Philips cx50 инструкция на русском

CX50 U l t r a s o u n d S y s t e m

User Manual

4535 616 38521 Rev B

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© 2012 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.healthcare.philips.com/ultrasound

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

European Union Representative

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

WARNING

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 Healthcare
(«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.

Unauthorized copying of this document, in addition to infringing copyright, might reduce the ability of Philips to provide
accurate and current information to users.

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 5,798,461; 6,450,958; 6,471,649;
6,527,721; 6,540,685; 6,572,547; 6,679,849. Other patent applications are pending in various countries.

«Chroma,» «Color Power Angio,» «High Q,» «QLAB,» «SonoCT,» and «XRES» are trademarks of Koninklijke Philips
Electronics N.V.

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

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Contents

1 Read This First………………………………………………………………………………15

Intended Audience………………………………………………………………………………………………15

Intended Use………………………………………………………………………………………………………..15

Warnings………………………………………………………………………………………………………………16

Warning Symbols…………………………………………………………………………………………………17

User Information Components…………………………………………………………………………..17

Product Conventions…………………………………………………………………………………………..18

User Information Conventions……………………………………………………………………………19

Upgrades and Updates………………………………………………………………………………………..21

Customer Comments………………………………………………………………………………………….21

Supplies and Accessories…………………………………………………………………………………….21

Customer Service………………………………………………………………………………………………..22

Recycling, Reuse, and Disposal……………………………………………………………………………22

2 Safety……………………………………………………………………………………………25

Basic Safety…………………………………………………………………………………………………………..25

Electrical Safety……………………………………………………………………………………………………26

Defibrillators…………………………………………………………………………………………………..29

Fire Safety……………………………………………………………………………………………………….30

Mechanical Safety…………………………………………………………………………………………………30

Equipment Protection………………………………………………………………………………………….31

Product Compatibility………………………………………………………………………………………….32

Symbols………………………………………………………………………………………………………………..33

Biological Safety……………………………………………………………………………………………………42

FDA Medical Alert on Latex…………………………………………………………………………..44

ALARA Education Program……………………………………………………………………………46

Output Display……………………………………………………………………………………………….50

Control Effects………………………………………………………………………………………………..54

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Related Guidance Documents…………………………………………………………………………..57

Acoustic Output and Measurement………………………………………………………………….57

Acoustic Output Tables…………………………………………………………………………………….61

Acoustic Measurement Precision and Uncertainty…………………………………………..61

Operator Safety………………………………………………………………………………………………………63

Repetitive Strain Injury …………………………………………………………………………………….63

Philips Transducers…………………………………………………………………………………………….63

Glutaraldehyde Exposure…………………………………………………………………………………..64

Infection Control……………………………………………………………………………………………….64

Electromagnetic Compatibility ………………………………………………………………………………66

Radio-Frequency Emissions……………………………………………………………………………….67

ECG Signal………………………………………………………………………………………………………….68

Electrostatic Discharge Precautions………………………………………………………………….69

Electromagnetic Emissions………………………………………………………………………………..70

Approved Cables for Electromagnetic Compliance………………………………………….70

Approved Transducers for Electromagnetic Compliance…………………………………71

Approved Accessories for Electromagnetic Compliance…………………………………72

Electromagnetic Immunity…………………………………………………………………………………72

Electromagnetic Interference…………………………………………………………………………….75

Recommended Separation Distance…………………………………………………………………78

Avoiding Electromagnetic Interference……………………………………………………………..80

Use Restrictions Due to Interference………………………………………………………………81

3 System Overview…………………………………………………………………………….83

System Capabilities…………………………………………………………………………………………………83

Measurements……………………………………………………………………………………………………83

Transducer Types……………………………………………………………………………………………….84

Image Acquisition and Review…………………………………………………………………………..84

Patient Data Protection…………………………………………………………………………………….85

System Options………………………………………………………………………………………………………85

Imaging Options…………………………………………………………………………………………………85

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Connectivity Options………………………………………………………………………………………..86

Clinical/Analysis Options…………………………………………………………………………………..86

Calculations………………………………………………………………………………………………………..87

QLAB Advanced Quantification Software Options………………………………………….87

Stress Echocardiography……………………………………………………………………………………88

Data Security……………………………………………………………………………………………………..88

System Components………………………………………………………………………………………………88

Video Monitor……………………………………………………………………………………………………90

Control Panel…………………………………………………………………………………………………….90

On/Off (Power) Control……………………………………………………………………………………91

Data Storage ……………………………………………………………………………………………………..92

Peripherals………………………………………………………………………………………………………….93

Transducer Receptacles and Cable Management……………………………………………..93

Physio (ECG) Receptacles…………………………………………………………………………………95

USB Hub…………………………………………………………………………………………………………….96

Wheel Controls…………………………………………………………………………………………………97

4 Preparing the System………………………………………………………………………99

Connecting Devices………………………………………………………………………………………………..99

External Printers………………………………………………………………………………………………100

Connecting an External Printer………………………………………………………………………102

Configuring Local Printers………………………………………………………………………………103

Connecting the Optional Foot Switch……………………………………………………………104

Configuring the Foot Switch……………………………………………………………………………104

Connecting an External Color Monitor ………………………………………………………..104

Attaching the System……………………………………………………………………………………………105

Removing the System……………………………………………………………………………………………106

System Configuration……………………………………………………………………………………………106

Standard Network Support…………………………………………………………………………….107

DICOM Networking Option…………………………………………………………………………..107

Configuration Information………………………………………………………………………………107

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Entering System Network Settings…………………………………………………………………109

Changing the PC Name…………………………………………………………………………………..111

Wireless Networking………………………………………………………………………………………112

Configuring Wireless Network Properties…………………………………………………….112

Enabling a Wireless Network Connection……………………………………………………..115

Removing a Wireless Network……………………………………………………………………….118

Troubleshooting Wireless Network Connections…………………………………………119

Remote Access………………………………………………………………………………………………..119

Enabling a Remote Access Session………………………………………………………………….120

Repairing Network Connections…………………………………………………………………….120

Moving the System………………………………………………………………………………………………..121

Preparing and Moving………………………………………………………………………………………122

Setting Up After Moving………………………………………………………………………………….123

5 Using the System…………………………………………………………………………..125

Turning the System On and Off……………………………………………………………………………125

Setting the System Time and Date……………………………………………………………………….126

System Cart…………………………………………………………………………………………………………..127

Installing the AC Adapter………………………………………………………………………………..127

Attaching the System……………………………………………………………………………………….130

Removing the System………………………………………………………………………………………130

Adjusting Cart Height……………………………………………………………………………………..130

Using the Wheel Controls………………………………………………………………………………132

Monitor Settings……………………………………………………………………………………………………133

Changing the Monitor Tint……………………………………………………………………………..134

Changing the Monitor Brightness……………………………………………………………………134

System Controls……………………………………………………………………………………………………135

Control Panel…………………………………………………………………………………………………..135

Control Status………………………………………………………………………………………………….136

Changing Control Panel Brightness…………………………………………………………………137

Enabling Automatic Brightness Control …………………………………………………………138

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Quick Key Controls…………………………………………………………………………………………138

Using Quick Key Controls………………………………………………………………………………139

System Keyboard……………………………………………………………………………………………..139

Typing Special Characters………………………………………………………………………………..140

Typing Accented Characters……………………………………………………………………………140

Status Icons………………………………………………………………………………………………………141

Power Management………………………………………………………………………………………………143

Battery and AC Indicators………………………………………………………………………………144

Changing Power Management Settings……………………………………………………………145

AC Adapter Operation ……………………………………………………………………………………….146

AC Adapter Indicator………………………………………………………………………………………147

Using the AC Adapter……………………………………………………………………………………..147

Battery Operation………………………………………………………………………………………………..148

Installing the Battery ………………………………………………………………………………………149

System Security…………………………………………………………………………………………………….151

Logging On to the System……………………………………………………………………………….151

Logging Off of the System……………………………………………………………………………….151

System and Data Security………………………………………………………………………………..152

Emergency Studies………………………………………………………………………………………………..153

Temporary ID…………………………………………………………………………………………………..153

Starting Emergency Studies……………………………………………………………………………..154

Imaging Display……………………………………………………………………………………………………..155

Image Size Settings………………………………………………………………………………………………..157

Transducer Receptacles and Cable Management…………………………………………………157

Connecting Transducers………………………………………………………………………………….159

Selecting a Transducer……………………………………………………………………………………..161

Selecting a Preset…………………………………………………………………………………………….162

Using Presets……………………………………………………………………………………………………162

Physio Feature……………………………………………………………………………………………………….163

DVD, CD, and USB Devices…………………………………………………………………………………164

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Media Compatibility…………………………………………………………………………………………164

Loading and Ejecting a Disc……………………………………………………………………………..165

USB Devices…………………………………………………………………………………………………….165

Erasing a DVD or USB Device………………………………………………………………………..167

6 Customizing the System………………………………………………………………..169

Presets…………………………………………………………………………………………………………………..169

Clinical Options and Predefined Presets…………………………………………………………169

Custom Presets……………………………………………………………………………………………….170

Creating Custom Presets………………………………………………………………………………..170

Modifying Custom Presets………………………………………………………………………………171

Deleting Custom Presets………………………………………………………………………………..172

Setting Up Autoselect Presets…………………………………………………………………………172

Presets Menu……………………………………………………………………………………………………173

Using the Presets Menu…………………………………………………………………………………..173

Modifying the Presets Menu…………………………………………………………………………….174

Copying Custom Presets…………………………………………………………………………………175

System Setups……………………………………………………………………………………………………….175

Changing Setups……………………………………………………………………………………………….176

Options…………………………………………………………………………………………………………………176

Installing Temporary Options………………………………………………………………………….176

7 Performing a Study………………………………………………………………………..179

New Patient Studies……………………………………………………………………………………………..179

Entering Patient Data Manually (Without Worklist)………………………………………180

Using Modality Worklist………………………………………………………………………………….181

Selecting a Transducer………………………………………………………………………………………….182

Imaging Modes………………………………………………………………………………………………………182

Using 2D Mode………………………………………………………………………………………………..183

Annotation…………………………………………………………………………………………………………….184

Placing a System-Defined Label on the Display………………………………………………184

Typing a Label on the Display………………………………………………………………………….185

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Placing a Body Marker on the Display…………………………………………………………….185

Printing………………………………………………………………………………………………………………….186

Review…………………………………………………………………………………………………………………..186

Starting Review………………………………………………………………………………………………..187

Navigating Thumbnails and Images………………………………………………………………….187

Acquiring Images and Loops ……………………………………………………………………………….188

Measurement and Analysis……………………………………………………………………………………189

Performing a 2D Distance Measurement………………………………………………………..190

Obtaining a Typical Labeled Measurement……………………………………………………..190

Obtaining a Calculation Result………………………………………………………………………..191

Ending a Study……………………………………………………………………………………………………….191

8 Transducers……………………………………………………………………………………193

Selecting a Transducer………………………………………………………………………………………….194

Selecting a Preset………………………………………………………………………………………………….194

Clinical Options and Transducers………………………………………………………………………..195

Indications for Use and Supporting Transducers…………………………………………………196

Transducer Maintenance……………………………………………………………………………………….198

Acoustic Artifacts…………………………………………………………………………………………………199

Acoustic Artifacts in 3D Imaging…………………………………………………………………….202

Transducer Covers……………………………………………………………………………………………….204

Transducer Storage……………………………………………………………………………………………….205

Storage for Transport …………………………………………………………………………………….205

Daily and Long-Term Storage………………………………………………………………………….205

9 Endocavity Transducers………………………………………………………………….207

Operators of Endocavity Transducers…………………………………………………………………207

Patient Safety During Endocavity Studies…………………………………………………………….207

Preparing Transducers for Endocavity Use………………………………………………………….208

C9-3v Description………………………………………………………………………………………………..209

C10-3v Description………………………………………………………………………………………………210

Patient-Contact Parts……………………………………………………………………………………………211

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Biopsy with Endocavity Transducers…………………………………………………………………….212

10 Transesophageal Transducers…………………………………………………………213

Operators of TEE Transducers…………………………………………………………………………….213

Patient Safety During TEE Studies………………………………………………………………………..213

Patient-Contact Parts………………………………………………………………………………………218

Preventing TEE Transducer Problems………………………………………………………………….219

Electrical Safety and TEE Transducers………………………………………………………………….221

Leakage Current and TEE Transducers…………………………………………………………..221

Reducing Risks of Using TEE Transducers………………………………………………………221

TEE Deflection Control Basics ……………………………………………………………………………222

Connecting a TEE Transducer………………………………………………………………………………224

X7-2t TEE Transducer Description……………………………………………………………………..224

TEE Transducer Components………………………………………………………………………………225

TEE Deflection Controls…………………………………………………………………………………227

Manipulating the TEE Tip…………………………………………………………………………………229

Rotating the TEE Image Plane ………………………………………………………………………..231

Checking the TEE Transducer…………………………………………………………………………232

Special Considerations for TEE Studies……………………………………………………………….233

Patient Selection for TEE Transducer Use……………………………………………………..233

Preparing Patients for TEE Studies………………………………………………………………….234

TEE Study Guidelines………………………………………………………………………………………235

Tip Fold-Over……………………………………………………………………………………………………….236

Recognizing Tip Fold-Over……………………………………………………………………………..236

Correcting Tip Fold-Over……………………………………………………………………………….236

Preventing Tip Fold-Over ……………………………………………………………………………….236

TEE Temperature Sensing…………………………………………………………………………………….237

Ensuring Safe TEE Temperatures…………………………………………………………………….238

Manual Auto-Cool Feature……………………………………………………………………………..239

Patient Temperature………………………………………………………………………………………..240

Entering Patient Temperature………………………………………………………………………….240

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Temperature Display………………………………………………………………………………………..241

Customizing the Temperature Display……………………………………………………………241

Resuming Imaging After Auto-Cool………………………………………………………………..242

Patient Care After a TEE Study……………………………………………………………………………243

TEE Accessories and Supplies………………………………………………………………………………243

Bite Guards………………………………………………………………………………………………………243

TEE Transducer Covers…………………………………………………………………………………..244

Tip Protectors………………………………………………………………………………………………….244

Disposable Drapes…………………………………………………………………………………………..244

TEE Leakage Current Test……………………………………………………………………………………244

TEE Test Background……………………………………………………………………………………….245

Testing TEE Transducer Leakage Current……………………………………………………….247

TEE Transducer References………………………………………………………………………………….248

11 Intraoperative Transducers……………………………………………………………249

Operators of Intraoperative Transducers……………………………………………………………249

Intended Uses for Intraoperative Transducers…………………………………………………….250

Patient Safety During Intraoperative Studies ………………………………………………………250

Patient-Contact Parts………………………………………………………………………………………251

Preventing Intraoperative Transducer Problems ………………………………………………..251

C9-3io Description……………………………………………………………………………………………….252

L10-4lap Description…………………………………………………………………………………………….254

L15-7io Description……………………………………………………………………………………………..256

Preparing Transducers for Intraoperative Use…………………………………………………….257

Disposable Drapes…………………………………………………………………………………………..258

Accessories for Intraoperative Transducers…………………………………………………..258

Electrical Safety and Intraoperative Transducers…………………………………………………258

Leakage Current Testing for Intraoperative Transducers……………………………………259

Testing Intraoperative Transducer Leakage Current (Source)……………………….264

Testing Intraoperative Transducer Leakage Current (Sink)……………………………264

12 ICE Catheter Transducer……………………………………………………………….267

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Connecting the ICE Catheter………………………………………………………………………………267

13 Biopsy Guides………………………………………………………………………………..269

Attaching and Removing a Biopsy Guide…………………………………………………………….269

Biopsy Guideline Display………………………………………………………………………………………270

Displaying the Biopsy Guideline………………………………………………………………………271

Moving the Needle Length Crosshair……………………………………………………………..272

Biopsy Guideline Quick Keys………………………………………………………………………….272

Biopsy Guide Alignment……………………………………………………………………………………….273

Preparation for Alignment Verification……………………………………………………………273

Verifying the Biopsy Guide Alignment…………………………………………………………….274

Performing a Biopsy Procedure……………………………………………………………………………276

Biopsy Guide Maintenance……………………………………………………………………………………277

Needle Visualization……………………………………………………………………………………………..278

Using Needle Visualization………………………………………………………………………………278

14 Transducer Care……………………………………………………………………………281

Transducer Care Safety………………………………………………………………………………………..281

Latex Product Alert…………………………………………………………………………………………282

Transmissible Spongiform Encephalopathy……………………………………………………..282

Acoustic Coupling Medium………………………………………………………………………………….283

Choosing a Disinfectant………………………………………………………………………………………..283

General Cleaning for All Transducers………………………………………………………………….284

Cleaning a Transducer……………………………………………………………………………………..285

Disinfecting Transducers Using a Wipe or Spray Method ………………………………….285

Cleaning and Disinfecting Cables and Connectors……………………………………………..288

Disinfection of Transducers by Immersion (High-Level Disinfection)………………..291

Disinfecting Transducers by Immersion………………………………………………………….292

Disinfecting TEE Transducers by Immersion…………………………………………………..294

Disinfecting TEE Transducers in an Automated Disinfector………………………….297

Sterilizing Transducers………………………………………………………………………………………….300

Disinfectants Compatibility…………………………………………………………………………………..302

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Disinfectant Types……………………………………………………………………………………………303

Factors Affecting Disinfectant Efficiency…………………………………………………………303

Disinfectants and Cleaning Solutions Compatibility Table……………………………..304

Gels Compatibility………………………………………………………………………………………………..311

15 System Maintenance……………………………………………………………………..313

Cleaning and Maintaining the System…………………………………………………………………..313

Cleaning the System and ECG Equipment……………………………………………………..313

Disinfectants for System Surfaces……………………………………………………………………315

Disinfecting System Surfaces……………………………………………………………………………315

Cleaning the Trackball……………………………………………………………………………………..316

Cleaning the Battery………………………………………………………………………………………..317

Cleaning the Adapter………………………………………………………………………………………317

Transducer Maintenance……………………………………………………………………………………….318

Printer Maintenance……………………………………………………………………………………………..319

Troubleshooting…………………………………………………………………………………………………….319

Error Messages……………………………………………………………………………………………………..320

For Assistance……………………………………………………………………………………………………….321

16 Specifications…………………………………………………………………………………323

Safety and Regulatory Requirements…………………………………………………………………..327

Index……………………………………………………………………………………………..329

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1 Read This First

This manual is intended to assist you with the safe and effective operation of

your Philips product. Before attempting to operate the product, read this

manual and strictly observe all warnings and cautions. Pay special attention to

the information in the

«Safety» section.

The user information for your Philips product describes the most extensive

configuration of the product, with the maximum number of options and

accessories. Some functions described may be unavailable on your product’s

configuration.

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.

Intended Use

This product is intended to be installed, used, and operated only in accordance

with the safety procedures and operating instructions given in the product

user information, and only for the purposes for which it was designed. For

indications for use, see

«Indications for Use and Supporting Transducers» on

page 196

. However, nothing stated in the user information reduces your

responsibility for sound clinical judgment and best clinical procedure.

Installation, use, and operation of this product is subject to the law in the

jurisdictions in which the product is used. Install, use, and operate the product

only in such ways that do not conflict with applicable laws or regulations, which

have the force of law.

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Use of the product for purposes other than those intended and expressly stated
by Philips, as well as incorrect use or operation, may relieve Philips or its agents
from all or some responsibility for resultant noncompliance, damage, or injury.

WARNING

System users are responsible for image quality and diagnosis.

Warnings

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

WARNINGS

• 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.

• 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 or
other flammable gases or liquids. Explosion can result.

• Medical equipment must 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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1

Warning Symbols

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

«Safety» section.

DescriptionSymbol

Identifies a safety note.

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.

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

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1

Read This First

procedures for basic operation. For detailed operating instructions, see the
Help.

• CX50 Integrated Ultrasound User Manual: This manual introduces you
to Integrated Ultrasound, helps you set it up, and provides basic operating
instructions. For more information on the use and operation of your Allura
XPer FD system with Integrated Ultrasound, see the Allura XPer FD
instructions for use.

• 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.

• 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 «trackball buttons,» are used with
the trackball. Those controls, located on either side of the trackball, operate

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1

somewhat similarly to PC mouse buttons. Both trackball buttons function
identically.

• In the system setups, tabs along the top of the monitor display let you
choose additional sets of setup options.

• 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. Move a slide control to change its setting.
Roll the trackball in the direction that you want to move an object. The
current trackball function is displayed in the trackball select menu at the
bottom of the display.

• Controls across the top of the control panel, called quick keys, function as
both buttons and knobs. To select one of the functions displayed above the
control, simply press the control. To select a setting for the function, also
displayed above the control, turn the control.

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 means to move the pointer to an object and press the left trackball
button.

• Select means to click a check box to put a check mark in it. Deselect means
clicking the check box to remove the check mark.

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

• Right-click means to point at an item and then press and immediately release
the right trackball button.

• Hover means to pause the pointer over an item on the display.

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

• Highlight means to change the color of a display selection (such as an item
in a list) or overlay it with a colored bar, usually by clicking.

• 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 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; bite
guards; biopsy guides; and other supplies and accessories, contact CIVCO Medical
Solutions:

CIVCO Medical Solutions

102 First Street South, Kalona, IA 52247-9589
Telephone: 800-445-6741 (USA and Canada), +1 319-248-6757 (International)
Fax: 877-329-2482 (USA and Canada), +1 319-248-6660 (International)
E-mail: info@civco.com
Internet: www.civco.com

To order the items listed in the following table, see the referenced section and
then contact your Philips representative.

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System Accessories

Additional InformationItem

Contact your Philips representative.Battery

See

«Approved Cables for Electromagnetic

Compliance» on page 70

Cables

Contact your Philips representative.Foot switch

See «External Printers» on page 100Printers

See

«Media Compatibility» on page 164Removable media

See

«Clinical Options and Transducers» on

page 195

Transducers

Customer Service

Customer service representatives are available worldwide to answer questions
and to provide maintenance and service. Please contact your local Philips
representative for assistance. You can also contact the following office for referral
to a customer service representative, or visit the Philips Healthcare «Contact
Us» website:

www.healthcare.philips.com/main/about/officelocator/index.wpd

Philips Ultrasound Headquarters
22100 Bothell-Everett Highway, Bothell, WA 98021-8431, USA

800-722-9377

Recycling, Reuse, and Disposal

Philips is concerned with helping protect the natural environment and helping
ensure continued safe and effective use of this system through proper support,
maintenance, and training. Philips designs and manufactures equipment in
compliance with relevant guidelines for environmental protection. As long as

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the equipment is properly operated and maintained, it presents no risk to the
environment. However, the equipment may contain materials that could be
harmful to the environment if disposed of incorrectly. Use of such materials is
essential for the implementation of certain functions and for meeting certain
statutory and other requirements.

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 website:

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

Recycling, reuse, and disposal information in this document is directed mainly at
the entity with legal authority over the equipment. Operators are usually
uninvolved in disposal, except in the case of certain batteries (see

«Battery

Operation» on page 148

).

Passing Your System to Another User

If you pass this system to another user who will use the system for its intended
purpose, then pass it on in its complete state. Particularly, ensure that all the
product-support documentation, including all instructions for use, are passed on
to the new user. Make the new user aware of the support services that Philips
Healthcare provides for installing, commissioning, and maintaining the system,
and for comprehensive operator training. Existing users must remember that
passing on medical electrical equipment to new users may present serious
technical, medical, privacy, and legal risks. The original user may remain liable,
even if the equipment is given away.

Philips strongly advises you to seek advice from your local Philips representative
before agreeing to pass on any equipment.

After you pass the system to a new user, you might still receive important
safety-related information, such as bulletins and field change orders. In many
jurisdictions the original owner has a clear duty to communicate such
safety-related information to new users. If you are unable or unprepared to do

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this, inform Philips Healthcare about the new user, so that Philips Healthcare
can provide the new user with safety-related information.

Final Disposal of Your System

Final disposal is when you dispose of the system in such a way that it can no
longer be used for its intended purposes.

WARNING

Do not dispose of this system (or any parts of it) with industrial or domestic
waste. The system may contain materials such as lead, tungsten, or oil, or other
hazardous substances that can cause serious environmental pollution. The system
also contains privacy-sensitive information, which should be properly removed
(scrubbed). Philips advises you to contact your Philips service organization before
disposing of this system.

Philips Healthcare gives support for the following:

• Recovery of useful parts

• Recycling of useful materials by competent disposal companies

• Safe and effective disposal of equipment

For advice and information, contact your Philips service organization, or see the
following website:

www.philips.com/about/sustainability/recycling/productrecyclingservices/index.page

Perchlorate Material

In this system, perchlorate material is present in lithium coin cells or batteries.
Special handling may apply to those items. For more information, see this website:

www.dtsc.ca.gov/hazardouswaste/perchlorate

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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.

Basic Safety

WARNINGS

• Do not use the system for any application until you have read, understood,
and know all the safety information, safety procedures, and emergency
procedures contained in this «Safety» section. Operating the system
without a proper awareness of safe use could lead to fatal or other serious
personal injury.

• Do not use this system for any application until you are sure that the
system’s periodic maintenance is current. If any part of the system is
known or suspected to be defective or incorrectly adjusted, do not use
the system until it is repaired. Operating the system with defective or
incorrectly adjusted components could expose you and the patient to
safety hazards.

• Do not use the system for any application until you are adequately and
properly trained on its safe and effective operation. If you are unsure of
your ability to operate the system safely and effectively, do not use it.

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Operation of the system without proper and adequate training could lead
to fatal or other serious personal injury.

• Do not operate the system with patients unless you have an adequate
understanding of its capabilities and functions. Using the system without
such understanding may compromise the system’s effectiveness and the
safety of the patient, you, and others.

• Never attempt to remove, modify, override, or frustrate any safety device
on the system. Interfering with safety devices could lead to fatal or other
serious personal injury.

• Use the system only for its intended purposes. Do not use the system with
any product that Philips does not recognize as compatible with the system.
Operation of the product for unintended purposes, or with incompatible
products, could lead to fatal or other serious injury.

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 (when mounted on its cart or plugged
directly into an AC power source), including all externally mounted
recording and monitoring devices, is not properly grounded. Protection
against electrical shock is provided by grounding the cart or the AC power
adapter with a three-wire cable and plug, which 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.

• Use only the AC adapter supplied with your system.

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• Use only Type CF transducers for invasive procedures. Type B transducers
are insufficiently electrically isolated 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,
disconnect it from the wall outlet, and remove the battery (see

«Installing

the Battery» on page 149

) 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 29.

• 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
to be a medical system. It is your responsibility to comply with
IEC 60601-1-1 and test the system to those requirements. If you have
questions, contact your Philips representative.

• Do not use nonmedical peripherals, such as report printers, within 1.5 m
(5 ft) of a patient, unless the nonmedical peripherals receive power from

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an isolated power outlet on the Philips ultrasound system, or from an
isolation transformer that meets medical safety standards, as defined by
standard IEC 60601-1-1.

• The system and patient-applied parts meet the standard IEC 60601-1.
Applied voltages exceeding the standard, although unlikely, may result in
electrical shock to the patient or operator.

• Connection of optional devices not supplied by Philips Ultrasound could
result in electrical shock. When such optional devices are connected to
your ultrasound system, ensure that the total system earth leakage current
does not exceed 500 µA, or in the United States, 300 µA.

• To avoid risk of electrical shock, do not use any transducer that has been
immersed beyond the specified cleaning or disinfection level.

• To avoid risks of electrical shock and fire hazards, inspect the system power
cord and plug regularly. Ensure that they are not damaged in any way.

• Do not drape the power cord over any of the cable hooks or the handle
on the system cart. Damage to the cord or power receptacle unit can occur
if the cart is raised.

• Operating the system with physio input signals that are below the specified
minimum levels may cause inaccurate results. See the

«Specifications» section.

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

• To avoid risk of a burn hazard, do not use transducers with high-frequency
surgical equipment. A burn hazard may result from a defect in the
high-frequency surgical neutral electrode connection.

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

CAUTIONS

• Although your system has been manufactured in compliance with existing
EMI/EMC requirements, use of this system in the presence of an
electromagnetic field can cause momentary degradation of the ultrasound
image. When interference is present or intermittent, use caution when
continuing to use the system. If interference occurs often, review the
environment in which the system is being used, to identify possible sources
of radiated emissions. These emissions could be from other electrical devices
used within the same room or an adjacent room. Communication devices
such as cellular phones and pagers can cause these emissions. The existence
of radio, TV, or microwave transmission equipment located nearby can
cause emissions. In cases where EMI is causing disturbances, it may be
necessary to relocate your system.

• For information on electromagnetic emissions and immunity as it applies
to the system, see

«Electromagnetic Compatibility» on page 66. Ensure that

the

operating environment of your system meets the conditions specified
in the referenced information. Operating the system in an environment that
does not meet those conditions may degrade system performance.

Defibrillators

Observe the following warnings when a defibrillation is required while using the
ultrasound system.

WARNINGS

• Before defibrillation, always remove all patient-applied parts from the patient.

• Before defibrillation, always disconnect invasive transducers from the system.

• A disposable transducer cover provides no protective electrical insulation
against defibrillation.

• A small hole in the outer layer of the transducer opens a conductive path
to grounded metal parts of the transducer. The secondary arcing that could

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occur during defibrillation could cause patient burns. The risk of burns is
reduced, but not eliminated, by using an ungrounded defibrillator.

Use defibrillators that do not have grounded patient circuits. To determine
whether a defibrillator patient circuit is grounded, see the defibrillator service
guide, or consult a biomedical engineer.

Fire Safety

WARNING

On electrical or chemical fires, use only extinguishers that are specifically labeled
for those purposes. Using water or other liquids on an electrical fire can lead to
fatal or other serious personal injury. Before attempting to fight a fire, if it is safe
to do so, attempt to isolate the product from electrical and other supplies, to
reduce the risk of electrical shock.

Use of electrical products in an environment for which they were not designed
can lead to fire or explosion. Fire regulations for the type of medical area being
used should be fully applied, observed, and enforced. Fire extinguishers should
be available for both electrical and nonelectrical fires.

Mechanical Safety

A list of precautions related to mechanical safety follows; observe these
precautions when using the system:

WARNINGS

• Be aware of the wheels on the system cart, especially when moving the
system. The system could cause injury to you or others if it rolls over feet
or into shins. Use caution when going up or down ramps.

• When attempting to overcome an obstacle, do not push the system from
either side with excessive force, which could cause the system to tip over.

• Position external hardcopy devices away from the system. Ensure that they
are secure. Do not stack them on the system.

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• When positioning the monitor, move it carefully to avoid pinching hands
or extremities against other objects, such as a bed rail.

• Never park the system on an incline.

• The brakes are intended as a convenience. To increase cart security, use
wheel chocks when the system is parked.

• If system operation is abnormal after you move or transport the system,
contact Philips Ultrasound Customer Service immediately. System
components are installed securely and can withstand considerable shock,
but excessive shock can cause a system failure.

• To avoid injury, Philips recommends against lifting the system cart.

CAUTIONS

• Before moving the system, ensure that the system is secured for transport.
On some systems, that may include ensuring that the monitor is latched,
to prevent monitor damage during transport.

• Ensure that the cables for all patient-applied parts are secure before moving
the system. Use the cable management system to ensure that transducer
cables are protected from damage.

• Do not roll the system over transducer cables or power cables.

• Do not use the system handle or transducer holders to move the cart.

• Never move the cart with the system on it, unless the system is properly
attached to the cart.

• To avoid the possibility of tipping the system cart when you move it over
a threshold, lift the cart slightly with the handle on the rear of the cart and
pull the cart over the threshold.

Equipment Protection

Follow these precautions to protect your system:

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CAUTIONS

• Excessive bending or twisting of cables on patient-applied parts may cause
failure or intermittent operation of the system. Do not roll the system over
cables, which may damage them.

• Improper cleaning or sterilization of a patient-applied part may cause
permanent damage. For cleaning and disinfection instructions, see the

«Transducer Care» section.

• Do not submerge the transducer connector in solution. The cables and
transducer bodies are liquid-tight, but the connectors are not.

• Do not use solvents, such as thinner or acetone, or abrasive cleaners on
the system, transducers, or any hardcopy device.

• For optimal performance, connect your ultrasound system to a circuit
dedicated solely for the system. Do not connect life-support devices to the
same circuit as the ultrasound system.

• If systems, transducers, and peripherals have been in an environment below
10°C (50°F), allow them to reach room temperature before connecting or
turning them on. Philips recommends allowing 24 hours for complete
normalization. Otherwise, condensation inside the devices could cause
damage. If the device was only briefly exposed to temperatures below 10°C
(50°F), then the time required for the device to return to room temperature
could be significantly less than 24 hours.

• To avoid damaging the flat-panel display in the monitor, do not store the
system where the ambient temperature exceeds 65°C (149°F).

Product Compatibility

Do not use your system in combination with other products or components,
unless Philips expressly recognizes those other products or components as
compatible. For information about such products and components, contact your
Philips representative.

Changes and additions to the system should be made only by Philips or by third
parties expressly authorized by Philips to do so. Such changes and additions must

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comply with all applicable laws and regulations that have the force of law within
the jurisdictions concerned, and best engineering practices.

WARNING

System changes and additions that are made without the appropriate training or
by using unapproved spare parts may void the Philips warranty. As with all
complex technical products, maintenance by unqualified persons or using
unapproved spare parts carries serious risks of system damage and personal
injury.

Symbols

The International Electrotechnical Commission (IEC) has established a set of
symbols for medical electronic equipment that classify a connection or warn of
potential hazards. Of those symbols, the following may be used on your Philips
product and its accessories and packaging.

Isolated patient connection (Type BF applied part).

Defibrillation-proof patient connection (Type BF
applied part).

Non-isolated patient connection (Type B applied
part).

Isolated patient connection for applied part intended
for intraoperative use, including direct cardiac
application and contact with major vessels (Type CF
applied part).

Defibrillation-proof patient connection (Type CF
applied part).

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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.

Identifies an On/Off control.

On a two-position power switch, represents On ( )
and Off (

).

Identifies a safety note.

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

Identifies equipotential ground.

Identifies earth ground.

Identifies protective earth ground.

Nonionizing electromagnetic radiation. Indicates that
interference may occur in the vicinity of equipment
marked with this symbol.

The radio component contained in this device is
compliant to Council Directive 1999/5/EC (Radio
Equipment and Telecommunications Terminal
Equipment Directive).

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Indicates conformance with European Council
Directive 93/42/EEC.

Class 2 radio equipment identifier per Directive
1999/5/EC. European Union member states may apply
restrictions on putting this device into service or
placing it on the market. This device is intended to
be connected to the Publicly Available Interfaces for
use throughout the European Economic Area.

Indicates that the device is protected against the
effects of vertically falling water. This degree of
protection can apply to transducers or foot-operated
devices.

Indicates that the device is protected against the
effects of splashing liquids. This degree of protection
can apply to foot-operated devices.

Indicates that the device is protected against the
effects of immersion. This degree of protection can
apply to transducers and foot-operated devices.

Indicates that the device is protected against the
effects of immersion for up to 60 minutes. This
degree of protection can apply to foot-operated
devices.

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Indicates the need for separate collection for
electrical and electronic equipment in compliance
with the Waste Electrical and Electronic Equipment

(WEEE) Directive. When accompanied by

or ,
components of the device may contain lead or
mercury, respectively, which must be recycled or
disposed of in accordance with local, state, or federal
laws. The backlight lamps in an LCD system monitor
contain mercury.

Do not throw away. Dispose of in accordance with
local, state, or federal laws.

Do not reuse.

Use-by date.

Global Medical Device Nomenclature Code.

Indicates a possible crushing hazard to hands.

Warns that the system should not be used stacked
with other equipment. If the system is used stacked
with or adjacent to other equipment, verify normal
operation before use.

Indicates the temperature range (noncondensing) for
transport and storage. (Does not apply to media.)

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Indicates the atmospheric pressure range for
transport and storage.

Indicates the relative humidity range (noncondensing)
for transport and storage.

Indicates that a connector receives alternating
current.

Identifies fuse boxes or their locations. For continued
protection from fire and shock, replace fuses only
with fuses of the same type and rating.

Identifies the date of manufacture.

Identifies the legal manufacturer.

This side up: Points toward the side of the shipping
crate that should be kept facing up.

Indicates that the device should be kept dry.

Indicates that the device is fragile; handle with care.

Do not use if damaged.

Warns of system over-balance due to external force.
(Do not push on the monitor or the transducer
holders to move the system.)

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Keep away from sunlight.

Non-sterile.

Sterilized using ethylene oxide.

Catalog number.

Batch code.

Serial number.

Universal part number.

The following symbols may also be used on the system and its accessories and
packaging:

Connection for a pencil probe

Connection for a pencil probe

Connection for a transducer

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Connection for ECG leads

Connection for ECG leads

Print remote output

Input port for audio left/right, VHS/S-VHS,
microphone, CD, or DVD

Output port for audio left/right, VHS/S-VHS, video
patient monitor, black-and-white printer, or
interlaced RGB output port

Input port

VGA or parallel output port

DVI video output receptacle

USB input/output port

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FireWire (IEEE 1394) input/output port

Ethernet connection

RS-232 serial port

System microphone

Isolated auxiliary power provided for connection of
Philips-approved remote accessories.

Foot switch

Indicates the atmospheric pressure range for
transport and storage.

SVGA or DVI-I connection.

S-Video connection

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B/W Composite video output connection

Color composite video output connection

Video print trigger connection

Russian approval (GOST)

Identifies the port for the PercuNav tool connection
unit.

Identifies the port for the PercuNav field generator.

Chinese Environmentally Friendly Use Period symbol.

UL (Underwriters Laboratories) classification symbol.

CSA (CSA International) classification symbol.

Indicates a possible pinch hazard when positioning
the monitor.

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The following symbols may be used inside the 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 equipotential ground.

Biological Safety

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

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

WARNINGS

• Do not use the system if an error message on the video display indicates
that a hazardous condition exists. Note the error code, turn off power to
the system, and call your customer service representative.

• Do not use a system that exhibits erratic or inconsistent image updating.
Discontinuities in the scanning sequence indicate a hardware failure that
must be corrected before use.

• Perform ultrasound procedures prudently. Use the ALARA (as low as
reasonably achievable) principle.

• Use only acoustic standoffs that have been approved by Philips Ultrasound.
For information on ordering approved accessories, see

«Supplies and

Accessories» on page 21

.

• Verify the alignment of the biopsy guide before use. See the

«Biopsy Guides»

section.

• Verify the condition of the biopsy needle before use. Do not use a bent
biopsy needle.

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• Transducer covers may contain natural rubber latex. Those covers may
cause allergic reactions in some individuals. See

«FDA Medical Alert on

Latex» on page 44

.

• The M2203A bite guard strap contains natural rubber latex, which may
cause allergic reactions. See

«FDA Medical Alert on Latex» on page 44.

• In contrast studies using a high-MI acoustic field, capillary rupture, due to
microbubble expansion within a capillary in an acoustic field, can cause
extravasation. References: (1) Skyba, D.M., Price, R.J., Linka, A.Z., Skalak,
T.C., Kaul, S. «Direct in vivo visualization of intravascular destruction of
microbubbles by ultrasound and its local effects on tissue.» Circulation, 1998;
98:290-293. (2) van Der Wouw, P.A., Brauns, A.C., Bailey, S.E., Powers, J.E.,
Wilde, A.A. «Premature ventricular contractions during triggered imaging
with ultrasound contrast.» Journal of the American Society of Echocardiography,
2000;13(4):288-94.

• Preventricular contractions can be caused by the oscillations of microbubbles
when a high-MI acoustic field is triggered in the heart at the end of systole.
In a very sick patient with certain risk factors, theoretically, this could lead
to ventricular fibrillation. Reference: van Der Wouw, P.A., Brauns, A.C.,
Bailey, S.E., Powers, J.E., Wilde, A.A. «Premature ventricular contractions
during triggered imaging with ultrasound contrast.» Journal of the American
Society of Echocardiography, 2000;13(4):288-94.

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

• If the system becomes contaminated internally with bodily fluids carrying
pathogens, you must immediately notify your Philips service representative.
Components inside the system cannot be disinfected. In that case, the
system must be disposed of as biohazardous material in accordance with
local or federal laws.

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• The backlight lamps in the system displays contain mercury and must be
recycled or disposed of according to local, state, or federal laws.

• Select the correct application when starting an exam, and remain in that
application throughout the exam. Some applications are for parts of the
body that require lower limits for acoustic output. One example is an
ophthalmic application activated by selecting an orbital transcranial Doppler
preset; when performing an ophthalmic exam, use only an ophthalmic preset.

• When used off the cart, the AC adapter and the system should not be
placed on the floor or on a patient’s bed. You can place it on a table or
chair.

FDA Medical Alert on Latex

March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices

Because of reports of severe allergic reactions to medical devices containing
latex (natural rubber), the FDA is advising health care professionals to identify
their latex sensitive patients and be prepared to treat allergic reactions promptly.
Patient reactions to latex have ranged from contact urticaria to systemic
anaphylaxis. Latex is a component of many medical devices, including surgical
and examination gloves, catheters, intubation tubes, anesthesia masks, and dental
dams.

Reports to the FDA of allergic reactions to latex-containing medical devices have
increased lately. One brand of latex cuffed enema tips was recently recalled after
several patients died as a result of anaphylactoid reactions during barium enema
procedures. More reports of latex sensitivity have also been found in the medical
literature. Repeated exposure to latex both in medical devices and in other
consumer products may be part of the reason that the prevalence of latex
sensitivity appears to be increasing. For example, it has been reported that 6%
to 7% of surgical personnel and 18% to 40% of spina bifida patients are latex
sensitive.

Proteins in the latex itself appear to be the primary source of the allergic
reactions. Although it is not now known how much protein is likely to cause

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severe reactions, the FDA is working with manufacturers of latex-containing
medical devices to make protein levels in their products as low as possible.

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

• When taking general histories of patients, include questions about latex
sensitivity. For surgical and radiology patients, spina bifida patients and health
care workers, this recommendation is especially important. Questions about
itching, rash or wheezing after wearing latex gloves or inflating a toy balloon
may be useful. Patients with positive histories should have their charts
flagged.

• If latex sensitivity is suspected, consider using devices made with alternative
materials, such as plastic. For example, a health professional could wear a
non-latex glove over the latex glove if the patient is sensitive. If both the
health professional and the patient are sensitive, a latex middle glove could
be used. (Latex gloves labeled “Hypoallergenic” may not always prevent
adverse reactions.)

• Whenever latex-containing medical devices are used, especially when the
latex comes in contact with mucous membranes, be alert to the possibility
of an allergic reaction.

• If an allergic reaction does occur and latex is suspected, advise the patient
of a possible latex sensitivity and consider an immunologic evaluation.

• Advise the patient to tell health professionals and emergency personnel
about any known latex sensitivity before undergoing medical procedures.
Consider advising patients with severe latex sensitivity to wear a medical
identification bracelet.

The FDA is asking health professionals to report incidents of adverse reactions
to latex or other materials used in medical devices. (See the October 1990 FDA
Drug Bulletin.) To report an incident, contact the FDA Problem Reporting
Program, MedWatch, at 1-800-332-1088, or on the Internet:

www.fda.gov/Safety/MedWatch/

For a single copy of a reference list on latex sensitivity, write to: LATEX, FDA,
HFZ-220, Rockville, MD 20857.

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NOTE

The ultrasound system and transducers described in this document do not
contain natural rubber latex that contacts humans. Natural rubber latex is not
used on any Philips ultrasound transducer. It also is not used on Philips ECG
cables for the products described in this document.

ALARA Education Program

The guiding principle for the use of diagnostic ultrasound is defined by the «as
low as reasonably achievable» (ALARA) principle. The decision as to what is
reasonable has been left to the judgment and insight of qualified personnel. No
set of rules can be formulated that would be sufficiently complete to dictate the
correct response to every circumstance. By keeping ultrasound exposure as low
as possible, while obtaining diagnostic images, users can minimize ultrasonic
bioeffects.

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

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

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

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Applying ALARA

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

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

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

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

Acoustic Output Limits

This ultrasound system maintains acoustic output below the appropriate limits
for each application, as listed here. The significant difference in magnitude
emphasizes the need to select the correct application and remain in that
application, so the correct application limits are in use for the appropriate
application.

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Limits for Non-Ophthalmic Applications

• I

spta.3

≤ 720 mW/cm

2

• MI ≤ 1.9

• TI ≤ 6.0

Limits for Ophthalmic Applications

• I

spta.3

≤ 50 mW/cm

2

• MI ≤ 0.23

• TI ≤ 1.0

Direct Controls

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

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

Indirect Controls

The indirect controls are those that have an indirect effect on acoustic intensity.
These controls affect imaging mode, pulse repetition frequency, focus depth,
pulse length, and transducer selection.

The choice of imaging mode determines the nature of the ultrasound beam. 2D
is a scanning mode; Doppler is a stationary or unscanned mode. A stationary
ultrasound beam concentrates energy in a single location. A moving or scanned

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ultrasound beam disperses the energy over an area and the beam is concentrated
on the same area for a fraction of the time as that of an unscanned mode.

Pulse repetition frequency or rate refers to the number of ultrasound bursts of
energy over a specific period of time. The higher the pulse repetition frequency,
the more pulses of energy in a period of time. Several controls affect pulse
repetition frequency: focal depth, display depth, sample volume depth, flow
optimization, scale, number of focal zones, and sector-width controls.

Focus of the ultrasound beam affects the image resolution. To maintain or
increase resolution at a different focus requires a variation in output over the
focal zone. This variation of output is a function of system optimization. Different
exams require different focal depths. Setting the focus at the proper depth
improves the resolution of the structure of interest.

Pulse length is the time during which the ultrasonic burst is turned on. The longer
the pulse, the greater the time-average intensity value. The greater the
time-average intensity, the greater the likelihood of temperature increase and
cavitation. Pulse length, burst length, or pulse duration is the output pulse
duration in PW Doppler. Increasing the Doppler sample-volume size increases
the pulse length.

Transducer selection indirectly affects intensity. Tissue attenuation changes with
frequency. The higher the transducer operating frequency, the greater the
attenuation of the ultrasonic energy. A higher transducer operating frequency
requires more output intensity to scan at a deeper depth. To scan deeper at the
same output intensity, a lower transducer frequency is required. Using more
gain and output beyond a point, without corresponding increases in image quality,
can mean that a lower frequency transducer is needed.

Receiver Controls

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

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An Example of Applying the ALARA Principle

An ultrasound scan of a patient’s liver begins with selecting the appropriate
transducer frequency. After selecting the transducer and the application, which
are based on patient anatomy, adjustments to output power should be made to
ensure that the lowest possible setting is used to acquire an image. After the
image is acquired, adjusting the focus of the transducer, and then increasing the
receiver gain to produce a uniform representation of the tissue follows. If an
adequate image can be obtained with the increase in gain, then a decrease in
output should be made. Only after making these adjustments should you increase
output to the next level.

Having acquired the 2D display of the liver, Color can be used to localize blood
flow. As with the 2D image display, gain and image processing controls must be
optimized before increasing output.

Having localized the blood flow, use the Doppler controls to position the sample
volume over the vessel. Before increasing output, adjust velocity range or scale
and Doppler gain to obtain an optimal Doppler trace. Only if maximum Doppler
gain does not create an acceptable image do you increase output.

In summary: Select the correct transducer frequency and application for the job;
start with a low output level; and optimize the image by using focus, receiver
gain, and other imaging controls. If the image is not diagnostically useful at this
point, then increase output.

Additional Considerations

Ensure that scanning time is kept to a minimum, and ensure that only medically
required scanning is performed. Never compromise quality by rushing through
an exam. A poor exam may require a follow-up, which ultimately increases
exposure time. Diagnostic ultrasound is an important tool in medicine, and like
any tool, it should be used efficiently and effectively.

Output Display

The system output display comprises two basic indices: a mechanical index and
a thermal index. The thermal index further consists of the following indices: soft

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