OsteoSys SONOST 3000 User manual

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
1
SONOST 3000
User’ Manual
Model: SONOST 3000
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENTAND
OF THE COUNCIL
Doc Version : 12.2_MDR (2022.09.05)
http://www.osteosys.com

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
2
OsteoSys Co., Ltd.
SONOST 3000
User Manual
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]
CAUTION!
1. You must be well acquainted with this manual before using it.
2. This manual should be placed where the user could read it
whenever necessary.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
3

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
4
Thank you for purchasing SONOST 3000 Ultrasound Bone Densitometer. To
ensure safe operation and long-term performance stability, it is essential that
you fully understand the functions and operating, 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 3000 DOC. No. : OT-IFU-S3K
5
The symbols which are shown in this manual or SONOST 3000
NOTE !
Check the symbol before using the SONOST 3000.
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 3000 DOC. No. : OT-IFU-S3K
6
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 regard 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

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
7
equipment, the environmental conditions below must be met.
- Working Temperature: Within 10 ~ 40℃
- 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.
Guidance and manufacturer’s declaration
Guidance and manufacturer’s declaration – Clinical information

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

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
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• 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 dysplasia 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 arthritis
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,
malnutrition, 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 apatient had some surgery like
implant which is placed by calcaneus bone.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
10
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
N/A
SONOST 3000 is not a disposable device.
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 dependson 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

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 fluidsor 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

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
12
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 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 3000 requires continued
operation during power mains
interruptions, it is recommended that the
model SONOST 3000 be powered from an
uninterruptible power supply or battery.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
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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
Guidance and manufacturer’s declaration – electromagnetic immunity
The model SONOST 3000 is intended for use in the electromagnetic environment specified below. The
customer or the user of model SONOST 3000 should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC61000-4-6
3
Vrm
s
150
kHz
to
80
MH
z
3
Vrms
150
kHz
to
80M
Hz
Portable and mobile RF communications equipment should
be used no closer to any part of the model SONOST 3000,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance.
d=[3.5/V1]√P
d=[3.5/E1]√P 80MHz to 800MHz
d=[7/E1]√P 800MHz to 2.5GHz
where P is the maximum output power rating of the
transmitter in watts(W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters(m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey, a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked
with the following symbol:
Radiated RF
IEC61000-4-3
10
V/
m
80
MH
z to
2.5
GHz
10
V/m
80M
Hz to
2.5
GHz
Note 1 At 80MHz and 800MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
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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.
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)

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
15
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
probe
C2MR-004
10 years
QC Phantom
C3ES-002
10 years
Power Cable
250VAC 10A
10 years
Input and output parts which are using for operate device.
Number
Name
Detailed specification
1
Paper for printing
Thermal paper, Thickness is over :
0.07mm
2
External printer
It requires WindowsXP driver
3
External monitor
It requires 800x600 of resolution with
a
VGA port
4
USB memory stick
It requires above USB 1.1
5
External mouse
USB or PS/2 supplied
6
External mouse
USB port supplied
6) Input and output parts which are using for operation of device.
(IEC60601-1 contents of test 6.8.2. Requirement

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
16
Table of Contents
1INTRODUCTION ........................................................................................ 17
2CONFIGURATION OF DEVICE..................................................................... 19
2.1 COMPOSITION OF DEVICE........................................................................................................................................19
2.2 INSTALLATION OF SONOST 3000 ........................................................................................................................ 23
2.3 BEFORE TURNING ON POWER................................................................................................................................. 24
3USING SONOST 3000 ................................................................................ 25
3.1 DAILY TEST ..................................................................................................................................................................25
3.2 SHUTTING DOWN PROCESSING ...............................................................................................................................29
3.3 THE ANALYSIS OF HOW TO ROTATE THE SCREEN...................................................................................................32
3.4 USING S/W ................................................................................................................................................................41
4MAINTENANCE AND REPAIR OF SONOST 3000.......................................... 80
4.1 RESOLUTION TO PROBLEMS......................................................................................................................................80
4.2 MAINTENANCE AND REPAIR.....................................................................................................................................81
4.3 SAFE USE OF SONOST 3000 ................................................................................................................................83
5SPECIFICATION & SOFTWARE UPDATES ................................................... 89
5.1 SPECIFICATIONS ..........................................................................................................................................................89
5.2 SOFTWARE UPDATES..................................................................................................................................................91
5.3 LABELS .........................................................................................................................................................................91
6REFERENCE ............................................................................................... 93
6.1 DEFINITION OF PARAMETER TERMINOLOGY...........................................................................................................93
6.2 REFERENCE DATA ........................................................................................................................................................95
7PRODUCT WARRANTY ............................................................................... 96
8SECURITY.................................................................................................. 97

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT06-2R7124
17
1Introduction
Osteoporosis is one of the serious diseases. This device is a bone densitometer
which estimates a bone mineral density of the calcaneus by ultrasound.
The measurement site is the calcaneus. It takes about 1 minute 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 3000 DOC. No. : OT06-2R7124
18
※Features and Cautions !
- This device is an ultrasound bone densitometer which has precision error
as follows. (Estimated index in vivo)
T-score -0.5 or more
T-score -0.5 or less
- The equipment must be operated only by, or under supervision of a qualified
person.
- When you give the appropriate commands in SONOST 3000 software,
ultrasonic waves are generated. The generated ultrasonic waves pass through
the Patient’s calcaneus and the electric signal is treated by SONOST 3000
algorithm.
- All operators must understand the potential hazards in the use of medical
electronic devices. They must be able to recognize hazards and protect them-
selves and others from injury.
- The system should be placed at least 20cm from any wall.
- Never remove any system covers.
- In case of changing the printer for other products, check them according to
IEC/EN60601-1-1.
- Unplug the power cord after using.

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT06-2R7124
19
2Configuration of Device
2.1 Composition of Device
2.1.1Shape and components of SONOST 3000
NO
Name
Function
1-1
Top cover
Protection for internal circuit
1-2
Calf supporter
Leg fixation for diagnosing
1-3
Prove
Generation of ultrasound
1-4
LCD
Display for measuring status
1-5
Thermal printer
Thermal printing for the measurement report
1-6
Switch panel
Connection for the power cord and power ON/OFF
switch
1-7
External connector
USB Port for printer, keyboard and mouse
1-2
1-3
1-4
1-1
1-5
1-7
1-6

User’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT06-2R7124
20
NOTE !
Use external device certificated by standard (IEC-60601-1).
NOTE !
Check the location and contents of the label attached to the product.
Check the location of the product power switch.