OsteoSys SONOST 3000 - Page 11

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
11
proper contact for path of ultrasound waves.
10
Contacting with
body fluids or
others
N/A
There is no contact between any body fluids or people during the
examination process.
11
Measurement site
A
The correct position for measurement for calcaneus bone on the heel is as
the below.
It's just below the area of the ankle, where you should apply enough amount
of ultrasound gel just like the below instructions. (need to apply to both
sides of feet)
*According to the article Selection of the optimal skeletal site for fracture
risk prediction, the most significant relationships of BMC to fracture risk
were observed for the Os-calcis (Richard D. Wasinch, Philip D. Ross, Lance K.
Heilbrun, and John M. Vogel)
*According to the article Diagnostic value of calcaneal quantitative
ultrasound in the evaluation of osteoporosis in middle-aged and elderly
patients, the study assessed calcaneal QUS and DXA in senile osteoporosis
diagnosis performance, as osteoporosis screening not only has good
specific degrees, and with the lumbar spine and proximal femur DXA has
good correlation, in screening for large-scale people play the role of more
convenient, economic. Therefore, calcaneal QUS can be recommended as a
pre-screening tool to determine whether DXA screening should be
performed and timely treatment should be performed for patients with pre-
existing risk of osteoporosis and patients with mild osteoporosis to reduce
the risk of fracture. (Changzhou Li, Jifeng Sun, Li Yu)
Guidance and manufacturer’s declaration – electromagnetic emissions
The model SONOST 3000 is intended for use in the electromagnetic environment specified below. The customer
or the user of the model SONOST 3000 should make sure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The model SONOST 3000 uses RF energy only for its internal
functions. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
The model SONOST 3000 is suitable for use in all establishments
including domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity