EchoNous Bladder - Power Supplies (Chargers); Biological Safety; Acoustic Output

EchoNous Bladder & Vein User Guide 85
Power supplies (chargers)
Power supplies (chargers)
The external EchoNous power supplies (chargers) comply with the requirements of EN IEC 60601-1 Edition 3.1.
Biological safety
The device can be disinfected for reuse on immunocompromised and non-immunocompromised patients after:
• Frequent contact with healthy skin (frequent low risk).
• Occasional contact with mucous membranes or contamination with particularly virulent or readily
transmissible organisms (occasional intermediate risk).
Acoustic output
Ultrasound imaging has been in regular use for over 20 years and has an excellent safety record. Even though
there are no known risks of ultrasound imaging, it heats the tissues slightly and may produce small pockets of gas
in body fluids or tissues (cavitation). The long-term effects of tissue heating and cavitation are not known.
Given potential does exist for bio-effects with ultrasound exposure, any exposure should be kept A
s Low As
R
easonably Achievable. Scans should only be performed when there is a medical benefit and in the shortest time
commensurate with obtaining an adequate study. As the acoustic output of the device does not exceed an MI or
TI of 1.0, visual display of MI and TI values is not required. A generic ALARA education program is supplied with
your System (see enclosed ISBN 1-93004 7-71-1, Medical Ultrasound Safety).
Do not open or modify the EchoNous Power Supply (P005179), the
EchoNous AI Station power supply (P005332), or any other supplied
power supplies - Risk of electric shock
The ALARA principle (As Low As Reasonably Achievable) should be
employed for all medical ultrasound exposure.
TABLE 4. B-mode acoustic output and uncertainties
I
SPTA.3
[mW/
cm
2
] TI type TI Value MI
I
PA.3
@MI
max
[W/
cm
2
]
EchoNous
Bladder Probe
Output
2.57 TIS 0.0366 0.925 90.1
EchoNous
Bladder Probe
Uncertainties
±8.4% ±8.6% ±4.3% ±8.4%