OsteoSys SONOST 3000 - Page 8

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
8
No
Contents
A or
N/A
Description
1
Intended Use
A
The SONOST 3000 system supports the doctor's activities for the diagnosis
of osteoporosis and the prevention of future fractures to the patient through
the measured BMD results. The measurement sites is calcaneus/ Heel bone.
2
Name of Disease or
Condition
A
Osteoporosis, Osteopenia, Normal healthy bone
3
Indications
A
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 fracture with minimal or no trauma, excluding 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
chemotherapeutically induced castration
Individuals with medical conditions that could alter BMD:
• Chronic renal failure
• Rheumatoid arthritis and other inflammatory arthritis
• Eating disorders, including anorexia nervosa and bulimia