Philips iU22 User Manual

iU22 U l t r a s o u n d S y s t e m

User Manual

4535 614 45861 Rev A

August 2010

© 2010 Koninklijke Philips Electronics N.V. All rights reserved. Published in USA.

Manufactured by Philips Ultrasound

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

Telephone: [phone] or 800-426-2670 Fax: [phone] www.philips.com/ultrasound

This Medical Device meets the provisions of the transposition of the Medical Device Directive 2007/47/EC within the country of origin of the Notified Body concerned with the device.

European Union Representative

Philips Medical Systems Nederland B.V.

Quality & Regulatory Affairs

Veenpluis 4-6

5684PC Best

The Netherlands

CAUTION

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

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

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

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.

Philips Ultrasound products may be manufactured under or operate in accordance with one or more of the following United States patents and corresponding patents in other countries: U.S. Patent Numbers 5,315,999; 5,381,795; 5,402,793; 5,479,930; 5,482,045; 5,482,047; 5,555,887; 5,603,323; 5,634,465; 5,706,819; 5,715,823; 5,718,229; 5,720,291; 5,735,281; 5,833,613; 5,851,186; 5,879,303; 5,908,389; 5,951,478; 5,961,462; 6,043,590; 6,050,942; 6,126,599; 6,210,328; 6,224,552; 6,231,510; 6,251,074; 6,283,919; 6,299,579; 6,306,089; 6,390,981; 6,416,477; 6,516,215; 6,544,177; 6,629,927; 6,648,825; 6,663,569; 6,676,606; D369,307; Re36,564. Other patent applications are pending in various countries.

2iU22 User Manual 4535 614 45861

"Color Power Angio," "HDI," "QLAB," "SonoCT," "SONOS," "xMATRIX," and "XRES" are trademarks of Koninklijke Philips Electronics N.V.

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

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Contents
1	Read This First..........................................................................................	17
	Intended Audience............................................................................................................	17
	Warnings..............................................................................................................................	17
	Warning Symbols...............................................................................................................	18
	User Information Components......................................................................................	19
	Product Conventions........................................................................................................	20
	User Information Conventions.......................................................................................	21
	Upgrades and Updates.....................................................................................................	23
	Customer Comments.......................................................................................................	23
	Supplies and Accessories.................................................................................................	23
	Customer Service..............................................................................................................	26
	WEEE Recycling Information..........................................................................................	27
2	Safety.........................................................................................................	29
	Electrical Safety..................................................................................................................	29
	Defibrillators.................................................................................................................	32
	Mechanical Safety...............................................................................................................	33
	Equipment Protection.......................................................................................................	34
	Symbols................................................................................................................................	35
	Biological Safety..................................................................................................................	44
	FDA Medical Alert on Latex......................................................................................	45
	ALARA Education Program.......................................................................................	47
	Output Display.............................................................................................................	52
	Control Effects..............................................................................................................	56
	Related Guidance Documents..................................................................................	59
	Acoustic Output and Measurement........................................................................	59
	Acoustic Output Tables..............................................................................................	63
	Acoustic Measurement Precision and Uncertainty..............................................	63

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Contents

Operator Safety.....................................................................................................................	64
Repetitive Strain Injury .................................................................................................	64
Foot Switch Warning......................................................................................................	65
Philips Transducers..........................................................................................................	65
Glutaraldehyde Exposure...............................................................................................	65
Infection Control.............................................................................................................	66
Electromagnetic Compatibility ..........................................................................................	67
ECG Signal.........................................................................................................................	69
Electrostatic Discharge Precautions............................................................................	69
Electromagnetic Emissions............................................................................................	70
Approved Cables for Electromagnetic Compliance.................................................	71
Approved Transducers for Electromagnetic Compliance.......................................	73
Approved Accessories for Electromagnetic Compliance.......................................	73
Electromagnetic Immunity.............................................................................................	75
Electromagnetic Interference........................................................................................	78
Recommended Separation Distance...........................................................................	80
Avoiding Electromagnetic Interference.......................................................................	82
Use Restrictions Due to Interference........................................................................	83
3 System Overview........................................................................................	85
System Capabilities...............................................................................................................	85
Measurements..................................................................................................................	85
Transducer Types.............................................................................................................	86
Image Capture and Review............................................................................................	86
Patient Data Protection.................................................................................................	86
System Options.....................................................................................................................	87
Imaging Options...............................................................................................................	87
Voice Control Option....................................................................................................	88
Connectivity Options.....................................................................................................	88
Clinical/Analysis Options...............................................................................................	89
Calculations Package Options......................................................................................	89

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Contents

QLAB Advanced Quantification Software Options	.................................................90
Stress Echocardiography................................................................................................	90
Data Security....................................................................................................................	91
Technical Administration Option.................................................................................	91
PercuNav Image Fusion and Navigation Device ......................................................	91
System Components............................................................................................................	92
Video Monitor..................................................................................................................	94
Control Module...............................................................................................................	94
Voice Control Headset...................................................................................................	96
Voice Annotation Microphone.....................................................................................	96
On/Off (Power) Control................................................................................................	96
Data Storage ....................................................................................................................	97
Peripherals.........................................................................................................................	99
Transducer Receptacles and Cable Management...................................................	101
Physio (ECG) Receptacles...........................................................................................	103
Rear Panel and Power Switch.....................................................................................	104
Wheel Brakes and Steering Locks.............................................................................	105
4 Preparing the System...............................................................................	107
Connecting Devices............................................................................................................	107
External Printers............................................................................................................	108
Connecting an External Printer.................................................................................	109
Connecting the Foot Switch.......................................................................................	112
External VCRs................................................................................................................	112
Connecting an External VCR......................................................................................	113
Configuring Print Functions........................................................................................	113
Connecting an External Color Monitor...................................................................	114
Connecting the System to a Network.....................................................................	115
Moving the System..............................................................................................................	116
Preparing and Moving...................................................................................................	117
Positioning in Confined Spaces...................................................................................	119

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Contents

Setting Up After Moving..............................................................................................	120
Transporting the System....................................................................................................	122
5 Using the System......................................................................................	125
Turning the System On and Off.......................................................................................	125
Setting the System Time and Date..................................................................................	127
Using the Brakes and Steering Locks.............................................................................	128
Monitor Adjustments.........................................................................................................	130
Positioning the Monitor...............................................................................................	130
Changing the Monitor Tint.........................................................................................	131
Changing the Default Monitor Brightness...............................................................	131
Adjusting for Ambient Light........................................................................................	132
Automatic Display Dimming.......................................................................................	132
System Controls..................................................................................................................	132
Control Panel.................................................................................................................	133
Positioning the Control Module................................................................................	134
Using the Retractable Keyboard................................................................................	134
Touch Screen Brightness Controls............................................................................	134
Touch Screen Controls................................................................................................	135
Touch Screen Knob Displays......................................................................................	137
Status Icons.....................................................................................................................	139
Voice Control.......................................................................................................................	141
Voice Control Icons......................................................................................................	143
Turning Headsets On and Off....................................................................................	144
Pairing Headsets............................................................................................................	144
Configuring Headsets...................................................................................................	146
Muting the Headset......................................................................................................	147
Enabling Voice Control.................................................................................................	147
Voice Profiles..................................................................................................................	147
Creating a Voice Profile...............................................................................................	148
Training Voice Profiles..................................................................................................	149

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Contents

Deleting Voice Profiles.................................................................................................	151
Background Noise.........................................................................................................	151
Communication Problems...........................................................................................	151
Troubleshooting Voice Controls................................................................................	152
Using Voice Commands...............................................................................................	152
Using the Keyword Feature........................................................................................	154
Specifying Keyword Default Settings.........................................................................	154
Voice Annotation Commands....................................................................................	154
Using Voice Annotation...............................................................................................	155
System Security...................................................................................................................	155
Logging On to the System...........................................................................................	156
Logging Off of the System...........................................................................................	156
Changing Your Password.............................................................................................	156
Emergency Studies..............................................................................................................	157
Temporary ID.................................................................................................................	157
Starting Emergency Studies.........................................................................................	158
Imaging Display....................................................................................................................	159
Setting the Auto Freeze Function...................................................................................	162
Transducer Receptacles and Cable Management.........................................................	162
Connecting Transducers..............................................................................................	164
Selecting a Transducer..................................................................................................	165
ECG Feature........................................................................................................................	166
DVD, CD, and USB Devices.............................................................................................	166
Media Compatibility......................................................................................................	166
DVD Drive......................................................................................................................	167
Loading and Ejecting a Disc.........................................................................................	168
Erasing a DVD................................................................................................................	168
USB Devices...................................................................................................................	169
6 Customizing the System..........................................................................	171
Presets...................................................................................................................................	171

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Contents

Clinical Options and Tissue Specific Presets...........................................................	172
Quick Save Presets........................................................................................................	172
Creating Quick Save Presets.......................................................................................	172
Deleting Quick Save Presets.......................................................................................	173
Copying Quick Save Presets to Removable Media................................................	174
Loading Quick Save Presets from Removable Media............................................	175
System Setups......................................................................................................................	175
Changing Setups.............................................................................................................	176
Hiding the Doppler Velocity Minus Sign..................................................................	176
Options.................................................................................................................................	177
Installing Temporary Options.....................................................................................	177
Purchasing Options.......................................................................................................	178
7 Performing an Exam.................................................................................	179
New Patient Exams............................................................................................................	179
Entering Patient Data...................................................................................................	180
Starting Emergency Studies.........................................................................................	180
Selecting in the Worklist.............................................................................................	181
Searching in the Worklist............................................................................................	182
Selecting a Transducer.......................................................................................................	182
Imaging Modes.....................................................................................................................	183
Using 2D Mode..............................................................................................................	183
Annotation............................................................................................................................	184
Adding Labels Using Annotate ..................................................................................	184
Adding Labels Using the Keyboard............................................................................	184
Adding an Image Title...................................................................................................	185
Displaying Body Markers.............................................................................................	185
Recording..............................................................................................................................	186
Using the VCR...............................................................................................................	186
Using the DVD Recorder............................................................................................	187
Printing..................................................................................................................................	188

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Contents

	Printing Images...............................................................................................................	188
	Review...................................................................................................................................	189
	Starting Review..............................................................................................................	189
	Navigating Thumbnails and Images............................................................................	189
	Capturing Images and Loops............................................................................................	190
	Measurement and Analysis................................................................................................	191
	Measuring 2D Distance................................................................................................	192
	Obtaining a Typical Labeled Measurement..............................................................	193
	Obtaining a Calculation Result...................................................................................	193
	Ending an Exam....................................................................................................................	194
8	Transducers................................................................................................	195
	Selecting a Transducer.......................................................................................................	196
	Clinical Options and Transducers...................................................................................	196
	Indications for Use and Supporting Transducers.........................................................	198
	xMatrix Array Transducers...............................................................................................	200
	X3-1 Description...........................................................................................................	201
	X6-1 Description...........................................................................................................	202
	X7-2 Description...........................................................................................................	202
	Transducer Maintenance....................................................................................................	202
	Acoustic Artifacts...............................................................................................................	203
	Acoustic Artifacts in 3D Imaging...............................................................................	206
	Transducer Covers.............................................................................................................	207
	Transducer Storage.............................................................................................................	208
	Storage for Transport .................................................................................................	208
	Daily and Long-Term Storage.....................................................................................	209
9	Intraoperative Transducers......................................................................	211
	Operators of Intraoperative Transducers.....................................................................	211
	Intended Uses for Intraoperative Transducers.............................................................	211
	Patient Safety During Intraoperative Studies ...............................................................	212
	Patient-Contact Parts...................................................................................................	213

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Contents

Preventing Intraoperative Transducer Problems ........................................................	213
Intraoperative Transducer Description..........................................................................	214
Preparing Transducers for Intraoperative Use.............................................................	215
Disposable Drapes........................................................................................................	216
Accessories for Intraoperative Transducers...........................................................	216
Electrical Safety and Intraoperative Transducers.........................................................	216
Leakage Current Testing for Intraoperative Transducers..........................................	217
Testing Intraoperative Transducer Leakage Current (Source)............................	222
Testing Intraoperative Transducer Leakage Current (Sink).................................	222
10 Transesophageal Transducers..................................................................	225
Operators of TEE Transducers........................................................................................	225
Patient Safety During TEE Studies...................................................................................	225
Patient-Contact Parts...................................................................................................	230
Preventing TEE Transducer Problems............................................................................	231
Electrical Safety and TEE Transducers............................................................................	233
Leakage Current and TEE Transducers....................................................................	233
Reducing Risks of Using TEE Transducers...............................................................	233
TEE Deflection Control Basics .......................................................................................	234
Connecting an S7-2omni Transducer ............................................................................	235
Connecting a T6H Transducer .......................................................................................	236
S7-2omni TEE Transducer Description..........................................................................	237
Using the S7-2omni Transducer.......................................................................................	239
S7-2omni Deflection Controls ..................................................................................	241
Manipulating the S7-2omni Tip...................................................................................	243
Rotating the S7-2omni Array......................................................................................	245
Calibrating the TEE Transducer.................................................................................	246
Checking the TEE Transducer..........................................................................................	247
TEE Transducer Inspection.........................................................................................	247
TEE Transducer Controls Inspection........................................................................	247
Special Considerations for TEE Studies.........................................................................	248

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Contents

Patient Selection for TEE Transducer Use	..............................................................249
Preparing Patients for TEE Studies............................................................................	249
TEE Study Guidelines...................................................................................................	250
Tip Fold-Over......................................................................................................................	251
Recognizing Tip Fold-Over.........................................................................................	252
Correcting Tip Fold-Over...........................................................................................	252
Preventing Tip Fold-Over ...........................................................................................	252
TEE Temperature Sensing.................................................................................................	253
Ensuring Safe TEE Temperatures...............................................................................	254
Manual Auto-Cool Feature.........................................................................................	254
Using the Temperature Display .................................................................................	255
Patient Temperature.....................................................................................................	255
Entering Patient Temperature.....................................................................................	256
Resuming Imaging After Auto-Cool..........................................................................	256
Patient Care After a TEE Study.......................................................................................	257
TEE Accessories and Supplies..........................................................................................	258
Bite Guards.....................................................................................................................	258
TEE Transducer Covers...............................................................................................	258
Tip Protectors................................................................................................................	259
Disposable Drapes........................................................................................................	259
TEE Leakage Current Test................................................................................................	259
TEE Test Background....................................................................................................	259
Testing TEE Transducer Leakage Current................................................................	262
TEE Transducer References..............................................................................................	263
11 Endocavity Transducers...........................................................................	265
Operators of Endocavity Transducers...........................................................................	265
Patient Safety During Endocavity Studies......................................................................	265
Preparing Transducers for Endocavity Use...................................................................	266
C8-4v Description..............................................................................................................	267
C9-5ec Description ...........................................................................................................	268

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Contents

	C10-3v Description............................................................................................................	269
	3D9-3v Description............................................................................................................	271
	Patient-Contact Parts.........................................................................................................	272
	Biopsy with Endocavity Transducers...............................................................................	273
12	Biopsy Guides............................................................................................	275
	Attaching and Removing a Biopsy Guide......................................................................	275
	Biopsy Guideline Display...................................................................................................	276
	Displaying the Biopsy Guideline.................................................................................	277
	Moving the Biopsy Depth Cursor.............................................................................	278
	Biopsy Guide Alignment....................................................................................................	279
	Preparation for Alignment Verification.....................................................................	280
	Verifying the Biopsy Guide Alignment......................................................................	280
	Performing a Biopsy Procedure.......................................................................................	282
	Biopsy Guide Maintenance................................................................................................	284
13	Transducer Care.......................................................................................	285
	Disinfectants and Gels Safety...........................................................................................	285
	Latex Product Alert......................................................................................................	286
	Transmissible Spongiform Encephalopathy..............................................................	286
	Acoustic Coupling Medium..............................................................................................	287
	Choosing a Disinfectant.....................................................................................................	287
	General Cleaning for All Transducers............................................................................	287
	Cleaning a Transducer..................................................................................................	288
	Disinfecting Transducers using a Wipe or Spray Method .........................................	289
	Cleaning and Disinfecting Cables and Connectors.....................................................	291
	Disinfection of Transducers by Immersion (High-Level Disinfection)....................	293
	Disinfecting Transducers by Immersion...................................................................	294
	Disinfecting TEE Transducers by Immersion................................................................	295
	Disinfecting TEE Transducers in an Automated Disinfector.....................................	298
	Sterilizing Transducers.......................................................................................................	299
	Disinfectants Compatibility...............................................................................................	302

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Contents

	Disinfectant Types.........................................................................................................	303
	Factors Affecting Disinfectant Efficiency..................................................................	303
	Disinfectants Compatibility Table .............................................................................	304
	Gels Compatibility..............................................................................................................	310
14	System Maintenance................................................................................	311
	Cleaning and Maintaining the System.............................................................................	311
	Cleaning the System and ECG Equipment..............................................................	311
	Disinfectants for System Surfaces..............................................................................	313
	Disinfecting System Surfaces.......................................................................................	314
	System Control Panel Maintenance..........................................................................	315
	Cleaning the Trackball..................................................................................................	315
	Air Filter Cleaning.........................................................................................................	316
	Cleaning System Air Filters.........................................................................................	316
	Specifying and Resetting the Air Filter Maintenance Status.................................	319
	Transducer Maintenance....................................................................................................	320
	Printer Maintenance...........................................................................................................	320
	VCR and DVD Recorder Maintenance..........................................................................	321
	Troubleshooting...................................................................................................................	322
	Error Messages....................................................................................................................	323
	Test Patterns........................................................................................................................	324
	Transferring the Test Patterns....................................................................................	324
	Using the Test Patterns................................................................................................	324
	Testing the System..............................................................................................................	325
	For Assistance......................................................................................................................	326
15	Specifications.............................................................................................	327
	Safety Requirements..........................................................................................................	330
	Index...........................................................................................................	331

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1 Read This First

This section contains important information about the user information for your product and about customer service.

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 document is intended for sonographers, physicians, and biomedical engineers who operate and maintain your Philips product.

Warnings

Before using the system, read these warnings and the "Safety" section.

WARNINGS

•Do not remove system covers; hazardous voltages are present inside the system. 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. Explosion can result.

•Medical equipment needs to be installed and put into service according to the special electromagnetic compatibility (EMC) guidelines provided in the "Safety" section.

•The use of portable and mobile radio-frequency (RF) communications equipment can affect the operation of medical equipment.

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Warning Symbols

The system may use the following warning symbols. For additional symbols used on the system, see the "Safety" section.

Symbol	Description
	Identifies a safety note.

May also indicate that there is an impending loss of data that must be acknowledged.

Warning: Indicates that there is a possibility of a system malfunction that might prevent the use of the ultrasound system.

Dangerous voltages: Appears adjacent to high-voltage terminals, indicating the presence of voltages greater than 1,000 Vac (600 Vac in the United States).

Identifies ESD (electrostatic-discharge) sensitivity of a connector that is not tested as specified in IEC 60601-1-2. Do not touch exposed connector pins. Touching exposed pins can cause electrostatic discharge, which can damage the product.

Indicates that the user should see the instructions for use for safety information.

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1

User Information Components

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

•Compact Disc (CD): Includes all of the user information, except the Operating Notes. The instructions for using the CD are included with the CD.

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

•User Manual: Provided with the product and included on the CD. The User Manual introduces you to features and concepts, helps you set up your system, and includes important safety information. This manual also includes procedures for basic operation. For detailed operating instructions, see the Help.

•PercuNav User Manual : Introduces you to PercuNav features and concepts, helps you set up your system, includes important safety information, and provides instructions for use specific to the PercuNav system when integrated with the ultrasound system. For information about using the ultrasound system, see the user information for your ultrasound system.

•Help: Available on the system in some languages and included on the CD, the Help contains comprehensive instructions for using the system. The Help also provides reference information and descriptions of all controls and display elements. To display the Help, press Help on the system keyboard.

•Voice Control Quick Guide: Provided with the system and included on the CD, the Voice Control Quick Guide contains procedures for using the voice control option and lists all commands used for voice control and voice annotation.

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•PercuNav Quick Reference Guide: Provides the most basic, procedural steps required to operate the PercuNav system.

•Acoustic Output Tables: Included on the CD, it contains information about acoustic output and patient-applied part temperatures.

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

•Shared Roles for System and Data Security: Included on the CD, it contains guidelines to help you understand how the security of your Philips product could be compromised and information on Philips efforts to help you prevent security breaches.

•Media Compatibility: Included on the CD, it contains current information on media that are compatible with your system.

Product Conventions

Your Philips product uses certain conventions throughout the interface to make it easy for you to learn and use:

•Two unlabeled buttons, referred to as "Select controls," are used with the trackball. Those controls, located on either side of the trackball, operate somewhat similarly to PC mouse buttons. Both Select controls function identically.

•Tabs along the top of the monitor display let you choose additional sets of setup options. Tabs along the top of the touch screen let you choose additional pages of controls.

•To type text into a text 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 box up or down.

•Controls on the control panel include buttons, knobs, slide controls, and a trackball. Press a button to activate or deactivate its function. Turn a knob to change the selected setting. Press a knob-button to activate its function, or turn it to change the selected setting. Move a slide control to change its setting. Roll the trackball in the direction that you want to move an object.

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1

The current trackball function is displayed in the trackball select menu at the bottom of the display.

•Controls on the touch screen include buttons and knobs. To use a touch screen button, simply touch it. To use a touch screen knob, adjust the corresponding knob below the knob display (located in the bottom row of the touch screen).

•Many tabs on the touch screen contain two pages of controls. Touch Next and Previous to display these pages.

•Controls on the touch screen use several methods to indicate their status. Buttons that are either on or off have an indicator in the upper corner that lights when it is on. Buttons that select a setting generally display the active setting either within the button or on the monitor display. An arrow in the lower right corner of a button indicates that the button displays or hides a group of related buttons. Where only one button in a group can be selected at a time, the selected button is indicated by a gold outline or background. For more information, see "Touch Screen Controls" on page 135.

User Information Conventions

The user information for your product uses the following typographical conventions to assist you in finding and understanding information:

•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. The only exceptions are the trackball and the buttons adjacent to it, which are unlabeled.

•Symbols appear as they appear on the system.

•The pointer is the cursor used to select elements on the display. Use the Pointer control to display the pointer.

•Point means to position the tip of the pointer or cursor on an item on the display.

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•Click or select means to move the pointer or cursor to an object and press one of the unlabeled Select buttons located on either side of the trackball.

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

•Drag means to place the pointer over an object and then press and hold one of the Select buttons while moving the trackball. Use this method to move an object on the display.

•Touch means to press a button on the touch screen, located above the control panel.

•Selecting means to specify an image or thumbnail to be exported or deleted. To select an image, either click on the thumbnail or the thumbnail number.

•Highlighting means to mark an image you want to reject during a protocol exam or an image you want to post-process. To highlight an image, click inside the image (but not on the number).

•The left side of the system is to your left as you stand in front of the system, facing the system. The front of the system is nearest to you as you operate it.

•Transducers and pencil probes both are referred to as transducers, unless the distinction is important to the meaning of the text.

Information that is essential for the safe and effective use of your product appears throughout your user information as follows:

WARNING

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

CAUTION

Cautions highlight ways that you could damage the product and consequently void your warranty or service contract or ways that you could lose patient or system data.

NOTE

Notes bring your attention to important information that will help you operate the product more effectively.

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Upgrades and Updates

Philips is committed to innovation and continued improvement. Upgrades may be announced that consist of hardware or software improvements. Updated user information will accompany those upgrades.

Customer Comments

If you have questions about the user information, or you discover an error in the user information, in the USA, please call Philips Ultrasound Customer Service at 800-722-9377; outside the USA, please call your local customer service representative.

Supplies and Accessories

To order ECG trunk cables, lead sets, and electrodes; transducer covers; biopsy guides; and other supplies and accessories, contact CIVCO Medical Solutions:

CIVCO Medical Solutions

102 First Street South, Kalona, IA 52247-9589

Telephone: [phone] (USA and Canada), [phone] (International)

Fax: [phone] (USA and Canada), [phone] (International)

E-mail: [e-mail]

Internet: www.civco.com

NOTE

Model or part numbers in the following tables are subject to change.

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	System Accessories
	Model/Part
Accessory	Number	Description
ECG cables and lead sets	–	See "Approved Cables for
		Electromagnetic Compliance" on
		page 71
ECG electrode	40420A	Pre-gelled snap electrode
Tip guards	610-748	Transducer tip protector for
		most TEE transducers
	610-945	Transducer tip protector for T6H
		and S7-2omni
Bite guard	M2203A	Bite guard for TEE transducers
Bite blocks	610-979	Pediatric bite block
	610-160	Bite block without strap
	610-749	Bite block with strap
Transducer covers	610-840	Protective sheath for TEE
	610-860	transducers
	610-933
	610-836	Protective sheath for endocavity
	610-843	transducers
	610-010
	610-214
	610-797	Intraoperative protective sheath
		for L15-7io transducers
	610-833	Covers for noninvasive or
		noncavity transducers

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	Model/Part
Accessory	Number		Description
Cables		–	See "Approved Cables for
			Electromagnetic Compliance" on
			page 71
Printers		–	See "External Printers" on page
			108
Foot switch	989605344671		Optional foot switch
VCRs		–	See "Approved Accessories for
			Electromagnetic Compliance" on
			page 73
DVD recorders		–	See "Approved Accessories for
			Electromagnetic Compliance" on
			page 73
Biopsy guides		–	See the following table
Transducers		–	See "Clinical Options and
			Transducers" on page 196
Removable media		–	See "Media Compatibility" on page
			166
	Biopsy Guides
Transducer		Compatible Biopsy
		Guide Model

3D9-3v 989605351091

C5-1 989605369041

C5-2 989605341511

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Transducer	Compatible Biopsy
	Guide Model
C8-4v	8500-8180-02
C8-5	989605341521
C9-4	8500-1290-01
C9-5ec	8500-1704-01
C10-3v	8500-8180-02
L12-5 50 mm	8500-9089-03
L17-5	989605341541
L9-3	989605352591
S4-1	989605341531
VL13-5	989605377711
X3-1	989605361851
X6-1	453561442341

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.philips.com/ultrasound

Corporate and North American Headquarters

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

800-722-9377

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1

Asia Pacific Headquarters

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

[phone]

European Headquarters (also serves Africa and the Middle East)

Philips Medizin Systeme Böblingen GmbH

Hewlett-Packard-Str. 2, 71034 Böblingen, Germany

[phone]

Latin American Headquarters

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

[phone]

WEEE Recycling Information

The European Union Directive on Waste Electrical and Electronic Equipment (WEEE) requires producers of electrical and electronic equipment to provide reuse and treatment information for each product. This information is provided in a Philips Healthcare Recycling Passport. Such "recycling passports" for Philips Ultrasound systems are available on this Web site:

www.healthcare.philips.com/main/about/sustainability/recycling/ultrasound.wpd

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2 Safety

Please read this information before using your ultrasound system. It applies to the ultrasound system, transducers, recording devices, and any optional equipment. This section covers general safety information only. Safety information that applies only to a specific task is included in the procedure for that task.

This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.

A WARNING describes precautions necessary to prevent injury or loss of life.

A CAUTION describes precautions necessary to protect the equipment and patient or system data.

Electrical Safety

This equipment has been verified by a recognized third-party testing agency as a Class I device with Type BF and Type CF isolated patient-applied parts, and Type B non-isolated patient-applied parts. (The safety standards met by this system are included in the "Specifications" section.) For maximum safety observe these warnings and cautions:

WARNINGS

•Shock hazards may exist if this system, including all externally mounted recording and monitoring devices, is not properly grounded. Protection against electrical shock is provided by grounding the chassis with a

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2 Safety

three-wire cable and plug. The system must be plugged into a grounded outlet. The grounding wire must not be removed or defeated.

•To avoid the risk of electrical shock, never connect the system power cord to a power strip or an extension cord. When using the power cord, always connect it directly to a grounded wall outlet.

•Because Type B and BF transducers are not isolated and have a higher inherent leakage current, those transducers are not intended for invasive use.

•Do not remove the protective covers on the system; hazardous voltages are present inside. Cabinet panels must be in place while the system is in use. All internal adjustments and replacements must be made by a qualified Philips Ultrasound field service engineer.

•Do not operate this system in the presence of flammable gases or anesthetics. Explosion can result. The system is not compliant in AP/APG environments as defined by IEC 60601-1.

•To avoid risk of electrical shock hazards, always inspect the transducer before use: Check the face, housing, and cable before use. Do not use if the face is cracked, chipped, or torn; the housing is damaged; or the cable is abraded.

•To avoid risk of electrical shock hazards, always turn off the system and disconnect it from the wall outlet before cleaning the system.

•All patient-contact devices, such as transducers, pencil probes, and ECG leads not specifically indicated as defibrillation-proof must be removed from patient contact before application of a high-voltage defibrillation pulse. See "Defibrillators" on page 32.

•During transesophageal echocardiographic (TEE) procedures, either remove the TEE transducer from the patient or disconnect the TEE transducer from the system immediately following image acquisition.

•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.

•When using additional peripheral equipment powered from an electrical source other than the ultrasound system, the combination is considered

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