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TELEMED MICRUS EXT-1H User Manual

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TELEMED
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
NOTE: Non-TELEMED product names may be trademarks or registered trademarks of their respective
owners.
MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18
MICRUS EXT-1H
USER GUIDE
Distributed by
Articulate Instruments Ltd
Queen Margaret Campus
Queen Margaret University Drive
Musselburgh. EH21 6UU
United Kingdom
Phone: +44 131 474 0000
Internet:
E-mail:
awrench@articulateinstruments.com
1
www.articulateinstruments.com

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Summary of Contents for TELEMED MICRUS EXT-1H

  • Page 1 Musselburgh. EH21 6UU phones: (+370-5) 2106272 (+370-5) 2106273 United Kingdom fax: (+370-5) 2306733 Phone: +44 131 474 0000 Internet: http://www.pcultrasound.com/ Internet: www.articulateinstruments.com E-Mail: info@telemed.lt E-mail: awrench@articulateinstruments.com NOTE: Non-TELEMED product names may be trademarks or registered trademarks of their respective owners.

  • Page 2: Table Of Contents

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 INTRODUCTION ............................4 About the system / Intended use ......................4 Delivery set ............................5 About the System Software ......................... 5 Technical Specification ........................5 SAFETY ................................. 8 Electrical safety ............................ 8 Equipment protection .........................
  • Page 3 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Warranty Shipments, Returns and Adjustments ................29 Service Contract..........................29 MAINTENANCE ............................29 General cleaning ..........................29 Inspecting the System ........................29 Probe maintenance and disinfection ....................29 9.3.1 ChemicaMicrUs that Damage Transducers: ................30 9.3.2...

  • Page 4: Introduction

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 1 1 1 1 INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION 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.

  • Page 5: Delivery Set

    OFTWARE OFTWARE 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.
  • Page 6 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Electronic convex • Electronic microconvex • DEPTH SELECTION 2 – 31 cm (depth range depends on probe type and scanner model) FOCUSING Transmitting variable, 8 zones • Receiving point to point, dynamic •...

  • Page 7: Recommended Computer Requirements

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 • TIFF • XLSX • DCM (DICOM uncompressed) • DCM (DICOM-JPEG RGB/YBR) • DCM (DICOM-JPEG RGB/YBR Video) • TPD (Telemed Picture Data) • TVD (Telemed Video Data) • Cineloop Recording / playback up to several thousands frames •...

  • Page 8: Operational Environment

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Type BF applied part • EMC/EMI standards IEC 60601-1-2: 2007, Part 1: General requirements for • basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests Ultrasound exposure IEC 60601-2-37: 2007-08 Particular requirements for the •...

  • Page 9: Equipment Protection

    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.

  • Page 10: Biological Safety

    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.

  • Page 11: Cybersecurity

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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;...
  • Page 12 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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.

  • Page 13: Labeling

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 3 3 3 3 LABELING LABELING LABELING LABELING Table 1 describes the purpose and location of safety labels and other important information provided on the equipment.
  • Page 14 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18...

  • Page 15: System Overview

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 4 4 4 4 SYSTEM SYSTEM SYSTEM SYSTEM OVERVIEW OVERVIEW OVERVIEW OVERVIEW Here is main information about Ultrasound Scanners. The system consists of, see figure below: Beamformer • Ultrasound Probe • Personal Computer (Desktop / Notebook / Tablet PC) •...

  • Page 16: Probe Unit

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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 •...

  • Page 17: Connection And Indication

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 4.3 C C C C I I I I ONNECTION AND ONNECTION AND NDICATION NDICATION ONNECTION AND ONNECTION AND NDICATION NDICATION Front view of MicrUs beamformer Rear view of MicrUs beamformer IMPORTANT NOTE: The Ultrasound Scanner is partially powered through USB from the computer to which it is connected.
  • Page 18 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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.

  • Page 19: System Setup

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 6 6 6 6 SYSTEM SYSTEM SYSTEM SYSTEM SETUP SETUP SETUP SETUP 6.1 S S S S R R R R W W W W YSTEM YSTEM YSTEM YSTEM EQUIREMENTS AND EQUIREMENTS AND...

  • Page 20: Software Installation For Windows

    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.
  • Page 21 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Welcome screen will appears; • Click Next. • Choose appropriate system (MicrUs); • Click Next • Install drivers window; • Click Next •...

  • Page 22: Echo Wave Ii Software Installation

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Finalize drivers installation • Click Finish • AFTER driver installation: Connect USB cable to beamformer. • Windows operating system will find new device, let Windows find the drivers automatically. • 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.
  • Page 23 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Welcome screen will appears; • Click Next to continue; • Warning screen will appears. This • screen remind you that all settings and presets will be overwritten; If you want to save settings and •...
  • Page 24 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Window with default shortcut folder • will appears; Click Next; • Software is ready to be installed • Click Next; • Installation in progress; • Please wait; •...
  • Page 25 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Installation is finished; • Click Finish; • 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.
  • Page 26 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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.

  • Page 27: Ultrasound Scanner Monitor Utility

    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);...

  • Page 28: Warranty And Service Information

    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.

  • Page 29: Warranty Shipments, Returns And Adjustments

    ONTRACT ONTRACT 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.

  • Page 30: Chemicamicrus That Damage Transducers

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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.

  • Page 31: Cleansing And Disinfection Of Transducers Used In Endocavity Procedures

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 1. After every patient exam, wiping the ultrasound transmission gel off the transducer. 2. Wiping the transducer and cable with a dry or water-moistened soft cloth. 3. Wiping the transducer with either: A recommended disinfectant Enzol (Cidezyme) •...

  • Page 32: Utilization

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 10.2 U U U U 10.2 10.2 10.2 TILIZATION TILIZATION TILIZATION TILIZATION Utilization/recycling of this equipment should be made by specialized company and be according to the local law.

  • Page 33: Declaration Of Conformity

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 11 11 11 11 DECLARATION DECLARATION DECLARATION DECLARATION OF OF CONFORMITY CONFORMITY CONFORMITY CONFORMITY The latest Declaration of Conformity can be found by the following link: https://www.pcultrasound.com/certificates/ 12 12 12 12 APPENDICES...

  • Page 34: Quality Assurance

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 o 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.

  • Page 35: Mechanical Effects

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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.

  • Page 36: References

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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).
  • Page 37 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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.

  • Page 38: Glossary Of Terms

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 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 39: Vigilance System

    IGILANCE SYSTEM IGILANCE SYSTEM 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...
  • Page 40 TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 Post-Marketing Vigilance Form 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 _____________________________________________________________________...

  • Page 41: Returned Product Form

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 12.3 R R R R 12.3 12.3 12.3 ETURNED PRODUCT FORM ETURNED PRODUCT FORM ETURNED PRODUCT FORM ETURNED PRODUCT FORM...

  • Page 42: Acoustic Output Tables

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 12.4 A A A A 12.4 O O O O T T T T 12.4 12.4 COUSTIC COUSTIC UTPUT UTPUT ABLES ABLES COUSTIC COUSTIC UTPUT UTPUT ABLES ABLES 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...

  • Page 43: Revision History

    TELEMED MicrUs EXT-1H User Guide, Rev 5.5 2023-05-18 13 13 13 13 R R R R EVISION EVISION EVISION HISTORY EVISION HISTORY HISTORY HISTORY REVISION REVISION COMMENTS ISSUE DATE File Info: Title changed to display correct document name. Ch.11 2023.05.18 Updated Declaration of Conformity.

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