EPIQ 7 Ultrasound System User Manual: Release 1.0
EPIQ 7 Ultrasound System User Manual: Release 1.0
User Manual
Release 1.0
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 either by customers, and is licensed to
them as part of their Philips equipment purchase, or to meet regulatory commitments as required by the FDA under 21 CFR
1020.30 (and any amendments to it) and other local regulatory requirements. 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.
This product and its accessories are manufactured under or operate in accordance with the following United States patents and
corresponding patents in other countries: U.S. Patent Numbers 5,469,851; 5,471,989; 5,482,045; 5,485,842; 5,577,505; 5,706,819;
5,720,291; 5,735,281; 5,795,297; 5,833,613; 5,879,303; 5,891,040; 5,908,389; 5,951,478; 5,993,390; 5,993,392; 6,036,643;
6,102,863; 6,126,599; 6,126,602; 6,210,328; 6,224,552; 6,231,510; 6,251,074; 6,283,919; 6,299,579; 6,306,089; 6,315,723;
6,319,203; 6,364,828; 6,368,281; 6,380,766; 6,390,981; 6,416,477; 6,443,896; 6,447,453; 6,465,937; 6,469,957; 6,471,649;
6,491,630; 6,497,660; 6,500,120; 6,516,215; 6,527,719; 6,527,721; 6,532,819; 6,540,684; 6,544,175; 6,544,177; 6,551,248;
6,575,910; 6,629,929; 6,632,179; 6,676,606; 6,679,849; 6,685,637; 6,723,050; 6,743,174; 6,755,786; 6,755,788; 6,761,689;
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 ........................................................................................................................... 27
Basic Safety .......................................................................................................................... 27
Electrical Safety ................................................................................................................... 29
Defibrillators ................................................................................................................33
Fire Safety ....................................................................................................................34
Mechanical Safety ................................................................................................................ 34
Equipment Protection .......................................................................................................... 36
Product Compatibility .......................................................................................................... 37
Symbols ................................................................................................................................ 38
Biological Safety ................................................................................................................... 46
FDA Medical Alert on Latex .........................................................................................49
ALARA Education Program ...........................................................................................50
Output Display .............................................................................................................54
Control Effects .............................................................................................................58
Related Guidance Documents .....................................................................................60
Acoustic Output and Measurement ............................................................................60
Acoustic Output Tables ................................................................................................63
Acoustic Measurement Precision and Uncertainty .....................................................63
Operator Safety ................................................................................................................... 65
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 176. 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.
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. Inspect the data that is being
used for the analysis and diagnosis and ensure that the data is sufficient both spatially and
temporally for the measurement approach being used.
Warnings
Before using the system, read these warnings and the “Safety” section.
WARNING
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.
WARNING
To avoid electrical shock, use only supplied power cords and connect only to properly
grounded wall (wall/mains) outlets.
WARNING
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.
WARNING
Medical equipment must be installed and put into service according to the special
electromagnetic compatibility (EMC) guidelines provided in the “Safety” section.
WARNING
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.
Warning Symbols
Symbol Description
Identifies a safety note.
• 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, touch
on the touch screen.
• 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:
• Three unlabeled buttons near the trackball are used with the trackball. The two buttons on
either side of the trackball are called the "left and right trackball buttons," and they operate
somewhat similarly to PC mouse buttons. The button above the trackball is called the
"middle trackball button," and it is used to update the imaging display, complete
measurements, and other operations as specified in procedures. The trackball arbitration
icon, at the bottom of the display, indicates the current functions of the trackball buttons.
• 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.
• Controls on the touch screen include buttons, knob labels, and sliders. To use a touch
screen button, simply touch it. To use a touch screen knob label, touch the label and adjust
the corresponding knob, located directly below it on the control panel. If two knob labels
are available for the knob, you must first touch the knob label that you want to adjust. To
use a slider, swipe the slider button, or touch a location on the slider, to move the slider
button.
• Many tabs on the touch screen contain two pages of controls. To display the second page,
place your finger on the touch screen and swipe to the left. To return to the first page, place
your finger on the touch screen and swipe to the right.
• Some areas of the display include chevrons . Clicking displays or hides additional
information, options, or fields.
• Drag means to place the pointer over an object and then press and hold the left or right
trackball button 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.
• Swipe means to touch the touch screen with the tip of your finger and move your finger in a
quick motion either to the left or to the right. This action displays an additional touch
screen, if one is available.
• 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.
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.
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
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.
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.
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
Discarding Batteries
Batteries should be discarded if there are visual signs of damage. Batteries should be discarded
in an environmentally safe manner. Properly dispose of batteries according to local regulations.
WARNING
Do not disassemble, puncture, or incinerate batteries. Be careful not to short the battery
terminals because this could result in a fire hazard.
CAUTION
Use caution when handling, using, and testing the batteries. Do not short circuit, crush, drop,
mutilate, puncture, apply reverse polarity, expose to high temperatures, or disassemble.
Misuse or abuse could cause physical injury.
NOTE
Wash skin with large amounts of water in the event of electrolyte leakage to prevent skin
irritation and inflammation.
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.
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.
Basic Safety
WARNING
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.
WARNING
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.
WARNING
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. Operation of the system without proper and adequate training
could lead to fatal or other serious personal injury.
WARNING
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.
WARNING
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.
WARNING
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.
WARNING
Stop use immediately if the system or the transducer appear to be malfunctioning. Contact
your Philips representative immediately.
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. (The safety standards met by this
system are included in the “Specifications” section.) For maximum safety, observe these
warnings and cautions:
WARNING
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.
WARNING
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.
WARNING
Use only Type CF transducers for invasive procedures. Type B transducers are insufficiently
electrically isolated for invasive use.
WARNING
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.
WARNING
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.
WARNING
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.
WARNING
To avoid risk of electrical shock hazards, always turn off the system and disconnect it from
the wall outlet before cleaning the system.
WARNING
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 33.
WARNING
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.
WARNING
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.
WARNING
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.
WARNING
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.
WARNING
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.
WARNING
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.
WARNING
To avoid risk of electrical shock, do not use any transducer that has been immersed beyond
the specified cleaning or disinfection level.
WARNING
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.
WARNING
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.
WARNING
Operating the system with physio input signals that are below the specified minimum levels
may cause inaccurate results. See the “Specifications” section.
WARNING
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.
WARNING
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.
WARNING
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.
CAUTION
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.
CAUTION
For information on electromagnetic emissions and immunity as it applies to the system, see
“Electromagnetic Compatibility ” on page 68. 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.
WARNING
Before defibrillation, always remove all patient-applied parts from the patient.
WARNING
Before defibrillation, always disconnect invasive transducers that remain in contact with the
patient from the system.
WARNING
A disposable transducer cover provides no protective electrical insulation against
defibrillation.
WARNING
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 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:
WARNING
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.
WARNING
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.
WARNING
Position external hardcopy devices away from the system. Ensure that they are secure. Do
not stack them on the system.
WARNING
When positioning the monitor, move it carefully to avoid pinching hands or extremities
against other objects, such as a bed rail.
WARNING
Never park the system on an incline.
WARNING
The brakes are intended as a convenience. To increase cart security, use wheel chocks when
the system is parked.
WARNING
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.
WARNING
To avoid injury, Philips recommends against lifting the system cart.
WARNING
If you park the system on a floor that is tilted 10 degrees or more and set the brakes, one of
the braked casters might not be touching the floor, which can cause the system to move.
WARNING
Before moving the system, ensure that the keyboard is retracted, the control panel is
centered, and the monitor is locked. 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.
CAUTION
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.
CAUTION
Do not roll the system over transducer cables or power cables.
Equipment Protection
Follow these precautions to protect your system:
CAUTION
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.
CAUTION
Improper cleaning or sterilization of a patient-applied part may cause permanent damage.
For cleaning and disinfection instructions, see the “Transducer Care” section.
CAUTION
Do not submerge the transducer connector in solution. The cables and transducer bodies are
liquid‑tight, but the connectors are not.
CAUTION
Do not use solvents, such as thinner or acetone, or abrasive cleaners on the system,
transducers, or any hardcopy device.
CAUTION
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.
CAUTION
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.
CAUTION
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 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.
USA federal law restricts this device to sale by or on the order of a physician.
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).
Indicates that the user should see the instructions for use for safety
information.
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 or
transducers.
Indicates the need for separate collection for electrical and electronic
equipment in compliance with the Waste Electrical and Electronic Equipment
Do not reuse.
Use-by date.
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 relative humidity range (noncondensing) for transport and storage.
Identifies fuse boxes or their locations. For continued protection from fire and
shock, replace fuses only with fuses of the same type and rating.
This side up: Points toward the side of the shipping crate that should be kept
facing up.
Warns of system over-balance due to external force. (Do not push on the
monitor or the transducer holders to move the system.)
Non-sterile.
Catalog number.
Batch code.
Serial number.
The following symbols may also be used on the system and its accessories and packaging:
Indicates a hazard to patients with pacemakers. Do not place field generator
within 200 mm (8 in) of a patient with a pacemaker.
Output port for audio left/right, VHS/S-VHS, video patient monitor, black-and-
white printer, or interlaced RGB output port
Input port
Ethernet connection
System microphone
Foot switch
Video Connection
S-Video connection
EU Authorized Representative
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.
WARNING
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.
WARNING
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.
WARNING
Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable)
principle.
WARNING
Use only acoustic standoffs that have been approved by Philips Ultrasound. For information
on ordering approved accessories, see “Supplies and Accessories” on page 21.
WARNING
Verify the alignment of the biopsy guide before use. See the “Biopsy Guides” section.
WARNING
Verify the condition of the biopsy needle before use. Do not use a bent biopsy needle.
WARNING
Transducer covers may contain natural rubber latex. Those covers may cause allergic
reactions in some individuals. See “FDA Medical Alert on Latex” on page 49.
WARNING
The M2203A bite guard strap contains natural rubber latex, which may cause allergic
reactions. See “FDA Medical Alert on Latex” on page 49.
WARNING
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.
WARNING
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.
WARNING
If a sterile transducer cover becomes compromised during an intraoperative application
involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob
disease, follow the guidelines of the 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.
WARNING
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.
WARNING
The backlight lamps in the system displays may contain mercury and must be recycled or
disposed of according to local, state, or federal laws.
WARNING
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.
• 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.
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.
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.
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 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.
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 mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of
0.1 for all applications except contrast, where the minimum increment is 0.01.
The thermal index further consists of the following indices: soft tissue (TIS), bone (TIB), and
cranial bone (TIC). Only one of these is displayed at any time. Each transducer application has a
default selection that is appropriate for that combination. The TIB, TIS, or TIC is continuously
displayed over the range of 0.0 to maximum output, based on the transducer and application,
in increments of 0.1. For the location of the output display, see “Imaging Display” on page 135.
The application-specific nature of the default setting is also an important factor of index
behavior. A default setting is a system control state that is preset by the manufacturer or the
operator. The system has default index settings for the transducer application. The default
settings are invoked automatically by the ultrasound system when power is turned on, when
new patient data is entered into the system database, or when an application change occurs.
The decision as to which of the three thermal indices to display should be based on the
following criteria:
• Appropriate index for the application: TIS is used for imaging soft tissue, TIB for a focus at or
near bone, and TIC for imaging through bone near the surface, as in a cranial exam.
• Mitigating factors that might create artificially high or low thermal index readings: location
of fluid or bone, or blood flow. For example, is there a highly attenuating tissue path so that
the actual potential for local zone heating is less than the thermal index displays?
• Scanned modes versus unscanned modes of operation affect the thermal index. For
scanned modes, heating tends to be near the surface; for unscanned modes, the potential
for heating tends to be deeper in the focal zone.
• Always limit ultrasound exposure time. Do not rush the exam. Ensure that the indices are
kept to a minimum and that exposure time is limited without compromising diagnostic
sensitivity.
Many of the assumptions used in the process of measurement and calculation are conservative
in nature. Overestimation of actual in situ intensity exposure, for the vast majority of tissue
paths, is built into the measurement and calculation process. For example:
• The measured water tank values are derated using a conservative, industry standard,
attenuation coefficient of 0.3 dB/cm-MHz.
• Conservative values for tissue characteristics were selected for use in the TI models.
Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat
capacity, and tissue thermal conductivity were selected.
• Steady State temperature rise is assumed in the industry standard TI models, and the
assumption is made that the ultrasound transducer is held steady in one position long
enough for steady state to be reached.
A number of factors are considered when estimating the accuracy of the displayed values:
hardware variations, estimation algorithm accuracy, and measurement variability. Variability
among transducers and systems is a significant factor. Transducer variability results from
piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens-
focusing parameter variations. Differences in system pulser voltage control and efficiencies is
also a contributor to variability. There are inherent uncertainties in the algorithms used to
estimate acoustic output values over the range of possible system operating conditions and
pulser voltages. Inaccuracies in laboratory measurements are related to, among others,
differences in hydrophone calibration and performance, positioning, alignment, and digitization
tolerances, and variability among test operators.
The conservative assumptions of the output estimation algorithms of linear propagation, at all
depths, through a 0.3 dB/cm-MHz attenuative medium is not considered in the accuracy
estimate for the display. Neither linear propagation, nor uniform attenuation at the 0.3 dB/cm-
MHz rate, occur in water tank measurements or in most tissue paths in the body. In the body,
different tissues and organs have dissimilar attenuation characteristics. In water, there is
almost no attenuation. In the body, and in particular, in water tank measurements, nonlinear
propagation and saturation losses occur as pulser voltages increase.
Therefore, the display accuracy estimates are based on the variability range of transducers and
systems, inherent acoustic output modeling errors, and measurement variability. Display
accuracy estimates are not based on errors in, or caused by measuring according to, the AIUM
measurement standards, or the effects of nonlinear loss on the measured values.
Control Effects
Power
The output power control affects the system acoustic output. Two real‑time output values are
on the display: TI and MI. They change as the system responds to power-control adjustments.
In combined modes, such as simultaneous Color, 2D, and PW Doppler, the individual modes
each add to the total TI. One mode will be the dominant contributor to this total. The displayed
MI will be from the mode with the largest MI value.
2D Controls
• Sector Width: Narrowing the sector angle may increase frame rate. This action will increase
the TI. Pulser voltage may be automatically adjusted down with software controls to keep
the TI below the system maximums. A decrease in pulser voltage will decrease MI.
• Zoom: Increasing the zoom magnification by pressing Zoom may increase frame rate. This
action will increase the TI. The number of focal zones may also increase automatically to
improve resolution. This action may change the MI, because the peak MI can occur at a
different depth.
• Number of Focal Zones: More focal zones may change both the TI and MI by changing
frame rate or focal depth automatically. Lower frame rates decrease the TI. MI displayed
will correspond to the zone with the largest MI value.
• Focus: Changing the focal depth will change MI. Generally, higher MI values will occur when
the focal depth is near the natural focus of the transducer.
• Color Sector Width: Narrower color sector width will increase color frame rate and the TI
will increase. The system may automatically decrease pulser voltage to stay below the
system maximum. A decrease in pulser voltage will decrease the MI. If PW Doppler is also
enabled, then PW Doppler will remain the dominant mode and the TI change will be small.
• Color Sector Depth: Deeper color sector depth may automatically decrease color frame rate
or select a new color focal zone or color pulse length. The TI will change due to the
combination of these effects. Generally, the TI will decrease with increased color sector
depth. MI will correspond to the MI of the dominant pulse type which is a color pulse.
However, if PW Doppler is also enabled then PW Doppler will remain the dominant mode
and the TI change will be small.
• Scale: Using the scale control to increase the color velocity range may increase the TI. The
system may automatically adjust pulser voltage to stay below the system maximums. A
decrease in pulser voltage will also decrease MI.
• Sector Width: A narrower 2D sector width in Color imaging will increase color frame rate.
The TI will increase. MI will change little, if at all. If PW Doppler is also enabled, then PW
Doppler will remain the dominant mode and the TI change will be small.
• Transducer: Each transducer type has unique specifications for contact area, beam shape,
and center frequency. Defaults are initialized when you select a transducer. Factory defaults
vary with transducer, application, and selected mode. Defaults have been chosen below the
FDA limits for intended use.
• 2D Depth: An increase in 2D depth will automatically decrease the 2D frame rate. This will
decrease the TI. The system may also automatically choose a deeper 2D focal depth. A
change of focal depth may change the MI. The MI displayed is that of the zone with the
largest MI value.
• Application: Acoustic output defaults are set when you select an application. Factory
defaults vary with transducer, application, and mode. Defaults have been chosen below the
FDA limits for intended use.
Since the ultrasonic path during an examination is likely to pass through varying lengths and
types of tissue, it is difficult to estimate the true in situ intensity. An attenuation factor of 0.3 is
used for general reporting purposes; therefore, the In Situ value which is commonly reported
uses the formula:
In Situ derated = Water [e-0.069lf]
Since this value is not the true in situ intensity, the term “derated” is used.
Mathematical derating of water based measurements using the 0.3 dB/cm-MHz coefficient,
may yield lower acoustic exposure values than would be measured in a homogenous
0.3 dB/cm-MHz tissue. This is true because nonlinearly propagating acoustic energy waveforms
experience more distortion, saturation, and absorption in water than in tissue, where
attenuation present all along the tissue path will dampen the buildup of nonlinear effects.
The maximum derated and the maximum water values do not always occur at the same
operating conditions; therefore, the reported maximum water and derated values may not be
related by the in situ (derated) formula. For example: A multi-zone array transducer that has
maximum water value intensities in its deepest zone may have its largest derated intensity in
one of its shallowest focal zones.
depends on each specific situation. For example, when the beam path is longer than 3 cm and
the propagation medium is predominantly fluid (conditions that may exist during
transabdominal OB scans), a more accurate value for the derating term is 0.1 dB/cm-MHz.
Fixed-path tissue models, in which soft tissue thickness is held constant, sometimes are used to
estimate in situ acoustical exposures when the beam path is longer than 3 cm and consists
largely of fluid. When this model is used to estimate maximum exposure to the fetus during
transabdominal scans, a value of 1 dB/MHz may be used during all trimesters.
The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad
range of values:
• A survey of 1990-equipment models yielded mechanical index (MI) values between 0.1 and
1 at their highest output settings. Maximum MI values of approximately 2 are known to
occur for currently available equipment. Maximum MI values are similar for real-time 2D,
M-mode, PW Doppler, and Color flow imaging.
• Computed estimates of upper limits to temperature elevations during transabdominal scans
were obtained in a survey of 1988 and 1990 PW Doppler equipment. The vast majority of
models yielded upper limits less than 1°C and 4°C for exposures of first-trimester fetal
tissue and second-trimester fetal bone, respectively. The largest values obtained were
approximately 1.5°C for first-trimester fetal tissue and 7°C for second-trimester fetal bone.
Estimated maximum temperature elevations given here are for a “fixed-path” tissue model
and are for devices having Ispta (derated) values greater than 500 mW/cm2. The
temperature elevations for fetal bone and tissue were computed based on calculation
procedures given in Sections 4.3.2.1 through 4.3.2.6 in "Bioeffects and Safety of Diagnostic
Ultrasound" (AIUM Report, January 28, 1993).
NOTE
Per Section 6.4 of the Output Display Standard, measurement precision on the following
quantities is determined by making repeated measurements and stating the standard deviation
as a percentage.
Operator Safety
The following issues and situations can affect operator safety when you are using an ultrasound
system.
WARNING
The foot switch is not intended for use in wet locations, such as emergency rooms and
operating theaters.
Philips Transducers
Use only transducers that are approved by Philips for use with your Philips ultrasound system.
See “Clinical Applications and Transducers” on page 174 for a list of the transducers that are
compatible with your ultrasound system.
In the United States, the FDA 510(k) regulatory clearance for use of the product is applicable
only when Philips-manufactured transducers are connected to the system.
Glutaraldehyde Exposure
The United States Occupational Safety and Health Administration (OSHA) has issued a
regulation covering levels of acceptable glutaraldehyde exposure in the working environment.
Philips does not sell glutaraldehyde-based disinfectants with its products, but this type of
disinfectant is recommended for the disinfection of transducers used in TEE, intraoperative,
endocavity, and biopsy procedures.
To reduce the presence of glutaraldehyde fumes in the air, be sure to use a covered or
ventilated soaking basin. Such systems are commercially available. The most-current
information about disinfection products and Philips transducers can be found on the Philips
Transducer Care website:
www.healthcare.philips.com/us_en/products/ultrasound/Transducers/transducer_care/
index.wpd
Infection Control
Issues related to infection control affect the operator and the patient. Follow the infection-
control procedures established in your facility for the protection of both the staff and the
patient.
CAUTION
Do not wipe the transducer housing joint, strain relief, or cable with isopropyl alcohol.
Isopropyl alcohol can damage these parts of the transducer. This damage is not covered by
the warranty or your service contract.
Use a gauze pad moistened with soap and water to remove blood on the system and the
transducer connectors and cables. Then dry the equipment with a soft cloth to prevent
corrosion. You can use a 70% solution of isopropyl alcohol on the system and only on certain
parts of some transducers. Additional cleaning agents are available for transducers. For more
information, see the “Transducer Care” section.
For more information about removing blood and other infectious material from the system, see
“Disinfecting System Surfaces” on page 290.
Disposable Drape
If you believe contamination of the system might occur during an exam, Philips recommends
that you take universal precautions and cover the system with a disposable drape. Consult your
facility's rules regarding equipment use in the presence of infectious disease.
CAUTION
Position the disposable drape so that it does not block the vents on the system, the monitors,
or the peripherals.
Electromagnetic Compatibility
Electromagnetic compatibility (EMC) is defined as the ability of a product, a device, or a system
to function satisfactorily in the presence of the electromagnetic phenomena that exists in the
location of the product, the device, or the system being used; and, in addition, to not introduce
intolerable electromagnetic disturbances to anything in that same environment.
Electromagnetic immunity is the ability of a product, a device, or a system to function
satisfactorily in the presence of electromagnetic interference (EMI).
Electromagnetic emissions is the ability of a product, a device, or a system to introduce
intolerable electromagnetic disturbances into the use environment.
Your system has been manufactured in compliance with existing electromagnetic compatibility
requirements. Use of this system in the presence of an electromagnetic field can cause
momentary degradation of the tracking ability. If this occurs often, review the environment in
which the system is being used to identify possible sources of radiated emissions. These
emissions could be from other electrical devices used within the same room or an adjacent
room, or from portable and mobile RF communications equipment such as cellular phones and
pagers, or from the existence of radio, TV, or microwave transmission equipment located
nearby. In cases where electromagnetic interference (EMI) is causing disturbances, it may be
necessary to relocate your system.
The system complies with International Standard CISPR 11 for radiated and conducted
electromagnetic disturbances. Compliance with this standard allows the system to be used in all
establishments, including domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for domestic purposes.
WARNING
Using cables, transducers, or accessories other than those specified for use with the system
may result in increased emissions or decreased immunity of the system.
CAUTION
Medical equipment has special precautions regarding EMC and must be installed and put into
service according to the EMC information provided in the system’s accompanying documents.
NOTE
See the other electrical-safety warnings and cautions in this section.
Radio-Frequency Emissions
The following information applies to the system and any radio-frequency device included in or
with the system. For information on related labeling, see “Symbols” on page 38.
FCC and Industry Canada Radio Compliance: This device complies with Part 15 of the FCC Rules
and RSS-210 of Industry Canada. Operation is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause
undesired operation. Any changes or modifications to this equipment not expressly
approved by Philips may cause harmful radio frequency interference and void your
authority to operate this equipment.
ECG Signal
WARNING
Operation of your system with ECG signals below 0.25 mV may cause inaccurate results.
The amplitude of the electrocardiogram (ECG) signal is critical for reliable frame triggering.
Frame triggering should be used only when a clean, noise-free ECG waveform is observed on
the ECG display. The ECG signal should be at least 0.25 mV to ensure reliable triggering when
the system is used in the presence of the electromagnetic phenomena described in this section
and elsewhere in your system user information.
CAUTION
Do not touch transducer connector pins or the system’s transducer receptacle.
CAUTION
Handle the transducer by the metal connector shell.
CAUTION
Make contact with a metal surface of the system before connecting a transducer to the
system.
CAUTION
The following precautions can help to reduce ESD: anti-static spray on carpets; anti-static
spray on linoleum; anti-static mats; or a ground wire connection between the system and the
patient table or bed.
CAUTION
On connectors labeled with the ESD sensitivity symbol , do not touch the connector pins,
and always observe the preceding ESD precautions when handling or connecting transducers.
NOTE
Electrostatic discharges (ESDs) may cause the ECG heart rate display to increase by 10% to 15%
for a few seconds after the discharge. However, the ECG heart rate display will return to normal
within 4 seconds.
Electromagnetic Emissions
The system is intended for use in the electromagnetic environment specified in the table. The
customer or the user of the system should ensure that it is used in such an environment.
WARNING
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.
Approved Cables
Cable Type Length Philips Part Number
Adult and pediatric ECG three-lead – 2.7 m (9 ft) with
patient trunk cable (for AAMI and IEC leadset
leadsets)
WARNING
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.
NOTE
The use of an Intracardiac Echocardiography (ICE) Probe or an Transesophageal
Echocardiogram (TEE) probe results in Class A Radiated Emissions and should be used in a
hospitable environment only.
When connecting other accessories to the system, such as a remote video monitor or
computer, it is the user’s responsibility to ensure the electromagnetic compatibility of the
system. Use only CISPR 11 or CISPR 22, Class B-compliant devices, unless otherwise noted.
WARNING
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.
CAUTION
Use only Class-B USB storage devices with the system. Some plastic-cased unshielded USB
devices may cause RF emissions that exceed Class-B limits. See the device’s documentation to
determine whether it is Class-B compliant.
Approved Accessories
Accessory Manufacturer Model Number
Ultrasonic imaging transducer Philips Use only the transducers listed in
“Clinical Applications and
Transducers” on page 174
DVD recorder Sony DVO-1000MD
Black-and-white printer Sony UP-D897MD
Color printer Sony UP-D25MD
Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified here. The
customer or the user of the system should ensure that it is used in such an environment.
NOTE
The guidelines specified here may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
NOTE
UT is the AC power voltage before application of the test level.
NOTE
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
CAUTION
If the system is connected to other customer-supplied equipment, such as a local area
network (LAN) or a remote printer, Philips cannot guarantee that the remote equipment will
work correctly in the presence of electromagnetic phenomena.
Although most remote devices comply with their applicable standards for immunity, those
device requirements may not be as stringent as those required for medical equipment. It is the
responsibility of the installer and the user of this remote customer-supplied equipment to
ensure that it functions properly in the electromagnetic environment where the system is
installed. Philips suggests that the installer or the user of such a system consult with experts in
the field of electromagnetic compatibility and safety for guidance to ensure the safe and
effective use of the created system.
Electromagnetic Interference
Electromagnetic interference may appear in many ways on the system and depends on the
mode the equipment is operating in, the imaging control settings, the type of transducer being
used, the type of electromagnetic phenomena, and the intensity level of the phenomena.
CAUTION
When interference is present or intermittent, use caution when continuing to use the system.
NOTE
Electromagnetic phenomena are not always present and may be transitory in nature. It may be
extremely difficult to identify the source of the interference.
NOTE
The following table describes a few typical interferences seen in imaging systems. It is
impossible to describe all manifestations of interference, because it depends on many
parameters of the transmitting device, such as the type of modulation used by the signal
carrier, the source type, and the transmitted level. It is also possible for the interference to
degrade the imaging system's performance and not be visible in the image. If the diagnostic
results are suspicious, other means should be used to confirm the diagnosis.
NOTE
For transmitters rated at a maximum output power not listed in the following table, the
recommended separation distance d in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
NOTE
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE
The recommended separation distance guidelines in the following table may not apply to all
situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
The information provided here, in conjunction with “Electromagnetic Interference” on page 77,
provides guidance on conducted and radiated interference from portable and fixed RF
transmitting equipment.
Recommended Separation Distances by Transmitter Frequency
Rated Maximum Output 150 kHz to 80 MHz 80 to 800 MHz 800 MHz to 2.5 GHz
Power of Transmitter (Watts)
0.01 117 m (384 ft) 0.12 m (4.7 in) 0.24 m (9.5 in)
0.1 369 m (1210 ft) 0.38 m (15 in) 0.76 m (30 in)
The conducted RF test level is 3 V, and the system has a compliance level of 3 mV. For the
system, this means that the imaging system is extremely sensitive to RF interference in the
transducer passband. For example, for a 5-MHz imaging transducer, the frequency range of
interference from a 3-V/m field may be from 2 to 10 MHz and manifest itself as described in
“Electromagnetic Interference” on page 77.
The 0.3 mV level is where the interference becomes acceptable to some clinical specialists.
Sensitivity to interference is dependent on operating mode and imaging control settings. The
order of increasing sensitivity to interference as a function of operating mode is 2D mode, 3D
mode, M-mode, Color mode, PW Doppler mode, and CW Doppler mode. The system is more
sensitive to interference in the CW Doppler or PW Doppler operating modes, but the
probability of interference is lower than in 2D mode or Color mode, because the susceptible
frequency range is lower. Therefore, you are more likely to see interference in 2D or Color
modes.
As an example, if a portable transmitter has maximum radiated power of 1 W and an operating
frequency of 156 MHz, it should only be operated at distances greater than 1.2 m (3.9 ft) from
the system. Likewise, a 0.01-W Bluetooth wireless LAN device operating at 2.4 GHz should be
placed no closer than 0.24 m (9.5 in) from any part of the system.
WARNING
The physician must determine if tracking is accurate. Tracking in an untested environment or
a location known to cause electromagnetic interference can contribute to inaccurate
information and possible personal injury.
3 System Overview
Use this section to acquaint yourself with the ultrasound system and its components.
System Capabilities
The EPIQ 7 Ultrasound System is a high-resolution system intended for general imaging,
interventional radiology, cardiology, vascular, and OB/GYN applications, and analysis. The cart
is ergonomically designed to be both highly mobile and adjustable for a range of users and
operating conditions. You can use it for 2D, Live 3D Echo, M-mode, Doppler, and Color imaging.
You can also perform Duplex, Triplex, and Live xPlane imaging. Stress echocardiography is
standard on the system, and QLAB Advanced Quantification Software Q-Apps are available as
options. The system supports a wide range of transducers. The system provides measurement
tools, analysis options, and DICOM network capabilities.
Measurements
The system provides tools and controls for measuring distance, area, and volume. Additionally,
the following application-specific tools are available:
• Aliasing Velocity
• 3D Volume
• Generic Angle
• Heart Rate
• High Q automatic Doppler analysis
• Hip Tools
• Percent Reduction
• Simpson's Method
• Time/Slope
• Velocity
• Volume Flow
After you perform measurements, the system makes the pertinent calculations and organizes
the measurements, calculations, and patient information into a patient report.
For information, see the Help. To display the Help, touch . To close the Help, touch again.
Transducer Types
Available transducer types include sector array, linear array, curved array, Doppler probes,
endocavity, intraoperative, transesophageal, volume, and xMATRIX. Applications for specific
transducers are listed in “Clinical Applications and Transducers” on page 174.
System Options
In addition to the standard features available in the system, other features are available as
purchasable options. The types of options available include clinical applications, QLAB
Advanced Quantification Software, protocols, imaging capabilities, and connectivity capabilities.
A foot switch is available as an option.
Imaging Options
• 3D/4D (mechanical transducers)
• 3D Single Sweep Color Flow
• 3D Fetal Echo STIC
• Auto Doppler Optimization
• Color for 3D imaging
• Contrast perfusion
• Strain Elastography
• ElastPQ Shear Wave Elastography
• Exam protocols
• Freehand 3D
• iSCAN Intelligent Optimization
• Live 3D and xPlane imaging (xMATRIX transducers)
• Panoramic 2D imaging
• Panoramic 3D imaging
• Physio
• Sleep/Portability Mode (Battery Option)
• Stress Echo protocols
• Tissue Doppler Imaging (TDI)
NOTE
The elastography feature is available only in selected regions. For information specific to your
region, contact your local Philips representative.
Connectivity Capabilities
The following features are standard:
• Image and waveform export to removable media
• Printing to DICOM printers
• Printing to local printers
• Printing report pages
• Wireless DICOM transfer
In addition to those standard features, the Basic Connectivity purchasable option includes the
following features:
• DICOM Networking
• Image and waveform export to network storage servers
• DICOM Modality Worklist
• DICOM Performed Procedure Step (PPS)
• DICOM Storage Commit (SC)
• DICOM Structured Reporting
• DICOM Query/Retrieve
• Digital Navigation Link (DNL)
Clinical/Analysis Applications
Clinical applications are available on the system as separate purchasable options. The following
clinical applications and their presets (for example, small parts superficial) are associated with
specific transducers:
• Abdominal
• Adult Echo
• Fetal Echo
• General
• GYN
• Intervention CV
• Intervention GI
• Musculoskeletal
• OB
• Pediatric Echo
• Pediatric GI
• Small Parts
• TCD
• Urology
• Vascular
NOTE
The EA Q-App is only available in the United States.
NOTE
The EQ Q-App is not available in the United States.
Stress Echocardiography
Stress Echocardiography (Stress Echo) is a protocol-driven study that allows a cardiologist to
assess cardiac wall motion at various heart rates by acquiring views of the heart at different
stages of the study. Stress Echo includes these Philips protocols:
• Exercise 2-Stage
• Exercise 3-Stage
• iRotate Stress
• Pharmacological 4-Stage
• Quantitative 4-Stage
• Wall Motion and Contrast
You can create custom presets based on those protocols.
Data Security
A data security feature is available to help maintain the confidentiality of archived patient files.
With this option, access to patient exam files is restricted to authorized personnel through user
ID and password protection. For more information, see “System Security” on page 133.
NOTE
PercuNav is a purchasable licensed option. Its user interface is available only when the
PercuNav license is enabled.
System Components
The system is housed in an ergonomic cart. The cart is adjustable to accommodate a wide range
of operator heights and operating positions. Adjustable components can be locked in place so
the cart can be safely moved. The major components include the monitor, control module,
On/Off switch, DVD+RW drive, peripheral bay, transducer receptacles, ECG/physio receptacles,
USB ports, brakes and steering locks, and foot switch receptacle.
System Components
1 Monitor
2 On/Off switch
3 Control module
4 Transducer receptacle locks
5 Transducer receptacles
6 Side panel
7 Brake/steering lock pedal
8 Touch screen
9 Peripheral bays
Video Monitor
The system video monitor consists of a 53.3-cm (21-in) flat-panel display on an articulated
mounting arm. The monitor is adjustable to accommodate different operating positions and
operator heights. The monitor can also be locked in position for moving the system (see
“Moving the System” on page 106).
Control Module
The control module includes three main components: the control panel, the touch screen, and
the keyboard. For more information on the control module, refer to “System Controls” on page
119.
The control panel contains the main imaging controls. These controls include buttons, knobs,
and a trackball. The control module also allows you to select transducers, enter patient data,
review and annotate images, perform measurements and calculations, and change setups.
The touch screen, located above the control panel, displays controls used to select applications
and imaging modes, as well as controls that are specific to the current operating mode. Touch
screen controls include buttons and knobs.
Control Module
1 Control panel
2 Touch screen
3 Trackball
4 TCG slide controls
You can adjust the position of the control module vertically and side-to-side. You can also
swivel the control module.
Beneath the control panel is a retractable keyboard. The keyboard is used to enter patient data,
comments, and text annotation on images.
Retractable Keyboard
On/Off Control
Data Storage
You can store exam data and images onto removable media. Removable media includes USB
storage devices and the DVDs and CDs. The DVD+RW drive is located on the right side of the
control panel behind the transducer holders.
DVD+RW Drive
Peripherals
The peripheral bays at the back of the system provide space for up to two peripheral devices.
Those devices can be any combination of the following devices: a black-and-white printer, a
color printer, and a DVD recorder.
NOTE
If your system configuration includes the PercuNav Image Fusion and Interventional Navigation
option, then the top peripheral bay is dedicated to the PercuNav hardware and is unavailable
for other peripherals. Only one other peripheral can be installed in the bay.
Peripheral Bays
Transducer Receptacles
1 Physio probe receptacle
2 Doppler probe receptacle
3 Imaging transducer receptacle
When a transducer is not in use, store it in one of the transducer holders on the system cart.
Always loop transducer cables over the cable hangers to prevent cables from being stepped on
or run over by the cart wheels.
Connecting Devices
In addition to the devices installed in the system cart, the system supports external devices.
These devices include printers, a foot switch, and a color monitor.
The system also supports a DVD recorder. This recorder is considered an external device, even
when it is installed on the system. The DVD recorder can be installed before the system is
shipped, or it can be installed later by your Philips representative.
WARNING
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.
WARNING
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 isolation transformer that meets
medical safety standards, as defined by standard IEC 60601-1.
WARNING
Philips ultrasound systems are tested to the requirements of IEC 60601-1, with on-cart
peripherals that are powered by the built-in system isolation. The system peripherals meet
general electrical safety usage requirements.
WARNING
Off-cart devices connecting to the ultrasound system must comply with the applicable IEC or
national standards, such as IEC 60601-1, IEC 60950, or the equivalent.
CAUTION
Using accessories, transducers, peripherals, or cables not supplied with the ultrasound
system or recommended by Philips can affect the system in the form of increased emissions
or decreased immunity to external EMI/EMC occurrences. Non-specified peripherals, and
cables in some cases, can also increase leakage current or compromise the safety of the
grounding scheme.
CAUTION
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.
NOTE
Any device that is not purchased from Philips or a Philips-authorized agent is not covered under
a Philips service agreement or warranty.
External Printers
You can connect different external printers to your system.
WARNING
Images printed on a report printer are intended only for reference and should not be used for
diagnostic purposes.
NOTE
Use only the printers listed here with your ultrasound system.
NOTE
The system uses the HP Universal Print Driver and the Epson Universal Print Driver, which
support additional printers not listed here. For the supported printers, see the manufacturer's
website and search for "universal print driver."
WARNING
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.
WARNING
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 isolation transformer that meets
medical safety standards, as defined by standard IEC 60601-1.
1. Turn off the system and unplug the power cord from the power source.
2. Connect a standard USB cable between the USB port on the printer and a USB port
on the system.
3. Connect the printer’s power cord into the back of the printer, and plug the other end into
an appropriate power source (see “Warnings” on page 16).
4. Plug the system's power cord into an appropriate power source.
5. Turn on the printer, and then turn on the system. The system installs the printer drivers
automatically.
6. After the system installs the new printer drivers, restart the system.
WARNING
Multi-image prints made on small-size paper are intended only for reference and should not
be used for diagnostic purposes. Text annotation and scaling markers may not be visible on
such prints.
NOTE
Before adding a local printer, connect the printer to the ultrasound system.
1. Touch Utilities.
2. On the System tab, touch Setups.
3. Click Acquisition/Capture.
4. Click the Archive/Printer tab.
5. To assign a printer to the Acquire 1 or the Acquire 2 control, do the following:
a. From the Acquisition Type list, select a type.
b. Select the printer that you want to use.
6. To assign a printer to a touch screen control, do the following:
a. Under Select a Touch Screen Button, select the name of the control that you want to
assign.
b. In Destination(s) for the Button, select a printer.
7. To exit the setups, touch Close.
The DisplayPort output includes the entire display. The aspect ratio of the screen is 16:9. To
display this properly, select the 16:10 or 16:9 mode on the monitor or projector, if available.
Also, you may be able to adjust the horizontal and vertical image size controls to create the
correct aspect ratio. You can best judge the aspect ratio by displaying the circle test pattern on
the system.
The setups provide these outputs:
Full Screen, 1920x1080 (1080p): The full display, which is output at 60 frames per second on
the DisplayPort connector. When this option is selected, you cannot use the S-video output.
Image Area Only,1024x768: Outputs the region of interest of the image area to the S-Video
connector in NTSC or PAL format (depending on the system setting).
WARNING
Be aware of the wheels, 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.
WARNING
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.
WARNING
Position external hardcopy devices away from the system. Ensure that they are secure. Do
not stack them on the system.
WARNING
When positioning the articulated monitor, move it carefully to avoid pinching hands or
extremities against other objects, such as a bed rail.
WARNING
Never park the system on an incline.
WARNING
The brakes are intended as a convenience. To increase cart security, use wheel chocks when
the system is parked.
WARNING
Before moving the system, ensure that the keyboard is retracted, the control panel is
centered, and the monitor is locked. 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.
WARNING
To avoid injury, Philips recommends against lifting the system cart.
CAUTION
Before moving the system, ensure that the brakes are completely released by moving the
brake pedal to its middle position. Otherwise, the engaged brake pad can damage the rubber
casters on the wheels.
CAUTION
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.
CAUTION
Do not roll the system over transducer cables or power cables.
CAUTION
When transporting the system in a vehicle, avoid exposing the monitor to direct sunlight, and
do not let the inside temperature of the vehicle exceed 65°C (149°F). Either of these
conditions can permanently damage the monitor.
CAUTION
When shipping the system, make sure the batteries are inserted upside down to prevent
electrical discharge.
WARNING
Do not move the system with the steering locks engaged and the wheels pointing in the
direction you are moving the system. To avoid system instability while moving it, engage the
steering lock only after you have moved the system a short distance in the intended
direction. This engages the steering locks with the wheels correctly aligned.
Front Handle
CAUTION
If the system behaves abnormally after moving, contact your Philips representative
immediately. The components are installed securely and can withstand considerable shock;
however, excessive shock can cause a system failure.
1. With the system in position, set the brakes, connect the power, network, and other cables
from the system to the appropriate wall receptacles.
2. Release the monitor from its locked transport position.
3. Position the monitor where you want it.
4. Squeeze the release button on the front handle and position the control module to the
position you want.
5. Press the (On/Off) control to turn on the system.
CAUTION
If you press and hold the (On/Off) control to force the system to shut down, you will have
to wait longer than usual to use your system the next time you turn it on. You may also
corrupt files, which can result in an inoperative system or the loss of patient data. Wait
90 seconds (or 3 minutes if DICOM activity is occurring) before forcing the system to shut
down.
CAUTION
The batteries are used to ensure quick system startup and easy movement of the system
only. You cannot perform scans while in battery mode.
NOTE
If battery power is unavailable, or if the battery charge level is critically low, as indicated by the
(low battery power) icon, connect the system power cord to a wall outlet.
NOTE
The system must be connected to a wall outlet to be used for imaging.
1. If you are turning off the system, first close all dialog boxes by clicking Close or Done
2. Do one of the following:
• When the system is off, press the (On/Off) control to turn it on.
• When the system is on, press the (On/Off) control to turn it off. A confirmation
message appears briefly on the display immediately before the system turns off.
3. If the system does not turn off after 90 seconds (or 3 minutes if DICOM activity is
occurring), press and hold the (On/Off) control for 7 to 10 seconds to force the system
to turn off.
4. To break the connection from the main power supply, remove the ultrasound system plug
from the wall outlet.
NOTE
The system time and date cannot be set when a study is active. It is recommended that you
check the system time and date periodically before a study, and set the correct time and date,
if necessary.
NOTE
If you change the system date while a study is paused, existing results for date-dependent
calculations in the paused study are not recalculated by the system at any time.
NOTE
When you enter invalid characters in the time and date setups on the Header tab of System
Settings, some characters are displayed and then erased, but others are not displayed at all. An
invalid date may be displayed in the setups but not entered when you close the setups. After
changing a date and exiting the setups, always check the date on the imaging display.
NOTE
This system supports the Network Time Protocol (NTP), which keeps your system's time
accurate by synching with the NTP server. To activate this feature, your system administrator
must create a connection to an NTP server.
1. Touch Utilities.
2. On the System tab, touch Setups.
3. Click System Settings and then Header.
4. In Set Time, select a Format (12 hours or 24 hours), click the time in the Time box to select
it, and then use the number keys to enter the correct setting. Select Am or Pm, if necessary.
5. In Set Date, select a Format, click the Date to select it, and then use the number keys to
enter the correct setting.
WARNING
Never park the system on an incline.
WARNING
The brakes are intended as a convenience. To increase cart security, use wheel chocks when
the system is parked.
Monitor Adjustments
CAUTION
To avoid damaging the flat-panel display in the monitor, do not operate it in direct sunlight.
Also, do not operate or store the system where the ambient temperature exceeds 65°C
(149°F).
The monitor is mounted on an articulated arm that permits it to be positioned vertically and in
an arc from side to side. The monitor arm can also be locked for moving the system. You can
adjust the brightness of the monitor image to compensate for ambient light. You can also
change the default brightness setting for the monitor.
• 1 is balanced toward a blue tint for those that have a cooler preference
• 2 is balanced toward a brown tint for those that have a warmer preference
1. Touch Utilities.
2. On the System tab, touch Setups.
3. Click System Settings, and then click the Display tab.
4. Select the appropriate Default Monitor Tint setting. Philips recommends the sRGB setting
for routine use.
5. Click Close.
NOTE
Rendered 3D volumes are particularly susceptible to changes in display tint. Some clinicians
prefer the following settings for optimal viewing of 3D volumes: set Default Monitor Tint to 1
or 2 and set Default Monitor Brightness to 1.
System Controls
System controls are located on the control panel, the touch screen, and the keyboard.
Control Panel
The control panel contains the main imaging controls. These controls include buttons, knobs,
TGC slide controls, and a trackball. The control module also allows you to select imaging modes,
review and annotate images, perform measurements and calculations, and access Philips
SupportConnect.
The touch screen, located above the control panel, displays controls used to select transducers,
enter patient data, select applications, and change setups.
Control Panel
1 Touch screen
2 Power and Sleep Mode controls
3 TGC slide controls
4 Trackball
5 Soft key knobs and mode controls
6 Philips SupportConnect
CAUTION
You must engage the brakes to change the position of the control panel. If the brakes are not
engaged, the release button on the front handle will light when pressed, but the control
panel will not unlock.
Touch Screen
The touch screen above the control panel provides controls that change function according to
the current mode or system function.
For more information about the layout of the touch screen, see “Touch Screen Layout” on page
123.
For more information about the available controls on the touch screen, see “Touch Screen
Controls” on page 124.
Touch Screen
A Workflow area: Contains tools that enable the major workflow activities for starting, performing, and
completing an exam.
1 Transducer selection controls
2 Tools
B Tabs: Contains mode-specific or application-specific controls in different tabs.
C Controls: The main area of the touch screen, which shows the controls for the currently selected tab in
the current mode or application.
3 Sub-mode controls
4 Page indicator: Touch the indicator to go to the next page of controls, or swipe the screen to move
between pages.
D Soft key labels: Displays the labels for the current functions of the soft keys. Some modes and
applications have two rows of labels, while some have no soft keys.
You can select the functions assigned to the soft keys by touching the labels or by pressing or turning
the knob below the label.
5 General-purpose soft keys
6 Dynamic soft keys
Name Description
External Video Brightness/ A control used to adjust the brightness and controls of an image that is being viewed
Contrast externally.
Hide Image Info A control used to show and hide image information in the imaging display.
Hide Patient Info A control used to show and hide the patient information in the patient bar. See
“Hiding Patient Name and ID on Images” on page 157.
Hide Thumbnails A control used to show and hide the image thumbnail pane in the imaging display.
Loop Type A control used to set the loop type to either Time (in seconds) or Beats (heart beats).
Loop length is then set using the Time control or the Beats control. The Loop Type
depends on the active transducer and preset. For example, the Beats control is
available only for cardiac transducers and presets.
Monitor Brightness A control used to adjust monitor brightness to compensate for changes in ambient
light. Use this control to quickly make temporary adjustments to the monitor
brightness setting in the setups. Touch Monitor Brightness to select a setting from 1
(darkest) to 5 (lightest).
Monitor Tint A control used to adjust the tint of the system display. This control affects only the
appearance of images on the monitor; it does not affect saved or exported images.
Print Screen A control used to save an image of the full screen to the system hard drive and a copy
to the same destination devices as the Print control. Print Screen is available in review
and when the image is frozen.
Setups A control used to access the system parameters that you can change.
Trackball
The trackball is located in the center of the control panel. Moving the trackball moves the active
object on the display, such as the pointer or the measurement caliper.
The tools and icons area of the imaging display includes a trackball icon that identifies the
function assigned to each trackball button. The functions of the buttons change to match your
current task. There are trackball assignments for each major system mode, protocols, labels,
body markers, calculations, and measurements.
For example, the functions of the left and right trackball buttons can include:
• Cycle through cineloop sequences when the image is frozen or in Review.
• Erase traces.
• Select measurements within a group.
The functions of the middle trackball button include:
• Activate the spectral trace in M-mode and Doppler imaging.
• Complete measurements and calculations.
The labels under the trackball image indicate the functions that are available for the entire
trackball.
NOTE
For some measurements, the trackball functions become available only after you press
Measure.
Also, you can configure the left and right trackball buttons by using the Left Select Key and
Right Select Key settings in the Tools & Results tab of the Analysis setups.
If a function is assigned to a soft key, the ring around the knob is amber. If no function is
assigned to a soft key, the ring is dark.
Sometimes, two functions are available for a soft key. Only one of the functions can be active at
a time. Pressing the corresponding knob on the control panel or touching the label selects the
active function. The label for active functions is amber. The label for inactive functions is white.
Many modes offer two or more pages of soft keys. To display the second page place your finger
on the touch screen and swipe to the left. To return to the first page place your finger on the
touch screen and swipe to the right. You can also touch the page indicator, located above the
soft keys, to display the next available page of soft keys.
Status Icons
Status icons on the display let you control certain features and check the status of tasks. Status
can be indicated by colors or symbols within an icon, and by the absence of an icon.
Icon Description
Displayed when the system is HIPAA compliant.
Displayed when remote access is enabled, but there is no active remote session.
Displayed when the system is acquiring an image or an image is opening in the Review
pane.
Icon Description
Indicates the status of the network and exports:
• Green dot: Connected
• Red X: Disconnected or error
Click the icon to view details of network status or export queue.
Indicates the status of the wireless network:
• Green dot: Connected
• Red X: Disconnected or error
• Blue vertical bands: Strength of wireless signal
Click the icon to open the DICOM Setup dialog box. This icon appears only if the DICOM
licensed options are installed.
Indicates the status of the DVD drive:
• No dot: Available
• Green dot: Writing data
• Yellow dot: Drive is empty (or malfunctioning)
• Red X: Failed
Click the icon to open the DVD Status dialog box. You can cancel, pause, or resume any data
transfer job listed.
Indicates the status of the DVD recorder (if installed):
• Green dot: DVD recorder is recording.
• Pause symbol: DVD recording is paused.
• Icon is hidden: DVD recorder is not recording.
Indicates the status of the current print job:
• Icon is displayed: a print job is being sent.
• Icon is hidden: a print job has been sent.
• Green dot: a print job is being printed.
• Red X: a print job has failed; an error occurred.
Power Management
The system includes a power management feature that monitors the power level of the
optional battery and notifies you when the battery is low on charge. Additionally, the power
management feature can safely shut down the system before the battery loses power.
CAUTION
The batteries are used to ensure quick system startup and easy movement of the system
only. You cannot perform scans while in battery mode.
CAUTION
When shipping the system, make sure the batteries are inserted upside down to prevent
electrical discharge.
NOTE
When the system is turned on and in Sleep Mode, the batteries power the system.
NOTE
When the battery-charge level reaches a critically low state, the system shuts down
automatically.
NOTE
The batteries may need to be replaced. For information on replacing the batteries, see the
system Service Manual.
Sleep Mode
Sleep Mode uses battery power and allows quick startup of the system. It does not eliminate
power consumption and should be used only for short periods of time, such as when you
transport the system between exam locations. The Sleep Mode control ( ) is in the upper left
corner of the control panel, next to the (On/Off) control. When the system is in Sleep Mode,
it freezes live imaging, pauses any open study, exits any QLAB study, and terminates any
remote connection. Awaken the system to resume normal system operation.
When the system is on battery power, the Sleep Mode time-out is approximately 20 minutes.
The system remains in Sleep Mode until it is awakened or powered off, or until the batteries
discharge to a critically low state. If the system batteries discharge to a critically low state, the
system safely shuts down from Sleep Mode.
To put the system in Sleep Mode, press or disconnect the power cord.
NOTE
When the system is in Sleep Mode and is connected to AC power, the system remains in Sleep
Mode until it is awakened.
Battery Indicators
The battery charge level is indicated by icons on the system display.
CAUTION
The batteries are used to ensure quick system startup and easy movement of the system
only. You cannot perform scans while in battery mode.
NOTE
The system batteries are a purchasable option. If this option is not purchased, the battery icon
is not displayed.
The system is running on AC power and the battery is 60% to 80% charged.
The system is running on AC power and the battery is 40% to 60% charged.
The system is running on AC power and the battery is 20% to 40% charged.
The system is running on AC power and the battery is not charged or is disconnected.
System Security
The data security feature, if enabled on your system, limits access to previously stored patient
data and images. To gain access to such data, you must first log on to the system using an ID
and a password. When you are finished using the system, you can log off manually or simply
shut down the system, which logs you off automatically. Only a registered user can change the
password.
The data security feature is set up by your system administrator. For information, see “System
Administration” in the Help. To display the Help, touch .
NOTE
Logging off of the system does not change the current patient, but it does deny further access
to protected patient data.
NOTE
The Auto Log Off time shown on the User Settings display indicates how long the system can be
inactive before you are logged off automatically. Only the system administrator can change this
setting.
1. Touch Utilities.
Imaging Display
The imaging display contains three, distinct regions:
Imaging Display
1 Patient bar
2 Image area
3 Tools and icons
Patient Bar
After you start an exam, patient and exam data appear in the patient bar, which is directly
above the ultrasound image. With the Header setting in the System Settings setups, you can
select three of the five additional information options to display on the patient bar: Patient
Birth Date, Patient Gender, Institution Name, System Model, and Performed By (three
initials).
Patient Bar
1 Patient name
2 Patient ID
3 Date and time
4 Expand patient bar icon: Click to view all of the available patient data during an exam.
Image Area
The image area is approximately in the center of the display and includes the following:
• Image tabs: The left tab displays the live image. Additional tabs provide quick access to
acquired images from the current exam, retrieved images from previous exams, images
acquired in other modalities, or analysis summary results (for example, fetal trending
graphs).
• Left pane: Lists available calculations and protocols, and the calculations and measurements
being performed; displays calculation results; and provides other tools as necessary. Tabs at
the top of the left pane enable you to switch among those lists. To hide the left pane, click
, in the top right corner of the pane.
• Imaging area: Displays the live image (or other applications, such as Q-Apps), a depth scale
that includes the focus setting (to the right of the image), a TGC curve, a grayscale bar, and
a color bar (to the right of the depth scale). In M-mode and Doppler, the sweeping display
appears either below the 2D image or to the right of it, depending on the format you select.
• Thumbnail pane: Displays thumbnail images from the current exam.
For general imaging, a scan plane orientation marker appears at the top left of the image.
For cardiac exams, the orientation marker appears at the top right of the image. The marker
corresponds to the orientation marker on the transducer. The marker always follows the
orientation of the image. When you invert the image by using Left/Right or Top/Bottom, the
marker position changes accordingly.
Image Area
A Left pane
B Imaging area
1 Image tabs
2 Scan plane orientation marker
3 MI and TI values
4 Focal indicator
5 Color bar
6 Grayscale bar
7 ECG Display
C Thumbnail images
Emergency Studies
If the system administrator has enabled the data security feature on your system, it is
important to understand how to start a study in an emergency situation.
In an emergency, you can start a study without entering patient data. During an emergency
study, the system provides a temporary ID for image acquisition and report editing. You should
change the temporary ID to correct the patient data before you end the study. Otherwise, the
temporary ID is the only identifier for that study.
Temporary ID
Use the temporary ID feature to start an exam quickly. This feature allows you to perform an
exam without first entering patient data. When you select this feature, the system enters
unique, temporary placeholders for the patient's last name and ID. Using the temporary ID
feature allows you to perform an exam as you would normally.
When you use the temporary ID workflow, images can be sent to a PACS or to a DICOM printer
before entering actual patient data, if the system is configured to send or print images as you
scan.
For an exam started with a temporary ID, edit patient data before ending the exam. After the
exam is ended, you cannot change patient data. When the patient data is changed, all images
are automatically resent to any local printers that they were previously sent to. If your system is
connected to a DICOM Worklist Server, you can load patient data to replace the temporary ID
data.
NOTE
If you have configured a DICOM performed-procedure-step-server, PPS messages are sent for
the temporary ID. If you have configured a PPS server, PPS discontinue messages are sent for
the temporary ID if you edit the patient data before you end the exam.
Transducer Receptacles
1 Physio probe receptacle
2 Doppler probe receptacle
3 Imaging transducer receptacle
When a transducer is not in use, store it in one of the transducer holders on the system cart.
Always loop transducer cables over the cable hangers to prevent cables from being stepped on
or run over by the cart wheels.
Selecting a Transducer
When the system is turned on, the system initializes the last active transducer. If that
transducer is not connected, the system initializes the transducer that is connected to the
leftmost connector, unless you have defined another transducer as the default transducer. If
you have set a default transducer and it is connected, then the system initializes that
transducer. For information on setting a default transducer, see “Setting the Default Transducer
and Preset” on page 148.
If multiple transducers are connected when the system is turned on, the system selects the
transducer that was in use when the system shut down. You can select among the connected
transducers during system operation. If the system does not recognize a transducer, it will
switch back to the original transducer. Disconnect and reconnect the unrecognized transducer
or move it to a different receptacle.
You can select or deselect a transducer during live imaging without damaging the transducer or
the system.
1. Touch the transducer name to select it.
2. Touch the clinical application preset that you want to use.
After you select the clinical application/preset, the system calibrates the transducer, enables
the transducer for operation, and updates system status to reflect the transducer type and the
preset you selected.
Selecting a Preset
When the system is turned on, the system selects the same preset that was in use when the
system shut down (unless it is incompatible with the initially selected transducer). For more
information, see “Setting the Default Transducer and Preset” on page 148.
During system operation, you can select a different preset for the selected transducer.
1. Touch the transducer name.
2. Touch a preset to select it.
ECG Feature
The system can display three physio traces, each representing a physiological input. These
inputs can include low-level ECG, high-level ECG, respiratory, pulse, phono, and auxiliary
signals. (Low-level ECG comes from leads connected to the patient; high-level ECG comes from
a patient monitor or other similar equipment.) Heart rate, derived from the ECG signal, is
displayed on the screen whenever ECG is connected and displayed.
Media Compatibility
CD media capacity is approximately 700 MB; single-layer DVD media capacity is approximately
4.7 GB. Rewritable media types (indicated by the RW suffix) can be erased and used again, but
you cannot erase media that has the R suffix. Dual-layer DVD media is unsupported.
DVD and CD media are available in a number of types. Not all media types are fully compatible
with the system DVD drive. To ensure consistent performance, use only high-quality CD or DVD
media in the system DVD drive. For more information, see Media Compatibility on the User
Information CD.
For information regarding USB media, see “USB Devices” on page 145.
Multiple studies can be written to a disc, during one upload, up to the limit of its capacity. After
the studies are written to the disc, the disc is finalized and cannot be written to again. To reuse
a finalized RW disc, you must first reformat it. To record multiple studies to a disc, you must
end the exam you just recorded before removing the disc.
NOTE
A single disc can be used between different EPIQ 7 systems, but only for writing logs and setup
data.
DVD Drive
The system includes a DVD drive, located on the right side of the control module. You can use
this drive to store and transfer patient files, including full exams, 3D data sets, and reports. In
addition, you can save, restore, and distribute configuration data.
You do not need to format a disc before storing data on it.
Erasing a DVD
Erasing a rewritable disc (DVD+RW, DVD-RW, or CD-RW) erases all of the data on it and
prepares it for reuse. After a disc is erased, the entire capacity of the disc is once again
available. You can also erase a write-once disc (DVD+R, DVD-R, or CD-R), but you will not be
able to write files to the erased portion of the disc.
NOTE
If the system cannot erase the disc, use a computer to erase it. If the computer cannot erase
the disc, it may be damaged.
1. Touch Review.
2. Load a disc into the drive and wait for it to become available.
3. In the Review Exam display, click Erase.
4. In the Erase Disc dialog box, click OK to erase the disc.
5. When the dialog box indicates that erasing is complete, click OK.
6. Click Close.
USB Devices
The system provides USB ports that can be used to connect USB storage devices. Such devices
include USB memory devices and USB hard disk drives. USB ports are on the front left of the
system behind the transducer holders and on the rear panel. Read the following information
before using USB storage devices.
The system supports the following USB devices:
• Single-partition USB flash memory drives
• USB flash memory drives that do not use or contain any antivirus or other executable
software
• USB hard disk devices that require 500 mA or less per USB port
• USB 2.0 compliant devices
• USB 3.0 compliant devices
Some portable hard drives do not work when connected to a single USB port on the system.
Connect a dual-port USB cable between the drive and two USB ports behind the right panel of
the system.
WARNING
Connecting externally powered USB hard disk drives to the system involves electrical safety
risks. If you connect such drives to the system, you must observe the electrical safety
warnings in the “Safety” section. Philips recommends that you use only USB hard disk drives
powered from the USB connector, or use USB flash memory devices.
CAUTION
When transferring data to or from a USB device, be sure the transfer is complete before
removing the USB device. For USB devices that have an indicator, be sure the indicator is no
longer flashing before removing the device.
CAUTION
Ultrasound systems may become vulnerable to security breaches when they accept
removable media. Removable USB storage devices may contain viruses. Philips recommends
that you use the system to format USB storage devices before working with them.
CAUTION
Philips does not recommend that you use USB storage devices for long-term storage. Follow
your IT department's recommended practices for intended use of USB storage devices. For
more information about security on the ultrasound system, see Shared Roles for System and
Data Security, included on your User Information CD.
CAUTION
Use only Class-B-compliant USB storage devices with the system. USB devices that are not
Class-B compliant may cause RF emissions that exceed Class B limits. See the device's
documentation to determine whether it is Class-B compliant.
DICOM Viewer
When you export patient data in DICOM format and select Include DICOM Viewer, the system
exports a copy of the DICOM viewer along with the patient data. The DICOM viewer lets you
view images, play clips, and adjust images. Changes made to the images cannot be saved. The
DICOM viewer lets you view stress echo data by stage or anatomic view. The viewer supports
the electronic submission requirements of ICAEL (Intersocietal Commission for the
Accreditation of Echocardiography Laboratories).
Presets
A preset is a group of settings that optimizes the system for a specific type of exam. Presets
establish many initial settings, such as gain value, color map, filter, and items on the touch
screen.
When you turn on your system, the default preset is active. Before you begin an exam, be sure
that the appropriate preset is active.
You can choose from several default presets. You cannot delete these default presets.
However, they provide a starting point from which you can create your own presets. You can
create and store up to 45 presets per transducer/application combination, depending on the
space available on the touch screen. If you need to create more than 45 presets per transducer,
you can save presets to a DVD or USB storage device and restore them when you need to use
them.
The available presets are determined by the selected transducer.
NOTE
Presets are available only if you purchased the corresponding application-package option.
NOTE
If you receive an error message when exporting data to a DVD or when viewing exam data on a
DVD, you may need to eject the DVD from the drive and re-insert it.
1. Load a DVD into the DVD drive, or connect a USB device to a USB port on the system.
2. On the control panel, press Support.
3. Click System Management.
4. Click Backup/Restore.
5. From the Select the Media menu, select the removable media that you are using.
6. Click Backup. The backup list shows the data that is backed up.
7. If a dialog box indicates that the media is too full to complete the copy process, replace the
media and click Backup again.
8. After the backup is complete, click Close.
9. Click Done.
System Setups
Setups are system parameters that you can change. By changing setups, you can customize the
system to meet your operating preferences.
Setups are organized into five standard categories: System Settings, Analysis, Annotation,
Acquisition/Capture, and Data Security. An additional category, Setup Wizard, helps you
quickly prepare your system for use. Changes in setups take effect immediately and remain in
effect until you change them again or load setups from a DVD or USB device.
NOTE
The institution name exported with DICOM data always reflects the name shown in the setups
at the time the study ended. Philips recommends restarting the system after changing
Institution Name in the setups.
Procedures for using setup options and descriptions of settings are included throughout the
Help.
Changing Setups
1. Touch Utilities.
2. On the System tab, touch Setups.
3. Click a setup category on the left side of the setups display.
4. Click a tab or sub-tab at the top of the setups display.
5. Enter text or make selections necessary to set up your system.
6. Click Close.
NOTE
When Hide Doppler Velocity Minus Sign is enabled, avoid using the Doppler velocity value
displayed in the results and report for manual calculations. The sign value, whether visible or
not, affects any calculations performed with the reported value. The system includes the sign
value in calculations.
System Options
In addition to the standard features available in the system, other features are available as
purchasable licensed options. The types of options available include clinical applications,
protocols, imaging capabilities, QLAB Advanced Quantification Software Q-Apps, PercuNav
Image Fusion and Interventional Navigation, and connectivity capabilities.
To add licensed options to your system, you purchase them from your Philips representative.
Once purchased, they are installed in your system by a Philips field service engineer.
Custom Procedures
You can automate a variety of workflows by creating custom procedures for specific patients,
transducers, and presets.
NOTE
Custom procedures are linked to specific transducers. If the transducer required for the
procedure is unconnected, procedures that use it do not appear in the Procedure menu.
1. Touch Patient.
2. In the Clinical Procedure section of the Patient Data form, select the custom procedure
from the Procedure menu.
3. Click Done.
4. Start the exam.
7 Performing an Exam
This section guides you through procedures commonly used in performing patient exams with
the system. These procedures include entering patient data; acquiring, annotating, and
reviewing images; and making measurements and calculations.
WARNING
Failing to end the current exam before starting a new exam can result in data being acquired
and stored under the wrong patient name.
You start an exam by entering patient data into the system. There are two ways to enter
patient data.
• If the Modality Worklist feature is disabled or unused on your system, you enter patient
data into the Patient Data form.
• If your system is connected to a DICOM network with the Modality Worklist feature
enabled, you can select an exam to load patient data instead of entering that information
manually. See “Selecting in the Worklist” on page 156.
If you want to start an exam without first entering patient data, you can select Use Temporary
ID after you acquire an image.
The system uses a unique ID to identify each patient. You can enter an ID, or you can have the
system create one automatically. Stored images, fetal growth graphs, and reports are stored
based on the patient ID.
If the sonographer name needs to be different on images within the exam, end the current
exam and append a new exam with the images from the new sonographer.
An accession number is an optional entry assigned to each patient file by an institution for
internal information-management purposes.
The exam date is set by the system when you first acquire an image during the exam.
NOTE
You can clear all patient data from the Patient Data form by clicking Clear. Do not use this
control unless you want to delete all of the patient data you have entered into the form.
1. Touch Patient.
2. Ensure that the previous exam ended by doing one of the following:
• Touch End Exam while the Patient Data form is displayed.
• Click End Exam on the Patient Data form.
3. On the Patient Data form, type the patient information. (Press the Tab key to move the
cursor from field to field.)
4. For Study Type, select the study you will be performing. It is important to select the correct
study type at this time. Selecting a study type after you have entered patient data and
exited the Patient Data form does not update the report with the correct study type.
5. Enter the pertinent study information for the patient.
6. If you have created a custom procedure for this patient, select the custom procedure from
the Procedure menu. (For information about custom procedures, see “Custom Procedures”
on page 152.)
7. When you are finished, click Done.
NOTE
You can also search for a patient by last name, patient ID, modality, accession number, or
procedure ID.
4. Click Search.
5. Select the patient from the worklist.
6. Click Done.
WARNING
Images printed without the patient name and ID could be incorrectly associated with another
patient. One way to alleviate this risk is to configure the DICOM printer so that the patient
data that is included in the header of the image file is printed along with the image. However,
some printers do not support that feature.
NOTE
If the intent of hiding the patient name and ID is patient privacy, be aware that if the original
file name includes the patient name, you will need to rename the file when you export it.
The patient name and ID are displayed in the patient bar, which is outside of the image area
and not acquired in an image. However, patient information is overlaid on to an image when it
is printed. To hide the patient name and ID on the printed image, touch Utilities, and then
touch Hide Patient Info on the System tab. All other information displayed in the patient bar
(time/date, institution name, and so on) remains in the overlay and is included on the printed
image.
Any loop or still frame acquired while the patient name is hidden will also be exported with the
patient name hidden.
Imaging Modes
Your ultrasound system offers a set of imaging modes to accommodate a variety of imaging
applications. Some modes display a live grayscale image. Others are Doppler modes to evaluate
the amplitude or the direction of the blood flow and the spectral information. Special modes
are also available for 3D imaging and Panoramic imaging.
NOTE
Some modes are available on your system only if the corresponding option has been purchased
and installed.
Selecting a Transducer
When the system is turned on, the system initializes the last active transducer. If that
transducer is not connected, the system initializes the transducer that is connected to the
leftmost connector, unless you have defined another transducer as the default transducer. If
you have set a default transducer and it is connected, then the system initializes that
transducer. For information on setting a default transducer, see “Setting the Default Transducer
and Preset” on page 148.
If multiple transducers are connected when the system is turned on, the system selects the
transducer that was in use when the system shut down. You can select among the connected
transducers during system operation. If the system does not recognize a transducer, it will
switch back to the original transducer. Disconnect and reconnect the unrecognized transducer
or move it to a different receptacle.
You can select or deselect a transducer during live imaging without damaging the transducer or
the system.
1. Touch the transducer name to select it.
2. Touch the clinical application preset that you want to use.
After you select the clinical application/preset, the system calibrates the transducer, enables
the transducer for operation, and updates system status to reflect the transducer type and the
preset you selected.
Annotation
You can place text labels and arrows on an image to identify anatomical structures and
locations. You can also annotate an image with a body marker graphic that indicates the part of
the anatomy that you are scanning.
Adding Labels
1. Press ABC Label.
NOTE
If you press a trackball button, unfreeze the image, or change the imaging mode or settings that
affect the trackball assignment, annotation mode goes into standby. To return to annotation,
press ABC Label.
NOTE
You cannot move a label once you have added it to the display.
NOTE
Erase Last erases all arrows from the image display before it erases text labels.
NOTE
During Review, the Body Markers touch screen is available only when 1‑up is selected for
Layout. You cannot add body markers and system-provided labels to single frame images in
Review, although you can add them to loops in Review. You can type text in single frame
images in Review.
2. Touch Body Markers on the ABC Label touch screen to display the Body Markers touch
screen for the current transducer and preset.
3. Touch a body marker control to put the corresponding body marker on the display in the
home location or to replace an existing body marker.
4. Use the trackball to position the transducer scan plane indicator on the body marker. Turn
Probe Rotate to change the orientation of the transducer scan plane indicator.
5. Do any of the following:
• To move the marker, exit and reenter the Body Markers touch screen, or exit and
reenter annotations mode. When you reenter the Body Markers touch screen you can
edit the marker.
• To remove a body marker, touch Erase Body Mark.
• To close the Body Markers touch screen, touch another tab title or press ABC Label.
Recording
You can record live imaging to a local DVD recorder and simultaneously record comments. You
can play back recordings on other DVD players. Playback is not supported on the system.
NOTE
Use only DVD+RW media in the DVD recorder.
NOTE
Always format a new disc before using it with the DVD recorder. Also, Philips recommends
reformatting a used disc before using it with the DVD recorder.
Printing
You can print single-frame images and reports to a local printer, usually installed in the system,
or to DICOM printers on a network.
WARNING
Multi-image prints made on small-size paper are intended only for reference and should not
be used for diagnostic purposes. Text annotation and scaling markers may not be visible on
such prints.
Two print controls are available for printing images, Print and Alt Print. The Acquire 1, Acquire
2, Acquire Screen, and Acquire Report controls also have print capabilities associated with
them. In the setups, you can assign each of these controls separately to one or more image
printers. In addition, you can select whether the controls print the entire display or just the
image area.
NOTE
If you print a monochrome image while a Chroma map is selected, the system sends the image
to the color printer. Also, if you export a monochrome image while a Chroma map is selected,
the system sends the image as a color image. This is normal. To ensure that black-and-white
images are sent to the black-and-white printer, set Chroma to Off.
NOTE
If your print setting includes multiple images per page, the printer will not print an image until
the total number is reached. For example, if you have a 2x2 format selected, the printer will not
print the page until you have captured four images or, if the number captured is less than four,
until the end of the exam.
Review
During or after an exam, you can use Review to examine and compare images acquired in the
exam. You can also review multiple exams for one patient.
In Review, you can look at the images or cineloop sequences that you stored. You can view,
send, print, and back up your stored images. You can also perform analysis on images in
Review. Images that are in image memory can be stored on the ultrasound system hard drive,
on removable media, or on DICOM‑compatible devices on a network. You can display images
within an exam in several layouts, and you can display images from different exams.
Starting Review
1. Touch Review to enter Review mode. You can also double-click a thumbnail image to open
that image in thumbnail review. The display that appears depends on whether an exam is
active on the system.
NOTE
If an exam is in progress, pressing Review opens the Image Review display. If no exam is in
progress, pressing Review opens the Patient Directory display.
NOTE
When reviewing images of an exam loaded from the Patient Directory, thumbnails are
unavailable in some circumstances. For example, exams copied from DVD to the hard drive may
not have thumbnails, if the images they contain are no longer in their native format.
either when you capture or print an image, or when you end an exam, depending on your
selection for Send Images/Clips on the Acquisition/Capture tab in the Acquisition/Capture
setups.
Use the Freeze control to stop and start system image acquisition and update. Pressing Freeze
results in the system entering cineloop pause and assigning the trackball to manual cineloop
review (frame-by-frame).
During acquisition, a spinning hourglass icon appears at the bottom of the display. When the
capture is complete, a thumbnail of the image is displayed.
Do one of the following:
• To capture a single image, press Freeze, and then press Acquire 1 or Acquire 2.
• To capture a cineloop sequence, press Acquire 1 or Acquire 2 in live imaging or while
reviewing a cineloop sequence. Capturing during live imaging saves prospective or
retrospective frames, as specified in Live Capture Type in the setups. A prospective capture
captures a specified acquired loop length. A retrospective capture captures a specified loop
length that was acquired previously. A retrospective capture captures a loop that ends
when you press Acquire 1 or Acquire 2. Capturing while reviewing a cineloop sequence
saves all retrospective frames in the cineloop sequence.
You can configure the Acquire 1, Acquire 2, and touch screen print controls in the
Acquisition/Capture setups. The default setting is for Acquire 1 to capture single frames
when the image is frozen and to capture loops when the image is live. Acquire 2 captures
single frames, regardless of the imaging state. If an Acquire control is set to acquire a still
frame, you can use it to acquire the frame without freezing the image.
NOTE
When an image is captured, you will hear a beep to confirm that the loop or image was saved in
the patient's study. Do not press Review until you hear the beep.
NOTE
If you press Acquire 1 in a non-simultaneous mode while a live M-mode or Doppler trace is
active, you capture a cineloop sequence. If you press Acquire 1 in a simultaneous mode, you
capture a single image.
NOTE
If you attempt to capture a loop that was imported from media, only a frame of the loop is
captured and displayed in the appending exam.
Labeled measurements and calculations are stored in the patient data and report. The
information is labeled according to the measurement or calculation label. Within the report,
the information is organized by the calculations package. The values displayed can be the
results of multiple measurements.
Calculations packages are system options that are associated with transducers and presets. A
calculations package contains one or more collections that organize measurements and
calculations into a coherent tool for diagnostic analysis. The Calc Package tab provides access
to the various measurements and calculations in the available calculations packages.
The measurements and their derived calculations included with the calculations packages are
based on medical references. See the "References" section in the Help.
NOTE
Ensure that you follow current medical practices when identifying specific measurement points
on an image.
NOTE
The left and right trackball buttons can each be set to one of three measurement operations:
End Measurement, Toggle, or Next Measurement.
• In the Calc List, click a collection and then click a measurement label.
4. If a set of associated measurements are required, touch or click a group label to display
multiple measurement labels.
5. Touch or click a measurement label and make the measurement. First, the caliper or trace
tool appears on the display. Then, as you make the measurement, the results and derived
calculations appear in the results and are simultaneously added to the patient report.
6. For each measurement label within a group, touch or click a label and make the
measurement.
7. Press the middle trackball button to complete the measurement.
NOTE
The measurement automatically completes if you unfreeze the image, change modes, or enter
a report.
NOTE
The measurement will be lost if you unfreeze the image or change modes before you assign a
label to it.
Ending an Exam
Each time you finish an exam, you must end the exam to save images, reports, and other exam
data. You can end an exam in the current exam display or with the current exam open in the
Review display. You cannot end a paused exam while in the Patient Directory.
You will not be able to end the exam until the system has saved exam data for the current
exam. (The system saves exam data when you acquire an image.) Ending an exam stores all
exam data, clears the Patient Data form, and prepares for the next exam.
WARNING
Failing to end the current exam before starting a new exam can result in data being acquired
and stored under the wrong patient name. If you turn off the system without ending the
exam, the system pauses the exam before shutting down.
8 Transducers
The transducer that you select is the most important factor in image quality. Optimal imaging
cannot be obtained without the correct transducer. The system is optimized for use based on
your transducer selection.
The system limits patient contact temperature to 43 degrees Celsius, and acoustic output
values to their respective U.S. Food and Drug Administration limits. A power-protection circuit
protects against over-current conditions. If the power monitor protection circuit senses an
over-current condition, then the drive voltage to the transducer is shut off immediately,
preventing overheating of the transducer surface and limiting acoustic output. Validation of the
power protection circuit is done under normal system operation.
Non-TEE transducers are rated minimum IPX7 in accordance with IEC 60529. Transesophageal
transducers are rated minimum IPX1 (control area) and IPX7 (endoscope area) in accordance
with IEC 60529.
WARNING
All TEE transducers are designed to be defibrillator safe in accordance with IEC 60601-1.
Nevertheless, always remove the transducer from the patient before defibrillation.
WARNING
To limit potential harm when scanning neonatal, pediatric, and medicated patients, minimize
the time spent imaging at temperatures above 41°C (106°F).
Selecting a Transducer
When the system is turned on, the system initializes the last active transducer. If that
transducer is not connected, the system initializes the transducer that is connected to the
leftmost connector, unless you have defined another transducer as the default transducer. If
you have set a default transducer and it is connected, then the system initializes that
transducer. For information on setting a default transducer, see “Setting the Default Transducer
and Preset” on page 174.
If multiple transducers are connected when the system is turned on, the system selects the
transducer that was in use when the system shut down. You can select among the connected
transducers during system operation. If the system does not recognize a transducer, it will
switch back to the original transducer. Disconnect and reconnect the unrecognized transducer
or move it to a different receptacle.
You can select or deselect a transducer during live imaging without damaging the transducer or
the system.
1. Touch the transducer name to select it.
2. Touch the clinical application preset that you want to use.
After you select the clinical application/preset, the system calibrates the transducer, enables
the transducer for operation, and updates system status to reflect the transducer type and the
preset you selected.
D2tcd TCD
D5cwc Vascular
X5-1 Description
Features of the X5-1 transducer include:
• Operating range: 1.3 to 4.2 MHz.
• 2D xMATRIX phased array with 3,000 elements.
• 2D imaging provides a 90-degree field of view, while volumetric imaging is 90 x 90 degrees.
• 2D imaging modes with PW, CW, M-mode, Color M-Mode, Color, TDI, TDI PW and LVO,
xPlane, xPlane Color, and xPlane LVO.
• 3D imaging modes with 3D Zoom, Live 3D grayscale, Live 3D color, Live 3D LVO, Full Volume
grayscale, Full Volume Color, and Full Volume LVO. (All 3D imaging modes available with
one-beat and multi-beat acquisition.)
X6-1 Description
Features of the X6-1 transducer include:
• Operating range: 1.5 to 6 MHz.
• Biopsy capable.
• Internal temperature monitoring.
• 2D xMATRIX phased array with more than 9,000 elements.
• 2D imaging provides a 100-degree field of view, while volumetric imaging is 90 x 90
degrees.
• 2D imaging modes with Tissue Harmonic Imaging, M-mode, PW, Color, and CPA.
• 3D and 4D imaging modes with xPlane, Elevation Compounding, single-sweep 3D grayscale,
Color, CPA, Directional CPA, live 4D grayscale imaging, 3D Panoramic, and iSTIC grayscale
and color with automated heart rate estimation.
Transducer Maintenance
Transducers require proper care, cleaning, and handling. Reasonable care includes inspection,
cleaning, and disinfection or sterilization, as necessary.
Inspect the transducer cable, case, and lens before each use. Check for cracks or other damage
that jeopardizes the integrity of the transducer. Report any damage to your Philips customer
service representative, and discontinue use of the transducer.
For all information on transducer cleaning and disinfection, see the “Transducer Care” section.
For all information about the use of acoustic coupling gels, see “Ultrasound Transmission Gels”
on page 184.
CAUTION
Some ultrasound coupling gels, as well as some solutions for precleaning, disinfecting, and
sterilizing can damage a transducer. Before using a gel or solution on a transducer, see
“Ultrasound Transmission Gels” on page 184 or the “Transducer Care” section. You can also
contact your local Philips representative. For contact information, see “Customer Service” on
page 22.
If you encounter poor image quality or transducer problems, see “Troubleshooting” on page
295.
Acoustic Artifacts
The transducer adds its own signature to the echo information in the form of beam width
effects, axial resolution limitations, and frequency characteristics. The control choices made by
the sonographer that affect amplification, signal processing, and echo signal display can lead to
significant differences in the displayed appearance of echo data. Following is a brief discussion
of acoustic artifacts. An understanding of the physical basis for the production of signals
displayed on ultrasound images is helpful in minimizing artifacts on images and interpreting the
results of studies.
An artifact is an echo displayed in a different position than its corresponding reflector in the
body. Artifacts can also be caused by intervening tissue properties. Artifacts can originate from
external noise, reverberations, multi-path reflections, or misadjusted equipment. They can also
come from the ultrasonic beam geometry and unusual changes in beam intensity. Artifacts and
their manifestations are listed below, and following are some definitions of various artifacts.
• Added objects displayed as speckle, section thickness, reverberation, mirror image, comet
tail, or ring down
• Missing objects due to poor resolution
• Incorrect object brightness due to shadowing or enhancement
• Incorrect object location due to refraction, multi-path reflections, side lobes, grating lobes,
speed error, or range ambiguity
• Incorrect object size due to poor resolution, refraction, or speed error
• Incorrect object shape due to poor resolution, refraction, or speed error
Acoustic saturation occurs when received signals reach a system's high-amplitude limit. At that
point the system becomes unable to distinguish or display signal intensities. At the point of
saturation, increased input will not increase output.
Aliasing occurs when the detected Doppler frequency exceeds the Nyquist limit. It is
characterized on the spectral display by the Doppler peaks going off the display, top or bottom,
and then continuing on the other side of the baseline. On the Color display an immediate
change in color from one Nyquist limit to the other is seen.
Comet tail is a form of reverberation artifact produced when two or more strong reflectors are
close together and have a high propagation speed. In this case, sound does not travel directly to
a reflector and back to the transducer; and a strong linear echo appears at the reflector and
extends deeper than the reflector.
Enhancement is an increased relative amplitude of echoes caused by an intervening structure
of low attenuation.
Focal enhancement, also known as focal banding, is the increased intensity in the focal region
that appears as a brightening of the echoes on the display.
Mirror imaging artifact is most commonly seen around the diaphragm; this artifact results from
sound reflecting off another reflector and back.
Mirroring is the appearance of artifacts on a spectral display when there is improper separation
of forward and reverse signal processing channels. Consequently, strong signals from one
channel mirror into the other.
Multi-path positioning and refraction artifacts describe the situation in which the paths to and
from a reflector are different. The longer the sound takes traveling to or from a reflector, the
greater the axial error in reflector positioning (increased range). Refraction and multi-path
positioning errors are normally relatively small and contribute to general degradation of the
image rather than to gross errors in object location.
Propagation speed errors occur when the assumed value for propagation speed by the
ultrasound system is incorrect. If the actual speed is greater than that assumed, the calculated
distance to a reflector is too small, and the reflector will be displayed too far from the
transducer. Speed error can cause a structure to be displayed with incorrect size and shape.
Range ambiguity can occur when reflections are received after the next pulse is transmitted. In
ultrasound imaging, it is assumed that for each pulse produced, all reflections are received
before the next pulse is sent out. The ultrasound system calculates the distance to a reflector
from the echo arrival time assuming that all echoes were generated by the last emitted pulse.
The maximum depth to be imaged unambiguously by the system determines its maximum
pulse repetition frequency.
Reverberation is the continuing reception of a particular signal because of reverberation rather
than reflection from a particular acoustic interface. This phenomenon is analogous to the effect
created by mirrors positioned on opposite walls when an object, a head for instance, is placed
between the mirrors. The image of the head is reflected back and forth infinitely between the
two mirrors, creating the optical illusion of multiple heads. Reverberations are easily
identifiable, because they are equally spaced on the display.
Scattering is the diffuse, low-amplitude sound waves that occur when acoustic energy reflects
off tissue interfaces smaller than a wavelength. In diagnostic ultrasound, Doppler signals come
primarily from acoustic energy back-scattered from red blood cells.
Shadowing is the reduction in echo amplitude from reflectors that lie behind a strongly
reflecting or attenuating structure. This phenomenon occurs when scanning a lesion or
structure with an attenuation rate higher than that of the surrounding tissue. The lesion causes
a decrease in beam intensity, which results in decreased echo signals from the structures
beyond the lesion. Consequently, a dark cloud behind the lesion image forms on the display.
This cloud, or shadow, is useful as a diagnostic clue.
Side lobes (from single-element transducers) and grating lobes (from array transducers) cause
objects that are not directly in front of the transducer to be displayed incorrectly in lateral
position.
Speckle appears as tissue texture close to the transducer but does not correspond to scatterers
in tissue. It is produced by ultrasound wave interference and results in general image
degradation.
Spectral broadening is a display phenomenon that occurs when the number of energy-bearing
Fourier frequency components increases at any given point in time. As a consequence, the
spectral display is broadened. Spectral broadening can indicate the disturbed flow caused by a
lesion, and therefore it is important diagnostically. However, broadening can also result from
interaction between flow and sample volume size, in which case it is an artifact.
Speed of sound artifacts occur if the sound propagation path to a reflector is partially through
bone, and the speed of sound is greater than in the average soft tissue. Echo position
registration artifacts will be produced. Reflectors appear closer to the transducer than their
actual distance because of this greater speed of sound, resulting in a shorter echo transit time
than for paths not containing bone.
thresholding that eliminates structures, and adjacent structure artifacts that add additional
information or hide structures. Editing artifacts result from data deleted from a rendered
image.
Color and Color Power Angio artifacts relating to gain may also be confusing in rendered
images. A color flash artifact can occur when the gain is set high and the transducer or patient
moves. When the gain is set too high, the color ROI box fills with color flash. When the gain is
set low, color bleed can occur. When the gain is set too low, insufficient color data renders the
image undiagnosable.
Color gain, directional, and motion artifacts can present themselves in 3D imaging. Color and
Color Power Angio gain artifacts are mainly related to the use of excessive gain resulting in
random color patterns in the 3D image that might be interpreted as diagnostically significant.
Directional artifacts are due to aliasing or directional confusion: The velocity range must be set
properly, and the relationship between the transducer orientation and the flow vector must be
understood. Patient motion can produce flash artifacts that are less obvious in 3D images than
in 2D imaging.
Dropout and shadowing are present in 3D imaging although they are more difficult to
recognize due to different and unfamiliar displays. Acoustic shadowing and other artifacts look
very different when displayed in 3D volumes and may be more difficult to recognize than on
standard 2D imaging. Those artifacts may produce apparent defects, such as limb abnormalities
or facial clefts, where they are not present. Acquiring data from multiple orientations may
avoid artifacts of this type.
Fetal limb deficit artifacts are specific to 3D volume images. Partially absent fetal limb bones
have been demonstrated. One explanation for the missing limbs was shadowing caused by
adjacent skeletal structures. Overcoming the limb deficit artifact can be accomplished by
changing the transducer position and the acquisition plane.
Motion artifacts in 3D volumes can be caused by patient motion, fetal movement, cardiac
motion, and movement of adjacent structures. Patient motion can produce flash artifacts that
are more obvious in 3D images than in 2D imaging.
Pseudoclefting and pseudonarrowing artifacts may be related to limb deficit artifacts. Artifacts
may be present in 3D imaging of the fetal face. Being aware of pseudoclefting of the fetal face
and pseudonarrowing of the fetal spine can help the sonographer understand and identify
these artifacts. As with 2D imaging, it is important to verify putative physical defects by using
additional images and other modalities.
Resolution, attenuation, and propagation artifacts are all common to 3D imaging. Careful
scrutiny of the original 2D images is necessary to identify and preclude these types of artifacts
from the 3D volume image.
Transducer Covers
To prevent contamination by blood-borne pathogens, sterile transducer covers are required for
intraoperative and biopsy procedures; in China, sterile covers are also required for transrectal,
intravaginal, and transesophageal procedures. Protective covers are recommended for
transrectal, intravaginal, and transesophageal procedures; the protective covers are mandatory
in China and Japan. Philips recommends the use of qualified covers.
For procedures for using transducer covers, see the instructions provided with the covers.
WARNING
Latex and talc are commonly used in sheaths marketed to help with infection control in
transesophageal, endocavity, and intraoperative imaging applications and during biopsies.
Examine the packaging to confirm latex and talc content. Studies have shown that patients
can experience allergic reactions with natural rubber latex. See the FDA Medical Alert, March
29, 1991, reprinted in “FDA Medical Alert on Latex” on page 49.
WARNING
In intraoperative applications, sterilized transducers should be used with sterile gel and a
sterile transducer cover.
WARNING
Do not apply the transducer cover until you are ready to perform the procedure.
WARNING
Inspect transducer covers before and after use.
WARNING
If the sterile transducer cover becomes compromised during an intraoperative application
involving a patient with Creutzfeldt-Jakob disease, follow the recommendations described in
“Transmissible Spongiform Encephalopathy” on page 257.
WARNING
Transducer covers are disposable and must not be reused.
WARNING
If an installed transducer cover is cut or contaminated before use, the probe should be
cleaned and disinfected or sterilized, and a new sterile cover installed.
WARNING
Do not apply the transducer gel until you are ready to perform the procedure. Transducers
should not be left soaking in gel.
WARNING
For intraoperative applications, use only the Sterile Aquasonic or Sterile Ultraphonic gel
provided with the transducer cover.
CAUTION
Do not use gels that contain mineral oil or lotion. Such products may damage the transducer
and void the warranty.
CAUTION
Gels listed here are recommended because of their chemical compatibility with product
materials.
Transducer Storage
Use the appropriate guidelines for storing transducers for transport, and daily and long-term
storage.
9 Intraoperative Transducers
An intraoperative transducer is used during surgery to help the surgeon locate and visualize
anatomical structures, to visualize blood flow patterns and quantify velocities, and to image
and measure anatomical and physiological parameters of interest to the surgeon.
The system supports the L15-7io transducer for use in intraoperative applications.
WARNING
All intraoperative transducers are designed to be defibrillator safe in accordance with IEC
60601-1. Nevertheless, always remove the transducer from the patient before defibrillation.
NOTE
Intraoperative transducers will be unavailable in the US and Canada until regulatory clearance is
received.
WARNING
Intraoperative transducers used in animal studies should not be used on humans. Transducer
disinfection procedures for cross-usage between animals and humans have not been
validated.
• Do not allow water or other liquids to drip onto the transducer connector, the interior of
the system, or the keyboard.
• Maintain a sterile field.
WARNING
All intraoperative studies must be performed with a Type CF classified transducer. If your
transducer is not labeled Type CF on the transducer connector, contact your Philips
service representative.
WARNING
Be sure to use a market-approved sterile transducer cover and sterile ultrasound
transmission gel when performing all intraoperative studies.
WARNING
Always remove the transducer from the patient before defibrillation.
Patient-Contact Parts
Latex is commonly used in sheaths marketed to help with infection control in transesophageal,
endocavity, and intraoperative imaging applications and during biopsies. Examine the packaging
to confirm latex content. Studies have shown that patients can experience allergic reactions
with natural rubber latex. See “FDA Medical Alert on Latex” on page 49.
NOTE
The ultrasound system and transducers discussed here do not contain natural rubber latex that
contacts humans. Natural rubber latex is not used on any Philips ultrasound transducers.
WARNING
If you find any signs of damage to the transducer, patient safety may be compromised. Do
not use the transducer, and contact your Philips service representative.
Meticulous inspection and correct and careful operation of intraoperative transducers are
imperative to patient safety. The situations listed here affect safe operation as well as the
ability to service mechanical problems under the Philips warranty or service contract.
Transducer repairs necessitated by misuse are not covered and can be very costly, often
requiring complete disassembly and rebuilding of the transducer.
There are three primary areas of transducer misuse:
• Cuts and abrasions on the transducer insulation and lens from sharp instruments such as
scalpels, scissors, and clamps
• Improper disinfection techniques, causing fluid to enter the transducer or damage
transducer materials
• Damage caused by dropping the transducer on a hard surface
To minimize the chance of damage, Philips strongly recommends that you clearly post stringent
protocols for the care of intraoperative transducers, based on the information provided here.
L15-7io Description
The L15-7io transducer is described here. For more information on connecting, activating,
caring for, and maintaining transducers, see the “Transducers” and “Transducer Care” sections.
L15-7io Transducer
NOTE
This transducer is available only in countries or regions where it is approved. For information
specific to your region, contact your local Philips representative.
2. Carefully inspect each transducer cover before use, and discard it if you find tears or
blemishes. Also inspect each transducer cover after use. If you find a tear, the patient or the
transducer may have been contaminated.
3. Insert the transducer into the transducer cover and unfurl the transducer cover until it
covers the transducer and its cable. The cover must be unfurled far enough to maintain the
sterile field.
4. Use a sterile elastic band or clip to hold the proximal end of the transducer cover in place.
5. Ensure that wrinkles and bubbles over the face of the transducer are minimized. Check the
transducer cover for tears or damage before proceeding.
6. When operating the transducer, make sure that proper orientation is maintained to avoid
interpretation confusion.
NOTE
To achieve good acoustic contact, make sure that the imaging surface is moist.
NOTE
Imaging improves with adequate coupling between the patient surface and the transducer-
cover surface. Sterile water is a good acoustic-coupling agent during surgery.
Disposable Drapes
During studies in which you believe contamination of the ultrasound system can occur, Philips
recommends that you take universal precautions and cover the system with a disposable drape.
Consult your hospital’s rules regarding equipment use in the presence of infectious disease.
WARNING
Only a technically qualified person should perform the leakage current test procedure.
Test 1 tests the current leakage, using a Dynatech Nevada 232 Safety/ECG Analyzer. This
procedure shows one example of a current leakage test (source and sink). The procedure for
your safety analyzer may be very different.
Test 1: Leakage Current Test with Mains Voltage Applied (Source) for Intraoperative Transducers
Z Impedance between the metal parts of the transducer and a test electrode placed
in the bucket of saline solution (about 850 kΩ with an intact outer insulating layer,
500 Ω with a hole in the layer)
A Microammeter to measure leakage current from the transducer to the earth lift
ground through Z to the test electrode
E Earth ground
Test 2: Leakage Current Test with Mains Voltage Applied (Sink) for Intraoperative Transducers
Z Impedance between the metal parts of the transducer and a test electrode placed
in the bucket of saline solution (about 850 kΩ with an intact outer insulating layer,
500 Ω with a hole in the layer)
E Earth ground
WARNING
Electrical shock hazard: Do not touch the lead that you connect to the safety analyzer in step
7.
WARNING
There is considerable hazard in performing this test. Use precautionary measures to avoid
accidental contact with line voltage. In addition, any time that the ground connection has
been opened, do not touch the chassis or the patient cable during the test.
This test checks leakage current with mains voltage applied. For a diagram of this test, Test 2,
see “Leakage Current Testing for Intraoperative Transducers” on page 193.
1. Plug the safety analyzer into the power source.
2. Plug the ultrasound system into the safety analyzer.
3. Connect the transducer being tested to the ultrasound system.
4. Immerse 5 cm (2 in) of the transducer in saline solution.
5. Set the safety analyzer Mode switch to the ECG position.
6. Set the safety analyzer Leads switch to the Isolation Test position.
7. Connect a lead to any ECG terminal on the safety analyzer. Leave the other end of the lead
disconnected for now.
8. Press and hold the Isolation Test button and note the leakage reading. This is the correction
factor that will be subtracted from the final reading.
9. Immerse the other end of the lead into the saline solution.
10. Press and hold the Isolation Test button and take the leakage reading again.
11. Subtract the correction factor found in step 8 to get the accurate leakage measurement.
The leakage must be less than 50 µA RMS.
10 Transesophageal Transducers
A transesophageal echocardiography (TEE) study is performed with a transducer mounted in a
gastroscope, which is positioned in the esophagus or stomach. TEE transducers offer images
that are unobstructed by lungs and ribs, making them important diagnostic tools for conditions
that transthoracic echocardiography cannot adequately image.
All transesophageal transducers are rated minimum IPX1 (control area) and IPX7 (endoscope
area) in accordance with IEC 60529.
The system supports the compact X7-2t and S7-3t TEE transducers. The imaging array in the
X7-2t and the S7-3t transducers can be rotated electronically using controls on the transducer
or on the control panel.
WARNING
All TEE transducers are designed to be defibrillator safe in accordance with IEC 60601-1.
Nevertheless, always remove the transducer from the patient before defibrillation.
WARNING
Never apply excessive force when inserting or withdrawing a TEE transducer, or when
operating the transducer deflection controls.
WARNING
Do not allow the transducer to remain at a maximum deflection for long periods of time.
WARNING
Lock medial/lateral movement of the TEE transducer during insertion.
WARNING
Whenever the TEE transducer is not being used during a procedure, ensure that it is in
freewheeling mode and unplugged from the system.
WARNING
To prevent tissue damage, Philips recommends that the tip of the TEE transducer be
straightened and both detent brakes released before you reposition the transducer or
withdraw the transducer from the patient. In the neutral position, the tip is straight when the
indicators on the control wheels are aligned and point toward the center of the array rotation
button.
WARNING
Bite guards are mandatory; protective transducer covers are recommended for TEE
transducers, but in China and Japan, the covers are mandatory. See “Electrical Safety and TEE
Transducers” on page 205.
CAUTION
To avoid damaging gastroscope cables, be sure that the distal tip of the transducer is in the
neutral (straight) position when inserting a transducer into, or removing it from, the
transducer cover.
The TEE transducers are classified as Type BF isolated patient-applied parts, as described in IEC
60601-1. There are no exposed conductive surfaces distal to the transducer handle. To ensure
safe operation of this transducer, read the cautions and warnings in the “Safety” section,
especially those that address electrosurgical units, pacemakers, and defibrillators.
The following table summarizes patient safety problems, describes how to prevent them, and
lists the sections in this manual where details are provided.
WARNING
If you encounter an irregularity not listed in the following table, do not use the transducer.
Potentially serious consequences could result. Contact your Philips representative.
Patient-Contact Parts
Latex is commonly used in sheaths marketed to help with infection control in transesophageal,
endocavity, and intraoperative imaging applications and during biopsies. Examine the packaging
to confirm latex content. Studies have shown that patients can experience allergic reactions
with natural rubber latex. See “FDA Medical Alert on Latex” on page 49.
NOTE
The ultrasound system and transducers discussed here do not contain natural rubber latex that
contacts humans. Natural rubber latex is not used on any Philips ultrasound transducers.
WARNING
For any other irregularity not listed in the following table, do not use the transducer.
Potentially serious consequences could result. Contact your Philips representative.
For safety information on electrosurgical units, pacemakers, defibrillators, and related topics,
see “Electrical Safety” on page 29.
WARNING
Before defibrillation, if you cannot remove the transducer from the patient, always
disconnect invasive transducers that remain in contact with the patient from the system.
To reduce the possibility of electrical risks associated with use of TEE transducers, follow these
recommendations:
• Visually and tactually inspect a TEE transducer for bumps, cracks, and cuts before each TEE
exam. A small bump on the shaft surface could indicate that a strand from the ground
shield has broken and is beginning to puncture the outer layer. If you suspect a problem
with the flexible shaft, perform the electrical safety check procedure. See “TEE Leakage
Current Test” on page 234.
• Use electrosurgical units (ESUs) that have isolated outputs. Return fault/ground fault
detection circuits provide additional protection. To determine if an ESU has an isolated
output, read the label on the ESU, see the ESU service guide, or ask a biomedical engineer.
• Require periodic electrical safety checks to ensure that the grounding system in your area
remains intact.
• If the transducer is left in a patient during periods when imaging is not taking place, unplug
the transducer from the system to reduce the possibility of leakage current or ESU
interaction. Also make sure that the deflection control brakes are off and that the
transducer is in freewheeling mode.
• Always remove the transducer from the patient before defibrillation.
WARNING
Never apply excessive force when inserting or withdrawing a TEE transducer, or when
operating the transducer deflection controls.
WARNING
Lock medial/lateral movement of the TEE transducer during insertion.
WARNING
Whenever the TEE transducer is not being used during a procedure, ensure that it is in
freewheeling mode and unplugged from the system.
WARNING
Do not allow the TEE transducer to remain at a maximum deflection for long periods of time.
WARNING
To prevent tissue damage, Philips recommends that the tip of the TEE transducer be
straightened and both detent brakes released before you reposition the transducer or
withdraw the transducer from the patient. In the neutral position, the tip is straight when the
indicators on the control wheels are aligned and point toward the center of the array rotation
button.
WARNING
Bite guards are mandatory; protective covers are recommended for TEE transducers, except
in China and Japan, where protective transducer covers are mandatory for TEE transducers.
WARNING
To avoid damaging gastroscope cables, be sure that the distal tip of the transducer is in the
neutral (straight) position when inserting a transducer into, or removing it from, the
transducer cover.
NOTE
Philips recommends that you use the X7-2t transducer only on patients weighing at least 30 kg
(66 lb), to ensure that the esophagus can comfortably accommodate the transducer.
Transducer connector
Component Description
Transducer handle
Deflection controls
Anterior/posterior control
Control Description
Image plane rotation buttons
Anterior/posterior control
Control Description
Image plane rotation buttons
4 Transducer handle
5 Deflection and array controls
WARNING
Verify that the maximum deflection of the tip is 120 degrees up and 90 degrees down. If the
up/down deflection shows an unwanted amount of free play or exceeds the maximal
deflection angles, do not use the transducer. Contact Philips to readjust the steering of the
transducer. Ensuring proper deflection limits minimizes the risk of the tip folding over in the
esophagus.
WARNING
To protect the patient and the transducer, straighten the tip of the transducer and unlock the
deflection control when inserting or withdrawing the transducer. On the S7-3t, the tip is
straight when the white line on the control wheel is aligned along the shaft of the transducer
handle.
S7-3t Controls
1 90-degree rotation indicator
2 Array control
3 Deflection control
4 Deflection lock
5 Neutral position indicators (no deflection)
Unlocked, freewheeling (white)
Locked (red)
CAUTION
Do not use excessive force on the array rotation control wheel at its outer positions because
this may damage the endoscope mechanism.
1. To rotate the imaging array, turn the array control (the larger wheel).
2. To rotate the array to 90 degrees, align the white bar on the side of the array control with
the center of the proximal end of the transducer handle.
3. To rotate the array to a specific setting, align a setting on the top of the array control with
the center of the proximal end of the transducer handle.
WARNING
The ability of a patient to swallow or accommodate the transducer should be considered.
WARNING
You must consider any history of gastroesophageal diseases as well as the possible effects of
other therapies that the patient is undergoing. You must also consider all gastroesophageal
abnormalities or difficulty swallowing.
The following table lists the minimum patient weight recommendations when using TEE
transducers.
TEE Transducer Minimum Patient Weight Recommendations
TEE Transducer Minimum Patient Weight
S7-3t 3.5 kg (7.7 lb)
X7-2t 30 kg (66 lb)
• Minimize the possibility of pressure necrosis (tissue death). Do not let the distal tip displace
any one segment of tissue for more than 5 consecutive minutes. Also make sure the
deflection area and the distal tip are in the position of least potential pressure. Be sure that
the transducer is in a freewheeling mode and unplugged whenever you are not imaging.
• Prevent potential esophageal damage. Philips recommends that you stop TEE scanning and
unplug the transducer from the system during periods of poor perfusion, circulatory arrest,
or the hypothermic phase of open heart surgery. To discontinue scanning, unlock the
transducer connector.
• Before each TEE study, carefully inspect the transducer, as described in “Checking the TEE
Transducer” on page 223. A thorough inspection procedure is required for the safety of the
patient and yourself, and to ensure the continued correct functioning of the transducer.
• Never use excessive force when inserting, operating, or withdrawing a transducer, and
make sure the deflection area is straight during insertion and withdrawal. Forceful
insertion, manipulation, or withdrawal of a transducer can result in lacerations, bleeding,
perforation, tearing of adhesions, and ligament damage. Also be aware that the tip can fold
over, causing similar damage.
• Refrain from handling the distal tip whenever possible. If you must handle the distal tip,
grasp it on the sides. Do not touch the top or bottom. Support the transducer’s proximal
head, either by having an assistant hold the steering mechanism or by clamping the
transducer at the steering mechanism. Ensure that the clamp does not interfere with
steering, and do not clamp any part of the flexible shaft, as this will damage the transducer.
Tip Fold-Over
On rare occasions, the tip of a TEE transducer has folded over during insertion. The effects can
be serious if the situation is handled incorrectly. The esophagus can be scraped, perforated, or
otherwise damaged.
WARNING
All patients should wear a bite guard during a TEE exam. A bite guard protects against
dangerous transducer mechanical and electrical malfunction caused by involuntary biting.
Even anesthetized patients require bite guards to prevent damage to both their teeth and to
the transducer. For information on bite guards available from Philips, see “Bite Guards” on
page 233.
Avoid the following when inserting any TEE transducer into a patient:
• Any excessive flexion of the transducer tip, particularly in the medial/lateral direction
• Catching the tip in pharyngeal recesses
• Insertion when a patient is being uncooperative or is having a convulsion or spasm
WARNING
If the patient temperature is above 37°C (98.6°F) and the Patient Temp control is set below
the actual patient temperature, then the system can overestimate the temperature of the
TEE transducer's distal tip. This can prematurely trigger the Auto-Cool feature. If the patient
temperature is at or near 37°C (98.6°F) and the Patient Temp control is set above the actual
patient temperature, then the system can underestimate the temperature of the distal tip.
This can expose patients to excessive temperatures.
NOTE
The patient temperature shown on the ultrasound display is always either 37°C (98.6°F) or the
temperature that you manually enter. The system does not monitor or report the actual patient
temperature.
If the distal tip temperature reaches 41°C (105.8°F), a warning message appears and the
transducer temperature is displayed in inverse video. If the temperature reaches 42.5°C
(108.5°F), a warning appears with the patient and the transducer temperatures, and the system
stops imaging until the distal tip cools to below 42°C (107.6°F). The system shuts down if the
patient-applied part temperature of the TEE transducer exceeds 42.5°C (108.5°F), given an
entered patient temperature of 37°C (98.6°F). It resumes scanning when the temperature falls
below 42°C (107.6°F) . If the patient temperature is higher than 37°C (98.6°F), the system
shutdown temperature adjusts accordingly. You may need to restart the system by turning it
on.
WARNING
To avoid the risk of esophageal burn for adult patients, minimize the time spent imaging at
distal tip temperatures in excess of 42°C (107.6°F). Exposure should be limited to 10 minutes
or less at 42°C (107.6°F) or higher.
WARNING
Sufficient data on thermal tolerance of the esophagus in neonate and pediatric patients does
not exist, but it is likely these patients are more vulnerable than adults. Minimize the time
spent imaging at distal tip temperatures in excess of 41°C (105.8°F).
NOTE
If you want the temperature display enabled by default, turn on the temperature display and
then create a preset as described in “Creating Quick Save Presets” on page 149.
Patient Temperature
Entering a patient’s temperature enables the Auto-Cool feature to calculate tip temperature
more accurately, which can prevent unnecessary interruptions while scanning. If a patient’s
temperature is above normal, entering a temperature can avoid exposing the patient to
excessive temperatures.
Always check the patient’s temperature before inserting a TEE transducer. If it is above normal,
whether from fever or therapeutic heating from a cardiac bypass heart-lung machine, perform
the procedure in “Entering Patient Temperature” on page 231 before inserting the transducer.
Also, follow that procedure if a patient’s temperature rises during a study.
Measure the patient’s core temperature, or more specifically, the actual temperature in the
esophagus. For patients undergoing surgery, determine the temperature in the esophagus by
direct measurement or by monitoring the temperature of blood returning from the bypass
pump heat exchanger.
For closed-chest situations, rectal temperature is the best estimate of core temperature. You
can also use oral temperatures, even though they can be one degree lower than the core
temperature. If you measure an auxiliary temperature, which can be two degrees lower than
the core temperature, add one or two degrees.
NOTE
Each time you turn off or reset the system, or enter a new patient ID, the system assumes that
the patient temperature is 37°C (98.6°F).
The system shuts down if the patient-applied part temperature of the TEE transducer exceeds
42.5°C (108.5°F), given an entered patient temperature of 37°C (98.6°F). If the patient
temperature is higher than 37°C (98.6°F), the system shutdown temperature adjusts
accordingly. You may need to restart the system by pressing the (On/Off) control .
WARNING
The Reconnect the Transducer error message is often caused by a poorly seated transducer
connector, but it could be caused by a failure in the Auto-Cool safety logic. In the case of a
logic failure, distal tip temperatures could reach 46.5°C (115.7°F) in hyperthermic patients
(40°C to 41°C or 104°F to 106°F) before the error causes scanning to stop. At this temperature,
esophageal burns may occur (see “TEE Transducer References” on page 238).
1. Move the locking lever to the unlocked position, and pull the connector out of the
receptacle.
2. Reseat the connector in the receptacle and move the locking lever to the locked position.
3. Select the transducer and preset.
4. If the system does not resume imaging after the transducer has initialized, shut down the
system and then restart it.
Bite Guards
WARNING
The M2203A bite guard strap contains natural rubber latex, which may cause allergic
reactions. For more information, see “FDA Medical Alert on Latex” on page 49.
CAUTION
Damage caused when patients bite or scrape a TEE transducer is not covered in the
transducer warranty or your service contract. Use bite guards to help prevent such accidents.
All patients must wear a bite guard during a TEE study. A bite guard prevents dangerous
transducer mechanical and electrical malfunctions caused by involuntary biting. Even
anesthetized patients require bite guards to prevent damage to their teeth and to the
transducer. Philips supplies disposable bite guards that are suitable for both awake and
anesthetized patients.
WARNING
Transducer covers often contain natural rubber latex and talc, which may cause allergic
reactions. For more information, see “FDA Medical Alert on Latex” on page 49.
Philips recommends the use of a market-approved transducer cover during every TEE study.
For procedures on using transducer covers (protective sheaths), see the instructions provided
with the covers.
Tip Protectors
When not using a carrying case to transport a TEE transducer, use a tip protector on its distal
tip. The tip protector helps prevent serious damage to the transducer lens. Philips supplies tip
protectors designed for each of its TEE transducers.
Disposable Drapes
During studies in which you believe contamination of the imaging system can occur, Philips
recommends that you take universal precautions and cover the system with a disposable drape.
Consult your hospital’s rules regarding equipment use in the presence of infectious disease.
WARNING
Only a technically qualified person should perform the leakage-test procedure.
Z Impedance between the metal parts of the TEE transducer and a test electrode
placed in the bucket of saline solution (about 850 kΩ with an intact outer insulating
layer, 500 Ω with a hole in the layer)
Symbol Definition
S1 Open earth lift ground switch
S3 Microammeter switch
E Earth ground
Current I, driven by line supply e, flows through all stray capacitances between the primary
wiring and the ultrasound system’s metal chassis. Ordinarily, current then flows from the metal
chassis through S3 and back to e through a third-wire ground. When S3 is thrown in the other
position, current I is forced:
• From the chassis through the metal parts of the transducer
• Through impedance Z, produced by the insulating layer that covers the metal parts of the
transducer and the saline solution
• Through the test electrode
Saline generally presents an impedance of about 500 Ω, so Z will vary between 850 kΩ and
500 Ω, depending on whether or not there is a conductive pathway caused by a hole in the
transducer’s insulating layer.
CAUTION
Do not make a DC measurement of impedance. This could set up a voltaic cell, with the metal
of the transducer and a test electrode in the salt bath forming the two electrodes and an
electrolyte. Such a voltaic cell produces inaccurate resistance measurements.
You need the following equipment to perform the electrical safety check procedure:
• Dempsey 432HD or 232D safety analyzer or equivalent
• Philips 21110A Disinfection Basin or equivalent
• Saline solution, 9 grams (0.3 oz) of salt to 1 liter (1 qt) of tap water, or one of the tested
disinfectants listed in the “Transducer Care” section.
WARNING
Only a technically qualified person should perform this procedure.
11 Endocavity Transducers
Endocavity transducers provide high-resolution endocavity imaging for obstetric and GYN
applications. The system supports the C10-3v and the C10-4ec endocavity transducers.
WARNING
All endocavity transducers are designed to be defibrillator safe in accordance with IEC
60601-1. Nevertheless, always remove the transducer from the patient before defibrillation.
• Do not allow water or other liquids to drip onto the transducer connector, the interior of
the system, or the keyboard.
• Use sterile ultrasound transmission gel when performing all endocavity studies.
• Protective covers are recommended for endocavity procedures; the protective covers are
mandatory in China and Japan.
WARNING
All endocavity transducers are designed to be defibrillator safe in accordance with IEC
60601-1. Nevertheless, always remove the transducer from the patient before defibrillation.
NOTE
To achieve good acoustic contact, make sure that the imaging surface is moist.
NOTE
Imaging improves with adequate coupling between the patient surface and the transducer-
cover surface. Sterile water is a good acoustic-coupling agent during surgery.
C10-3v Description
The C10-3v transducer is described here. For more information on connecting, activating, caring
for, and maintaining transducers, see the “Transducers” and “Transducer Care” sections.
C10-4ec Description
The C10-4ec transducer is described here. For more information on connecting, activating,
caring for, and maintaining transducers, see the “Transducers” and “Transducer Care” sections.
Patient-Contact Parts
Latex and talc are commonly used in transducer covers marketed to help with infection control
in transesophageal, endocavity, and intraoperative imaging applications and during biopsies.
Examine the packaging to confirm latex and talc content. Studies have shown that patients can
experience allergic reactions with natural rubber latex. See the “FDA Medical Alert on Latex” on
page 49.
NOTE
The ultrasound system and transducers discussed here do not contain natural rubber latex that
contacts humans. Natural rubber latex is not used on any Philips ultrasound transducers.
NOTE
CIVCO Medical Solutions supplies biopsy kits for Philips transducers that are biopsy capable. For
information on proper attachment of a biopsy bracket, consult the manufacturer’s instructions.
12 Biopsy Guides
The biopsy guide feature helps you position transducers with biopsy needle-guide attachments.
The biopsy guide feature displays guidelines on the image that show the anticipated path of the
needle. You can use those guidelines to ensure that the needle or instrument is following the
correct path.
Starter kits, which include the biopsy guide or biopsy guide bracket and procedure kits, are
available from Philips. Biopsy guides and supplies are available from CIVCO Medical Solutions
(see “Supplies and Accessories” on page 21).
For detailed information about using, cleaning, and sterilizing biopsy guides and brackets, see
the instructions provided with the biopsy starter kits, guides, and brackets.
NOTE
The biopsy guides for the L12-5 50 mm, and L18-5 transducers have infinite-angle capability and
can be installed on either side of the transducer; they do not constrain the biopsy needle to a
particular path. Because the needle path is unpredictable, the Biopsy control is unavailable, and
the biopsy graphics do not appear on the display when you are using these transducers. A
biopsy with these transducers is a manual action. The C5-1 and the C9-2 also support infinite-
angle biopsy guides but the graphics should not be used.
WARNING
Do not attempt to use the biopsy guide until you have read the instructions for selecting the
display, installing the sterile transducer cover, and verifying alignment of the biopsy guide.
WARNING
Inspect all components and the transducer. Ensure that the biopsy guide you are using is the
correct one for the transducer, the system, and system software. Your Philips representative
can verify this information for you.
WARNING
Use only Philips-approved biopsy guides, transducers, covers, brackets, supplies,
components, and accessories. Other brands may not properly fit Philips transducers.
Improper installation may result in patient injury.
WARNING
Some biopsy guides must be installed over a sterile transducer cover.
WARNING
After each use, biopsy guides must be either sterilized or disposed of, depending upon the
type. See the instructions included with the biopsy guide.
WARNING
Most transducers can only be disinfected; they cannot be sterilized. Only the transducer
cover provides the sterile barrier.
WARNING
Do not attempt to use the biopsy guide until you have read the instructions for selecting the
display, installing the sterile transducer cover, and verifying alignment of the biopsy guide.
The system generates a biopsy guideline through the displayed real-time ultrasound image to
indicate the anticipated path of the needle. You can use that guideline to ensure that the
needle or instrument is following the correct path.
When the biopsy display is active, a biopsy guideline is displayed, entering from the left or right
side of the screen, depending on the clinical application and image presentation you have
selected. When you reverse the image presentation by touching Left/Right, the biopsy
guideline moves to the opposite side. Image presentation is defined by the location of the
orientation marker.
When depth is changed, the biopsy display redraws to reflect the new relationships at the new
depth setting.
WARNING
When using a transducer with an infinite-angle biopsy guide, do not display a fixed-angle
biopsy guideline.
The biopsy guideline can have a single, fixed path or multiple paths. The system determines
which guideline to display based on the type of biopsy guide available for the transducer you
have selected.
NOTE
The following procedure applies specifically to non-intervention applications.
Biopsy Depth
WARNING
Alignment verification is necessary before performing procedures with the biopsy guide.
WARNING
Do not use the biopsy guide if the needle is not following the intended path. Contact your
Philips representative.
WARNING
The needle used for this alignment verification must not be used for the actual procedure.
Always use a new, sterile needle for each biopsy procedure.
WARNING
To assist in an accurate projection of the needle, use a straight, new needle for each
alignment procedure.
WARNING
If the needle enters from the unexpected side of the display or cannot be seen, verify that the
biopsy guide is correctly mounted on the transducer and that the orientation of the
transducer is correct. If the needle is still not following the expected path along the guideline,
do not use the biopsy guide. Contact your Philips representative.
1. Attach the biopsy guide. Although some transducers require the use of a second transducer
cover for biopsy procedures, a second transducer cover is unnecessary for this alignment
verification.
2. Connect the transducer to the system, and select the appropriate applications and preset.
3. Set the system depth for the procedure to be performed.
4. Display the biopsy guideline.
5. Without changing the position of the biopsy depth cursor, note the default depth shown at
the bottom of the display.
6. Immerse the transducer no more than 6 mm (0.25 in) into the water bath.
14. Insert the needle into a guide channel that corresponds to the size of the needle and the
angle you selected. Continue sliding the needle in until the mark on the needle aligns with
the origin on the biopsy guide. (The origin is the point at which the needle enters the biopsy
guide.)
15. Move the biopsy depth cursor to the tip of the needle, as seen on the display, and verify
that the displayed depth is within 4 mm (0.16 in) of the value noted in step 5.
16. Confirm that the needle is visible along its expected path. If so, then the biopsy guide is
properly aligned.
WARNING
Before the biopsy procedure, perform alignment verification at the selected depth, to ensure
that the biopsy guide and the needle have been installed properly.
WARNING
Use a straight, new, sterile needle for each procedure.
WARNING
Do not perform the biopsy guide procedure if the needle is not visible
WARNING
The biopsy guideline is intended only to provide an indication of the expected path of the
needle. Actual position must be verified by identifying the echoes from the needle.
WARNING
If the needle is not following the expected path, discontinue the procedure and contact your
Philips representative.
WARNING
Thin needles can bend when entering tissue. Actual position must be verified by identifying
the echoes from the needle.
WARNING
Reverberation or other tissue artifacts may produce false needle images, which can cause
confusion in locating the actual needle image. Ensure the needle path is along the guideline,
and that you are not using a false needle image to locate the needle.
WARNING
When using a transducer with an infinite-angle biopsy guide, do not display a fixed-angle
biopsy guideline.
WARNING
Philips does not recommend anatomical survey of the prostate with the biopsy guide
attached.
1. Install the transducer cover and the biopsy guide according to the instructions provided
with the biopsy guide.
2. Select a new, straight needle that matches the needle-gauge size on the biopsy guide clip
you are using (if applicable), and select the guide channel on the biopsy guide.
3. Set the system imaging controls for the biopsy procedure.
4. Touch a preset.
5. Touch the 2D tab.
6. Touch Biopsy.
7. Orient the transducer to match image presentation. Use the orientation marker .
8. If necessary, apply sterile acoustic coupling gel to the patient.
9. Begin scanning the patient. Position the transducer so that the puncture target is
intersected by the guideline on the display.
10. Do one of the following:
• For guides with a single angle, insert the needle into the needle guide groove closest to
the transducer.
• For guides with multiple angles, insert the needle into the needle guide groove that
corresponds to the angle you previously selected.
11. Perform the puncture by sliding the needle through the groove in the guide until the
needle, as shown on the display, intercepts the target.
12. If you are using a biopsy guide bracket and procedure kit, you can remove the transducer
from the patient while the needle is still inserted in the patient: Separate the needle from
the biopsy guide by pulling the tab up so that the clip snaps out of the needle guide,
allowing the clip (still attached to the needle) and needle to separate from the biopsy guide
(still attached to the transducer).
13. Remove the biopsy guide after use.
WARNING
The biopsy procedure kit components are disposable and must not be reused.
For information and instructions on cleaning, disinfecting, and sterilizing the biopsy guide, see
the instructions provided with the biopsy guide.
13 Transducer Care
This section contains information on cleaning, disinfecting, and sterilizing transducers that are
compatible with your ultrasound system.
For information on the gels that are safe to use with your system's transducers, see
“Ultrasound Transmission Gels” on page 184.
These instructions are intended to assist in effective cleaning, disinfection, and sterilization. In
addition, these instructions will help avoid damage, which could void your warranty, during
cleaning, disinfection, and sterilization.
WARNING
Disinfectants listed in this manual are recommended because of their chemical compatibility
with product materials, not their biological effectiveness. For the biological effectiveness of a
disinfectant, see the guidelines and recommendations of the disinfectant manufacturer, the
U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.
WARNING
The level of disinfection required for a device is dictated by the type of tissue it will contact
during use. Ensure the disinfectant type is appropriate for the type of transducer and the
transducer application. For information on the levels of disinfection requirements, see
“Choosing the Correct Transducer-Care Method” on page 257. Also, see the disinfectant label
instructions and the recommendations of the Association for Professionals in Infection
Control, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.
WARNING
Sterile transducer covers with sterile ultrasound transmission gel are required for
intraoperative and biopsy procedures, and protective covers are recommended for
transrectal and intravaginal procedures, but in China and Japan, the covers are mandatory.
Philips recommends the use of qualified covers.
WARNING
Bite guards are mandatory for TEE transducers. See “Bite Guards” on page 233.
WARNING
In intraoperative applications, sterilized transducers should be used with sterile gel and a
sterile transducer cover.
For information on ordering transducer covers, contact CIVCO Medical Solutions (see “Supplies
and Accessories” on page 21).
WARNING
Transducer covers can contain natural rubber latex, which may cause allergic reactions in
some individuals.
WARNING
The M2203A bite guard strap contains natural rubber latex, which may cause allergic
reactions.
For information on allergic reactions to latex-containing medical devices, see “FDA Medical
Alert on Latex” on page 49.
WARNING
If a sterile transducer cover becomes compromised during an intraoperative application
involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob
disease, follow the guidelines of the 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.
The care method for your transducer determines the appropriate disinfectant for your
transducer. For details about compatible disinfectants, see “Disinfectants Compatibility” on
page 276.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
WARNING
If a premixed solution is used, be sure to observe the solution expiration date.
WARNING
Transducers must be cleaned after each use. Cleaning the transducer is an essential step
before effective disinfection or sterilization. Be sure to follow the manufacturer’s instructions
when using disinfectants.
CAUTION
Attempting to disinfect a cable or connector by using a method other than the one included
here can damage the device and voids the warranty.
CAUTION
Do not allow sharp objects, such as scalpels or cauterizing knives, to touch transducers or
cables.
CAUTION
When handling a transducer, do not bump the transducer on hard surfaces.
CAUTION
Do not use a surgeon’s brush when cleaning transducers. Even the use of soft brushes can
damage transducers.
CAUTION
Do not use a brush on the connector label.
CAUTION
During cleaning, disinfection, and sterilization, orient the parts of the transducer, connector,
or cable that must remain dry higher than the wet parts until all parts are dry. This will help
keep liquid from entering unsealed areas of the transducer.
CAUTION
Do not allow any type of fluid to enter the connector. Ensure that fluid does not enter
through the strain relief, through the connector, through the electrical contacts, or through
the areas surrounding the locking-lever shaft and the strain relief. Fluid in the connector may
void the device warranty.
CAUTION
You can use an alcohol solution for disinfection on the connector only. Ensure the solution is
only 70% alcohol or less. Solutions of more than 70% alcohol can cause product damage.
CAUTION
Do not use any alcohol or alcohol-based products on the cable or strain relief.
CAUTION
Avoid disinfectant contact with the connector label.
CAUTION
Be sure to use the proper concentration of enzymatic cleaner and rinse thoroughly.
CAUTION
Do not use paper products or products that are abrasive when cleaning the transducer. They
damage the soft lens of the transducer.
CAUTION
Before storing transducers, ensure that they are thoroughly dry. If it is necessary to dry the
transducer lens after cleaning, use a soft cloth and a blotting motion, instead of a wiping
motion.
Cleaning a Transducer
NOTE
All imaging transducers are rated at a minimum IPX7 in accordance with IEC529. This rating
indicates that the device is protected against the effects of immersion. Continuous wave
(nonimaging) transducers are rated IPX1. This rating indicates that the device is protected
against the effects of vertically falling water. For all TEE transducers, the control module is rated
IPX1, while the endoscope is rated IPX7, in accordance with IEC529.
Before cleaning a transducer, read the warnings and cautions in “Transducer, Cable, and
Connector Cleaning” on page 258 and “Transducer Care Safety” on page 255.
1. After every patient study, use a moist cloth to remove the ultrasound transmission gel from
the transducer.
2. Disconnect the transducer from the system, and remove any accessories attached to or
covering the transducer.
3. To remove all organic matter and other residue, use a pre-cleaner or detergent to assist in
removing protein residuals. Enzymatic cleaners must be diluted prior to use per the
manufacturer’s instructions for dilution. Enzymatic cleaners are generically approved for
use.
4. When cleaning the lens, use a blotting motion rather than a wiping motion.
5. To remove remaining particulate and cleaning residue, rinse thoroughly with water up to
the immersion point shown in “Disinfecting Non-TEE Transducers by Immersion” on page
268 and “Disinfecting TEE Transducers by Immersion” on page 270.
6. Optional: Wipe with a dry cloth. To dry the lens, use a soft cloth and a blotting motion
instead of a wiping motion.
NOTE
If you use cleaning wipes, it may be unnecessary to rinse the transducer with water. Always
follow the product label recommendations.
CAUTION
Do not bend or crimp the gastroscope or cable.
4. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean the cable,
the strain reliefs, and the connector. A soft-bristled brush can be used to clean only the
metal surfaces of the connector.
5. Mix the disinfection solution compatible with your cable (see “Disinfectants and Cleaning
Solutions Compatibility Table” on page 278) according to label instructions for solution
strength.
6. Wipe or spray the cable, strain relief, and connector with the disinfectant, following
disinfectant label instructions for wipe durations, solution strengths, and duration of
disinfectant contact with the cable. Ensure that the solution strength and duration of
contact are appropriate for the intended clinical use of the device. Ensure that the
disinfectant solution does not enter the device or the connector or come into contact with
the connector label.
7. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant
label.
8. Examine the device and cable for damage such as cracks, splitting, sharp edges, or
projections. If damage is evident, discontinue use of the device and contact your Philips
representative.
Transducer Disinfection
To disinfect transducers, you can use either an immersion method or a wipe method with a
disinfectant recommended by Philips Ultrasound. Use the method that is biologically
appropriate, as described in “Choosing the Correct Transducer-Care Method” on page 257.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
CAUTION
Wipe only the distal tip of the transducer up to 2.5 cm (1 in) from the strain relief/housing
joint with an isopropyl alcohol solution.
CAUTION
Do not use isopropyl alcohol on the strain relief/housing joint, the strain relief, or the cable.
CAUTION
Do not use isopropyl alcohol on TEE transducers, except for the handle.
CAUTION
The use of 70% isopropyl alcohol (rubbing alcohol) on transducers is restricted. Wipe only the
distal tip of the transducer up to 2.5 cm (1 in) from the strain relief/housing joint with an
isopropyl alcohol solution. Do not use isopropyl alcohol on the strain relief/housing joint, the
strain relief, or the cable. Do not use isopropyl alcohol on TEE transducers, except for the
handle. Isopropyl alcohol can cause damage to these parts of the transducer. This damage is
not covered by the warranty or your service contract.
NOTE
Transducers can be disinfected using the wipe method only if the product labeling of the
compatible disinfectant you are using indicates it can be used with a wipe method.
1. Clean the transducer and cable according to the procedures in “Transducer, Cable, and
Connector Cleaning” on page 258.
2. After cleaning, wipe or spray the transducer and cable with a low-level disinfectant. Allow
for the manufacturer’s recommended contact time. For a list of compatible disinfectants,
see “Disinfectants Compatibility” on page 276.
NOTE
If you use cleaning wipes, it may be unnecessary to rinse the transducer with water. Always
follow your product label recommendations.
3. Examine the device and cable for damage such as cracks, splitting, sharp edges, or
projections. If damage is evident, discontinue use of the device and contact your Philips
representative.
WARNING
If a premixed disinfectant is used, be sure to observe the expiration date.
NOTE
All imaging transducers are rated at a minimum IPX7 in accordance with IEC529. This rating
indicates that the device is protected against the effects of immersion. Continuous wave
(nonimaging) transducers are rated IPX1. This rating indicates that the device is protected
against the effects of vertically falling water. For all TEE transducers, the control module is rated
IPX1, while the endoscope is rated IPX7, in accordance with IEC529.
CAUTION
Using non-recommended disinfectants, using incorrect solution strengths, or immersing a
transducer deeper or longer than recommended can damage or discolor the transducer and
voids the transducer warranty.
CAUTION
Do not immerse transducers longer than the minimum time needed for your level of
disinfection. For information on the levels of disinfection requirements, see “Choosing the
Correct Transducer-Care Method” on page 257.
WARNING
Residual OPA on TEE transducers may cause temporary staining of the mouth and lip area
and irritation or chemical burns of the mouth, throat, esophagus, and stomach.
To minimize the effects from residual OPA, or any other disinfectant, Philips recommends the
following:
WARNING
Follow the disinfectant manufacturer’s instructions very carefully. For example, the
manufacturer of Cidex OPA recommends soaking transducers three times in fresh water.
WARNING
Use a protective transducer cover during endocavity and TEE studies.
WARNING
Use a sterile protective transducer cover with sterile ultrasound transmission gel during
intraoperative and biopsy studies.
WARNING
Limit the time that transducers are soaked in the disinfectant solution to the minimum time
recommended by the disinfectant manufacturer (for example, the manufacturer of Cidex OPA
recommends a minimum of 12 minutes).
Immersing Transducers
1 Immerse this section only, up to 5.1 cm (2 in) from the connector’s strain relief.
2 Maximum allowable immersion depth; you are not required to immerse to this depth if it is unnecessary.
CAUTION
Never sterilize the transducer with autoclave, gamma-radiation, gas, steam, or heat
sterilization techniques. Severe damage will result. Avoidable transducer damage is not
covered by the warranty or service contract.
CAUTION
Do not bend the shaft into a circle with a diameter of less than 0.30 m (1 ft).
CAUTION
Do not use bleach on the transducer and shaft.
CAUTION
Do not use isopropyl alcohol-based products on the transducer and shaft.
CAUTION
Do not soak the transducer for extended periods of time. Limit the time that transducers are
soaked in disinfectant solution to the minimum time recommended by the disinfectant
manufacturer.
CAUTION
Do not rinse or immerse the control housing, cable, connector, or the portion of the cable
near the connector.
CAUTION
Do not immerse or rinse the steering mechanism.
CAUTION
Follow the recommendations of the disinfectant manufacturer.
CAUTION
The transducer steering mechanism is unsealed. If disinfectant or other fluid enters the
steering mechanism, it corrodes the gears and electrical connections. Avoidable transducer
damage is not covered by the warranty or service contract.
Upon receiving your new transducer, disinfect it before performing the first study. Clean and
disinfect the transducer immediately after each use to protect patients and personnel from a
variety of pathogens. Establish and clearly post a cleaning procedure that includes the following
steps.
Methods for disinfecting transesophageal (TEE) and non-TEE transducers differ. For non-TEE
transducers, see “Disinfecting Non-TEE Transducers by Immersion” on page 268.
1. Disconnect the transducer from the system.
2. Clean the transducer and flexible shaft using any of the following: enzymatic cleaner, mild
soap solution, or an approved wipe. Follow the manufacturer's instructions for use.
3. Use water to rinse the distal tip and flexible shaft thoroughly.
4. Immerse the distal tip and flexible shaft into the appropriate disinfectant as shown in the
illustration.
5. Remove the tip and shaft from the disinfectant and thoroughly rinse with water according
to the instructions from the disinfectant manufacturer.
6. Check the transducer for any residual organic material. If any is present, remove it and
disinfect the transducer again.
7. Gently dry the distal tip and flexible shaft with a sterile cloth or pad, or allow it to air dry.
8. Lightly wipe only the steering mechanism and handle with a pad moistened with rubbing
alcohol (70% isopropyl alcohol), or use approved cleaners as directed on the handle and
steering mechanism.
9. Hang the transducer on a wall-mounted rack, and let it air dry.
Transducer Sterilization
Sterilization is required if the transducer enters otherwise sterile tissue without a sterile cover.
If you use a sterile cover, you should sterilize but you can disinfect (high-level disinfection). For
information about disinfecting a transducer, see “Transducer Disinfection” on page 263.
WARNING
Always use protective eyewear and gloves when cleaning, disinfecting, or sterilizing any
equipment.
WARNING
In intraoperative applications, sterilized transducers should be used with sterile gel and a
sterile transducer cover.
WARNING
Sterile transducer covers are disposable and must not be reused.
WARNING
If a premixed solution is used, be sure to observe the solution expiration date.
CAUTION
Transducers must be cleaned after each use. Cleaning the transducer is an essential step
before effective disinfection or sterilization. Be sure to follow the manufacturer’s instructions
when using disinfectants.
CAUTION
Use only liquid solutions to sterilize transducers. Using autoclave, gas (EtO), or other methods
not approved by Philips will damage your transducer and void your warranty.
CAUTION
Do not allow sharp objects, such as scalpels and cauterizing knives, to touch transducers or
cables.
CAUTION
When handling a transducer, do not bump the transducer on hard surfaces.
CAUTION
Ensure the solution strength and duration of contact are appropriate for sterilization. Be sure
to follow the manufacturer’s instructions.
Immersing Transducers
1 Immerse this section only, up to 5.1 cm (2 in) from the connector’s strain relief.
2 Maximum allowable immersion depth; you are not required to immerse to this depth if it is unnecessary.
Disinfectants Compatibility
Read this information before performing disinfection and sterilization procedures. It discusses
recommended disinfectants and choosing an appropriate disinfectant for the required level of
disinfection. You must check “Disinfectants and Cleaning Solutions Compatibility Table” on page
278 for the chemical compatibility of disinfectants and cleaners with specific transducers. In
addition, the table indicates if a device can be sprayed or wiped only, or if it can be soaked.
WARNING
Not all disinfectants are effective against all types of contamination. Ensure the disinfectant
type is appropriate for the type of transducer and that the solution strength and time of
contact are appropriate for the intended clinical use.
WARNING
Disinfectants listed in this section are recommended because of their chemical compatibility
with product materials, not their biological effectiveness. For the biological effectiveness of a
disinfectant, see the guidelines and recommendations of the disinfectant manufacturer, the
Association for Professionals in Infection Control, the U.S. Food and Drug Administration, and
the U.S. Centers for Disease Control.
WARNING
If a premixed solution is used, be sure to observe the solution expiration date.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
CAUTION
Using a non-recommended disinfection solution, using an incorrect solution strength, or
immersing a transducer deeper or longer than recommended can damage the device and
voids the warranty.
Disinfectant Types
WARNING
The level of disinfection required for a device is dictated by the type of tissue it will contact
during use. Ensure the disinfectant type is appropriate for the type of transducer and the
transducer application. For information on the levels of disinfection requirements, see
“Choosing the Correct Transducer-Care Method” on page 257. For more information, see the
disinfectant label instructions and the recommendations of the Association for Professionals
in Infection Control, the U.S. Food and Drug Administration, and the U.S. Centers for Disease
Control.
CAUTION
If you use an isopropyl alcohol-based product for disinfection, ensure the solution is only 70%
alcohol or less. Solutions of more than 70% alcohol can cause product damage. Do not use
alcohol on the transducer’s strain relief or cable, or on TEE transducers (except the handle).
CAUTION
Do not use hydrogen-peroxide products on Doppler transducers.
CAUTION
Isopropyl alcohol (IPA) products are approved for use on the transducer only and only if the
IPA content does not exceed 70%. Do not use IPA-based products on the connector cable and
strain relief. All other product types listed here can be used on the transducer and cable.
NOTE
TEE transducers require unique methods for disinfection. See “Disinfecting TEE Transducers by
Immersion” on page 270 or “Disinfecting TEE Transducers with an AER” on page 273.
Based on material compatibility testing and product use profile and active ingredients, Philips
has approved for use the following types of low-level disinfectants used as a spray or wipe for
surface (skin contact) and transvaginal or transrectal probes:
• Sodium hypochlorite based (for example 10% household bleach solution with active sodium
hypochlorite at approximately 0.6%)
• Quaternary ammonium (QUAT) based (for example, products that contain n-alkyl (x)benzyl
ammonium chloride solution where (x) can be any organic functional group such as ethyl
and methyl, and so on; concentration at use should be less than 0.5% total for all QUATs
listed)
• Accelerated hydrogen peroxide based, except on Doppler transducers (D2cwc, D2tcd, and
D5cwc)
• Activated hydrogen peroxide based, except on Doppler transducers (D2cwc, D2tcd, and
D5cwc)
• Alcohol or alcohol plus QUAT based (product alcohol content cannot exceed 70%)
Products not specifically listed in the following table but with similar active ingredients, as
indicated above, and marketed for medical use may be used. Because of the large number of
products available, it is impossible to have an all-inclusive list. If you are unsure of the suitability
of a particular product, please contact your Philips representative for assistance.
For more information:
• Philips Ultrasound Transducer Care website (www.healthcare.philips.com/us/products/
ultrasound/transducers/transducer_care/)
• In North America, call Philips at 800-722-9377.
• Outside North America, contact your local Philips representative.
Solution Origin Qualified Active C5-1 D2cwc L12-3 S5-1 S7-3t V6-2 X5-1 X6-1 X7-2t
Use Ingredients C8-5 D2tcd L12-5 50 S8-3
C9-2 D5cwc L15-7io S12-4
C10-3v L18-5
C10-4ec
Antigermix S1 FR S1 UV-C T,C N T,C T,C N N T,C T,C N
System
Banicide US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Bleach (10% All Spray/ Sodium T,C T,C T,C T,C C T,C T,C T,C C
solution of Wipe Hypochlorite
5.25% Bleach)
CaviWipes US Wipe Alcohol, Quat. T T T T H T T T H
Ammonia
Cidex US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Cidex 7 US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Cidex OPA US Soak 1
Ortho-phthal T,C N T,C T,C T T,C T,C T,C T
aldehyde
Cidex PAE 14J FR Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Cidex Plus US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Cleanisept DE Spray/ Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Wipes Wipe Ammonia
Descoton Extra DE Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Dispatch US Spray/ Sodium T,C T,C T,C T,C C T,C T,C T,C C
Wipe Hypochlorite
Endo FC FR Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Endosporine FR Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Enzol US Pre- Enzymes T,C N T,C T,C T T,C T,C T,C T
cleaner
Epizyme Rapid AU Pre- Enzymes T,C N T,C T,C T T,C T,C T,C T
cleaner
Gigasept FF DE Soak1 Succinic T,C N T,C T,C T T,C T,C T,C T
(neu) dialdehyde
Gigasept PAA DE Soak1 Peracetic T,C N T,C T,C N T,C T,C T,C T
Solution Origin Qualified Active C5-1 D2cwc L12-3 S5-1 S7-3t V6-2 X5-1 X6-1 X7-2t
Use Ingredients C8-5 D2tcd L12-5 50 S8-3
C9-2 D5cwc L15-7io S12-4
C10-3v L18-5
C10-4ec
Incidin DE Spray/ Alcohol T T T T H T T T H
Wipe
Incidur Spray DE Spray/ Alcohol, Quat. T T T T H T T T H
Wipe Aldehyde
Instruzyme FR Pre- Enzymes, Quat. T,C N T,C N T T,C N T,C T
cleaner Ammonia,
Biguanide
Klenzyme US Pre- Enzymes T,C N T,C T,C T T,C T,C T,C T
cleaner
Kohrsolin DE Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Korsolex Basic FR Soak 1
Aldehyde T,C N T,C T,C T T,C T,C T,C T
Releasing
Korsolex Extra FR Soak1 Aldehydes/ T,C N T,C T,C T T,C T,C T,C T
Quaternary
Ammonium
Korsolex PAE FR Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
MaxiCide Plus US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
MedDis UK Soak 1
Quat. T,C N T,C T,C T T,C T,C T,C T
Ammonia,
Sulfamic Acid
Medistel UK Soak1 Quat. T,C N T,C T,C T T,C T,C T,C T
Ammonia,
Sulfamic Acid
MetriCide US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
MetriCide 28 US Soak 1
Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
MetriCide OPA US Soak1 Ortho- T,C N T,C T,C T T,C T,C T,C T
Plus phthalaldehyde
MetriCide Plus US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
30
Solution Origin Qualified Active C5-1 D2cwc L12-3 S5-1 S7-3t V6-2 X5-1 X6-1 X7-2t
Use Ingredients C8-5 D2tcd L12-5 50 S8-3
C9-2 D5cwc L15-7io S12-4
C10-3v L18-5
C10-4ec
MetriZyme US Pre- Enzymes T,C N T,C T,C T T,C T,C T,C T
cleaner
Mikrozid PAA DE Wipe Peracetic Acid T,C N T,C T,C N T,C T,C T,C T
Mild Soap All Pre- Surfactants/ T,C T,C T,C T,C T,C T,C T,C T,C T,C
Solution cleaner Soap
Milton AU Spray/ Sodium T,C T,C T,C T,C C T,C T,C T,C C
Wipe Hypochlorite
NDP Med SP Soak1 N- T,C N T,C T,C T T,C T,C T,C T
Concentrated Duopropenide,
Plus Alkylamine
Omnicide 14NS US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Omnicide 28 US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Opti-Cide 3 US Spray/ Alcohol, Quat. T T T T H T T T H
Wipe Ammonia
Oxivir US Wipe Hydrogen T,C N T,C T,C N T,C T,C T,C T,C,H
Peroxide
Peracetic Acid UK Soak1 Peracetic Acid T,C N T,C T,C N T,C T,C T,C T
OCS
PeraSafe UK Soak1 Peracetic Acid T,C N T,C T,C T T,C T,C T,C T
Powder
Perastel UK Soak1 Peracetic Acid T,C N T,C T,C N T,C T,C T,C T
(formerly
Perascope)
PerCept Wipes CA Wipe Hydrogen T,C N T,C T,C T,C,H T,C T,C T,C T,C,H
Peroxide
Phagocide D FR Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Phagozyme ND FR Pre- Enzymes, Quat. T,C N T,C N T T,C N T,C T
cleaner Ammonium
Pro-Cide US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Solution Origin Qualified Active C5-1 D2cwc L12-3 S5-1 S7-3t V6-2 X5-1 X6-1 X7-2t
Use Ingredients C8-5 D2tcd L12-5 50 S8-3
C9-2 D5cwc L15-7io S12-4
C10-3v L18-5
C10-4ec
Pro-Cide 14NS US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Pro-Cide 28 US Soak 1
Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Pro-Cide NS US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Pro-Cide Plus US Soak 1
Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Prolystica 2X US Pre- Enzymes T,C N T,C T,C T T,C T,C T,C T
cleaner
Protex US Spray/ Quat. ammonia T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Disinfectant Wipe
Spray
PSS Select 14 US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Day
PSS Select 28 US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Day
PSS Select Plus US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Quaternary All Spray/ Quat. T,C T,C T,C T,C C T,C T,C T,C C
Ammonium Wipe Ammonia
Rapicide US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Resert XL HLD US Soak Hydrogen T,C N T,C T,C N T,C T,C T,C N
Peroxide
Rivascop FR Spray/ Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Wipe Ammonia
Salvanios pH FR Spray/ Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
10 Wipe Ammonia
Sani-Cloth US Wipe Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Active Ammonia
Sani-Cloth AF US Wipe Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Ammonia
Sani-Cloth AF3 US Wipe Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Ammonia
Solution Origin Qualified Active C5-1 D2cwc L12-3 S5-1 S7-3t V6-2 X5-1 X6-1 X7-2t
Use Ingredients C8-5 D2tcd L12-5 50 S8-3
C9-2 D5cwc L15-7io S12-4
C10-3v L18-5
C10-4ec
Sani-Cloth US Wipe Sodium T,C T,C T,C T,C C T,C T,C T,C C
Bleach Hypochlorite
Sani-Cloth Plus US Wipe Alcohol, Quat. T T T T H T T T H
Ammonia
SDS 14 NS US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
SDS 28 US Soak 1
Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Sekucid N FR Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Sekusept Aktiv DE Soak 1
Peracetic Acid T,C N T,C T,C T T,C T,C T,C T
Sekusept Easy DE Soak1 Peracetic Acid T,C N T,C T,C T T,C T,C T,C T
Sekusept Plus DE Soak 1
Glucoprotamin T,C N T,C N T T,C N T,C T
Steranios 2% FR Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
TD-5 US TD-100 Glutaraldehyde N N N N T N N N T
Reproces
sor
T-Spray US Spray/ Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Wipe Ammonia
T-Spray II US Spray/ Quat. T,C T,C T,C T,C T,C,H T,C T,C T,C T,C,H
Wipe Ammonia
Tristel Duo UK Foam/ Chlorine T,C N T,C T,C N N T,C T,C N
Wipe Dioxide
Tristel Fuse for UK Stella Chlorine T,C N T,C T,C T N T,C T,C T
Instruments System Dioxide
Tristel UK Wipe Chlorine T,C T,C T,C T,C T N T,C T,C T
Sporicidal Dioxide
Wipes
Trophon EPR AU Trophon Hydrogen T,C N T,C T,C N T,C T,C T,C N
EPR Peroxide
Reproces
sor
Solution Origin Qualified Active C5-1 D2cwc L12-3 S5-1 S7-3t V6-2 X5-1 X6-1 X7-2t
Use Ingredients C8-5 D2tcd L12-5 50 S8-3
C9-2 D5cwc L15-7io S12-4
C10-3v L18-5
C10-4ec
Vaposeptol FR Spray/ Alcohol, T T T T H T T T H
Wipe Biguanide
Vespore US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Virox 5 RTU CA Wipe Hydrogen T,C N T,C T,C T,C,H T,C T,C T,C T,C,H
Peroxide
Wavicide -01 US Soak1 Glutaraldehyde T,C N T,C T,C T T,C T,C T,C T
Wip'Anios FR Wipe Alohol, Quat. T T T T H T T T H
Ammonia
14 System Maintenance
Maintenance should be performed regularly and as needed.
Because the system is a piece of medical equipment that contains several circuit boards,
extensive service diagnostics, and complex operating software, Philips recommends that only
trained personnel service the system.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
CAUTION
Attempting to disinfect a cable or connector by using a method other than the one included
here can damage the device and voids the warranty.
CAUTION
Orient the parts that must remain dry higher than the wet parts until all parts are dry.
Use the following procedure to clean the display; the system control panel; all the external
surfaces of the system and the cart; and the ECG trunk cables, leads, and electrodes.
1. Before cleaning, turn off the system and unplug the power cord from the power source.
2. Wipe with a soft cloth moistened with soap and water.
CAUTION
Do not spill or spray liquid on the controls, into the system cabinet, or into the transducer
connection receptacle.
3. Remove any solid matter around the keys or the controls with a cotton swab or toothpick to
ensure that solids are not pushed into the cabinet.
4. If blood or other infectious material comes in contact with the system or any cable other
than a transducer cable, wipe with a 70% solution of isopropyl alcohol.
CAUTION
If blood or other infectious material comes in contact with a transducer or transducer cable,
do not wipe with isopropyl alcohol until you have read the “Transducer Care” section for
specific cleaning guidelines. Isopropyl alcohol should not be used on some parts of the
transducer and should never be used on any parts of the transducer cable. Additional
cleaning agents are also available for transducers.
CAUTION
Do not use strong solvents, common cleaning products, or abrasive cleansers, which will
damage the system surfaces.
CAUTION
Do not touch the displays with sharp objects or use paper towels to clean them, which may
damage them.
5. Remove dust from the monitor screen and touch screen with a soft, lint-free cloth. A micro-
fiber cloth is recommended. Clean the monitor screen and touch screen using a liquid
screen cleaner specifically designed for LCDs. Spray the liquid onto the cleaning cloth or
spray sparingly onto the displays. You can also use pre-moistened screen wipes. Dry the
displays with a soft, lint-free cloth.
CAUTION
When cleaning the system control panel, monitor screen, touch screen, and keyboard, take
care not to get any solution inside the housings. Also take care not to scratch the face of the
monitor while cleaning it.
CAUTION
Do not use cleaners containing bleach on the touch screen. It may damage the surface.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
CAUTION
Use only compatible disinfectants on system surfaces.
CAUTION
If you use an isopropyl alcohol solution for disinfection, ensure the solution is only 70%
alcohol or less. Solutions of more than 70% alcohol can cause product damage.
Before performing this procedure, read “Disinfectants for System Surfaces” on page 289.
1. Turn off the system and disconnect the system power cord from the wall outlet.
2. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean exterior
surfaces on the system.
3. Mix the disinfection solution compatible with your system according to label instructions
for solution strength.
CAUTION
Do not spray disinfectant directly on system surfaces. When wiping, do not allow disinfectant
to pool or run on system surfaces. In either case, disinfectant may leak into the system,
damaging the system and voiding the warranty. Wipe only with a cloth or applicator that is
lightly dampened.
4. Wipe system surfaces with the disinfectant, following disinfectant label instructions for
wipe durations, solution strengths, and disinfectant contact duration. Ensure the solution
strength and duration of contact are appropriate for the intended clinical application.
5. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant
label.
6. Because the system is a piece of medical equipment that contains several circuit boards,
extensive service diagnostics, and complex operating software, Philips recommends that
only trained personnel service the system.
WARNING
Before performing maintenance or cleaning, always turn off the system, and then disconnect
the system from the wall outlet.
CAUTION
Turn off power before you remove the air filter. Do not turn on power without the air filter
installed.
CAUTION
Ensure that air filter is dry before installing it. Installing a wet or damp air filter can damage
the system.
1. Locate the air filter handle at the bottom of the left side of the system.
2. Pull the air filter handle straight out, until the filter is completely removed from the system.
3. Inspect the filter. Depending on the condition of the air filter, vacuum or rinse the filter with
water to clean it. If the filter is worn out, or cannot be cleaned, replace it with a spare.
4. To reinstall the filter, slide the filter into place at the bottom of the left side of the system.
Transducer Maintenance
Transducers require proper care, cleaning, and handling. Reasonable care includes inspection,
cleaning, and disinfection or sterilization, as necessary.
Inspect the transducer cable, case, and lens before each use. Check for cracks or other damage
that jeopardizes the integrity of the transducer. Report any damage to your Philips customer
service representative, and discontinue use of the transducer.
For all information on transducer cleaning and disinfection, see the “Transducer Care” section.
For all information about the use of acoustic coupling gels, see “Ultrasound Transmission Gels”
on page 184.
CAUTION
Some ultrasound coupling gels, as well as some solutions for precleaning, disinfecting, and
sterilizing can damage a transducer. Before using a gel or solution on a transducer, see
“Ultrasound Transmission Gels” on page 184 or the “Transducer Care” section. You can also
contact your local Philips representative. For contact information, see “Customer Service” on
page 22.
If you encounter poor image quality or transducer problems, see “Troubleshooting” on page
295.
WARNING
If the device is internal to the system, turn off the system and disconnect the system from the
wall outlet. If the device is external to the system, disconnect the device from the wall outlet.
CAUTION
Do not scratch the roller or allow dirt and dust to contact the roller of a printer.
CAUTION
Do not use strong solvents such as thinner or acetone, or abrasive cleaners, because those
will damage a device cabinet.
CAUTION
Do not unplug the system from the wall outlet until the system is completely off. If you
unplug your system before the shutdown message appears, you will have to wait longer than
usual to use your system the next time you turn it on. You may also corrupt files, which can
result in an inoperative system or the loss of patient data.
Periodically clean the external surfaces of a device with a soft cloth. Difficult stains may be
removed with a cloth lightly dampened with a mild detergent solution.
Troubleshooting
If you encounter difficulty in the operation of the system, use the information here to help
correct the problem. If the problem is not covered here, contact your Philips representative.
The troubleshooting table contains a list of symptoms and the actions to take to correct the
problems.
Troubleshooting
Symptoms Corrective Action
The system does not power up. The monitor indicator 1. Verify the power connections.
light is off. 2. Check the circuit breaker on the back of the system.
No image displays on the monitor. 1. After power up, the system takes about 20 seconds to
initialize. During this time the monitor is blank.
2. After 20 seconds, adjust the monitor brightness.
3. Check the monitor cables and connections.
No audio comes from the system speakers. Adjust the volume to ensure that the speakers are not
muted.
An error message is displayed. Run the system test (see “Testing the System” on page
297).
An error message indicates that the system is above 1. Click Continue. The system will power down
normal operating temperature. automatically in 30 minutes.
2. With power off, check for obstructed air filters (see
“Cleaning the System Air Filter” on page 291).
Error Messages
The system displays error messages in response to operating or error conditions detected by
the system.
The error messages must be noted and reported to your Philips representative, who may ask
you to run the system test (see “Testing the System” on page 297).
Test Patterns
Two sets of test patterns are available for testing the image quality of the system, peripheral
devices, review stations, or a PACS.
• The original set of test patterns (labeled Test Patterns) includes images intended for a
variety of tests. Unlike the TG-18 test patterns, however, these test patterns are not tied to
a unified standard.
• The newest set of test patterns was created by the American Association of Physicists in
Medicine Task Group 18 (TG-18). The TG-18 test patterns on the system were adapted for
the 1024 x 768 pixel image area of the 54.6-cm (21.5-in) system monitor. For information
on using these test patterns, read IEC publication 61223-3-6 (62B/588/CD).
• To send a test pattern to a local printer, double-click a test pattern to display it full-
screen, and touch Alt Print.
• To send a test pattern to a DICOM printer or archive server, click a test pattern
number to select it, click Send To, select a device, and click OK.
NOTE
The system test can take several minutes to run.
For Assistance
If you are unable to correct a problem, call your local Philips representative.
15 Specifications
Philips reserves the right to change specifications contained herein or discontinue manufacture
at any time without prior notice. Current specifications are supplied with each system
purchased or are available from your Philips representative.
Dimensions
• Width: 59.2 cm (23.3 in)
• Height (with fully extended monitor): 188.6 cm (74.25 in)
• Height (with monitor folded down): 125.7 cm (49.5 in)
• Depth (Maximum extension): 111.8 cm (44 in)
• Depth (Minimum extension): 79.4 cm (31.25 in)
• Weight: 102 kg (225 lb)
Gray Shades
255 in 2D, M-mode, and Doppler
Scan Lines
Up to 1,024 scan lines, depending on transducer and mode
Monitor
• 54.6 cm (21.5 in) flat-panel monitor on a tilt/swivel arm
• 128 hues of color available
• 24-bit color
Input Signals
• Four transducer receptacles
• Pencil probe receptacle
• Physio pulse, phono, auxiliary 1, and auxiliary 2
• High- and low-level ECG
Output Signals
• External printer
• USB serial data
• Video: S-Video, and Digital DisplayPort
• Physio analog signal
Data Connections
• Ethernet network (Gigabit, 10Base-T, and 100Base-T)
• Wireless network (IEEE 802.11 b/g)
• USB 3.0 devices at USB 2.0 speeds
• Digital Navigation Link (DNL)
Modality Interface
DICOM standard. DICOM conformance statements for Philips products are available at this
website:
www.healthcare.philips.com/us/about/connectivity/dicom_conformance_main.wpd
Physio
• ECG amplitude range between 0.15 mV and 5.0 mV
• Duration of the QRS wave between 40 ms and 120 ms
• Lower Frequency Cut-off: 0.70 Hz ±10%
• Upper Frequency Cut-off: 17 Hz ±10%
• Nominal Input Amplitude: ±5 mV peak
• Minimum QRS Wave Amplitude: 0.05 mV
Peripherals
• Black-and-white image printer
• Foot switch
• Color image printer
• DVD recorder
• Report printer
• External monitor
Electrical Parameters
AC Voltage
• AC voltage 100-240 V~
• 50 or 60 Hz
• 600 VA
Power must be available through a grounded outlet.
In the United States, power must be available through a grounded, hospital-grade outlet.
Languages
Localized user interface (including international symbols on key caps) and Help:
Danish German Spanish
Dutch Italian Swedish
French Norwegian
Pressure Limits
• Operating: 525 mmHg to 795 mmHg (700 hPa to 1,060 hPa)
• Storage: 427 mmHg to 795 mmHg (570 hPa to 1,060 hPa)
Humidity Limits
• Operating: 15% to 80%
• Storage: 15% to 95%
Temperature Limits
• High operating temperature: 40°C (104°F) between 1060 hPa and 795 hPa (795 mmHg to
596 mmHg), linearly decreasing to 35°C (95°F) at 700 hPa (525 mmHg)
• Low operating temperature: 10°C (50°F) from 700 hPa to 1060 hPa (525 mmHg to
795 mmHg)
• Storage temperature range: -20°C to 60°C (-4°F to 140°F)
Compliance
Philips products comply with relevant international and national standards and laws.
Information on compliance will be supplied by your local Philips representative, or the
manufacturer, on request.
16 Index
Numerics Allergic reactions to latex, 49
2D distance measurement, 168 Analysis, 167
3D Analysis applications, 86
acoustic artifacts, 181 Applications
imaging options, 85 analysis, 86
clinical, 86
A
Applications, clinical, 86, 152
Accessories, 21
Artifacts, 179, 181
Accessories, electromagnetic compliance, 73
Assistance, 22, 297
Acoustic artifacts, 179, 181
Audience, intended, 15
Acoustic coupling medium, 184, 255
Audio, troubleshooting, 295
Acoustic output limits, 50
Auto Freeze function, 140
Acoustic output measurement, 60, 63
Auto-Cool, 228, 229, 231
Acoustic output tables, 18, 54, 63
Acquisition status, 129 B
Adjusting Battery indicators, 132
control panel, 121 Battery operating time, 130
monitor, 116 Biological safety, 46
Air filter, cleaning, 291 Biopsy
ALARA principle endocavity, 243
applying, 50 guideline display, 247
education program, 50 maintaining guides, 254
example, 50 procedure, 252
related guidance documents, 60 safety precautions, 46, 245
Alcohol, restricted use on transducers, 264 Biopsy guides, 245
User information X
about, 15 X7-2t transducer
components, 17 controls, 211, 213
conventions, 19 description, 209
User Information CD, 17 manipulating tip, 213
parts, 210
V
rotating image plane, 215
Verifying biopsy guide alignment, 249, 250
xMatrix array transducers, 177, 178, 209, 210
Video monitor, 90
Voltage precautions, 36
Volume control, troubleshooting, 295
W
Warning symbols, 17, 38
Warnings
described, 27
general, 16, 27
Waste Electrical and Electronic Equipment,
European Union Directive, 22
Website, Philips, 22
WEEE recycling information, 22
Wheel brakes, 34, 99
Wheels, 34, 106
Worklist
searching for exams, 157
selecting patient, 156