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Summary of Contents for Esaote MyLab
- Page 1 Rev. G January 2013 MyLab SAFETY AND STANDARDS OPERATOR MANUAL Doc # 81B15EN07...
- Page 3 Introduction MyLab This manual provides information on Safety and Standards for the product. This manual is organized in the following chapters: Chapter 1: Operator Safety This chapter describes the situations that could affect the operator safety when an ultrasound system is used.
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Page 5: Table Of Contents
The Output Default Settings __________________________________________________________________________ 2-7 Methodology and Accuracy of Display __________________________________________________________________ 2-7 Maximum Acoustic Output ___________________________________________________________________________ 2-8 Acoustic Output Controls ____________________________________________________________________________ 2-8 Implementing ALARA with MyLab ___________________________________________________________________ 2-10 Acoustic Output Tables _____________________________________________________________________________ 2-11 Glossary and Definition of Terms _____________________________________________________________________ 2-11... - Page 6 DEVICES STANDARDS _______________________________________________________________ 3-1 Medical Device Directive ______________________________________________________________________________ 3-1 Medical Electrical Equipment Standard _________________________________________________________________ 3-1 Electromagnetic Compatibility _________________________________________________________________________ 3-1 Biocompatibility_____________________________________________________________________________________ 3-2 Standards Summary Table ____________________________________________________________________________ 3-2 Acoustic Output _____________________________________________________________________________________ 3-3 Peripherals Standard Requirements ____________________________________________________________________ 3-3...
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Page 7: Operator Safety
The same manual also contains all information MyLab on the recommended peripherals that may be connected to the system. If help is needed, ESAOTE personnel will be glad to provide you with the necessary assistance to install your system. Warnings Incorrect installation of the system may cause operator hazard. -
Page 8: Wireless Safety
This symbol identifies a recyclable component. Depending on the dimensions of a recyclable component, this symbol and the component’s material are printed on the component by ESAOTE. In this system, packing materials are reusable and recyclable; the (plastic) casing of the unit and display and most of the (plastic) cart components are also recyclable. -
Page 9: Moving The Equipment
M y L a b – Moving the Equipment system is designed to be easily moved by the operator. However the MyLab equipment weight could require assistance during transportation. The MyLab “Getting Started” manual details the weight and dimensions of your configuration. -
Page 10: Explosive Hazard
M y L a b – an arm-held model should be packed in the original shipment case (or other protective devices as available through ESAOTE) during transportation, for mobile systems, make sure the cart wheels are blocked and the cart secured during transportation. -
Page 11: Repetitive Strain Injury
S A F E T Y A N D S T A N D A R D M y L a b – The Endocavity transducer requires specific cleaning and disinfecting procedures. See the “Transducers and Consumables” manual for complete details on these procedures. -
Page 12: Safety Symbols
S T A N D A R D M y L a b – Safety Symbols device uses the EN60601-1 safety symbols for medical electronic MyLab devices to classify a connection or to warn of any potential hazards. On (power) Off (power) Type BF applied part High Voltage This symbol generically means "Attention". -
Page 13: Patient Safety
• Do not replace the system fuses with types different from those specified by the Getting Started” manual. MyLab “ • Mobile configurations provide insulated plugs and connectors to manage optional hard copy devices (Printers, etc). Follow the instructions in the “Getting Started” manual to install such a device. -
Page 14: Electromagnetic Compatibility
• Contacting ESAOTE Service personnel for help. E l e c t r o - S u r g i c a l U n i ts (E S U s ) Electro-surgical units or other devices that introduce radiofrequency electromagnetic fields or currents into the patient may interfere with the ultrasound image. -
Page 15: Items In Contact With Patient
M y L a b Items in Contact with Patient ESAOTE probes that are in contact with the patient comply with EN ISO 10993 “Biocompatibility Tests Requirements”, according to their intended use. No negative reactions to these materials have been reported. -
Page 16: Ultrasound Bioeffects
S A F E T Y A N D S T A N D A R D – M y L a b identified in the future, current data indicate that the benefits to patients deriving from the prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present. -
Page 17: On-Screen Real-Time Acoustic Output Display
This makes it possible for the user to get the best image possible while following the ALARA principle and thus to maximize the benefits/risks ratio. incorporates a real-time acoustic output display according to the MyLab O D S AIUM /NEMA "Standard for Real-Time Display of Thermal and Mechanical... -
Page 18: The Thermal Index
S A F E T Y A N D S T A N D A R D – M y L a b bioeffect is actually occurring: the index is not intended to give an "alarm" but to use it to implement the ALARA principle. The Thermal Index The purpose of the Thermal Index (TI) is to keep the user aware of conditions that may lead to a temperature rise under certain defined assumptions. -
Page 19: The Output Display
System default settings depend upon the probe, the mode of operation and the application which is selected during the patient ID procedure. The defaults MyLab the transmit power to obtain output levels that are below the historic Ispta limits established by the FDA for the selected application. -
Page 20: Maximum Acoustic Output
Ispta is limited to the preamendments FDA limit for peripheral vascular applications (720 mW/cm Other application limits have been established as per this table: Application Preamendments Ispta MyLab Maximum Limits (mW/cm 2 ) (mW/cm 2 ) OB/Fetal Cardiac... - Page 21 MyLab by varying the beam profile. Generally, higher MI's and TI's will occur with closer focal points. If more than one transmit focal point is activated, MI and TI values will each correspond to the zone with the largest value.
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Page 22: Implementing Alara With Mylab
In Doppler modes, if the tracings are displayed with an updated 2D, the 2D values are used if higher than the Doppler indices. Implementing ALARA with MyLab Prudent use implies that during an exam the user should use for the shortest time the least amount of acoustic output to obtain the necessary clinical information for diagnostic purposes. -
Page 23: Acoustic Output Tables
According to the IEC 61157 and EN 60601-2-37, the acoustic output tables provide the acoustic output data for each probe in every operating mode. These tables are located in the Operator Manual CD. MyLab Glossary and Definition of Terms "In Situ" Intensities Calculations 2-11... - Page 24 S A F E T Y A N D S T A N D A R D – M y L a b When determining the possible effects of the ultrasound beam on tissue, the The intensity measurements made intensity encountered at the tissue site must be calculated. Because of attenuation in water in the of the beam within the body, the intensity at the tissue site ("in situ") may be 10 to laboratory must be...
- Page 25 S A F E T Y A N D S T A N D A R D – M y L a b The peak rarefactional pressure (p in MPa) is the temporal peak rarefactional Peak Rarefactional pressure amplitude at a specified point. Pressure The Pulse Intensity Integral (PII) is the time integral of instantaneous velocity for Pulse Intensity...
- Page 26 S A F E T Y A N D S T A N D A R D – M y L a b (z) (cm) Equivalent beam diameter π (cm) Equivalent aperture diameter aprt π (MHz) Center frequency. (mW/cm Equivalent to the spatial peak temporal average derated SPTAB.3 (0.6 dBcm ) intensity...
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Page 27: Devices Standards
Medical Device Directive This system complies with the Medical Device Directive (MDD) 93/42/EEC, according to which ESAOTE has classified this device as a Class IIa device. Note for U.S. Customers U.S. Federal Law restricts this device to sale, distribution and use by or on the order of a physician. -
Page 28: Biocompatibility
– S A F E T Y A N D S T A N D A R D M y L a b further notice. The “alert sign” on the product enclosure and on the packaging advises users accordingly. Users in the United States of America: This equipment contains radio modules fully compliant with CFR47 Part 15 Sub. -
Page 29: Acoustic Output
Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Acoustic Output acoustic output complies with the requirements of the FDA Track 3 MyLab guidance. Peripherals Standard Requirements When peripherals are connected to an ultrasound system, they become part of a medical system. - Page 30 – S A F E T Y A N D S T A N D A R D M y L a b...
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