Related Manuals for TELEMED ArtUs EXT-1H
Summary of Contents for TELEMED ArtUs EXT-1H
- Page 1 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 ArtUs EXT-1H ArtUs EXT-2H Ultrasound Diagnostic System USER GUIDE...
- Page 2 ArtUs User Guide, REV 1.6 2022.04.20 Manufactured by TELEMED UAB Savanoriu pr. 178A Vilnius, LT-03154 Lithuania Telephones: (+370-5) 2106272 (+370-5) 2106273 Fax: (+370-5) 2306733 Internet: http://www.telemed.lt 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 ArtUs User Guide, REV 1.6 2022.04.20 1. INTRODUCTION .................... 5 1.1. About the system / Intended use ..............5 1.2. Delivery set ..................... 6 1.3. About the system software ................7 1.4. Technical Specifications ................. 8 2. SAFETY ....................... 12 2.1. - Page 4 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 7.3. Service Contract ................... 33 8. MAINTENANCE ................... 34 8.1. General cleaning ................... 34 8.2. Inspecting the System ................... 34 8.3. Transducers maintenance and disinfection ........... 34 8.3.1. Chemicals that Damage Transducers: ..............35 8.3.2.
-
Page 5: Introduction
It is an ideal budget solution for hospitals, specialized diagnostic centers, public and private clinics. Here in the User Guide you can find information about ArtUs EXT-1H/2H and its safety and maintenance information. Echo Wave II Software Operation Manual contains a description of the controls. -
Page 6: Delivery Set
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 Common view of ArtUs EXT-1H is shown below (without transducer). Common view of ArtUs EXT-1H is shown below (without transducer). 1.2. Delivery set Beamformer ● Operation Manual ● This User Guide ● Software and manuals (eIFU) ●... -
Page 7: About The System Software
1.3. 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: Technical Specifications
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 1.4. Technical Specifications Table 1 contains technical specifications of ArtUs EXT-1H/2H. Table 1 IMAGING MODES B-steer for linear transducers Compound for linear and convex transducers Virtual convex for linear transducers Expanded view angle for convex transducers... - Page 9 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 Real-time spatial filter: 4 values CFM palette: 10 maps B/Color priority control Color threshold control CFM baseline control Doppler frequency selection: 2-3 frequencies for each transducer Color frame averaging: 8 values DEPTH SELECTION 1.
- Page 10 • TELEMED Drivers Package Drivers • Echo Wave II software (B/W + Doppler modes) Software DIMENSIONS AND WEIGHT 136 x 189 x 28 (ArtUs EXT-1H) Dimensions W x D x H, 140 x 205 x 65 (ArtUs EXT-2H) 0.66 (ArtUs EXT-1H) Weight, kg 1.10 (ArtUs EXT-2H)
- Page 11 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 • USB 3.0 connection 5 VDC, 0.13 A Max SAFETY • IEC 60601-1 Medical electrical equipment part 1: General requirements for safety. Electromechanical safety Class II Type BF applied part • European Norm...
-
Page 12: Safety
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 requirements (occurrence or probability of risk) you must to inform the local dealer and the manufacturer immediately. -
Page 13: Equipment Protection
• do not supply power to the system from unapproved AC power supply, not supplied by TELEMED; • only use accessories and peripherals recommended by TELEMED. WARNING: To allow quick and easy disconnecting of equipment from power source in case of emergency place the equipment so that there is a gap at least 10 cm between the rear panel and the other object (wall, toher equipment, tec.) and the power plug is accessible by hand. -
Page 14: 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 transducers do not contain natural rubber latex that contacts humans. Observe the following precautions related to biological safety: •... -
Page 15: Cybersecurity
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 This default level is set: • when the system is first turned on; • when the transducer is first turned on. It is highly recommended to set the default level: • when changing from one exam category to another;... -
Page 16: Confidentiality
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 Use a network supporting Wi-Fi 802.11n and WPA (Wi-Fi Protected Access) or WPA2 (Wi-Fi Protected Access II) as your security protocol. Refer to your network equipment documentation for setting wireless network security. Do not use untrusted wireless access points, it may allow third party to perform harmful actions. - Page 17 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 18 ** 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. Other Measurement and Calculation Accuracy Parameter...
-
Page 19: Labeling
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 manufacturer... -
Page 20: System Overview
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 SYSTEM OVERVIEW The ArtUs EXT-1H/2H system handles the multi-element transducers. Here is main information about Ultrasound Scanner. The system consists of, see figure below: • Beamformer • Power Supply +12VDC • Ultrasound Transducer •... -
Page 21: Components & Modifications
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 4.2. Components & Modifications 4.2.1. Basic unit / Beamformer Basic unit functions are: • excite electric pulses to fire the transducer; • ultrasound echo signals pre-amplification; • compensation of the ultrasound attenuation due to travel depth;... -
Page 22: Peripherals/Compatibility
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 4.3. Peripherals/Compatibility ArtUs EXT-1H/2H scanner can work / operate with standard PC features: • SVGA monitor • mouse • Laser printer 600 dpi, (preferred HP • keyboard printers), optional Optional accessories: • Biopsy Clip Bracket C- type (for •... -
Page 23: Using The System
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 USING THE SYSTEM 5.1. INSTALLATION WARNINGS • The ultrasound scanner should be installed in a room specifically designated for this use, such as an ultrasound scanner laboratory, with an area of at least 10 m and with window coverings to provide some ambient lighting. -
Page 24: Getting Started
• Chapter 5.3 Windows configuring 1. Connect the power supply and USB cable. Insert the transducer connector into the socket firmly until it locks with spring latches – please refer to the picture below (according to configuration of ArtUs EXT-1H). -
Page 25: Ultrasound Scanner Monitor Utility
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 2. Switch on the computer power and wait until Windows is ready. 3. Start Echo Wave II application. Note: For USA market by FDA recommendation the system performs transducer elements check each time when transducer is connected to the system or activated. - Page 26 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 • When the icon is highlighted in GREEN – the drivers for the ArtUs beamformer are properly installed and the beamformer is connected to the USB port and the system is ready to start;...
- Page 27 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 unplug the power cable once this has been done.
-
Page 28: Windows Configuring
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 5.4. Windows Configuring 5.4.1. E-mail Configure the E-mail program (for example, Microsoft Outlook Express, Mozilla Thunderbird). It is necessary for normal operation of the direct E-mail sending feature of the ultrasound software. 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. -
Page 29: Firewall
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 • Microsoft Security Essentials Download https://support.microsoft.com/en-us/help/14210/security- essentials-download • Windows Defender https://support.microsoft.com/en-us/help/17464/windows- defender-help-protect-computer • Updating your Microsoft antimalware and antispyware software https://www.microsoft.com/security/portal/definitions/adl.a 5.4.5. Firewall It is strongly recommended that on computer will be turned on Windows Firewall. -
Page 30: Windows Applocker
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 • Digital Signatures for Kernel Modules on Systems Running Windows Vista https://msdn.microsoft.com/en-us/library/bb530195.aspx • Digital signatures and certificates https://support.office.com/en-us/article/Digital- signatures-and-certificates-8186cd15-e7ac-4a16-8597- 22bd163e8e96 5.4.9. Windows AppLocker It is strongly recommended that in Windows will be configured what applications can be run by what user(s) by using Windows AppLocker. -
Page 31: Troubleshooting
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 TROUBLESHOOTING Read this chapter carefully before calling the Technical Support service. 6.1. FAQ Question: An increased level of noise and interference is observed on ultrasound images as shown at image below. What do I need to do in order to reduce the noise... - Page 32 • Serial number of the scanner (for example: 2351-120428-9686); • Transducer type (for example: C5-2H60-A5); • Serial number of the transducer (for example: 3241-120504-9701); • TELEMED Drivers Package version (for example: TELEMED Drivers Package 1.17.3); • Echo Wave II software version (for example: Echo Wave II 3.7.1);...
-
Page 33: 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 34: Maintenance
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 35: Chemicals That Damage Transducers
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 Transducer model Compatible disinfectant BIPC6.5/10/128Z-4 + BIPL7.0/60/128Z-4 BIPC8-4R10N-4 + BIPL10-4L60N-4 Cidex Plus, Cidex OPA, Anioxyde 1000, 75% BIPC9-4R10H-4 + BIPL12-5L70H-4 IPA, Sani-cloth bleach, Metricide OPA plus, HL9.0/40/128Z-4 Rely+On PeraSafe, Cydezyme XTRA, L12-5L40N-4 Cleansept Wipes, Nu-Cidex, Alkazyme,... -
Page 36: Recommended Procedures For Transducer Processing
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 WARNING: Some of chemicals, such as phenol, benzethonium chloride, hexachlorophene (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 37: Cleansing And Disinfection Of Transducers Used In Endocavity Procedures
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 38: Transportation, Storage And Utilization
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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. Disposal Disposal/recycling of this equipment should be carried out by a specialized company... -
Page 39: Declaration Of Conformity
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 DECLARATION OF CONFORMITY... -
Page 40: Appendices
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 APPENDICES 11.1. Guidelines for the safe use of diagnostic ultrasound • 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 41 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 • ultrasonically induced capillary hemorrhaging of the intestine where intestinal peristalsis is inhibited or conditions promote intraluminal or sub-mucosal gas collections; • ultrasonically induced capillary hemorrhaging in other soft tissues when Gas Contrast Agents are used.
- Page 42 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 exceeds 1. • The Soft Tissue Thermal Index (TIS) is the appropriate indicator of the...
- Page 43 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 44 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 where it 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 45 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 46 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 47 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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.
- Page 48 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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.
-
Page 49: Acoustic Output
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 50 TELEMED ArtUs User Guide, REV 1.6 2022.04.20 _________________________________________________________ Contact person/ Department __________________________________ Address __________________________________________________ Phone _________________________ Fax _____________________ Email __________________________ Date _____________________ Signature ________________...
-
Page 51: Returned Product Form
TELEMED ArtUs User Guide, REV 1.6 2022.04.20 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 52 TELEMED ArtUs User Guide, REV 1.6 2022.04.20...
-
Page 53: Revision History
ArtUs User Guide, REV 1.6 2022.04.20 REVISION HISTORY Revision History REVISION REVISION COMMENTS ISSUE DATE Initial release of the ArtUs EXT-1H/2H User Guide 2018.10.18 TROUBLESHOOTING additions, some typo 2019.07.02 changes Changes in chapter 4. Illustrations updated 2020.01.06 Updated pictures with new case. Updated the list 1.3 –...
Need help?
Do you have a question about the ArtUs EXT-1H and is the answer not in the manual?
Questions and answers