OsteoSys SONOST 3000 - Page 10

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
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Target
group
User
A
Education: Bachelor or higher.
Physician or trained medical personnel located in hospitals and clinics
Knowledge: Educated or trained for BMD (Bone Mineral Density) under the
relevant majors such as orthopedics, internal medicine, obstetrics &
gynecology, etc.
Language Understanding: English/Korean.
Experience: More than 2 years of work experience in hospital as a doctor, a
sonographer and etc.
(Patient does not operate the BMD device)
Patient
A
a) Ages: 20 – 100 years old
b) The patient condition: Osteopenia, Osteoporosis or Normal healthy bone
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Disposable device
N/A
SONOST 3000 is not a disposable device.
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Invasive device
N/A
Not intended to be invasive
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Implantable device
N/A
Not intended to be implantable
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Duration of use or
contact with body
A
BMD measurement is performed once a year or once every two years
(It depends on the patient's situation).
Contact with body:
SONOST-2000: there are contact point between calcaneus part and balloon
as below image.
SONOST 3000: It als same as SONOST-2000
Need to apply ultrasound gel in between skin and probe in order to get