Philips iu22 руководство пользователя

User Manual

4535 614 45861 Rev A

August 2010

«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.

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.

Warning Symbols

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

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

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

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

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

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

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.

1Read This First

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

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

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

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

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

Product Conventions

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

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

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

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

•

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

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

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.

1Read This First

•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.

Upgrades and Updates

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

Customer Comments

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

Supplies and Accessories

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

CIVCO Medical Solutions

102 First Street South, Kalona, IA 52247-9589

Telephone: 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

NOTE

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

3D9-3v 989605351091

C5-1 989605369041

C5-2 989605341511

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

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

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

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

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

to be a medical system. It is your responsibility to comply with IEC 60601-1 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 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.

•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. See the «Transducer Care» section.

•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.

•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.

2Safety

•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.

•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 67. 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 using a transducer when a defibrillation is required.

WARNINGS

•Before defibrillation, always remove the transducer from the patient.

•Before defibrillation, always disconnect the transducer 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 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 or not a defibrillator patient circuit is grounded, see the defibrillator service guide, or consult a biomedical engineer.

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.

•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.

•Before moving the system, ensure that the keyboard is retracted, the control panel is centered, and the monitor is locked (see «Positioning the Control Module» on page 134 and «Preparing and Moving» on page 117). When extended, the keyboard might be damaged if it hits another object, and the video monitor could swing out during transport, causing injury or equipment damage.

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.

Equipment Protection

Follow these precautions to protect your system:

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 cables of patient-applied parts in solution. The cables are not liquid-tight beyond the applied part/cable or cable/connector interfaces.

•In general, only the area of the transducer acoustic window is liquid-tight. Except where specified in specific transducer-cleaning instructions, do not immerse the remainder of a transducer in any liquid.

•Do not use solvents, such as thinner or benzine, 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).

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).

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).

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.

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.)

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.

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

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

Connection for ECG leads

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

VGA or parallel output port

DVI video output receptacle

USB input/output port

Ethernet connection

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 connection

Two video receptacles provide DVI-D digital video for flat-panel monitors.

S-Video connection

B/W Composite video output connection

Color composite video output connection

Video print trigger connection

Russian approval (GOST)

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).

Indicates 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 23.

•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.

•Transducer covers may contain natural rubber latex. Those covers may cause allergic reactions in some individuals. See «FDA Medical Alert on Latex» on page 45.

•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.

•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 the ophthalmic application, which is activated by selecting a Tissue Specific preset such as Orbital TCD. When performing an ophthalmic exam, use only an ophthalmic preset.

FDA Medical Alert on Latex

March29,1991,AllergicReactionstoLatex-ContainingMedicalDevices

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

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

Proteins in the latex itself appear to be the primary source of the allergic reactions. Although it is not now known how much protein is likely to cause severe reactions, the FDA is working with manufacturers of latex-containing medical devices to make protein levels in their products as low as possible.

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

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

•If latex sensitivity is suspected, consider using devices made with alternative materials, such as plastic. For example, a health professional could wear a non-latex glove over the latex glove if the patient is sensitive. If both the health professional and the patient are sensitive, a latex middle glove could

be used. (Latex gloves labeled “Hypoallergenic” may not always prevent adverse reactions.)

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

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

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

The FDA is asking health professionals to report incidents of adverse reactions to latex or other materials used in medical devices. (See the October 1990 FDA Drug Bulletin.) To report an incident, call the FDA Problem Reporting Program, operated through the U.S. Pharmacopoeia toll-free number: 800-638-6725. (In Maryland, call collect 301-881-0256.)

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

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.

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.

Limits for Non-Ophthalmic Applications

•Ispta.3 ≤ 720 mW/cm2

•MI ≤ 1.9

•TI ≤ 6.0

Limits for Ophthalmic Applications

•Ispta.3 ≤ 50 mW/cm2

•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 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