Sonoace x6 инструкция на русском языке

В настоящий момент товары недоступны для заказа на samsung.com/ru

В настоящий момент товары недоступны для заказа на samsung.com/ru

Выберите свое местоположение и язык.

SonoAce X6 — многофункциональный ультразвуковой сканер компании Samsung Medison с оптимальным набором функций и всеми видами чувствительного допплера. Аппарат позволяет проводить обследование большого потока пациентов — рекомендуется для применения в медицинских центрах, женских консультациях, больницах и поликлиниках.

Области применения: акушерство и гинекология, абдоминальные исследования и маммология, урология и эхокардиография, поверхностно расположенные органы и исследования сосудов, мускуло-скелетные исследования, а также педиатрия.

Базовая комплектация: сканер SonoAce X6 (монитор 15″; допплеры: цветной, энергетический, импульсный (в том числе HPRF), 2-я гармоника, SonoView-II Pro (архивация изображения и кинопетли); кинопамять; встроенный дисковод DVD-RW; 4 USB-порта, встроенная клавиатура с трекболом, флакон геля 250 мл и руководство оператора).

Опции для сканера SonoAce X6: кардиопакет: тканевый допплер (TDI) + цветной М-режим (CM) + программное обеспечение; непрерывноволновой допплер (CW); ЭКГ модуль; устройства хранения информации (USB флеш-карта, USB флеш-диск); система DICOM.

Конвексные датчики

Биплановые датчики

Фазированные датчики

Линейные датчики

Допплеровские датчики

SONOACE X6 Service Manual

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 Eqiupment, Part 1General Requirements for Safety.

—IEC/EN 60601-1-1 Safety requirements for medicalelectrical 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 2601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

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

««`Contents

Contents

Contents

Contents

Contents

Contents

Contents

Contents

Contents

Contents

Contents

Content

Contents

1General Information

1.1Overview

Chapter1containstheinformationnecessarytoplantheTroubleshootingofSONOACEX6

TheSONOACE X6 isahigh-resolutioncolor ultrasoundsystemwith high penetration andavarietyofmeasurement functions

Contents General Information

Chapter 1. General Information 1-1

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

Theconsoleconsistsoftwoparts–the inner unitandtheouterunit.

Theinterioroftheconsolemainlycontainsdevicesthat produceultrasoundimages. Ontheexterioroftheconsole iscomposed ofvariousconnectors, probeholders, storagecompartments,handles,wheels,etc.

LCD Monitor

LCD Arm

Control Panel

DVD-RW Drive

Probe Connector

Pencil probe Connector

Wheel

[Figure 1-1] Console of SONOACE X6

Chapter 1. General Information 1-3

[Figure 1-2] Rear and side of SONOACE X6

Chapter 1. General Information 1-4

1.3.2LCDMonitor

The LCD monitor of this system is a color VGA monitor, which displays ultrasound images and additional information. Use the monitor arm to adjust the height or position of the monitor.

[Figure 1-3] LCD Arm

Chapter 1. General Information 1-5

Chapter 1. General Information 1-6

1.3.4Probe

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

NOTE For more information, refer to `Chapter 9 Probes’.

Chapter 1. General Information 1-7

Chapter 1. General Information 1-8

Chapter 1. General Information 1-10

2Safety

2.1Overview

Chapter 2 contains the information necessary to Safety.

Chapter 2. Safety 2-1

Chapter 2. Safety 2-2

Chapter 2. Safety 2-3

Chapter 2. Safety 2-4

2) Rear

[ Figure 2-2] Labels of Rear

Chapter 2. Safety 2-5

Chapter 2. Safety 2-6

Chapter 2. Safety 2-8

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

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.

Chapter 2. Safety 2-9

Chapter 2. Safety 2-10

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

Chapter 2. Safety 2-11

Chapter 2. Safety 2-12

2.3.5.3Recommended separation distances between portable and mobile RF communications equipment and the SONOACE X6

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.

Chapter 2. Safety 2-13

Chapter 2. Safety 2-14

2.4Mechanical Safety

2.4.1Moving the Equipment

Before transporting the product, check that the brakes on the front wheels are unlocked. Also, make sure to retract the monitor arm completely so that it is secured in a stationary position.

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 the MEDISON Customer Service Department.

WARNING The product weighs more than 60kg. Be extra careful when transporting it. Careless transportation of the product may result in product damage or personal injury

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.

[Figure 2-5] Precautions on Ramps

Chapter 2. Safety 2-15

Chapter 2. Safety 2-16

2.5Biological Safety

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

yDo 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.

yDo 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.

yThe 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 bioeffects.

Since the threshold for diagnostic ultrasound bioeffects 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 2-17

Chapter 2. Safety 2-18

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 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 timeaverage 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.

2.5.1.5AdditionalConsiderations

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.

Chapter 2. Safety 2-19

Chapter 2. Safety 2-20

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 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, occurs in water tank measurements or in most tissue paths in the body. In the body,

Chapter 2. Safety 2-21

Chapter 2. Safety 2-22

2.5.1.9 Color 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.

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.

Chapter 2. Safety 2-23

Chapter 2. Safety 2-24

2.5.1.13Acoustic Output andMeasurement

Since the first usage of diagnostic ultrasound, the possible human biological effects (bioeffects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine(AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffects 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 “Bioeffects 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)

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 ) ]

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

Chapter 2. Safety 2-25

Chapter 2. Safety 2-26

2.5.1.16Acoustic Measurement Precision and Uncertainty

The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below

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 measurementaccuracy, including.

yOscilloscope vertical accuracy.

yOscilloscope offset accuracy.

yOscilloscope clock accuracy.

yOscilloscope Digitization rates.

yNoise.

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:

yBalance system calibration.

yAbsorbing (or reflecting) target suspension mechanisms.

yLinearity of the balance system.

yExtrapolation to the moment of switching the ultrasonic transducer (compensation for

Chapter 2. Safety 2-27

Chapter 2. Safety 2-28

2.6Environmental Protection

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

yDisposal of waste shall be disposed in accordance with national laws.

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

Waste Electrical and Electronic Equipment

NOTE This symbol is applied in the European Union and other European countries

This symbol on the product indicates that this product shall not be treated as household waste. Instead it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment. By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this product. The recycling of materials will help to conserve natural resources. For more detailed information about recycling of this product, please contact your local city office, your electrical and electronic waste disposal service or the shop where you purchased the product.

Chapter 2. Safety 2-29

Loading…