OsteoSys SONOST-2000 User manual

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
1
SONOST-2000
User’ Manual
Model: SONOST-2000
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENTAND
OF THE COUNCIL
Doc Version : 12.2_MDR (2022.09.05)
http://www.osteosys.com
OsteoSys Co., Ltd.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
2
SONOST-2000
User’ Manual
CAUTION !
You must be well acquainted with this manual before using it.
This manual should be placed where the user could read it whenever
necessary.
Manufacturer and EC Authorized Representative Information
♣Manufacturer: OsteoSys Co., Ltd.
901~914, 9F, JnK Digitaltower, 111 Digital-ro 26, Guro-gu, Seoul, REPUBLIC
OF KOREA
[email protected]
Tel: [phone] Fax：[phone]
♣ European Representative: CMC Medical Devices & Drugs S.L.
C/Horacio Lengo Nº18, CP 29006, Málaga, Spain
TEL: [phone] FAX: [phone]

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
3
Thank you for purchasing SONOST-2000 Ultrasound Bone Densitometer. To ensure
safe operation and long-term performance stability, it is essential that you fully
understand the functions and operating, and maintenance instructions by reading this
manual before operating the equipment.
Particular attention must be paid to all warnings, cautions and notes incorporated
herein.
Incorrect operation, or failure of the user to maintain the equipment relieves the
manufacturer or his agent of the system’s noncompliance with specifications or of
responsibility for any damage or injury.
The following conventions are used throughout the manual to denote information of
special emphasis.
WARNING !
“Warning” is used to indicate the presence of a hazard that can cause severe
personal injury, death or substantial property damage if the warning is ignored.
CAUTION !
“Caution” is used to indicate the presence of hazard that will or can minor personal
injury and property damage if the caution is ignored.
NOTE !
“Note” is used to notify the user of installation, operation or maintenance
information that is important but not hazard related.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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The symbols which are shown in this manual or SONOST-2000
NOTE !
Check the symbol before using the SONOST-2000.
The noticed information should be concerned with explanation in
this manual.
The noticed information when the device is operated.
The reference page or section.
Applied Part Type B.
I and O on power switch represent ON and OFF, respectively.
The Attention symbol that marks warning and important
information in the user’s manual.
The conductor provides a connection between equipment and the
potential equalization bus-bar of the electrical installation.
The date of manufacture.
This symbol indicates “caution” for the hot surface.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
5
User Manual
User of the equipment to check how to check the product.
Communication Status
It indicates communication status of the equipment.
The protecting device from external electromagnetic wave
This equipment can be affected from external electromagnetic waves which is related to
precision and operation. When you are using this equipment, we strongly recommend
that you refrain from using other devices to protect the euipment from electromagnetic
waves.
Disposal of device
This symbol which is printed on the user manual or box means you do not regret as just
waste from home. If you would like to dispose this device, you should send to a place
for reuse of electrical device. It will help environment and human’s healthy life. Reuse
of this equipment contributes to saving natural resources. If you want to more detail
things about disposal of device, ask to manufacturer or distributor.
Cautionary Notes
(1) Environmental Condition
The environmental conditions below must be met to prevent possible performance loss
or malfunction of some components which can be caused by sudden and excessive
environmental changes, which may then lead to shortening of life cycle of the
equipment, the environmental conditions below must be met.
- Working Temperature: Within 10 ~ 40℃

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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- Working Humidity: Within 20~ 80%
- Air Pressure: Within 800 ~ 1060hPa
(2) Pre-operation Checklist
- Check the switch connection and polarity indicator status to ensure the device works
properly.
- Check all cable connections for correct and safe operation of the device.
- Double-check the areas that make direct contact with the patient.
- Check the device and the patient for any abnormal conditions.
- If any uncertainty is witnessed with the device or the patient, take appropriate actions
including suspending device operation under safe conditions.
(3) Cautions for Storage
- Do not apply excessive force when connecting or disconnecting cables.
- Auxiliary devices should be maintained clean, and in working conditions.
- Devices should be positioned in their proper positions, so as not to interfere with
operator's or patient's movement.
(4) Cautions regarding specialist prescription
This device is designed for the diagnosis of osteoporosis and therefore should only be
used for diagnosis performed by doctors. Its use must be prescribed and managed by
specialists.
(5) Biocompatibility - Ultrasound gel, etc.
To prevent damage to skin and cells, use commercially available ultrasound gels that
have passed ISO 10993-5(Cytoxicity), ISO 10993-10(Skin sensitization), and ISO
10993-23(Skin irritation) tests.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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Guidance and manufacturer’s declaration
Guidance and manufacturer’s declaration – Clinical information
No
Contents
A or
N/A
Description
1
Intended Use
A
The SONOST-2000 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 fractures 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

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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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
• Organ transplantation
• Prolonged immobilization
• Conditions associated with secondary osteoporosis, such as
gastrointestinal malabsorption or malnutrition, sprue, osteomalacia,
vitamin D deficiency, endometriosis, acromegaly, chronic alcoholism
or established cirrhosis, and multiple myeloma
• Individuals who have had a gastric bypass for obesity
Individuals considering pharmacologic therapy for osteoporosis.
Individuals monitored for:
• Assess the effectiveness of osteoporosis drug therapy
• Follow-up medical conditions associated with abnormal BMD.
Children or adolescents with medical conditions associated with
abnormal BMD including but not limited to:
• Individuals receiving (or expected to receive) glucocorticoid
therapy for more than 3 months
• Individuals receiving radiation or chemotherapy for malignancies
• Individuals with an endocrine disorder known to adversely affect BMD
(e.g., hyperparathyroidism, hyperthyroidism, growth hormone
deficiency or Cushing’s syndrome)
• Individuals with bone dysplasias known to have excessive fracture risk
(osteogenesis imperfecta, osteopetrosis) or high bone density
• Individuals with medical conditions that could change BMD, for
example:
1. Chronic renal failure
2. Rheumatoid arthritis and other inflammatory arthritides
3. Eating disorders, including anorexia nervosa and bulimia
4. Organ transplantation
5. Prolonged immobilization
6. Conditions associated with secondary osteoporosis, such as;
gastrointestinal malabsorption, sprue, inflammatory bowel disease,
malnKKutrition, osteomalacia, vitamin D deficiency, acromegaly, cirrhosis,
HIV infection, prolonged exposure to fluorides
QUS may be indicated in the diagnosis, staging, and follow-up of
individuals with conditions that result in pathologically increased BMD,
such as osteopetrosis or prolonged exposure to fluoride.
4
Contraindications
A
There are no absolute contraindications to performing QUS.
Possibly of limited value or require modification of the technique or
rescheduling of the examination in some situations, including:
- Try to measure the other side of heel if patient had some surgery like
implant which is placed by calcaneus bone.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
9
5
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
6
Disposable device
A
SONOST-2000 has silicon balloon on the probe part which can keep the
water inside of balloon as media for path of ultrasound wave more
efficiently.
7
Invasive device
N/A
Not intended to be invasive
8
Implantable device
N/A
Not intended to be implantable
9
Duration of use or
contact with body
A
BMD measurement is performed once a year or once every two years
(it’s depending 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 also same as SONOST-2000

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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Need to apply ultrasound gel in between skin and probe in order to get
proper contact for path of ultrasound waves.
10
Contacting with
body fluids or
others
N/A
There are no contact between anybody fluid of human during the
examination process.
11
Measurement site
A
Correct position for measurement for calcaneus bone on heel as below
That point is just below area of ankle and then apply ultrasound gel with
enough amount just like below instruction. (need to apply to both side
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 Oscalcis (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 I 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-2000 is intended for use in the electromagnetic environment specified below. The customer
or the user of the model SONOST-2000 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The model SONOST-2000 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-2000 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

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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Guidance and manufacturer’s declaration – electromagnetic immunity
The model SONOST-2000 is intended for use in the electromagnetic environment specified below. The customer
or the user of the model SONOST-2000 should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment –guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for
input/output lines
2 kV for power
supply lines
1 kV for
input/output lines
Main power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common
mode
1 kV differential
mode
2 kV common
mode
Main power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
short
interruption, and
voltage
variations on
power supply
input lines
IEC 61000-4-11
< 5 % UT
(> 95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
< 5 % UT
(> 95 % dip in UT)
for 5 s
< 5 % UT
(> 95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
< 5 % UT
(> 95 % dip in UT)
for 5 s
Main power quality should be that of a
typical commercial or hospital
environment. If the user of the model
SONOST-2000 requires continued
operation during power interruptions, it is
recommended that the model SONOST-
2000 be powered from an uninterruptible
power supply or battery.
Power frequency
(50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment
Note : UT is the a.c. mains voltage prior to application of the test level.
Safety consideration about parts of device and compartment
For use safely, you must use parts of device which are supplied or approved from OsteoSys.
NOTE !
If you use parts of device which are not approved from OsteoSys, we do not guarantee
safety to user. Moreover, it become dangerous and prone to producing errors and wrong
results to users or patients. In this case, the user has the sole responsibility.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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1) Protect device from external electromagnetic wave (IEC60601-1, 6.8.2
Requirement)
2) Disposal of device (IEC60601-1, 6.8.2 Requirement)
3) Safety considerations about part of device and compartment
(IEC60601-1,6.8.2 Requirement)
The exchange and usage period of consumable goods
Name
Part number
The period for
exchange
The method of exchange
expandable products
Foot supporter
FOOT SUPPORTER 0 :
A3MM-013
10 years
You should request the
manufacturer or distributor to
have these replaced.
FOOT SUPPORTER 1 :
A3MM-014
10 years
FOOT SUPPORTER 2 :
A3MR-005
10 years
QC Phantom
A3MR-009
10 years
Probe
A3ES-001
10 years
Power Cable
250VAC 10A
10 years

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K
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Table of Contents
1INTRODUCTION ........................................................................................ 15
1.1 GENERAL PRODUCT INFORMATION .........................................................................................................................15
2CONFIGURATION OF SONOST-2000 .......................................................... 17
2.1 COMPOSITION OF SONOST-2000 ...................................................................................................................... 17
2.2 INSTALLATION OF SONOST-2000........................................................................................................................ 21
2.3 BEFORE TURNING ON POWER................................................................................................................................. 22
3USING SONOST-2000 ................................................................................ 24
3.1 USING H/W ...............................................................................................................................................................24
3.2 USING S/W ................................................................................................................................................................34
4MAINTENANCE AND REPAIR OF SONOST-2000 ......................................... 78
4.1 RESOLUTION TO PROBLEMS......................................................................................................................................78
4.2 MAINTENANCE AND REPAIR ....................................................................................................................................79
4.3 SAFE USE OF SONOST-2000................................................................................................................................ 82
5SPECIFICATION & SOFTWARE UPDATES ................................................... 87
5.1 SPECIFICATIONS..........................................................................................................................................................87
5.2 SOFTWARE UPDATES ..................................................................................................................................................88
5.3 LABELS ....................................................................................................................................................................... 89
6PRODUCT WARRANTY ............................................................................... 92
7SECURITY.................................................................................................. 94

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT01-2R7123
15
1Introduction
1.1 General product information
Osteoporosis is one of the serious diseases. This device is a bone densitometer which
estimates bone mineral density of the calcaneus by using ultrasound
It takes about 15 seconds to measure the density and to display the shape of ultrasonic
waves by computing simulation on the monitor.
To ensure safe operation and long-term performance stability, it is essential that you
fully understand the functions, operating and maintenance instructions by reading this
manual before operating the equipment.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT01-2R7123
16
※Features and Cautions !
-This device is an ultrasound bone densitometerwhich has ±0.2(T-score) precision
error.
-The equipment must be operated only by, or under supervision of a qualified
person.
-When you give appropriate commands in SONOST-2000 software, ultrasonic
waves are generated. The generated ultrasonic waves pass through the patient’s
calcaneus and the electric signals are treated by SONOST-2000 algorithm.
-SONOST-2000 measures speed of sound(SOS) and the frequency-dependent
attenuation of the sound waves(BUA), and combines them to form a clinical
measure called Bone Quality Index(BQI)
-All operators must understand the potential hazards in the use of medical
electronic devices. They must be able to recognize hazards and protect
themselves and others from injury.
-The system should be placed at least 20cm from any wall. However the USB
cable length should not be longer than 3.0m.
-Never remove any system covers.
-In case of changing the PC or the printer for other products, check them according
to IEC/EN60601-1-1.
-Unplug the power cord before you move or clean the device and after using
SONOST-2000
-For installation and operation of this equipment, national regulations shall be
considered.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT01-2R7123
17
2Configuration of SONOST-2000
2.1 Composition of SONOST-2000
2.1.1 Shape and componennts of SONOST-2000
NO
Name
Function
1-1
TOP COVER
Protection for internal circuit
1-2
BOTTOM PLATE
Fixation for device position & top cover
1-3
SWITCH PANEL
Switch, Power cord, RS-232 Connector
1-4
BALLOON
Connect between heel and ultrasound probe
1-5
CALF SUPPORT
Leg fixation for diagnosing
1-6
FOOT GUIDE
Foot fixation for diagnosing
1-7
STATUS LAMP
Present status of the Device

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT01-2R7123
18
2.1.2 Keyboard
Activate SONOST-2000 by pressing a key on the keyboard according to the
instructions shown on the monitor.
The manual shows keys required to activate SONOST-2000 are as shown below.
NOTE !
Check the location and contents of the label attached to the product.
Check the location of the product power switch.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT01-2R7123
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NOTE !
Use accessories which are defined in the user‘s manual.
Check the following accessories before installing the system
2.1.3 Accessories list
Check the following accessories before installing the system.
If they are not in good condition, contact OsteoSys or local authorized
dealer for service.
Names of Products
Number
Uses
User’s Manual
1
Make sure to keep it at a designated place so
that users can read it anytime they need to.
Foot Positioner
3
Use them in accordance with patients’ foot size.
QC Phantom
1
It is used to calibrate the system.
Keep it in the specified place and protect
it against deformation by heat or
pressure.
Injector
1
It helps to take water into the balloon easily.
Guide
5
It helps to take water into the balloon easily.
USB Cable
1
It is used to connect the computer to the main
body of SONOST-2000.
Power Cable
1
It is used to connect to the source of electric
power with the main body of SONOST-2000
Make sure to connect it with a grounded
electric outlet.
If you want to change a power cord, then
you must use a power cord stronger than
Appendix A of KS C IEC60227-1:2007.
Program CD
1
It is used to install the software program on the
computer.(The program is factory installed on
the computer before being delivered).

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000 DOC. No. : OT01-2R7123
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2.1.4 Articles list
Check the following accessories before installing the system.
If they are not in good condition, contact to OsteoSys or local authorized
dealer for this service.
4.2.2 Stockpiles and Replacement of Articles
Names of
Products
Number
Uses
Balloon /
Housing
Balloon : 8
Housing : 1
It connects a foot with the ultrasound probes
and helps ultrasound to progress between
them.
Keep the spare balloons and housings
in a cool place.
Alcohol
1 box
It removes some material which prevents
ultrasound from progressing.