Руководство к аппарату узи самсунг

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ENGLISH

Document No. CSD-SMESAR7

Revision 03

Copyright SAMSUNG MEDISON Co., LTD.

Safety Requirements

Classifications:

—Type of protection against electrical shock: Class I

—Degree of protection against electrical shock (Patient connection):Type BF equipment

—Degree of protection against harmful ingress of water: Ordinary equipment

—Degree of safety of application in the presence of a flammable anesthetic material with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

—Mode of operation: Continuous operation

Electromechanical safety standards met:

—IEC/EN 60601-1 Medical Electrical Equipment, Part 1General Requirements for Safety.

—IEC/EN 60601-1-1 Safety requirements for medical electrical systems.

—IEC/EN 60601-1-2 Electromagnetic compatibility -Requirements and tests.

—IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

—IEC 61157 Declaration of acoustic output parameters.

—ISO 10993-1 Biological evaluation of medical devices.

—UL 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

—CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

Declarations:

This is CSA symbol for Canada and United States of America

This is manufacturer’s declaration of product compliance

0123 with applicable EEC directive(s) and the European notified body.

This is manufacturer’s declaration of product compliance with applicable EEC directive(s).

This is GMP symbol for Good Manufacturing Practice of

Korea quality system regulation.

Certificate of Excellent Service Quality is to certify that the above company has served customers with excellent services by the Ministry of Knowledge Economy Republic of Korea.

READ THIS FIRST

How to Use Your Manual

This manual addresses the reader who is familiar with ultrasound techniques. Only medical doctors or persons supervised by medical doctors should use this system. Sonography training and clinical procedures are not included here. This manual is not intended to be used as training material for the principles of ultrasound, anatomy, scanning techniques, or applications. You should be familiar with all of these areas before attempting to use this manual or your ultrasound system.

This manual does not include diagnosis results or opinions also, check the measurement reference for each application’s result measurement before the diagnosis.

It is useless to make constant or complex adjustments to the equipment controls. The system has been preset at the factory to produce an optimum image in the majority of patients. User adjustments are not usually required. If the user wishes to change image settings, the variables may be set as desired. Optimal images are obtained with little difficulty.

We are not responsible for errors that occur when the system is run on a user’s PC. Non-Medison product names may be trademarks of their respective owners.

Please keep this user guide close to the product as a reference when using the system.

For safe use of this product, you should read ‘Chapter1. Safety’ and ‘Chapter8. Maintenance’ in this manual, prior to starting to use this system.

DANGER˙ ˙ ˙ ˙ ˙ ˙

Describes precautions necessary to prevent user hazards of great urgency. Ignoring a DANGER warning will risk life-threatening injury.

W˙ A˙ RNIN˙ ˙˙˙ G˙

Used to indicate the presence of a hazard that can cause serious personal injury, or substantial property damage.

CAUTION˙ ˙ ˙ ˙˙ ˙ ˙

Indicates the presence of a hazard that can cause equipment damage.

NOTE˙ ˙ ˙ ˙

A piece of information useful for installing, operating and maintaining a system. Not related to any hazard.

Contents

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Contents

Chapter 1. General Information

1.1Overview

Chapter 1 contains the information necessary to plan the Troubleshooting of SonoAceR7.

The SonoAceR7 is a high-resolution color ultrasound scanner with high penetration and a variety of measurement functions.

Contents

Chapter 1. General Information 1-1

1.2Features and Advantages of SonoAceR7

High-end Digital Beam forming : The SonoAceR7 utilizes the newly developed Digital Beam forming technology.

A variety of applications : The SonoAceR7 is optimized for use in a variety of ultrasound departments, cardiac, vascular, abdomen, Obstetrics, Urology, Gynecology.

Various diagnostic Modes : 2D Mode, M Mode, Color Doppler Mode, Power Doppler Mode, PW Spectral Doppler Mode, etc.

Measurement and Report Functions : Besides the basic distance, area, circumference and volume measurement functions, the SonoAceR7 also provides application-specific measurement functions. The report function collates measurement data.

Review of Scanned Images : The SonoAceR7 displays Cine images of 7084 frames and loop images of 8192 lines.

SonoView TM : This is a total ultrasound image management system, which allows a user to archive, view and exchange documents.

Digital Imaging and Communication in Medicine (DICOM) Function : This is used to archive, transmit and print DICOM images through a network.

Peripheral/Accessory Connection : A variety of peripheral devices including VCRs and printers can be easily connected to the SonoAceR7.

Chapter 1. General Information 1-2

1.3Product Configuration

This Product consists of the monitor, the control panel, the console and, the probes.

1.3.1Console

The console consists of two parts – the inner unit and the outer unit.

The interior of the console mainly contains devices that produce ultrasound images.

The outside of the console consists of various connection ports, probe holder, storage space, wheel and handles.

LCD Monitor

Handle

Probe holder

Wheel

[Figure 1-1] Console of SonoAce R7

Chapter 1. General Information 1-3

Probe Connector

[Figure 1-2] Front and Back of SonoAce R7

Type of Probe port

Mini DLP type of probe is used for SonoAce R7 v2.00.00. In lower version of product, the shape of the probe port can be different.

256 Pin is necessary for 3D probe.

Chapter 1. General Information 1-4

1.3.2LCD Monitor

The monitor of this system is a color VGA monitor, which displays ultrasound images and additional information. Monitor arm can control to be tilted to the optimal viewing angle.

[Figure 1-3] LCD Monitor

Chapter 1. General Information 1-5

1.3.3Control Panel

The control panel can be used for controlling the system.

Alpha-Numeric

Button

Dial Button

Track Ball

Slide Volume

[Figure 1-4] Control Panel

1.3.4Probe

Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation.

NOT˙ ˙ ˙E˙

For more information, refer to ‘Chapter 9. Probes’.

Chapter 1. General Information 1-6

1.4 Specifications

Chapter 1. General Information 1-8

Chapter 2. Safety

2.1Overview

Chapter2. contains the information necessary to Safety.

Please read this chapter before using the SAMSUNG MEDISON ultrasound system. It is relevant to the ultrasound system, the probes, the recording devices, and any of the optional equipment.

SonoAce R7 is intended for use by or by the order of, and under the supervision of a licensed physician who is directly qualified to use the medical device.

Contents

Chapter 2. Safety 2-1

2.2Safety – Related Information

2.2.1Safety Symbols

The International Electro Technical Commission (IEC) has established a set of

symbols for medical electronic equipment, which classifies a connection or warn of potential hazards. The classifications and symbols are shown below.

USB port

Power switch (Supplies/cuts the power for product)

Power switch (Supplies/cuts power to the product)

Identifies an equipotential ground.

Data Output port

Data Input port

Data Input/Output port

Foot switch connector

ECG connector

Chapter 2. Safety 2-3

2.2.2LABEL

To protect the system, you may see ‘Warning’ or ‘Caution’ marked on the surface of the product

[ Figure 2-1. Marked on the back sides of the product]

[ Figure 2-2. Marked below OUTLET ]

[ Figure 2-3. Prohibition of seating on Control panel ]

Chapter 2. Safety 2-4

2.3Electrical Safety

This equipment has been verified as a Class I device with Type BF applied parts.

2.3.1Prevention of Electric Shock

In a hospital, dangerous currents are due to the potential differences between connected equipment and touchable conducting parts found in medical rooms. The solution to the problem is consistent equip potential bonding. Medical equipment is connected with connecting leads made up of angled sockets to the equip potential bonding network in medical rooms.

[Figure 2-4] Equip potential bonding

Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the

WARNING˙ ˙ ˙ ˙ ˙ ˙ ˙

 Electric shock may exist result if this system, including and all of its externally mounted recording and monitoring devices, is not properly grounded.

Do not remove the 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 MEDISON Customer Service Department.

Check the face, housing, and cable before use. Do not use, if the face is cracked, chipped, or torn, the housing is damaged, or if the cable is abraded.

Always disconnect the system from the wall outlet prior to cleaning the system.

All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to application of a high voltage defibrillation pulse.

The use of flammable anesthetic gas or oxidizing gases (N20) should be avoided.

CAUTION˙ ˙ ˙ ˙˙ ˙ ˙

The system has been designed for 100-120VAC and 200-240VAC; you should select the input Outlet voltage of monitor, printer and VCR. Prior to connecting an OEM power cord, verify that the voltage indicated on the power cord matches the voltage rating of the OEM device.

An isolation transformer protects the system from power surges. The isolation transformer continues to operate when the system is in standby.

Do not immerse the cable in liquids. Cables are not waterproof.

The operator does not contact the parts (SIP/SOP) and the patient simultaneously.

Chapter 2. Safety 2-5

2.3.2ECG-Related Information

WARNING˙ ˙ ˙ ˙ ˙ ˙ ˙

This device is not intended to provide a primary ECG monitoring function, and therefore does not have means of indicating an inoperative electrocardiograph.

Do not use ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in burns to the patient

Do not use ECG electrodes during cardiac pacemaker procedures or other electrical stimulators.

Do not use ECG leads and electrodes in an operating room.

2.3.3ESD

Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. During low humidity conditions, electrical charges naturally build up on individuals, creating static electricity. An ESD occurs when an individual with an electrical energy build-up comes in contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals.

CAUTION˙ ˙ ˙ ˙˙ ˙ ˙

The level of electrical energy discharged from a system user or patient to an ultrasound system can be significant enough to cause damage to the system or probes.

Always perform the pre-ESD preventive procedures before using connectors marked with the ESD warning label.

—Apply anti-static spray on carpets or linoleum.

—Use anti-static mats.

—Ground the product to the patient table or bed.

It is highly recommended that the user be given training on ESD-related warning symbols and preventive procedures.

2.3.4EMI

Although this system has been manufactured in compliance with existing EMI

(Electromagnetic Interference) requirements, use of this system in the presence of an electromagnetic field can cause momentary degradation of the ultrasound image.

If this occurs often, SAMSUNGMEDISON suggests a review of 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 radios, TVs, or microwave transmission equipment nearby can also cause interference.

CAUTION˙ ˙ ˙ ˙˙ ˙ ˙

In cases where EMI is causing disturbances, it may be necessary to relocate this system.

Chapter 2. Safety 2-6

2.3.5EMC

The testing for EMC(Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC60601-1-2). This IEC standard was adopted in Europe as the European norm (EN60601-1-2).

2.3.5.1Guidance and manufacturer’s declaration — electromagnetic emission

This product is intended for use in the electromagnetic environment specified below.

The customer or the user of this product should assure that it is used in such an environment.

2.3.5.2Approved Cables, Transducers and Accessories for EMC

1)Approved Cable for Electromagnetic Compliance

Cables connected to this product may affect its emissions;

Use only the cable types and lengths listed below table.

2) Approved Transducer for Electromagnetic Compliance

The probe listed in ‘Chapter 9. Probes’ when used with this product, have been tested to comply with the group1 class B emission as required by International Standard CISPR 11.

Chapter 2. Safety 2-7

3) Approved Accessories for Electromagnetic Compliance Accessories used with this product may effect its emissions

CAUTION˙ ˙ ˙ ˙˙ ˙ ˙

When connecting other customer-supplied accessories to the system, such as a remote printer or VCR, 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

WARNING˙ ˙ ˙ ˙ ˙ ˙ ˙

The use of cables, transducers, and accessories other than those specified may result increased emission or decreased Immunity of the Ultrasound System.

Chapter 2. Safety 2-8

NOTE Uт is the a.c. mains voltage prior to application of the test level.

Interference may occur in the vicinity of equipment marked with the following symbol :

NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Ultrasound System is used exceeds the applicable RF compliance level above, the Ultrasound System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation.

b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.

Chapter 2. Safety 2-9

2.3.5.3Recommended separation distances between portable and mobile RF communications equipment and the SonoAce R7

This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, 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 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

2.3.5.4Electromagnetic environment – guidance

The Ultrasound System must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location. Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m.

It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification.

CAUTION˙ ˙ ˙ ˙˙ ˙ ˙

If the system is connected to other customer-supplied equipment, such as a local

area network (LAN) or a remote printer, SAMSUNGMedison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena.

Chapter 2. Safety 2-10

2.3.5.5Avoiding Electromagnetic Interference

Typical interference on Ultrasound Imaging Systems varies depending on Electromagnetic phenomena. Please refer to following table.

ESD caused by discharging of electric charge build-up on insulated surfaces or persons.

RF energy from RF transmitting equipment such as portable phones, hand-held radios, wireless devices, commercial radio and TV, and so on.

Conducted interference on power lines or connected cables caused by other equipment, such as switching power supplies, electrical controls, and natural phenomena such as lightning.

A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference.

SamSungMedison Ultrasound System does not generate interference in excess of the referenced standards.

An Ultrasound System is designed to receive signals at radio frequency and is therefore susceptible to interference generated by RF energy sources. Examples of other source of interference are medical device, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Customers should consider the following in an attempt to locate the source:

Is the interference intermittent or constant?

Does the interference show up only with one transducers operating at the same frequency or with several transducer?

Do two different transducer operating at the same frequency have the same problem?

Is the interference present if the system is moved to a different location in the facility?

The answers to these questions will help determine if the problem reside with the system or the scanning environment. After you answer the question, contact your local SAMSUNG MEDISON Technical Support Group.

Chapter 2. Safety 2-11

2.4Mechanical Safety

2.4.1Moving the Equipment

WARNING˙ ˙ ˙ ˙ ˙ ˙ ˙

Always turn the power off and disconnect the cables before moving the product.

Before transporting the product, check that the brakes on the front wheels are

Always use the handles at the back of the console and move the product slowly.

This product is designed to resist shocks. However, excessive shock, for example if the product falls over, may cause serious damage.

If the system operates abnormally after repositioning, please contact with the SAMSUNG MEDISON Technical Support Group.

2.4.1.1The Brakes

Brakes are mounted to the front wheels of the console only. To lock the brakes, press the top part of the brake with your foot. To unlock them, press the part labeled Off at the bottom of the brake with your foot.

You can use the brakes to control the movement of the product. We recommend that you lock the brakes when using the product.

2.4.1.2Precautions on Ramps

Always make sure that control panel is facing the direction of movement

WARNING˙ ˙ ˙ ˙ ˙ ˙ ˙

Be aware of the castors, especially when moving the system. SAMSUNGMEDISON recommends that you exercise caution when moving the product up or down ramps

When moving the product down a ramp or resting it temporarily on a ramp, the product may tilt over even with the brakes on depending on the direction of the product. Do not rest the product on ramps.

Chapter 2. Safety 2-12

2.4.2Safety Note

CAUTIO˙ ˙ ˙ ˙˙ ˙ N˙

Do not press the control panel excessively.

Never attempt to modify the product in any way.

Check the operational safety when using the product after a prolonged break in service.

Make sure that other objects, such as metal pieces, do not enter the system.

Do not block the ventilation slots.

To prevent damage to the power cord, be sure to grip the plug head – not the cord – when unplugging.

Excessive bending or twisting of cables on patient-applied parts may cause failure or intermittent operation of the system.

Incorrect cleaning or sterilization of a patient-applied part may cause permanent damage.

Please refer to “Chapter 8. Maintenance” for detailed information on protecting, cleaning and disinfecting the equipment.

2.4.2.1Safety Note for Monitor

When adjusting the height or position of the monitor, be careful of the space in the middle of the monitor arm. Having your fingers or other body parts caught in it may result in injury.

[Figure 2-5] Safety Note for Monitor

Chapter 2. Safety 2-13

2.5Biological Safety

Verify the alignment of the Probe before use. See the “Chapter 9. Probes” section of this manual.

CAUTION˙ ˙ ˙ ˙˙ ˙ ˙

Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If there is no medical benefit, minimize the exposure time

and maintain the ultrasound wave output level at low. Please refer to the ALARA principle.

Do not use the system if an error message appears on the video display indicating that a hazardous condition exists. Note the error code, turn off the power to the system, and call your local MEDISON Customer Service Department.

Do not use a system that exhibits erratic or inconsistent updating. Discontinuities in the scanning sequence are indicative of a hardware failure that should be corrected before use. The system limits the maximum contact temperature to 43 degree Celsius, and the ultrasonic waves output observes American FDA regulations.

2.5.1ALARA Principle

Guidance for the use of diagnostic ultrasound is defined by the “as low as reasonably achievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct response for every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bio effects. Since the threshold for diagnostic ultrasound bio effects is undetermined, it is the sonographer’s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, the ultrasound system provides controls that can be manipulated during the exam to optimize the results of the exam.

The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound not only in the technology but also in the applications of the technology, have resulted in the need for more and better information to guide the user. The output 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 mass, 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 the user controls it. The ability to limit the index values over time support the ALARA principle

Chapter 2. Safety 2-14

2.5.1.1Applying ALARA

Guidance for the use of diagnostic ultrasound is defined by the “as low as reasonably achievable” (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct response for every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bio effects. Since the threshold for diagnostic ultrasound bio effects is undetermined, it is the sonographer’s responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, the ultrasound system provides controls that can be manipulated during the exam to optimize the results of the exam.

The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound not only in the technology but also in the applications of the technology, have resulted in the need for more and better information to guide the user. The output 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 mass, 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 the user controls it. The ability to limit the index values over time support the ALARA principle..

2.5.1.2Direct Controls

Application selection and the output intensity 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 required during any exam. For example, peripheral vascular intensity levels are not recommended for fetal exams. Some systems automatically select the proper range for a particular procedure, while others require manual selection. Ultimately, the user bears the responsibility for proper clinical use. The SAMSUNG MEDISON system provides both automatic and user-definable settings.

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

2.5.1.3Indirect 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 probe selection.

The choice of imaging mode determines the nature of the ultrasound beam. 2Dmode is a scanning mode, Doppler is a stationary or unscanned mode. A

Chapter 2. Safety 2-15

stationary ultrasound beam concentrates energy on a single location. A moving or scanned ultrasound beam disperses the energy over a wide area and the beam is only concentrated on a given area for a fraction of the time necessary in 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 given period of time. Several controls affect pulse repetition frequency: focal depth, display depth, sample volume depth, color sensitivity, 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 to 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 cavitations. Pulse length or burst length or pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample volume increases the pulse length.

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

2.5.1.4Receiver 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 increasing output. For example; before increasing output, optimize gain to improve image quality.

2.5.1.5Additional 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 will require a follow-up, which ultimately increases the time. Diagnostic ultrasound is an important tool in medicine, and, like any tool, should be used efficiently and effectively.

2.5.1.6Output Display Features

The system output display comprises two basic indices: a mechanical index and a thermal index.

Chapter 2. Safety 2-16

The thermal index consists of the following indices: soft tissue (TIs) and bone (TIb). One of these three thermal indices will be displayed at all times. Which one depends upon the system preset or user choice, depending upon the application at hand.

The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1.

The thermal index consists of the three indices, and only one of these is displayed at any one time.

Each probe application has a default selection that is appropriate for that combination. The TIb or TIs is continuously displayed over the range of 0.0 to maximum output, based on the probe and application, in increments of 0.1.

The application-specific nature of the default setting is also an important factor of index behavior.

A default setting is a system control state which is preset by the manufacturer or the operator.

The system has default index settings for the probe application. The default settings are invoked automatically by the ultrasound system when power is turned on, new patient data is entered into the system database, or a change in application takes place.

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; and TIb for a focus at or near bone.

Some factors might create artificially high or low thermal index readings e.g. presence of fluid or bone, or the flow of blood. A highly attenuating tissue path, for example, will cause the potential for local zone heating to be 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.

1) Mechanical Index (MI) Display

Mechanical bio effects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The potential for mechanical bio effects varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bio effects occurring but there is no specific MI value that means that a mechanical effect will actually occur.

The MI should be used as a guide for implementing the ALARA principle.

Chapter 2. Safety 2-17

2) Thermal Index (TI) Display

The TI informs the user about the potential for temperature increase occuring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, and mode of operation etc. The TI should be used as a guide for implementing the ALARA principle.

The bone thermal index (TIb) informs the user about potential heating at or

near the focus after the ultrasound beam has passed through soft tissue or fluid, for example, at or near second or third trimester fetal bone.

The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near the surface, for example, cranial bone.

The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue.

You can select either TIs or TIb using the TIs/TIb selection on the Miscellaneous system setups.

TIc is displayed when you select a trans-cranial application.

3) Mechanical and Thermal indices Display Precision and Accuracy

The Mechanical and Thermal Indices on the system are precise to 0.1 units.

The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables manual. These accuracy estimates are based on the variability range of probes and systems, inherent acoustic output modeling errors and measurement variability, as described below.

The displayed values should be interpreted as relative information to help the system operator achieve the ALARA principle through prudent use of the system. The values should not be interpreted as actual physical values investigated tissue or organs. The initial data that is used to support the output display is derived from laboratory measurements based on the AIUM measurement standard. The measurements are then put into algorithms for calculating the displayed output values.

Many of the assumptions used in the process of measurement and calculation are conservative in nature. Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into the measurement and calculation process. For example:

The measured water tank values are de-rated using a conservative, industry standard, attenuation coefficient of 0.3dB/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 probe 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 display values: hardware variations, algorithm accuracy estimation and measurement variability. Variability among probes and systems is a significant factor. Probe

Chapter 2. Safety 2-18

variability results from piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens focusing parameter variations.

Differences in the system pulse voltage control and efficiencies are also a contributor to variability.

There are inherent uncertainties in the algorithms used for estimating acoustic output values over the range of possible system operating conditions and pulse voltages. Inaccuracies in laboratory measurements are related to 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 0.3dB/cm-MHz attenuated medium are not taken into account in calculation of the accuracy estimate displayed. Neither linear propagation, nor uniform attenuation at the 0.3dB/ 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 particularly in water tank measurements, non-linear propagation and saturation losses occur as pulse voltages increase.

The display accuracy estimates take into account the variability ranges of probes 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. They are also independent of the effects of non-linear loss on the measured values.

2.5.1.7Control Affecting the indices

As various system controls are adjusted, the TI and MI values may change. This will be most apparent as the POWER control is adjusted; however, other system controls will affect the onscreen output values.

1) POWER

Power controls the system acoustic output. Two real-time output values are on the screen: a TI and a MI. They change as the system responds to POWER adjustments.

In combined modes, such as simultaneous Color, 2D-mode and pulsed 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 peak pressure.

2.5.1.82D mode Controls

1) 2D mode size

Narrowing the sector angle may increase the frame rate. This action will increase the TI. Pulse voltage may be automatically adjusted down with software controls to keep the TI below the system maximums. A decrease in pulse voltage will decrease MI.

Chapter 2. Safety 2-19

2) ZOOM

Increasing the zoom magnification 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 MI since the peak intensity can occur at a different depth.

3) Persistence

A lower persistence will decrease the TI. Pulse voltage may be automatically increased. An increase in pulse voltage will increase MI.

4) Focal no.

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 peak intensity.

5) FOCUS

Changing the focal depth will change the MI. Generally, higher MI values will occur when the focal depth is near the natural focus of the transducer.

2.5.1.9Color and Power Controls 1) Color Sensitivity

Increasing the color sensitivity may increase the TI. More time is spent scanning for color images. Color pulses are the dominant pulse type in this mode.

2) Color Sector Width

Narrower color sector width will increase color frame rate and the TI will increase. The system may automatically decrease pulse voltage to stay below the system maximum. A decrease in pulse voltage will decrease the MI. If pulsed Doppler is also enabled then pulsed Doppler will remain the dominant mode and the TI change will be small.

3) 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 peak intensity of the dominant pulse type, which is a color pulse. However, if pulsed Doppler is also enabled then pulsed Doppler will remain the dominant mode and the TI change will be small.

4) SCALE

Using the SCALE control to increase the color velocity range may increase the TI. The system will automatically adjust pulse voltage to stay below the system maximums. A decrease in pulse voltage will also decrease MI

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5) SEC WIDTH

A narrower 2D-mode sector width in Color imaging will increase color frame rate. The TI will increase. MI will not change. If pulsed Doppler is also enabled, then pulsed Doppler will remain as the primary mode and the TI change will be small.

2.5.1.10 M mode and Doppler Controls 1) Speed

M-mode and Doppler sweep speed adjustments will not affect the MI. When M- mode sweep speed changes, TI changes

2) Simultaneous and Update Methods

Use of combination modes affects both the TI and MI through the combination of pulse types. During simultaneous mode, the TI is additive. During autoupdate and duplex, the TI will display the dominant pulse type. The displayed MI will be from the mode with the largest peak pressure.

3) Sample Volume Depth

When Doppler sample volume depth is increased the Doppler PRF may automatically decrease. A decrease in PRF will decrease the TI. The system may also automatically decrease the pulse voltage to remain below the system maximum. A decrease in pulse voltage will decrease MI.

2.5.1.11 Doppler, CW, M-mode, and Color Imaging Controls

When a new imaging mode is selected, both the TI and the MI will change to default settings. Each mode has a corresponding pulse repetition frequency and maximum intensity point. In combined or simultaneous modes, the TI is the sum of the contribution from the modes enabled and MI is the MI for the focal zone and mode with the largest derated intensity. If a mode is turned off and then reselected, the system will return to the previously selected settings.

1) Probe

Each probe model available has unique specifications for contact area, beam shape, and center frequency. Defaults are initialized when you select a probe. SAMSUNG MEDISON factory defaults vary with probe, application, and selected mode. Defaults have been chosen below the FDA limits for intended use.

2) DEPTH

An increase in 2D-mode depth will automatically decrease the 2D-mode frame rate. This would decrease the TI. The system may also automatically choose a deeper 2D-mode focal depth. A change of focal depth may change the MI. The MI displayed is that of the zone with the largest peak intensity.

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3) Application

Acoustic output defaults are set when you select an application. MEDISON factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended use.

2.5.1.12Related Guidance Documents

For more information about ultrasonic bio effects and related topics refer to the following;

AIUM Report, January 28, 1993, “Bio effects and Safety of Diagnostic Ultrasound”

Bio effects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1998: Vol. 7, No. 9 Supplement

Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM, NEMA. 1998)

Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998)

Second Edition of the AIUM Output Display Standard Brochure, Dated March 10, 1994. (A copy of this document is shipped with each system.)

Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. FDA. September 1997. FDA.

Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998)

WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound, Ultrasound in Medicine and Biology, 1998: Vol. 24, Supplement1.

2.5.1.13Acoustic Output and Measurement

Since the first usage of diagnostic ultrasound, the possible human biological effects (bio effects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine(AIUM) Bio effects Committee (Bio effects

Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement) sometimes referred to as the Stowe Report, which reviewed available data on possible effects of ultrasound exposure. Another report“Bio effects and Safety of Diagnostic Ultrasound,” dated January 28, 1993 provides more up to date information.

The acoustic output for this system has been measured and calculated in accordance with the December 1985 “510(K) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices,” except that the hydrophone meets the requirements of “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992)

Chapter 2. Safety 2-22

2.5.1.14In Situ, Derated, and Water Value Intensities

All intensity parameters are measured in water. Since water does not absorb acoustic energy, these water measurements represent a worst case value. Biological tissue does absorb acoustic energy. The true value of the intensity at any point depends on the amount and type of tissue and the frequency of the ultrasound that passes through the tissue. The intensity value in the tissue, In

Situ, has been estimated using the following formula: In Situ = Water [ e(0.23alf ) ]

where: In Situ = In Situ Intensity Value Water = Water Value Intensity

e = 2.7183

a = Attenuation Factor

l = skin line to measurement depth (cm)

f = Center frequency of the transducer/system/mode combination (MHz)

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 purpose; 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.

The maximum derated and the maximum water values do not always occur at the same operating condition; therefore, the reported maximum water and derated values may not be related to the In Situ (derated) formula. Take for example a multi-zone array transducer that has maximum water value intensities in its deepest zone: the same transducer may have its largest derated intensity in one if its shallowest focal zones.

2.5.1.15Acoustic Output and Measurement

The terms and symbols used in the acoustic output tables are defined in the following paragraphs.

ISPTA.3 The derated spatial-peak temporal-average intensity (milliwatts per square centimeter).

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ISPPA.3 The derated spatial-peak pulse-average intensity (watts per square centimeter). The value of IPA.3 at the position of global maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the global maximum MI is reported.

2.5.1.16Acoustic Measurement Precision and Uncertainty

The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below.

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1) Systematic Uncertainties

For the pulse intensity integral, derated rarefaction pressure Pr.3, center frequency and pulse duration, the analysis includes considerations of the effects on accuracy of:

Hydrophone calibration drift or errors. Hydrophone / Amp frequency response. Spatial averaging.

Alignment errors.

Voltage measurement accuracy, including. Oscilloscope vertical accuracy. Oscilloscope offset accuracy. Oscilloscope clock accuracy. Oscilloscope Digitization rates.

Noise.

The systematic uncertainties Acoustic power measurements using a Radiation Force are measured through the use of calibrated NIST acoustic power sources.

We also refer to a September 1993 analysis done by a working group of the IEC technical committee 87 and prepared by K. Beissner, as a first supplement to IEC publication 1161.

The document includes analysis and discussion of the sources of error / measurement effects due to:

Balance system calibration.

Absorbing (or reflecting) target suspension mechanisms. Linearity of the balance system.

Extrapolation to the moment of switching the ultrasonic transducer (compensation for ringing and thermal drift).

Target imperfections.

Absorbing (reflecting ) target geometry and finite target size. Target misalignment.

Ultrasonic transducer misalignment. Water temperature.

Ultrasonic attenuation and acoustic streaming. Coupling or shielding foil properties. Plane-wave assumption.

Environmental influences. Excitation voltage measurement. Ultrasonic transducer temperature.

Effects due to nonlinear propagation and saturation loss.

The overall findings of the analysis give a rough Acoustic Power accuracy figure of +/- 10% for the frequency range of 1 — 10 MHz.

Chapter 2. Safety 2-25

2.6Environmental Protection

CAUT˙ ˙ ˙ ˙˙ION˙ ˙

The console and peripherals could be sent back to manufacturers for recycling or proper disposal after their useful lives.

Disposal of waste shall be disposed in accordance with national laws.

The waste sheaths are to be disposed of safely and national regulations must be observed.

Chapter 2. Safety 2-26

Chapter3. Installing the Product

3.1Overview

Chapter 3 contains the information necessary to plan the installation of SonoAce R7 and install it. This chapter describes the requirements for the transportation and installation environment for the product, so that the product is installed in the best condition.Also included are product installation and set up procedures and electrical security check procedures. In addition, procedures for connecting probes and external equipment are included.

Contents

Chapter 3. Installing the Product 3-1

Chapter 3. Installing the Product 3-2

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• Zeiss CIRRUS

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