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TELEMED SmartUs EXT-1M User Manual

Ultrasound diagnostic system
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TELEMED
Ultrasound Diagnostic System
1
SmartUs EXT-1M
SmartUs EXT-3M
USER GUIDE
SmartUs User Guide, REV 3.10 2023.02.15

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  • Page 1 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 SmartUs EXT-1M SmartUs EXT-3M Ultrasound Diagnostic System USER GUIDE...
  • Page 2 SmartUs User Guide, REV 3.10 2023.02.15 Manufactured by TELEMED, UAB Savanoriu ave. 178A Vilnius, LT-03154 Lithuania Telephones: (+370-5) 2106272, (+370-5) 2106273 Fax: (+370-5) 2306733 Internet: https://www.pcultrasound.com E-Mail: info@pcultrasound.com NOTE: Non-TELEMED product names may be trademarks or registered trademarks of their respective owners.

  • Page 3: Table Of Contents

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 1. INTRODUCTION 1.1. About the system / Intended use 1.2. Delivery set 1.3. About the system software 1.4. Technical Specification 2. SAFETY 2.1. Electrical safety 2.2. Equipment protection 2.3. Biological safety 2.4. Ultrasound exposure and ALARA principle 2.5.
  • Page 4 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 7.2. Warranty Shipments and Returns 7.3. Service Contract 8. MAINTENANCE 8.1. General cleaning 8.2. Inspecting the System 8.3. Transducer maintenance and disinfection 8.3.1 Chemicals that Damage Transducers: ........... 33 8.3.2 Recommended Procedures for Transducer Processing ......33 8.3.3 General Cleansing for Transducers Used in Non-Invasive Procedures .

  • Page 5: Introduction

    • Digitally controlled acoustic power; • Lightweight, true mobility, flexible architecture. Here in the User Guide, you can find information about SmartUs EXT-1M/3M and safety and maintenance information. Echo Wave II Software Operation Manual contains a description of the controls.
  • Page 6 A variety of available ultrasound transducers provides many different applications for examinations in therapy, obstetrics, gynecology, urology, pediatrics, oncology, and other areas. A common view of SmartUs EXT-1M is shown below. A common view of SmartUs EXT-3M is shown below.

  • Page 7: Delivery Set

    About the system software Your diagnostic system contains Echo Wave II software to control its operation. TELEMED provides the latest Echo Wave II software version and drivers package together with your system. In the software, the unique technologies making the intellectual property of TELEMED company are used.
  • Page 8 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 • ultrasound image size: • cineloop recording/play: several automatically adjustable to screen thousand frames (depends on resolution computer memory size and scan • grayscale: 256 mode) • zoom mode: from 60% to 600% in •...
  • Page 9 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 • Programmable focus area presets • Transmit variable focus, 8 points Dynamic focus mode • Dynamic receive focus, 8 zones SIGNAL PROCESSING • High Line Density scan mode for better resolution • TGC Control, 5 sliders 40 dB •...
  • Page 10 • Direct e-mail sending function Internet with image or video attachment • Standard TV output using computer's display adapter TV output (option) ULTRASOUND SOFTWARE • TELEMED Drivers Package Drivers • software (B/W + Doppler modes) Echo Wave II Software DIMENSIONS AND WEIGHT...
  • Page 11 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 diagnostic ultrasound equipment.1992. • Main unit IPX1 Degree of protection • Transducers IPX7 (only the area of the transducer (watertight) array acoustic window) OPERATIONAL ENVIRONMENT • Environment temperature : 10 - 40 ° C Nominal operational •...

  • Page 12: Safety

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 SAFETY CAUTION : Please read this information before using the diagnostic system. It applies to the ultrasound system, transducers, accessories and peripherals. WARNING: In the event of detecting a discrepancy regarding patient safety...

  • Page 13: Equipment Protection

    • inspect the power supply, AC power supply cable and electrical plug on a regular basis to ensure they are not damaged; • do not connect non-original AC power supply, not supplied by TELEMED; • only use accessories and peripherals recommended by TELEMED.

  • Page 14: Ultrasound Exposure And Alara Principle

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 Observe the following precautions related to biological safety: • do not use the system if it displays erratic or inconsistent behavior; • interruptions to the scanning sequence are signs of hardware failure that must be corrected before use;...

  • Page 15: Cybersecurity

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 used to optimize the image before increasing the acoustic output level. Follow the ALARA principle during all patient examinations. The SmartUs devices employ the ALARA principle in configuring factory defaults. CONTRAINDICATION : This device is contraindicated for ophthalmic use or any application that causes...

  • Page 16: Confidentiality

    The accuracy of measurements is determined not only by the TELEMED Echo Wave II software but also by the proper use of medical protocols. Distance and area/circumference measurements are displayed to 0.1 mm.
  • Page 17 * Full scale for distance implies the maximum depth of the image. ** An ATS model 539 phantom with 0.7 dB/cm-MHz attenuation was used. *** Full scale for time implies the total time displayed on the scrolling graphic image. **** TELEMED special test equipment was used.
  • Page 18 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 Other Measurement and Calculation Accuracy Parameter System Reference / Formula Tolerance Volume < ±9% 4.2.3 Perimeter, square and volume measurements by Ellipse method Fetus Weight 1 method < ±16% 4.5.1 Hadlock85 (USA) 2 method <...

  • Page 19: Labeling

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 LABELING Table 2 describes the purpose and location of safety labels and other important information provided on the equipment. Table 2 LABEL/SYMBOL DESCRIPTION LOCATION CE mark This mark is a declaration by the...
  • Page 20 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 Protection (watertight, only the area of the IPX7 Transducer transducer acoustic window) ID Label UDI GS1 Data Matrix 2D barcode Transducer...

  • Page 21: System Overview

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 SYSTEM OVERVIEW The SmartUs EXT-1M/3M system handles the multi-element transducers. Here is main information about Ultrasound Scanners. The system consists of, see figure below: • Beamformer • Ultrasound Transducer • Personal Computer (Desktop / Notebook / Tablet PC) •...

  • Page 22: Transducer Unit

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 • excite electric pulses to fire the transducer; • ultrasound echo signals pre-amplification; • compensation of the ultrasound attenuation due to travel depth; • re-ordering the receiving signal sequence and focusing by applying the appropriate time delays;...

  • Page 23: Peripherals/Compatibility

    ● ● P8-3L10SI-6 3…8 90° 4.3. Peripherals/Compatibility SmartUs EXT-1M scanner can work / operate with standard PC features: • SVGA monitor • mouse • Laser printer 600 dpi, (preferred • keyboard HP printers), optional Optional accessories: • Biopsy Clip Bracket C- type (for convex transducers) •...

  • Page 24: Installation Warnings

    Before starting an examination, carefully consider where to set the cut to be scanned by the transducer so that the region to be examined can be precisely localized by the ultrasound. • If you have any questions or suggestions about this diagnostic system please contact TELEMED Company.

  • Page 25: Getting Started With

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 NOTES: The term “Acquisition” used here refers to the image forming process whereby a picture is displayed on the monitor screen as a result of emitting ultrasound waves and receiving echoes by the transducer in the ultrasound transducer.

  • Page 26: Ultrasound Scanner Monitor Utility

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 Switch on the computer power and wait until Windows is ready. Double click on the ECHO WAVE II icon displayed on the desktop. The ultrasound software now starts. Note. See the battery status (charging, battery volume etc) in the tray. If the system is battery powered a warning will be displayed on the screen when only 15% is remaining.

  • Page 27: Windows Configuring

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 Using the left mouse button double click on the GREEN highlighted Ultrasound Scanner Monitor icon and this message will appear; Using the left mouse button double click on the RED highlighted Ultrasound Scanner Monitor icon and this message will appear;...

  • Page 28: Windows Account

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 Note. There is no need to configure the e-mail software if you are not planning to use it or if your computer is not currently connected to the Internet. 5.3.2 Windows account For each system user must be created Windows account with separate login and password.

  • Page 29: Windows Updates

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 5.3.6 Windows updates It is strongly recommended that computers will have turned on Windows Updates. • Windows Update: FAQ https://support.microsoft.com/en-us/help/12373/windows-update-faq 5.3.7 Network communication It is strongly recommended that for network communication will be used secure Virtual Private Networks (VPN).

  • Page 30: Troubleshooting

    • Serial number of the scanner (for example: 2351-120428-9686); • Transducer model (for example: C7-3R50N-5); • Serial number of the transducer (for example: 3241-120504-9701); • TELEMED Drivers Package version (for example: TELEMED Drivers Package 1.13.1); • Echo Wave II software version (for example: Echo Wave II 3.0.3);...

  • Page 31: Warranty And Service Information

    TELEMED qualified field engineer or only with the express permission of TELEMED. Items not included in this warranty are misuse, negligence or accidental damage. TELEMED wishes to point out that the loss of data loss is not included in this guarantee.

  • Page 32: Maintenance

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 MAINTENANCE Performance and Safety Checks see in the table below: Recommended Maintenance Frequency General cleaning As Need Inspect the system, cables and transducers Before Use/Daily System accuracy and performance verification Annually 8.1. General cleaning The LCD/CRT screen and all external surfaces can be cleaned with a soft cloth dampened with a neutral detergent.

  • Page 33: Chemicals That Damage Transducers

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 8.3.1 Chemicals that Damage Transducers: Some of these chemicals, such as phenol, benzothonium chloride, pHisohex, benzoyl peroxide, hydrogen peroxide, are commonly found in clinics or hospital settings while others are often found in antibacterial skin cleaners or lotions. Use of these chemicals will cause damage to a transducer.

  • Page 34: Cleansing And Disinfection Of Transducers Used In Endocavity Procedures

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 8.3.4 Cleansing and Disinfection of Transducers Used in Endocavity Procedures It is highly recommended to use Transducer’s Sheaths for Endocavity and Invasive uses. The transducer disinfection should be done prior to the first exam, and following every exam thereafter.

  • Page 35: Transportation, Storage And Utilization

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 TRANSPORTATION, STORAGE AND UTILIZATION 9.1. Transportation and storage The ultrasound scanner should be stored and moved according to the package technical documentation and the standard procedures. 9.2. Utilization Utilization/recycling of this equipment should be carried out by a specialized...

  • Page 36: Declaration Of Conformity

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 DECLARATION OF CONFORMITY...

  • Page 37: Appendices

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 APPENDICES 11.1. Guidelines for the safe use of diagnostic ultrasound A. Recommendations General • The use of diagnostic ultrasound to obtain information about functions or structures in human beings should be restricted to situations in which the medical benefit that may accrue from the diagnostic data outweighs any foreseeable risk.
  • Page 38 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 o ultrasonically induced capillary hemorrhaging in other soft tissues when Gas Contrast Agents are used. • Use of Gas Contrast Agents during a diagnostic ultrasound examination is not recommended within 24 hours before extracorporeal shock wave lithotripsy.
  • Page 39 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 • 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 principally made up of homogeneous soft tissue or a soft tissue/fluid path, as during a first trimester fetal examination or an abdominal examination.
  • Page 40 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 tissue affected, the potential for achieving clinical significance may increase in premature infants. • At the current maximum values for the MI of 1.9, it is unlikely that diagnostic ultrasound exposure could lead to clinically significant intestinal hemorrhaging in human beings.
  • Page 41 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 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.
  • Page 42 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 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.
  • Page 43 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 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.
  • Page 44 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 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.
  • Page 45 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 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.

  • Page 46: Acoustic Output

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 11.2. Acoustic Output...
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  • Page 95: Vigilance System

    TELEMED office or local Competent Authority or our official dealer/distributor including sending us the following form (or reporting the same data contained in this form in some other manner) and do not use this device.
  • Page 96 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 Date _____________________ Signature ________________...

  • Page 97: Returned Product Form

    TELEMED SmartUs User Guide, REV 3.10 2023.02.15 11.4. Returned product form RETURNED PRODUCT №_______ 20__.____.____ COMPANY ADDRESS PRODUCT □ TELEMED □ OTHER SERIAL NUMBER REASON FOR RETURN INSTRUCTIONS REGISTERED BY NC REPORT № □ □ □ PROPERTY OF TELEMED CUSTOMER WARRANTY □...
  • Page 98 TELEMED SmartUs User Guide, REV 3.10 2023.02.15 REVISION HISTORY Revision Revision COMMENTS ISSUE Date Initial release of the SmartUs EXT-1M User Guide 2013.09.28 Changes by test results 2013.11.04 IPX protection is added 2013.11.15 Corrections 2013.12.15 Labeling corrections, DoC 2015-03-25 SmartUs EXT-3M added 2016.01.19...

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