system.

Turning the System On and Off


To turn the system on or off
Press the On/Off button that is located on the right side of the soft key panel, as
shown in Figure 4-1.
Figure 4-1 On/Off Button

On/Off button

When the system is off, press the On/Off button to turn it on. The green
LED above the On/Off button is lit when the system is on.
When the system is on, press the button to start the shutdown process and
to turn off the system completely.
NOTE
Do not unplug the system from the wall outlet until the system is completely off.

CAUTION
If you unplug your system before the shutdown message appears, or if you press
and hold On/Off for longer than 3 seconds, you will have to wait longer than
usual to use your system the next time you turn it on. You may also corrupt files
and lose patient data.

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If the system does not turn off after 90 seconds, press and hold On/Off for
5 seconds to force the system to turn off. For more information, see Trouble-
shooting on page 113.
NOTE
Pressing and holding On/Off to force the system to shut down can cause the
same problems as prematurely unplugging the system. Wait the full 90 seconds
before assuming that the system has failed to shut down normally.

The fan comes on periodically to regulate the temperature within the system,
even when the system is turned off.
NOTE
To break the connection from the main power supply, remove the ultrasound sys-
tem plug from the wall outlet.

Positioning the Control Panel and Monitor


This section provides information about adjusting the display and information on
raising, lowering, and swiveling the system control panel and the monitor. For
instructions on moving and transporting the system, see Moving and Transport-
ing the System on page 106.
There are two ways you can adjust the system:
Adjust the display settings for ambient light changes. For instructions, see
Adjusting the Monitor Display on page 81.
Positioning the monitor and control panel for comfortable use.

Adjusting the Monitor Position


The monitor is mounted on an articulated arm that permits it to be positioned
vertically and in an arc from side to side. The monitor arm can also be locked for
moving the system.
You can adjust the position of the monitor to suit different operating positions
and operator heights. When it is released from its locked transport position, the
monitor can be tilted up and down, swiveled right and left, and moved from side
to side.

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To adjust the monitor position
Grasp it by the sides and tilt, swivel, move up or down, or from side to side.

Locking and Unlocking the Monitor Arm


Lock the monitor arm when moving and transporting the system.

To lock the monitor arm


1. Press the articulating portions of the arm together.
2. Slide the lock lever to the locked position.

To unlock the monitor arm

1. Slide the lock lever to the unlocked position.


2. Position the monitor.

Adjusting the Monitor Display


You can adjust the monitor display brightness to compensate for ambient light
changes. You can also customize the tint of the display.

To adjust the display brightness


1. Press Setup.
2. Click the System tab.
3. Select the appropriate Monitor brightness setting. Use the lowest setting
(1) for very dark rooms and the highest setting (5) for bright conditions, such
as operating rooms. Philips recommends setting 3 for normal scan room light-
ing conditions.
4. Click Apply.
5. Click Close.
NOTE
To cycle through the brightness settings, press Ctrl+M repeatedly.

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To adjust the display tint


1. Press Setup.
2. Click the System tab.
3. Select the appropriate Monitor tint setting. Philips recommends the sRGB
setting for routine use.
4. Click Apply.
5. Click Close.
NOTE
To cycle through the brightness settings, press Ctrl+T repeatedly.

Raising, Lowering, and Swiveling the System Control Panel


To raise, lower, or swivel the system control panel and the monitor
1. To unlock the system control panel, do either of the following:
Grasp the adjustment handle under the system control panel and pull it
toward you.
Squeeze either button in the center of the system handle.
2. Raise or lower the control panel, or rotate the control panel left or right as
needed.
3. Release the handle or buttons to lock the system control panel in place.
For help locating the adjustment handle, see Figure 3-1.

Using the System Control Panel


The system control panel is the horizontal surface that contains keys that you
press, knobs that you push and turn, and slide controls that you move left and
right or up and down.

Soft Keys
The soft keys are the keys above the system control panel and below the monitor.
The functions of the soft keys change depending on the mode, the application, the
preset, and the transducer. The function of each soft key is shown above the soft
key on the bottom of the display.
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To use a soft key
Press the up arrow or the down arrow on the soft key to choose or change the
selection that corresponds to the key on the display.

To locate a soft key


Press the Next soft key to see if it appears in the second level of soft keys.
Press the Select key to change the word that is highlighted in the Select
menu. In some modes, the soft keys change depending on the active function
of the trackball.

Keyboard
Use the keyboard on the system control panel to type information into fields and
to type labels, titles, and text labels onto the display.

Select and Enter Keys and the Trackball


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.

Clicking an Item on the Display or Selecting an Option


To click an item on the display or to select an option
Use the trackball to move the cursor over the item or the option, and press the
Enter key.

Changing the Active Function of the Trackball


In many circumstances, you can use the trackball for more than one function. The
possible functions of the trackball for the current mode, transducer, and preset
are listed in the Select menu above the soft key labels. The active trackball func-
tion is highlighted, and its associated screen elements appear in blue.

To change the active trackball function


Press Select.

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Changing the Current Input Language


You can enter patient information and annotation labels by using any of your sys-
tems input languages.
NOTE
To learn how to specify the input languages for your system, see the Help.

To display or hide the IME status window


Press the World (labeled with a globe) key twice.

To change the current input language


Press the left Alt key and either Shift key at the same time.
If the Locale is set to Japanese, the Patient Identification window includes the
Ideographic or Phonetic options for entering patient information. All representa-
tions of the patient information appear in the patients report.

Customizing Your System


You can customize your system in many ways. You can create presets designed
specifically for the exams you perform, you can change system settings to reflect
your needs, and you can add options to enhance your imaging abilities.
The system provides a Setup window for you to modify system settings and set-
tings for modes, options, presets, and peripherals.
For more information on using the Setup window, see the Help.

About Presets
A preset is a group of settings that optimizes the system for a specific type of
exam. Presets establish many initial settings, such as gain value, color map, filter,
and items on the Label menu.
When you turn on your system, the most recently used preset is active. Before
you begin an exam, be sure that the appropriate preset is active.
You can choose from several default presets. You cannot delete these default pre-
sets. However, they provide a starting point from which you can create your own
presets. You can create up to 20 presets for each of the 9 exam types. If you need

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to create more than 180 presets, you can save presets to a CD and restore them
when you need to use them.

NOTES
Presets are only available if you purchased the corresponding application pack-
age option.
The system contains application presets and DICOM presets. Unless DICOM
is specified, when preset is mentioned in the documentation, it is referring to
application presets.

You can save multiple sets of DICOM configuration settings by using DICOM Pre-
sets. For example, if you move your system among departments that use different
DICOM settings, you can create a preset for each department and then easily
change your system to a different DICOM preset each time you move the system.
It is important to make a backup copy of your presets to preserve them in the
event of a hard disk drive failure, or before you upgrade your system software.
For more information, see Making Backups on page 86.
For more information about presetsincluding how to create, select, delete,
modify, save, and restore presetssee the Help.

Changing and Saving System Settings


To change system settings
1. Press Setup and click the System tab.
2. To apply your changes to the current state of the system, make the changes
and click Apply or Close.
3. To save your changes to a preset, click Save.
For detailed instructions on how to change specific settings, see the Help.

Installing, Removing, and Disabling Options


When you receive your system, the options you purchased are installed and
enabled. At some point, however, you may need to install a new option, to
remove an option, or to disable an option.

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To install, remove, or disable an option


Press Setup, and then click the Options tab. For detailed instructions on the
information and steps needed to install, remove, or disable options, see the Help.

Assigning Option Keys


Before you can use any of the following features, you must assign an option key to
the feature:
Contrast (for Contrast soft keys; available if the Contrast option is installed)
Stress (available if the Stress Echo option is installed)
The option keys are labeled Option 1 and Option 2. To use the application,
press the option key assigned to the feature.
For detailed instructions on how to assign an option key to the Contrast or Stress
features, see the Help.

Making Backups
It is very important to back up the information on your system in case your sys-
tems memory fails for any reason. Backing up your system safeguards your cus-
tomized settings and preserves your preferred configurations. If your settings are
subsequently changed, they can be quickly restored from the backup copy, with-
out having to reset them manually. Keeping a backup copy also eliminates the need
to manually reconfigure your settings after a software upgrade.

Backing Up Presets
You need to back up the presets that you create. If you do not and your systems
memory fails, you will need to re-create all of the presets you created.
If you need to create more presets than you can store on your system, you can
save the presets to a CD and restore them when you need to use them.
For more information and detailed instructions on backing up presets, see the
Help.

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Backing Up System Settings


Every time you back up presets, your system settings, printer and VCR settings,
and options settings are automatically backed up as well. You can restore one or
more of these at any time.
For more information and detailed instructions on backing up system settings, see
the Help.

Backing Up Patient Folders


The data in your systems memory is temporary storage. The oldest patient fold-
ers on your system are automatically deleted when your systems memory is full,
or the system will prompt you to manually select studies to be deleted depending
on the Disk Full Strategy. For more information, see the Help.
You need to save any important patient data and images to a CD-R, a CD-RW, an
MOD, or to a DICOM PACS. If your systems memory fails and you did not back
up patient folders, all patient information, images, and measurements will be lost.
NOTE
The MOD drive and network capabilities are components of DICOM options.

For more information and detailed instructions on backing up patient folders, see
the Help.

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Managing Patient Data


After you complete an ultrasound exam, there are many things you can do with
the data. You can:
Review the images in Image Review. Image Review has a powerful search capa-
bility so that you can easily find any study that is still located on the systems
hard disk drive.
Generate a report by using Report mode.
Print images to an attached USB printer.
Print images to a DICOM printer.
Export images to a DICOM PACS.
Export images and reports to removable media such as a CD or an optional
MOD for viewing on a personal computer or a PACS, or for archiving the
studies.
If you choose to export images to removable media, you have several choices
regarding the export media and format.
For more information and detailed instructions on managing patient data, see the
Help.
Table 4-1 lists and describes the types of removable media available and the
export formats. For detailed information on how to configure your system and
export images, see the Help.
Table 4-1 Removable Media and Export Formats
Item Description
Removable Media Drive
CD-RW You can use either a CD-R or a CD-RW with the systems CD drive.
CD-RWs can be erased and reused, but are more expensive than
CD-R
CD-Rs. CD-Rs cannot be erased, but are more likely to be
compatible with your personal computer.
MOD The MOD drive is optional on the system. MODs can be erased and
reused numerous times, but they are more expensive than CD-Rs
and CD-RWs.

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Table 4-1 Removable Media and Export Formats (Continued)
Item Description
Export Format
PC format The system stores still images as BMP files, loops as AVI files, and
report pages as HTML files. You can view these standard file types on
any personal computer. However, PC format files cannot be
reimported into the system.
DICOM format Your system must have an MOD drive to export images in DICOM
format. However, if you have both an MOD drive and a CD drive,
you can export images in DICOM format to either an MOD or to a
CD-R or CD-RW. Exporting images as DICOM format lets you view
images on a PACS system or on another DICOM viewer. You can
also reimport the images into the system, and view them in Review
mode.
Export format If your system does not have an MOD drive, you can use the export
format to store studies on a CD. Studies exported in this format
cannot be viewed on a personal computer, or on a DICOM viewer,
but you can reimport the images into the system to view them in
Review mode.

Managing Data Security


The Health Insurance Portability and Accountability Act (HIPAA) was passed by
the U.S. Congress on August 2, 1996, and became effective April 2003. The pri-
mary purpose of HIPAA is to provide improved portability of health benefits and
better accountability in the area of health-care fraud. To help hospitals comply
with HIPAA, this system protects the health-care information of individuals
against access without consent or authorization.
You can configure a variety of security settings on the system to protect patient
information from unauthorized access. For more information about security set-
tings, see the Help.

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Configuring Network Settings


This section provides the information needed to configure the network settings
on the system. It includes:
Configuring the Systems Network Settings on page 90
Adding a DICOM Server on page 91
Associating DICOM Servers with Roles on page 92
Checking the DICOM Job Manager on page 93
For a list of the DICOM options available for the system, see Table 3-12. For
information about enabling options on your system, see the Help.

Configuring the Systems Network Settings


Before you can connect to a DICOM network, you need to configure the systems
network settings. Check with your system administrator for the specific values
that you need to enter.

To configure the systems network settings


1. Press Setup to open the Setup window.
2. Click the System tab.
3. Click the DICOM button.
4. In the DICOM Preset tab, verify that the correct preset is displayed. If not,
click Change DICOM Preset and select the preset.
5. Click Change Settings for current preset.
6. In the This System tab, type the AE title that the network administrator
assigned to this system.
7. Set the Port number to the number assigned to the system by the network
administrator.
8. Click Network settings.

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9. In the Network Settings window, click TCP/IP Properties to open the
Internet Protocol (TCP/IP) Properties window.
10. Enter the network settings that you obtained from your system administrator
and click OK.

Adding a DICOM Server


The next step in configuring your DICOM functionality is to add each DICOM
server to a list of known servers. A DICOM server can store study content or
can print study images.

To add a DICOM Server


1. In the DICOM Preset tab, verify that the correct preset is displayed. If not,
click Change DICOM Preset and select the preset.
2. Click Change Settings for current preset.
3. Click the Servers & Roles tab.
4. Click New for each new server you want to add.
5. Enter the following information for each server into the Servers section:
Name: The name you will use to refer to this DICOM server. This name
will be used in dialog boxes and error messages.
AE Title: The DICOM Application Entity (AE) Title associated with the
DICOM server. This is often the same as the server name.
Host/IP Address: The network location of the DICOM server. You can
specify the host by using a fixed Internet Protocol (IP) address (for exam-
ple, 130.30.72.106) or a Dynamic Host Configuration Protocol (DHCP)
name (for example, Jamaica).
Port: Enter the port number specified by your network administrator.
NOTE
The default port number, 104, is assigned to ultrasound systems at most institu-
tions.

After you enter the server information, the rest of the fields in the Server
section of the DICOM Setup window are automatically filled in with default
values.

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6. In the Servers area, click Done.


7. Click Ping to test the network communication between your system and the
server. A message confirms that the system can communicate with the server
or printer.
NOTE
If you are unsure about what information to enter in the Servers section of the
DICOM Setup window, or if you receive an error message after clicking Ping,
contact your network administrator for information about which values to use.

Associating DICOM Servers with Roles


The final step in configuring your network settings is to associate a DICOM
server with each role. For example, one of the servers could be the Storage SCP
(Service Class Provider) and another could be the B&W Printer SCP. Each role is
assigned to only one server; however, a single server can have multiple roles. To
assign each server to a role, use the Roles section in the Servers & Roles tab of
the DICOM Setup window.
You can assign DICOM servers to the following roles:
Primary Storage SCP, Secondary Storage SCPThe server assigned
to this role receives and stores images acquired from the system. You can
assign two Storage SCP servers (Primary and Secondary).
Storage Commit SCPThe server assigned to this role takes ownership
of the study.
SR Storage SCPThe server assigned to this role receives and stores
structured reporting data.
SR Storage Commit SCPThe server assigned to this role takes owner-
ship of the structured reporting data.
Black-and-White (B&W) Printer SCPThe server assigned to this role
is the black-and-white printer.
Color Printer SCPThe server assigned to this role is a color printer.
MWL SCP(Modality Worklist) The server assigned to this role provides
information about scheduled patients to the system.

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MPPS SCP(Modality Performed Procedure Step) The server assigned to
this role receives information about studies that are started and completed on
the system.

NOTES
You cannot associate the same DICOM server with both the black-and-white
and the color DICOM printer roles.
If you assign a server to the black-and-white printer, and not to the color
printer, then all images, black-and-white and color, are printed on the
black-and-white printer (color images are converted to black-and-white). If
you only assign a server to the color printer and not to the black-and-white
printer, then all images, black-and-white and color, are printed on the color
printer. If you assign both a black-and-white printer, and a color printer, then
black-and-white images are printed on the black-and-white printer, and color
images are printed on the color printer.
For the system to communicate with the DICOM server, you need to set
some of the Advanced selections. For example, you must choose the correct
image format for the Storage SCP, and the correct parameters for the Printer
SCP. Click the Advanced buttons associated with each role to further specify
storage and printer settings.

To further specify storage and printer settings


Click the Advanced buttons associated with each role.
For information about using DICOM presets, see the Help.

Checking the DICOM Job Manager


At the end of the day, you can check the DICOM Job Manager to ensure all
DICOM jobs were successfully sent to the network.

To access DICOM Job Manager


Press the Ctrl key and the J key (Ctrl+J) at the same time to open the Job Man-
ager window.
If there are jobs left in the queue, you can resend them to the network. For more
information, see the Help.

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Connecting Peripherals
This section provides information about how to connect optional peripherals to
your system.

WARNINGS
Using accessories, transducers, peripherals, or cables not supplied with the
ultrasound system or not recommended by Philips can result in increased
emissions or decreased immunity of the ultrasound system.
If you use additional peripheral equipment powered from an electrical source
other than the ultrasound system, the combination of the peripheral equip-
ment and the ultrasound system is considered to be a medical system. It is
your responsibility to comply with IEC 60601-1-1 and to test the system to
those requirements. For more information, see Safety on page 23. If you
have questions, contact your Philips representative.
If you have a modem, make sure it is not connected to a telephone line while
you are performing an ultrasound exam on a patient.

Figure 4-2 shows where each peripheral is connected to the system. If you are
connecting more than one of the optional peripherals to the system and plan to
store them together on the cart, you need to place either the VCR or the color
printer tray between each peripheral. For more information, see Printers and
Printer Accessories on page 265.

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Figure 4-2 Input/Output Connections

Foot switch
connector

Serial interface
connector S-Video output
connector

Network B&W composite


connector video output
connector
Color composite
USB connector video output
connector
Print trigger
output connector

Analog telephone line


input connector

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Table 4-2 lists and describes each connector.


Table 4-2 Peripheral Connectors
Connector Description
Serial interface Connects the ultrasound system to an offline review
station
Network Connects the ultrasound system to a DICOM
network
USB Connects a plain-paper printer to the ultrasound
system
Foot switch Connects a foot switch to the ultrasound system
S-Video output Connects a generic VCR or video input printer to the
ultrasound system
B&W composite Connects a device such as a multi-format camera to
video output the ultrasound system
Color Connects a video monitor or video input printer to
composite video the ultrasound system
output
Print trigger Connects a trigger to start a print on a video input
output printer
Analog Connects an analog telephone line to the ultrasound
telephone line system for remote service assistance
input

For a description of each symbol on the I/O Panel, see the System Input/Output
Connections on page 139.
Figure 4-3 shows the system cart with the cables protruding through the access
hole. Each system comes standard with:
Two power cords
Two Universal Serial Bus (USB) cables
VCR cables (two audio, two video, and one RS-232)

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Figure 4-3 System Cart and Cables

Connecting a Printer
You can connect the following types of printers to your ultrasound system:
Sony USB printer
Video printer
Philips-authorized USB plain-paper printer
Each system includes a standard black-and-white USB printer.

Connecting a USB Printer


This section provides instructions for connecting the Sony USB color printer to
the system. The color printer is mounted on the rear shelf of the system.
If you purchased a plain-paper printer, see Connecting a Plain-Paper USB
Printer on page 100 for information and instructions on how to connect that
type of printer.

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To connect the Sony USB color printer


1. Turn off the system and unplug the power cord from the power source.
2. Connect the USB cable and the power cord to the back of the printer in the
appropriate connections. For an illustration of the peripheral connections, see
Figure 4-2. For an illustration of the system cart and cables, see Figure 4-3.
3. Lift the peripheral housing garage up and off of the back of the system cart.
4. Loosen the cart strap and slide the printer under the strap on top of the cart.
5. Tighten the strap to secure the printer in place.
6. Align the peripheral housing garage with the four pins on the cart and push
the garage into place on the back of the cart.

WARNINGS
If you use peripheral equipment powered from an electrical source other than
the ultrasound system, the combination of the peripheral equipment and the
ultrasound system is considered to be a medical system. It is your responsibil-
ity to comply with IEC 60601-1-1 and to test the medical system according to
the requirements. If you have questions, contact your Philips representative.
Do not use nonmedical peripherals within 1.5 m (6 ft) of a patient, unless the
nonmedical peripherals receive power from an isolated power outlet on the
Philips ultrasound system, or from an isolation transformer that meets medi-
cal safety standards, as defined by standard IEC 60601-1-1.

7. Reconnect the systems power cord to the power source.


8. Turn on the printer, and then turn on the system.
For information on assigning a record key, see Assigning Keys to Peripherals on
page 103.
For information on ordering USB printers, paper, cartridges, power cords, and
cables, see HD11 XE System Supplies, Peripherals, and Accessories on
page 259.

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Connecting a Video Printer


You can connect either a black-and-white or a color video printer to the system.
NOTE
You may need to purchase a BNC adapter to attach the video trigger connector
from your video printer to the system.

To connect the video printer


1. Turn off the system and unplug the power cord from the power source.
2. Position the video printer on a surface other than the system cart. You may
need a longer set of cables and a longer power cord, and an isolation trans-
former.

WARNINGS
If you use peripheral equipment powered from an electrical source other than
the ultrasound system, the combination of the peripheral equipment and the
ultrasound system is considered to be a medical system. It is your responsibil-
ity to comply with IEC 60601-1-1 and to test the medical system according to
the requirements. If you have questions, contact your Philips representative.
Do not use nonmedical peripherals within 1.5 m (6 ft) of a patient, unless the
nonmedical peripherals receive power from an isolated power outlet on the
Philips ultrasound system, or from an isolation transformer that meets medi-
cal safety standards, as defined by standard IEC 60601-1-1.

3. Plug the power cord into the back of the video printer and insert the other
end into an appropriate power source. See the preceding Warnings.
4. Connect the video printer cables:
a. Plug the video input cable into the video input connection on the back of
the video printer (this connection may be labeled Composite Video). For a
black-and-white video printer, plug the other end into the B/W composite
video output connector on the I/O panel located on the back of the cart.
For a color video printer, plug the other end into the S-Video output con-
nector on the I/O panel. For an illustration, see Figure 4-2.

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b. Plug the video print trigger cable into the print trigger connector on the
back of the video printer, and plug the other end of the cable into the
print trigger connector on the I/O panel on the back of the cart. For an
illustration, see Figure 4-2.
NOTE
On some video printers, the video print trigger connector may be labeled Remote.

5. Reconnect the systems power cord to the power source.


6. Turn on the video printer, and then turn on the system.
For information on assigning a record key, see Assigning Keys to Peripherals on
page 103.

Connecting a Plain-Paper USB Printer


This section provides instructions for connecting a plain-paper USB printer to
your system.

NOTES
Check with your Philips-qualified service representative before purchasing or
connecting a plain-paper USB printer to make sure it is compatible with the
ultrasound system and to obtain a Commercial Off-the-Shelf Software
(COTS) CD-ROM. The COTS CD-ROM includes the printer driver informa-
tion necessary for your printer to communicate with the system.
Because a plain-paper printer is typically larger than the Sony printers, it does
not fit on the system cart. Use a 3-m (10-ft) USB cable to connect the
plain-paper printer to the USB connector on the back of the system.

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To connect a plain-paper printer
1. Make sure that the printer is authorized by Philips and that you have obtained
a COTS CD-ROM from your Philips-qualified service representative.
NOTE
You will only need the COTS CD-ROM if your system does not already support
the printer you purchased.

CAUTION
Do not attempt to use the installation CD-ROM provided by the printer manufac-
turer. Doing so could cause conflicts with the operating system and render it
inoperable. Instead, use the COTS CD-ROM provided by your Philips-qualified
service representative.

2. Turn off the system and unplug the power cord from the power source.
3. Connect the printers USB cable into the back of the printer, and plug the
other end into the system.
4. Connect the printers power cord into the back of the printer, and plug the
other end into an appropriate power source.

WARNINGS
If you use peripheral equipment powered from an electrical source other than
the ultrasound system, the combination of the peripheral equipment and the
ultrasound system is considered to be a medical system. It is your responsibil-
ity to comply with IEC 60601-1-1 and to test the medical system according to
the requirements. If you have questions, contact your Philips representative.
Do not use nonmedical peripherals within 1.5 m (6 ft) of a patient, unless the
nonmedical peripherals receive power from an isolated power outlet on the
Philips ultrasound system, or from an isolation transformer that meets medi-
cal safety standards, as defined by standard IEC 60601-1-1.

5. Reconnect the systems power cord to the power source.


6. Turn on the plain-paper printer, and then turn on the system.
For information on assigning a record key, see Assigning Keys to Peripherals on
page 103.

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Connecting a VCR
You can connect either an NTSC or a PAL VCR to your ultrasound system. The
system only supports the Mitsubishi HS-MD3000 VCR for controlling the VCR
through the system control panel. If you connect an unsupported VCR, you must
control the VCR features by using the controls on the VCR.

To connect the VCR


1. Turn off the system and unplug the power cord from the power source.
2. Lift the peripheral housing garage up and off of the back of the system cart.
3. Loosen the cart strap and slide the VCR under the strap on top of the cart.
4. Tighten the strap to secure the VCR in place.
5. Connect the cables. For an illustration of the peripheral connections, see
Figure 4-2. For an illustration of the system cart and cables, see Figure 4-3.
a. Connect the audio in and audio out cables to the back of the VCR.
b. Connect the S-Video in and S-Video out cables to the back of the VCR.
c. Connect the power cord to the back of the VCR.
d. If the VCR is supported, connect the 25-pin control cable to the back of
the VCR. This allows you to control the VCR features, using the system
control panel.
NOTE
The VCR must have S-Video in and S-Video out ports to accept S-Video as input.

6. Align the peripheral housing garage with the four pins on the cart and push
the garage into place on the back of the cart.
7. Reconnect the systems power cord to the power source.
8. Turn the VCR on, and then turn on the system.

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Assigning Keys to Peripherals


If you have a VCR, a printer, or a serial output cable, you must assign a record key
to each one. The record keys, which appear on the system control panel, are
labeled Rec 1, Rec 2, and Rec 3. You can also assign the Acquire key to a local
printer.

To assign a key to a peripheral or to a serial output cable


1. Press Setup.
2. Click the Peripherals tab.
3. On the Peripherals tab, select from the menu the device that you want asso-
ciated with each Record key.
4. Click Config to configure the device, if required.
5. To use the Acquire key to print, select the printer.
Click Config to configure USB printer drivers, if required.
If you are printing multiple images per page, click Auto Print to specify
Batch mode or Send as you go.
6. To print multiple pages per sheet:
Select the Key to use for multiple images per sheet from the menu.
Click Layout to specify the number of images per page.
7. Click Apply or Save, and then click Close.
NOTE
Your Philips representative types a value for the Tape Time setting when install-
ing peripherals. This setting determines the time displayed on the display when a
videotape is inserted into the VCR. You can change this setting when you assign a
Record key to a peripheral.

Connecting and Configuring the Foot Switch


The foot switch lets you control three of the most commonly used functions with
your foot. This keeps your hands free to use the transducer and the other system
controls. You can use the foot switch during 2D and stress imaging. For 2D imag-
ing, you can change the default configuration of the foot pedals, but you cannot
for stress imaging.
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WARNING
Do not use the foot switch in the operating room. IEC 60601-1 specifies that
foot-operated control devices used in the operating room must meet watertight
construction requirements. The foot switch supplied with the ultrasound system
meets only drip-proof construction requirements.

Connecting the foot switch involves two steps, as described in this section:
Connecting the Foot Switch on page 104
Configuring the Foot Switch Pedals on page 104

Connecting the Foot Switch


This section provides instructions for connecting the foot switch to the system
and for configuring the functions of each pedal.

To connect the foot switch


1. Turn off the system and unplug the power cord from the power source.
2. Insert the foot switch cable into the 9-pin connector on the I/O panel, as
shown in Figure 4-2.
3. Position the foot switch on the floor in front of the system.
4. Reconnect the systems power cord to the power source.
5. Turn on the system.

Configuring the Foot Switch Pedals


Table 4-3 shows the default settings for each foot pedal.
Table 4-3 Foot Switch Functions
Mode Left Pedal Middle Pedal Right Pedal
2D Rec 1 Freeze Rec 2
Stress None Enter Acquire

NOTE
You can only configure the 2D foot switch functions.

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To configure the foot switch
1. Press Setup on the system control panel.
2. Click the Peripherals tab.
3. In the Foot Switch section, click the down arrow associated with each pedal
to select from the following functions:
Rec 1
Rec 2
Rec 3
Freeze
4. Click Apply and then click Close to save your changes.

Configuring and Using the Data Transfer Feature


The Data Transfer feature allows patient report data to be sent through the sys-
tems RS-232 port to an offline printer, computer, or workstation.
For more information on the data transfer formats, contact your Philips represen-
tative.

Assigning a Record Key


Before you can use the Data Transfer feature to transfer study data, you must
configure the system by assigning Serial Output to one of the record keys.

To assign a record key


1. Press Setup and click the Peripherals tab.
2. Select Serial Output as the device to associate with a record key.
3. Click Apply, and then click Close.

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Transferring Data
The printer, computer, or workstation to which you intend to send data must be
set up for serial data transfer as follows:
9,600 Baud
8-bit data
No parity
1 stop bit

To transfer data
1. Make sure the RS-232 serial cable is connected to the system.
2. Open a study, or create a new study.
3. Press Report.
4. Press the record key that you assigned as Serial Output. A confirmation
message appears.

Moving and Transporting the System


The weight of the system depends on the peripherals installed. Although the sys-
tem is designed to be mobile, the typical weight (including the monitor, but with-
out peripherals) is approximately 100 kg (220 lb).
WARNING
This weight dictates discretion when moving the system. The ability to move the
machine, is, however, directly related to an individuals size and strength. Seek
assistance to move the system when necessary.
The system dimensions, including the display monitor are as follows:
Height 151.1 cm to 174 cm (59.5 in to 68.5 in)
Width 55.88 cm (22 in)
Depth 111.76 cm (44 in) from front of keyboard to rear of base
Weight < 100 kg (220 lb) without peripherals

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Taking Precautions When Moving the System


Be careful when you move the ultrasound system. Although it is designed to be
mobile, remember that it weighs approximately 100 kg (220 lb). Therefore, take
the precautions described in this section when moving the system.
Turn off the system and unplug it from the power source. Coil the power cord
on the hook that is located on the back of the system.
If you have a LAN cable connected to the system, unplug it from the systems
network jack.
Always use the front handle to push the system. Do not push the system from
the side or the back. Do not use the handle to lift the system.
Be sure the system control panel and monitor arm are locked. Rotate the
control panel left and right; it will lock automatically. See Locking and
Unlocking the Monitor Arm on page 81.
Disconnect and remove external devices and all loose equipment from the
top of the system.
Before transporting the system in a vehicle, remove transducers from the
holders, receptacles, and front cable holder.
Make sure the strap that holds the system peripherals on top of the system is
securely tightened.
When moving the system, never strap or secure the system above the handle.
Use caution when moving the system over uneven surfaces. Do not move the
system over uneven elevator entrances by lifting up on the machine.
WARNING
Use two people to transport the ultrasound system when you are moving it up
and down ramps longer than 6 m (20 ft) or steeper than 5 degrees. (Wheelchair
ramps are usually less than 5 degrees.) It is, however, possible to exceed this
amount of incline when the system is moved over a roadside curb or some other
small but steep incline. Use extreme care when moving the system. Avoid ramps
that are steeper than 5 degrees to eliminate the potential danger of the system
tipping over.

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Using the Wheel Controls


The front wheels on the system, as shown in Figure 4-4, have wheel controls that
you can engage and disengage independently.
The red lever is the wheel lock.
The green lever is the steering-lock function.
The gray lever is the wheel lock or steering-lock release lever.
The back wheels do not have controls.
WARNING
Do not use the wheel controls to hold the system on an incline greater than
5 degrees.

Figure 4-4 Front Wheels

To lock the front wheels for moving the system in a straight line
Press down on the green lever on each front wheel.

To apply the brakes to each wheel


Press the red levers down.

To release the wheel locks or the steering locks


Press the gray levers down.

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Using the System 4

Moving the System


This system is equipped with a front handle and brakes on the front wheels.
Always use the handle at the front of the cart to move the system from one loca-
tion to another.

To move the system


1. Unlock the wheel brakes (press the gray levers) before moving the system.
2. Lock the rotation of the system control panel so that it cannot pivot during
transportation.
3. Press the green lever down on each front wheel to ease straight-line travel.
4. Push with the handle at the front of the cart.
5. After the system is in position, press the red (brake) lever on each wheel to
immobilize it.

Transporting the System in a Vehicle


Follow these guidelines to transport the system in a vehicle:
Before transporting the system in a vehicle, remove the transducers from the
holders. To protect the transducers, put them in a packing box.
Lock the monitor arm and protect the monitor with padding during transpor-
tation. See Locking and Unlocking the Monitor Arm on page 81.
Transport the system in the upright position. Never transport the system on
its back or side.
The strap used to secure the system in a vehicle should not be located across
any of the systems plastic side panels. Secure the strap so that it is located as
low as possible across the lift column.
Be sure that the transporting vehicle can handle the weight and volume of the
system or systems plus the passengers.
Be sure the load capacity of the loading lift can accommodate the weight of
the ultrasound system. Philips recommends a minimum capacity of 227 kg
(500 lb).

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WARNING
Never ride on the loading lift with the ultrasound system. Your weight coupled
with the systems weight may exceed the lifts load capacity.
Load and unload the system when the transporting vehicle is parked on a level
surface. If the parking surface is unlevel, make sure the brakes are applied to
both wheels.
The weight of the system on the extended loading lift may cause the trans-
porting vehicle to tilt, which could cause personal injury or system damage.
Always secure the ultrasound system while it is on the loading lift so that it
cannot roll. Use wood chocks, restraining straps, or other similar types of
constraints. Do not attempt to manually hold it in place.
Be sure the ultrasound system is firmly secured while it is inside the trans-
porting vehicle. Make sure the brakes are applied to both wheels during trans-
port. Any movement, coupled with the weight of the system, could cause it to
break loose.

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Using the System 4

Getting Help and Troubleshooting Your System


This section provides instructions on using the Help, getting technical support,
and troubleshooting your system.

Using the Help


The Help provides detailed information and instructions for using the ultrasound
system.

To start the Help


Press Help on the system control panel.
The Help provides three ways for you to navigate to the information you need:
Click the Contents tab to scroll through the table of contents. Information is
organized by major tasks.
Click the Index tab to search for Help topics by keyword and to view a list of
related topics.
Click the Search tab to search the entire Help by using a specific keyword or
term.
For more information on using the Help, see Using Help in the Help.

Getting Technical Support


If you have any trouble using the ultrasound system, there are several sources of
information that can help you get the answers you need.

Do the following before contacting technical support


Review the Help topics. The Help gives detailed instructions on how to use
the system. If you are having trouble finding the information you need, use the
Index or the Search tabs to search for topics by keywords.
Review Transducers on page 145 for questions related to using specific
transducers with the system.

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Review Troubleshooting on page 113 to see if the problem has already been
addressed.
If you experience a problem using the system, press Ctrl+u to insert a
marker in the systems event log. Your Philips representative may need to
review the event log file to help troubleshoot your system. The marker helps
to identify the events surrounding the problem.

Information Needed for Technical Support


If you have followed these steps and are still experiencing difficulties with the sys-
tem, contact your Philips representative for technical assistance.

To facilitate technical support


Be prepared to state your name, the name of your institution, and the ultra-
sound model number (Model number 989605325131).
Have your system serial number available, and if possible, the software revi-
sion number. See Finding Your System Serial Number, Model Number, and
Software Revision Number on page 112.
Be prepared to give a detailed description of the problem, including the steps
you took leading up to it, and any error messages you received.
Be prepared to provide any information on the steps you have taken so far to
solve the problem.

Finding Your System Serial Number, Model Number, and Software


Revision Number
You can find your system serial number in one place if your system is on and in
another if it is off.
If the system is on, do the following to locate the system serial number, model
number, and software revision number. All of these items will help facilitate your
technical support call.

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Using the System 4
To find your system serial number, model number, and software
revision number when the system is on
1. Press Setup and click the Options tab.
2. Click Options. The serial number, model number, and software revision num-
ber appear on the top blue border of the Options window.

To find your system serial number if the system is off or is not


functioning properly
Locate the system serial number on the lower back of the system, near the power
cord.

Troubleshooting
This section provides information on troubleshooting your system.

System Does Not Turn On


To troubleshoot a system that does not turn on when you press the On/
Off button
1. Look at the power supply LED indicator. The LED indicator is located to the
left of where the power cord attaches to the system.
2. If the LED is off, it indicates that there is no power to the system. Do the fol-
lowing:
a. Check to make sure the power cord is firmly plugged into the wall outlet.
b. Make sure the other end of the power cord is securely connected to the
system.
3. If the LED is on, it indicates the system does have electrical power. Do the fol-
lowing:
a. Unplug the power cord from the wall outlet and wait at least 30 seconds
before reconnecting the power cord.
b. Press the On/Off button to restart the system. It may take several min-
utes for the system to restart.
4. If the system still does not start, contact your Philips representative.

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System Freezes
To troubleshoot a system that freezes, or some controls that seem to
freeze
1. Press and release the On/Off button to shut down the system. Wait at least
90 seconds for the system to shut down. If the system does not respond, con-
tinue to step 2.
2. Press and hold the On/Off button for at least 10 seconds to force the system
to turn off. When the system is completely off, press the On/Off button to
restart the system. It may take several minutes for the system to restart. If the
system does not respond, continue to step 3.
3. If the system does not respond to any of the procedures listed in the previous
steps, do the following:
a. Unplug the power cord from the wall outlet.
b. Wait at least 30 seconds, and then reconnect the power cord.
c. Press the On/Off button to restart the system. It may take several min-
utes for the system to restart.

Trackball Does Not Move Cursor or Moves Cursor Erratically


Clean the trackball. See Cleaning the Trackball on page 122.

Fan Turns on Periodically When the System Is Off


If the system is turned off, but is still plugged into the wall outlet, the fan comes
on periodically to regulate the temperature within the system. This is normal.

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5 Cleaning and Maintaining the System
It is important to clean and maintain the ultrasound system, transducers, and
peripherals. Thorough cleaning is particularly important for pieces of peripheral
equipment because they contain electromechanical devices. If exposed to con-
stant and excessive environmental dust and humidity, these devices will suffer in
both performance and reliability.
It is essential to clean the transducers used with your ultrasound system. The
cleaning procedures vary for the different types of transducers and their uses. For
detailed instructions on how to clean and maintain each type of transducer used
with the system, see Cleaning, Disinfecting, and Sterilizing Transducers on
page 161.
This section includes information for cleaning and maintaining the system.

Cleaning and Disinfecting System Surfaces


The exterior surfaces of the system can be disinfected using a compatible disinfec-
tant with a wipe method. System surfaces include the monitor screen and plastic
and painted surfaces. The following products can be used on system surfaces:
Mild soap solution
70% isopropyl alcohol (rubbing alcohol)
T-Spray II (quaternary ammonium-based)
Theracide Plus (quaternary ammonium/isopropyl alcohol-based)
Sani-Cloth HB (quaternary ammonium-based)
Sani-Cloth Plus (quaternary ammonium/isopropyl alcohol-based)
Other products that are based on quaternary ammonium compounds (QUAT) or
QUAT/isopropyl can also be used in disinfecting system surfaces.
Use the following procedure to disinfect system surfaces.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any
equipment.

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5 Cleaning and Maintaining the System

CAUTIONS
Use only compatible disinfectants on system surfaces.
If you use an isopropyl alcohol solution for disinfection, ensure the solution is
only 70% isopropyl alcohol or less. Solutions of more than 70% isopropyl alco-
hol can cause product damage.

To clean and disinfect system surfaces


1. Turn off the system and disconnect the system power cord from the wall out-
let.
2. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean
exterior surfaces on the system.
3. Mix the disinfection solution compatible with your system (see the list on
page 115) according to label instructions for solution strength.
CAUTION
Do not spray disinfectant directly on system surfaces. When wiping, do not allow
disinfectant to pool or run on system surfaces. In either case, disinfectant may
leak into the system, damaging the system and voiding the warranty. Wipe only
with a cloth or an applicator that is lightly dampened.

4. Wipe system surfaces with the disinfectant, following disinfectant label


instructions for wipe durations, solution strengths, and disinfectant contact
duration. Ensure the solution strength and duration of contact are appropriate
for the intended clinical application.
5. Air dry or towel dry with a sterile cloth according to the instructions on the
disinfectant label.

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Cleaning and Maintaining the System 5

Cleaning the Cables and the Connectors


This section provides instructions for cleaning the cables and the connectors. For
instructions on cleaning and disinfecting system surfaces, see Cleaning and Disin-
fecting System Surfaces on page 115.
NOTE
For detailed instructions on how to clean and maintain each type of transducer
used with the system, see Transducer Care and Maintenance on page 155.

To clean ECG trunk cables, leads, and electrodes


1. Before cleaning, turn off the system and unplug the power cord from the
power source.
2. Wipe with a gauze pad moistened with soap and water.
CAUTION
Do not spill or spray water on the controls, into the system cabinet, or into the
transducer connection receptacle.

3. Remove any solid matter around the keys or the controls with a cotton swab
or toothpick to ensure that solids are not pushed into the cabinet.
4. If blood or other infectious material comes in contact with the system or any
cable other than the transducer cable, wipe with 70% isopropyl alcohol (rub-
bing alcohol).
CAUTION
If blood or other infectious material comes in contact with a transducer or trans-
ducer cable, do not wipe with isopropyl alcohol until you see Transducer Care
and Maintenance on page 155 for specific cleaning guidelines. Isopropyl alcohol
should not be used on some parts of the transducer and should never be used on
any parts of the transducer cable. Additional cleaning agents are also available for
transducers.

5. Remove any residue with a cloth moistened with sterile water.


6. Be sure to dry the equipment to prevent potential corrosion.

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5 Cleaning and Maintaining the System

Preventive Maintenance
Philips recommends basic preventive maintenance that is intended to minimize
the possibility of unexpected failure. Most recommendations rely on thorough
cleaning.
Preventive maintenance of the system consists primarily of periodically and con-
sistently cleaning the air filter and maintaining the cart.
Thorough cleaning is particularly important for pieces of peripheral equipment
because they contain electromechanical devices. If exposed to constant and
excessive environmental dust and humidity, these devices will suffer in both per-
formance and reliability.

Recommended Frequency of Maintenance Procedures


The frequency of system preventive maintenance plays a key role in extending or
eliminating downtime due to poor performance or unexpected breakdown.
Table 5-1 offers recommendations, but you can make necessary adjustments
based on factors such as the frequency of usage and environmental conditions. In
all cases, Philips recommends that you frequently check safety-related items.
Table 5-1 Recommended Frequency of Maintenance Tasks
Item Frequency Task See
TEE Before each Check the surface of the transducer TEE Transducers
transducers use by sight and by touch, and verify the on page 203
operation of the controls.
Transducers Before each Check for cracks, bent pins, or Inspecting
use other abnormalities. Transducers for
Damage on
page 156
Cart As necessary Clean as instructed. Wheels have Cleaning and
sealed bearings, and no lubrication Disinfecting System
is necessary. Surfaces on
page 115

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Cleaning and Maintaining the System 5
Table 5-1 Recommended Frequency of Maintenance Tasks (Continued)
Item Frequency Task See
Monitor As necessary Clean as instructed. Cleaning and
Disinfecting System
Surfaces on
page 115
Air filter 3 months or Clean as instructed. Cleaning the Air
more often Filter on page 121
Trackball 3 months Clean as instructed. Cleaning the
Trackball on
page 122
VCR 6 months Clean video heads and tape path. VCR on page 123
Video 6 months Clean print head, rollers, and Video Printers on
printers sensors. page 123
Fan 1 year Check for good airflow without Service
excessive noise. Documentation on
Safety 1 year Perform ground impedance/leakage page 119
tests.

Service Documentation
Because the system is a piece of medical equipment that contains several circuit
boards, extensive service diagnostics, and complex operating software, Philips rec-
ommends that only trained personnel service the system.
Service manuals are not shipped with each system. However, you can purchase a
service manual from your Philips representative. It contains parts lists, a brief the-
ory of operation, error codes, and preventive maintenance and safety testing
instructions.

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5 Cleaning and Maintaining the System

The circuit boards in the system are manufactured using surface mount technol-
ogy. Circuit schematics are excluded for the following reasons:
Repairing these boards requires special equipment and technicians trained in
repairing surface mount boards.
The density of components on the circuit board prevents the online system
diagnostics from identifying component failures. Therefore, it is nearly impos-
sible to identify component failures without special test fixtures available only
at the Philips factory.

Electrostatic Discharge Guidelines


Follow these electrostatic discharge (ESD) guidelines when performing service or
maintenance procedures to avoid the possibility of inadvertent deterioration or
destruction of sensitive electronic components:
Avoid working in carpeted areas that are not approved for ESD.
Use a grounding wrist strap to be properly grounded. The system should be
plugged into the power outlet and turned off.
Use a grounding mat for assembly work on sensitive areas.
WARNING
To protect your safety, you must follow ESD guidelines when performing service
and maintenance procedures.

CAUTION
If you use a vacuum cleaner to clean the interior of the system or any ESD-sensi-
tive part of the system, take the necessary static discharge precautions to avoid
damaging the electronics.

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Cleaning and Maintaining the System 5

Maintaining the System Control Panel


The system control panel and other outer surfaces are most likely to be affected
by liquid spills and other materials such as excessive amounts of gel. These mate-
rials may seep into electrical components under the panel and cause intermittent
failures. During preventive maintenance, look for such potential problems includ-
ing loose knobs and worn controls.
Regularly clean the outside of the system as described in Cleaning and Disinfect-
ing System Surfaces on page 115.

Cleaning the Air Filter


All power for the carts electronics is provided by the power supply box located
inside the cart. To ensure good airflow to the power supply box, you must clean
the systems air filter on a regular basis. The air filter is located on the bottom of
the system between two channels, as shown in Figure 5-1.
Figure 5-1 Location of Air Filter

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5 Cleaning and Maintaining the System

To remove the filter


1. Turn off the system and unplug it from the power source.
2. From either side of the system, slide the filter from between the two chan-
nels.

To clean the filter


1. Vacuum the air filter, or rinse the filter under water.
2. If you rinsed the filter under water, allow the filter to air dry. Be sure the filter
is thoroughly dry before reinstalling it.

To reinstall the filter


Slide the filter back in between the two channels.
CAUTION
Be sure to position the system so that the vents on the back of the system are
not blocked by a drape, a curtain, or another object.

Cleaning the Trackball


Cleaning the trackball regularly prolongs its useful life and prevents service calls.

To clean the trackball


1. With your fingers, unscrew the ring around the trackball.
2. Put your finger in the access hole underneath the trackball, and push the
trackball up.
3. Clean the trackball and the mounting area with a lint-free cloth or a small
brush.
4. Place the ball back on the mounting area.
5. With your fingers, screw the ring back on.

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Cleaning and Maintaining the System 5

Cleaning and Maintaining Peripherals


For information about cleaning the system peripherals, see the manufacturers
manual that accompanied the peripheral, or contact your local Philips representa-
tive. The procedures generally require the removal of the unit from the cart and
therefore should be performed by appropriate service personnel.

VCR
The VCR requires the following maintenance.

To clean the video heads


1. Disconnect the VCR cables from the system.
2. Remove the VCR from the cart.
3. Remove the top cover.
4. Thoroughly clean the individual video heads, using an appropriate solvent and
a lint-free cloth or chamois.

To clean the videotape path


Using an appropriate solvent and lint-free cloth or chamois, clean the entire vid-
eotape path as well as the audio and control heads. If you need to lubricate the
heads, use a very light oil and be very careful not to contaminate the videotape
path.

Video Printers
Optional devices, such as video printers, require that you periodically partially dis-
assemble the print heads to effectively remove paper debris and abrasive material.
To minimize maintenance, consistently use high-quality paper coated with an anti-
static protecting chemical. Because dirty sensor surfaces are often the cause of
malfunction, it is important to keep the sensors clean.

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5 Cleaning and Maintaining the System

Replacing the System Battery


The systems lithium battery, located inside the system electronics, maintains con-
figuration settings at all times, even when the system is off.
The memory backup life of the battery is approximately 3 years if left unplugged.
When the system is plugged in, the standby current from the power supply
extends the life of the battery. The battery rating is CR2032 3-V Single Cell,
225 mAh.
If, however, the system battery loses its charge, the system defaults to the stan-
dard configuration settings, and the system clock may fail to show the correct
time. However, there are no patient safety concerns. To replace the battery, con-
tact your Philips service representative.
WARNING
There is a danger of explosion if the battery is replaced incorrectly. The battery
should be replaced only with the same or equivalent type recommended by the
equipment manufacturer. Used batteries must be discarded according to the man-
ufacturers instructions and local ordinances.

Disposing of Equipment
Dispose of the ultrasound system according to local ordinances. Dispose of
peripheral equipment in accordance with manufacturers instructions and local
ordinances.

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6 Device Standards
This section describes specifications and standards for the system.

Specifications
This section provides specification information about the ultrasound system.

Model Number
Philips 989605325131

Power Requirements
100 to 240 V 10%, 50/60 Hz, 1,150 VA

Operating Environment

Temperature Range 0C to 40C (32F to 104F)


Relative Humidity 20% to 80%, noncondensing
Atmospheric Pressure 697 to 1,013 hPa

Storage Environment

Temperature Range 20C to 60C (4F to 140F) (excluding


media)
Relative Humidity 20% to 90%, noncondensing
Atmospheric Pressure 572 to 1,013 hPa

Regulatory Compliance

Agency Clearances FDA and JTA


Product Marks CE (MDD), GOST, ICES-001

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6 Device Standards

Standards and Directives


The system meets or complies with the standards and directives listed in
Table 6-1.
Table 6-1 Standards and Directives
Country Standard Year
Australia / AS/NZS 3200.1.0 1998
New Zealand AS/NZS 3200.1.1 1995, AM-1:1997
Canada CAN/CSA-C22.2 1990, S-1:1994, B:1996
No. 601.1-M90
CAN/CSA-C22.2 2002
No. 60101-1-1-02
Europe EN 60601-1 1990, AM-1:1993, AM-11:1993,
AM-12:1993, AM-2:1995, AM-13:1996
EN 60601-1-1 2001
EN 60601-1-2 2002
EN 60601-2-37 2001
International IEC 60601-1 1998, AM-1:1991, AM-2:1995
IEC 60601-1-1 2000
IEC 60601-1-2 2001
IEC 60601-2-37 2001
IEC 61157 1992
Japan JIS T 0601-1 1999
JIS T 0601-1-1 1999
JIS T 1501 1984
United States UL 2601-1 1997

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Device Standards 6
Table 6-2 lists and describes the classification symbols and their meanings. See
Table 2-3 for a description of the symbols used on this system.
Table 6-2 Classification Symbols
Symbol Meaning
All remaining transducers are rated for type BF isolation.

All intraoperative transducers are rated for type CF isolation. Some


additional transducers are rated for type CF isolation.
ECG physio isolation is type CF, defibrillator proof.
Suitable for all patient applications including direct cardiac application.
IPX0 The system has ordinary protection against the entry of liquids.
IPX1 The foot switch meets drip-proof construction requirements.
IPX7 Protected against the effects of temporary immersion in water.

This system is in continuous operation.


This system is Group 1: It is provided with basic insulation and protective earth
accessible metal parts.
WARNING
The equipment is not suitable for use in the presence of a flammable anesthetic
mixture with air, oxygen, or nitrous oxide.

Audible Acoustic Output


The maximum sound pressure level achieved when the system is operated in tem-
peratures up to 40C (104F) is 50 dBa.

Electromagnetic Compatibility
The testing for electromagnetic compatibility (EMC) of this system has been per-
formed according to the international standard for EMC with medical devices
(IEC 60601-1-2). This IEC standard was adopted in Europe as the European norm
(EN 60601-1-2).

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6 Device Standards

NOTE
The headphone jack on the CD-ROM drive is not functional on this system. If
headphones are plugged into this jack, the EMC characteristics of this system may
change.

Electromagnetic Emissions
The ultrasound system is intended for use in the electromagnetic environment
specified in Table 6-3. The customer or the user of the ultrasound system should
assure that it is used in such an environment.

Table 6-3 Electromagnetic Emissions


Electromagnetic Environment
Emissions Test Compliance Guidance
RF emissions CISPR 11 Group 1 The HD11 XE ultrasound system uses
RF energy only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions CISPR 11 Class B The HD11 XE ultrasound system is
suitable for use in all establishments,
Harmonic emissions Class A
including domestic establishments and
IEC 61000-3-2
those directly connected to the public
Voltage fluctuations/ Complies low-voltage power supply network that
flicker emissions supplies buildings used for domestic
IEC 61000-3-3 purposes.

Approved Cables, Transducers, and Accessories for EMC


This section provides lists of cables and accessories approved for electromagnetic
compliance for use with the ultrasound system.
For a list of transducers approved for electromagnetic compliance for use with
the ultrasound system, see Supported Transducers on page 145.

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Device Standards 6

Approved Cables for Electromagnetic Compliance


WARNING
The use of cables, transducers, and accessories other than those specified may
result in increased emissions of the ultrasound system.
Cables connected to the ultrasound system may affect its emissions. Use only the
cable types and lengths listed in Table 6-4.
Table 6-4 Approved Cables for Electromagnetic Compliance
Philips Part
Cable Type Length Number
ECG 3-lead Shielded 2.7 m (9 ft) M1500A
safety connector
patient trunk
cable, AAMI
ECG 3-lead Shielded 2.7 m (9 ft) M1510A
safety connector
patient trunk
cable, IEC
ECG Aux input Shielded < 3 m (< 9.8 ft) --
Composite Shielded coaxial Any --
video
S-Video Shielded Any --
LAN Twisted Pair Any --
Trigger Shielded < 3 m (< 9.8 ft) --
Foot switch Shielded 1.5 m (4.9 ft) Included with foot
switch assembly
RS-232 interface Shielded 2 m (6.5 ft) --
USB Shielded <3 m (10 ft) --

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Approved Transducers for Electromagnetic Compliance


The imaging transducers used with the ultrasound system may affect its emissions.
The transducers listed in Table 7-1 on page 146, when used with the ultrasound
system, have been tested to comply with the Group 1, Class B emissions as
required by International Standard CISPR 11.

Approved Accessories for Electromagnetic Compliance


Accessories used with the ultrasound system may affect its emissions. The acces-
sories listed in Table 6-5, when used with the ultrasound system, have been tested
to comply with the Group 1, Class B emissions as required by International Stan-
dard CISPR 11.
When connecting other customer-supplied accessories to the system, such as a
remote video monitor or a computer, it is the users responsibility to ensure the
electromagnetic compatibility of the system. Use only CISPR 11 or CISPR 22,
Class B compliant devices, unless otherwise noted.

Table 6-5 Approved Accessories for Electromagnetic Compliance


Accessory Manufacturer Model Number
Ultrasonic Imaging Philips Use only Philips
Transducer transducers.
VCR Mitsubishi HS-MD3000
Black-and-White Printer Sony UP-D895MD
Color Printer Sony UP-D23MD
Color Laser Jet Printer Hewlett-Packard Make sure that the printer
is authorized by Philips and
Black-and-White Laser Jet Hewlett-Packard
that you have obtained a
Printer
COTS CD-ROM from your
Ink Jet Printer Hewlett-Packard Philips-qualified service
representative.

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Device Standards 6

Electromagnetic Immunity
The ultrasound system is intended for use in the electromagnetic environment
specified in Table 6-6. The customer or the user of the ultrasound system should
ensure that it is used in such an environment.

NOTES
The guidelines specified in Table 6-6 may not apply in all situations. Electro-
magnetic propagation is affected by absorption and reflection from structures,
objects, and people.
UT is the AC mains voltage before application of the test level.
At 80 and 800 MHz, the separation distance for the higher frequency range
applies.

Table 6-6 Electromagnetic Immunity


IEC 60601 Test Compliance Electromagnetic
Immunity Test Level Level Environment Guidance
Electrostatic 6 kV contact Same as Floors should be wood,
discharge (ESD) IEC 60601 test concrete, or ceramic tile. If
8 kV air
level floors are covered with
IEC 61000-4-2
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast 2 kV for power Same as Mains power quality should
transient/burst supply lines IEC 60601 test be that of a typical
IEC 61000-4-4 level commercial or hospital
1 kV for input/
output lines environment.

Surge 1 kV differential Same as Mains power quality should


IEC 610004-5 mode IEC 60601 test be that of a typical
level commercial or hospital
2 kV common
environment.
mode

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6 Device Standards

Table 6-6 Electromagnetic Immunity (Continued)


IEC 60601 Test Compliance Electromagnetic
Immunity Test Level Level Environment Guidance
Voltage dips, < 5% UT Same as IEC Mains power quality should
short 60601 test level be that of a typical
interruptions, > 95% dip in UT for commercial or hospital
and voltage 0.5 cycle environment. If you require
variations on 40% UT continued operation during
power supply power mains interruptions,
input lines 60% dip in UT for Philips recommends that
5 cycles the system be powered
IEC 61000-4-11
70% UT from an uninterruptible
power supply or a battery.
30% dip in UT for
25 cycles
< 5% UT
> 95% dip in UT for
5 seconds
Power frequency 3 A/m Same as IEC Power frequency magnetic
(50/60 Hz) 60691 test level fields should be at levels
magnetic field characteristic of a typical
location in a typical
IEC 61000-4-8
commercial or hospital
environment.
Conducted RF 3 VRMS 0.01 V For recommended
separation distances, see
IEC 61000-4-6 150 kHz to 80 MHz
Recommended Separation
Radiated RF 3 V/m 3 V/m Distance on page 135.
IEC 61000-4-3 80 MHz to 2.5 GHz

Cables, transducers, and accessories connected to the system may affect its
immunity to the electromagnetic phenomena listed in Table 6-6. Use only cables,
transducers, and accessories listed in Approved Cables, Transducers, and Acces-
sories for EMC on page 128 to minimize the change of performance degradation
of the ultrasound system due to these types of electromagnetic phenomena.

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CAUTION
If the system is connected to other customer-supplied equipment, such as a local
area network (LAN) or a remote printer, Philips cannot guarantee that the
remote equipment will work correctly in the presence of electromagnetic phe-
nomena.

Although most remote devices will likely comply with their applicable standards
for immunity, those device requirements may not be as stringent as those
required for medical equipment. It is the responsibility of the installer and user of
this remote customer-supplied equipment to ensure that it functions properly in
the electromagnetic environment where the system is installed. For this reason,
Philips does not provide a list of compatible accessories. Philips suggests that the
installer or user of such a system consult with experts in the field of electromag-
netic compatibility and safety for guidance to ensure the safe and effective use of
the created system.
Electromagnetic interference may appear in many ways on the ultrasound system
and depends on the mode the equipment is operating in, the imaging control set-
tings, the type of transducer being used, the type of electromagnetic phenomena,
and the intensity level of the phenomena.
NOTE
Electromagnetic phenomena are not always present and may be transitory in
nature. It may be extremely difficult to identify the source of the interference.

CAUTION
When interference is present or intermittent, use caution when continuing to use
the ultrasound system.

NOTE
Table 6-7 describes a few typical interferences seen in imaging systems. It is not
possible to describe all manifestations of interference because it depends on many
parameters of the transmitting device such as the type of modulation used by the
signal carrier, the source type, and the transmitted level. It is also possible for the
interference to degrade the imaging systems performance and not be visible in
the image. If the diagnostic results are suspicious, other means should be used to
confirm the diagnosis.

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Table 6-7 Typical Interference on Ultrasonic Imaging Systems

Imaging
Mode ESDa RFb Power Linec

2D or Change of operating For sector imaging White dots, dashes,


3D/4D mode, system transducers, white radial diagonal lines, or
settings, or system bands or flashes in the diagonal lines near
reset. centerlines of the image. the center of the
image.
Brief flashes in the For linear imaging
displayed or transducers, white
recorded image. vertical bands,
sometimes more
pronounced on the
sides of the image.

Color Color flashes, radial or Color flashes, dots,


vertical bands, increase dashes, or changes in
in background noise, or the color noise level.
changes in image color.

Doppler Horizontal lines in the Vertical lines in the


spectral display, tones spectral display,
and abnormal noise in popping noise in the
the audio, or both. audio, or both.

M-mode Increase in the image White dots, dashes,


background noise or diagonal lines, or
white M-mode lines. increase in image
background noise.
a. Electrostatic discharge (ESD) caused by discharging of electric charge build-up on insulated sur-
faces or persons.
b. Radio frequency (RF) energy from RF transmitting equipment such as portable phones,
hand-held radios, wireless devices, commercial radio and TV stations, and so on.
c. Conducted interference on power lines or connected cables caused by other equipment such as
switching power supplies, electrical controls, and natural phenomena such as lightning.

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Recommended Separation Distance


Table 6-8 provides guidance on the distances any radio frequency (RF) transmit-
ting equipment should be kept away from the ultrasound system to reduce the
risk of interference with the imaging system. Portable and mobile RF communica-
tions equipment should be used no closer to any part of the system, including
cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter. Field strengths from fixed RF trans-
mitters, as determined by an electromagnetic site survey1 should be less than the
compliance level in each frequency range as noted in Table 6-6. Interference may
occur in the vicinity of equipment marked with the following symbol:

NOTES
For transmitters rated at a maximum output power not listed in Table 6-8, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maxi-
mum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
At 80 MHz and 800 MHz, the higher frequency range applies.
The recommended separation distance guidelines in Table 6-8 may not apply
to all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.

Table 6-8, in conjunction with Table 6-6, provides guidance on conducted and
radiated interference from portable and fixed RF transmitting equipment.
The conducted RF test level is 3 V and the ultrasound system has a compliance
level of 0.01 V.

1. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) tele-
phones and land mobile radios, amateur radio, AM and RM radio broadcast, and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the system is used exceeds the applicable RF compli-
ance level in Table 6-6, the system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relo-
cating the system.

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Table 6-8 lists the recommended separation distances for the ultrasound system.

Table 6-8 Recommended Separation Distances


Separation Distances According to Frequency of
Transmitter (Meters)
Rated
Maximum 150 kHz to 800 MHz to
Output 80 MHz 80 to 800 MHz 2.5 GHz
Power of
Transmitter
(Watts)
0, 01 35 m 0.12 m 0.24 m
0, 1 110 km 0.38 m 0.76 m
1 350 m 1.2 m 2.4 m
10 1.1 km 3.8 m 7.6 m
100 3.5 km 12 m 24 m

The conducted RF test level is 3 V and the system has a compliance level of
0.01 V. For the system, this means that the imaging system is extremely sensitive
to RF interference in the transducer passband. For example, for a 5-MHz imaging
transducer, the frequency range of interference from a 3-V/m field may be from 2
to 10 MHz, and manifests as itself as described in Table 6-7.
The 0.01-V level is where the interference becomes acceptable to some clinical
specialists.
NOTE
Sensitivity to interference is dependent on operating mode and imaging control
settings. The system has been tested while set to its maximum gain setting, mak-
ing it very susceptible to interference. You might not use your system at this set-
ting, but it represents a worse-case condition.

The order of increasing sensitivity, using these settings, as a function of operating


mode is 2D mode, 3D/4D mode, M-mode, Color mode, PW Doppler mode, and
CW Doppler mode. The system is more sensitive to interference in the CW
Doppler or PW Doppler operating modes but the probability of interference is
lower than 2D mode or Color mode because the susceptible frequency range is
less. Therefore, you are more likely to see interference in 2D or Color modes.
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As an example, if a portable transmitter has maximum radiated power of 1 W and
an operating frequency of 156 MHz, it should only be operated at distances
greater than 1.2 m (3.9 ft) from the system. Likewise, a 0.01-W Bluetooth wire-
less LAN device operating at 2.4 GHz should be placed no closer than 0.24 m
(10 in) from any part of the system.

Avoiding Electromagnetic Interference


A medical device can either generate or receive electromagnetic interference.
The EMC standards describe tests for both emitted and received interference.
Emission tests deal with interference generated by the device being tested. Philips
ultrasound systems do not generate interference based on the tests described in
the referenced standards.
An ultrasound system is designed to receive signals at radio frequencies and is
therefore susceptible to interference generated by RF energy sources. Examples
of other sources of interference are medical devices, information technology
products, and radio and television transmission towers. Tracing the source of
radiated interference can be a difficult task. Customers should consider the fol-
lowing in an attempt to locate the source:
Is the interference intermittent or constant?
Does the interference show up only with one transducer or with several
transducers?
Do two different transducers operating at the same frequency have the same
problem?
Is the interference present if the system is moved to a different location in the
facility?
Can the EMC coupling path be attenuated? Moving the ECG leads too close to
the UP-D895MD printer could cause electromagnetic interference. For exam-
ple, placement of a transducer or printer close to an ECG cable can increase
electromagnetic interference. Moving the cable or other medical equipment
away from the location of the transducer or printer can result in reduced
electromagnetic interference.
The answers to these questions will help determine if the problem resides with
the system or the scanning environment. After you answer the questions, contact
your Philips service representative.
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Restrictions for Use


The physician needs to determine if an artifact caused by radiated interference
will have a negative impact on image quality and the subsequent diagnosis.

Immunity Level Test Results


The EMC standards state that manufacturers of patient-coupled equipment must
specify immunity levels for their systems. It is recognized that this type of device is
designed to receive and amplify low-level signals in the same bandwidth as the
interference.
Immunity is defined in the standard as the ability of a system to perform without
degradation in the presence of an electromagnetic disturbance. Degradation in
image quality is a qualitative assessment that can be subjective. The simplest way
to assess degradation is to note when the first sign of an artifact is seen in the
image. This method has two advantages. It removes the issue of subjective deci-
sion making and it provides the most stringent test results.
Be cautious when comparing immunity levels of different ultrasound systems. The
criteria used for degradation is not specified by the standard and may vary with
the manufacturer.
Testing has been performed on each class of Philips transducer for every operat-
ing mode over a wide range of frequencies.
Table 6-9 lists the results of immunity testing. Testing was performed on a typical
ultrasound system configuration.
NOTE
Electrostatic discharges (ESDs) may cause the ECG heart rate display to increase
by 10% to 15% for a few seconds after the discharge. However, the ECG heart
rate display will return to normal within 4 seconds.

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Table 6-9 Immunity Testing Results


Radiated Immunity EN 61000-4-3:1996 .08 to 3 V/m from 26 to 80 MHz
3 VRMS, amplitude modulated 80% at 2 Hz ECG, 1 kHz
others
Fast Transient Immunity IEC 801-4:1988 0.2-kV power line, 0.2-kV signal line
Surge Immunity EN 61000-4-5:1995 0.5-kV common mode, 1-kV
differential mode

Electrosurgical Units
Electrosurgical units (ESUs) and other devices intentionally introduce radio fre-
quency electromagnetic fields or currents into patients. Because imaging ultra-
sound frequencies are coincidentally in the radio frequency range, ultrasound
transducer circuits are susceptible to radio frequency interference. While an ESU
is in use, severe noise interferes with the black-and-white image and completely
obliterates the color image.

Input/Output Connections
This section describes the system input/output connections and the ECG/physio
input/output connections.

NOTES
Connect only to equipment approved according to IEC 60950.
When connecting other equipment to the ultrasound ports, you must ensure
that equipment connections comply with the requirements of the Medical
Electrical System Standard (IEC 60601-1-1).
Do not place equipment (or open access covers) in a way that enables the
patient to have access to any of the ultrasound ports. Do not touch port pins
and the patient simultaneously.

System Input/Output Connections


Figure 4-2 on page 95 shows the input and output connections on the systems
two I/O panels. The I/O panels are located on the back of the system.

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WARNINGS
Do not use the foot switch in the operating room.
Do not apply voltages of more than 15 V with respect to ground to external
panel input connectors.
The network interface connection connector is not intended for direct con-
nection to the telephone lines.
If you have a modem, make sure it is not connected to a telephone line while
you are performing an ultrasound exam on a patient.

Table 6-10 lists the signal descriptions and nominal voltages for connectors on the
I/O panel.
Table 6-10 I/O Panel Pinouts
Maximum
Input/ Output
Pin Signal Output Voltage
RS-232 Serial Data Export
1 DCD I --
2 RXD I --
3 TXD O 12 V
4 DTR O 12 V
5 Ground -- --
6 DSR I --
7 RTS O 12 V
8 CTS I --
9 RI I --
Foot Switch Input
1 Right I 6V
2 Middle I 6V
3 N/C -- --
4 Left I 6V

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Table 6-10 I/O Panel Pinouts (Continued)
Maximum
Input/ Output
Pin Signal Output Voltage
5 N/C -- --
6 N/C -- --
7 N/C -- --
8 N/C -- --
9 Ground -- --
S-Video Output
1 Ground -- --
2 Luma O 1V
3 Chroma O 1V
4 Ground -- --
Color Composite Video Output
1 Ground -- --
2 Composite O 2V
video
B & W Composite Video Output
1 Ground -- --
2 Composite O 2V
video
Print Trigger Output
1 Ground -- --
2 Trigger O 7V
Network Connection
1 TX+ O 5V
2 TX O 5V
3 RX+ I --

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Table 6-10 I/O Panel Pinouts (Continued)


Maximum
Input/ Output
Pin Signal Output Voltage
4 Ground -- --
5 Ground -- --
6 RX I --
7 Ground -- --
8 Ground -- --
USB Connection
1 +5 V O 6V
2 USB O 5V
3 USB+ I --
4 Ground -- --

ECG/Physio Input Connections


Figure 6-1 shows the ECG/physio input connections. The physio panel is located
on the front of the system, below the CD-ROM drive. For a description of each
symbol on the physio panel, see Symbols Used on the System on page 45.

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Figure 6-1 ECG and Physio Panel Connections

External physio input connector

ECG cable connector

NOTE
The minimum amplitude on the ECG input for proper ECG signal processing is
0.25 mV. Signals below this level may cause inaccurate results.

WARNINGS
Do not use ECG patient cables with detachable lead wires that have exposed
male pins. There is danger of electrocution if these pins are plugged into AC
power.
Do not apply voltages of more than 15 V with respect to ground to external
panel connectors.

Table 6-11 lists and describes the ECG and physio input parameters and values.

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Table 6-11 ECG/Physio Input Parameters and Values

Element Parameter Value

ECG input 3-dB bandwidth 1.0 Hz 0.5 Hz to 30 Hz


6 Hz

Minimum input signal to 0.25 mV


trigger R-wave detector

Common mode rejection > 90 dB at 60 Hz

Forward leakage to ground < 6.5 at 260 VRMS

Forward leakage to mains < 40 at 264 VRMS

Reverse leakage to ground < 6.5 at 240 VRMS

Reverse leakage to mains < 40 at 264 VRMS

Spark gap breakdown voltage 500 to 680 VRMS

Input for full scale at 100% 5.5 mV P-P


gain setting in Dual M-Mode

Aux ECG input Input for full scale at 100% 1.25 V P-P 0.25 V
gain setting

3-dB bandwidth DC to 100 Hz min

Maximum input signal 4V

Aux physio Input for full scale at 100% 3.0 V P-P


input gain setting in Dual MMode

3-dB bandwidth DC to 100 Hz min

Maximum input signal 4 V P-P

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7 Transducers
Before you use the transducers or the ultrasound system, read Safety on
page 23, System Overview on page 61, and Using the System on page 79. You
must be thoroughly familiar with the operation of the ultrasound system to oper-
ate the transducer described in this section. For information about system fea-
tures, modes, and controls, see the Help.

NOTES
This manual does not
Provide instruction in esophagogastroscopic, intraoperative, endocavity, or
biopsy techniques.
Present medical protocols for conducting a TEE, intraoperative, or endocavity
exam.
Discuss interpretation of transesophageal, intraoperative, or endocavity imag-
ing patterns.

This section provides information about the transducers that can be used with
the ultrasound system, and how to connect and activate them.
For information and instructions on maintaining transducers, see Transducer
Care and Maintenance on page 155.
For procedures on using transducer covers, refer to the instructions provided
with the covers.
For information on specific types of transducers, see the following:
Endocavity Transducers on page 193
TEE Transducers on page 203
Biopsy-Capable Transducers on page 241
Intraoperative Transducers on page 245

Supported Transducers
Table 7-1 lists and describes the transducers that are supported by the system.
The transducers are grouped by type.

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Table 7-1 HD11 XE System Transducers by Type

Biopsy Connector
Name Model Applications Capable Style

Curved Array Transducers

C5-2 21426A Abdominal, OB/GYN Yes Cartridge

C6-3 989605359591 Abdominal, OB/GYN Yes Explora

C8-4v 21437A Endovaginal, OB/GYN Yes Cartridge

C8-5 8500-1664-01 Neonatal head, Yes Explora


abdominal, OB/GYN,
pediatric

C9-4 8500-1658-01 Abdominal, OB/GYN, Yes Explora


pediatric

C9-5ec 8500-1655-01 Endocavity Yes Explora

Sector Array Transducers

PA4-2 21422Aa Cardiac, TCD, Yes Cartridge


abdominal, OB/GYN

S3-1 21711A Cardiac, TCD, No Explora


abdominal

S4-2 989605344981 Cardiac, TCD, Yes Cartridge


abdominal, OB/GYN

S8-3 21750A Cardiac, neonatal No Explora


head, OB/GYN,
pediatric abdominal

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Table 7-1 HD11 XE System Transducers by Type (Continued)

Biopsy Connector
Name Model Applications Capable Style

S12-4 21780A Pediatric cardiac, No Explora


pediatric abdominal,
intraoperative,
neonatal head

TEE Transducers

S7-2omni 21778A Transesophageal No Explora


(adult and pediatric
cardiac)

T6H 21378Aa, b Transesophageal No Standard


(adult and pediatric
cardiac)

S7-3t 21781A Transesophageal No Explora


(adult and pediatric
cardiac)

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Table 7-1 HD11 XE System Transducers by Type (Continued)

Biopsy Connector
Name Model Applications Capable Style

Linear Array Transducers

L8-4 8500-1659-01 Vascular, small parts, Yes Explora


abdominal, pediatric
hips, musculoskeletal

L9-3 989605353301 Vascular, small parts, Yes Explora


abdominal, pediatric
hips, musculoskeletal

L12-3 21475A Vascular, small parts, Yes Cartridge


pediatric hips,
abdominal,
musculoskeletal

L12-5 8500-1660-01 Vascular, small parts, Yes Explora


pediatric hips,
abdominal

L15-7io 989605341571 Cardiac, No Explora


intraoperative,
vascular,
musculoskeletal

Doppler Pencil Transducers

D2cwc 4000-0947-01 Cardiac No Pencil

D2tcd 8500-1860-01 Transcranial Doppler No Pencil

D5cwc 4000-0950-01 Cardiac, vascular No Pencil

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Table 7-1 HD11 XE System Transducers by Type (Continued)

Biopsy Connector
Name Model Applications Capable Style

3D/4D Transducers

3D6-2 8500-2032-01 Abdominal, OB/GYN, Yes Explora


pediatric

3D8-4 989605345331 Abdominal, OB/GYN, Yes Explora


pediatric

3D9-3v 8500-1715-01 Endovaginal, OB/GYN Yes Explora

V6-2 989605357561 Abdominal, OB/GYN, Yes Explora


pediatric

V8-4 989605360971 Abdominal, OB/GYN, Yes Explora


pediatric
a. Indicates that this transducer is not sold with the system, but is supported.
b. Requires an adapter for use on the system.

Specialty Transducers
Table 7-2 lists the specialty transducers. For more information about each trans-
ducer, see the associated section.

Table 7-2 Specialty Transducers


Specialty Name See
Endocavity C8-4v Endocavity Transducers on page 193
3D9-3v
Transesophageal T6H TEE Transducers on page 203
S7-2omni
S7-3t
Intraoperative L15-7io Intraoperative Transducers on page 245
S12-4

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Connecting Transducers
Your system can be configured so that you can connect up to five transducers to
it at one time. For details about configuring your system, see your Philips repre-
sentative. Your system may include slots, as shown in Figure 7-1, for connecting
the various types of transducer connectors.
CAUTION

The ESD (electrostatic discharge) symbol appears next to the transducer


connectors to warn you not to touch exposed pins. Touching exposed pins can
cause electrostatic discharge, which can damage the product.

Follow these guidelines when connecting transducers:


Never force a transducer into place. If you feel any resistance, reposition the
transducer connector and try again.
If No Probe is displayed, either the system is running an identification check
or the transducer is not properly connected. Reposition the transducer con-
nector and try again.
If Probe is displayed, the transducer is not latched into position. This message
could indicate that the transducer connector is not locked into place. Check
the connection.
Before disconnecting a transducer with an Explora-style connector, be sure to
unlock the connector by turning the latch to the unlocked position.
When using an OmniPlane III TEE transducer, always make sure the TEE tip
and shaft are straight before connecting the transducer.

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Figure 7-1 Transducer Connectors

Cartridge-style

Explora-style

Nonimaging-style

Connecting Transducers with Cartridge-Style Connectors


To connect a transducer with a cartridge-style connector
Align the connector as shown in Figure 7-3 and plug it in.

To remove a cartridge-style transducer


Press the Release button on the connector and pull the connector toward you.

Connecting Nonimaging Transducers


To connect a nonimaging transducer
Align the connector, and gently plug it in.

To remove a nonimaging transducer


Grasp the transducer and pull it toward you. Do not pull the connector by the
cable or the strain relief connector.

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Connecting Transducers with Explora-Style Connectors


To connect a transducer with an Explora-style connector
Turn the latch to the unlocked position and plug the transducer into the slot. To
lock, turn the transducer latch to the locked position, as shown in Figure 7-3.

To remove a transducer with an Explora-style connector


Turn the latch to the unlocked position and pull the connector toward you.

Connecting OmniPlane III Transducers


Before you connect the OmniPlane III TEE transducer, be sure the tip and shaft
are straight. When you connect the transducer, it automatically recalibrates itself
to the 0-degree (horizontal plane) position. As with any array movement, the
motor makes a humming sound while recalibrating.
With TEE transducers, if the Calibration failed message appears, try unlocking
the transducer connector, straightening the tip and shaft, and then locking the
connector.
For more information on calibration, see Calibration on page 217.
NOTE
The T6H OmniPlane III transducer requires an adapter for use with the system.
Figure 7-2 shows the back and front of the OmniPlane Adapter.

To connect the T6H transducer to the OmniPlane Adapter and to the


system
1. Plug the adapter into the system transducer connector with the latch side fac-
ing out.
2. Turn the latch on the adapter to lock the adapter to the system.
3. Plug the T6H transducer into the adapter.
4. Turn the latch 90 degrees clockwise to lock the transducer into the adapter.

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To remove the T6H transducer from the OmniPlane Adapter
Turn the latch to the unlocked position (90 degrees counterclockwise) and pull
the connector toward you.

To remove the adapter from the system


Turn the adapter latch to its unlocked position and pull it toward you.
Figure 7-2 OmniPlane Adapter

Back of adapter
Front of adapter (system connection)
(transducer connection)

Figure 7-3 shows how each of the transducer connector types connect to the sys-
tem.

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Figure 7-3 Inserted Transducer Connectors

Cartridge-style

Explora-style

Activating Transducers
If more than one transducer is connected to your system, press Probe to choose
which transducer is active. Each time you press Probe, a different transducer
becomes active. The label for the active transducer is displayed on the screen.
When you turn on your system, the last transducer you used is active if it is still
connected. Otherwise, the transducer in the top connector is active.

Transducer Supplies and Accessories


To order biopsy kits, transducer covers, supplies, and accessories, see Trans-
ducer Supplies on page 263.

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8 Transducer Care and Maintenance
This section contains information on the general care, handling, cleaning, and
storing of Philips transducers for the ultrasound system.
This section contains the latest cleaning and disinfection information for all sup-
ported transducers as of the date of this publication. It is important, however, that
you periodically check the following Philips Web site for the very latest cleaning
and disinfection guidelines for all supported transducers:
www.medical.philips.com/transducercare

Handling Transducers
Although a transducer is designed for durability, use care when handling it. Drop-
ping or banging the transducer can damage the acoustic lens and piezoelectric
crystals. Cuts in the transducer cable or cracks in the housing can destroy the
electrical safety features of the transducers. This damage is not covered by the
warranty or your service contract.
When you are not using the transducer, place it in the transducer holder located
on the side of your system to assure safe, convenient storage. For more informa-
tion on storing transducers, see Storing Transducers on page 157.
CAUTION
When you are shaking an ultrasound gel bottle, be careful not to hit the trans-
ducer face with the tip of the bottle. Striking the transducer face with a hard
object can damage the transducer. This damage is not covered by the warranty or
your service contract.

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Inspecting Transducers for Damage


All transducers are exposed to potentially damaging situations during use and
cleaning. Before use, check each transducer for the following signs of damage:
Cracks on the handle
Cracks on the nose piece
Cuts or gouges on the lens material
Swelling of the lens material
Cracks or other signs of damage to the connector
Bent or damaged pins on the connector
Signs of damage to the cable or inflexibility of the cable
WARNING
Although no lethal voltages are present during normal use, if there is a crack in
the transducer, it is possible for the operator to feel a tingle that could result in a
nervous reaction and potential injury. Cracks also interfere with standard cleaning
procedures.

CAUTION
If you see any sign of damage to the transducer, immediately discontinue use of
the transducer.

Installing and Cleaning the Ergonomic Grip


Repetitive ultrasound scanning has been associated with carpal tunnel syndrome
(CTS) and repetitive strain injury. For more information, see Repetitive Strain
Injury on page 56.
Philips offers a slip-on reusable grip to provide alternative grip options for the fol-
lowing transducers: S3-1, S4-2, S8-3, and PA4-2.

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To install the ergonomic grip
1. Insert the cable through the slot in the grip.
2. Align the slot with the orientation indicator.
3. Slip the transducer head into the grip.
CAUTION
During installation, avoid transducer lens damage from fingertips and nails by
pressing the transducer into the grip with the palm of your hand.

To clean the ergonomic grip


1. Remove the grip and wipe off excess gel.
2. Wash with soap and running water, rinse thoroughly, and air dry.
3. Alternatively, it can be low level disinfected by wiping or spraying the grip with
a bleach (10%), a quaternary ammonium, or a 70% isopropyl alcohol (rubbing
alcohol) product for the recommended contact time. Do not allow the disinfec-
tant to dry on the grip. Rinse and air dry.

Storing Transducers
This section provides information on storing transducers for transport, and daily
and long-term storage.

Storage for Transport


If a carrying case is provided with your transducer, always use the carrying case to
transport the transducer from one site to another.
Follow these guidelines to properly store transducers for transport:
Make sure that the transducer is clean and disinfected before placing it in the
case to avoid contaminating the foam that lines the carrying case.
Place the transducer in the case carefully to prevent kinking of the cable.
Before closing the lid, make sure no part of the transducer is protruding from
the case.

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Wrap the case in plastic material containing air pockets (bubble wrap), and
pack the wrapped case in a cardboard carton.
To avoid damaging the shaft or steering mechanism of TEE transducers, do not
bend or coil the flexible shaft of the transducer in less than a 0.30-m (1-ft)
diameter circle.

Daily and Long-Term Storage


Follow these guidelines to protect your transducer:
Always store transducers in the transducer holders on the side of your sys-
tem or on a securely mounted wall rack when you are not using them.
Make sure the transducer holders are clean before storing transducers. For
details on cleaning the system, see Cleaning, Disinfecting, and Sterilizing
Transducers on page 161.
Avoid storing transducers in areas of temperature extremes or in direct sun-
light.
Store transducers separately from other instruments to avoid inadvertent
transducer damage.
When storing transducers, use the cable-management clips to secure the
transducer cable.
Before storing transducers, make sure they are thoroughly dry.
For TEE transducers, be sure the distal tip is straight and protected before
storing the transducer.
Never store a TEE transducer in the carrying case, except to transport it.

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Safety Considerations When Using Disinfectants and Gels


Observe the following warnings and cautions when using disinfectants and gels.
More specific warnings and cautions are included within the various procedures in
this section and on the labels of the cleaning or disinfection solutions.

WARNINGS
Disinfectants listed in Disinfectants Compatibility Table on page 178 are rec-
ommended because of their chemical compatibility with product materials, not
their biological effectiveness. For the biological effectiveness of a disinfectant, see
the guidelines and recommendations of the disinfectant manufacturer, the U.S.
Food and Drug Administration, and the U.S. Centers for Disease Control.
The level of disinfection required for a device is dictated by the type of tissue
it will contact during use. Ensure the disinfectant type is appropriate for the
type of transducer and the transducer application. For information on the lev-
els of disinfection requirements, see Table 8-1. Also, see the disinfectant label
instructions and the recommendations of the Association for Professionals in
Infection Control, the U.S. Food and Drug Administration, and the U.S. Cen-
ters for Disease Control.
Some transducers cannot be sterilized. For intraoperative procedures,
high-level disinfections and the use of a sterile transducer cover and gel (as
described in the instructions provided with the transducer cover) is an
accepted method of infection control. See the FDA Guidance document
Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers, September 30, 1997. The guidance
document is located on the following Web site:
www.fda.gov/cdrh/ode/ulstran.pdf
For information on ordering transducer covers, contact CIVCO (see HD11
XE System Supplies, Peripherals, and Accessories on page 259).
The use of protective transducer covers and coupling gel is recommended for
clinical applications of all intracavity transducers (including transesophageal).
Use a sterile protective transducer cover with sterile ultrasound transmission
gel during intraoperative and biopsy examinations.

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WARNINGS
Do not apply the transducer cover and gel until you are ready to perform the
procedure. Transducers should not be left soaking in gel.
In neurosurgical applications, sterilized transducers should be used with ster-
ile gel and a sterile pyrogen-free transducer cover.
Transducer covers can contain natural rubber latex, which may cause allergic
reactions in some individuals. See Latex Product Alert on page 160.

Latex Product Alert


The Philips ultrasound system and transducers do not contain natural rubber
latex that contacts humans. Natural rubber latex is not used on any ultrasound
transducer, including transthoracic, intraoperative, and transesophageal echocar-
diography (TEE) transducers. It also is not used on Philips ECG cables for the
products in this manual.
For information from the FDA regarding allergic reactions to latex-containing
medical devices, see FDA Medical Alert on page 52.

Transmissible Spongiform Encephalopathy


WARNING
If a sterile transducer cover becomes compromised during an intraoperative
application involving a patient with transmissible spongiform encephalopathy, such
as Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Center for Disease
Control and this document from the World Heath Organization: WHO/CDS/
CSR/APH/2000/3, WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies. The transducers for your system cannot be decontaminated
using a heat process.

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Acoustic Coupling Medium


For proper transmission of the acoustic beam, use the ultrasound transmission
gel supplied by or recommended by Philips, or another glycol, glycerol, or
water-based acoustic coupling medium.
CAUTION
Do not use mineral oil, oil-based couplants, gels with lotions or emollients of any
kind, or other unapproved materials because they might damage the transducer.

Cleaning, Disinfecting, and Sterilizing Transducers


This section provides information and instructions for cleaning, disinfecting, and
sterilizing transducers, cables, and connectors.

Choosing a Disinfectant
To choose an appropriate disinfectant, you first must determine the required level
of disinfection, based on the device classification (Table 8-1).
Table 8-1 Levels of Disinfection Requirements
Classification Definition Level of Disinfection
Critical Device enters otherwise sterile Sterilizationa
tissue (for example, intraoperative
applications)
Semi-critical Device contacts mucous High
membranes (for example,
intracavity applications)
Noncritical Device contacts intact skin Intermediate or low
a. High-level disinfection and the use of a sterile gel and a sterile transducer cover, as
described in the instructions provided with the transducer cover, is an accepted
method of infection control for ultrasound transducers. See the FDA Guidance
document Information for Manufacturers Seeking Marketing Clearance of Diag-
nostic Ultrasound Systems and Transducers, September 30, 1997. For more
information, see the following Web site: www.fda.gov/cdrh/ode/ulstran.pdf

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General Cleaning Procedures for All Transducers


These general cleaning instructions are indicated for all transducers. It is impor-
tant that you clean the transducer and cable according to the following proce-
dures.
CAUTIONS
Transducers must be cleaned after each use. Cleaning the transducer is an
essential step before effective disinfection or sterilization. Be sure to follow
the manufacturers instructions when using disinfectants.
Do not allow sharp objects, such as scalpels or cauterizing knives, to touch
transducers or cables.
When handling a transducer, do not bump the transducer on hard surfaces.
Do not use a surgeons brush when cleaning transducers. The use of even soft
brushes can damage transducers.
During cleaning, disinfection, and sterilization, orient the parts of the trans-
ducer that must remain dry higher than the wet parts until all parts are dry.
This will help keep liquid from entering permeable areas of the transducer.

To clean a transducer
1. After every patient exam, wipe the ultrasound transmission gel off of the
transducer.
2. Disconnect the transducer from the system and remove any transducer cov-
ers, biopsy guides, or tip guards.
3. Use a soft cloth lightly dampened in a mild soap or an enzymatic cleaner (in
accordance with the manufacturers instructions) to remove any particulate
matter or body fluids that remain on the transducer or cable. Enzymatic
cleaners should have a pH of 6.0 to 8.0. These cleaners are further diluted
during use. For a list of approved enzymatic cleaners, see Table 8-2.
4. To remove remaining particulate and cleaning residue, rinse thoroughly with
water up to the immersion point shown in Figure 8-3.
5. Wipe with a dry cloth.

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Disinfecting Transducers with Wipes and Sprays (Low to


Intermediate-Level Disinfection)
To disinfect transducers, you can use either an immersion method or a wipe
method with a disinfectant recommended by Philips Ultrasound. Use the method
that is biologically appropriate, as described in Table 8-1.
This section provides instructions on using the wipe or spray method. For infor-
mation on the immersion method, see Disinfecting Transducers by Immersion
(High-Level Disinfection) on page 167.

To use the wipe or spray method to disinfect transducers


NOTE
Transducers can be disinfected using the wipe method only if the product labeling
of the compatible disinfectant you are using indicates it can be used with a wipe
method.

WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any
equipment.

1. After cleaning the transducer and cable, wipe or spray the transducer and
cable with a low-level disinfectant. Allow for the manufacturers recom-
mended contact time. For a list of compatible disinfectants, see Table 8-2.
2. Remove any residue with a water-moistened soft cloth. Do not allow any
solutions to air dry on the transducer.
CAUTION
The use of 70% isopropyl alcohol (rubbing alcohol) on transducers is restricted.
Wipe only the distal tip of the transducer up to 2.5 cm (1 in) from the strain
relief/housing joint with an isopropyl alcohol solution. Do not wipe the strain
relief/housing joint, the strain relief, or the cable with isopropyl alcohol. Isopropyl
alcohol can cause damage to these parts of the transducer. This damage is not
covered by the warranty or your service contract. See Figure 8-1.

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Figure 8-1 Restricted Use of Isopropyl Alcohol to Clean Transducers

Strain relief Strain relief/housing joint

Cable

2.5 cm Housing
(1 inch)

You can use


alcohol in
Do not use alcohol in this area this area

3. Examine the device and cable for damage such as cracks, splitting, sharp edges,
or projections. If damage is evident, discontinue use of the device and contact
your Philips Ultrasound representative.

Cleaning and Disinfecting Cables and Connectors with Wipes


and Sprays
Use the following procedure to disinfect the cables and connectors for all trans-
ducers that can be disinfected using a recommended wipe or spray disinfectant.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any
equipment.

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CAUTION
Attempting to disinfect a cable or connector by using a method other than the
one included here can damage the device and will void the warranty. Orient the
parts that must remain dry higher than the wet parts until all parts are dry.

To clean and disinfect cables and connectors


1. Disconnect the device from the system.
2. Orient the device and the connector so they are both facing up (Figure 8-2).
CAUTIONS
Do not allow any type of fluid to enter the connector. Fluid in the connector
may void the transducer or device warranty.
Do not use a brush on the connector label.

3. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean
the cable and the connector. A soft-bristled brush can be used to clean only
the metal surfaces of the connector. Do not allow any type of fluid to enter
the device. Be careful that fluid does not enter through the strain relief,
through the connector, through the electrical contacts, or through the areas
surrounding the locking lever shaft and the strain relief. (Figure 8-2).
WARNING
If a premixed solution is used, be sure to observe the solution expiration date.

CAUTIONS
You can use an alcohol solution for disinfection on the connector only. Ensure
the solution is only 70% isopropyl alcohol or less. Solutions of more than 70%
alcohol can cause product damage (see Figure 8-1).
Do not use any alcohol or alcohol-based products on the cable.
Avoid disinfectant contact with the connector label.

4. Mix the disinfection solution compatible with your cable (see Table 8-2)
according to label instructions for solution strength.
5. Wipe or spray the cable and connector with the disinfectant, following disin-
fectant label instructions for wipe durations, solution strengths, and duration
of disinfectant contact with the cable. Ensure that the solution strength and

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duration of contact are appropriate for the intended clinical use of the device.
Ensure that the disinfectant solution does not enter the device or the connec-
tor or come into contact with the connector label.
6. Air dry or towel dry with a sterile cloth according to the instructions on the
disinfectant label.
7. Examine the device and cable for damage such as cracks, splitting, sharp edges,
or projections. If damage is evident, discontinue use of the device and contact
your Philips Ultrasound representative.
Figure 8-2 Disinfecting Cables and Connectors

For cable disinfection, orient the device and the


connector facing up (strain reliefs on the bottom) Electrical contacts

Connector
strain relief

Locking lever shaft


Strain relief

Wipe strain reliefs, cable, and


connector with a compatible
disinfectant

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Disinfecting Transducers by Immersion (High-Level


Disinfection)
This section provides information about using the immersion method to disinfect
transducers. TEE transducers require unique methods for disinfection by immer-
sion. For details, see Disinfecting TEE Transducers by Immersion on page 169.

WARNINGS
If a premixed disinfectant is used, be sure to observe the expiration date.
If you use Cidex OPA Solution (Cidex OPA), residual solution may remain on
your transducers if you do not carefully follow the manufacturers instructions.
Residual Cidex OPA on TEE transducers may cause the following:
Temporary staining of the mouth and lip area
Irritation or chemical burns of the mouth, throat, esophagus, and stomach
To minimize the effects from residual Cidex OPA, or any other disinfectant, Phil-
ips recommends that you
Follow the disinfectant manufacturers instructions very carefully. For exam-
ple, the manufacturer of Cidex OPA recommends soaking transducers three
times in fresh water.
Use a protective transducer cover during endocavity and TEE examinations.
Use a sterile protective transducer cover with sterile ultrasound transmission
gel during intraoperative and biopsy examinations.
Limit the time that transducers are soaked in the disinfectant solution to the
minimum time recommended by the disinfectant manufacturer (for example,
the manufacturer of Cidex OPA recommends a minimum of 12 minutes).
Check for the required level of disinfection. The level of disinfection required
for a device is dictated by the type of tissue it will contact during use. Ensure
the solution strength and duration of contact are appropriate for the intended
clinical use of the transducer. For information on the levels of disinfection
requirements, see Table 8-1. Also see the disinfectant label instructions and
the recommendations of the Association for Professionals in Infection Con-
trol, the U.S. Food and Drug Administration, and the U.S. Centers for Disease
Control.

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CAUTIONS
Using non-recommended disinfectants, incorrect solution strengths, or
immersing a transducer deeper or for a longer contact time can damage or
discolor the transducer and will void the transducer warranty.
Do not immerse transducers longer than the minimum time needed for your
level of disinfection. For information on the levels of disinfection require-
ments, see Table 8-1.

To disinfect transducers by using the immersion method


1. Clean the transducer according to the General Cleaning Procedures for All
Transducers on page 162.
2. Mix the disinfection solution compatible with your transducer (see Table 8-2)
according to label instructions for solution strength. A disinfectant listed in
Table 8-2 with the footnote FDA 510(k) cleared is recommended in the
U.S.1
3. Immerse the transducer into the appropriate disinfectant for your transducer
as shown in Figure 8-3.
Follow the instructions on the disinfectant label for the duration of transducer
immersion. Do not immerse transducers longer than the minimum time
needed for your level of disinfection.
4. Using the instructions on the disinfectant label, rinse the transducer up to the
point of immersion, then air dry or towel dry with a sterile cloth.
5. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or
sharp edges or projections. If damage is evident, discontinue use of the trans-
ducer and contact your Philips Ultrasound representative.

1. See the list of FDA-cleared sterilants and high-level disinfectants with general claims for pro-
cessing reusable medical and dental devices. For more information, see www.fda.gov/cdrh/
ode/germlab.html

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Figure 8-3 Immersing Transducers

Immerse this section only, up to


5.08 cm (2 in) from strain relief
on connector.

Disinfecting TEE Transducers by Immersion


Disinfection by immersion is the accepted method of infection control for TEE
transducers. Philips recommends that a protective transducer cover be used dur-
ing examinations.
Upon receiving your new transducer, disinfect it before performing the first exam.
Clean and disinfect the transducer immediately after each use to protect patients
and personnel from a variety of pathogens. Establish and clearly post a cleaning
procedure that includes the following steps.

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WARNINGS
If you use Cidex OPA Solution (Cidex OPA), residual solution may remain on
your transducers if you do not carefully follow the manufacturers instructions.
Residual Cidex OPA on TEE transducers may cause the following:
Temporary staining of the mouth and lip area
Irritation or chemical burns of the mouth, throat, esophagus, and stomach
To minimize the effects from residual Cidex OPA, or any other disinfectant,
Philips recommends that you
Follow the disinfectant manufacturers instructions very carefully. For exam-
ple, the manufacturer of Cidex OPA recommends soaking transducers three
times in fresh water.
Use a protective transducer cover during endocavity and TEE examinations.
Use a sterile protective transducer cover with sterile ultrasound transmission
gel during intraoperative and biopsy examinations.
Limit the time that transducers are soaked in the disinfectant solution to the
minimum time recommended by the disinfectant manufacturer (for example,
the manufacturer of Cidex OPA recommends a minimum of 12 minutes).

To disinfect a TEE transducer by immersion


1. Disconnect the transducer from the system.
2. Use the following procedure to remove all organic matter and other residue:
a. Soak gauze pads in mild, soapy water. Do not use iodine-based soaps.
b. Do either of the following:
Wipe the distal tip and flexible shaft up to the control housing (steer-
ing mechanism) with the gauze pads.
Use an enzymatic cleaner to assist in removing protein residuals. Enzy-
matic cleaners should have a pH of 6.0 to 8.0. These cleaners are fur-
ther diluted during use. Follow the manufacturers instructions for
dilution.

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3. Use water to rinse the distal tip and flexible shaft thoroughly.
CAUTION
Do not rinse or immerse the control housing, cable, or connector.

4. Disinfect the distal tip and flexible shaft by placing them in the appropriate dis-
infectant, as listed in Table 8-2.
Do not bend the shaft into a circle with a diameter of less than
0.30 m (1 ft).
Do not use bleach on any TEE transducer.
Do not use strong solvents such as isopropyl alcohol, acetone, freon, and
other industrial cleaners on transducers.
Do not soak the transducer for extended periods of time. Limit the time
that transducers are soaked in disinfectant solution to the minimum time
recommended by the disinfectant manufacturer.
Do not rinse or immerse the connector or the portion of the cable near
the connector.
Do not immerse or rinse the steering mechanism.
NOTE
Follow the recommendations of the disinfectant manufacturer.

5. Remove the tip and shaft from the disinfectant and thoroughly rinse with
water according to the instructions for use from the disinfectant manufac-
turer.
6. Check the transducer for any residual organic material. If any is present,
remove it and disinfect the transducer again.
7. Dry the distal tip and flexible shaft with a sterile cloth or pad, or allow it to air
dry.
8. Lightly wipe the steering mechanism of the handle only, with a pad moistened
with rubbing alcohol (70% isopropyl alcohol).

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9. Hang the transducer on a wall-mounted rack and let it air dry.


CAUTION
The transducer steering mechanism is not sealed. If disinfectant or other fluid
enters the steering mechanism, it will corrode the gears and electrical connec-
tions. Avoidable transducer damage is not covered by the warranty or service
contract.

CAUTION
Never sterilize the transducer with autoclave, ultraviolet, gamma radiation, gas,
steam, or heat sterilization techniques. Severe damage will result. Avoidable trans-
ducer damage is not covered by the warranty or service contract.

Disinfecting Intraoperative Transducers by Immersion


For transducers used in intraoperative procedures, high-level disinfection by
immersion and the use of a sterile transducer cover and sterile ultrasound trans-
mission gel is an accepted method of infection control.
Use the disinfection method described in this section for the L15-7io transducer.
WARNING
Intraoperative transducers used in animal studies should not be used on humans.
Transducer disinfection procedures for cross-usage between animals and humans
have not been validated.

To disinfect intraoperative transducers by immersion


1. Clean the transducer according to the General Cleaning Procedures for All
Transducers on page 162.
2. Mix the disinfection solution compatible with your transducer (see Table 8-2)
according to label instructions for solution strength. A disinfectant listed in
Table 8-2 with the footnote FDA 510(k) cleared is recommended in the U.S.
3. Immerse the transducer into the appropriate disinfectant for your transducer
as shown in Figure 8-3. Follow the instructions on the disinfectant label for
the duration of transducer immersion. Do not immerse transducers longer
than the minimum time needed for your level of disinfection. For information
on the levels of disinfection requirements, see Table 8-1.

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4. Using the instructions on the disinfectant label, rinse the transducer up to the
point of immersion, and then air dry or towel dry with a sterile cloth.
5. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or
sharp edges or projections. If damage is evident, discontinue use of the trans-
ducer and contact your Philips Ultrasound representative.

Sterilizing Transducers
Sterilization is required if the device is classified as a critical device, and is used
without a sterile cover or if the sterile cover is breached.

WARNINGS
Always use protective eyewear and gloves when cleaning, disinfecting, or ster-
ilizing any equipment.
In neurosurgical applications, sterilized transducers should be used with a
pyrogen-free transducer cover.
If a premixed solution is used, be sure to observe the solution expiration date.
CAUTIONS
Transducers must be cleaned after each use. Cleaning the transducer is an
essential step before effective disinfection or sterilization. Be sure to follow
the manufacturers instructions when using disinfectants.
Sterilize transducers by using only liquid solutions. Using autoclave, gas (EtO),
or other methods not approved by Philips Ultrasound will damage your trans-
ducer and will void your warranty.
Do not allow sharp objects, such as scalpels and cauterizing knives, to touch
transducers or cables.
When handling a transducer, do not bump the transducer on hard surfaces.
Ensure the solution strength and duration of contact are appropriate for ster-
ilization. Be sure to follow the manufacturers instructions.

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To sterilize a transducer
1. Clean the transducer according to the General Cleaning Procedures for All
Transducers on page 162.
2. Mix the sterilization solution compatible with your transducer (see Table 8-2)
according to label instructions for solution strength. A disinfectant listed in
Table 8-2 with the footnote FDA 510(k) cleared is recommended in the U.S.
3. Immerse the transducer in the sterilization solution as shown in Figure 8-4.
4. Follow the instructions on the sterilization label for the duration of trans-
ducer immersion required for sterilization.
5. Remove the transducer from the sterilization solution after the recommended
sterilization time has elapsed.
6. Using the instructions on the sterilization label, rinse the transducer in sterile
water up to the point of immersion, and then air dry or towel dry with a ster-
ile cloth.
7. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or
sharp edges or projections. If damage is evident, discontinue use of the trans-
ducer, and contact your Philips Ultrasound representative.

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Figure 8-4 Immersing Sterilizable Transducers

Immerse this section only, up to


5.08 cm (2 in) from strain relief
on connector.

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Disinfectants Compatibility
Read this information before performing disinfection and sterilization procedures.
It discusses recommended disinfectants and choosing an appropriate disinfectant
for the required level of disinfection. It also includes a table (Table 8-2) listing the
chemical compatibility of various disinfectants and cleaners with specific transduc-
ers and related devices. In addition, the table lists if a device can be sprayed or
wiped only, or if it can be soaked.

WARNINGS
Not all disinfectants are effective against all types of contamination. Ensure the
disinfectant type is appropriate for the type of transducer and that the solu-
tion strength and time of contact are appropriate for the intended clinical use.
Disinfectants listed in this section are recommended because of their chemical
compatibility with product materials, not their biological effectiveness. For the
biological effectiveness of a disinfectant, see the guidelines and recommenda-
tions of the disinfectant manufacturer, the FDA, the Association for Profes-
sionals in Infection Control, the U.S. Food and Drug Administration, and the
U.S. Centers for Disease Control.
If a premixed solution is used, be sure to observe the solution expiration date.
Always use protective eyewear and gloves when cleaning and disinfecting any
equipment.

CAUTION
Using a non-recommended disinfection solution, using an incorrect solution
strength, or immersing a transducer deeper or longer than recommended can
damage the device and will void the warranty.

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Disinfectant Types
WARNING
The level of disinfection required for a device is dictated by the type of tissue it
will contact during use. Ensure the disinfectant type is appropriate for the type of
transducer and the transducer application. For information on the levels of disin-
fection requirements, see Table 8-1. For more information, see the disinfectant
label instructions and the recommendations of the Association for Professionals
in Infection Control, the U.S. Food and Drug Administration, and the U.S. Centers
for Disease Control.

CAUTION
If you use an alcohol solution for disinfection, ensure the solution is only 70% iso-
propyl alcohol or less. Solutions of more than 70% isopropyl alcohol can cause
product damage. Do not use isopropyl alcohol on the transducers strain relief or
cable, or on TEE transducers (except the handle).

See page 161 through page 176 for standard industry recommendations on disin-
fection, for information that can help you choose an appropriate disinfectant for
the required level of disinfection, and for transducer-specific instructions.

Factors Affecting Disinfectant Efficiency


The following factors will affect the efficiency of a disinfectant solution:
Duration of exposure
Age of the solution
Concentration and potency of the disinfectant
Quantity and location of the contamination
Resistance of the contaminate
Organic matter on the item to be disinfected

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Disinfectants Compatibility Table


Table 8-2 lists the disinfectants compatible with the transducer available for your
system.
For all non-critical transducers, low-level and intermediate-level disinfectants
marked for use on medical instruments and based on quaternary ammonium
compounds (QUATS) or sodium hypochlorite (NaOCl), equal to or less than
0.6%, are approved for use. In addition, 70% isopropyl alcohol (IPA) and house-
hold bleach at a concentration of 10% or less are also acceptable for use for all
non-critical transducers. All products must be used with a spray or wipe method.
Do not use these products on TEE transducers except as specified in Table 8-2.
If you require more information:
In North America, call Philips Ultrasound Customer Service at 800-722-9377.
Outside North America, contact your local Philips Ultrasound representative.
NOTE
Disinfectants that are not approved for use on a specific transducer appear in
Table 8-2 as shaded entries so that you can easily determine when a disinfectant
should not be used on a transducer.

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Table 8-2 Disinfectants Compatibility

C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
70% Isopropyl All Spray/ Alcohol T T T T T T T H H
Alcohol Wipe
abcoCIDE USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
abcoCIDE 28 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Aidal AUS Soak 1 Glutaraldehyde T,C T,C N T,C T T,C T,C T T

Transducer Care and Maintenance


Aidal Plus AUS Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
HD11 XE Getting Started

Alkaspray F Spray/ Alcohol, T T T T T T T N N


Wipe Alkylamine
4535 612 62651

C = Approved for use on the cable 1 FDA 510(k) cleared F = France


N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
179

8
Table 8-2 Disinfectants Compatibility (Continued)
180

8
C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec
4535 612 62651
HD11 XE Getting Started

Transducer Care and Maintenance


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Ampholysine F Spray/ Biguanide/Quat. T,C T,C T,C T,C N T,C T,C C C
Basique Wipe Ammonia
Banicide USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Bleach 5.25% USA Spray/ Sodium T,C T,C T,C T,C T,C T,C T,C C C
Wipe Hypochlorite
(10% Solution)
CIDEX 1 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T

CIDEX 7 1 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T

CIDEX OPA 1 USA Soak 2 Ortho-phthalald T,C T,C N T,C T,C T,C T,C T T
ehyde
C = Approved for use on the cable 1 FDA 510(k) cleared F = France
N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
Table 8-2 Disinfectants Compatibility (Continued)

C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Cidex PAE 14J F Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,CL T T

CIDEX Plus 1 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Desconton D Soak 2 Gluteraldehyde T,C T,C N T,C T,C T,C T,C T T
Extra
Dispatch USA Spray/ Sodium T,C T,C T,C T,C T,C T,C T,C C C

Transducer Care and Maintenance


Wipe Hypochlorite
Endo FC F Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
HD11 XE Getting Started

Endosporine F Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T


4535 612 62651

C = Approved for use on the cable 1 FDA 510(k) cleared F = France


N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
181

8
Table 8-2 Disinfectants Compatibility (Continued)
182

8
C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec
4535 612 62651
HD11 XE Getting Started

Transducer Care and Maintenance


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Enzol USA Pre-clean Enzymes T,C T,C N T,C T,C T,C T,C T T
er
Epizyme Rapid AUS Pre-clean Enzymes T,C T,C N T,C T,C T,C T,C T T
er
Gigasept FF D Soak 2 Succindialde-hyd T,C T,C N T,C N T,C N N N
e dimethoxy
tetrahydrofuran
Glutacide Plus USA Soak 2 Gluteraldehyde T,C T,C N T,C T,C T,C T,C T T
Incidin D Spray/ Alcohol T T T T T T T H H
Wipe
C = Approved for use on the cable 1 FDA 510(k) cleared F = France
N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
Table 8-2 Disinfectants Compatibility (Continued)

C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Incidur Spray D Spray/ Alcohol Quat. T T T T T T T N N
Wipe Aldehyde
Instruzyme F Pre-clean Enzymes, Quat. T,C T,C N T,C N T,C N T N
er Ammonia,
Biguanide
Klenzyme USA Pre-clean Enzymes T,C T,C N T,C T,C T,C T,C T T

Transducer Care and Maintenance


er
Kohrsolin D Soak 2 Gluteraldehyde T,C T,C N T,C T,C T,C T,C T T
HD11 XE Getting Started

Korsolex PAE F Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
4535 612 62651

C = Approved for use on the cable 1 FDA 510(k) cleared F = France


N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
183

8
Table 8-2 Disinfectants Compatibility (Continued)
184

8
C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec
4535 612 62651
HD11 XE Getting Started

Transducer Care and Maintenance


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
MaxiCide Plus USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T

MetriCide 1 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T

MetriCide 28 1 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Metricide Plus USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
30 1
MetriZyme USA Pre-clean Enzymes T,C T,C N T,C T,C T,C T,C T T
er
Mild Soap All Pre-clean Surfactants / T,C T,C T,C T,C T,C T,C T,C T T
Solution er Soap
C = Approved for use on the cable 1 FDA 510(k) cleared F = France
N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
Table 8-2 Disinfectants Compatibility (Continued)

C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Milton AUS Spray/ Sodium T,C T,C T,C T,C T,C T,C T,C C C
Wipe Hypochlorite
Omnicide 1 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Omnicide USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
14NS

Transducer Care and Maintenance


Omnicide 28 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Omnicide Plus USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
HD11 XE Getting Started

1
C = Approved for use on the cable 1 FDA 510(k) cleared F = France
4535 612 62651

N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
185

8
Table 8-2 Disinfectants Compatibility (Continued)
186

8
C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec
4535 612 62651
HD11 XE Getting Started

Transducer Care and Maintenance


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Perasafe E Soak 2 Peracetic acid/ N N N N N N N T N
Powder Hydrogen
Peroxide
Perascope E Soak 2 Peracetic acid/ N N N N N N N T N
Hydrogen
Peroxide
Perfektan Endo D Spray/ Quat. Ammonia T,C T,C T,C T,C N T,C T,C C C
Wipe
Phagocide D F Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
C = Approved for use on the cable 1 FDA 510(k) cleared F = France
N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
Table 8-2 Disinfectants Compatibility (Continued)

C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Phagozyme F Pre-clean Enzymes, T,C T,C N T,C N T,C N T N
ND er Quaternary
Ammonium
ProCide USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
ProCide 14NS USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
1

Transducer Care and Maintenance


ProCide 28 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
HD11 XE Getting Started

ProCide NS USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
ProCide Plus USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
4535 612 62651

C = Approved for use on the cable 1 FDA 510(k) cleared F = France


N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
187

8
Table 8-2 Disinfectants Compatibility (Continued)
188

8
C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec
4535 612 62651
HD11 XE Getting Started

Transducer Care and Maintenance


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
PSS Select 14 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Day
PSS Select 28 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Day
PSS Select Plus USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Rivascop F Spray/ Quat. Ammonia T,C T,C T,C T,C N T,C T,C C C
Wipe
Salvanios pH F Spray/ Quat. Ammonia T,C T,C T,C T,C N T,C T,C C C
10 Wipe
C = Approved for use on the cable 1 FDA 510(k) cleared F = France
N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
Table 8-2 Disinfectants Compatibility (Continued)

C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Sani-Cloth (all) USA Wipe Alcohol, Quat. T T T T T T T N N
Ammonia
SDS 14 NS USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
SDS 28 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Sekucid N F Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T

Transducer Care and Maintenance


Sekusept Aktiv D Soak 2 Peracetic acid/ N N N N N N N T N
Hydrogen
HD11 XE Getting Started

Peroxide
4535 612 62651

Sekusept Plus D Soak 2 Glucoprotamin T,C T,C N T,C N T,C N N N


C = Approved for use on the cable 1 FDA 510(k) cleared F = France
N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
189

8
Table 8-2 Disinfectants Compatibility (Continued)
190

8
C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec
4535 612 62651
HD11 XE Getting Started

Transducer Care and Maintenance


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Steranios 2% F Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
Theracide Plus USA Spray/ Alcohol, Quat. T T T T T T T N N
Wipe Ammonia
T-Spray USA Spray/ Quat. Ammonia T,C T,C T,C T,C T,C T,C T,C C C
Wipe
T-Spray II USA Spray/ Quat. Ammonia T,C T,C T,C T,C T,C T,C T,C C C
Wipe
C = Approved for use on the cable 1 FDA 510(k) cleared F = France
N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
transducers)
Table 8-2 Disinfectants Compatibility (Continued)

C5-2, C6-3, C8-4v, C8-5, C9-4,C9-5ec


3D6-2, 3D8-4, 3D9-3v, V6-2, V8-4

PA4-2, S3-1, S4-2, S8-3, S12-4


D2cwc, D5cwc, D2tcd
Country of Origin

Active Ingredient

L8-4, L9-3, L12-5

S7-2omni, T6H
Qualified Use

L15-7io
L12-3

s7-3t
Solution
Vaposeptol F Spray/ Alcohol, T T T T T T T H H
Wipe Biguanide
Vespore USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T

Wavicide -01 1 USA Soak 2 Glutaraldehyde T,C T,C N T,C T,C T,C T,C T T
C = Approved for use on the cable 1 FDA 510(k) cleared F = France

Transducer Care and Maintenance


N = Not approved for use 2 Soak or per product instructions USA = United States of America
T = Approved for use on the transducer
H =Approved for use on the handle only (TEE
HD11 XE Getting Started

transducers)

T,C
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191

8
8 Transducer Care and Maintenance

Gels Statement
Couplant gels that do not contain mineral oil or lotion are acceptable for use.
Some recommended gels include:
Aquasonic 100
Aquasonic Clear
Carbogel-ULT
ECG Gel (Nicom)
Nemidon Gel
Ultraphonic
Scan

HD11 XE Getting Started


192 4535 612 62651
9 Endocavity Transducers
Endocavity transducers deliver the critical images needed for obstetrical, gyneco-
logical, urological, and prostatic studies. The endovaginal and endorectal trans-
ducer features end-firing imaging arrays that deliver a wide field of viewa key to
an accurate diagnosis. This feature lets you consider the whole picture when mak-
ing your diagnosis.
This section provides information about the C8-4v, the 3D9-3v, and the C9-5ec
endocavity transducers.

Operator
To operate an endocavity transducer, you must be a physician or a sonographer
who is properly trained in endocavity techniques, according to currently approved
relevant medical standards. You also must be thoroughly familiar with the safe
operation, care, and maintenance of the ultrasound system, as well as proficient at
interpreting the images generated. Use informed judgment when selecting
patients for endocavity exams.

Patient Safety
You can help ensure patient safety when using an endocavity transducer by
Verbally preparing each patient for the procedure before the exam.
Scrutinizing the entire transducer and testing all of the controls before each
use. See Inspecting Transducers for Damage on page 156.
Using mandatory protective equipment, such as a market-approved trans-
ducer cover or condom, during an exam.
Inserting and operating the transducer properly.
Not allowing water or other liquids to drip into the transducer connector,
into the interior of the system, or onto the keyboard.
Table 9-1 summarizes patient safety problems, describes how to prevent them,
and lists the sections in this manual where details are provided.

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193
9 Endocavity Transducers

WARNING
For any other irregularity not listed in Table 9-1, do not use the transducer. Poten-
tially serious consequences could result. Contact your Philips representative.

Table 9-1 Patient Safety Summary


Effect on
Problem Patient Prevention See
Mechanical Severe trauma, Inspect the transducer, using both Inspecting
damage cuts, bleeding, sight and touch, before the exam. Transducers
perforations for Damage
on page 156
Insufficient Spread of illness or Thoroughly clean and disinfect the Transducer
cleaning disease transducer after each use. Cover Care and
protocol the transducer with a protective Maintenance
transducer cover. Cover the on page 155
imaging system with a disposable
drape if pathogenic organisms are
known or suspected.
Improper Cuts, bleeding, Never use force when inserting or Endocavity
insertion or ligament damage, removing a transducer. Examination
withdrawal perforations Guidelines on
page 201
Defibrillation Electrical burns Disconnect the transducer and Defibrillators
issues remove the transducer connector on page 51
before defibrillation.

NOTE
The ultrasound system and transducers discussed in this manual do not contain
natural rubber latex that contacts humans. Natural rubber latex is not used on
any ultrasound transducer, including transthoracic, intraoperative, and transe-
sophageal transducers. It is also not used on Philips ECG cables. For more infor-
mation, see Latex Materials and Patient Contact on page 52 and FDA Medical
Alert on page 52.

HD11 XE Getting Started


194 4535 612 62651
Endocavity Transducers 9

Equipment Operation
Meticulous inspection and correct and careful operation of an endocavity trans-
ducer are imperative to patient safety. The situations listed in this section affect
safe operation as well as the ability to service mechanical problems under the
Philips warranty or service contract. Repairs necessitated by misuse are not cov-
ered and can be very costly, often requiring complete disassembly and rebuilding
of the transducer.
The primary areas of misuse are
Cuts and abrasions on transducer insulation from sharp instruments such as
scalpels, scissors, and clamps
Improper disinfection of the transducer, causing fluid to enter the transducer
Damage caused by dropping the transducer on a hard surface

Electrical Safety
For information on the precautions to observe when defibrillation is required, see
Defibrillators on page 51.

Description and Use


This section lists and describes the important features of the C8-4v, the 3D9-3v,
and the C9-5ec endocavity transducers.

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195
9 Endocavity Transducers

C8-4v Endocavity Transducer


This section lists important features of the C8-4v endocavity transducer shown in
Figure 9-1.
Figure 9-1 C8-4v Endovaginal Transducer

Features Enables high-resolution imaging for obstetrical and gynecological


studies.
Designed to be easy to hold and manipulate and to provide
maximum clinician and patient comfort.
Connection See Connecting Transducers on page 150.
Frequency Operating range: 4 to 8 MHz
Max Sector 133 degrees
Image
Specifications Length (transducer and cable): approximately 2.1 m (7 ft)
Length of handle and tip: 30 cm (12 in)
Radius of curvature: 1.0 cm (0.4 in)

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196 4535 612 62651
Endocavity Transducers 9

3D9-3v Endocavity Transducer


This section lists important features of the 3D9-3v endocavity transducer shown
in Figure 9-2.
Figure 9-2 3D9-3v Endocavity Transducer

Features A curved array transducer with a 130-degree field of view that


supports: high-resolution 2D imaging; high-resolution quantitative,
single-sweep 3D volume acquisition; and 4D imaging up to 22 volumes
per second for endovaginal obstetrical and gynecological applications.
Connection See Connecting Transducers on page 150.
Frequency Operating range: 3 to 9 MHz
Sector Angle 2D image plane: 130 degrees
3D sweep direction: 85 degrees
Specifications Length (transducer and cable): approximately 2.38 m (7.8 ft)
Length of handle and tip: 30 cm (12 in)
Radius of curvature: 11.5 mm (0.45 in)

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197
9 Endocavity Transducers

C9-5ec Endocavity Transducer


This section lists important features of the C9-5ec endocavity transducer shown
in Figure 9-3.
Figure 9-3 C9-5ec Endocavity Transducer

Features A broadband curved array transducer with a150-degree field of


view that supports: iSCAN Intelligent Optimization; steerable
pulsed Doppler, color Doppler and Color Power Angio; Freehand
3D, Panoramic, SonoCT, and XRES imaging for endocavity
applications including endovaginal and endorectal.
Connection See Connecting Transducers on page 150.
Frequency Operating range: 5 to 9 MHz
Max Sector 150 degrees
Image
Specifications Length (transducer and cable): approximately 2.26 m (7.4 ft)
Length of handle and tip: 28 cm (11 in)
Radius of curvature: 0.8 cm (0.3 in)

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198 4535 612 62651
Endocavity Transducers 9

The Endocavity Exam


This section provides information for preparing the transducer and patient for an
exam, and endocavity exam guidelines.

Preparing the Endocavity Transducer for an Exam


Follow these steps to prepare the transducer for use. These instructions apply to
all endocavity transducers.
CAUTIONS
Do not use gels that contain any of the following agents:
Acetone
Methanol
Denatured ethyl alcohol
Mineral oil
Iodine
Any lotions or gels containing perfume

If you have any questions regarding the contents of the gel, check with the gel
manufacturer.

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199
9 Endocavity Transducers

To prepare the transducer for an endocavity exam


WARNING
Wear gloves during the following procedure.
1. Place an adequate amount of ultrasound transmission gel at the tip of the
inside surface of the transducer cover.

CAUTION
Use ultrasound transmission gel only inside the transducer cover; do not use
ultrasound transmission gel outside of the transducer cover. For proper transmis-
sion of the acoustic beam, use the ultrasound transmission gel supplied by Philips,
or another glycol, glycerol, or water-based couplant inside the transducer cover.
Do not use mineral oil, oil-based couplants, or other unapproved materials
because they might damage the transducer.

2. Place the transducer cover over the transducer or unroll the transducer
cover until it covers the insertable portion of the transducer.

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3. Use an elastic band to hold the transducer cover in place at the transducer
handle. The elastic band fits into the groove at the base of the shaft.
4. Gently pat the transducer cover to remove any air pockets. Check for tears
or damage.
5. Place enough commercially available water-based lubricant or sterile jelly on
the end of the covered transducer to facilitate insertion.
CAUTION
Do not use ultrasound transmission gel as a lubricant for endocavity exams.

Preparing a Patient for an Endocavity Exam


Before performing an endocavity exam, it is important that you thoroughly
explain the exam and procedure to the patient. Follow your department guide-
lines for patient preparation.

Endocavity Examination Guidelines


Use the following guidelines when you perform an endocavity exam:
Never use excessive force when inserting, operating, or withdrawing a trans-
ducer. Forceful insertion, manipulation, or withdrawal of a transducer can
result in lacerations, bleeding, perforation, tearing of adhesions, and ligament
damage.
Minimize the possibility of pressure necrosis (tissue death). Do not let the tip
displace any one segment of tissue for more than 5 consecutive minutes. Also
make sure the tip is in a position of least potential pressure.

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Before each exam, carefully inspect the transducer. A thorough inspection of


the transducer is important for your safety, the patients safety, and the contin-
ued functioning of the transducer. See Inspecting Transducers for Damage
on page 156.
Refrain from handling the tip of the transducer. Use the handle of the trans-
ducer as much as possible.
For information about using a disposable drape, see Disposable Drape on
page 59.

Accessories for Endocavity Transducers


For information on ordering accessories for endocavity transducers, see HD11
XE System Supplies, Peripherals, and Accessories on page 259.
NOTE
Biopsy needle guides are available for these transducers. See Biopsy-Capable
Transducers on page 241.

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A transesophageal echocardiography (TEE) exam is performed with a transducer
mounted in a gastroscope, which is positioned in the esophagus or stomach. TEE
transducers offer images that are unobstructed by lungs and ribs, making them
important diagnostic tools for conditions that transthoracic echocardiography
cannot adequately image.
This section provides specific information on the following transducers:
T6H
S7-2omni
S7-3t

Operator
The OmniPlane III TEE transducers are designed to be used by physicians who are
properly trained in esophagogastroscopic techniques according to currently
approved relevant medical practices. Philips recommends that physicians who
operate the OmniPlane TEE transducers are
Proficient in recognizing and interpreting transesophageal imaging patterns
Thoroughly familiar with the safe operation, care, and maintenance of the
ultrasound system and the OmniPlane III TEE transducers
Fully informed about the latest TEE methods through literature and seminars
NOTE
As of the date of this publication, you can find the latest cleaning and disinfection
information for TEE and other transducers in Transducer Care and Mainte-
nance on page 155 in this manual. It is important, however, that you periodically
check the following Philips Web site for the latest updates on cleaning and disin-
fecting guidelines for TEE transducers: www.medical.philips.com/transducercare

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Patient Safety
Philips transducers are built to be safe, sturdy, and reliable. However, on a few
occasions patients have experienced complications due to improper use of a TEE
transducer. This section provides information on patient safety when using a TEE
transducer.
NOTE
Philips recommends that you practice using the controls before performing any
procedure mentioned in this section.

You must also be thoroughly familiar with the safe operation, care, and mainte-
nance of the ultrasound imaging system used with the TEE transducer, as well as
proficient at interpreting the images generated.
You can help ensure patient safety when using a TEE transducer by
Using informed judgment when selecting patients for TEE exams.
Verbally preparing each patient for the procedure before the exam. See Pre-
paring Patients for a TEE Examination on page 224.
Scrutinizing the entire transducer and testing all of the controls before each
use. See Checking the TEE Transducer on page 218.
Inserting, removing, and operating the transducer properly.
Ensuring that the transducer handle does not rest on or touch the patient.
Using protective equipment, such as a bite guard and a market-approved ster-
ile transducer cover during a TEE exam. See TEE Accessories on page 235.
CAUTION
Bite guards are mandatory; protective transducer covers are recommended for
TEE transducers, except in Japan, where protective transducer covers are manda-
tory for TEE transducers.

Not allowing water or other liquids to come in contact with the transducer
connector or the interior of the system, or to drip onto the keyboard.
CAUTION
To avoid damaging gastroscope cables, be sure that the distal tip of the transducer
is in the neutral (straight) position when inserting a transducer into, or removing
it from, the transducer cover.

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Table 10-1 summarizes patient safety problems, describes how to prevent them,
and lists the sections in this manual where details are provided.
WARNING
For any other irregularity not listed in Table 10-1, do not use the transducer.
Potentially serious consequences could result. Contact your Philips representa-
tive.

Table 10-1 Preventing Harm to Patients


Effect on
Problem Patient Prevention See
Mechanical Severe trauma, Inspect the transducer, using both Checking the
damage cuts, bleeding, sight and touch, before the exam. TEE
perforations Transducer on
page 218
Electrical Esophageal Check the transducer for frayed Electrical
damage burns insulation, kinks, or other Safety on
abnormalities. Follow electrical page 208
safety check procedures.
Biting, Tooth damage, Always use a bite guard. Bite Guards
scraping esophageal on page 235
transducer burns
Insufficient Spread of illness Thoroughly clean and disinfect the Transducer
cleaning or disease transducer after each use. Cover Care and
protocol the tip and shaft with a transducer Maintenance
cover. Cover the imaging system on page 155
with a disposable drape if highly
pathogenic organisms are known or
suspected.
Improper Esophageal Never use force when inserting, Examination
insertion or cuts, bleeding, removing, or manipulating the Guidelines on
withdrawal ligament transducer. During insertion, lock page 225
damage, the medial/lateral controls. During
perforations withdrawal, place the medial/lateral
controls in freewheeling mode.

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Table 10-1 Preventing Harm to Patients (Continued)


Effect on
Problem Patient Prevention See
Pressure Death of Keep deflection controls in Examination
necrosis esophageal freewheeling mode and unplug the Guidelines on
lining tissue transducer from the system when page 225
not imaging. Minimize the pressure
applied to deflection area and distal
tip. Do not let the distal tip displace
a tissue area for more than 5
consecutive minutes.
Increased Esophageal Use the TEE preset that has been Entering the
transducer burns established to minimize the effects Patient
temperature of temperature. For febrile patients, Temperature
use the Auto-Cool feature. on page 230
Improper Transient Never use the transducer during Examination
patient unilateral vocal any procedure requiring extreme Guidelines on
position cord paralysis neck flexion, such as sitting page 225
craniotomies.
Nonisolated Electrical burns Only use isolated-output Electrosurgical
ESUs electrosurgical units (ESUs). The Units on
ESU label or service guide or your page 209
biomedical department should
identify whether or not the ESU is
isolated. Unplug transducer from
the system when you are not
imaging.
Defibrillation Electrical burns Disconnect the transducer and Defibrillators
issues remove the transducer connector on page 51
before defibrillation.

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NOTE
The Philips diagnostic ultrasound systems and transducers in this manual do not
contain natural rubber latex that contacts humans. Natural rubber latex is not
used on any ultrasound transducer, including transthoracic, intraoperative, and
transesophagael transducers. It is also not used on Philips ECG cables for the
products in this manual. For more information, see Latex Materials and Patient
Contact on page 52 and FDA Medical Alert on page 52.

Equipment Operation
Meticulous inspection and correct and careful operation of an OmniPlane III TEE
transducer is imperative to patient safety. The situations listed in this section
affect safe operation as well as the ability to service mechanical problems under
the Philips 1-year warranty or service contract. Transducer repairs necessitated
by misuse of the transducer are not covered and can be very costly, often requir-
ing complete disassembly and rebuilding of the transducer.
The primary areas of customer misuse are
Cuts and abrasions on the transducer and insulation from teeth or sharp
instruments such as scalpels, scissors, and clamps
Improper disinfection techniques, causing fluid to enter the control head
assembly, control housing, and the rest of the transducer
Consistently applying too much force to the control wheels of a TEE trans-
ducer, which can break the steering mechanism
Review Table 10-2 to familiarize yourself with specific problems, to learn how to
avoid them, and to identify the sections in this manual where details are provided.
Philips also strongly recommends that you clearly post stringent protocols for
TEE transducer care, based on the information in this manual, to minimize the
chance of damage.
WARNING
For any other irregularity not listed in Table 10-2, do not use the transducer.
Potentially serious consequences could result. Contact your Philips representa-
tive.

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Table 10-2 Preventing Equipment Problems


Effect on
Problem Equipment Prevention See
Current Serious electrical Check the transducer for cuts, Electrical
leakage hazards frayed insulation, kinks, or other Safety Check
abnormalities. Procedure for
TEE
Transducers
on page 236
Biting Mechanical and Cover the patients teeth with a Bite Guards
transducer electrical hazards bite guard. Cover the distal tip on page 235
and flexible shaft with a
transducer cover
(recommended).
Forcing Steering Operate the deflection controls Deflection
deflection mechanism broken gently. Control
controls Basics on
page 212
Incorrect Possible damage to Suspend the transducer from a Storing
storage highly sensitive wall-mounted rack and cover the Transducers
elements, cuts in distal tip with a tip protector on page 157
flexible shaft when not in use.
Internal Severe transducer Never sterilize the transducer by Cleaning,
exposure to damage that affects using bleach, steam, heat, or Disinfecting,
liquids the image quality, ethylene oxide (EtO). Never and Sterilizing
the steering immerse the steering mechanism Transducers
mechanism, and in any disinfectant or liquid. on page 161
electrical safety

Electrical Safety
The ultrasound system and the transducers discussed in this manual comply with
common medical device electrical safety standards.
This section includes information about TEE transducer leakage current, interac-
tion with other devices, accident prevention, and the electrical safety check pro-
cedure.

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Leakage Current
For the TEE transducers discussed in this manual, the insertion tube and tip are
type BF , as described in IEC 60601-1. There are no exposed conductive sur-
faces distal to the control housing. Within the flexible shaft, all active circuits and
conductors are surrounded by a chassis-grounded shield that runs the length of
the transducer.
If the outer layer of the shaft is punctured or cracked, a patients esophagus could
be exposed to chassis leakage current. This leakage current is not hazardous pro-
vided that the ground connector (third wire) in the ultrasound system power
cable is intact and is connected to a properly grounded wall outlet. Even if the
ground connector breaks, leakage current does not exceed 100 when con-
nected to a 120-V outlet, or 200 when connected to a 240-V outlet.
Leakage hazards are further reduced when the ultrasound system is plugged into
an isolated power outlet, which is standard in most operating rooms.

Electrosurgical Units
Electrosurgical units (ESUs) and other devices intentionally introduce radio fre-
quency electromagnetic fields or currents into patients. Because imaging ultra-
sound frequencies are coincidentally in the radio frequency range, ultrasound
transducer circuits are susceptible to radio frequency interference. While an ESU
is in use, severe noise interferes with the black-and-white image and completely
obliterates the color image.
Combinations of failures in an ESU or other device and in the outer layer of the
transducer shaft can cause electrosurgical currents to return along the transducer
conductors. This could burn the patient, and the ultrasound system and the trans-
ducer could also be damaged. Be aware that a disposable transducer cover pro-
vides no protective electrical insulation at ESU frequencies.

Pacemakers
For information on the use of pacemakers and transducers, see Pacemakers on
page 51.

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Defibrillators
For information on precautions to observe when a defibrillation is required, see
Defibrillators on page 51.

Accident Prevention
Visually and tactilely inspect a TEE transducer for bumps, cracks, and cuts before
each TEE exam. A small bump on the shaft surface could indicate that a strand
from the ground shield has broken and is beginning to puncture the outer layer. If
you suspect a problem with the flexible shaft, perform the electrical safety check
procedure. See Electrical Safety Check Procedure for TEE Transducers on
page 236.
Use ESUs that have isolated outputs. Return fault/ground fault detection circuits
provide additional protection. To determine if an ESU has an isolated output, read
the label on the ESU, see the ESU service guide, or ask a biomedical engineer.
Require periodic electrical safety checks to ensure that the grounding system in
your area remains intact.
If the transducer is left in a patient during periods when imaging is not taking
place, unplug the transducer from the system to reduce the possibility of leakage
current or ESU interaction. Also make sure that the deflection control brakes are
off and that the transducer is in freewheeling mode.

OmniPlane III Transducers


This section discusses the basic parts of OmniPlane III TEE transducers and lists
important features of the following TEE transducers:
T6H
S7-2omni

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Basic Transducer Parts


This section labels and describes individual parts that are common to TEE trans-
ducers. Many of the parts and their operation are similar among Philips TEE trans-
ducers. The following differences are not shown in Figure 10-1:
Brakes for OmniPlane transducers
Array rotation buttons for the OmniPlane transducers
Figure 10-1 Basic TEE Transducer Parts

Deflection controls

Control housing

Distal tip

Deflection area

Flexible shaft

Transducer connector

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Deflection Control Basics


The deflection controls on the TEE transducers discussed in this manual move the
deflection area, located between the distal tip and flexible shaft. The deflection
area bends when you operate the controls, permitting anterior, posterior, and lat-
eral positioning for most transducers. Figure 10-2 provides an illustration of
deflection control movement.
Figure 10-2 Deflection Control Movement

WARNINGS
To prevent tissue damage such as pressure necrosis, gastroesophageal lacerations,
bleeding, tearing of adhesions, ligament damage, and perforation:
Never apply excessive force when inserting or withdrawing the transducer, or
when operating the deflection controls.1, 2
Lock medial/lateral movement during insertion. Use freewheeling mode when
withdrawing the transducer any time you are not imaging.
Never apply excessive force when operating the deflection controls during
imaging. Do not allow the transducer to remain at a maximum deflection for
long periods of time.1, 2

1. Urbanowitz, John H. et al. Transesophageal Echocardiography and Its Potential for Esoph-
ageal Damage. Anesthesiology, Vol. 72, No. 1, 1990.
2. Radwin, Martin et al. Transesophageal Echocardiography: Intubation Techniques. Philips Appli-
cation Note 5091-2804E, 1992.

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WARNING
To prevent tissue damage, Philips recommends that the tip of the transducer be
straightened and both friction brakes released before you withdraw the trans-
ducer from the patient. In the neutral position, the tip is straight when both white
circles on the control wheels are aligned and point toward the center of the array
rotation button.

CAUTION
When repositioning or withdrawing a TEE transducer, put the controls in free-
wheeling mode. Also, whenever the transducer is not being used during a proce-
dure, make sure it is in freewheeling mode and is unplugged from the system.

Temperature Controls
The TEE transducers discussed in this section have temperature sensors in the
distal tip. An automatic warning appears on the ultrasound display if the distal tip
temperature exceeds a specified limit, and the system discontinues scanning.
Use the TEE Auto-Cool feature to enter above-normal patient temperatures.
Entering a patients temperature enables the system to calculate tip temperature
more accurately, and can prevent unnecessary interruptions while scanning. For
more details of the TEE Auto-Cool feature, see TEE Manual Auto-Cool Safety
Feature on page 229.

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Description and Use: OmniPlane III Transducer


Figure 10-3 shows the OmniPlane III transducer.
Figure 10-3 OmniPlane III

Features Ultraband transducer technology sensor for Contrast


Harmonic Imaging. Enables high-resolution imaging and
360-degree views of the heart, unobstructed by lungs
and ribs. Capable of harmonic imaging, contrast
research, tissue Doppler, color flow imaging, steerable
CW and PW Doppler, frequency agility, and
electrocautery suppression. Tip surface constantly
monitored for patient safety. Convenient hanging ring.
Connection See Connecting Transducers on page 150.
Specifications Tip: 1.5 cm (0.6 in) diameter, 3.5 cm (1.4 in) long
Shaft: 1.0 cm (0.4 in) diameter, 0.9 m (2.95 ft) long

NOTE
Philips recommends that you only use the OmniPlane III transducer on patients
weighing at least 25 kg (55 lb), to ensure the esophagus can comfortably accom-
modate the transducer.

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Manipulating the OmniPlane III Tip


This section contains details of OmniPlane III deflection controls and brakes that
are shown in Figure 10-4. Be sure to read Deflection Control Basics on
page 212 for background information pertaining to TEE transducers.
Figure 10-4 OmniPlane III Deflection Controls and Brakes

Array rotation buttons

Neutral position indicators


Anterior/posterior control (no deflection)

Medial/lateral control

Detent brake actuator

The larger inner knob controls anterior/posterior movement, while the smaller
outer knob controls medial/lateral movement.

To place the tip of the TEE transducer into the neutral position
Align the ribs on each knob with the center of the array rotation buttons.

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The knobs can be controlled by a detent brake that holds the tip position without
locking it in place. This allows the tip to straighten if it meets additional resistance.
When the detent brake actuator is turned counterclockwise, (as shown) both
knobs are in the freewheeling mode.
When the detent brake actuator is centered, the small knob (medial/lateral
movement) is in the detent mode.
When the actuator is turned clockwise, both knobs are in the detent mode.

During insertion, engage medial/lateral detent to limit movement1 or use free-


wheeling mode (no deflection and no brake resistance)2 to prevent patient injury.
CAUTION
When repositioning or withdrawing a TEE transducer, put the controls in free-
wheeling mode. If the transducer is left in the patient for an extended period,
unplug the transducer from the system to reduce the possibility of leakage cur-
rent or ESU interaction. Also make sure the transducer is in freewheeling mode.

Rotating the OmniPlane Array


You can rotate the OmniPlane array to achieve a 360-degree view of the heart.
Use the array rotation buttons on the transducer handle, as follows:
To increase rotation, press the array rotation button that is distal to the sys-
tem.
To decrease rotation, press the button that is proximal to the system. Rota-
tion stops when you release either button.
An icon shows the current degree of rotation. Depending on image orientation,
the icon appears in the upper or lower right side of the display. Because the cen-
ter of the array is the pivot point, you can achieve a 360-degree view, as shown in
Figure 10-5.

1. Radwin, Martin et al. Transesophageal Echocardiography: Intubation Techniques. Philips Appli-


cation Note 5091-2804E, 1992.
2. Urbanowitz, John H. et al. Transesophageal Echocardiography and its Potential for Esoph-
ageal Damage. Anesthesiology, Vol. 72, No. 1, 1990.

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Figure 10-5 OmniPlane Array

210e005a

Calibration
Before connecting the OmniPlane III TEE transducer, be sure the tip and shaft are
straight. When you lock the connector into the transducer slot, the OmniPlane III
transducer recalibrates itself to the 0-degree (horizontal plane) position. As with
any array movement, the motor makes a humming sound while recalibrating.
NOTE
Do not turn the control knobs while calibration is in progress.

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You can continue to image even if the Calibration failed message appears. How-
ever, the transducer may lack the full 180-degree rotation capacity, and the rota-
tion displayed could be inaccurate. Perform the following procedure if you see
this message.

To calibrate the OmniPlane III TEE transducers


1. Make sure that the transducers shaft and tip are straight (the neutral position
indicators must be aligned with the array rotation buttons).
2. Unlock the transducer connector from the system.
3. Reseat the transducer connector in the system slot.
If you still see the message, contact your Philips service representative.

Checking the TEE Transducer


Before each TEE exam, carefully inspect the transducer and try the controls, as
described in the following sections.

Inspecting the Transducer


Carefully inspect the entire surface of the distal tip and flexible shaft for protru-
sions, holes, dents, abrasions, cuts, burrs, or cracks that could be extremely haz-
ardous to both you and your patient. For more information, see Inspecting
Transducers for Damage on page 156.
Carefully feel the tip and shaft, and visually scrutinize the entire transducer. If you
suspect an electrical problem, follow the electrical safety check procedure
described in Electrical Safety Check Procedure for TEE Transducers on
page 236.
Also check for excessive flexibility in the tip, particularly in the medial/lateral
direction. Do not use the transducer if the tip is extremely flexible. If you have any
questions about tip flexibility, contact your Philips service representative.

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Verifying Operation of the Controls


Use the deflection controls to position the tip in every possible direction, both to
ensure that the controls work properly and to get used to the feel of the particu-
lar TEE transducer. Make sure that the controls operate smoothly without bind-
ing, and that you can achieve all possible positions easily before introducing the
TEE transducer into the patient.
Test the friction brakes and freewheeling mode. Remember that the controls
must be in freewheeling mode (no deflection and no brake resistance) when repo-
sitioning or withdrawing the transducer, as well as whenever you are not imaging.
See Manipulating the OmniPlane III Tip on page 215.

S7-3t TEE Transducer


Figure 10-6 shows the S7-3t TEE transducer.

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Figure 10-6 S7-3t TEE Transducer

Features A small transducer that enables high-resolution imaging


and 360-degree views of the heart, unobstructed by
lungs and ribs. The array inside the tip can be rotated
180 degrees. A manual rotation of the wheel on the
handle of the transducer controls the rotation of the
scan plane. A deflection control wheel on the handle
controls the deflection of the tip. This transducer is
capable of color flow imaging, steerable CW and PW
Doppler, and frequency agility. Tip surface temperature
is constantly monitored for patient safety.
Connection See Connecting Transducers on page 150.
Specifications Tip: 10.7 mm x 8.0 mm, 27 mm long (0.42 in x 0.31 in,
1.1 in long)
Shaft: 7.4 mm diameter, 70 cm long (0.29 in diameter,
27.5 in long)

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Selecting Patients for the S7-3t Transducer


Although the S7-3t TEE transducer can provide clinical data not available from
other instruments, you should consider which patients can safely use the trans-
ducer.
Philips recommends that you use the S7-3t TEE transducers only on patients
weighing at least 3.5 kg (7.7 lb).
CAUTION
The ability of a patient to swallow or accommodate the transducer should be
considered.

You must consider any history of gastroesophageal diseases as well as the possible
effects of other therapies that the patient is undergoing. You must also consider
all gastroesophageal abnormalities or difficulty swallowing.

Deflection and Scan Plane Rotation Control


The control handle is designed for one-hand operation. Normally, you should
operate the control handle with your left hand. The thumb, first, and second fin-
gers control the deflection and the scan plane rotation control wheels.
The smaller wheel on the handle is for controlling the transducer tip deflection.
This wheel has a locked mode and a freewheeling mode. In the locked mode, the
movement of the deflection wheel is restrained to allow you to hold the tip in a
certain position. A metallic ring around the body of the handle, which clicks on
and off, controls the lock.
The larger wheel on top is the scan plane rotation control wheel.

Tip Deflection Control


The deflection control wheel on the handle of the transducer controls deflection
of the S7-3t TEE transducer tip.
WARNING
Check if the maximum deflection of the tip is 120 degrees upward and 90 degrees
downward. If the up/down deflection shows an unwanted amount of free play or
exceeds the maximal deflection angles, do not use the transducer. Contact Philips
to readjust the steering of the transducer. In this way, the risk of buckling or caus-
ing the U-turn of the transducer in the esophagus is minimized.

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Lock Operation
To protect the patient and the transducer, unlock the deflection control when
inserting or withdrawing the transducer. Figure 10-7 shows the lock operation.
Figure 10-7 S7-3t Lock Operation

White

Unlock

Red

Lock

Transducer Scan Plane Rotation Control


The transducer scan plane can be rotated from 0 degrees (transversal plane)
through 90 degrees (longitudinal plane) to 180 degrees (transversal plane, left/
right inverted). Figure 10-8 shows the scan plan rotation control. You can also
select all planes in between to scan a conical imaging volume.

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Figure 10-8 S7-3t Scan Plane Rotation Control

Short axis
Angle= 0o

Long axis
Angle= 90o

Short axis
Angle= 180o

CAUTION
Do not use excessive force on the scan plane rotation control wheel at its outer
positions because this may damage the endoscope mechanism. 1, 2

1. Radwin, Martin et al. Transesophageal Echocardiography: Intubation Techniques. Philips Appli-


cation Note 5091-2804E, 1992.
2. Urbanowitz, John H. et al. Transesophageal Echocardiography and Its Potential for Esoph-
ageal Damage. Anesthesiology, Vol. 72, No. 1, 1990.

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Special Considerations for TEE Examinations


Special considerations regarding TEE exams are advisable for patients with exist-
ing gastroesophageal abnormalities, such as esophageal varices, hiatal hernia,
tumor, diverticula, esophageal webs and rings, fistulae, or peptic ulcers, as well as
for patients who have had anti-reflux procedures. In addition, you should do the
following:
Consider the patients size and ability to accommodate the transducer tip and
shaft.
Check the patients history for gastroesophageal disease or difficulty swallow-
ing.
Evaluate the potential overall effects of any treatment that the patient is
undergoing, such as mediastinal radiation, chemotherapy, anticoagulation, or
steroid therapy.
Be aware that you may discover unsuspected esophageal pathology during an
exam. Be alert for congenital problems with the esophagus or stomach, par-
ticularly with pediatric patients.
When examining a patient with an above-normal temperature, use the
Auto-Cool feature and enter the patient temperature. The Auto-Cool feature
is described in Entering the Patient Temperature on page 230.
This list is not comprehensive. Rather, it suggests areas to investigate when con-
sidering TEE for a particular patient.

Preparing Patients for a TEE Examination


These suggestions for pre-exam patient preparation do not constitute an exhaus-
tive list of all possible factors to explore before performing transesophageal
echocardiography, nor do they imply medical protocols. Instead, they reflect basic
guidelines resulting from extensive consultation with physicians throughout the
design, development, and clinical investigation periods of Philips TEE transducers.
In addition to gathering routine background information such as current med-
ication and allergies, investigate any history of chronic obstructive lung dis-
ease, esophageal strictures, varices, or bleeding.
Thoroughly explain the procedure to the patient before the exam.

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Inform the patient not to eat or drink for at least 6 hours before the exam.
Advise the patient that he or she should not plan to drive after the exam,
because sedatives are often used.
Follow institutional guidelines for obtaining patient consent for a transesoph-
ageal echocardiography (TEE) examination.
Be sure that a recent ECG, CBC, and SMA6 are available as a baselines.

Examination Guidelines
During a TEE exam, an assistant can provide oral and pharyngeal suctioning of the
patient, and can monitor the patients blood pressure and general responses. For
unexpected occurrences, an emergency cart with basic life-support equipment
should be ready. Throughout the exam, it is important to carefully monitor the
patients reactions and to assure that ventilation and vital signs are stable.
In the operating room, do not use TEE transducers during surgical procedures
requiring extreme neck flexion, such as sitting craniotomies. The following are
important guidelines for TEE examinations:1, 2
Minimize the possibility of transducer tip fold-over.
This problem has occurred rarely, but its consequences can be serious. See
Tip Fold-Over on page 227.
Maintain a patent airway.
For surgical patients, endotracheal intubation establishes a stable, patent air-
way before insertion of the transducer. For patients who are awake, carefully
monitor the patients breathing at all times.

1. Gussenhoven, Elma et al. Transesophageal Two-dimensional Echocardiography: Its Role in


Solving Clinical Problems. Journal of the American College of Cardiology, 975-979, 1986.
2. Cucchiara, R. F. et al. Air Embolism in Upright Neurosurgical Patients: Detection and Local-
ization by Two-dimensional Transesophageal Echocardiography. Anesthesiology, 353-355, 1984.

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Minimize the possibility of pressure necrosis (tissue death).


Do not let the distal tip displace any one segment of tissue for more than 5
consecutive minutes. Also make sure the deflection area and the distal tip are
in the position of least potential pressure. Be sure that the transducer is in a
freewheeling mode and is unplugged whenever you are not imaging.1
Prevent potential esophageal damage.
Philips recommends that you stop TEE scanning and unplug the transducer
from the system during periods of poor perfusion, circulatory arrest, or the
hypothermic phase of open heart surgery. To discontinue scanning, unlock the
transducer connector according to the instructions in Connecting Transduc-
ers on page 150.
Before each TEE exam, carefully inspect the transducer, as described in
Checking the TEE Transducer on page 218.
A thorough inspection procedure is required for the safety of the patient and
yourself, and to ensure the continued correct functioning of the transducer.
Never use excessive force when inserting, operating, or withdrawing a trans-
ducer, and make sure the deflection area is straight during insertion and with-
drawal.
Forceful insertion, manipulation, or withdrawal of a transducer can result in
lacerations, bleeding, perforation, tearing of adhesions, and ligament damage.
Also be aware that the tip can fold over, causing similar damage. See the next
section, Tip Fold-Over on page 227.
Refrain from handling the distal tip whenever possible.
If you must handle the distal tip, grasp it on the sides. Do not touch the top or
bottom. Support the transducers proximal head, either by having an assistant
hold the steering mechanism or by clamping the transducer at the steering
mechanism. However, be sure that the clamp does not interfere with steering,
and do not clamp any part of the flexible shaft, because this will damage the
transducer.

1. Urbanowitz, John H. et al. Transesophageal Echocardiography and Its Potential for Esoph-
ageal Damage. Anesthesiology, Vol. 72, No. 1, 1990.

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Tip Fold-Over
On rare occasions, the OmniPlane TEE transducer tip can fold over during inser-
tion. The effects can be serious if the situation is handled incorrectly. The esopha-
gus can be scraped, perforated, or otherwise damaged. Read the following
guidelines to better understand the problem and how to avoid it.

Preventing Tip Fold-Over


The following factors can cause the tip to fold over. This list is not exhaustive;
other factors can also be involved.

Incorrect Insertion Technique


You may find transducer insertion easier if you guide the transducer into the
patients mouth with your fingers. You also may want to lock medial/lateral tip
movement.
CAUTION
All patients should wear a bite guard during a TEE exam. A bite guard protects
against dangerous transducer mechanical and electrical malfunction caused by
involuntary biting. Even anesthetized patients require bite guards to prevent dam-
age to both their teeth and to the transducer. For information on bite guards
available from Philips, see Bite Guards on page 235.

Avoid the following when inserting any TEE transducer into a patient:
Any excessive flexion of the transducer tip, particularly in the medial/lateral
direction
Catching the tip in pharyngeal recesses
Insertion when a patient is being uncooperative or is having a convulsion or
spasm

Patient Esophageal Pathology


Carefully review a patients medical history for obstructing pathologies or ana-
tomical irregularities before performing a TEE exam.

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Improper Transducer Maintenance


Thoroughly examine the transducer and test the controls before each exam. Be
sure to check for excessive flexibility in the tip. See Checking the TEE Trans-
ducer on page 218.

Recognizing Tip Fold-Over


The TEE transducer tip might be folded over in the patient if you encounter any of
the following:
Resistance to advancing or removing the transducer
An inability to turn the control knobs
Fixation of the control knobs in the maximum flexion position
Extreme difficulty in obtaining an image

Correcting Tip Fold-Over


If you suspect the transducer tip is folded over, Philipss physician consultants rec-
ommend that you gently try to manipulate the transducer. If the tip is not locked
or jammed in a doubled-over position and you can move it forward, advance the
transducer into the stomach. Then straighten the tip and remove the transducer.
If you cannot move the tip in any direction, Philipss consultants recommend that
you x-ray the patient to evaluate the situation. You might also want to involve a
gastroenterologist or anesthesiologist.

Ensuring Accurate Temperature Sensing


The OmniPlane and S7-3t TEE transducers contain a built-in temperature sensor
near the distal tip of the transducer. The sensor monitors the transducers temper-
ature to prevent potential burning of esophageal tissue.
The sensor is affected by patient core temperatures. The system assumes that the
patient temperature is normal, and calculates the distal tip temperature accord-
ingly. If the patient temperature is above 37C (98.6F), the Auto-Cool feature
can miscalculate the temperature of the distal tip. This can expose patients to
excessive temperatures or cause an unwarranted Auto-Cool condition in which
the system stops scanning.

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To ensure patient safety and to avoid unnecessary interruption while
scanning
Ensure distal tip temperature accuracy by entering an accurate patient core
temperature.
Decrease the transducer temperature by using the Power knob before intro-
ducing a TEE transducer to decrease acoustic output, and keep the control at
the lowest possible setting during an exam. For information about controlling
the power, see the Help.
Use the TEE Manual Auto-Cool safety feature to enter the patient tempera-
ture if it is above 37C (98.6F), as described in the next section.

TEE Manual Auto-Cool Safety Feature


Use the TEE Manual Auto-Cool feature to enter above-normal patient tempera-
tures. By default, the system shows both the patient and distal tip temperature
while scanning.
NOTE
The patient temperature displayed on the ultrasound screen is always either 37C
(98.6F) or the temperature that you manually enter. The system does not report
the actual patient temperature.

If the distal tip temperature reaches 41C (105.8F), a warning message


appears and the transducer temperature is displayed in inverse video.
If the distal tip temperature reaches 42.5C (108.5F), a warning appears with
the patient and the transducer temperatures, and the system stops imaging
until the distal tip cools to 42.0C (107.6F) or lower.
If the temperature reaches 46.5C (115.7F) when using the T6H transducer,
or 45C (113F) when using the S7-2omni or the S7-3t transducer, the system
shuts down. You must turn it off and then on to restart it.

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WARNINGS
To avoid the risk of esophageal burn for adult patients, minimize the time
spent imaging at distal tip temperatures in excess of 42C (107.6F). Exposure
should be limited to 10 minutes or less at 42C (107.6F) or higher.
Sufficient data on thermal tolerance of the esophagus in neonate and pediatric
patients does not exist, but it is likely these patients are more vulnerable than
adults. Minimize the time spent imaging at distal tip temperatures in excess of
41F (105.8F).

Entering the Patient Temperature


Always check the patients temperature before inserting a TEE transducer. If it is
above normal, whether from fever or therapeutic heating from a cardiac bypass
heart-lung machine, perform the following steps before inserting the transducer.
Also, follow these steps if a patients temperature rises during an exam.
WARNING
To protect the patient and to ensure the effectiveness of the Auto-Cool safety
feature, be sure to enter the correct patient temperature.

Measure the patients core temperature, or more specifically, the actual tempera-
ture in the esophagus.
For patients undergoing surgery:
Determine the temperature in the esophagus by direct measurement or
by monitoring the temperature of blood returning from the bypass pump
heat exchanger.
For closed chest situations:
Rectal temperature is the best estimate of core temperature.
You can also use oral temperatures, even though they can be 1 lower
than the core temperature.
If you measure an auxiliary temperature, which can be 2 lower than the
core temperature, add 1 or 2.

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WARNING
Each time you turn off or reset the system, or enter a new patient ID, the system
displays the patient temperature as 37C (98.6F). You need to manually enter the
actual temperature.

To enter the patient temperature


1. Press Probe repeatedly until the TEE transducer is active, as displayed on the
screen.
2. Press the Patient Temp soft key to enter the patients temperature. (To
learn about soft keys, see the Help.)

Monitoring the Distal Tip Temperature


The transducer temperature appears on the upper part of the display, in inverse
video, if the distal tip exceeds 41C (105.8F).
By default, the patient temperature and the distal tip temperature are displayed
throughout a TEE exam (Figure 10-9).
Figure 10-9 TEE Temperature Display

PAT T:37.0C
TEE T:37.0C

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A less-than sign (<) after TEE T indicates that the transducers distal tip tem-
perature is below the patient temperature (PAT T)either 37C (98.6F) or
the temperature you entered.
A colon (:) after TEE T indicates that the distal tip temperature is greater
than or equal to the patient temperature.
If the distal tip temperature reaches 41C (105.8F) during imaging, an Auto-Cool
imminent message appears, as shown in Figure 10-10.
Figure 10-10 TEE Auto-Cool Imminent Display

PAT T:37.0C
TEE T:41.0C

TEE auto cool imminent. Reduce Power. Adjust


Patient Temp if appropriate.

300 004

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If the distal tip temperature reaches 42.5C (108.5F) during imaging, an
Auto-Cool in progress message is displayed, as shown in Figure 10-11.
Figure 10-11 TEE Auto-Cool in Progress Display

PAT T:37.0C
TEE T:42.5C

TEE auto cool in progress. Wait for


transducer to cool or adjust Patient Temp to
set the current patient temperature.

Resuming Imaging After an Auto-Cool Interruption


When the distal tip temperature drops below 42.0C (107.6F), the system
resumes imaging. If the Auto-Cool message persists longer than 1 minute or an
error message is displayed, contact your Philips Ultrasound service representa-
tive.
WARNING
The Reconnect the transducer error message is often caused by a poorly
seated transducer connector, but could be caused by a failure in the Auto-Cool
Safety logic. In the case of a logic failure, distal tip temperatures could reach
46.5C (115.7F) in hyperthermic patients (40C to 41C (104F to 105.8F))
before the error causes scanning to stop. At this temperature, esophageal burns
may occur.1, 2

1. Ding-Jiu et al. Thermodamage, Thermosensitivity and Themotolerance of Normal Swine


Esophagus. International Journal of Hyperthermia, Vol. 3, No. 2: 143-151.
2. Moritz, A. R. and Henriques, F. C. Studies of Thermal Injury, II. The Relative Importance of
Time and Surface Temperature in the Causation of Cutaneous Burns. American Journal of
Pathology, Vol. 23: 695-720, 1947.

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To respond to the Reconnect the transducer message


1. Be sure the transducer connector is properly seated.
2. Press the Reset button.
If the system does not resume imaging immediately, contact your Philips represen-
tative.

Changing Temperature Display Options


To change the way the patient temperature and the distal tip
temperature are displayed
1. Press Setup.
2. Click the System tab.
3. In the TEE temperature units section, select Celsius or Fahrenheit for
the TEE temperature units, as follows:
Select Celsius to display the patient and distal tip temperature in centi-
grade.
Select Fahrenheit to display the patient and distal tip temperature in
Fahrenheit.
NOTE
You can also specify the following display settings in the TEE temperature
units section: Height and weight units, background color, and 2D image size.

4. Click Apply or Save, and then Close to save the changes.

Checking the Patient After a TEE Examination


You should follow your institutional guidelines for post TEE exams. In addition,
you might want to include the following recommendations in your guidelines.
These recommendations are neither exhaustive nor restrictive, but are steps you
might want to incorporate into your post TEE exam routine.
Inspect the patients throat for any bleeding.
Examine the patient for postural hypotension or difficulty walking.
Instruct the patient to contact you immediately if he or she experiences any
fever, chills, chest pain, or bleeding.

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Instruct the patient not to eat or drink for at least 2 hours or until swallowing
returns to normal after anesthesia has worn off. It is especially important that
the patient not ingest hot foods or fluids during this period.
Follow up with a call to the patient the day after the exam to make sure there
are no complications.

TEE Accessories
Each OmniPlane TEE transducer comes with two disposable bite guards and a dis-
posable tip protector. This section describes bite guards, tip protectors, and TEE
transducer covers. For information on ordering TEE accessories, see HD11 XE
System Supplies, Peripherals, and Accessories on page 259.

Bite Guards
All patients must wear a bite guard during a TEE exam. A bite guard prevents dan-
gerous transducer mechanical and electrical malfunction caused by involuntary
biting. Even anesthetized patients require bite guards to prevent damage to their
teeth and to the transducer. Philips supplies disposable bite guards that are suit-
able for both awake and anesthetized patients.
WARNING
The M2203A bite guard strap contains natural rubber latex, which may cause
allergic reactions. For more information, see Latex Materials and Patient Con-
tact on page 52 and FDA Medical Alert on page 52.

CAUTION
Damage caused when patients bite or scrape a TEE transducer is not covered in
the transducers warranty or your service contract. Be sure to use bite guards to
help prevent such accidents.

Tip Protector
When not using a carrying case to transport a TEE transducer, you should use a
tip protector on its distal tip. The tip protector helps prevent serious damage to
the transducers lens. Philips supplies tip protectors designed for each of its TEE
transducers.

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Transducer Covers
Philips recommends the use of a market-approved protective transducer cover
during every TEE exam.
WARNING
Transducer covers often contain natural rubber latex, which may cause allergic
reactions. For more information, see Latex Materials and Patient Contact on
page 52 and FDA Medical Alert on page 52.
For procedures on using transducer covers (protective sheaths), see the instruc-
tions provided with the covers.

Disposable Drape
For information on using a disposable drape, see Disposable Drape on page 59.

Electrical Safety Check Procedure for TEE Transducers


This section provides instructions for performing an electrical safety check proce-
dure on TEE transducers. Regularly perform the safety check described here to
determine if there is a hole in a transducers outer insulating layer. This procedure
detects liquid pathways to the interior parts of the transducer shaft and tip by
measuring third-wire leakage current. You can perform this procedure with any
commercially available safety analyzer that is designed for hospital use.
A technically qualified person should perform this procedure.

Test Background
The test procedure (Figure 10-12) involves making an AC measurement of the
ultrasound system current without a transducer. The results are then compared
with the current measured when it is forced to flow through the insulating layer of
the TEE transducer. If the two currents are nearly the same, it means there is a
hole in the transducers outer insulating layer that must be fixed before using the
transducer.

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Figure 10-12 Electrical Safety Check Procedure for TEE Transducers

Insulating outer layer


i internal metal sheath

Ultrasound system
Saline
Safety analyzer (metal chassis)
S3
A L i 3.3 ft
S2
e (1 m)
S1 N Test tube
C (nonconductive)
E i
Test electrode
TEE transducer

Key:
C Stray capacitance from the ultrasound system power wiring to the system
grounded metal chassis (1 to 3 M reactance)
Z Impedance between the metal parts of the TEE transducer and a test
electrode placed in the bucket of saline solution (about 850 k with an intact
outer insulating layer, 500 with a hole in the layer)
A Microammeter to measure third-wire current, either directly from the chassis
or through Z to the test electrode
e Line power source, either 110 Vac or 220 Vac
i Current caused by e and stray capacitance, and optionally Z
S1 Open Earth Lift Ground switch
S2 Line Polarity switch
S3 Microammeter switch

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L Line mains supply


N Neutral mains supply
E Earth Ground

Current i, driven by line supply e, flows through all stray capacitances between the
primary wiring and the ultrasound systems metal chassis. Ordinarily, current then
flows from the metal chassis through S3 and back to e through a third-wire
ground. When S3 is thrown in the other position, current i is forced:
1. From the chassis through the metal parts of the transducer
2. Through impedance Z, produced by the insulating layer that covers the metal
parts of the transducer and the saline solution
3. Through the test electrode
Saline generally presents an impedance of about 500 , so Z will vary between
850 k and 500 , depending on whether or not there is a conductive pathway
caused by a hole in the transducers insulating layer.
NOTE
Do not make a DC measurement of impedance. This could set up a voltaic cell,
with the metal of the transducer and a test electrode in the salt bath forming the
two electrodes and an electrolyte. Such a voltaic cell produces inaccurate resis-
tance measurements.

Equipment and Procedure


You need the following equipment to perform the electrical safety check proce-
dure:
Dempsey 432HD or 232D safety analyzer or equivalent
Philips 21110A Disinfection Basin or equivalent
Saline solution (9 grams (0.3 oz) of salt to 1 liter (1 qt) of tap water) or one of
the tested disinfectants listed in this section

To perform the electrical safety check procedure


1. Gather the equipment in the preceding list.
2. Fill the basin to the fill line with saline solution.

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3. Place the distal tip and shaft of the transducer into the basin.
4. Connect the transducer to the system.
5. Plug the ultrasound systems power cord into the test receptacle on the safety
analyzer.
6. Attach a lead from the safety analyzer binding post labeled RL to a metal plate
submerged in the basin.
7. On the safety analyzer, set the Leads switch to RL. Set the Line Polarity
switch (S2) to NORMAL.
8. Turn on the safety analyzer and the ultrasound system.
9. Set the Mode switch (S3) on the safety analyzer to the Case Leakage -
Ground Conductor position. Press the Lift Ground switch (S1) on the
safety analyzer and record the chassis leakage current.
10. Set the Mode switch (S3) on the safety analyzer to the ECG position. Press
the Lift Ground switch (S1) on the safety analyzer and record the patient
leakage current.
The transducer fails the test if the patient leakage current recorded in step 10 is
greater than 80% of the chassis leakage current recorded in step 9.
This failure indicates that there is a hole in the insulating layer of the TEE shaft. A
hole enables a conductive pathway to internal metal parts of the transducer and
presents a potentially hazardous condition to a patient undergoing external
defibrillation or electrosurgery. A hole also allows invasion of organic material,
making it difficult to completely disinfect all portions of the transducer. For these
reasons, the transducer must be repaired before it is used.

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11 Biopsy-Capable Transducers
This section provides the following information about the biopsy-capable trans-
ducers that you can use with the ultrasound system.

Transducers Supporting Biopsy


Table 11-1 lists the transducers that support biopsy procedures. For information
on ordering biopsy kits, see HD11 XE System Supplies, Peripherals, and Acces-
sories on page 259.

Table 11-1 Biopsy-Capable Transducers

Transducer Type Name

Curved Array C5-2

C6-3

C8-4v

C8-5

C9-4

C9-5ec

Sector Array PA4-2

S4-2

Linear Array L8-4

L9-3

L12-3

L12-5

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Table 11-1 Biopsy-Capable Transducers (Continued)

Transducer Type Name

3D/4D 3D6-2

3D8-4

3D9-3v

V6-2

V8-4

For information and instructions on cleaning and disinfecting transducers used in


biopsy procedures, see Cleaning, Disinfecting, and Sterilizing Transducers on
page 161.

Biopsy Guide Instructions


CIVCO supplies biopsy kits for all transducers in this document that support
biopsy. Follow the manufacturers instructions for needle guide use. The following
instructions are covered in the CIVCO users guide for each needle guide:
Preparation for use
Attaching the bracket
Applying a sterile cover
Attaching a needle guide
Cleaning and sterilization
Using reusable needle guides, if applicable

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Using the Biopsy Needle Guide


The system displays biopsy guidelines that direct the operation of the biopsy nee-
dle. Activate the on-screen guidelines and carefully watch the image while you are
inserting the needle to verify the needle path.
For a description of system controls for biopsy use, see the Help.
WARNING
The biopsy guide for the L12-5 has infinite angle capability and can be installed on
either side of the transducer; it does not constrain the biopsy needle to a partic-
ular path. Because the needle path is not predictable, neither biopsy soft keys nor
biopsy graphics appear on the display when you are using the L12-5 transducer.

Biopsy Precautions
Always follow these basic precautions when using a biopsy needle guide and
bracket:
All biopsy procedures must be performed using highly controlled sterile pro-
cedures. Be sure that the biopsy needle package has not been opened or dam-
aged and that the date has not expired.
Before performing the biopsy setup for the first time, Philips strongly recom-
mends that you familiarize yourself with each possible needle position, proce-
dure, transducer, and screen display. For information on the Biopsy Guide
feature, see the Help.
For most transducers, before inserting the biopsy needle, ensure that the nee-
dle guide is on the same side as the orientation rib on the transducer handle.
For transducers that do not have an orientation rib, such as the C8-4v, the
biopsy needle bracket can attach to the transducer only in the correct orien-
tation. For the L12-5, you can attach the needle guide on either side of the
transducer.
Most needle guides are shipped sterile. Verify on the package that the guide is
sterile.
Use a sterile protective transducer cover and sterile ultrasound transmission
gel with the biopsy needle.

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Most needle guides are disposable. Do not reuse disposable needle guides.
After use, remove the needle guide from the bracket and discard the needle
guide.
Most biopsy brackets are not shipped sterile. Follow the manufacturers
instructions to disinfect the biopsy bracket.
For a description of the system controls for biopsy use, see the Help.

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12 Intraoperative Transducers
An intraoperative transducer is used during surgery to help the surgeon locate
and visualize anatomical structures, to visualize blood flow patterns and quantify
velocities, and to image and measure anatomical and physiological parameters of
interest to the surgeon.
This section shows you how to prepare the L15-7io and S12-4 transducers for
use in intraoperative applications.

Operator
Philips intraoperative transducers are designed for use under the guidance of phy-
sicians who are properly trained in intraoperative ultrasound imaging techniques,
according to currently approved relevant medical practices. Philips recommends
that physicians operating any Philips intraoperative transducer are
Proficient in recognizing and interpreting imaging patterns
Thoroughly familiar with the safe operation, care, and maintenance of the
ultrasound system and intraoperative transducers
Fully informed about the latest intraoperative methods through literature and
seminars

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Intended Use
Intraoperative studies are performed by surgeons, anesthesiologists, physicians,
or sonographers to obtain images that can be used to
Help a surgeon locate and visualize anatomical structures before, during, or
after a surgical procedure
Help a surgeon visualize blood flow patterns and quantify velocities before,
during, or after a surgical procedure
Image and measure anatomic and physiologic parameters before, during, or
after a surgical procedure
The transducers discussed in this section can be used for adult, pediatric, and
neonatal heart and vessel imaging.
WARNING
Intraoperative transducers used in animal studies should not be used on humans.
Transducer disinfection procedures for cross-usage between animals and humans
have not been validated.

Patient Safety
This section lists conditions that can adversely affect patients when you are using
an intraoperative transducer.
To operate an intraoperative transducer, you must be under the guidance of a
physician who is properly trained in intraoperative ultrasound imaging techniques,
according to currently approved relevant medical practices. You also must be
thoroughly familiar with the safe operation, care, and maintenance of the ultra-
sound imaging system used with the transducer, as well as proficient at interpret-
ing the images generated.
You can help ensure patient safety when using an intraoperative transducer by
Scrutinizing the entire transducer before each use. See Inspecting Transduc-
ers for Damage on page 156.
Using mandatory protective equipment, including an approved sterile protec-
tive transducer cover during intraoperative exams. For information about
ordering transducer covers, see HD11 XE System Supplies, Peripherals, and
Accessories on page 259.
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Intraoperative Transducers 12
Operating the transducer properly.
Not allowing water or other liquids to drip onto the transducer connector,
the interior of the system, or the keyboard.

WARNINGS
All intraoperative studies must be performed with a type CF classified
transducer. If your transducer is not labeled type CF on the transducer
connector, contact your Philips service representative.
Be sure to use a market-approved sterile transducer cover and sterile ultra-
sound transmission gel when performing all intraoperative studies.
Always remove the transducer from the patient before defibrillation.

Patient Contact Parts


Latex is commonly used in transducer covers marketed to help with infection
control in transesophageal, endocavity, and intraoperative imaging applications, or
with transducer covers used during biopsy. Examine the package to confirm latex
content. Studies have shown that allergic reactions with natural rubber latex can
be experienced. The U.S. Food and Drug Administration has published a medical
alert on latex products dated March 29, 1991. For more information, see FDA
Medical Alert on page 52.
NOTE
The ultrasound system and transducers discussed in this manual do not contain
natural rubber latex that contacts humans. Natural rubber latex is not used on
any ultrasound transducer, including transthoracic, intraoperative, and transe-
sophageal transducers. It is also not used on ECG cables.

Equipment Operation
Meticulous inspection and correct and careful operation of intraoperative trans-
ducers are imperative to patient safety. The situations listed in this section affect
safe operation as well as the ability to service mechanical problems under the
Philips 1-year warranty or service contract. Transducer repairs necessitated by
misuse are not covered and can be very costly, often requiring complete disas-
sembly and rebuilding of the transducer.

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The primary areas of customer misuse are


Cuts and abrasions on the transducer insulation and lens from sharp instru-
ments such as scalpels, scissors, and clamps
Improper disinfection techniques, causing fluid to enter the transducer or
damage transducer materials
Damage caused by dropping the transducer on a hard surface
WARNING
If you find any signs of damage to the transducer, patient safety may be in ques-
tion. Do not use the transducer, and contact your Philips service representative.
To minimize the chance of damage, Philips strongly recommends that you clearly
post stringent protocols for the care of intraoperative transducers based on the
information in this manual.

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Description and Use


This section lists important features of the L15-7io (Figure 12-1) and the S12-4,
(Figure 12-2) intraoperative transducers, and shows you how to prepare the
transducers for use in intraoperative applications.
Figure 12-1 L15-7io Transducer

Features Broadband linear array with exceptional near-field


resolution and clarity. Excellent contrast resolution and
tissue differentiation for high-frequency superficial
imaging. The ergonomic shape provides comfortable
manipulation.
Connection See Connecting Transducers on page 150.
Specifications Nose Footprint: 1.04 cm x 3.16 cm (0.41 in x 1.2 in)
Handle Length: 8.91 cm (3.51 in)
Cable Length: 2.4 m (8 ft)

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Figure 12-2 shows and describes the S12-4 transducer.


Figure 12-2 S12-4 Transducer

Features Provides imaging in a range of frequencies up to


12.0 MHz, which enables high resolution for the finest
anatomical structures.
Small, lightweight design with a thin, flexible cable that
permits easier manipulation when used for neonatal and
pediatric patients or on an organ surface.
Connection See Connecting Transducers on page 150.
Specifications Nose Footprint: 1.7 cm x 1.0 cm (0.7 in x 0.4 in)
Handle Length: 6.0 cm (2.4 in)
Cable Length: 1.8 m (5.9 ft)

Preparing a Transducer for Intraoperative Imaging


For procedures on using transducer covers (protective sheaths), see the instruc-
tions provided with the covers.

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Intraoperative Transducers 12
During exams where you believe contamination of the imaging system can occur,
Philips recommends that you take universal precautions and cover the imaging
system with a disposable drape. Consult your hospitals rules regarding equipment
use in the presence of infectious disease.

To prepare a transducer for use in Intraoperative imaging applications


1. Place 20 cc of sterile gel or saline into the transducer cover.
2. Carefully inspect each transducer cover before use and discard it if you find
tears or blemishes. Also inspect each transducer cover after use. If you find a
tear, the patient or the transducer may have been contaminated.
3. Insert the transducer into the transducer cover and unfurl the transducer
cover until it covers the transducer and its cable. The transducer cover must
be unfurled far enough to maintain the sterile field.

4. Use a sterile elastic band or clip to hold the proximal end of the transducer
cover in place.

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12 Intraoperative Transducers

5. Ensure that wrinkles and bubbles over the face of the transducer are mini-
mized. Check the transducer cover for tears or damage before proceeding.
6. When operating the transducer, make sure that proper orientation is main-
tained to avoid interpretation confusion.

NOTES
To achieve good acoustic contact, make sure that the imaging surface is moist.
Imaging improves with adequate coupling between the patient surface and the
transducer cover surface. Sterile water works as a good acoustic coupling
agent during surgery.

Disposable Drape
For information about using a disposable drape, see Disposable Drape on
page 59.

Accessory Equipment
For information on ordering accessory equipment, see Supplies on page 259.

Electrical Safety
All Philips ultrasound systems and transducers comply with common medical
device electrical safety standards.
For information on performing leakage current tests on intraoperative transduc-
ers, see Testing Leakage Current on Intraoperative Transducers on page 253.

Defibrillators
For precautions to observe when a defibrillation is required, see Defibrillators
on page 51.

Accessory Equipment
For information on ordering intraoperative transducer supplies and accessories,
see HD11 XE System Supplies, Peripherals, and Accessories on page 259.

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Intraoperative Transducers 12

Testing Leakage Current on Intraoperative Transducers


This section provides instructions for testing leakage currents on intraoperative
transducers.

NOTE
A technically qualified person should perform this procedure.

Leakage Current
Philips transducers approved for intraoperative use are labeled on the transducer
connector as type CF in accordance with the IEC 60601-1. Type CF classifica-
tion indicates that the degree of protection from electrical shock afforded by the
transducer is suitable for all patient applications including direct cardiac and intra-
operative applications.

Leakage Current Testing


Leakage current tests should be performed by a technically qualified person any
time that the transducer is dropped or if cracks or cuts are found on the trans-
ducer.
Normal leakage current testing frequency should be based on the procedures
established by the hospital for operating-room-based equipment.
NOTE
Attach the transducer to the ultrasound system and test with an appropriate
safety analyzer to ensure that IEC 60601-1 type CF leakage limits are not
exceeded.

Figure 12-3 tests the current leakage, using a Dynatech Nevada 232 Safety/ECG
Analyzer. This procedure shows one example of a current leakage test (source
and sink). The procedure for your safety analyzer may be very different.
Perform the following leakage current tests shown in Figure 12-3 and Figure 12-4.
Steps to perform the tests appear following the figures.

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12 Intraoperative Transducers

Figure 12-3 Test 1Transducer Leakage Current Test (Source)

i Saline
Ultrasound system
(metal chassis) Test container
(nonconductive)
Z
A L
S2

N e
S1
Test electrode
E C
Intraoperative transducer
immersed in saline solution

Key:
C Stray capacitance from the ultrasound system power wiring to the system
grounded metal chassis (1 to 3 M reactance)
Z Impedance between the metal parts of the transducer and a test electrode
placed in the bucket of saline solution (about 850 k with an intact outer
insulating layer, 500 with a hole in the layer)
A Microammeter to measure leakage current from the transducer to the Earth
Lift Ground through Z to the test electrode
e Line power source, either 110 Vac or 220 Vac
i Current caused by e and stray capacitance, and optionally Z
S1 Open Earth Lift Ground switch
S2 Line polarity switch

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L Line mains supply


N Neutral mains supply
E Earth Ground

To perform Test 1Transducer Leakage Current Test (Source)


1. Plug the safety analyzer into the power source.
2. Plug the ultrasound system into the safety analyzer.
3. Connect the transducer being tested to the ultrasound system.
4. Immerse 5 cm (2 in) of the transducer in the saline solution.
5. Set the safety analyzer Mode switch to the ECG position.
6. Set the safety analyzer Leads switch to the ALL (all ECG leads) position.
7. Connect a lead to any ECG terminal on the safety analyzer and immerse the
other end into the saline solution.
WARNING
Electrical Shock Hazard: Do not touch the lead that was connected to the
safety analyzer in step 7.

8. Set the safety analyzer Line Polarity switch to Normal.


9. Note the normal condition leakage reading.
10. Press and hold the safety analyzer Ground Open switch in the Open posi-
tion (Single Fault condition), and note the leakage reading on the output dis-
play.
11. Repeat step 9 and step 10 with the Polarity switch in the Reverse position.
The applicable limits are
10 A RMS (normal condition)
50 A RMS (Single Fault condition)

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12 Intraoperative Transducers

Figure 12-4 Test 2Transducer Leakage Current Test with Mains Voltage
Applied (Sink)

i=less than 50 A
Saline

Ultrasound system i
Safety analyzer (metal chassis)

Z Test container
A S2 L (nonconductive)
e
N
S1
Test electrode
C
S3 E Intraoperative transducer
immersed in saline

Key:
C Stray capacitance from the ultrasound system power wiring to the system
grounded metal chassis (1 to 3 M reactance)
Z Impedance between the metal parts of the transducer and a test electrode
placed in the bucket of saline solution (about 850 k with an intact outer
insulating layer, 500 with a hole in the layer)
A Microammeter to measure leakage current from a line supply to the
transducer and back to Earth Ground through electrode Z and the equipment
chassis
e Line power source, either 110 Vac or 220 Vac
i Current caused by e and stray capacitance, and optionally Z
S1 Open Earth Lift Ground switch
S2 Line polarity switch

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Intraoperative Transducers 12

S3 Isolation Test button


L Line mains supply
N Neutral mains supply
E Earth Ground

WARNING
There is considerable hazard in performing this test. Use precautionary measures
to avoid accidental contact with line voltage. In addition, any time that the ground
connection has been opened, do not touch the chassis or the patient cable during
the test.

To perform Test 2Transducer Leakage Current Test with Mains


Voltage Applied (Sink)
1. Plug the safety analyzer into the power source.
2. Plug the ultrasound system into the safety analyzer.
3. Connect the transducer being tested to the ultrasound system.
4. Immerse 5 cm (2 in) of the transducer in the saline solution.
5. Set the safety analyzer Mode switch to the ECG position.
6. Set the safety analyzer Leads switch to the Isolation Test position.
7. Connect a lead to any ECG terminal on the safety analyzer. Leave the other
end of the lead disconnected for now.
8. Press and hold the Isolation Test button and note the leakage reading on the
output display. This is the correction factor that will be subtracted from the
final reading.
9. Immerse the other end of the lead into the saline solution.
10. Press and hold the Isolation Test button and take the leakage reading again.
11. Subtract the correction factor found in step 8 to get the accurate leakage
measurement. The leakage must be less than 50 A RMS.

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12 Intraoperative Transducers

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Appendix A HD11 XE System Supplies,
Peripherals, and Accessories
This appendix lists the supplies and accessories available for use with the ultra-
sound system, and provides information on ordering. Items are categorized as fol-
lows:
For consumable items, see Supplies on page 259.
For printers and VCRs, see Peripherals on page 265.
For option items that you can purchase separatelysuch as the microphone,
foot switch, cables, and so onsee Accessories on page 266.

Ordering Parts
Unless otherwise specified, address all parts orders or inquiries to your local
Philips Sales and Service office. To locate your local sales office, see Customer
Service on page 20.

Supplies
This section lists supplies that you can order for your ultrasound system.

Physio Supplies
Table A-1 lists and describes the trunk cables, lead sets, and electrodes that you
can order for use with the Physio option.
Table A-1 Physio Supplies
Description Product Number Part Number
Trunk Cables
3-Lead Trunk Cable, AAMI M1500A 989803103811
3-Lead Trunk Cable, IEC M1510A 989803103871

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A HD11 XE System Supplies, Peripherals, and Accessories

Table A-1 Physio Supplies (Continued)


Description Product Number Part Number
AAMI Lead Sets (for North America and Australia)
3-Lead Set, Grabber M1603A 989803104371
3-Lead Set, Snap M1605A 989803104381
3-Lead Set, Mini Clip 0.45 m M1608A --
(1 ft 5 in)
3-Lead Set, Mini Clip 0.7 m M1609A 989803104411
(2 ft 3 in)
IEC Lead Sets (All Other Countries)
3-Lead Set, Grabber 1.0 m M1611A --
(3 ft 3 in) (OR use)
3-Lead Set, Grabber 1.0 m M1613A 989803104451
(3 ft 3 in) (ICU use)
3-Lead Set, Snap M1615A --
Unshielded 3-Lead Set, IEC, M1619A 989803104481
Mini Clip
Electrodes
Foam Electrodes, Rectangular, 40420A 989803101301
Pre-gelled, 10/card, 100
cards/case
Cloth Electrodes, Pre-gelled, 13944B --
5/card, 300/case
Pediatric Electrodes, Cloth, 13951C 989803100491
Pre-gelled, 30/pack, 300/case
Foam Electrodes, Round, 40493E --
Pre-gelled, 30/pack, 300/case

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HD11 XE System Supplies, Peripherals, and Accessories A

Printer Supplies
Table A-2 lists and describes the supplies you can order for use with your printer.
For information on ordering USB printers and accessories, see Table A-6 on
page 265.
NOTE
Philips recommends the use of high-glossy paper to maximize print image quality.
the use of high-density or standard paper will significantly degrade the print qual-
ity.

Table A-2 Printer Supplies


Product
Description Number Part Number
Black-and-White Thermal Printer Paper
High Glossy Printing Paper (box of 5 rolls, SNY110HG 989803110101
Sony UPP-110HG)
High Density Printing Paper (box of 5 rolls, SNY110HD 989803110091
Sony UPP-110HD)
High Quality Printing Paper (box of 5 rolls, SNY110S 989803110111
Sony UPP-110S)
Color Printer Paper
Sony UPC-21L SNY21L 453563486801

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VCR Supplies
Table A-3 lists and describes the videotapes that you can order for use with the
VCR option on the system. For information on ordering VCRs and accessories,
see Table A-7 on page 266.
NOTE
Using VHS tapes degrades the playback image quality. Philips requires you to use
S-VHS videotapes.

Table A-3 VCR Supplies


Product
Description Number Part Number
S-VHS Tapes (case of 10 tapes, SQ-T120) 13921B --

Removable Media
Table A-4 lists and describes the types of removable media you can use with your
system. The ultrasound system comes standard with a R/W (Readable/Writable)
CD-ROM drive. The optical disk drive is an option that you can purchase sepa-
rately.
Table A-4 Removable Media
Product
Description Number Part Number
CD-RW 700-MB CD-R/W Media -- You can purchase
CDs directly from
CD-R 700-MB CD-R Certified 40x Media --
a computer or an
office supply
store.
3.5-inch Magneto-optical Disc (MOD) M2540-80101 453563468731
540-MB Rewritable ISO/IEC 15041
3.5-inch Magneto-optical Disc (MOD) M2540-80105 453563489541
1.3 GB

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HD11 XE System Supplies, Peripherals, and Accessories A

Transducer Supplies
This section provides information on ordering transducer supplies. For more
information about transducers, see Transducers on page 145.

Ordering Transducer SuppliesPhilips Medical Supply Center


Table A-5 lists and describes the ultrasound gels and TEE accessories that you can
purchase for use with ultrasound system transducers.
Table A-5 Transducer Supplies
Description Product Number Part Number
Ultrasound Gel
8.5-oz bottles (case of 12) 40483A --
5-liter bottle (to refill 40483A) 40483B --
TEE Supplies
OmniPlane III TEE Tip Protector M4604A 989803133811
(box of 24)
Bite Guards (case of 24) M1828A --
TEE Disinfection Basin 21110A --
TEE Sheath Kit (12 sheaths/kit) 40487A --

To order bite guards, tip protectors, transducer covers, and disinfection


basins
In the United States, contact the Philips Medical Supplies Center
1-800-225-0230
In Canada, call
1-800-387-3154
In other countries, contact your local Philips sales representative.
For the latest ordering information, go to the following Philips Web site:
www.medical.philips.com

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A HD11 XE System Supplies, Peripherals, and Accessories

Ordering Transducer SuppliesCIVCO Medical Instruments


To order transducer covers, biopsy guides, and other supplies and
accessories from CIVCO

CIVCO Medical Instruments Co.


102 First Street
Kalona, IA 52247-9589 USA

E-mail: info@civcomedical.com
www.civco.com
Telephone (within the United States): 800-445-6741
Telephone (outside of the United States): +1 319-656-4447
Fax: +1 319-656-4451

Ordering EPMedSystems FlexMate ICE Catheter Transducers


To order ICE catheter transducers from EPMedSystems
EPMedSystems, Inc.
Cooper Run Executive Park
575 Route 73, North Unit-D
West Berlin, NJ 08091

www.epmedsystems.com

Telephone (toll free): 800-537-6285


Telelephone:+1 856-753-8533
Fax: +1 856-753-8544
Technical Support: 800-361-6464

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HD11 XE System Supplies, Peripherals, and Accessories A

Peripherals
This section lists the peripherals that you can purchase for use with the ultra-
sound system.

Printers and Printer Accessories


Table A-6 lists the USB printers that you can connect to the system, and the
printer accessories that you can purchase. The necessary print drivers are already
installed on your system.
NOTE
When you initially order your ultrasound system, the accessory items are auto-
matically included depending on which peripherals you order.

Table A-6 USB Printer and Accessories


Product
Description Number Part Number
USB Printers
Sony Black-and-white USB printer UP-D895MD 453563468611
Sony Color USB printer UP-D23MD 453561121361
Sony Color USB printer UP-D55MD 453561220781
Printer Accessories
Color Printer Adapter Kit -- 453563468831

You can also connect a color or a black-and-white plain-paper USB printer, such
as those that can be purchased at an office supply store. Check with your Philips
representative for a list of authorized USB printers before you purchase a printer.
Your Philips representative will also send you a Commercial Off-the-Shelf Soft-
ware (COTS) CD that provides the printer driver and configuration information
necessary for using the printer with your system.
For information on ordering printer supplies, see Table A-2 on page 261. For
instructions on connecting a printer to the system, see Connecting a Printer on
page 97.

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VCRs
You can connect a VCR to your ultrasound system. VCRs that are supported can
be controlled using the system control panel. Unsupported VCRs can only be
controlled manually.
Table A-7 lists the VCRs and accessories.
Table A-7 VCRs and Accessories
Product
Description Number Part Number
VCRs
Mitsubishi NTSC VCR with Serial Interface HS-MD3000U 989605347681
Mitsubishi PAL VCR with Serial Interface HS-MD3000E 989605347691
VCR Accessories
Video in/out cable -- 453563468671
Audio in/out cable -- 453563468691
Serial cable M2540-69090 453563468681

For information on ordering VCR tapes, see Table A-3 on page 262. For instruc-
tions on connecting a VCR to the system, see Connecting a VCR on page 102.

Accessories
This section lists the cables, power cords, and foot switch that you can purchase
for use with the ultrasound system.
Table A-8 lists and describes the cables, the power cords, and the foot switch that
you can purchase for use with the system.
Table A-8 Cables, Power Cords, and Foot Switch
Description Part Number
Cables
LAN External Cable 453563470861
1.8 m (6 ft) USB Printer Cable 453563470871

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HD11 XE System Supplies, Peripherals, and Accessories A
Table A-8 Cables, Power Cords, and Foot Switch (Continued)
Description Part Number
3.0 m (10 ft) USB Cable 453563470881
Internal RS-232 Cable 453563470891
External RS-232 Cable 453563486771
Power Cords
United Kingdom 453563468451
Australia 453563468461
Europe 453563468471
U.S., Canada, and Japan 453563468481
Switzerland 453563468491
Denmark 453563468501
South Africa 453563468511
Israel 453563468521
Argentina 453563468531
Peoples Republic of China 453563468541
Foot Switch
Foot Switch 453563471071

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Index
Numbers B
2D and 3D mode, uses of, 62 Backing up the system, 86
3D/4D mode, uses of, 62 Backlight lamps, disposal, 28
3D/4D option packages, 77 Battery, system, 124
70% isopropyl alcohol, 115 Biological safety
overview, 27
related documents, 39
A Biopsies
Abdominal studies, 62, 63 needle guides, 243
AC power requirements, 50 precautions for, 243
Accessories, 20 Bite guards, 204
approved for electromagnetic Blood, removing from system, 58
compliance, 130 Brakes
ordering, 259 OmniPlane III deflection controls and,
Acoustic exposure and patient safety, 66 215
Acoustic intensity, 30 wheel, 108
Acoustic measurement precision and Breast studies, 68
uncertainty, 43 Brightness, adjusting, 81
Acoustic output and measurement, 40
Acoustic output tables, 17, 43, 66
Activating transducers, 154 C
Air filter maintenance, 119, 121 Cables
ALARA principle, 27, 28 approved for electromagnetic
ALARA, applying, 29, 32 compliance, 129
Alcohol, restricted use of, 164 cleaning, 58, 117
Anatomical M-mode, 61, 73 ordering, 266
Application packages, 74 protecting from damage, 165
Array rotation controls,TEE, 216 standard system, 96
Assigning Calcs analysis, uses of, 62
option keys, 86 Calibration, 217, 218
record keys, 103, 105 Cardiac option package, 74
Assistance, 20 Cardiac studies, 62, 64
Audible acoustic output, 127 Carpal tunnel syndrome (CTS), 56, 156
Auto-Cool, 48, 229 CD, user information, 16, 17
Changing system settings, 85
Cidex OPA warning, 167, 170

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Index

CIVCO Medical Instruments, 20, 264 Connections


Classification symbols, 127 cleaning, 117
Cleaning peripherals, 55
air filter, 121 symbols on, 45
ECG cables, 58 Contrast imaging, microbubble expansion,
ergonomic grip, 156 28
internal components, 28 Control panel
lead sets, 58 components, 71
peripherals, 123 maintenance, 121
system surfaces, 115 Controls
trackball, 122 2D, effect on MI and TI, 37
transducers, 155 direct, 30
Color and Power controls, effect on MI effects on TI and MI, 36
and TI, 37 frozen, 114
Color flow, uses of, 62 indirect, 31
Color Printer SCP, 92 verifying operation of TEE transducer,
Color printer, connecting, 98 219
Color Sector Depth, effect on MI and TI, Convention
37 user information, 18
Color sector effect on MI and TI, 37 Conventions
Combination modes, effect on MI and TI, system, 17
38 user information, 17
Compliance COTS CD-ROM, 100, 130
approved cables, transducers, and Covers
accessories for electromagnetic, 128 transducer, 159
Components transducer, latex, 28
control panel, 71 Creutzfeldt-Jakob disease, 28, 54, 160
ultrasound system, 69 Critical device classification, 161
Configuring Customer comments, 19
foot switch pedals, 104 Customer service, 20
network settings, 90 Customizing your system, 84
Connecting CW Doppler mode, intended uses of, 62
foot switch, 103
peripherals, 94
plain-paper USB printers, 100
D
transducers, 150 Damage
USB printers, 97 from improper handling, 155
VCRs, 102 from improper cleaning, 172
video printers, 99 Data security, managing, 89
Data transfer, 105

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Index

Defibrillators, 51
Deflection controls, 212
E
Depth, effect on MI and TI, 39 ECG
Diagnostic applications for system, 61 cleaning cables and lead sets, 58
DICOM parameters and values, 144
adding a server, 91 physio panel connections, 142
associating servers with roles, 92 signal, 26
configuring network settings, 90 Electrical safety
Conformance Statement, 62 intraoperative transducers, 253
presets, 85 TEE transducers, 208, 236
Structured Reporting, 61, 75, 76 Electrical warnings and patient safety, 48
Direct effect, controls, 30 Electromagnetic compatibility, 24, 139
Directives and standards, list of, 126 Electromagnetic compliance
Disabling options, 85 approved accessories, 130
Disinfectants approved cables, 129
choosing, 161 approved transducers, 130
compatibility table, 178 Electromagnetic emissions, 128
factors affecting efficiency, 177 Electromagnetic immunity, 131
safety considerations, 159 Electromagnetic interference, 133
types, 177 Electrostatic discharge (ESD)
Disinfecting guidelines, 120
cables and connectors, 176 precautions, 26
internal components, 28 Electrosurgical units (ESUs), 139, 209
system surfaces, 115 Endocavity examination
transducers, 169 guidelines, 201
Display preparing patient for, 201
adjusting brightness and tint, 81 preparing transducer for use in, 199
components, 72 Endocavity transducers
output, 33 checking and maintaining equipment
Disposable drapes, 59, 252 operation, 195
Disposal covers, 200
mercury lamps, 28 examination guidelines, 201
of equipment, 124 operator safety, 193
Distal tip patient safety, 193
changing temperature display, 234 preparing for use, 199
monitoring temperature, 231 ultrasound transmission gel, 200
Enter key, using with trackball, 83
EPMedSystems, contact information, 264
Equipment disposal, 124
Ergonomic grips, 56, 156
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Index

Explosive hazards, 52
Export formats, 88
I
ICE imaging option package, 74
ICE transducer, ordering, 264
F Imaging modes, effect on MI and TI, 38
Fan Immersing sterilizable transducers, 175
maintenance, 119 Immunity test level results, 138
turns on periodically, 114 In situ, derated, and water value intensities,
FDA medical alert, allergic reactions to 41
latex, 52, 160 Indirect effect, controls, 31
Fetal studies, 67 Infection control, 58
Finding the system serial number, 112 Input language, changing, 84
FlexMate transducer, ordering, 264 Input/output connections, 95, 139
Focal Zones, 37 Installation requirements, 49, 50
Focus, effect on MI and TI, 37 Installing options, 85
Folders, backing up, 87 Intacardiac echo imaging option, 74
Foot switch Intensities, in situ, derated, and water
configuring the pedals, 104 value, 41
connecting, 103 Interference, 134
operating room warning, 57 Interference and electrosurgical units
symbols on, 46 (ESUs), 139
Frozen controls, 114 Intraoperative studies, 62, 65
Intraoperative transducers, 252
checking and maintaining equipment
G operation, 247
Gate depth, effect on MI and TI, 38 disinfecting by immersion, 172
Gels intended uses, 246
safety considerations, 159 leakage current testing, 253
statement, 192 misuse, common problems caused by,
General imaging option package, 74 248
Glutaraldehyde, 57 patient safety, 246
Ground symbols, 45 preparing for imaging, 250
Gynecological studies, 62 transducer covers, 251
iSCAN Intelligent Optimization, 73
H
Hazards, 23, 52 J
Help, 16, 111 Job Manager, checking, 93
High Q Automatic Doppler Analysis, 73
HIPAA, 89

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Index

Media, removable, 262


K Medical Ultrasound Safety, 17
Keyboard, 83 Messages, on-screen
Keys Calibration failed, 218
assigning option, 86 TEE Auto Cool, 232
assigning record, 103, 105 M-mode and Doppler controls, effect on
soft, 82 MI and TI, 38
Knobs, system control panel, 71 M-mode, uses of, 62
Model number, 125
L Monitor
Language output options, 84 adjusting, 80
Latex, FDA Medical Alert, 52, 160 adjusting brightness, 81
Lead sets, cleaning, 58 adjusting position, 81
Leakage current adjusting tint, 82
TEE transducers, 209 cleaning, 116
testing intraoperative transducers, 253 locking and unlocking, 81
Ligament studies, 66 raising, lowering, and swiveling, 82
Locating the system serial number, 112 Moving the system
Locking and unlocking monitor arm, 81 precautions, 107
Lowering the control panel and monitor, wheel controls, 108
82 MPPS SCP, 93
Multiplanar reformatting (MPR), 73
Musculoskeletal studies, 62, 65
M MWL SCP, 92
Maintenance
air filters, 119, 121
cleaning cables and connectors, 117 N
control panel, 121 Needle guides, 243
fans, 119 Neonatal head studies, 62, 66
peripherals, 123 Network
preventive, 118 configuring settings, 90
recommended frequency of, 118 testing connection, 92
system cart, 117 Neurosurgical applications, 160, 173
transducers, 118 Noncritical device classification, 161
VCR, 119, 123 Nonimaging transducers, 151
of video printers, 123
Managing patient data, 88
Mechanical index (MI)
display, 34
precision and accuracy, 35
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Index

Output display, 33
O Output tables, acoustic, 17
OB/GYN option package, 74
Obstetrical studies, 62, 66
OmniPlane III transducers P
calibration, 217 Pacemakers, 51
damage from improper cleaning, 172 Parts, ordering, 259
deflection control basics, 212 Patient data, managing, 88
deflection controls and brakes, 215 Patient folders, backing up, 87
manipulating the tip, 215 Patient safety
parts, 210 defibrillators and, 51
rotating the arrray, 216 electrical warnings, 48
On/Off button, 79 explosive hazards, 52
Online Help. See Help intraoperative transducer use and, 246
Operating environment, 125 latex materials and, 52
Operating notes, 17 pacemakers and, 51
Operator safety peripherals connections and, 55
carpal tunnel syndrome, 56 TEE transducers, 204
disposable drapes and, 59 ultrasound exposure and, 47
electrical warnings, 48 Pedals, configuring foot switch, 104
ESD guidelines, 120 Pediatric studies, 62, 67
explosive hazards, 52 Peripherals
glutaraldehyde exposure, 57 cleaning and maintaining, 123
infection control, 58 connecting, 94
removing blood and infectious material, connections, 55
58 ordering supplies for, 265
TEE transducers, 203 Physio
transducers, 57 input parameters and values, 144
Options panel connections, 142
assigning keys, 86 supplies, 259
installing, removing, and disabling, 85 See also ECG
purchasable, 75 Power button, 79
Ordering Power control, 30, 36
application packages, 74 Power cords, 267
cables, 266 Power requirements, 125
ICE transducer, 264 Precision and accuracy, MI and TI, 35
power cords, 267 Presets
supplies and accessories, 20, 259 about, 84
USB printers and accessories, 265 backing up, 86
VCRs and accessories, 266 effect on MI and TI, 39

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Preventive maintenance, 118 disinfectants and gels, 159


Printer SCPs, 92 electrical shock hazard, 23
Printers EMC, 24
assigning a record key, 103 ESD, 26
connecting color, 98 explosion hazard, 24
connecting USB, 97, 100 latex and patient contact, 52
connecting video, 99 medical ultrasound, 17
maintaining video, 123 operator, 56
ordering, 265 patient, 47
ordering supplies for, 261 Sani-Cloth HB, 115
PW Doppler, uses of, 62 Sani-Cloth Plus, 115
Saving system settings, 85
Scale, effect on MI and TI, 38
Q Scanning considerations, 32
QLAB Advanced Quantification software, Scrotum studies, 68
61, 78 Sector Width control, effect on MI and TI,
Quaternary ammonium compounds 37
(QUAT), 115 Sector Width, effect on MI and TI, 38
Quick Guide, 16 Security
managing data, 89
R system and data, 17
Radio Frequency (RF), recommended Select key, using with trackball, 83
separation distance, 135 Serial number, finding system, 112
Raising control panel and monitor, 82 Serial Output, 105
Receiver controls, effect, 32 Server, adding a DICOM, 91
Record keys, assigning, 103, 105 Service documentation, 119
Regulatory compliance, 125 Slide controls, 71
Related documents, 39 Small parts studies, 62, 67
Removable media, 88, 262 Soft keys, 82
Removing options, 85 Software options, 78
Repetitive strain injury (RSI), 56, 156 SR Storage Commit SCP, 92
Resident Self Test, 78 SR Storage SCP, 92
Restrictions for use, 138 Standards and directives, list of, 126
Sterilizing transducers, 161
Storage commit SCP, 92
S Storage environment, 125
Safety, 23 Storage SCP, 92
biological, 27 Storing transducers
biological, related documents, 39 daily and long-term storage, 158
dangerous voltages symbol, 23 for transport, 157
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Index

Structured Reporting (DICOM), 61, 75, 76 guidelines, 225


Studies, 63 preparing patients for, 224
Supplies, 20 TEE transducers, 203
physio, 259 accessories, 235
printer, 261 array rotation controls, 216
removable media, 262 checking before each use, 218
transducer, 263 electrical safety, 208
VCR, 262 electrical safety check procedure, 236
Surfaces, disinfecting system, 115 equipment operation, 207
Symbols, system, 45 ESUs, 209
System leakage current, 209
battery, 124 operator safety, 203
cleaning, 116 patient safety, 204
components, 69 preventing accidents, 210
conventions, 17 preventing equipment problems, 208
customizing, 84 preventing harm to patients, 205
input/output connections, 139 temperature controls, 213
moving and transporting, 106 tip fold-over, 227
overview, 61 Temperature
serial number, finding, 112 ensuring accurate sensing, 228
turning on and off, 79 TEE Auto-Cool and, 229
System control panel Tendon studies, 66
components, 71 Testing network connections, 92
maintaining, 121 Theracide Plus, 115
raising, lowering, and swiveling, 82 Thermal exposure, 48
using, 82 Thermal index (TI)
System settings displays, 34
backing up, 87 precision and accuracy, 35
changing and saving, 85 Thyroid studies, 68
preserving, 86 Tint, adjusting, 82
Tip deflection control, 221
Tip fold-over, TEE transducers and, 227
T Tissue models, 42
Tables Trackball
acoustic output, 17 cleaning, 122
disinfectants compatibility, 178 using, 83
Technical support, 112 Transcranial studies, 63, 68, 69
TEE exams Transducers
checking patients after, 234 acoustic coupling medium, 161
considerations for, 224 activating, 154
276 HD11 XE Getting Started
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Index

alcohol and restricted use, 164 intraopertive studies and, 247


approved for electromagnetic recommendations, 161
compliance, 130 Upgrades, system, 19
checking TEE, 218 USB printers, connecting, 101
connectors, 151 User information CD, 16, 17
covers for, 159, 236 User information conventions, 18
damage from improper handling, 155 User information set, description, 16
disinfecting, 169
effect on MI and TI, 39
ergonomic grips, 156
V
handling, 155 Vascular application package option, 74
immersing sterilizable, 175 Vascular option package, 74
inspecting for damage, 168, 173, 174 Vascular studies, 63, 68
intraoperative, 245 VCRs
ordering supplies, 263 assigning a record key, 103
sterilizing, 161 connecting, 102
storing, 157 maintaining, 119, 123
supported, 145 ordering, 266
supporting biopsies, 241 ordering supplies for, 262
TEE, 203 Video printers
ultrasound transmission gel, 200 connecting, 99
Transferring data, 106 maintaining, 119, 123
Transmissible Spongiform Encephalopathy,
28, 54 W
Transporting the system, 106 Warning symbols, 45
Troubleshooting Warnings
fans turns on when system is off, 114 aiming ultrasound beam, 66
system does not turn on, 113 Cidex OPA, 167, 170
system hangs, 114 cleaning and disinfecting equipment,
T-Spray II, 115 115, 164
Turning system on and off, 79 damage to transducers, 156
defibrillation, 51
U ECG signal, 26, 143
Ultrasound exposure and patient safety, 47 electrical, 23, 48
Ultrasound transmission gel equipment environment, 127
biopsy needles and, 243 explosive hazard, 24, 52
critical device applications and, 167, following ESD guidelines, 120
170 foot switch, 57, 104
endocavity exams and, 200 in case of device malfunction, 48

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Index

intraoperative transducers used in


animal studies, 172
latex, 52
life-support devices, 50
moving the system, 106, 110
operating the system, 15
peripheral equipment, 94, 98, 101
replacing the battery, 124
RF communications equipment hazard,
24
sterilizing transducers, 173
symbols on system, 16
system input/output connections, 140
telephone line connections, 94
tranmissible spongiform
encephalopathy, 54
transporting the system, 107
use of peripheral equipment, 55
using cables, transducers, and
accessories, 26, 94, 129
using disinfectants, 176
using disinfectants and gels, 159
using premixed solutions, 165
using wheel controls on inclines, 108
Wheel controls, 108
World Heath Organization, 54, 160

Z
Zoom control, effect on MI and TI, 37

278 HD11 XE Getting Started


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