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SONOST 3000
User’s Manual
Model: SONOST 3000
Council Directive 93/42/EEC Concerning Medical Device http://www.osteosys.com
OsteoSys Co., Ltd.
User ’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
SONOST 3000
User’s Manual
Manufacturer and EC Authorized Representative Information
♣
Manufacturer: OsteoSys Co., Ltd.
901-914, 9F, JnK Digitaltower, 111 Digital-ro 26, Guro-gu, Seoul
152-848, Republic of Korea [email protected]
Tel: +82 26124 5900 Fax ： +82 26124 5958
♣
European Representative: Finlink
Myllärintie 10/76 00920 Helsinki Finland
Tel: +358 44 511 5324
Fax: +358 9 222 3533
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.
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User ’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
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 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.
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User ’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
The symbols which are shown in this manual or SONOST 3000
The noticed information which 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 Manual
User of the product to check how to check the product..
Communication Status
It indicates communication status of the equipment.
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User ’s Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
The protecting device from external electromagnetic wave.
1)
This device can be affect from external electromagnetic wave which is related to precision and operation. When you using this device, we strongly recommend you, avoid from other device from protect electromagnetic wave.
Disposal of device.
2)
This symbol which is printed on the product 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 some place for reuse electrical device. It will helpful for environment and human’s healthy life. The reuse of this material is good for save natural resources If you want to more detail things about disposal of device, ask to manufacturer or distributor.
Cautionary Notes
(1) Environmental Condition
To prevent possible performance loss or malfunction of device components caused by sudden and excessive environmental changes, as well as the resultant shortening of their life cycle, the environmental conditions below must be met.
- Working Temperature : Within 10 ~ 40 ℃
- Working Humidity : Within 30~ 75%
- Air Pressure : Within 700 ~ 1060hPa
(2) Pre-operation Checklist
- Check the switch connection and polarity indicator status, and verify the device works properly.
- Check all cable connections for their accuracy and safety.
- Double-check the areas that make direct contact with the patient.
- Check the device and the patient for any anomaly.
- If anomaly is found with the device or the patient, take appropriate actions including suspending device operation under safe conditions.
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Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
(3) Cautions for Storage
- Do not apply excessive force when connecting or disconnecting cables.
- Auxiliary devices should be maintained clean, in working conditions.
- Devices should be positioned in their proper positions, so as not to interfere with worker or patient movement.
(4) Cautions regarding specialist prescription
This device is designedfor osteoporosis diagnosis, and therefore should be used for the purpose of diagnosis performed by doctors. Its use must be prescribed and managed by specialists.
Guidance and manufacturer’s declaration
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 assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
Compliance
Group 1
Class A
Class A
Electromagnetic environment - guidance
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.
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.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Complies
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Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
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 the model SONOST-3000 should assure that it is used in such an environment .
Immunity test
Electrostatic discharge
IEC 60601 test level
6 kV contact
8 kV air
Compliance level
6 kV contact
8 kV air
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with
(ESD)
IEC 61000-4-2 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
2 kV for power supply lines
1 kV for
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5 input/output lines
1 kV differential mode
2 kV common mode input/output lines
1 kV differential mode
2 kV common mode
Mains 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
Power frequency
(50/60 Hz)
< 5 % U
T
(> 95 % dip in U
T
) for 0.5 cycle
40 % U
T
(60 % dip in U
T
) for 5 cycles
70 % U
T
(30 % dip in U
T
)
< 5 % U
T
(> 95 % dip in U
T
) for 5 s
3 A/m
< 5 % U
T
(> 95 % dip in U
T
) for 0.5 cycle
40 % U
T
(60 % dip in U
T
) for 5 cycles
70 % U
T
(30 % dip in U
T
)
< 5 % U
T
(> 95 % dip in U
T
) for 5 s
3 A/m
Mains 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 .
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
IEC 61000-4-8
Note :
U
T is the a.c. mains voltage prior to application of the test level.
commercial or hospital environment
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Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
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 IEC 60601 Compliance Electromagnetic environment - guidance test
Conducted
RF
IEC61000-
4-6
Radiated
RF
IEC61000-
4-3 test level
3 Vrms
150 kHz to
80MHz
10 V/m
80MHz to
2.5 GHz level
3 Vrms
150 kHz to
80MHz
10 V/m
80MHz to
2.5 GHz
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 meteres(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:
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.
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Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
Safety considerations about part of device and compartment.
3)
For use safely, you must use part of device which supplied or approved from Osteosys.
NOTE !
If you use part of device which is not approved from Osteosys, we do not guarantee safety to user.
Moreover, it become dangerous and errors and wrong results to users or patients. In this case, user has 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)
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The exchange and using period of expandable goods
Name Part number
The period for exchange
The method of exchange expandable products
Foot supporter
FOOT SUPPORTER 0 :
A3MM-013
FOOT SUPPORTER 1 :
A3MM-014
FOOT SUPPORTER 2 :
A3MR-005
FOOT SUPPORTER P :
A3MR-105
C3MR-004
250VAC 10A
10years
10years
10years
10years
You should require to manufacturer or distributor where can repair this device.
QC Phantom
Power Cable
10years
10years
Input and output parts which are using for operate device.
4)
Number Name Detailed specification
1
2 paper for printing
External printer
3
4
5
6
External monitor
USB memory stick
External mouse
External mouse
Thermal paper,Thickness is over : 0.07mm
It required WindowsXP driver
It requires 800x600 of resolution and supplied
VGA port
It requires above USB 1.1
It supplied USB or PS/2
It supplied USB port
6) Input and output parts which are using for operate device.
(IEC60601-1 contents of test 6.8.2. Requirement
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Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
Table of Contents
Chapter 1. Introduction ................................................................................................................ 13
Chapter 2. Configuration of Device ............................................................................................. 15
2.1 Composition of Device ................................................................................................... 15
2.1.1 Shape and Components of Device ...................................................................... 15
2.1.2 Accessories List ...............................................................................................
1 6
2.1.3 Articles List ...................................................................................................... 17
Chapter 3. Using SONOST 3000 ................................................................................................ 20
3.1. Daily Test ....................................................................................................................... 20
3.1.1 Preparation .......................................................................................................... 20
3.1.2 Daily Test Procedure ............................................................................................ 21
3.2 Shutting down processing .............................................................................................. 24
3.2.1 Position of shutdown button ................................................................................ 2 5
3.2.2 Shutting down processing ................................................................................. 2 6
3.3 The analysis of how to rotate the screen ....................................................................... 27
3.3.1 The location of screen rotation button ............................................................... 2 7
3.3.2 The method and sequence order of the screen rotation button ......................... 2 8
3.3 Using H/W ...................................................................................................................... 29
3.3.1 Patient Measurement Procedure ......................................................................... 29
3.3.2 Selection of the foot supporter ............................................................................. 30
3.3.3 Where and how much apply to the patient's heel ............................................. 3 1
3.3.4 Correct position for patient's foot & body .......................................................... 3 2
3.3.5 OSD (Auto screen alignment) ........................................................................... 3 3
3.3.6 Setting of Internal Printer ..................................................................................... 33
3.4 Using S/W ...................................................................................................................... 35
3.4.1 Progress Table of Program .................................................................................. 35
3.4.2 Execution of Program .......................................................................................... 36
3.4.3 Setting of the Incipient Environment .................................................................... 37
3.4.4 Measurement of Bone Mineral Density................................................................ 43
3.4.5 Revision and Deletion of Patient’s Information .................................................... 53
3.4.6 Inquiry and Deletion of Clinical History of Existing Patients ................................ 50
3.4.7 DailyTest of SONOST 3000 ................................................................................. 55
3.4.8 Printing of clinical history and Result ................................................................... 57
3.4.9 Customize the logo in printing ............................................................................. 60
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3.4.10 The function of Shot Count ................................................................................ 61
3.4.11 Setup the worklist ............................................................................................ 6 2
3.4.12 Setup and sending function of PACS .............................................................. 6 3
3.5 The method of Data manager S/W ............................................................................... 6 8
3.5.1 Program operation process ................................................................................. 68
3.5.2 Start to program ................................................................................................ 6 9
3.5.3 Program setup ................................................................................................... 7 0
3.5.4 Backup .............................................................................................................. 7 1
3.5.5 Patient search and delete ................................................................................. 7 5
3.5.6 Searching, erasing and printing the result about patients' disease history ....... 7 8
Chapter 4. Maintenance and Repair of SONOST 3000 .............................................................. 80
4.1 Resolution to Problems .................................................................................................. 80
4.2 Maintenance and Repair ................................................................................................ 81
4.2.1 Cleaning, Disinfection, Sterilization. .................................................................... 81
4.2.2 Product’s life ........................................................................................................ 82
4.2.3 Stockpile and Replacement of Articles ................................................................ 82
4.2.4 Storage ................................................................................................................ 82
4.3 Safe use of SONOST 3000 ......................................................................................... 8 3
4.3.1 Safety rules ....................................................................................................... 8 3
4.3.2 Cautions related to use electronic medical equipment ..................................... 8 4
Chapter 5. Specifications & Software updates ......................................................................... 8 8
5.1 Specifications .............................................................................................................. 8 8
5.2 Software updates ........................................................................................................ 9 0
Chapter 6. Reference .................................................................................................................. 91
6.1 Definition of Parameter Terminology .............................................................................. 91
6.2 Reference Data .............................................................................................................. 93
Chapter 7. Product Warranty .................................................................................................... 9 4
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Chapter 1. Introduction
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 wave 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 reading this manual before operating the equipment.
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※
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 : BQI(C.V.%) 5
T-score -0.5 or less : BQI(C.V.%) 2
- 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 the 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.
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Chapter 2. Configuration of Device
2.1 Composition of Device
2.1.1 Shape and Components of Device
1-2
1-3
1-4
1-1
1-5
Function
1-6
NO Name
1-1 TOP COVER Protection for internal circuit
1-2 CALF SUPPORTER Leg fixation for diagnosing
1-7
1-3 PROBE
1-4 LCD
Generation of ultrasound
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
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NOTE !
Use external device which certificated by standard (IEC-60601-1).
NOTE !
Use Accessory which defined at user‘s manual.
2.1.2 Accessories List
Check the following accessories before installing the system.
If they are not in good condition, contact to OsteoSys or its authorized dealer for this service.
Names of
Products
Number Uses
User’s Manual
Foot supporter
QC Phantom
1
4
1
Make sure to keep it at a designated place so that users can read it anytime they need to.
Use them in accordance with patients’ foot size.
( base, 0, 1, 2, 3(P) )
It is used to calibration the system.
Keep it in the specified place and protect it against deformation by heat or pressure.
It is used to connect to the source of electric power with the main body of SONOST 3000.
Power Cable 1
Make sure to connect it with a grounded electric outlet.
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Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
2.1.3 Articles List
Check the following accessories before installing the system.
If they are not in good condition, contact to OsteoSys or its authorized dealer for this service
4.2.3 Stockpiles and Replacement of Articles
Names of Products Number Uses
Ultrasound Gel 2 bottles
It helps ultrasound to progress between a probe and patient’s heel.
Alcohol 1 box
It removes some material which prevents ultrasound from progressing.
Printer Paper 2 rolls
Result paper is printed at printer paper.
Minimum paper thickness : 0.07mm
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Model Designation: SONOST 3000 DOC. No. : OT06-2R0423-06-MUL
2.2 Installation of SONOST 3000
NOTE !
Since SONOST3000is made up of precise components, you should install the product according to instructions below.
Do not install and keep SONOST3000 at excessively high or low temperatures.
Proper temperature:
18~27 ℃
Do not install or keep SONOST3000 in the place where the machine can be rocked or shaken. Make sure to place the system parallel to the floor.
Do not install the system in the place with polluted air and high humidity and do not expose the machine to direct ray sunlight. It is advisable to use SONOST3000 in the place equipped with air conditioning or heating.
Proper humidity:
20~80%
Install SONOST3000 in the place where it is free from water or chemicals.
Do not share the power outlet with other products through an extension cord.
For escaping from electronic noise, do not install near a electronic generator, X-ray equipment, broadcasting equipment.
It causes a result to be inaccurate.
Do not cover ventilation of the system or place it near the wall. High inside temperature of the machine might cause a fire.
100-240V is usable. When SONOST3000 is taken out of a warehouse, insulating transformers should be set to 100-240V.
Since sudden power outage can remove all data saved in the product, you should install
SONOST3000 in the place where a power supply is stabilized.
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2.3 Before Turning on Power
Connection of Power Cable(with the outlet)
CAUTION !
- Make sure that the covering of cable is
not damaged to prevent electric shock or short circuit.
- If you find any damage or any sign of it,
immediately contact an agency.
- Put the Power cord into only oneplug.
- Make sure not to share the power outlet to prevent SONOST 3000 from being affected.
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Chapter 3. Using SONOST 3000
3.1. Daily Test
The SONOST 3000 system is checkedusing the daily test.
The daily test should be performed at least once a day, before patient’s measurements.
3.1.1. Preparation
SONOST 3000 device, Phantomand ultrasound transmission gel
Dailytest Recommendation
The daily test should be performedwithin operating temperature.
(Recommended temperature : 18 ~ 27 ℃ )
The phantom should be kept beside of device closely.
Daily test should be done just after turning on the device.
Turn on the device and then do Dailytest immediately at beginning time of day before warming up the device.
Turn off the device after using at closing time of day.
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3.1.2. Daily Test Procedure
Phantom’s value checking
Switch on the device and the main screen appears after booting up.
Select “setup” button to check the value of phantom.
When you see the bottom of the phantom, you can find a label which is two kind of different label. You should check contents on the label and below two clauses.
1. the value of SOS and the range of BUA are correctly write on Phantom info.
2. If you can see 'V0.2' on the right side of label, you have to tick on the '0.2Ver'
radio box, if no, you must check the radio box. The box should be blank.
(If it is wrong with the information which comes from the label, you have to revise it.)
Check the Bottom part of label type 1 type 2
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Phantom’s setting
Apply the ultrasound transmission to the phantom to the area which will be in contact with both probes when the phantom is on the foot rest. The amount of the gel should be same as the area of the phantom in contact with the probe.
Put the phantom on the foot supporter 1 (don’t use foot supporter 2 when dailytest) in the measuring position of device.
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Perform the dailytest
Press the DailyTest button
The Daily test should be done if the color of button is red.
When the daily test is finished, red colored character will be disappear.
After click the daily test button, you can see the message. If you put the ultrasound transmission on the phantom, press “YES” button.Input the temperature referring to the thermo label on the surface of the device.
The correct temperature is the highest digit between appeared with color on the thermo label.
Execute <the daily test> by pushing the ‘start’ button.
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The following images are the execution screen of the daily test.
“Complete Daily Test” appears when the daily test is done.
Complete the process of <the daily test> by pushing the “OK” button.
Youare now able to enter BMD measurement mode and perform a patient test.
3.2Shutting down processing
The following is the instruction for Shutdown function of the system
NOTE !
To avoiding losing data, you should follow our instruction to shutting down system.
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3.2.1 Position of Shutdown button
The shutdown button is located as below 4 screens.
① Main screen ② Patient screen
③ History screen ④ History detail screen
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3.2.2 Shutting down processing
Click shutdown button
Click [OK]
Waiting until the black or blue screen appear
Turning off the main switch of the system
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3.3 The analysis of how to rotate the screen
The procedure of rotate the screen is as below
NOTE !
This function is applicated some devices. The adopted device’s serial number is start from AC1TA.
3.3.1 The location of screen rotation button
The screen rotation button is located in 4part of the screen as below images.
① Main screen ② Patients list
③ Disease history
– standard screen
④ Disease history
– detailed screen
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3.3.2 The method and sequence order of the screen rotation button
Press the screen rotation button on the top right
side of the screen
Press the confirm button.
Touch calibration program will be running. And then it will start the calibration. After calibration, the screen will rotate 180 degrees.
If the graphic card does not support, the screen does not rotate and you can see message like left picture.
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3.3 Using H/W
3.3.1 Patient Measurement Procedure
Clean the surface of the Coupling Pad with an alcohol pad and apply sufficient gel to probes.
Clean the both side of patient’s heelwith an alcohol pad and apply gel.
Insert patient’s foot.
Let a patient move his foot up to down just like this picture.
Start measure after insertion and positioning. Ensure correct Foot
Positioner 1 or 2 is used depending on patients foot size
NOTE !
Insert patient’s foot only if gap between probe’s is wide enough, because probe pad is made from soft silicon.
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3.3.2Selection of the foot supporter
Put the foot supporter according to the below guide.
The section is arranged for each size of the foot.
If the foot of patient is belong to
* Section 1 : use only foot supporter 1.
* Section 2 : use foot supporter 1 and 2 together.
* Section P: use foot supporter1, 2and P together.
1 2 3
(foot supporter 1) (foot supporter 2) (foot supporter P)
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3.3.3 Where and How Much Apply to the Patient’s Heel
Before measuring, use alcohol to rub patient’s heel : this provides protection for removing air bubbles surface of patient’s skin and other infections.
Apply plenty of ultrasound gel to both side of patient’s heel
Good
No Good
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3.3.4 Correct position for Patient’s foot & body
Place heel in the unit as shown in the 3 points below.
Make sure measuring device and body should be one line as shown below.
Patient
Device
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3.3.5OSD (Auto screen alignment)
The size and position of LCD screen is adjusted automatically by pushing the button on the LCD cover.
3.3.6 Setting of Internal Printer
- Paper type : Thermal paper width 58mm. thickness : MIN 0.07mm
(About 80 reports are printable by one roll)
- Paper character : Only printable in the outer surface
- Purchasing : Purchase from the headquarters or an agency.
Paper inserting side
1)Cover opening : Pull-down open the dark gray cover on the device’sback
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2) Paper inserting : Insert the paper as shown below.Outer surface ofpaper shouldface to the inside of the device. Paper isscrolled in automatically.
3) Cover shutting : Put the paper to the gap in the cover, then shut thecoverup.
4) Paper cutting : For a sharp outline of report printing, cut off the remained paperonce by a saw tooth in the cover.
CAUTION !
Do not touch the metal part of the thermal printer head. The hot surface may cause to burn.
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3.4 Using S/W
3.4.1 Progress Table of Program
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3.4.2 Execution of Program
CAUTION !
If you hear any strange noise from the screen, switch it off and contact to OsteoSys or its Authorized dealer.
Turn on the power switch.
10 seconds after calibration that checks functions of the system and memory device, the program is automatically activated and you should configure the incipientenvi- onment.
This is the start up screen.
Home of the startup screen
There are Main buttons on the top line, It is used when the screen is moved.
The bottom line is consisted of Sub buttons, it is used for sub function.
Other screens are similar formation.
- QuickMeasure : Direct measuring function without patient’s registration process.
- DailyTest : Daily test function.
When the daily test is needed, the color of button is red.
When not needed, the color of button is the same as the others.
- Setup : Consists of functions which are related with program setting.
- Information : Display information about the program and device.
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3.4.3 Setting of the Incipient Environment
Click the <Setup>button on the Home Screen, then environment window is appeared.
'Setup' Window
- <Settings> : Fundamental settings related Software.
- <System> : Settings related Operating System.
- <Cleaning> : It makes probe is moved of user’s own accord for cleaning.
- <Backup> : Control of measured data.
- <Patch> : Software upgrade.
Settings
It makes fundamental settings related Software.
Setup>Settings Window
- Hospital Name : Insert the hospital name which will be on the report.
- Default Scan Site : Select the default scan site when measure.
- Default Gender : Choose the gender when insert the patient’s information.
- Default Ethnicity : Choose the ethnicity when insert the patient’sinformation.
- DailyTest Interval : Fix the interval of daily test
- Default Printer : Choose the internal thermal printer or external general printer.
- Print Graph : Choose the Graph included when use the internal printer
- Ink-Economic : Choose the Ink-Economic mode when use the external printer.
- : Setup printer.
- Temp. Compensation : To choose the temperature compensation function when
Dailytest and measuring.
- Phantom Info : the value of the user phantom.
- Check version of phantom whether it is 02ver or not.
- Activate Pediatry(Activate BMD) : To switch the mode of BMD and Pediatry.
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System
It makes settings related Operating System.
Setup>System Window
- System Date/ Time: Present time setting. It becomes standard for patient’s registered date, measured date and printed date.
Fix the time and click the <Save>button.
- Touch Panel calibration : It is used when the touch panel is out of order.
Read the screen message carefully, then press the arrow indicated point exactly.
- Storage Server :If you would like to send images through PACS, you should inputinformation.
You have to get own IP address and port from the hospital to connect storage server and then input these things exactly. (You
should request for server information from the manager who is
working at hospital.)
-Worklist Server :The form of Worklist, using for when you get information from server which is people checked through device,You have to get own IP address and port from the hospital to
connect storage server and then input these things exactly.
Moreover, in terms of Worklist, you must input correctly due to patients are classified by Modality. you can find 3.4.12, we explained more detail things.
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- Query :You should input some conditions which are get information about patients from the worklist server.When you input modality in Query should be the same as the modality in worklist server.
You can choice which is today, week(7days before), weeks(14days be- fore), month(30days before) from Query.It is based on the system date from server.It can show person’s information which is someone check- ed through this device.
NOTE !
Using DICOM, which related to storage/worklist server IP, Port, Modality should be request from the server manager in the hospital.You must input server information exactly which is get from the hospital.
Cleaning
It makes probe is moved of user’s own accord for cleaning.
- Narrow : It makes narrow the probe’s interval
- Stop : It makes the probe stop.
- Widen : It widen the space of two probes.
Setup>Cleaning Window
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Backup
It controls the measured data.
※ If a USB memory has many files and folders , the speed of recognition of the
USB memory could be lower. Connect a USB memory after empty.
Setup>Backup Window
- Export : If you click this button, you can export data to USB memory stick or external printer.
Setup>Backup>Export Window
∙ All : Export all data.
∙ By period : Export data within a selected period of time.
∙ Individual : Export selected patient’s data.
∙ Destination : You can select USB Memory Stick or Printer.
(But, If you are select ‘Individual’, you can’t select printer)
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- Clear : If you click this button, you can clear data.
Setup>Backup>Clear Window
∙
All : Clear all data.
∙
By period : Clear data within a selected period of time.
- Import : If you click this button, you can import the exported data.
Setup>Backup>Import Window
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Patch
It is upgrade the Software.
At first, Prepare a USB removable disk which support USB 2.0. You can use mp3 player or digital camera too.Copy the setup file(file name : setup.exe) to USB removable disk.
Insert USB removable disk into SONOST 3000 device’s USB port.
Select [Setup>Patch>Exit to Windows] for close the program.
Execute the setup.exe in the setup folder of USB memory stick.
Choose the remove to delete former installed program.
After removing, execute the setup.exe file for installation again.
Restart SONOST 3000.
You can confirm by seeing software information at Home>Information.
NOTE !
During patch, if you turn off device or take USB removable disk off,
Critical problem will occur.
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3.4.4 Measurement of Bone Mineral Density
Selection of BMD and GDP
- Pediatry mode : when you want to get the result and graph of Pediatry BMD and
GDP (growth rate factor) for under 20 years old.
Click the [Activate Pediatry] which is changed to [Activate BMD]
- BMD mode : when you want to get the result and graph of adult BMD for over 20 years old.
Click the [Activate BMD] which is changed to [Activate Pediatry]
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Patient Registration
If you click the <patient>button on the top line at the incipient screen, you can move to “Patient List” which display and control the registered patient
Left list mean registered patient’s birth year. If you click the year, you can see the patient’s ID and name list were bone in the same year.
Patient List Window
If you want to register a new patient, then click the <Add>button on the bottom line.
Then “Add Patient” window is appeared which insert the patient’s information.
If you insert and click the <Ok>button, then patient is registered and displayed on the screen.
Add Patient Window
- PatientID : Insert the ID which can identify the patient.(64 characters are MAX)
- Name : Insert the patient’s name. (64 characters are MAX)
- Year of Birth : Insert the patient’s year of birth.
- Gender : Insert the patient’s gender.
- Ethnicity : Insert the patient’s ethnicity.
- Foot Supporter : Choose the Foot Supporter according to the foot size.
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- Height : Input the height of patient.
- Weight : Input the weight of patient.
- Father’s H. : Input the height of patient’s father. (it is disabled on BMD mode)
- Mother’s H. : Input the height of patient’s mother.(it is disabled on BMD mode)
Patient Search
If you want to search the registered patient, click the <Search>button on the bottom line and make it appear the “Search Patient” window. It apply search condition of the patient’s ID, name, gender and year of birth.
If you insert the related information and click the <Ok>button, then the result is displayed on the screen.
Search Patient Window
Search Result Window
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Measurement of Patients
If you want to measure the patient’s Bone Density, select a desired patient in the
Patient List screen and click the <Measure>button. Then the “Measure” screen appears as shown below.
Measure Screen
Click the <Start>button on the bottom of left.You could find the dialog box for the temperature. Input the temperature referring to the attached thermo label on the surface of the device. (choose the highest digit for the temperature among the colored digit on the thermo label)
※ If you select the option of non-use Temperature Compensation, the temperature dialog box is not appeared.
Temperature screen
Click the next button.And Select the site of the foot and push the OK button.
Ultrasound waves are generated from the probe.
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Select Site Window
When ultrasound waves are generated, the <Start>button is changed into
<Stop>button. In case of emergency, click this button, and you can stop measuring. In the normal condition, ultrasound waves generation is finished about 15 seconds after, then the “Measure Complete” window is appeared with the alarm sound.
If you click the <Ok> button, the detailed results is displayed as shown below.
Detailed results screen.
If you click the <Print>button on the bottom of results screen, then the report is printed.
3.4.8Printing of clinical history and Result
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Pediatricfunction
Accessory is arranged for more convenience of pediatric measurement.
If you want to purchase below item, contact to Osteosys.
- Top cover for Pediatry
- Foot supporter for Pediatry
If you want to view the graph of pediatry for children, select Activate Pediatry button in setup window.
The button of Activate is used to toggle between PEDIATRY mode to BMD mode.
When you choose the Activate Pediatry, you can see the followings.
- Pediatric BMD result and graph
- the result and graph of Current height and predicted adult height.
(supported from version 5.00)
∙ the graph of current weight.
∙ the result and graph of BMI.
※ Pediatric BMD
[History View] [Detailed Result View]
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※
Current Height and Predicted adult height
[History View] [Detailed Result View]
※
Weight
※ BMI
[History View] [Detailed Result View]
[History View] [Detailed Result View]
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※
When [Activate BMD] is selected.
[History View] [Detailed Result View]
3.4.5 Revision and Deletion of Patient’s Information
Revision of Patient’s Information
If you want to revise the registered patients’ information, select a desired patient and click the <Modify>button on the bottom.
Then the “Modify Patient” screen appears as shown below, in this condition, if you enter a new value to make desired changes in the patient’s information and click the
<OK>button, the patient’s information is revised.
Modify Patient Window
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Deletion of Patient’s Information
If you want to delete the registered patients’ information, select a desired patient in the “Patient List” screen and click the <Delete>button on the bottom.
Then the message box “Delete Patient” inquiring about the whether to delete the information surely appears and if you click the <OK> button, the information is deleted.
Delete Patient Window
Worklist
If you click <Worklist> button on the lower part of patient list, it will updated to latest patient list, however it depends on patients are already registered on worklist server.
After press the <worklist> button, 4buttons will turned to non-active status aside from
<worklist> button.If you click the <worklist> button, it will go back to previous
<worklist> status.
The result of requested worklist from system
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Worklist - Giving a test to someone who is already registered on the system.
After selection of patient from the list, you can take a test or see the disease history from <Disease history> or <Test> tab. (If someone already registered on the system
but, they do not have any disease history, the system will show you error message).
Worklist - Giving a test to someone who is not registered yet on the system.
If someone is not registered yet, you can listed on the system when you after click
<Test> button.
※
When worklist server is active, other buttons such as <save>, <find>,<modifi- cation> and <Deletion>, will turned to non-active status. Therefore, if you would
like to give a test to patient, you should select the person who will have a test, and then click the <test> button on the screen. The device will start to the test.
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3.4.6 Inquiry and Deletion of Clinical History of Existing Patients
Inquiry of Clinical History of Existing Patients
If you want to retrieve the clinical history of existing patients, select a desired patient and click the <History>button on the top of the “Patient List” screen.
Then “History List” screen appears that contains the patient’s clinical history as shown below. On the right side, the left and right foot’s measurement results list shows. If you select a measurement result in the list, the relevant clinical history represented by a graph on the left side.
History List Screen
The lower part of screen, you can see <PACS> button. When you press the <PACS> button, result will send to server.
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Detailed Representation of Clinical History of Existing Patients
If you click the <Detail>button on the “History List” screen, the detailed result of the selected patient appears in the full screen.
Detailed Result Screen
Deletion of Clinical History of Existing Patients
If you want to delete the clinical result of patients, select a desired result and click the
<Delete>button on the bottom of the result screen. Then the message box “Delete
History?” that inquiring about whether to delete the result or not appears. If you click the <OK>button, the result is deleted.
Delete Patient Window
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3.4.7 DailyTest of SONOST 3000
DailyTest
Make sure to calibrate the system to reduce a margin of error and to get accurate value in times of examining bone density. It is to raise credibility of examination results through checking of system reliability on a daily basis.
To calibrate the system, click the <DailyTest>button in the “Home” screen.
Then the “DailyTest” screen appears as shown below. When you click the
<StartDailyTest>button, DailyTest is started. If the DailyTest is successful, the message box “Complete Dailytest” appears press “OK” and return to “Home” screen.
If you select the “Time” tap, graph appears in the time domain.
If you selectthe “Frequency” tap, graph appears in the frequency domain.
DailyTest Screen
Whenever you calibrate the system, you should use the QC Phantom included in the accessories list.
If you input the temperature and then click the <Start>button on the bottom, ultrasonic waves are generated and the word on the <Start> button is changed into
<Stop>. In case of emergency, click this button and you can stop daily testing. In the normal condition, the message box “Complete Dailytest” appears as shown below with an alarm sound after progressing calibration of the system and if you click<OK>button, the progress of calibration is completed.
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NOTE !
In case of the screen shows the calibration has failed, do not use the system and execute “DailyTest” once again. If calibration fails continually, contact to
OsteoSys or its authorized dealer.
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3.4.8 Printing of clinical history and Result
SONOST 3000 support inner printer(thermal printer) and external printer(normal
USB printer). (If the selected model is exclusive use of external printer. Inner printer will not be provided.)
Inner Printer (Thermal Printer)
Inner printer is affixed on the device back inside. It will be able to use without software setting.
Printed result paper
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External Printer (Normal Printer)
Available printer : All USB printer supporting Windows XP driver.
For the installation of printer driver, exit program (Setup > Patch > Exit to
Windows)
Copy the printer driver to USB memory stick.
Connect the USB memory stick to USB port on the back of device.
Execute the setup file of driver on the memory stick.
After installation is completed, reboot device.
Select External and then click the icon of printer setting.
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You can find the installed printer above and check it default printer (default printer : printer with checked mark)
If you want to change the default printer, select the printer and then choose [File] –
[default printer] on the top menu.
Printed Paper
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3.4.9 Customize the logo in printing
Make the bitmap filesfor the color printing and gray printing as 272 px X 70 px X
24 bit.
70px
272px
Give the name and extension name to bmp (ex: NHIC_C.bmp, NHIC_G.bmp)
Copy the files to the USB memory stick and connect to the device.
Push the button looks like folder shaped and select the image file for color and gray sequentially.
Push the button of Logo Copy
The logo on the bottom of printed paper is changed.
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3.4.10 The function of Shot Count
Connect USB keyboard or PS/2 keyboardto the device.
At Home screen push the button “Ctrl +
Alt + C” simultaneously.
Push the number 1686.
The total number of measurement is shown at shot count.
If Reset button is selected the shot count is set to default value of 0.
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3.4.11 Setup the worklist
Connect to worklist
In terms of Worklist, it makes database from people who checked through this device.
This database saved in the hospital server. Later, you can get this information from the PC which is connecting to server. It cannot change information on the local PC
Set up User Interface in Worklist
At the beginning of SONOST3000 program, you should press the <set up> button, and then move on to <System>
You should get information from someone who work in hospital or manager of
OCS in hospital.
∙
Worklist IP →1
∙
Port number → 2
∙ Remote ATitle → 3
∙
Local ATitle → 4
∙ Modality → 5
- Local A-title in SONOST300 means SONOST3000, you should tell to a manager of OCS. It cannot change
- Modality is basically “DX”, it can be change
- You should input modality in Query which is next to set up of Worklist server.
Next, you should choice date on the person.
- When you finish input server and Query, press the “confirm’ button. .
- Move on to “List of patients”, you can use worklist which reference from '3.4.5'
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3.4.12 Setup and sending function of PACS
PACS requirements
∙
USB Ethernet Adapter
∙
You should get specification IP, Serve net mask, basic gateway from hospital network.
∙
PACS server IP and Port (Hospital already get information about PACS server)
∙
Remote A-Title(You should ask to a manager of PACS in hospital)
The method connect to PACS
- Connect of Device
Connect the Ethernet cable to the LAN port on the back of the device.
Ethernet cable
- Network set up
You can see ‘My Network Places’ on the screen. Select this item and press the right side of mouse. You should select “properties”
- Setup of the LAN Card
When you set up LAN card, you should turn on the device.
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When you connect to PACS network in hospital, you should choice Local area. Next, click the right side of mouse on ‘properties’. If you see message, you should choice
Internet Protocol(TCP/IP) and click the ‘properties’
You should input IP address, serve net mask, gateway for connect PACS server.
After that, press the ‘confirm’ button.
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You should press the start and command button for connect to PACS server in hospital. When Command board appeared, you should input CMD. Next, you can see DOS mode.
You should input IP address for connect to PACS
For instance) C:\>ping 192.168.20.3
You should input IP address(192.168.20.3) which is get from hospital
When you input command, you can see information which related to connection
You can see ‘Reply from (IP address): byte=32 time=128’ message 4times and
If you get ‘Packet : Send = 4, Receive = 4’ message, it is a normal sign.
Running SONOST3000 user program
At the beginning of SONOST3000 program, you should press the <control> button, move on to <System>
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This pictures figure the same as Worklist server control, when you input IP, Port,
Atitle which are bring from server manager in hospital.
- Sending PACS
After move on to ‘list of patients’, you can see ‘disease history’ or ‘result’ screen. you should select ‘disease history’ which is you would like to send to PACS. After, press the <PACS> button.
<PACS> button on disease history
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The alarming message whether when sending disease history to server success or not.
Sending successfulSending failure
When it comes to sending failure message, you should check below parts.
1) The Network line is connected properly
2) The contents of storage server in system are correct.
3) Storage server is running properly.(You should require to server manager)
Send result sheet to PACS server
The report of disease history The report of result
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3.5 The Method of Data manager S/W
3.5.1Program operation process
Configuration
Start
Export
Home
Backup
Clear
Import
Patient List
Patient Information
Print Result
Delete Patient
Search Patient
Delete Result
Search Result
Print History
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3.5.2 Start to program
You can operate the program, when you click "SONOSTO 3000 DM" on the screen or on the srart button.
Home screen
Screen is consist of 4 buttons and <Information> button which is you can show software information.
- view data : You can search results and print the report.
- Backup : you can get the data from other device or from this device and turn to at the beginning of status.
- configuration : you can set up this device which relate to program.
- program exit : you can close this program
- information : you can print the information of program which is on the right side of screen.
Information screen
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3.5.3 Program Setup
You can setup this program
- Hospital name : you can input name. This information, when you printer you port, you can see it.
-Hospital Address : you can input address. This information, when you print report, you can see it.
-Hospital Telephone: you can input telephone number. This information, when you print report, you can see it
-Printer mode: This set up is for the saving Ink. If you choice ‘Economic’, you can save the ink.
-Print preview: when you print a report, you can choice preview of print
-Language: You can choice language. When you change the language, you should restart the OS. If not, the language will not change.
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3.5.4 Backup
This function is if you send data to others such as USB memory stick, Printer and MS
Excel file or get from USB memory stick, or delete the data.
Backup window
-Export: When you send data in PC to USB memory stick, or print data or make a file via MS Excel.
-Clear: You can delete data according as the condition.
-Import: you can get data to data manager from Software in PC or before exported data from data manager
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Export
This function is data saved in PC and export to other device.
You can export to USB memory stick, it can be send data to other PC and device.
Also, you can print. Out. Moreover, you can make excel file.
1
2
Export window
Export window are divided by two. You can set up the range and target.
Range set up is setting up the range of data for export. There are three way of methods.
-All : It can process data which are saved in PC.
- By period : It can process data when you set up the period which is ‘From’ and
‘ To’
- Individual: It is processed only chosen patients
(It can export via only USB memory stick)
Target set up is setting up the range of data for export. There are three way of
methods..
-USB Memory Stick: It is export via USB memory stick
-Printer : It is print out the result list.
-Excel File : It is make a excel file which is the result list
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* When you export data to USB memory stick, you should choice the version correctly. If it is transfer data between data manager, it will be no problem. However, if it is transfer data between device, you must check and make the same version.
* When you click <?> button on the right side of screen, you can see data file’s version.
* When you export to USB memory stick, it makes folder which is included the information of date and method of range set up. These data will save in this folder.
Therefore, If you want to import data, you have to remember the date of export and method of range set up.
Data File Version window
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Clear
This is delete data in PC
1
2
Clear window
Clear window are divided by two which are range set up and delete the patients’ information set up.
Range set up is setting up the range of data for delete. There are two way of methods.
-All : It can process data which are saved in PC
- By period : It can process data when you set up the period which is ‘From’ and ‘ To’
Delete the patients’ information set up mode can be delete basic information such as patients’ ID, name and birth date
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Import
This function is get data from USB memory stick to PC.
Import window
You can choice the data from SELECT and then click <OK> button. The contents in list of SELECT are when it exported on time and range. You should remember when you exported data.
3.5.5 Patient search and delete
When you click <View Data> button on the screen, you can see patients’ list as below picture. On the left side of folders show patients’ birth date and central part of screen, you can see patients’ list which are lined up by birth date.
Patient List window
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Search the Patient
If you click <Patient Search> on “Patient List” window, you can see “Search Patient” window
Search Patient window
You should input information correctly, and click <OK> button. It can show you
Search Result window and then find the patient
Doing search, if you find the result, you can stop search through click <Stop Search> button.
Search Result window
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After, select the patient, click <OK> button, you can choice the patient on the “Patient
List” window
Delete the patient's info
If you want to delete patient, you should click <Patient Delete> button on “Patient
List” window. Then it will show you “Delete Patient” window, when you press <OK> button, patient will be delete.
Delete Patient window
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3.5.6 Searching, erasing and printing the result about patients'
Disease history
Searching Patients’ disease history
When you search about patients’ disease history, you should choice patient on the
'Patient List' screen. Next to click <Patient Info> button, it will show you patient’s
disease history and result on the 'Patient Information' window.
You can see disease on the left side of screen, on the right side, you can see detailed
information which are chosen by user. On the lower part of left side screen, you can
see disease history on each foot. If you choice disease history on the list, you can
Patient Information window
Delete the patient’s disease history
When you click <Delete Result> button, it will show you 'Delete Result?' window
which means whether delete this data or not. If you would like to delete this result,
you should click <OK> button.
Delete result window
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Print out the result sheet
There are two type of result sheet. One of them is disease history result sheet.
The other one is normal result sheet. If you click <Print> button in the left side,
you will get disease history result. And If you click on the right side of <print>
button, you will get normal result sheet.
The report of disease historyThe report of result
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Chapter 4. Maintenance and Repair of
SONOST 3000
4.1 Resolution to Problems
If SONOST 3000 shows following symptoms, check the system as follows.
Problems
SONOST 3000 is not activated with the power on.
Result of calibration of the system turns out to be abnormal
Checking Points
Is the device properly plugged?
Isn’t the power cord damaged?
3.4.7DailyTest of SONOST3000
Result of measurement turns out to be abnormal
3.3.1 Patient Measurement
Procedure
3.4.7 DailyTest of SONOST3000
Despite measurement according to the instructions, its result turns out to be abnormal
Is the desired part of the body properly placed?
4.2.1. Cleaning, Disinfection,
Sterilization
CAUTION !
If you cannot resolve the problem, contact to OsteoSys or its authorized dealer.
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4.2 Maintenance and Repair
4.2.1 Cleaning, Disinfection, Sterilization.
CAUTION !
Turn off the power before cleaning the device.
Product
Device
Instructions
After using the device, wash with Alcohol swap.
The device should be cleaned with clean soft cloth wrung a water everyday, because gel remains around the probe or below the device. Especially, gel stained on the probe should be removed.
After this procedure, clean the stained area with a dry piece of cloth.
Probe endurance condition
Temperature range : -40 ℃ ~70 ℃
Humidity 0~90%
Atmospheric pressure : 50~106kPa
External force 0~1N
Make sure not to put water or detergent on the device directly because it can cause fatal damage in the electric circuit contained inside.
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4.2.2 Product’s life
This product’s life is 7 years. (Except Accessory)
4.2.3 Stockpile and Replacement of Articles
Make sure to keep following articles of consumption all the time.
2.1.3 Articles List
Articles Specifications
Gel
Gel is a necessary article when measuring BMD.
Please purchase new one before it being out of stock.
4.2.4 Storage
Daily
Storage
- Unplug the power cord.
- Dust on the product can damage the system. After use, make sure to cover it with a vinyl cover.
- If the hardened gel remains in the device, it can effect on BMD results. Please clean the device everyday.
4.2.1 Cleaning, Disinfection, Sterilization
Storage for a long time period
- Unplug the power cord.
- Put cover on the product to avoid dust.
- Keep the product according to instructions described in “2.2
Installation of SONOST 3000”
2.2 Installation of SONOST 3000
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4.3 Safe Use of SONOST 3000
4.3.1 Safety Rules
The followings are instructions for safe use of the product
Make sure to comply with the instructions when you activate the system.
Refer to “4.3.2 Caution related to electronic medical equipment”
4.3.2 Cautions Related to Use of Electronic Medical Equipment
CAUTION !
Do not open it because there are some high-tension components inside. It might cause serious danger.
Check if the cable coating is not damaged before turning on the system to prevent electric shock or leakage of electricity. If it is damaged or broken, immediately contact an agency.
Do not share the power outlet with other products.
If you share the outlet it will affect the product.
CAUTION !
Read user’s instructions carefully before using the product.
Place the user’s instructions at a designated place so that users can read it anytime they need it.
If you hear a strange noise or if you find any abnormality on the LCD screen after turning on the product, contact the headquarters or an agency.
Make sure to turn off the power switch before cleaning the product.A
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4.3.2 Cautions Related to Use Electronic Medical Equipment
Safety rules described below are based on Paragraphs 495 of laws and ordinances promulgated by Ministry of Welfare of Japan. The safety rules pertain to use of electric medical equipment. Read them carefully for safe use of the product and make sure to refer to “4.3.1Safety rules”
4.3.1 Safety Rules
１ Nobody can handle SONOST 3000 except for doctors and authorized personnel
２ Comply with followings in times of installation of SONOST 3000. Do not install it in following places.
A) Places where the product is exposed to water vapor
B) Places where the product is exposed to spray or splashing water.
C) Places where the product is exposed to high density oil vapor
D) Places where the product is subject to excessive shocks or vibrations.
E) Places where the angle of inclination of the mounting surface exceeds 10 degrees.
F) Places where air pressure, temperature or humidity drastically changes.
G) Places exposed to direct sunlight or places where air is polluted due to dirt, salt and sulfur
H) Places where chemicals are kept or toxic gas is leaked.
I) Places where the AC power line voltage fluctuates heavily
J) Places where the AC power line voltage fluctuates heavily while this product is operating.
K) Places where there is a ventilation problem.
L) Do not lean, shake or rock the product during transportation.
M) Adjust frequency, voltage or current to the product.
N) The product is portable but make sure to put a brake on it when you stop the product.
O) Ground the product by using ground wire.
P) Do not share the power outlet.
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３ Check followings before using the product.
A) Whether power is off before putting a plug in the socket.
B) Whether the power supply line is suitable with that of the system
(AC 100~240 V)
C) Whether the system is fully grounded.
D) Whether all the connection parts(power and optional equipment) are connected with the system properly.
2.3 Before Turning on Power
E) The product has been factory-set for optimum performance. Do not attempt to adjust any preset controls or switches except for operation as specified in this manual.
F) If you experience any trouble with the product, turn it off immediately and contact OsteoSys or its authorized dealer for assistance.
G) Before electrically or mechanically connection any other manufactures’ devices to SONOST 3000, contact OsteoSys or its authorized dealer for instructions
H) Do not operate the product improperly when you use it with other products.
I) Make sure to check whether external parts of the device directly touches the patient.
J) Make sure to check whether the products keep distances at least 20cm from walls.
CAUTION !
Equipotential Bonding
In hospital, doctors and patients are subjected to dangerous, uncontrollable compensating currents. These currents are due to the potential differences between connected equipment and touchable conducting parts as found in medical rooms. The safest solution to the problem is accomplished is consistent equipotential bonding. Medical equipment is connected with connecting leads made up with angle sockets to the equipotential bonding network in medical rooms.
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NOTE !
Try to place the system far from power generators, X-ray machines, broadcasting stations, and transmission lines to avoids electrical noise during scanning. Otherwise, abnormal images may result. An independent circuit and a safely grounded outlets are strongly recommended for SONOST 3000. Poor or abnormal images may occur if the system shares a power source with other electrical or electronic equipment.
NOTE !
The classification according to standard IEC/EN 60601-I
Type of protection against electric shock : Class I
Degree of protection against electric shock : Type B
Degree of protection against harmful ingress of water : IPX 0
Methods of sterilization or disinfection : See Chapter 4.2.1
Not suitable for use in the pressure of flammable anesthetic mixtures
４ Check followings while the device is in operation.
A) Whether the product and the patient are normal
B) Whether the products keep distances with one another
C) If you find any abnormality related to the product or patient, stop its operation and check if it can cause any danger to the patient.
D) If the fuses are gone, exchange the same type (250V T315AL). Otherwise a fire may occur or you may receive electric shock.
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５ Checking points after use of product
A) Make sure to clean the product so that use Deactivate the product and turn the power off in order.
B) Do not pull the power cord forcibly.
C) Comply with followings to keep the product properly.
① Avoid places that can wet the product.
② Avoid places where air pressure, temperature and humidity drastically change and where there are direct ray of sun, dirt, salt and sulfur.
③ Do not lean, shake or rock the product.
D) Clean accessories after use.
E) Make sure to clean the product so that users can use it immediately
６ If the product is out of order, do not try to repair it for yourself.
７ Do not modify use the product. If any modification is desired, ask OsteoSys or its authorized dealer for this service.
８ Check, maintenance and repair
９ Cautions in times of transportation of cart
If you have to move the cart on incline floor, you should detach the product from the cart so that the product does not slip to the ground.
１０ Environmental protection
If the products are at the end of their useful lives, do not dispose them at your option. Contact OsteoSys or its authorized dealer for this service.
１１ Others
Read the user’s instructions carefully and use the product properly.
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Chapter 5. Specifications & Software
Updates
5.1 Specifications
*General
*Device
Classification
Dimensions
Weight
Input Voltage
Class Ⅰ , Type BF Applied part
615mm × 293mm × 310mm
15Kg
AC 100V ~ 240V,
Free Voltage (Single Phase)
1A, Class I Input Current
Frequency 50/60Hz
Power consumption
Ultrasonic Probe Diameter
220W max.
Ø 25mm
Ultrasonic Center Frequency
Ultrasonic Probe Position Setting
Patient’s Measurement Posture
Accessory
0.5MHz
Variable Measurement 12
QC Phantom
~
In a sitting posture
136mm
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*Environmental
Operating Temperature
Transport / Storage Temperature
Operating Humidity
Transport / Storage Humidity
Atmosphere
Shock
15 ~ 30 ℃
-10 ~ 70 ℃
30 ~ 75% relative humidity
0 ~ 90% relative humidity, non-condensing
700 ~ 1060 hPa
Not to exceed 2G in six millisecond
Dust, Fumes, Airborne debris
Install system in a clean, well-ventilated area. Excessive dust and other airborne debriscontaminants can impair sensitive parts. We recommend instituting a “No
Smoking” policy in system area.
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5.2 Software Updates
1. Updates to SONOST 3000 software are irregular, we will inform you through your email whenever SONOST 3000 software needs to be updated.
2. For details, call the OsteoSys Co., Ltd customer service department or your OsteoSys Co., Ltd distributor.
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Chapter 6. Reference
6.1 Definition of Parameter Terminology
BUA(Broadband Ultrasound Attenuation)
Parameter which reflect bone density and structure by reduction analysis of ultrasound pulse intensity which through the bone.
SOS(Speed Of Sound)
Velocity of ultrasound wave through the bone which reflect bone mineral density
BQI(Bone Quality Index)
Generally SOS is in proportion to the temperature, and BUA is in inverse proportion to the temperature. These correlation coefficients are (α, β) combined for as shown below. This Parameter which is represented constant number compensates the precision error from the temperature.
The relation between age and BQI (Refer to the picture)
BQI = α x SOS + β x BUA
T-Score
Average BQI in twenties(Young adult), that is BQI standard deviation in twenties.
1) More than -1 : Normal
2) -1 ~ -2.5 : Osteopenia
3) -2.5 and below : Osteoporosis
T- Score’s meaning in the view of probability
T-Score represents the patient’s BQI above or below a reference “Young adult” mean and is expressed in standard deviation(SD) units.
Therefore, If patient’s BMD value makes normal distribution shape, then T-Score means in the view of probability as below.
1) T < -6, T > +6 : 2 of 1,000,000,000 persons
2) T < -5, T > +5 : 3.8 of 100,000,000 persons
3) T < -4, T > +4 : 6.3 of 10,000 persons
4) T < -3, T > +3 : 2.7 of 1,000 persons
5) T < -2, T > +2 : 4.6 of 100 persons
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For example, Person in T<-3 exist 1.35 ratio of 1,000 persons in whole population.
Z-Score
Average BQI in the same age, that is BQI standard deviation in the same age.
1) More than 0 : BMD is higher than the average of the same age.
2) 0 : Average value of the same age.
3) 0 and below : BMD is lower than the average of the same age.
Explanations of BUA Measurement MODE Terminology
1)PEAK : Maximum value of signal in the frequency domain.
2) Center Frequency : Value of center frequency.
3) Percent : % Bandwidth(3dB bandwidth
÷
Center Frequency
×
100)
Generally, as these values are lower, BUA values is higher.
Explanations of SOS Measurement MODE Terminology
1) Zero Point : Cross point of the time Ox which is used for acquiring the signal’s position.
2) Gain : Amplification degree of ultrasonic signal which is controlled automatically.
3) Peak : Maximum value of signal in the time domain.
4) TOF(Time Of Flight) : Elapsed time of ultrasonic signal from transmission to reception. It is used for SOS calculation.
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6.2 Reference Data
Reference Data
We achieved reference data from several group with different environment in Korea.
And the data is analyzed by statistical method.
Ages
5~
9
10~ 15~
14 19
20~ 25~ 30~
24 29 34
35~ 40~ 45~ 50~ 55~
39 44 49 54 59
60~ 65~ 70~ 75~
64 69 74 80
Mean 76.0 84.6 93.0 100 103 104 98.9 95.7 89.3 83.2 81 79.3 77.7 74.7 74.2
SD 16.0 16.2 16.4 15.3 19 15.9 15.9 12 15.6 12.5 10.5 12.7 11.6 12.7 12.5
N 36 41 39 40 38 35 38 40 42 37 41 35 37 38 35
Where we make the BQI(Bone Quality Index) by weighting sum of SOS, BUA
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Chapter 7 . Product Warranty
Scope and Period of Warranty
(1) OsteoSys Co., Ltd. guarantees all new product against faults in materials or workmanship for a period of one year from date of shipment to purchaser.
OsteoSys Co., Ltd. will, as sole and exclusive remedy, at no charge, replace any such defective unit returned to its service designated warranty period.
(2)This warranty applies only to failures from operating the product under conditions for which it was designed. Warranted product is to be used only for the intended and labeled indications presented in the literature accompanying the product.
(3)OsteoSys Co., Ltd. will charge service fees in following cases.
If the product is out of order after the warranty period expires.
If the product is out of order due to natural disasters such as fire, flood, windstorm, hail, lightning and earthquake.
If the product is out of order due to improper transportation after installation and careless use.
If the product is out of order due to improper repair or renovation by someone other than service personnel of the company.
(4) Cosmetic defects or deterioration will not be refinished or replaced.
The costs of replacement of fuses are not covered.
(5) OsteoSys Co., Ltd. will not be responsible for any loss, damage, or injury
resulting from delay in rendering service under this warranty.
(6) OsteoSys Co., Ltd. will not be responsible to you for incidental or consequential damages of any kind arising from or connected with the use of its equipment.
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What Should be Noted in Times of Request of Repair
(1) If the product is out of order, stop using it and read the manual carefully.
(2)Before you request for repair, switch off the product and contact a designated service agency after checking the name of model, serial number and date of purchase. OsteoSys Co., Ltd. will replace the defective product at no cost to you. OsteoSys Co., Ltd. will pay the shipping and insurance costs of product sent to you.
(3)Defective equipment shipped from you to OsteoSys Co., Ltd. must be packed in the replacement cartons. Shipping and insurance costs for the return of the defective product must be pre-paid by you.
(4)If you request the product information to repair the defective product yourself, we provide you with the proper information.
This limited is in lieu of all other warranties expressed or implied, including warranties of merchant ability or fitness for any particular use. No representative or other person is authorized to represent or assume for OsteoSys
Co., Ltd. any warranty liability beyond that set forth herein.
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