International Ultrasound Standards Flashcards
What conditions must ultrasound scanners meet in order to produce the higher derated intensity?
Must display real-time MI 7& TI values, must provide an ALARA education programme.
What is the limit for derated I(spta)?
720mW/cm^2
What in the limit for the derated I(sppa)?
190W/cm^2
What MI does 190W/cm^2 equate to?
MI=1.9
What is the MI limit for opthalmology?
MI=0.23
What information should be issued with transducers supplied by a manufacturer?
- Maximum MI & TI values
- Derated Peak negative pressure
- Acoustic Power
- Centre Frequency
- Aperture Dimensions
- Pulse duration
- Focal lengths
What should be covered by the Track 3 Education Programme?
- Benefits and Risk of Use
- Risk of NOT use
- Risk associated with increasing Acoustic power
- Benefits of increasing Acoustic power
- Responsibility of user at higher acoustic powers
- ALARA principle
What is the I(spta) limit for ophthalmology?
50mW/cm^2
What are the MI and TI limits for ophthalmology?
MI - 0.23, TI - 1.0
What are the MI and TI limits for all other scanning? (FDA)
MI - 1.9, TI - 6.0
To what class, under EU MDD, do ultrasound scanners belong?
Class IIa - medium risk
Under IEC 60601-2-37, for what is the operator responsible?
- Understanding the risks of the output of the equipment
- Obtaining the diagnostic information whilst minimising the risk to the patient.
Under IEC 60601-2-37, What are general requirements for using Ultrasound?
- Prudent use and regular testing statements must be provided.
- Real time MI and TI valuer must be displayed (if the scanner is capable of exceeding an MI or TI of 1.0).
- Maximum Mi and TI values should be provided for each mode.
Transducer surface temperatures must not exceed 43 (in”use”) or 50 (in air) degC. - For trans-oesophageal probes, real-time surface temperatures must be displayed if T exceeds 41 degC.
What guidance is given under IEC 60601-2-37?
- There are no stated TI or MI intensity limits
- Output should be limited due to the manufacturers risk management
- TI values over 1.0 might best be avoided in obstetrics.
When is the MI of greater importance?
- When using contrast material
- Cardiac scanning (proximity to lung)
Abdominal bowel scanning (presence of bowel gas)