Philips HD11 XE Getting Started Manual

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Getting Started

4535 612 62651 Rev A

September 2006

HD11 XE Ultrasound System

Manufactured by Philips Ultrasound

22100 Bothell-Everett Highway Bothell, WA 98021-8431 USA Telephone: +1 425-487-7000 or 800-426-2670 Fax: +1 425-485-6080

www.medical.philips.com

This Medical Device meets the provisions of the transposition of the Medical Device Directive 93/42/EEC within the country of origin of the Notified Body concerned with the device.

European Union Representative

Philips Medical Systems Nederland B.V. PMS Quality and Regulatory Affairs Europe Veenpluis 4-6 5684 PC Best The Netherlands

CAUTION

United States federal law restricts this device to sale by or on the order of a physician.

This document and the information contained in it is proprietary and confidential information of Philips Medical Systems ("Philips") and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Philips Legal Department. This document is intended to be used by customers and is licensed to them as part of their Philips equipment purchase. Use of this document by unauthorized persons is strictly prohibited.

Philips provides this document without warranty of any kind, implied or expres sed, inc luding, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.

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Philips has taken care to ensure the accuracy of this document. However, Philips assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability, function, or design. Philips may make improvements or changes in the products or programs described in this document at any time.

This product may contain remanufactured parts equivalent to new in performance, or parts that have had incidental use.

“Color Power Angio,” “HD11,” “High Q,” “OmniPlane,” “QLAB,” “SonoCT,” “Ultraband,” and “XRES” are trademarks of Koninklijke Philips Electronics N.V.

Non-Philips product names may be trademarks of their respective owners.

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HD11 XE Getting Started 4535 612 62651

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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Contents

Intended Uses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62

Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63

Abdominal Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63

Cardiac Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64

Gynecological Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64

Intraoperative Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

Neonatal Head Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66

Obstetrical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66

Pediatric Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

Small Parts Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

Transcranial Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68

Vascular Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68

Ultrasound System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69

System Control Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72

About Standard Features, Clinical Options, and Purchasable Options. . . . . . . . . . . .73

Standard Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Clinical Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Purchasable Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

4 Using the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79

Turning the System On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79

Positioning the Control Panel and Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

Adjusting the Monitor Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

Locking and Unlocking the Monitor Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

Adjusting the Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

Raising, Lowering, and Swiveling the System Control Panel . . . . . . . . . . . . . . . . .82

Using the System Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

Soft Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

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Select and Enter Keys and the Trackball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Changing the Current Input Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

Customizing Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

About Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

Changing and Saving System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Installing, Removing, and Disabling Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Assigning Option Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Making Backups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Backing Up Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Backing Up System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Backing Up Patient Folders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Managing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88

Managing Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

Configuring Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

Configuring the System’s Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

Adding a DICOM Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

Associating DICOM Servers with Roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

Checking the DICOM Job Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Connecting Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

Connecting a Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97

Connecting a VCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102

Assigning Keys to Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103

Connecting and Configuring the Foot Switch . . . . . . . . . . . . . . . . . . . . . . . . . . .103

Configuring and Using the Data Transfer Feature. . . . . . . . . . . . . . . . . . . . . . . . . . .105

Assigning a Record Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105

Transferring Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106

Moving and Transporting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106

Taking Precautions When Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . .107

Using the Wheel Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108

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Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109

Transporting the System in a Vehicle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109

Getting Help and Troubleshooting Your System . . . . . . . . . . . . . . . . . . . . . . . . . . .111

Using the Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111

Getting Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113

5Cleaning and Maintaining the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .115

Cleaning and Disinfecting System Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115

Cleaning the Cables and the Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117

Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118

Recommended Frequency of Maintenance Procedures . . . . . . . . . . . . . . . . . . .118

Service Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119

Electrostatic Discharge Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120

Maintaining the System Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121

Cleaning the Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121

Cleaning the Trackball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122

Cleaning and Maintaining Peripherals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123

VCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123

Video Printers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123

Replacing the System Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124

Disposing of Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124

6Device Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Model Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Storage Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

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Standards and Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126

Audible Acoustic Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127

Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128

Approved Cables, Transducers, and Accessories for EMC . . . . . . . . . . . . . . . .128

Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131

Recommended Separation Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135

Avoiding Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137

Restrictions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138

Immunity Level Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138

Electrosurgical Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139

Input/Output Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139

System Input/Output Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139

ECG/Physio Input Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142

7 Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Supported Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145

Specialty Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149

Connecting Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150

Activating Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154

Transducer Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154

8 Transducer Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Handling Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155

Inspecting Transducers for Damage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156

Installing and Cleaning the Ergonomic Grip. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156

Storing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157

Storage for Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157

Daily and Long-Term Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158

Safety Considerations When Using Disinfectants and Gels . . . . . . . . . . . . . . . . . . .159

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Latex Product Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160

Transmissible Spongiform Encephalopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160

Acoustic Coupling Medium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161

Cleaning, Disinfecting, and Sterilizing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . .161

Choosing a Disinfectant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161

General Cleaning Procedures for All Transducers . . . . . . . . . . . . . . . . . . . . . . .162

Disinfecting Transducers with Wipes and Sprays

(Low to Intermediate-Level Disinfection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163

Cleaning and Disinfecting Cables and Connectors with Wipes and Sprays . . . .164

Disinfecting Transducers by Immersion (High-Level Disinfection). . . . . . . . . . .167

Sterilizing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .173

Disinfectants Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176

Disinfectant Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177

Factors Affecting Disinfectant Efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177

Disinfectants Compatibility Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178

Gels Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .192

9 Endocavity Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193

Operator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193

Equipment Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195

Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195

Description and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195

C8-4v Endocavity Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .196

3D9-3v Endocavity Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .197

C9-5ec Endocavity Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .198

The Endocavity Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .199

Preparing the Endocavity Transducer for an Exam . . . . . . . . . . . . . . . . . . . . . . .199

Preparing a Patient for an Endocavity Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . .201

Endocavity Examination Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201

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Contents

Accessories for Endocavity Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .202

10 TEE Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

Operator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .203

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .204

Equipment Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .207

Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .208

Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209

Electrosurgical Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209

Pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209

Defibrillators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210

Accident Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210

OmniPlane III Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210

Basic Transducer Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211

Deflection Control Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212

Temperature Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213

Description and Use: OmniPlane III Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . .214

Manipulating the OmniPlane III Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .215

Rotating the OmniPlane Array. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .216

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217

Checking the TEE Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .218

Inspecting the Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .218

Verifying Operation of the Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219

S7-3t TEE Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219

Selecting Patients for the S7-3t Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . .221

Deflection and Scan Plane Rotation Control. . . . . . . . . . . . . . . . . . . . . . . . . . . .221

Tip Deflection Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .221

Lock Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .222

Transducer Scan Plane Rotation Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .222

Special Considerations for TEE Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .224

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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 manual.

ARNINGS

• Do not remove system covers; hazardous voltages are present inside the sys-

tem. To avoid electrical shock, use only supplied power cords and connect only to properly grounded wall (wall/mains) outlets.

• Do not operate the system in the presence of flammable anesthetics. Explo-

sion can result.

• Medical equipment needs to be installed and put into service according to the

special electromagnetic compatibility (EMC) guidelines provided in “Electro-

magnetic Compatibility” on page 24.

• The use of portable and mobile radio-frequency (RF) communications equip-

ment can affect the operation of medical equipment.

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Read This First

Warning Symbols

The system uses the following warning symbols (Table 1-1). For additional sym- bols used on the system, see “Symbols Used on the System” on page 45.

Symbol Description

Documentation: The product is marked with this symbol when it is necessary to refer to the user information.

Dangerous voltages: This symbol appears adjacent to high-voltage terminals. It indicates the presence of voltages greater than 1,000 Vac (600 Vac in the United States).

ESD (electrostatic discharge): The product is marked with this symbol to warn the user not to touch exposed pins. Touching exposed pins can cause electrostatic discharge, which can damage the product.

Ta b l e 1 - 1 W a r n i n g S y m b o l s

About Your User Information

The user information provided with your system includes the following components:

• Compact Disc (CD): Includes all of the user information, except the Operat- ing Notes.

• Getting Started: Introduces you to system features and concepts, and helps you set up your ultrasound system. This manual also includes procedures for basic operation. For detailed operating instructions, refer to Help or the User Reference.

• Help: Help is available on the system in some languages and the information in Help is also included in the User Reference on the CD. Help contains comprehensive instructions for using the system. Press Help on the system control panel to display Help. It includes a glossary containing descriptions of all controls and display elements.

• Quick Guide: The Quick Guide is provided with the system and is also included on the CD. It contains procedures, imaging tips, and information on system controls.

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• Acoustic Output Tables: Included on the CD, it contains information about mechanical index (MI) and thermal index (TI) precision and accuracy, the acoustic output default tables, and the acoustic output tables.

• Medical Ultrasound Safety: Included on the CD, it contains information on bioeffects and biophysics, prudent use, and implementing ALARA (as low as reasonably achievable).

• Operating Notes: Contains information that clarifies certain system responses that might be misunderstood or cause user difficulty.

• Shared Roles for System and Data Security: Contains guidelines to help you understand how the security of your ultrasound system could be compromised and information on Philips efforts to help you prevent security breaches.

About Your Compact Disc

The CD contains all of the user information, except the Operating Notes. The instructions for using the CD are included with the CD.

Read This First

Conventions

The system uses certain conventions throughout the interface to make it easy for you to learn and use. The accompanying user information also uses typographical conventions to assist you in finding and understanding information.

System Conventions

These conventions are used in the system:

• The trackball, the Enter key, and the Select key work together somewhat like a computer mouse. Moving the trackball is like moving the mouse. Pressing the Enter key is like pressing the left mouse button. In Image Review, pressing the Select key is like pressing the right mouse button.

• To enter text into a field, click in the field and use the keyboard.

•To display a list, click the down arrow. To scroll through a list, click the arrows at either end of the scroll bar or drag the scroll bar up or down.

• Controls on the control panel include buttons, soft keys, hard keys, option and record keys, knobs, slide controls, and a trackball. Press a button to acti-

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vate or deactivate its function. Turn a knob to change the selected setting. Move a slide control to change its setting. Roll the trackball in the direction that you want to move a caliper or object.

•The Point er control has multiple functions, depending on the mode: Press it to show or hide the system pointer, to exit an active application, to start a function from an icon on the Report and Review pages, or to select and view thumbnails on the display.

User Information Conventions

The user information follows these conventions:

• Hypertext links appear in blue.

• All procedures are numbered, and all subprocedures are lettered. You must complete steps in the sequence they are presented to ensure success.

• Bulleted lists indicate general information about a particular function or procedure. They do not imply a sequential procedure.

• Control names and menu items or titles are spelled as they are on the system, and they appear in bold text.

• Symbols appear as they appear on the system.

• The left side of the system is to your left as you stand in front of the system,

• Transducers and pencil probes both are referred to as transducers, unless the

• Click means to move the pointer to an object and press the Enter key.

• Double-click means to quickly click twice to select an object or text.

• Select means to move the pointer to an object and press the Select key.

• Drag means to place the pointer over an object and then press and hold the

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facing the system. The front of the system is nearest you as you operate it.

distinction is important to the meaning of the text.

Enter key while moving the trackball. Use this method to move an object on the display.

Read This First

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 consequently void your warranty or service contract.

WARNING

Warnings highlight information vital to the safety of you, the operator, and the patient.

Upgrades and Updates

Philips Ultrasound is committed to innovation and continued improvement. When upgrades that consist of hardware or software improvements are released, updated user information sets will accompany those system upgrades.

Customer Comments

If you have questions about the user information set, or to report an error in the user information set

• For U.S. customers, call Philips Ultrasound Customer Service at 800-722-9377.

• For customers outside the USA, call your local customer service representative or contact one of the offices under “Customer Service” on page 20.

You can also send e-mail to Philips Ultrasound Technical Communications at the following address:

bothell.techpubs@philips.com

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Ordering Supplies and Accessories

You can order transducer covers, biopsy guides, and other supplies and accessories from CIVCO Medical Instruments:

CIVCO Medical Instruments 102 First St. South Kalona, IA 52247-9589

Telephone: 800-445-6741, Ext. 1 for Customer Service (USA)

+1 319-656-4447 (International)

Fax: 877-329-2482 (USA)

+1 319-656-4451 (International)

E-mail: info@civcomedical.com

Internet: civco.com

For more information on ordering supplies and accessories, see “HD11 XE Sys-

tem Supplies, Peripherals, and Accessories” on page 259.

Customer Service

Customer service representatives are available worldwide to answer questions and to provide maintenance and service. Please contact your local Philips Ultrasound representative for assistance. You can also contact one of the following offices for referral to a customer service representative, or visit the Philips Ultrasound Web site:

www.medical.philips.com

Corporate and North American Headquarters

22100 Bothell-Everett Highway Bothell, WA 98021-8431 USA

800-722-9377

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Asia Pacific Headquarters

Level 9, Three Pacific Place 1 Queen’s Road East Wanchai Hong Kong

+852 2821 5888

European Headquarters (also serves Africa and the Middle East)

Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2 71034 Böblingen Germany

+49 40 5078 4532

Latin American Headquarters

1550 Sawgrass Corporate Parkway, Suite 300 Sunrise, FL 33323 USA

+1 954-628-1000

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2Safety

Read this section before you use the ultrasound system. Also refer to the Quick Guide and the Help.

Before you use any transducer for the first time, be sure to read all applicable usage, patient-safety, operator-safety, and electrical-safety guidelines in this manual.

If you have any comments or questions about safety, contact your Philips representative.

This section includes critical information about the intended uses of the ultrasound system.

Dangerous Voltages Symbol

The dangerous voltages symbol appears adjacent to high-voltage terminals.

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

Warnings

Before using the system, read the following warnings and this “Safety” section:

Electrical Shock Hazard

WARNING

Do not remove system covers. To avoid electrical shock, use only supplied power cords and connect only to properly grounded wall (wall/mains) outlets. For more information regarding operator and patient safety, see “Electrical Warnings” on

page 48.

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Explosion Hazard

WARNING

Do not operate the system in the presence of flammable anesthetics. For more information regarding operator and patient safety, see “Explosive Hazards” on

page 52.

Radio Frequency Communications Equipment Hazard

WARNING

The use of portable and mobile RF communications equipment can affect the operation of medical equipment.

Electromagnetic Compatibility

Electromagnetic compatibility (EMC) is defined as the ability of a product, a device, or a system to function satisfactorily in the presence of the electromagnetic phenomena that exists in the location of the product, the device, or the system being used; and, in addition, to not introduce intolerable electromagnetic disturbances to anything in that same environment.

Electromagnetic immunity is the ability of a product, a device, or a system to function satisfactorily in the presence of electromagnetic interference (EMI).

Electromagnetic emissions is the ability of a product, a device, or a system to introduce intolerable electromagnetic disturbances into the use environment.

The ultrasound system has been manufactured in compliance with existing electromagnetic compatibility requirements. Use of this system in the presence of an electromagnetic field can cause momentary degradation of the ultrasound image. If this occurs often, review the environment in which the system is being used to identify possible sources of radiated emissions. These emissions could be from other electrical devices used within the same room or an adjacent room, or from portable and mobile RF communications equipment such as cellular phones and pagers, or from the existence of radio, TV, or microwave transmission equipment located nearby. In cases where electromagnetic interference (EMI) is causing disturbances, it may be necessary to relocate your system.

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The system complies with International Standard CISPR 11 for radiated and conducted electromagnetic disturbances. Compliance with this standard allows the system to be used in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CAUTION

Medical equipment has special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the system’s accompanying documents.

“Electromagnetic Compatibility” on page 127 includes information on electro-

magnetic emissions and immunity as it applies to the system. Ensure that the operating environment of your system meets the conditions specified in the referenced information. Operating the system in an environment that does not meet these conditions may degrade system performance.

The information and warnings contained in this and other sections should be observed when installing and using the ultrasound system to ensure its EMC.

Safety

The ultrasound system will remain safe and will provide the following essential performance if it is operated within the electromagnetic environment listed in

Table 6-6 on page 131:

• Imaging (See “Electromagnetic Compatibility” on page 127 for conducted immunity limitations and rationale.)

• Doppler audio and spectral display

•Measurements

• Acoustic output

• ECG triggering

• VCR recording and playback

• Printing using the system printers

• Patient information

• Date/time information

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WARNING

Using cables, transducers, or accessories with the system other than those specified for use with the system may result in increased emissions or decreased immunity of the system.

ECG Signal

The amplitude of the electrocardiogram (ECG) signal is critical for reliable frame triggering. Frame triggering should only be used when a clean, noise-free ECG waveform is observed on the ECG display.

The ECG signal should be at least 0.25 mV to ensure reliable triggering when the system is used in the presence of the electromagnetic phenomena described in this manual.

WARNING

Operation of your system below 0.25 mV may cause inaccurate results. See

“ECG/Physio Input Connections” on page 142 for more information.

Electrostatic Discharge Precautions

Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air-conditioning. During low humidity conditions, electrical charges naturally build up on individuals and objects and can create static discharges.

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The following cautions can help to reduce ESD effect:

CAUTIONS

• Do not touch transducer connector pins or the system’s transducer recepta-

cle.

• Handle the transducer by the metal connector shell.

• Make contact with a metal surface of the system before connecting a trans-

ducer to the system.

• On connectors that display the ESD sensitivity symbol , do not touch the

connector pins, and always observe the preceding ESD precautions when handling or connecting transducers. For more information, see “Electrostatic Dis-

charge Guidelines” on page 120.

Biological Safety

This section contains information about biological safety and a discussion of the prudent use of the system.

A list of precautions related to biological safety follows; observe these precautions when using the system. For more information refer to Medical Ultrasound

Safety on your user information CD.

Safety

ARNINGS

• Do not use the system if an error message appears on the video display indi-

cating that a hazardous condition exists. Note the error code, turn off power to the system, and call your customer service representative.

• Do not use a system that exhibits erratic or inconsistent image updating. Dis-

continuities in the scanning sequence are indicative of a hardware failure that must be corrected before use.

• Perform ultrasound procedures prudently. Use the ALARA (as low as reason-

ably achievable) principle.

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ARNINGS

• Use only acoustic standoffs that have been approved by Philips Ultrasound.

• Transducer covers may contain natural rubber latex. Those covers may cause

allergic reactions in some individuals. Refer to the FDA Medical Alert on Latex Products, dated March 29, 1991.

• In contrast studies using a high-MI acoustic field, capillary rupture, due to

microbubble expansion within a capillary in an acoustic field, can cause extravasation.

• Preventricular contractions can be caused by the oscillations of microbubbles

when a high-MI acoustic field is triggered in the heart at the end of systole. In a very sick patient with certain risk factors, theoretically, this could lead to ventricular fibrillation. References: 1. Skyba DM, Price RJ, Linka AZ, Skalak TC, Kaul S. Direct in vivo visualization of intravascular destruction of microbubbles by ultrasound and its local effects on tissue. Circulation 1998;98:290-293. 2. van Der Wouw PA, Brauns AC, Bailey SE, Powers JE, Wilde AA. Premature ventric- ular contractions during triggered imaging with ultrasound contrast. J Am Soc Echocardiogr 2000;13(4):288-94.

• If the sterile transducer cover becomes compromised during an intraopera-

tive application involving a patient with Creutzfeldt-Jakob disease, follow the recommendations described in “Transmissible Spongiform Encephalopathy”

on page 54.

• If the system becomes contaminated internally with bodily fluids carrying

• The backlight lamps in the system displays contain mercury and must be recy-

ALARA Education Program

The guiding principle for the use of diagnostic ultrasound is defined by the “as low as reasonably achievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgement and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct

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pathogens, you must immediately notify your Philips Ultrasound service representative. The system’s internal components cannot be disinfected. In this case, the system must be disposed of as biohazardous material in accordance with local or federal laws.

cled or disposed of according to local, state, or federal laws.

Safety

response to every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bioeffects.

Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s responsibility to control total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, an ultrasound system provides controls that can be manipulated during the exam to optimize the results of the exam.

The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound not only in the technology but in the applications of that technology, have resulted in the need for more and better information to guide the user. The output display indices are designed to provide that important information.

There are a number of variables which affect the way in which the output display indices can be used to implement the ALARA principle. These variables include index values, body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because it is controlled by the user. The ability to limit the index values over time supports the ALARA principle.

Applying ALARA

The system imaging mode used depends upon the information needed. 2D and M-mode imaging provide anatomical information, while Doppler, Philips Color Power Angio (CPA), and Color imaging provide information about blood flow. A scanned mode, like 2D, CPA, or Color, disperses or scatters the ultrasonic energy over an area, while an unscanned mode, like M-mode or Doppler, concentrates ultrasonic energy. Understanding the nature of the imaging mode being used allows the sonographer to apply the ALARA principle with informed judgement. Additionally, the transducer frequency, system setup values, scanning techniques, and operator experience allow the sonographer to meet the definition of the ALARA principle.

Special care must be taken to enter the correct application when conducting an exam, and to remain in that application throughout the course of that examination. In the future, HD11 XE may add some applications, such as ophthalmic appli-

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cations, dealing with delicate parts of the body which require lower limits for acoustic output.

The decision as to the amount of acoustic output is, in the final analysis, up to the system operator. This decision must be based on the following factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically useful information, and the potential localized heating of the patient due to transducer surface temperatures. Prudent use of the system occurs when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results.

Although a high index reading does not mean that a bioeffect is actually occurring, a high index reading should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting exposure time is an effective way to accomplish this goal.

There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA. These controls can be divided into three categories: direct, indirect, and receiver controls.

Direct Controls

Application selection and the Power control directly affect acoustic intensity. There are different ranges of allowable intensity or output based on your selection. Selecting the correct range of acoustic intensity for the application is one of the first things that occurs in any exam. For example, peripheral vascular intensity levels are not recommended for fetal exams. Some systems automatically select the proper range for a particular application, while others require manual selection. Ultimately, the user has the responsibility for proper clinical use. The ultrasound system provides both automatic (default) settings and manual (user-selectable) settings.

Power has direct impact on acoustic intensity. Once the application has been established, the Power control can be used to increase or decrease the intensity output. The Power control allows you to select intensity levels less than the established maximum. Prudent use dictates that you select the lowest output intensity that is consistent with good image quality.

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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 ultrasound beam concentrates energy in a single location. A moving or scanned ultrasound 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 repetition 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-average 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 attenuation 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 output intensity, a lower transducer frequency is required. Using more gain and output 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 controls 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 patient’s liver begins with selecting the appropriate transducer 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 adequate 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 Doppler 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 indices 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 maximum 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 appropriate 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 surface, as in a cranial exam.

•Mitigating factors that might create artificially high or low thermal index readings: 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 temperature 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 heating 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 Tabl es . These accuracy estimates are based on the variability range of transducers and systems, inherent acoustic output modeling errors and measurement variability, as discussed below.

The displayed values should be interpreted as relative information to help the system operator achieve the ALARA principle through prudent use of the system. The values should not be interpreted as actual physical values in interrogated tissue 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 perfusion 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. Transducer variability results from piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens focusing parameter variations. Differences 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, alignment, and digitization tolerances, and variability among test operators.

The conservative assumptions of the output estimation algorithms of linear propagation, at all depths, through a 0.3 dB/cm-MHz attenuative medium is not considered 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 measurements 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 attenuation. In the body, and in particular, in water tank measurements, non-linear propagation 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 measurement 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 adjustments.

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 correspond 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 combination of these effects. Generally, the TI will decrease with increased color sector depth. MI will correspond to the peak MI value of the dominant pulse type

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Safety

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 maximums. 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 displayed 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 automatically 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 contribution from the modes enabled and the displayed MI is the largest of the MI values 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 transducer 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.

Ta b l e 2 - 1 A c o u s t i c M e a s u r e m e n t P re c i s i o n

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.

Quantity

Pr is the underated peak rarefactional pressure measured in MegaPascals.

Wo is the ultrasonic power in milliWatts.

fc is the center frequency in MHz (NEMA UD-2 definition).

PII.3 is the derated spatial-peak pulse intensity integral in Joules/cm2.

Table 2-2 Acoustic Measurement Uncertainty

Quantity

Precision

(Percentage Standard Deviation)

Pr: 5.4%

6.2%

<1%

PII.3: 3.2%

Measurement Uncertainty

(percentage, 95% confidence

value)

Pr is the underated peak rarefactional pressure measured in MegaPascals.

Wo is the ultrasonic power in milliWatts.

is the center frequency in MHz

(NEMA UD-2 definition).

PII.3 is the derated spatial-peak pulse intensity integral in Joules/cm

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Pr ± 11.3%

± 10%

± 4.7%

PII.3: +18% to -23%

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.

Safety

Ty p e CF Defibrillator Proof

Attention See the accompanying documentation.

Dangerous voltages

Input The connector near either of these symbols receives an

Output The connector near this symbol sends an outgoing signal.

Alternating current

Ground Protective earth ground.

The patient-applied part provides a degree of protection from electrical shock. This symbol indicates that the patient-applied part is defibrillator proof. The patient-applied part is suitable for all patient applications including direct cardiac applications.

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).

incoming signal.

The connector near this symbol receives alternating voltages.

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Safety

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

Symbol Meaning Description

Equipotential grounding post

Electrostatic discharge

Mercury content and proper disposal

Recycle Dispose of properly in accordance with local, state, or

Global Medical Device Nomenclature

Used post for establishing common ground between instruments.

Warns the user not to touch exposed pins. Touching exposed pins can cause electrostatic discharge, which can damage the product.

This symbol indicates that the system display contains mercury. Dispose of properly in accordance with local, state, or federal laws.

This symbol also indicates separate collection for electrical and electronic equipment in compliance with the Waste Electrical and Electronic Equipment (WEEE) Directive.

federal laws.

Indicates the symbol for the Global Medical Device Nomenclature Code.

The following symbols may appear on the optional foot switch:

Record pedal

Print pedal Press this pedal to print the display image.

Freeze pedal Press this pedal to freeze the display image.

Press this pedal to record the display image.

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Safety

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 pressure

Relative humidity

Ambient temperature

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 frequencies, 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:

Atmospheric pressure range of 572 to 1,013 hPa for transport and storage.

Relative humidity range of 20% to 90% (noncondensing) for transport and storage.

Ambient temperature range –20°C to +60°C (–4°F to +140°F) (noncondensing) for transport and storage. (Does not apply to media.)

• 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 examination 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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Safety

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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ARNINGS

• 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.

Safety

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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Safety

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

• The AC outlet must be able to handle intermittent currents of up to 15 A (for

• 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 ultrasound 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:

surges and fluctuations.

100/120 Vac) or 10 A (for 200/240 Vac).

• 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 service guide, or consult a biomedical engineer.

Observe the following precautions when using a transducer when a defibrillation is required.

ARNINGS

• 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.

Safety

Pacemakers

Philips ultrasound equipment in normal operation, as with other medical electronic diagnostic equipment, uses high-frequency electrical signals that can interfere 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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Safety

Explosive Hazards

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

ARNINGS

• 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 applications 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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Safety

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 systemic 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 reactions. 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.

FDA’s recommendations to health professionals in regard to this problem are as follows:

When taking general histories of patients, include questions about latex sensitivity. For surgical and radiology patients, spina bifida patients and health care workers, this recommendation is especially important. Questions about itching, 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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Safety

•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 personnel about any known latex sensitivity before undergoing medical procedures. Consider advising patients with severe latex sensitivity to wear a medical identification bracelet.

The FDA is asking health professionals to report incidents of adverse reactions 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 number: 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.

Tr a n s m i s s i b l e S p o n g i f o r m E n c e p h a l o p a t h y

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 encephalopathies. 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.

ARNINGS

• 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 responsibility 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.

Safety

• 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 requirements, but not necessarily medical device standards.

Devices connecting to the network interface of the ultrasound system must comply with the applicable IEC or national standards. In addition, the device must be certified to IEC 60950 or equivalent.

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Safety

WARNING

The use of cables, transducers, or accessories not supplied with the HD11 XE system can result in increased electromagnetic emissions or decreased electromagnetic 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 recommendations:

NOTE

• Maintain your joints in optimum positions with a balanced posture while scanning.

• Allow frequent breaks to give soft tissue a chance to recuperate from awkward positions and repetitive movement.

• Avoid gripping the transducer with excessive force.

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 Factors Among Diagnostic Medical Sonographers.” Journal of Diagnostic Medical Sonographers.” Vol. 13 , N o. 5 : 2 19 -22 7, Sep te mbe r 1 99 7.

2. Necas, Martin. “Musculoskeletal Symptomatology and Repetitive Strain Injuries in Diagnostic Medical Sonographer.” Journal of Diagnostic Medical Sonographers, 266-273, November/December 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 ultrasound 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.

Safety

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 disinfection of transducers used in TEE, intraoperative, endocavity, and biopsy procedures.

To reduce the presence of glutaraldehyde fumes in the air, be sure to use a covered 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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Safety

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.

Tr a n s d u c e r s

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 (rubbing alcohol) on the system and only on certain parts of some transducers. Additional cleaning agents are also available for transducers. For more detailed information, see “Cleaning, Disinfecting, and Sterilizing Transducers” on page 161.

To l e a r n m o r e a b o u t r e m o v i n g b l o o d a n d other infectious material from the system, 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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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 hospital’s 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 ultrasound system, the monitors, or the peripherals.

Safety

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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 system 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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System Overview

NOTE

Some features are options and are not available on all systems. For more information 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 Philips 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.

Ta b l e 3 - 1 I n t e n d e d U s e s

3D/4D

2D Mode

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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M-mode

PW Doppler

CW Doppler

Color Flow

Color Power Angio

Calcs Analysis

System Overview

Ta b l e 3 - 1 I n t e n d e d U s e s ( C o n t i n u e d )

3D/4D

2D Mode

Imaging

Application

Tr an scr ani al X X X X X X

Transesophageal X X X X X X

Vascular X X X X X X

M-mode

PW Doppler

CW Doppler

Color Flow

Color Power Angio

Studies

The following sections provide information about the imaging applications listed in

Table 3-1.

Calcs Analysis

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.

Target Approach Patients

Abdominal organs, arteries, and veins

Ta b l e 3 - 2 A b d o m i n a l S t u d i e s

Transabdominal Adult, pediatric, and neonatal

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System Overview

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 vessels

Table 3-3 lists important information about cardiac studies.

Ta b l e 3 - 3 C a r d i a c S t u d i e s

Ta r g e t A p p r o a c h P a t i e n t s

Heart and vessels Transthoracic Adult, pediatric, and neonatal

Heart and vessels Transesophageal

echocardiography (TEE)

Heart and vessels Transabdominal Fetal heart

Adult and pediatric (recommended weight: at least 25 kg (55 lb))

Gynecological Studies

Gynecological studies are performed with fundamental imaging or Tissue Harmonic 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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System Overview

Table 3-4 Gynecological Studies

Ta r g e t A p p r o a c h P a t i e n t s

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

Ta r g e t A p p r o a c h P a t i e n t s

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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System Overview

Table 3-6 Musculoskeletal Studies

Target Approach Patients

Tendons and ligaments Shoulder

Wrist/hand

Knee

Ankle/foot

Muscles Extremities Adult and pediatric

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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System Overview

Ta b l e 3 - 8 O b s t e t r i c a l S t u d i e s

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 following 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 inappropriate 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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System Overview

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

Ta b l e 3 - 9 S m a l l P a r t s S t u d i e s

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.

Tr a n s c r a n i a l S t u d i e s

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

Tr a n s e s o p h a g e a l E c h o c a r d i o g r a p h y (TEE) Studies

For information about transesophageal echocardiography (TEE) studies, see “Car-

diac Studies” on page 64.

Vascul ar 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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System Overview

Ta b l e 3 - 1 0 Va s c u l a r S t u d i e s

Target Approach Patients

Cerebrovascular arteries and veins

Upper extremity arteries and veins

Lower extremity arteries and veins

Abdominal vessels Abdominal Adult and pediatric

Superficial Vessels Intraoperative and

Neck Adult, pediatric, and neonatal

Transcranial Adult

Arms Adult, pediatric, and neonatal

Legs Adult, pediatric, and neonatal

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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System Overview

Microphone

Transducer and gel holders

Handle

Figure 3-1 HD11 XE System

Monitor

Soft key panel

Control panel

Printer

CD-RW drive

Physio panel

MOD drive

Storage bin

NOTE

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

Transducer connector panel

Wheels

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System Overview

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 panel

Keyboard

Option keys

Control panel keys

Knobs

On/Off

Help

Slide controls

Record keys

Trackball

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System Overview

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.

Patient and study data area

Image data area

Figure 3-3 Display

Thumbnail area

Icon area

Soft key labels

Select menu and prompts

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System Overview

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 capabilities.

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System Overview

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 disabling 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.

Ta b l e 3 - 1 2 P e r f o r m a n c e a n d Image Management Options

Name Description Requirements

Advanced Clinical Performance Package

Contrast Package Provides low mechanical index (MI)

DICOM Networking Provides an MOD drive plus connectivity to

Features SonoCT Real-time Compound 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 with Pulse Inversion Harmonics for left ventricular opacification (LVO) evaluation in cardiac and vascularity of the abdominal area in general imaging. This 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.

an RIS/CIS or PACS, and supplies DICOM Modality Worklist, Modality Performed Procedure Step, Print and Store, and Structured Reporting (OB, Cardiac).

One of the following clinical options: Cardiac or General Imaging

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System Overview

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

Name Description Requirements

DICOM Networking Software Upgrade

Panoramic Imaging This option provides a more complete view

Stress Echo This option provides for efficient stress

Provides connectivity to an enterprise data management system or PACS, and supplies DICOM Modality Worklist, Modality Performed Procedure Step, Print and Store, and Structured Reporting (OB, Cardiac).

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.

echo exams. It includes the ability to define 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.

MOD drive installed on the system

Cardiac application

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 option—it is a hardware option that requires the purchase 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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System Overview

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.

Fetal STIC

4D Vaginal Package

Presents the fetal heart beating in a multiplanar display, preserving spatial and temporal relationships to aid in detecting anomalies during routine obstetrical exams.

This package includes the 4D Imaging option and the 3D9-3v transducer.

4D Abdominal Package

Includes the 4D Imaging option, and one curved array transducer (choose from either 3D6-2 or 3D8-4).

Yo u m u s t purchase the Fetal STIC option separately.

4D Combo Package

4D Complete Package

Includes the 4D Imaging option, the 3D9-3v transducer for endovaginal applications, and one curved array 3D volume transducer (choose from either 3D6-2 or 3D8-4).

Includes the 4D Imaging option, the 3D9-3v transducer for endovaginal applications, and two curved array 3D volume transducers (3D6-2 and 3D8-4).

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Yo u m u s t purchase the Fetal STIC option separately.

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System Overview

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

QLAB–GI 3DQ OB/GYN Clinical

Application Package

QLAB–2DQ Cardiac Clinical Application

Package

QLAB–SQ Cardiac Clinical Application

Package

QLAB–ROI Cardiac Clinical and

General Imaging Application Packages

QLAB–IMT Vascular Clinical

Application Package

DICOM Networking DICOM Networking

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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

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

• When the system is on, press the button to start the shutdown process and

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.

LED above the On/Off button is lit when the system is on.

to turn off the system completely.

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Using the System

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.

To break the connection from the main power supply, remove the ultrasound system 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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Using the System

➤ 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 c y c l e t h r o u g h t h e b r i g htness settings, press Ctrl+M repeatedly.

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Using the System

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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Using the System

➤ 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 function is highlighted, and its associated screen elements appear in blue.

➤ To change the active trackball function

Press Select.

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Using the System

Changing the Current Input Language

You can enter patient information and annotation labels by using any of your system’s input languages.

NOTE

To learn how to specify the input languages for your system, see the Help.

➤ To d i s p l a y o r h i d e t h e I M E s t a t u s w i n d o w

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 representations of the patient information appear in the patient’s report.

Customizing Your System

Yo u c a n c u s t o m i z e y o u r s y s t e m i n m a n y 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 presets. 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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NOTES

Using the System

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

• Presets are only available if you purchased the corresponding application package 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 Presets. 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 presets—including how to create, select, delete, modify, save, and restore presets—see 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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Using the System

➤ 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 system’s memory fails for any reason. Backing up your system safeguards your customized settings and preserves your preferred configurations. If your settings are subsequently changed, they can be quickly restored from the backup copy, without 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 system’s 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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Using the System

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 system’s memory is temporary storage. The oldest patient folders on your system are automatically deleted when your system’s 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 system’s 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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Using the System

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 capability so that you can easily find any study that is still located on the system’s 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

CD-R

MOD The MOD drive is optional on the system. MODs can be erased and

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You can use either a CD-R or a CD-RW with the system’s CD drive. CD-RWs can be erased and reused, but are more expensive than CD-Rs. CD-Rs cannot be erased, but are more likely to be compatible with your personal computer.

reused numerous times, but they are more expensive than CD-Rs and CD-RWs.

Using the System

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 primary 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 settings, see the Help.

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Using the System

Configuring Network Settings

This section provides the information needed to configure the network settings on the system. It includes:

• “Configuring the System’s 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 System’s Network Settings

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

➤ To c o n f i g u r e t h e s y s t e m ’ s n e t w o r k s e t t i n g s

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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Using the System

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.

NOTE

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 example, 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.

The default port number, 104, is assigned to ultrasound systems at most institutions.

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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Using the System

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 SCP—The 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 SCP—The server assigned to this role takes ownership of the study.

• SR Storage SCP—The server assigned to this role receives and stores

• SR Storage Commit SCP—The server assigned to this role takes owner-

• Black-and-White (B&W) Printer SCP—The server assigned to this role

• Color Printer SCP—The server assigned to this role is a color printer.

• MWL SCP—(Modality Worklist) The server assigned to this role provides

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structured reporting data.

ship of the structured reporting data.

is the black-and-white printer.

information about scheduled patients to the system.

NOTES

Using the System

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

• 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.

ARNINGS

• 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 equipment 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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Serial interface connector

Figure 4-2 Input/Output Connections

Foot switch connector

S-Video output connector

Using the System

Network connector

USB connector

B&W composite video output connector

Color composite video output connector

Print trigger output connector

Analog telephone line input connector

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Using the System

Table 4-2 lists and describes each connector.

Ta b l e 4 - 2 Pe r i p h e r a l C o n n e c t o r s

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 video output

Color composite video output

Print trigger output

Analog telephone line 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

Connects a device such as a multi-format camera to the ultrasound system

Connects a video monitor or video input printer to the ultrasound system

Connects a trigger to start a print on a video input printer

Connects an analog telephone line to the ultrasound system for remote service assistance

•VCR cables (two audio, two video, and one RS-232)

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Figure 4-3 System Cart and Cables

Connecting a Printer

Using the System

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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Using the System

➤ 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.

ARNINGS

• If you use peripheral equipment powered from an electrical source other than

• 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 medical safety standards, as defined by standard IEC 60601-1-1.

7. Reconnect the system’s 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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Using the System

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 transformer.

ARNINGS

• If you use peripheral equipment powered from an electrical source other than

• Do not use nonmedical peripherals within 1.5 m (6 ft) of a patient, unless the

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 connector on the I/O panel. For an illustration, see Figure 4-2.

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Using the System

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

NOTES

On some video printers, the video print trigger connector may be labeled Remote.

5. Reconnect the system’s 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.

• 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 information 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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Philips HD11 XE Getting Started Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

1 Read This First

Intended Audience

Warnings

Warning Symbols

Ta b l e 1 - 1 W a r n i n g S y m b o l s

About Your User Information

About Your Compact Disc

Conventions

Upgrades and Updates

Customer Comments

Ordering Supplies and Accessories

Customer Service

2Safety

Dangerous Voltages Symbol

Warnings

Electromagnetic Compatibility

ECG Signal

Electrostatic Discharge Precautions

Biological Safety

Ta b l e 2 - 1 A c o u s t i c M e a s u r e m e n t P re c i s i o n

Table 2-2 Acoustic Measurement Uncertainty

Symbols Used on the System

Table 2-3 Symbols Used on the System

Patient Safety

Operator Safety

3 System Overview

About the HD11 XE Ultrasound System

Intended Uses

Ta b l e 3 - 1 I n t e n d e d U s e s

Studies

Ta b l e 3 - 2 A b d o m i n a l S t u d i e s

Ta b l e 3 - 3 C a r d i a c S t u d i e s

Table 3-4 Gynecological Studies

Table 3-5 Intraoperative Studies

Table 3-6 Musculoskeletal Studies

Table 3-7 Neonatal Head Studies

Ta b l e 3 - 8 O b s t e t r i c a l S t u d i e s

Ta b l e 3 - 9 S m a l l P a r t s S t u d i e s

Ta b l e 3 - 1 0 Va s c u l a r S t u d i e s

Ultrasound System Components

Figure 3-1 HD11 XE System

Figure 3-2 System Control Panel

Figure 3-3 Display

About Standard Features, Clinical Options, and Purchasable Options

Table 3-11 Clinical Option Packages

Ta b l e 3 - 1 2 P e r f o r m a n c e a n d Image Management Options

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

Table 3-14 Software Options

4 Using the System

Turning the System On and Off

Figure 4-1 On/Off Button

Positioning the Control Panel and Monitor

Using the System Control Panel

Changing the Current Input Language

Customizing Your System

Making Backups

Managing Patient Data

Table 4-1 Removable Media and Export Formats

Managing Data Security

Configuring Network Settings

Connecting Peripherals

Figure 4-2 Input/Output Connections

Ta b l e 4 - 2 Pe r i p h e r a l C o n n e c t o r s

Figure 4-3 System Cart and Cables