[ Micro Ultrasound System User Guide PDF from 2023 ]
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MICRUS EXT-1H
USER GUIDE
| Manufactured by TELEMED UAB Highway Business Centre Savanoriu pr. 178A Vilnius, LT-03154, Lithuania phones: (+370-5) 2106272 (+370-5) 2106273 fax: (+370-5) 2306733 Internet: http://www.pcultrasound.com/ E-Mail: info@telemed.lt |
Distributed by Articulate Instruments Ltd Queen Margaret Campus Queen Margaret University Drive Musselburgh. EH21 6UU United Kingdom Phone: +44 131 474 0000 Internet: www.articulateinstruments.com E-mail: awrench@articulateinstruments.com |
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NOTE: Non-TELEMED product names may be trademarks or registered trademarks of their respective owners.
1 INTRODUCTION 4
1.1 About the system / Intended use 4
1.2 Delivery set 5
1.3 About the System Software 5
1.4 Technical Specification 5
2 SAFETY 8
2.1 Electrical safety 8
2.2 Equipment protection 9
2.3 Biological safety 9
2.4 Ultrasound waves/exposure 10
2.5 Cybersecurity 11
2.6 Accuracy Measures 11
3 LABELING 13
4 SYSTEM OVERVIEW 15
4.1 Principle of operation 15
4.2 Components 15
4.2.1 Beamformer 15
4.2.2 Probe Unit 16
4.2.3 Personal Computer 16
4.3 Connection and Indication 17
4.4 Peripherals/Compatibility 17
5 INSTALLATION WARNINGS 17
6 SYSTEM SETUP 19
6.1 System Requirements and Windows configuring 19
6.1.1 Hardware 19
6.1.2 Software 19
6.1.3 Windows configuring 19
6.2 Ultrasound Hardware installation / connection 19
6.3 Software installation for Windows 20
6.3.1 TELEMED Drivers Package installation 20
6.3.2 ECHO WAVE II software installation 22
6.3.3 Ultrasound Scanner Monitor utility 27
7 TROUBLESHOOTING 27
7.1 Contact with technical support service 27
8 WARRANTY AND SERVICE INFORMATION 28
8.1 Warranty 28
8.2 Warranty Shipments, Returns and Adjustments 29
8.3 Service Contract 29
9 MAINTENANCE 29
9.1 General cleaning 29
9.2 Inspecting the System 29
9.3 Probe maintenance and disinfection 29
9.3.1 ChemicaMicrUs that Damage Transducers: 30
9.3.2 Recommended Procedures for Probe Processing 30
9.3.3 General Cleansing for Transducers Used in Non-Invasive Procedures 30
9.3.4 Cleansing and Disinfection of Transducers Used in Endocavity Procedures 31
9.4 System accuracy and performance verification 31
10 TRANSPORTATION, STORAGE AND UTILIZATION 31
10.1 Transportation and storage 31
10.2 Utilization 32
11 DECLARATION OF CONFORMITY 33
12 APPENDICES 34
12.1 Guidelines for the safe use of diagnostic ultrasound 34
A. Recommendations 34
12.1.1.1 General 34
12.1.1.2 Thermal Effects 34
12.1.1.3 Mechanical Effects 34
12.1.1.4 Quality Assurance 35
B. Conclusions 35
12.1.1.5 General 35
12.1.1.6 Thermal Effects 35
12.1.1.7 Mechanical Effects 36
12.1.1.8 Biological Effects 36
C. References 37
D. Glossary of Terms 39
12.2 Vigilance system 40
12.3 Returned product form 42
12.4 Acoustic Output Tables 43
13 REVISION HISTORY 63
Dear customer,
Our ultrasound scanner is intended for multipurpose ultrasound visual feedback and analysis, based on electronic convex array scanning. It is an ideal budget solution for universities, hospitals, and public / private clinics.
Our new class of PC-based compact ultrasound scanners now is featuring:
- Scan-converter free architecture beamformer;
- Connectivity via fast USB 2.0 / 3.0 interface to any PC (Desktop /Notebook /Tablet PC);
- powered from medical grade external power supply or USB;
- Digitally controlled acoustic power;
- Light weight, true mobility, flexible architecture.
In this User Guide you will find general information about ultrasound scanners, how to assemble the system components and install the Echo Wave II software, safety and maintenance information. The Operation Manual contains Echo Wave II software description.
The system distributed by Articulate Instruments is intended for visual feedback of tongue movement (adult and paediatric) and for analysis and research into tongue movement.
In general MicrUs scanners may be used for applications in cardiac (adult and pediatric), fetal, abdominal, pediatric, small organ, transvaginal, peripheral vessel and musculo-skeletal. The MicrUs is a highly portable PC controlled ultrasound systems used to acquire and display real time high resolution ultrasound data in B-mode, M-mode, B+B-mode, 4B-mode, B+M-mode, Compound, Trapezoid or in a combinations of these modes.
The systems have measurement capabilities for anatomical structures and fetal biometry that can provide clinical diagnostic information. It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
System offers to get a real-time and “frozen” echo images in all scanning modes. Unlike ordinary ultrasound devices this scanner is based on modern digital technologies. PC and USB application enables many powerful innovative features such as:
- user friendly, easy-to-use intuitive graphic user interface;
- echo images storage on hard disk or any other storage device
- storage a sequence of full size echo images (cineloop) with possibility to save it in video file format;
- telecommunication possibilities;
- using a variety of peripheral devices.
| Common view of MicrUs |
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| Beamformer | |
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| Operation Manual | |
| User Guide | |
| Software and manuals (USB key) | |
| USB mini cable | |
| Power supply (medical grade) XP Power VEP 15US05 | |
| Ultrasound probe(s) |
Your ultrasound system contains Echo Wave II software to control its operation. TELEMED provides latest Echo Wave II software version and TELEMED Drivers Package with your system. Articulate Instruments provides the latest version of AAA and/or SonoSpeech software for speech analysis and visual feedback. Latest software version can be downloaded from http://www.articulateinstruments.com . See Software User Manuals and Reference Manuals on USB key.
IMAGING MODES | |
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B B=B 4B B+M M Compound Trapezoid |
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ULTRASOUND IMAGING | |
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SCANNING METHOD | |
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DEPTH SELECTION | |
2 – 31 cm (depth range depends on probe type and scanner model) |
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FOCUSING | |
Transmitting |
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Receiving |
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SIGNAL PROCESSING | |
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FUNCTIONS | |
General Measurements and Calculations |
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Human Measurements and Calculations Packages |
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User Interface |
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Image and video save / load |
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Cineloop |
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Printing |
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Telemedicine |
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Internet |
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TV output |
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RECOMMENDED COMPUTER REQUIREMENTS | |
Computer type |
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Interface |
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CPU |
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Monitor / Graphics |
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Operating system |
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RAM |
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ULTRASOUND SOFTWARE | |
Drivers |
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Software |
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Plug-Ins |
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Library for programmers |
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DIMENSIONS AND WEIGHT OF BEAMFORMER | |
Dimensions W x D x H mm |
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Weight, kg |
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POWER | |
External AC medical grade power supply (if connected to USB 2.0) |
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from USB port (if connected to USB 3.0) |
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SAFETY | |
Electromechanical safety |
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EMC/EMI standards |
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Ultrasound exposure |
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Degree of protection (watertight) |
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OPERATIONAL ENVIRONMENT | |
Nominal operational environment |
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Storage conditions |
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CAUTION : Please read this information before using the diagnostic system. It applies to the ultrasound system, transducers, accessories and peripherals. |
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WARNING: In the event of detecting a discrepancy regarding patient safety requirements (occurrence or probability of risk) you must to inform the local dealer and the manufacturer immediately |
This system complies with the applicable medical equipment requirements and meets IEC 60601-1, Class II powered by Class II approved external medical power supply Type BF safety requirements.
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NOTE : All persons connecting computer equipment as medical appliance are configuring a medical system and are therefore responsible for ensuring that the system complies with IEC 60601-1. The achievement of PC compliance with the IEC 60601-1 requirements is based on electrical safety. A standard PC power supply is almost certain to not comply with IEC 60601-1 electrical requirements in several ways, e.g. leakage current requirements, dielectric strength requirements. One possible solution is powering the PC (and computer monitor) via a 1:1 medical insulation transformer, which has been designed to meet IEC 60601-1 requirements. The best solution is a fully IEC 60601-1 certified PC or a battery operated portable PC and wireless peripheral devices. All systems (including monitors and other connected parts) must be configured to comply with IEC 60601-1. If in any doubt please contact the technical service department of your local representative. Note that regardless of the above stipulations all personal computers used should be approved regarding the IT (information technology) safety standards for electrical ) equipment (such as IEC 60950 or equivalent) . |
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Electrical specification is shown below and placed on the rear panel of scanner. To avoid electrical shock use only the supplied power cables and connect it to properly grounded power socket. Do not use a three pin to two pin adapter. This defeats the purpose of safety grounding. System should be operated within the voltage limits. If ultrasound scanner will be moved or left for a long time without switching on it must be disconnected from power supply. If scanner will be switched on, do not make any interrupts while operating system and ultrasound software is loading. Time for this operation is approx. 1-2 min.
To avoid the risk of electrical shock and fire hazard:
- before using the probe, inspect the probe face, housing, and cable, do not use the probe if the probe or its cable is damaged;
- always disconnect the AC power supply from the system before cleaning the system;
- do not use any probe that has been immersed beyond the specified cleaning or disinfection level;
- inspect the power supply, AC power supply cable and plug on a regular basis, ensure they are not damaged;
- do not connect non-original AC power supply, not supplied by TELEMED;
- use only accessories and peripheral devices recommended by TELEMED.
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WARNING: To avoid risk of electrical shock don’t open cover of device/blocks. There are no parts that can be repaired by yourself. In case of difficulties contact Articulate Instruments Ltd or TELEMED. |
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To protect your ultrasound system, transducer and accessories, follow these precautions:
- excessive cables bending or twisting can cause a failure or intermittent operation;
- improper cleaning or disinfecting of any system part can cause permanent damage, for cleaning and disinfecting instructions see chapter below;
- do not use solvents such as thinner/benzene, or abrasive cleaners on any part of the system;
- do not spill liquid on the system;
- incorrect assembly or configuration and using an improper power source may damage the system.
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WARNING: Ultrasound probes can easily be damaged by improper handling! Failure to follow these precautions can result in serious injury and equipment damage! |
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WARNING: Some probe covers may contain talc and natural rubber latex. Examine the package labelling to confirm latex content. We strongly recommend that health-care professionals identify their latex-sensitive patients, and refer to the FDA’s March 29, 1991 Medical Alert on Latex products. Be prepared to treat allergic reactions promptly. NOTE: TELEMED diagnostic ultrasound systems and probes do not contain natural rubber latex that contacts humans. |
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Observe the following precautions related to biological safety:
- do not use the system if it exhibits erratic or inconsistent behaviour;
- discontinuities in the scanning sequence are hardware failure indication that must be corrected before use;
- do not use the system if it exhibits artifacts on the LCD screen, either within the clinical image or on the area outside it;
- artifacts are indication of hardware and/or software errors that must be corrected before use;
- perform ultrasound procedures prudently, use the ALARA (As low As Reasonably Achievable) principle (see APPENDIX 12.1: Guidelines for the safe use of diagnostic ultrasound);
- devices are contraindicated for ophthalmic use or any application that causes the acoustic beam to pass through the eye.
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WARNING: At detection of discrepancy to patient’s safety requirements (occurrence or probability of risk) you need to inform immediately Articulate Instruments Ltd and the manufacturer. |
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Ultrasound waves used in diagnostic system have frequencies from 2 MHz to 10 MHz. Sound waves with such frequency are weaken in air, so can be measured for example in water. Detailed information is expounded in:
APPENDIX 12.1: Guidelines for the safe use of diagnostic ultrasound.
APPENDIX 12.2: Acoustic output
Perform ultrasound procedures prudently, use the ALARA (As low As Reasonably Achievable) principle (see APPENDIX 12.1). The interactive system features (user controls) that may affect the acoustic output are:
- acoustic output control,
- transmit frequency;
- scanning depth;
- transmit focal length;
- scanning angle
- range in 2D-Mode,
Also acoustic output depends on the imaging mode selected. The choice of mode (B-Mode, M-Mode, B+M-Mode) determines whether the ultrasound beam is stationary or in motion. B+M Mode has highest acoustic output.
The default output level is set at the factory and is based on device settings that yield an optimum image for the type of use and do not exceed the recommended limits. This default level is set:
- when the system is first turned on;
- when the probe is first turned on. It is highly recommended to set default level;
- when changing from one exam category to another;
- when changing from one application to another;
- when changing from one probe to another;
- when a new patient is entered.
Once an optimal image is achieved, the need for increasing acoustic output or prolonging the exposure cannot be justified. Watch the POWER level (on-screen display) permanently. Where possible, controls and system features should be used to optimize the image before increasing the acoustic output level. Follow the principle of ALARA in all patient exams. MicrUs employs the principle of ALARA in configuring factory defaults.
The system and transducer combination do not exceed an MI or TI of 1.0 in any operating mode. Therefore, the MI or TI output display is not required and is not displayed on the system for these modes.
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CAUTION : Gas ultrasound contrast agents are used during echocardiography to enhance a cardiac image but may cause side effects (cardiac rhythm disturbances during perfusion studies). Because of this, see the package labelling / insert about the risks of both cardiopulmonary and hypersensitivity reactions (unstable status). It is recommended the monitoring of vital signs, cardiac rhythm and oxygen saturation, and having equipment for resuscitation and trained personnel readily available. Additional Information: FDA MedWatch Safety Alert. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection). October 12, 2007. http://www.fda.gov/medwatch/safety/2007/safety07.htm#bubble |
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CONTRAINDICATION : This device is contraindicated for ophthalmic use or any application that causes the acoustic beam to pass through the eye |
Vulnerabilities in cybersecurity may represent a risk to the safe and effective operation of networked medical devices.
Network administrators in health care organizations and information technology vendors should assure an adequate degree of protection from threats such as viruses and worms, to avoid the opportunity for unauthorized access to the network or the medical device/database.
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WARNING: Clinical diagnostic errors may result from the inappropriate use of calculations. Review the referenced source of the stated formula or method to become familiar with the intended uses and possible limitations of the calculation. Calculation formulas and databases are provided as a tool to assist the user, but should not be considered an undisputed database, in making a clinical diagnosis. |
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The accuracy of measurements is determined not only by the TELEMED Echo Wave II software, but also by proper use of medical protocols. Distance and area/circumference measurements are displayed to 0.1 mm. The following general assumptions can be made about the accuracy of any ultrasound system:
- Velocity of sound is constant - 1540 m/s
- Velocity of sound uncertainty = 5%
- Caliper placement accuracy is one pixel (operator dependent)
- Measurement accuracy is based on the root-mean-square combination of all independent sources of error
- RMS errors are due to velocity of sound uncertainty, pixel error, and typical transducer geometry
Note: The below measurement accuracies apply to all transducers and to all modes. The linear distance measurement components have the accuracy and range shown in the following tables:
Table 1 describes the purpose and location of safety labels and other important information provided on the equipment.
Here is main information about Ultrasound Scanners. The system consists of, see figure below:
- Beamformer
- Ultrasound Probe
- Personal Computer (Desktop / Notebook / Tablet PC)
- powered from
- Power Supply +5V
Ultrasound diagnostic system is based on the effect of ultrasound wave reflection from the tissue edges with different acoustic impedance levels. Ultrasound waves sent out by the probe head are emitted into the patient’s body. Reflections from the specific types of tissue and their external surface/edges cause partial reflections of the propagating sound wave. Return echo comes back to the probe head and after being detected and amplified is displayed on the monitor screen as a pixel combination with various shades of brightness, creating an ultrasound image.
Beamformer functions are:
- excite electric pulses to fire the probe;
- ultrasound echo signals pre-amplification;
- compensation of the ultrasound attenuation due to travel depth;
- reordering the receiving signal sequence and focusing by applying the appropriate time delays;
- shifting the center frequency of BPF (band pass filter) to follow the frequency shift that occurs according to the travel depth;
- preparing digital data for transferring via USB interface
Probe unit is piezoelectric transformer which provides the acoustical pulse used to exanimate the medium and used for both transmission and reception, i.e., the transducer is used in pulse-echo mode. A voltage waveform is applied to the transducer and the converted into an acoustic waveform (inverse piezoelectric effect). Acoustic pulse is then partially transmitted and partially reflected by intervening soft tissues structures in the body. The reflected acoustic waveform is received by the same transducer and is converted into a voltage waveform (direct piezoelectric effect). Probe enclosure has a relief to affix the scanning direction.
All controls apply by computer keyboard and mouse / trackball / touchpad. Refer Echo Wave II Software User Manual and Echo Wave II Software Reference Manual on USB key. As a result, all ultrasound data and the software interface can be observed on SVGA monitor (LCD panel).
| Front view of MicrUs beamformer | | |
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| Rear view of MicrUs beamformer | | |
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The Ultrasound Scanner is partially powered through USB from the computer to which it is connected.
For compliance with IEC 60601-1 any computer equipment connected to the USB interface of the Ultrasound Scanner must be certified to IEC standards (e.g. IEC 950) and configured to comply with IEC 60601-1. Everybody who connects computer equipment to this interface configures a medical system and is therefore responsible for ensuring that the system complies with IEC 60601-1. If in any doubt contact the technical service department of your local representative. | |
Ultrasound Scanners can work / operates with standard PC features:
- mouse
- keyboard
- SVGA monitor
- Laser printer 600 dpi, (preferred HP printers), optional
Optional accessories:
- Image Processing Packages
- 3DView o PanoView
- Additional Probes
- Probes Carrying Сases
- Biopsy Clip Bracket C- type (for convex probes)
- Biopsy Clip Bracket HL- type (for linear probes)
- PV-Biopsy Clip Bracket PV- type (for microconvex probes)
Ultrasound scanner should be installed in the premises specifically intended such as an ultrasound scanner lab, which area no less than 10 m², with window coverings to provide some diffused illumination.
- Power supply wires and other accessories used with the device should be delivered by producer or be the same type as in specification.
- For proper work and excellent effects use set completed and recommended by producer.
- Do not connect too many electrical devices to the same power net. It may cause problems with proper work or even make failure of the device.
- Device connected to power net is still supplied even if switched off.
- Any changes made in ultrasound scanner made by user are prohibited and cause loss of guarantee.
- Always disconnect the scanner from power supply if in response to any of the following:
- Failure of power supply cable
- Device was dropped
- Device not working correctly
- Strange noises or smoke from the cover of device.
- Damage of the scanner when used in a manner or for a purpose not indicated in this manual will result in loss of guarantee.
- Avoid exposing scanner and probes to temperature shock.
- When the scanner is moved from a cold environment to a warm one, wait 0,5 to 1 hour before switch on to allow water condensation on electronic parts to evaporate.
- Do not use the scanner close to a moisture source or in an environment with high moisture.
- Do not use compressed air or vacuum to clean the device.
- Do not drop, hit or shake.
- Take care when working with ultrasound probes. Probes should be cleaned after work to remove gel and other deposits. Do not use any aggressive chemicals. To increase life time of probes, always leave them in the freeze acquisition state when not actively scanning and switch off after use.
- Changing probes should be done only in FREEZE mode or POWER OFF.
- Ultrasonic waves have a low permeability in air and gas within the living body. If air is present between the probe and the skin, examination may be impossible.
- Therefore, it is necessary to apply an acoustic coupler (special gel, olive oil, liquid paraffin, etc.) so that the probe adheres closely to the skin.
- It is also impossible to examine regions of the body which contain gas or air, such as the lungs.
- The quality of an ultrasound diagnosis depends on where the scan cut is set.
- Before starting an examination, carefully consider where to set the cut to be scanned by the probe so that the region to be examined could be precisely localized by ultrasound.
- If you have any questions or suggestions about diagnostic system used for speech analysis or speech visual feedback please contact Articulate Instruments Ltd or for all other applications contact TELEMED Company.
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NOTES: The term “Acquisition” is understood here as the image forming process whereby a picture is displayed on monitor screen as a result of emitting the ultrasound wave and receiving echoes by the transducer in the ultrasound probe. Both the transducer and the probe are activated during the acquisition process. The term “FREEZE” is understood as the stoppage of the acquisition. |
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IMPORTANT NOTE: This description and screenshots based on Windows XP Service Pack 2. Dialog windows of Windows 7,8,10 can differ, but generally software installation process is the same. |
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We recommend the following PC minimum configuration:
- Windows ® operating system compatible desktop, notebook or Tablet PC
- Intel chipset based motherboard with integrated USB 2.0/3.0 controller
- CPU i5/i7 1.8 GHz or better
- 2 GB RAM or more
- 2 GB free hard disk space
- monitor with 1024x768 resolution or better, IPS technology display adapter with Cuda support
- for 4D a display adapter that supports Pixel Shader 2.0 and
- Vertex Shader 1.0 or higher
- TCO certified display
- computer power supply certified for medical use
Windows® 7, Windows® 8 (all versions 32/64-bit), Windows® 10 (all versions 32/64-bit)
Configure e-mail program (Outlook Express for example). It is necessary for normal operation of the direct e-mail sending feature of the Echo Wave II software.
Note: No need to configure e-mail software if you are not planning to use it or your computer is not connected to Internet.
Read the User Guide manual chapters before start:
- SAFETY
- OPERATIONAL ENVIRONMENT
- INSTALLATION WARNINGS
Configure the computer according to the requirements. Always connect power cable’s female part to the power connector and the male part to the hospital grade power socket of a proper voltage.
- Connect external power supply to the power socket on side panel.
- DO NOT insert USB cable to the beamformer and PC ports.
Start the software installation according to chapter 6.3. Software installation for Windows
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NOTE : Beamformer can be powered from PC via the USB 3.0 and draws approx. 1000 mA . If you need to use a USB Hub to share the USB connection with other devices it is important to ensure that you use a self-powered Hub that can supply power to its connected devices. The device may not function if connected to a passive or bus powered USB Hub. If the power is not sufficient, use external 5V power supply from delivery set |
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Ultrasound scanners software consists of 2 packages:
- TELEMED Drivers Package
- Echo Wave II First at all it is necessary to install TELEMED Drivers Package. This package contains USB drivers for the beamformer and ultrasound probes.
At second it is necessary to install Echo Wave II software package. It is graphical user interface.
The installation process of the TELEMED Drivers Package and Echo Wave II is described below.
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IMPORTANT: DO NOT connect USB cable to beamformer (for all systems) during installation. To install ultrasound software package you must be logged on as an Administrator or a member of the Administrators group. Uninstall previous version of ultrasound software if it is present. Close all application programs running on PC. |
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Turn computer on;
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AFTER driver installation:
- Connect USB cable to beamformer.
- Windows operating system will find new device, let Windows find the drivers automatically.
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Note: If pop-up message appears (stating the driver is not digitally signed by Microsoft). You will need to acknowledge this message (by clicking Continue Anyway / Allow, not Cancel) to proceed with driver installation. Information for advanced users. After installation drivers are stored in the C:\Program Files\TELEMED\Drivers folder. |
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NOTE: (for Windows XP only) Echo Wave II requires Microsoft.NET Framework 2.0 to be installed. If your operating system is Windows Vista or Windows 7, 8, 10 then there is no need to install it. |
- The Echo Wave II icon will appear at the desktop after installation;
- Connect the power cable and the probe;
- Double click on Echo Wave II icon, please wait a while, you will then see images like those shown below…
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NOTE: Do not unplug power cable during scan mode. You can damage the scanner. Exit from software first and then, only after that, unplug power cable. Do not unplug USB cable during scan mode. You can damage scanner. Exit from software first and, only after that, unplug the USB cable. |
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The ultrasound Scanner Monitor utility is used for system status monitoring. Also this utility indicates when and how MicrUs beamformer is connected to computer.
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If there are problems during installation or operation fails and you can’t solve it by yourself, contact the distributer (Articulate Instruments) at email address <awrench@articulateinstruments.com> in the first instance. Support can also be requested by email to <support@telemed.lt>.
In your email, provide the following information for the technical support service:
- Scanner type (for example: MicrUs);
- Serial number of the scanner (for example: 2578-140428-9686);
- Probe type (for example: MCV9-5R10S-3);
- Serial number of the probe (for example: 3951-090504-9701);
- TELEMED Drivers Package version (for example: TELEMED Drivers Package 1.15.2);
- Echo Wave II software version (for example: Echo Wave II 3.3.2);
- Detailed description of the problem (for example: drivers and software installed correctly, system works but I see very weak echo-signal);
- Attach an example of the bad image if need (scanner settings must be in default settings, see Operation Manual for details).
- Attach the Log file generated by Ultrasound System Information utility:
Run Ultrasound System Information software as shown; |
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Wait a while, utility will collect all necessary information about ultrasound device and installed ultrasound software; |
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Technical details of MicrUs operation will appear in this window.
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Shortly after receiving this information, technical support service will reply with recommendations for steps to solve the problem.
TELEMED warrants the diagnostic system to be free from defects in material and workmanship at the original purchaser's location for 24 months (exception: the probe is warranted for 18 months). This warranty covers parts for the full 24 months (or 18 months, respectively) and labour for 90 days. In order to comply with this warranty, all servicing must be performed by a TELEMED qualified field engineer or with the express permission of TELEMED. Items excluded from this warranty are misuse, negligence or accidental damage. TELEMED points out that data loss is not warranted. The foregoing warranty is exclusive and in lieu of all other warranties and representations, expressed or implied including but not limited to any warranty of merchantability or fitness for any particular trade usage. This warranty is also in lieu of any other obligation, liability, right or claim, whether in contract or in tort, including any right arising from negligence on the part of TELEMED for any direct, incidental, consequential or other damage.
- A warranty claim must be made promptly and must be received during the applicable warranty period by TELEMED.
- If it becomes necessary to return a product for repair and/or adjustment, prior authorization from TELEMED must be obtained. Instructions as to how and where these products should be shipped will be provided by TELEMED.
- Any product or component returned for examination and/or warranty repair shall be sent insured prepaid via the means of transportation specified by TELEMED. Shipping charges for all products or components replaced or repaired under warranty should be defined separately.
- In all cases, TELEMED has sole responsibility for determining the cause and nature of failure, and TELEMED's determination with regard thereto shall be final.
A service contract may be obtained from TELEMED to run after the warranty period has expired. The contract provides for any service calls that may be necessary to keep the system operational and will include at least one regularly scheduled service visit per year. As part of the scheduled maintenance, the service representative will do a complete inspection and test / calibration of the system. To provide our customers with the best possible support, send your comments and suggestions to support@telemed.lt
Performance and Safety Checks see in the table below:
| Recommended Maintenance | Frequency |
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| General cleaning | As Needed |
| Inspect the system, cables and probes | Before Use/Daily |
| System accuracy and performance verification | Annually |
The LCD/CRT screen and all external surfaces may be cleaned with a soft cloth dampened with a neutral detergent. Do not use solutions with chlorine, ammonia, fluoro-carbons or hydrocarbons. Do not use abrasive cleaners or high fiber wipes that may scratch the surface.
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NOTE: Before cleaning the unit, ensure the unit is powered off and the mains power cable and USB cable are disconnected. |
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Examine the exterior for cleanliness and general physical condition. Ensure the housing is intact, hardware is present and secure, and labelling is legible. Check the cables (especially power cable). If there is any peeling or cracking of the outside insulation, carefully disconnect the cable and replace it with a new one.
All transducers are supplied non-sterile.
Transducers in Endocavity Procedures should normally be used with a sterile sheath.
The following disinfectants have been tested with your transducers.
Using of any other disinfectants can void system warranty and service contract.
The following disinfectants for soaking or wiping are recommended:
High level Disinfectants |
Low level Disinfectants |
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NOTE: Among the above disinfectants, High level disinfectants can be applied to Endocavity probe, however Low level disinfectants are not appropriate for disinfects for Endocavity probe. CAUTION: Customers must follow the disinfectant manufacturer's instructions carefully. Do not submerge transducers above strain relief. |
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Some of these chemicals, such as phenol, benzothonium chloride, pHisohex, benzoyl peroxide, hydrogen peroxide, are commonly found in clinic or hospital settings; others are found in antibacterial skin cleaners or lotions. Use of these chemicals will cause damage to a transducer. This damage is not covered by the warranty or service contract.
Inspect probe cable, connector and lens surface. Contacts on the probe connector must be without bends. The surface of probe lens must be clean without scraps and bladders. Check for any crack which will allow liquid to enter the probe (especially joints such as cable/connector and cable/probe). If any such damage is found do not use the probe till replaced.
Use care to avoid getting solution in the probe connector. Wrap the connector in the plastic bag to avoid liquid contact with the connector.
Use an EPA registered germicide intended for use on plastic medical instruments (2% Glutaraldehyde type solutions without surfactants are recommended). Follow the germicide manufacturer’s instructions regarding concentration, time of contact, storage and disposal. Do not use alcohol or alcohol based solutions. Thoroughly rinse all residues from the probe with sterile distilled water after removal from the germicide.
Do not wipe the strain relief/housing joint, the strain relief, or the cable with isopropyl alcohol. Isopropyl alcohol can cause damage to these parts of the transducer. This and any mechanical damage is not covered by the warranty or your service contract.
These general cleaning instructions are indicated for non-critical category transducers. All transducers which do not contact mucus membranes, blood, compromised tissue, and are not used in sterile fields can be cleaned by using these instructions. It is important that customer cleans the transducer and cable according to the following procedures:
- After every patient exam, wiping the ultrasound transmission gel off the transducer.
- Wiping the transducer and cable with a dry or water-moistened soft cloth.
- Wiping the transducer with either: A recommended disinfectant
- Enzol (Cidezyme)
- Metrizyme
- Klenzyme
- Also is possible to wipe the cable with T-spray, a low-level disinfectant for the cleaning of external transducers only. Not allowed to use isopropyl alcohol on the cable and strain relief/housing joint.
It is highly recommended to use Transducer’s Sheath for Endocavity and Invasive uses. The transducer disinfection should be done prior to the first exam, and after every exam thereafter. The disinfectant procedure includes the following steps:
- Unplugging the transducer from the system.
- Washing the transducer head and cable with soap and water to remove any protein buildup; however the transducer must not be rinsed or immersed near the strain relief.
- Disinfection the transducer and the cable with one of the disinfectants listed as Legally Marketed. During the disinfection it is necessary:
- To avoid transducer contact with strong solvents such as acetone, freon, and other industrial cleansers.
- To do not soak the transducer for extended periods of time, such as overnight.
- To do not rinse or immerse near the strain relief.
- Removing the transducer from the disinfectant and thoroughly rinsing with sterile water.
- Checking the transducer for any residual organic material. If any is present, disinfection of the transducer should be done again.
System accuracy and performance verification should be conducted annually or if doubt exists about image quality or distance estimation.
Use tissue mimicking phantoms for evaluation of accuracy and performance of the system. Refer to Manual supplied with the phantom for detailed description of accuracy and performance verification.
During the performance assessment or tests (using phantoms etc) the probe lens may be short-time immersed in water or other special liquid.
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NOTE: The System was designed for sound velocity in tissue 1540 м/sec. For accuracy verification, it is necessary to use phantoms which are calibrated for this sound velocity. |
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Ultrasound scanner should be stored and moved according to the package technical documentation and the standard procedures.
Utilization/recycling of this equipment should be made by specialized company and be according to the local law.
The latest Declaration of Conformity can be found by the following link:
https://www.pcultrasound.com/certificates/
- The use of diagnostic ultrasound to obtain information about function or structure in human beings should be restricted to situations in which the medical benefit that may accrue from the diagnostic data outweighs any foreseeable risk. Most such situations are limited to clinical examinations of the ill or potentially ill patient, or pregnant women.
- Situations of training, demonstration or research may also provide a medical benefit from diagnostic data that outweighs any foreseeable risk. Here, information is obtained for people, who are not necessarily in the categories of Recommendation (1), above. In all situations of training, demonstration or research, if either of the Thermal Index or Mechanical Index will be greater than 1, then a subject should be informed of the anticipated exposure condition and how it compares in safety with conditions for normal diagnostic practice.
- Ultrasound should not be used for any of the following:
- to have a picture of the fetus, solely for non-medical reasons;
- to learn the sex of the fetus solely for non-medical reasons;
- for commercial purposes, such as trade shows, or producing pictures or videos of the fetus.
- M-mode is valuable clinical tool and, despite potential risks, is not contraindicated. However operators should be careful to limit exposure to critical structures and utilize the exposure information provided by the manufacturer.
- In particular, users should employ exposures which are As Low As Reasonably Achievable (ALARA)1 because of the potential for ultrasonic heating of tissue during M-mode imaging and, normally to a significantly greater extent, Doppler ultrasound blood flow examinations. Exposure can be reduced by either reducing the Thermal Index using output controls or by reducing the dwell time, the amount of time that the transducer remains in one place.
- Users should employ exposures, in any relevant mode, which are As Low As Reasonably Achievable (ALARA) because of the potential for:
- ultrasonically induced capillary hemorrhaging in lung if it is exposed during pediatric diagnostic ultrasound examinations, particularly for infants and neonates, especially if they are pre-term;
- ultrasonically induced capillary hemorrhaging of the intestine where intestinal peristalsis is inhibited or conditions promote intraluminal or submucosal gas collections;
- ultrasonically induced capillary hemorrhaging in other soft tissues when Gas Contrast Agents are used.
- Use of Gas Contrast Agents in a diagnostic ultrasound examination is not recommended within 24 hours before extracorporeal shock wave lithotripsy.
- Exposure can be reduced by lowering the Mechanical Index using output controls. Reducing the dwell time is of use if threshold pressures are exceeded.
It is recommended that equipment operators implement quality assurance measures to maintain the capability of obtaining reliable diagnostic information at acoustic exposures which are As Low As Reasonably Achievable.
As the quality of diagnostic information depends, in part, on operator training, it is also recommended that sonographers (ultrasound technologists) be appropriately qualified and registered in regional organizations of ultrasound professionals.
- Although there are many exposure conditions for which the risk of injury during a diagnostic ultrasound examination is negligible, this is not the case for every possible exposure condition using currently available equipment. Therefore, the persons responsible for the ultrasonic exposure must ensure that the exposure is justified, i.e., that reliable diagnostic information can be achieved and that the benefits outweigh the risk
- The conclusions listed below provide guidance as to the risks due to thermal and mechanical effects arising from ultrasound exposure. To be useful, all the conclusions need to be taken into consideration.
- At the time of writing, the information published on output levels during B-mode imaging indicates that the risk of injury from ultrasonic heating is negligible during this type of examination. At this time, there appears to be no reason on thermal grounds to limit such scanning for any clinical indication, including ultrasound examination of normal pregnant women.
- In all other operating modes, especially those used for Doppler blood flow examinations, risk of injury from ultrasonic heating depends on the temperature elevation and the dwell time, as indicated by the conclusions given below.
- If the Thermal Index (TI) does not exceed 1, currently available evidence indicates that the risk of an injury due to ultrasonic heating is negligible for the vast majority of conditions of the diagnostic ultrasound examination.
- For first trimester transabdominal fetal examinations through a bladder path greater than 5 cm in length, evidence indicates that it is possible that the maximum temperature elevation which could be obtained is as much as 2-3 times that of the displayed Soft Tissue Thermal Index (TIS). More caution may be warranted in these situations, particularly if the TIS exceed 1.
- The Soft Tissue Thermal Index (TIS) is the appropriate indicator of the potential for ultrasonic heating for examinations in which the ultrasound beam travels a path which is made up principally of homogeneous soft tissue or a soft tissue/fluid path, as in a first trimester fetal examination or an abdominal examination.
- If bone, including 2nd or 3rd trimester fetal bone is within the ultrasound beam, then the Bone Thermal Index (TIB) is often the appropriate indicator, except as noted in the next conclusion.
- If bone is in contact with the transducer then the Cranial Thermal Index (TIC) is the appropriate indicator. If bone is within about 1 cm of the transducer and this is closer than the nearest focal zone, the Cranial Thermal Index (TIC) is the appropriate indicator. More caution may be warranted in these cases because of the potential for transducer selfheating; heating of the transducer may add significantly to any ultrasonic heating which may occur.
- Generally, more caution may be warranted for transvaginal, transesophegeal and transrectal examinations because heating of the transducer has the potential to produce additional heat to adjacent tissue.
- This conclusion and the following one provide guidance to the user if the temperature elevation in the fetus could exceed 1 °C as a result of a diagnostic ultrasound exposure. If the exposure produces a maximum in situ temperature of no more than 38.5 °C (1.5 °C above normal physiological levels) then it may be used clinically without reservation on thermal grounds.
- To be considered potentially hazardous on thermal grounds, it appears that a diagnostic ultrasound exposure must elevate embryonic and fetal in situ temperatures to the following temperatures for approximately the corresponding durations:
-
-
- 39 °C, (2 degrees above normal), 60 minutes;
- 40 °C, (3 degrees above normal), 15 minutes;
- 41 °C, (4 degrees above normal), 4 minutes;
- 42 °C, (5 degrees above normal), 1 minute;
- 43 °C, (6 degrees above normal), 0.25 minutes;
- 39 °C, (2 degrees above normal), 60 minutes;
-
-
- At exposures that do not exceed the output limits recommended in Section Thermal effects, there is no demonstrated risk of clinically significant damage in humans from mechanical effects of ultrasound exposure during a diagnostic examination. However, capillary hemorrhaging has been observed in lung and the intestine of mammals at diagnostically relevant exposures. This effect has also been observed in other soft tissues if gas contrast agents are used. For the most part, thresholds are just as likely to be exceeded for B-mode as for pulsed Doppler or color flow Doppler modes. However, thresholds are lower for pulsed Doppler modes with relatively long pulses.
- If the Mechanical Index (MI) exceeds 1, there is a small risk of capillary hemorrhaging in the lung during ultrasound examinations involving exposure of the neonatal and infant chest. The risk may increase in more unusual exposures where the surface of the lung is near the focus. Although clinically significant hemorrhaging is unlikely, in part because of the small volume of tissue that is affected, the potential for achieving clinical significance may increase in the premature infant.
- At the current maximum values for the MI of 1.9, it is unlikely that diagnostic ultrasound exposure would lead to clinically significant intestinal hemorrhage in humans. However, the likelihood may increase for pathologic conditions inhibiting intestinal peristalsis and promoting intraluminal and submucosal gas collections.
- A limited number of experimental studies suggests that use of ultrasound gas contrast agents (GCAs) (micro bubbles) during a diagnostic examination has the potential to increase the likelihood of capillary hemorrhaging in tissues other than lung. In experiments on animals, the risk of significant hemorrhaging from lithotripter fields is increased for several hours after injection.
- As long as the recommended output limits are not exceeded, mechanical effects are far less likely to be important in obstetrical ultrasound because of the absence of gas bodies.
The clinical effect of an exposure depends on the nature and degree of tissue injury. This can be assessed from biological effects studies. Several extensive reviews have been published regarding the adverse biological effects of ultrasonic heating based on animal studies, particularly in mammalian species (Lele 1985, NCRP 1992, WFUMB 1992, AIUM 1993, WFUMB 1998). With regard to adult tissues, the available literature suggests that tissue temperature elevations in the range of 8-10 °C, sustained for 1 to 2 minutes will cause tissue injury (Bly, et al., 1992, Lele 1985). The reviews have also considered studies of teratogenic effects, usually on the developing brain, due to whole body heating of the embryo or fetus. The recommendations resulting from these reviews can be succinctly expressed as follows (WFUMB 1998):
- a diagnostic ultrasound exposure that produces a maximum in situ temperature rise of no more than 1.5 °C above normal physiological levels (37 °C) may be used clinically without reservation on thermal grounds,
- a diagnostic ultrasound exposure that elevates embryonic and fetal in situ temperature above 41 °C (4 °C above normal temperature) for 5 minutes or more should be considered potentially hazardous,
- the risk of adverse effects is increased with the duration of exposure.
In addition, it has been reported that water immersion body heating of rats yielded the development of encephalocoeles in the rat fetuses in as little as 1 minute at a temperature elevation of 5 °C above normal physiological temperature. (WFUMB 1998).
For temperature elevations greater than 1.5 °C above normal physiological levels (37 °C), this information can be approximately matched to a functional form recommended by the NCRP (NCRP 1992). This yields an equation for combinations of temperature elevation and time which should be considered potentially hazardous:
where t is the time in minutes at the specified temperature and is the temperature elevation above normal (37 °C).
Barnett, et al., (1997) have recently published an updated review of thermal effects, focusing on the potential for effects on the fetus. They note that there is little information on the teratogenic effects from localized heat damage by ultrasound.
Abbott, JG. Rationale and derivation of MI and TI - a review. Ultrasound in Med. and Biol. 25:431- 441; 1999.
American Institute of Ultrasound in Medicine (AIUM). Bioeffects and safety of diagnostic ultrasound. Laurel, MD: AIUM Publications; 1993.
American Institute of Ultrasound in Medicine/National Electrical Manufacturers Association (AIUM/NEMA). Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment, Revision 2. Laurel, MD: AIUM Publications; 2004.
American Institute of Ultrasound in Medicine/National Electrical Manufacturers Association (AIUM/NEMA). Acoustic output measurement standard for diagnostic ultrasound equipment. Laurel, MD: AIUM Publications; 2004.
American Institute of Ultrasound in Medicine (AIUM). Medical ultrasound safety. Rockville, MD: AIUM Publications; 2002.
American Institute of Ultrasound in Medicine (AIUM). Standard Methods for Measuring Performance of Pulse Echo Ultrasound Imaging Equipment. Rockville, MD: AIUM Publications; 1991.
American Institute of Ultrasound in Medicine (AIUM). Methods for Measuring Performance of PulseEcho Ultrasound Equipment, Part II: Digital Methods. Rockville, MD: AIUM Publications; 1995a.
American Institute of Ultrasound in Medicine (AIUM). AIUM Quality Assurance Manual for GrayScale Ultrasound Scanners. Rockville, MD: AIUM Publications; 1995b.
American Institute of Ultrasound in Medicine (AIUM). Mechanical Bioeffects from Diagnostic Ultrasound: AIUM Consensus Statements. J. Ultrasound in Medicine 19: number 2; (February 2000). (Also available from AIUM Publications.)
Apfel, R.E. and Holland, C.K. Gauging the likelihood of cavitations from short-pulse, low duty cycle diagnostic ultrasound. Ultrasound in Med. and Biol. 17:179-185; 1991.
Barnett, S.B., ter Haar, G.R., Ziskin, M.C., Rott, H.D., Duck, F.A. and Maeda, K. International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine. Ultrasound in Med. and Biol. 26:355-366; 2000.
Bly, S.H.P., Vlahovich, S., Mabee, P.R. and Hussey, R.G. Computed estimates of maximum temperature elevations in fetal tissues during transabdominal pulsed Doppler examinations. Ultrasound in Med. and Biol. 18:389-397; 1992.
Carstensen, E.L., Duck, F.A., Meltzer, R.S., Schwarz, K.Q., Keller, B. Bioeffects in echocardiography. Echocardiography 6:605-623; 1992.
Child, S.Z., Hartman, C.L., McHale, L.A and E.L. Carstensen. Lung damage from exposure to pulsed ultrasound. Ultrasound in Med. and Biol. 16:817-825; 1990.
Dalecki, D., Raeman CH, Child SZ, et al, . The influence of contrast agents on hemorrhage produced by lithotripter fields. Ultrasound in Med. and Biol. 23:1435-1439; 1997.
Doody, C. Porter, H., Duck, F.A. and Humphrey, V.F. In vitro heating of human fetal vertebra by pulsed diagnostic ultrasound. Ultrasound in Med. and Biol. 25:1289-1294; 1999.
Duck, F.A., Starritt, H.C., ter Haar, G.R. and Lunt, M.J. Surface heating of diagnostic ultrasound transducers. Br. J. Radiology 67:1005-1013; 1989.
Duggan, P.M. and McCowan, L.M.E. Reference Ranges and Ultrasonographic Exposure Conditions for Pulsed Doppler Sonographic Studies of the Fetal Internal Carotid Artery. J Ultrasound in Medicine 12:719 - 722; 1993.
Henderson, J., Willson, K., Jago, J.R. and Whittingham, T. A survey of the acoustic outputs of diagnostic ultrasound equipment in current clinical use. Ultrasound in Med. and Biol. 21:699-705; 1995.
Holland, C.K., Deng, C.X., Apfel, R.E., Alderman, J.L., Fernandez, L.A., and Taylor, K.J.W. Direct evidence of cavitation in vivo from diagnostic ultrasound. Ultrasound in Med. and Biol. 22:917-925; 1996.
Lele, P.P. Local hyperthermia by ultrasound for cancer therapy. In: Nyborg, W.L.; Ziskin, M.C., eds. Biological effects of ultrasound. Clinics in diagnostic ultrasound, Vol.16. New York: Churchill Livingstone: 135-155; 1985.
Lopez, H. How to Interpret the Ultrasound Output Display Standard for Higher Acoustic Output Diagnostic Ultrasound Devices. J. Ultrasound in Medicine, Vol 17, pg 535 (1998).
Miller, D.L. and Gies, R.A. Gas-body-based contrast agent enhances vascular bioeffects of 1.09 MHz ultrasound on mouse intestine. Ultrasound in Med. and Biol. 24:1201-1208; 1998.
National Council on Radiation Protection and Measurements (NCRP). Exposure criteria for medical diagnostic ultrasound: I. Criteria based on thermal mechanisms. Bethesda, MD: NCRP; June 1, 1992.
National Council on Radiation Protection and Measurements (NCRP). Exposure criteria for medical diagnostic ultrasound: II. Criteria based on mechanical mechanisms. Bethesda, MD: NCRP; in preparation O'Neill, T.P., Winkler, A.J. and Wu, J. Ultrasound heating in a tissue-bone phantom. Ultrasound in Med. and Biol. 20:579-588; 1994.
Patton, C.A., Harris, G.R. and Phillips, R.A. Output Levels and Bioeffects Indices from Diagnostic Ultrasound Exposure Data Reported to the FDA. IEEE Trans Ultras Ferro, Freq Cont 41:353-359; 1994.
Ramnarine, K.V., Nassiri, D.K., Pearce, J.M., Joseph, A.E.A., Patel, R.H. and Varma, T.R. Estimation of in situ ultrasound exposure during obstetric examinations. Ultrasound in Med. and Biol. 19:319-329; 1993.
Shaw, A., Preston, R.C. and Bond, A.D. Assessment of the likely thermal index values for pulsed Doppler ultrasonic equipment - Stage I: calculation based on manufacturers' data. NPL Report CIRA (EXT) 018; 1997.
Shaw, A., Pay, N.M. and Preston, R.C. Assessment of the likely thermal index values for pulsed Doppler ultrasonic equipment - Stages II and III: experimental assessment of scanner/transducer combinations. NPL Report CMAM 12; 1998.
Siddiqi, T.A., O'Brien, W.D., Meyer, R.A., Sullivan, J.M. and Miodovnik, M. In situ human obstetrical ultrasound exposimetry: estimates of derating factors for each of three different tissue models. Ultrasound in Med. and Biol. 21:379-391; 1995.
U.S. Food and Drug Administration (FDA). Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. Rockville, MD: FDA; Sept 30, 1997.
World Federation for Ultrasound in Medicine and Biology (WFUMB) WFUMB Symposium on Safety and Standardization in Medical Ultrasound, Chapter 1, ed., Barnett, S.B. and Kossoff, G. Ultrasound in Med. and Biol. 18:739-750; 1992.
World Federation for Ultrasound in Medicine and Biology (WFUMB) WFUMB Symposium on Safety of Ultrasound in Medicine. Conclusions and recommendations on thermal and non-thermal mechanisms for biological effects of ultrasound. ed., Barnett, S.B. Ultrasound in Med. and Biol. 24: Supplement 1, 1998.
ALARA (As Low As Reasonably Achievable): a principle which is used to reduce unnecessary, potentially hazardous exposure to individuals, by keeping doses As Low As Reasonably Achievable. As shown throughout this guideline, application of the ALARA principle to diagnostic ultrasound differs from its common usage in diagnostic X-ray imaging where it is assumed that there is no threshold exposure. In the use of diagnostic ultrasound, there are three ranges of exposure, i.e., combinations of Thermal or Mechanical Indices and dwell time that need to be considered. At exposures that are clearly below the thresholds for health effects, further reduction of exposure is not justified, whether it is via reductions in dwell time or acoustic output. There can also be exposures that are or may be above thresholds for health effects. In these cases, ALARA refers to using the lowest value of potentially hazardous exposure, i.e. combination of acoustic output and dwell time, needed to achieve the required diagnostic information.
Bone Thermal Index (TIB): the Thermal Index for an exposure model in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone.
Cranial Bone Thermal Index (TIC): the Thermal Index for an exposure condition in which the ultrasound beam passes through bone near the beam entrance into the body.
derated: a derated quantity is one which has been measured in water using standard methods and then multiplied by a derating factor. This accounts for attenuation of the ultrasound field by the tissue between the transducer and a particular location in the body along the beam axis. The derating factor is 0.3 dB/cm-MHz in these guidelines. derated spatial peak time average
intensity: the largest value in an ultrasound beam of any derated time averaged intensity.
dwell time: the amount of time that the transducer is actively transmitting ultrasound while staying in one place during part of an examination.
rarefactional pressure: the amplitude of a negative instantaneous ultrasonic pressure in an ultrasound beam Soft Tissue Thermal Index (TIS): the Thermal Index for an exposure model in which the ultrasound beam heats primarily soft tissue. spatial average, pulse average intensity at the face of the transducer: the spatial average, temporal average intensity at the face of the transducer divided by the duty factor, where the duty factor is the product of the pulse duration and the pulse repetition frequency.
spatial average, temporal average intensity at the face of the transducer: the time averaged intensity, averaged over the face of the transducer.
Thermal Index (TI): a quantity related to the potential for ultrasonic heating. It is proportional to a calculated or estimated temperature rise for model exposure conditions. The Thermal Index is given by the ratio of the ultrasonic power emitted by the transducer to the ultrasonic power required to raise tissue temperature by 1 °C for the model exposure conditions. In the calculation of all Thermal Indices, the average ultrasonic attenuation in the body is assumed to be 0.3 dB/cm-MHz along the beam axis (e.g., the ultrasonic intensity is reduced by 3 dB, a factor of 2, for a 5 MHz beam, 2 cm into the body along the beam axis.)
Mechanical Index (MI): a quantity related to the potential for mechanical effects during a diagnostic ultrasound examination. It is given by the ratio of the largest value in the ultrasound beam of any derated rarefactional pressure to the square root of the transducer frequency. The pressure is in Megapascals and the frequency is in MHz.
ultrasonic heating: the heating of tissue (including bone) due to the absorption of ultrasound.
ultrasonic power: the total amount of ultrasound energy emitted by the transducer per unit time.
This equipment is a subject to TELEMED vigilance system (post-marketing vigilance) in case of potential or real hazards for the patient or for the operator which might occur during the normal system functioning, in order to be able to remove them with the best efficiency and timing. Therefore if the user records any malfunction or deterioration in the characteristics and/or performances of the device, as well as any inadequacy in the labelling or the instructions for use which might lead to potential or real hazards for a patient or for an operator, we kindly request to inform immediately TELEMED office or local Competent Authority or our official dealer/distributor sending the following form (or reporting in other way the same data containing in this form) and do not use this device. All data relating to the system can be found on its identification label. In this way we’ll be able to take all adequate, opportune and effective actions.
Post-Marketing Vigilance Form
To:
Quality Assurance Department
UAB "TELEMED"
Highway Business Centre
Savanoriu pr. 178A
Vilnius, LT-03154,
Lithuania
Phone1: (+370-5) 2106272
Phone2: (+370-5) 2106273
Fax: (+370-5) 2306733
System/device name ________________________
Serial number _________________________
Description of potential hazard ____________________
_____________________________
Notes and suggestions ______________________
_____________________________
Contact person/ Department _____________________
Address __________________________
Phone _________ Fax _________
E-mail __________________
Date _________ Signature __________
The MicrUs system with any transducer combination is not exceeding neither TI (Thermal Index) of 1.0 nor MI (Mechanical Index) of 1.0 in any operating mode, thus the following mean of the global maximum value for each transducer of ISPTA.3, TI (TIS, TIB, or TIC), MI, and IPA.3 @ Mimax are provided in a table below.
System: MicrUs
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- Intended use does not include cephalic so TIC is not computed.
| REVISION | REVISION COMMENTS | ISSUE DATE |
|---|---|---|
| File Info: Title changed to display correct document name. Ch.11 Updated Declaration of Conformity. Ch.12.4. Acoustic tables replaced with a more compact index maximums summary table. | 2023.05.18 | |
| 5.4 | Chapter 2.1 changes, warning added | 2019.05.15 |
| 5.3 | Address update and distributor contact details | 2018.12.30 |
| 5.2 | Correction by FDA approval | 2017.08.30 |
| 5.1 | Corrections for FDA | 2016.05.02 |
| 5.0 | Corrections | 2015.03.21 |
| 4.0 | Edited 2.4 Ultrasound waves/exposure | 2014.12.29 |
| 3.0 | Labelling corrections | 2014.12.18 |
| 1.0 | Initial release of the MICRUS User Guide | 2014.07.24 |
