Philips iU22 User Manual
User Manual
4535 614 45861 Rev A
August 2010
iU22 Ultrasound System
© 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: +1 425-487-7000 or 800-426-2670
Fax: +1 425-485-6080
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.
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"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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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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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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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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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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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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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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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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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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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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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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Read This First
1
Warning Symbols
The system may use the following warning symbols. For additional symbols used
on the system, see the "Safety" section.
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).
DescriptionSymbol
18
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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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.
Read This First
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1
• 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:
20
• 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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Read This First
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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1
• 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:
Read This First
1
NOTE
CIVCO Medical Solutions
102 First Street South, Kalona, IA 52247-9589
Telephone: 800-445-6741 (USA and Canada), +1 319-656-4447 (International)
Fax: 877-329-2482 (USA and Canada), +1 319-656-4451 (International)
E-mail: info@civco.com
Internet: www.civco.com
Model or part numbers in the following tables are subject to change.
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1
Read This First
System Accessories
Model/Part
NumberAccessory
Description
Transducer covers
610-748Tip guards
610-945
610-840
610-860
610-933
–ECG cables and lead sets
See "Approved Cables for
Electromagnetic Compliance" on
page 71
Pre-gelled snap electrode40420AECG electrode
Transducer tip protector for
most TEE transducers
Transducer tip protector for T6H
and S7-2omni
Bite guard for TEE transducersM2203ABite guard
Pediatric bite block610-979Bite blocks
Bite block without strap610-160
Bite block with strap610-749
Protective sheath for TEE
transducers
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610-836
610-843
610-010
610-214
610-797
610-833
Protective sheath for endocavity
transducers
Intraoperative protective sheath
for L15-7io transducers
Covers for noninvasive or
noncavity transducers
Model/Part
NumberAccessory
Read This First
Description
1
–Cables
See "Approved Cables for
Electromagnetic Compliance" on
page 71
–Printers
See "External Printers" on page
108
Optional foot switch989605344671Foot switch
–VCRs
See "Approved Accessories for
Electromagnetic Compliance" on
page 73
–DVD recorders
See "Approved Accessories for
Electromagnetic Compliance" on
page 73
See the following table–Biopsy guides
–Transducers
See "Clinical Options and
Transducers" on page 196
–Removable media
See "Media Compatibility" on page
166
Transducer
Biopsy Guides
Compatible Biopsy
Guide Model
9896053510913D9-3v
989605369041C5-1
989605341511C5-2
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1
Read This First
Transducer
Compatible Biopsy
Guide Model
8500-8180-02C8-4v
989605341521C8-5
8500-1290-01C9-4
8500-1704-01C9-5ec
8500-8180-02C10-3v
8500-9089-03L12-5 50 mm
989605341541L17-5
989605352591L9-3
989605341531S4-1
989605377711VL13-5
989605361851X3-1
453561442341X6-1
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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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
WEEE Recycling Information
Read This First
1
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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1
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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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Safety
2
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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