8
Other Accessories
i.
Coupling Gel:
Two containers of hypoallergenic
ultrasound coupling gel, which is 96% water, are
provided with your EXOGEN™ device. You must apply
coupling gel to the transducer surface at the start of
each treatment period in order to permit transmission
of the ultrasound signal from the transducer surface
to the skin over the fracture site. Each container has
200ml of coupling gel. A single pump (1.4cc) portion
is the recommended amount of coupling gel for each
treatment session. Each bottle will provide enough gel
for approximately 140 treatments. Please replace the
clear plastic top on the gel bottle after dispensing gel.
There are other coupling mediums which can be
used if a skin reaction is noted with the standard gel.
Please call the Patient Service Department of Smith &
Nephew, Inc., if this occurs.
Note: EXOGEN ultrasound coupling gel supplied is
the recommended gel for use with this system. Do
not substitute other gels as they may damage the
transducer surface or impede signal transmission.
Please call the Patient Service Department of Smith &
Nephew, Inc., if you need more coupling gel.
Manuals:
This manual describing how to use the
EXOGEN 4000+ System is included.
E. Adverse Effects
In laboratory, animal and clinical research, the EXOGEN
device intensity (power level) (See Section D — “Device
Description”) was assessed for its potential for producing
significant temperature increases in body tissue, the most
common and best understood effect of conventional
ultrasound. Conventional therapeutic ultrasound
applications utilize ultrasound intensities of approximately
1,000 to 5,000 mW/cm
2
, and must be applied in a stroking
manner to avoid tissue necrosis caused by excessive
temperature increases due to stationary application. The
30 mW/cm
2
output intensity of the device you received is
typically only 1% to 5% of the output intensity of
conventional therapeutic ultrasound devices and therefore
can be used in a stationary application. The ultrasound
intensity is comparable to diagnostic ultrasound (1 to 50
mW/cm
2
), such as the intensities used in obstetrical
sonogram procedures (fetal monitoring). The results of the
PMA safety report on the EXOGEN device and EXOGEN
PMA research indicate that the EXOGEN device is
incapable of producing harmful temperature increases in
body tissue and there is also no evidence of non-thermal
adverse effects.
