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TELEMED UAB ClarUs User Manual

Ultrasound diagnostic system
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TELEMED
ClarUs User Guide, REV 4.0 2013.12.04
ClarUs
ClarUs EXT-1M
Ultrasound Diagnostic System
USER GUIDE
1

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  • Page 1 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 ClarUs ClarUs EXT-1M Ultrasound Diagnostic System USER GUIDE...
  • Page 2 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 Manufactured by TELEMED UAB Dariaus ir Gireno str. 42 Vilnius LT-02189 Lithuania Telephones: (+370-5) 2106272 (+370-5) 2106273 Fax: (+370-5) 2306733 Internet: http://www.telemed.lt E-Mail: info@telemed.lt NOTE: Non-TELEMED product names may be trademarks or registered trademarks...

  • Page 3: Table Of Contents

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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 ClarUs User Guide, REV 4.0 2013.12.04 8.3.3 General Cleansing for Transducers Used in Non-Invasive Procedures ..31 8.3.4 Cleansing and Disinfection of Transducers Used in Endocavity Procedures 8.4. System accuracy / performance verification 9. TRANSPORTATION, STORAGE AND UTILIZATION 9.1.

  • Page 5: Introduction

     Industry standard tZIF-260 (Zero Insertion Force) probe connector;  Digitally controlled acoustic power;  Light weight, true mobility, flexible architecture. Here in the User Guide you can find information about ClarUs and safety and maintenance information. Echo Wave II Software Operation Manual contains a description of the controls.
  • Page 6 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 Common view of ClarUs shown below. Figure 1 Common view of ClarUs EXT-1M shown below. Figure 2...

  • Page 7: Delivery Set

    In the software the unique technologies making the intellectual property of TELEMED company are used. Latest software versions can be downloaded directly on the Internet from http://www.telemed.lt 1.4. Technical Specification Table 1 contains technical specifications of ClarUs: Table 1 IMAGING MODES  Color Doppler (CFM) ...
  • Page 8 TELEMED ClarUs User Guide, REV 4.0 2013.12.04  cineloop recording/play: several  ultrasound image size: automatically thousands frames (depends on adjustable to screen resolution computer memory size and scan  mode) gray scale: 256   zoom mode: from 60% to 600% in all color scale: 256 ...
  • Page 9 TELEMED ClarUs User Guide, REV 4.0 2013.12.04  High Line Density scan mode for better resolution  TGC Control, 5 sliders 40 dB  dynamic range: 120 dB, 8 values  overall gain control  M - mode sweep speed control ...
  • Page 10 TELEMED ClarUs User Guide, REV 4.0 2013.12.04  Direct e-mail sending function Internet with image or video attachment  Standard TV output using computer's display adapter TV output (option) ULTRASOUND SOFTWARE  Drivers TELEMED Drivers Package  Software Echo Wave II software (B/W + Doppler modes) ...
  • Page 11 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 ultrasound equipment.1992. OPERATIONAL ENVIRONMENT  Environment temperature : 10 - 40 ° C Nominal operational  Relative humidity not to exceed: 85 % environment  Atmospheric pressure: 70 - 106 kPa...

  • Page 12: Safety

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 If the ultrasound scanner will be moved or left unused for a long period of time without being switched on it is recommended that it be disconnected from power supply. If a scanner is to be switched on, do not interrupt this while operating the system and while the ultrasound software is being loaded.

  • Page 14: Ultrasound Exposure And Alara Principle

    Watch the POWER level (on-screen display) permanently. Whenever possible, controls and system features should be used to optimize the image before increasing the acoustic output level. Follow the ALARA principle during all patient examinations. The ClarUs employs the ALARA principle in configuring factory defaults.

  • Page 15: Cyber Security

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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).
  • Page 16 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 diagnosis. 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: Labeling

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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  Manufacturer name and address; Identification and  Model;...

  • Page 18: System Overview

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 SYSTEM OVERVIEW The ClarUs system handles the multi-element probes. 4.1. Principle of operation The 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.

  • Page 19: Clarus

    2.0 - 5.0 ● ● ● ● ● L12-5L40N 5.0 - 12.0 4.2.3 ClarUs ClarUs is an all-in-one modification combined beamformer and notebook 4.2.4 ClarUs EXT-1M ClarUs EXT-1M is the beamformer to be connected to a PC through USB 2.0...

  • Page 20: Connection And Indication Clarus

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 4.3. Connection and Indication ClarUs Front view Rear view...
  • Page 21 The ClarUs features a USB hub For IEC601.1 compliance any computer equipment connected to the USB interface of the ClarUs must be certified to IEC standards (e.g. IEC 60950) and configured to comply with IEC 60601-1-1. individuals who connect computer equipment to this interface are configuring a medical system and they are therefore responsible for ensuring that the system complies with IEC 60601-1-1.

  • Page 22: Peripherals/Compatibility

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 4.4. Peripherals/Compatibility ClarUs family scanners can work / operate with standard PC features:  USB mouse  USB keyboard  SVGA monitor  Laser printer 600 dpi, (preferred HP printers), optional Optional accessories: ...

  • Page 23: Installation Warnings

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 INSTALLATION WARNINGS  The ultrasound scanner should be installed in the premises specifically intended for such use such as an ultrasound scanner lab with an area not less than 10 m2 and with window coverings to provide some diffused lighting.

  • Page 24: Getting Started With Clarus

    Ultrasound Scanner Monitor utillity Ultrasound Scanner Monitor utility is used for system status monitoring. In addition, this utility helps to see when and how the ClarUs is connected to the computer and to view the generated Log file.  Utility icon is located in the...
  • Page 25 USB port;  When the icon is highlighted in GREEN – the drivers for the ClarUs beamformer are properly installed and the beamformer is connected to the USB port and the system is ready to start;...

  • Page 26: Windows Configuring

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 NOTE: Do not unplug the power cable during the scan mode. Doing this may cause damage to the scanner. Exit the software and only unplug the power cable once this has been done.

  • Page 27: Troubleshooting

    A. The reason for this appearance may be electronic equipment and devices which emit this type of electromagnetic noises. 6.2. Fuses locations (ClarUs) 2 fuses 250V 4A are under cover nearby power switch (ClarUs rear panel)

  • Page 28: Contact With Technical Support Service

    First send technical support service the following information:  Scanner type (for example: ClarUs EXT-1M);  Serial number of the scanner (for example: 2351-090428-9686);  Probe type (for example: C7-3R50N);  Serial number of the probe (for example: 3241-090504-9701);...

  • Page 29: Warranty And Service Information

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 WARRANTY AND SERVICE INFORMATION 7.1. Warranty TELEMED guarantees that the diagnostic system is free from defects regarding materials and workmanship at the original purchaser's location for a period of 24 months (the one exception being the probe which is guaranteed for 18 months).

  • Page 30: Maintenance

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 MAINTENANCE Performance and Safety Checks see in the table below: Recommended Maintenance Frequency General cleaning As Need Inspect the system, cables and probes 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 31: Chemicals That Damage Transducers

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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 32: Cleansing And Disinfection Of Transducers Used In Endocavity

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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 33: Transportation, Storage And Utilization

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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 34: Declaration Of Conformity

    TELEMED ClarUs User Guide, REV 4.0 2013.12.04 10. DECLARATION OF CONFORMITY DECLARATION OF CONFORMITY 0482 TELEMED UAB Dariaus ir Gireno str. 42, Vilnius, LT-02189 Lithuania Declare under our sole responsibility that: Equipment Probes Ultrasound scanner ClarUs MC10-5R10N ClarUs EXT-1M MCV9-5R10N...
  • Page 35 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 APPENDIX 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 36 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 particularly in the case of infants and neonates and especially if they are pre-term; o ultrasonically induced capillary hemorrhaging of the intestine where intestinal peristalsis is inhibited or conditions promote intraluminal or sub-mucosal gas collections;...
  • Page 37 TELEMED ClarUs User Guide, REV 4.0 2013.12.04  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.
  • Page 38 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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.
  • Page 39 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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).
  • Page 40 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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.
  • Page 41 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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.
  • Page 42 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 ALARA (As Low As Reasonably Achievable): a principle which is used to reduce any unnecessary and 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.
  • Page 43 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 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...
  • Page 44 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 2. Vigilance system This equipment is subject to the TELEMED vigilance system (post-marketing vigilance) in casse of potential or real hazards for the patient or for the operator which might occur during normal system functioning, in order to be able to remove them with the best efficiency and timing.
  • Page 45 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 3. Returned product form RETURNED PRODUCT №_______ 200 _.____.____ COMPANY ADDRESS PRODUCT □ TELEMED □ OTHER SERIAL NUMBER REASON FOR RETURN INSTRUCTIONS REGISTERED BY NC REPORT № □ □ □ PROPERTY OF TELEMED...
  • Page 46 TELEMED ClarUs User Guide, REV 4.0 2013.12.04 REVISION HISTORY Revision History REVISION ISSUE DATE REVISION COMMENTS 2013.12.04 Added fuses and labels 2012.03.28 Corrections 2011.03.29 ClarUs EXT-1M added 2009.11.09 Initial release of the ClarUs User Guide...

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Clarus ext-1m

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