OsteoSys SONOST 3000 User Manual
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OsteoSys SONOST 3000 User Manual

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

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  • Page 1 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K SONOST 3000 User’ Manual Model: SONOST 3000 REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Doc Version : 12.2_MDR (2022.09.05) http://www.osteosys.com...
  • Page 2 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K 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 info@osteosys.com...
  • Page 3 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K...
  • Page 4 Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K 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.
  • Page 5 OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K 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.
  • Page 6 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K 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.
  • Page 7 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K equipment, the environmental conditions below must be met. - Working Temperature: Within 10 ~ 40℃ - Working Humidity: Within 20~ 80% - Air Pressure: Within 800 ~ 1060hPa...
  • Page 8 A or Contents Description The SONOST 3000 system supports the doctor's activities for the diagnosis Intended Use of osteoporosis and the prevention of future fractures to the patient through the measured BMD results. The measurement sites is calcaneus/ Heel bone.
  • Page 9 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K • Organ transplantation • Prolonged immobilization • Conditions associated with secondary osteoporosis, such gastrointestinal malabsorption or malnutrition, sprue, osteomalacia, vitamin D deficiency, endometriosis, acromegaly, chronic alcoholism or established cirrhosis, and multiple myeloma •...
  • Page 10 (Patient does not operate the BMD device) a) Ages: 20 – 100 years old Patient b) The patient condition: Osteopenia, Osteoporosis or Normal healthy bone SONOST 3000 is not a disposable device. Disposable device Not intended to be invasive Invasive device...
  • Page 11 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...
  • Page 12 DOC. No. : OT-IFU-S3K 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. Electromagnetic environment –...
  • Page 13 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...
  • Page 14 Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K 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.
  • Page 15 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K The exchange and usage period of consumable goods The period The method of exchange Name Part number expandable products exchange FOOT SUPPORTER 0 : 10 years...

  • Page 16: Table Of Contents

    ..........................29 HUTTING DOWN PROCESSING ....................32 HE ANALYSIS OF HOW TO ROTATE THE SCREEN S/W ................................41 SING MAINTENANCE AND REPAIR OF SONOST 3000 .......... 80 ............................80 ESOLUTION TO PROBLEMS ............................. 81 AINTENANCE AND REPAIR SONOST 3000 ..........................83 AFE USE OF SPECIFICATION &...

  • Page 17: Introduction

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 18 - 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.

  • Page 19: Configuration Of Device

    OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Configuration of Device 2.1 Composition of Device 2.1.1 Shape and components of SONOST 3000 Name Function Top cover Protection for internal circuit Calf supporter Leg fixation for diagnosing...
  • Page 20 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 21 Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 2.1.2 Accessories list Check the following accessories before installing the system. If they are not in good condition, contact to OsteoSys or your local authorized dealer for this service. Names of Products Number Uses Make sure to keep it at a designated place so that User’s Manual...
  • Page 22 Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 2.1.3 Articles list Check the following accessories before installing the system. If they are not in good condition, contact OsteoSys or local authorized dealer for service. 4.2.2 Stockpiles and Replacement of Articles Names of Number...

  • Page 23: Installation Of Sonost 3000

    Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 2.2 Installation of SONOST 3000 NOTE ! Since SONOST 3000 is made up of sensitive components, you should install the product according to instructions below. NOTE! Do not install and keep SONOST 3000 at Do not install or keep SONOST 3000 in a excessively high or low temperatures.

  • Page 24: Before Turning On Power

    - If you find any damage or any sign of potential damage, immediately contact a local dealer. - Put the Power cord into only one plug. - Make sure not to share the power outlet in order to prevent SONOST 3000 from being affected.

  • Page 25: Using Sonost 3000

    DOC. No. : OT06-2R7124 Using SONOST 3000 3.1 Daily test The system of SONOST 3000 can be maintained by running Daily Test on a daily basis. The daily test should be performed at least once a day, before patient’s measurements.
  • Page 26 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 1) The values of SOS and the range of BUA are correctly written on Phantom info. 2) If you can see 'V0.2' on the right side of label, you have to tick on the '0.2Ver'...
  • Page 27 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124  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 gel should be enough to cover the area of the phantom that comes in contact with the probes.
  • Page 28 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124  Perform the Daily Test Press the Daily Test button The Daily test should be done if the color of the button is red. When the daily test is finished, the color of the button will turn back to its original color(blue).

  • Page 29: Shutting Down Processing

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 30 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.2.1 Position of shutdown The shutdown button can be found at four different screens. ① Main screen ② Patient screen ③ History screen ④ History detail screen...
  • Page 31 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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 NOTE ! Push the power switch to "0"...

  • Page 32: The Analysis Of How To Rotate The Screen

    3.3 The analysis of how to rotate the screen The procedure of rotate the screen is as below NOTE ! This function is NOT applied to all Sonost 3000 devices. The adopted device will have its serial number starting with AC1TA. 3.3.1...
  • Page 33 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Press the "Ok” button Touch calibration program will be running. And then it will start the calibration. After calibration, the screen will rotate 180 degrees.
  • Page 34 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.3.3 Patient measurement procedure Clean the surface of the Coupling Pad with an alcohol pad and apply sufficient gel to probes. NOTE ! To remove debris from the...
  • Page 35 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Insert patient’s foot only if the gap between probes is wide enough, because probe pad is made from soft silicon.
  • Page 36 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.3.4 Selection of the foot supporter Put the foot supporter according to the below guide. The section is arranged for each size of the foot.
  • Page 37 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.3.5 Where and how much to 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.
  • Page 38 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.3.6 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.
  • Page 39 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.3.7 OSD (Auto screen alignment) The size and position of LCD screen is adjusted automatically by pushing the button on the LCD cover. 3.3.8 Setting of internal printer Paper type: Thermal paper with 58mm width, and minimum thickness of 0.07mm (About 80 reports are printable with one roll)
  • Page 40 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 ② Paper inserting: Insert the paper as shown below. Outer surface of paper should face to the inside of the device. Paper will scroll in automatically.

  • Page 41: Using S/W

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 CAUTION Do not touch the metal part of the thermal printer head. The hot surface may cause to burn. 3.4 Using S/W 3.4.1 Program Table of program...
  • Page 42 Execution of program CAUTION ! If you hear any strange noise from the screen, switch it off and contact to OsteoSys or your local authorized dealer. NOTE ! When the device is powered on, the power LED turns green. Turn on the power switch and power LED is turn on green.
  • Page 43 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 - Information : Display information about the program and device. 3.4.3 Setting of the incipient environment Click the <Setup>button on the Home Screen, then environment window appears.
  • Page 44 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 : Setup printer. - Temp. Compensation: To choose the temperature compensation function when Performing Daily Test. - Phantom Info : the values on the bottom label on the phantom.
  • Page 45 You must input server information exactly which can be only obtained from the hospital. We support several languages. Contact Osteosys if you need to make changes or select your language using language option.
  • Page 46 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 ③ Cleaning: It makes probes to manually move for the user to clean them. <Setup>Cleaning Window - Narrow : the interval between the two probes becomes narrow.
  • Page 47 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 <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.
  • Page 48 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] to close the program. Execute the setup.exe in the setup folder of the USB memory stick.
  • Page 49 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 NOTE ! During patch, if you turn off device or take out the USB removable, There may be critical problem to the system.
  • Page 50 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.4.4 Registration, Modification & Deletion of users NOTE ! Enter user information accurately. (1) As soon as you configure the user environment, the “Doctor Selection”...
  • Page 51 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 NOTE ! After login, it is automatically locked for 15 minutes after the last touch.
  • Page 52 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 (2) If you are a new user(doctor), click the “Add” button in the “Doctor Selection” window, and then the “Add” window appears. If you enter your information(name, department and password) and click the “OK”...
  • Page 53 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 (3) If you want to modify registered users, select a desired user and click “Modify” from the “Doctor Selection” window. Enter the password in the edit box from “Password Enter”...
  • Page 54 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 (4) If you want to delete registered users, select a desired user and click “Delete” from the “Doctor Selection” window. Enter the password in the edit box from the “Password Enter” window and click “OK” to delete the user.
  • Page 55 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.4.5 Measurement of Bone Mineral Density NOTE ! Measurements may not be accurate if patient information is entered incorrectly. <Patient Registration> If you click <patient> from the top menu, you will be directed to “Patient List” which displays and allows you to manage all the registered patients.
  • Page 56 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 - 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.
  • Page 57 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Search Result Window <Measurement of Patients> If you want to measure the patient’s Bone Density, select a desired patient in the Patient List screen and click <Measure>. Then the “Measure” screen appears as shown below.
  • Page 58 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Temperature screen Click <Next> to select the scan site of the foot and click <OK>. Ultrasound waves are generated from the probes. Select Site Window When ultrasound waves are being generated, the <Start>button will change to...
  • Page 59 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Detailed results screen. Click <Print> on the bottom of results screen, then the report is printed. 3.4.8Printing of clinical history and Result 3.4.6 Modification and Deletion of patient’s information ①...
  • Page 60 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 ② Deletion of patient’s information If you want to delete registered patients’ information, select a desired patient in the “Patient List” screen and click <Delete> from the bottom menus.
  • Page 61 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 The result of requested worklist from system Worklist - Giving a test to someone who is already registered on the system. After selection of a patient from the list, you can take a test or see the disease history From <Disease history>...
  • Page 62 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124...
  • Page 63 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.4.7 Inquiry and deletion of clinical history of existing patients Inquiry of Clinical History of Existing Patients ① If you want to retrieve the clinical history of existing patients, select a desired patient and click <History>...
  • Page 64 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Detailed Result Screen Deletion of Clinical History of Existing Patients ③ 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.
  • Page 65 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.4.8 Daily test of SONOST 3000 Daily test 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.
  • Page 66 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 NOTE ! In case of Daily Test failure, do not use the system and execute “DailyTest” once again. If calibration fails continuouly, contact to OsteoSys or your local authorized dealer.
  • Page 67 DOC. No. : OT06-2R7124 3.4.9 Printing of clinical history result SONOST 3000 supports using the inner printer (thermal printer) and external printer (normal USB printer). (If the selected model is exclusive use of external printer. The inner printer will not be provided.) Inner Printer (Thermal Printer) Inner printer is affixed to the rear of the system inside.
  • Page 68 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 <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.
  • Page 69 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 (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.
  • Page 70 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.4.10 Customize the logo Make the bitmap files for 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)
  • Page 71 PC. Set up User Interface in Worklist At the beginning of SONOST 3000 program, you should press the <set up> button, and then nevigate to <System> You should get information from someone in charge of the server, the manager of OCS in hospital.
  • Page 72 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 You should input modality in Query which is next to set up of Worklist server. Next, you should choose date on the person. When you finish input server and Query, press the “confirm’ button.
  • Page 73 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 - Setup of the LAN Card When you set up LAN card, you should turn on the device. When you connect to PACS network in hospital, you should choose Local area. Next, right click your mouse and select ‘properties’.
  • Page 74 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 You should press the start and command button for connect to PACS server in the hospital. When Command board appeared, you should input CMD. Next, you can see DOS mode.
  • Page 75 DOC. No. : OT06-2R7124 Running SONOST 3000 user program At the beginning of SONOST 3000 program, you should press the <control> button, and move on to <System> This pictures figure the same as Worklist server control, when you input IP, Port, Atitle which can be available from the server manager in hospital.
  • Page 76 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 The message showing whether sending the disease history to the server is successful or not. Sending successful Sending failure When it comes to receiving a failure message, you should check below parts.
  • Page 77 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 3.4.13 FRAX FRAX Mode predicts the risk of fracture within the next 10 years using the patient's lifestyle and medication use. The FRAX results predict the risk of femoral fractures and major osteoporotic fractures (vertebral, wrist, femur, and shoulder fractures) within 10 years.
  • Page 78 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124  Input on Detailed History Screen. On the Detailed History screen, select FRAX Button and enter the FRAX information.  The screen configuration is shown as below.
  • Page 79 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 sized beer (285ml), a cup of distilled liquor (30ml), a medium-sized wine (120ml), or a pre-drinking glass (60ml). Currently smoking Check the box ifyou are currently smoking.

  • Page 80: Maintenance And Repair Of Sonost 3000

    Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Maintenance and Repair of SONOST 3000 4.1 Resolution to problems If SONOST 3000 shows following symptoms, check the system as follows. Problems Checking Points SONOST 3000 is not Is the device properly plugged? activated with the power Isn’t the power cord damaged?

  • Page 81: Maintenance And Repair

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 4.2 Maintenance and repair 4.2.1 Cleaning CAUTION ! Turn off the power before cleaning the device. Product Instructions After using the device, wash with Alcohol swap.
  • Page 82 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 4.2.2 Product’s life This product’s life is 10 years. (Except Accesory) 4.2.3 Storage - Unplug the power cord. - Dust on the product can damage the system. After use, make sure to cover it with a vinyl cover.

  • Page 83: Safe Use Of Sonost 3000

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 84 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.
  • Page 85 OsteoSys or its authorized dealer for assistance. G) Before electrically or mechanically connecting a third party 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.
  • Page 86 Otherwise, it may lead to abnormal 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.
  • Page 87 6) If the product is out of order, do not try to repair it for yourself. 7) Do not attempt to modify product yourself. If any modification is desired, ask OsteoSys or its authorized dealer for this service. 8) Check, maintenance and repair...
  • Page 88 10) Environmental protection If the products are at the end of their lifecyles, do not dispose them at your own discretion. Contact OsteoSys or its authorized dealer for service. 11) Others Read the user’s manual carefully and use the product accordingly.

  • Page 89: Specification & Software Updates

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Specification & Software Updates 5.1 Specifications *General ClassⅠ, Type B Applied part Classification *Device 615(W) × 310(D) × 312(H) (Calf Dimensions (W x D x H) supporter folded) 615(W) ×...
  • Page 90 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Ultrasonic Probe Position Setting Variable Measurement 12~136mm Patient’s Measurement Posture In a sitting posture Accessory QC Phantom *Environmental 10 ~ 40℃ Operating Temperature -5 ~ 50℃...

  • Page 91: Software Updates

    Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 92 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 <packing label>...

  • Page 93: Reference

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 94 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 ④ T < -3, T > +3 : 2.7 of 1,000 persons ⑤ T < -2, T > +2 : 4.6 of 100 persons For example, Person in T<-3 exist 1.35 ratio of 1,000 persons in whole population.

  • Page 95: Reference Data

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 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...

  • Page 96: Product Warranty

    (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.

  • Page 97: Security

    SEC.1. Introduction This section describes the security features, functionality and management requirements of OsteoSys software. The manual is intended to assist medical facilities in using the system in a manner that protects the privacy and security of patients and to perform their work in accordance with national regulatory requirements.
  • Page 98 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Software users should use risk management procedures to assess and prioritize security and privacy risks. Based on your risk assessment, you can make the most of the software's performance.
  • Page 99 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 • When to grant access • access information Access control includes electronic as well as physical aspects, and includes authentication and authorization. You can use Windows to set security policies that control access to software and patient files.
  • Page 100 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 NOTE ! Audit Log will be added every data handling action. SEC.5. Certification Authentication is the process of providing an individual's identity and is a key component of an access control system.
  • Page 101 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 numbers, password guessing difficult. special characters. Password reuse To avoid password prediction, you should not use reuse password previously used passwords. Users should avoid creating passwords that are not...
  • Page 102 Customers should visit the OsteoSys website for up-to-date information about vulnerability information and the impact on software. Customers need to install validated Microsoft security software patches. 1. OsteoSys software computing system holders must apply a validated Microsoft security software patch for their Windows operating system version. patch...
  • Page 103 Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 NOTE ! When the user wants to update the system, please contact OsteoSys to receive appropriate service. SEC.11. Third-Party Components in Product Lifecycle Roadmap OsteoSys provides information security throughout the entire life cycle of the product from its launch to discontinuation.
  • Page 104 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 NOTE ! Third party component updates will proceed with the distribution of patch files from OsteoSys during product warranty. SEC.12. Software and Application Hardening Prohibit the use of unauthorized programs while using the UI program.
  • Page 105 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 SEC.14. Virus protection software You can protect your computer by following the standard computer running procedures. Antivirus programs are an appropriate way to make sure that your electronic media and files are free of viruses before they are introduced to your network.
  • Page 106 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 Without appropriate logoff, leaving the work spot could be dangerous. NOTE ! The database connection will be disconnected after 8 hours from no actions to database or at 0 AM.
  • Page 107 Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 To provide security of health data stored in products or media, OsteoSys uses a database and a specific file system. In order to access, view, and modify patient health data, it is necessary to obtain access to the database and to interpret the specific file system.
  • Page 108 CAUTION ! Do data backup at least every week. OsteoSys could not recover the data not performed latest data backup when the disaster occurred. SEC.23. Data Backup and Disaster Recovery The UI Program backs up data and database once a week.
  • Page 109 SEC.25. Remote service Often, the most efficient and effective way to service OsteoSys is to access the system remotely. Every effort is made to ensure the security of these connections. OsteoSys software requires separate TeamViewer remote access. In no case is the instrument activated remotely.
  • Page 110 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 • DICOM connection to other DICOM devices • Remote service connection via TeamViewer SEC.27. Network Interface Technical Specification Connection name PC Motherboard NIC IEEE 802.3 10/100 / 1000BASE-T...
  • Page 111 WARNING ! When DICOM transmission is succeeded but transmitted data is malformed, first contact the network manager and the DICOM server provider. OsteoSys has verified DICOM features with other DICOM systems. SEC.30. Required Characteristics The network must meet the specific requirements for a subset of the functions, use cases required by users in the responsible organization, and all of the above flows related to the workflow.
  • Page 112 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST 3000 DOC. No. : OT06-2R7124 • Permanent loss or damage of images, examination information or patient data. • Responsible organizations must continue to identify, analyze, assess, and control risk.

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