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User's Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000
Guidance and manufacturer's declaration
Guidance and manufacturer's declaration – Clinical information
No
Contents
1
Intended Use
Name of Disease
2
or Condition
3
Indications
A or
N/A
The SONOST-2000 system supports the doctor's activities for the
diagnosis of osteoporosis and the prevention of future fractures to the
A
patient through the measured BMD results. The measurement sites is
calcaneus/ Heel bone.
A
Osteoporosis, Osteopenia, Normal healthy bone
All women 65 years and older and men 70 years and older for
asymptomatic screening.
Women younger than 65 years old at risk for osteoporosis:
Estrogen deficiency
History of maternal hip fracture before the age of 50
Low body mass (less than 57.6kg/127 pounds)
History of amenorrhea more than 1 year before the age of 42.
Women younger than 65 years old or men younger than 70 years old
with the following risk factors:
Current cigarette smoker
Loss of height
Thoracic Kyphosis
Individuals at any age with bone mass osteopenia or fragility fractures on
imaging studies.
Individuals 50 years and older who developed wrist, hip, spine, or
proximal humerus fractures with minimal or no trauma, excluding
A
pathologic fractures.
People of any age who developed one or more insufficiency fractures.
Individuals receiving (or expected to receive) glucocorticoid therapy
equivalent to > or = to 5 mg of prednisone or equivalent per day for >
or = 3 months.
Individuals beginning or receiving long-term therapy with medications
known to affect BMD adversely:
• Anticonvulsants
• Androgen deprivation therapy
• Aromatase inhibitor therapy
• Chronic heparin
Individuals with an endocrine disorder known to affect BMD adversely
• Hyperparathyroidism
• Hyperthyroidism
• Cushing's syndrome
Hypogonadal men 18 years and older and men with surgically or
DOC. No. : OT-IFU-S2K
Description
7
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