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OsteoSys SONOST 3000 User Manual

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SONOST 3000
User's 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
OsteoSys Co., Ltd.

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  • Page 1 SONOST 3000 User’s 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 OsteoSys Co., Ltd.
  • Page 2 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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, REPUBLIC OF KOREA info@osteosys.com...
  • Page 3 NOTE ! “Note” is used to notify the user of installation, operation or maintenance information that is important but not hazard related. The symbols which are shown in this manual or SONOST 3000 ３...
  • Page 4 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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...

  • Page 5: Disposal Of Device

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 The protecting device from external electromagnetic wave. 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.

  • Page 6: Guidance And Manufacturer's Declaration

    Guidance and manufacturer’s declaration – Clinical information A or Contents Description The SONOST 3000 system supports the doctor's activities for the diagnosis of osteoporosis and the prevention of future fractures to the patient Intended Use through the measured BMD results. The measurement sites is calcaneus/ Heel bone.
  • Page 7 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 Women younger than 65 years old or men younger than 70 years old with the following risk factors: Current cigarette smoker Loss of height  Thoracic Kyphosis ...
  • Page 8 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 • Prolonged immobilization • Conditions associated with secondary osteoporosis, such as gastrointestinal malabsorption or malnutrition, sprue, osteomalacia, vitamin D deficiency, endometriosis, acromegaly, chronic alcoholism or established cirrhosis, and multiple myeloma •...
  • Page 9 Duration of use or contact with body balloon as below image. SONOST 3000: It also same as SONOST-2000 Need to apply ultrasound gel in between skin and probe in order to get proper contact for path of ultrasound waves. ９...

  • Page 10: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    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.
  • Page 11 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 RF emissions Class A The model SONOST-3000 is suitable for use in all CISPR 11 establishments including domestic and those directly connected to the public low-voltage power supply network...

  • Page 12: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 13 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 14 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.
  • Page 15 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 The exchange and using period of expandable goods The period for The method of exchange Name Part number exchange expandable products FOOT SUPPORTER 0 : 10years...

  • Page 16: Table Of Contents

    2.1.1 Shape and Components of Device ..............２０ 2.1.2 Accessories List ....................２１ 2.1.3 Articles List ..................... ２１ 2.2 Installation of SONOST 3000 ................... ２２ 2.3 Before Turning on Power .................... ２３ Chapter 3. Using SONOST 3000 ..................... ２５ 3.1. Daily Test ........................２５...
  • Page 17 3.4.11 Setup the worklist .................... ６７ 3.4.12 Setup and sending function of PACS .............. ６８ 3.4.13 FRAX ......................７３ Chapter 4. Maintenance and Repair of SONOST 3000 ............７６ 4.1 Resolution to Problems .................... ７６ 4.2 Maintenance and Repair ..................... ７７...

  • Page 18: Chapter 1. Introduction

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

  • Page 19: Chapter 2. Configuration Of Device

    - 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 20: Shape And Components Of Device

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 2.1.1 Shape and Components of Device Name Function TOP COVER Protection for internal circuit CALF SUPPORTER Leg fixation for diagnosing PROBE Generation of ultrasound Display for measuring status...

  • Page 21: Accessories List

    Power Cable Make sure to connect it with a grounded electric outlet. 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 ２１...

  • Page 22: Installation Of Sonost 3000

    Result paper is printed at printer paper. Printer Paper 2 rolls Minimum paper thickness : 0.07mm 2.2 Installation of SONOST 3000 NOTE ! Since SONOST3000is made up of precise components, you should install the product according to instructions below. ２２...

  • Page 23: Before Turning On Power

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 Do not install and keep SONOST3000 at Do not install or keep SONOST3000 in the excessively high or low temperatures. place where the machine can be rocked or shaken.
  • Page 24 - If you find any damage or any sign of it, immediately contact an agency. - Put the Power cord into only one plug. - Make sure not to share the power outlet to prevent SONOST 3000 from being affected. ２４...

  • Page 25: Chapter 3. Using Sonost 3000

    DOC. No. : OT06-2R7124 Chapter 3. Using SONOST 3000 3.1. Daily Test The SONOST 3000 system is checked using 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, Phantom and ultrasound transmission gel Dailytest Recommendation ...

  • Page 26: Daily Test Procedure

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • 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 the gel should be same as the area of the phantom in contact with the probe.
  • Page 28 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124  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.

  • 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: Position Of Shutdown Button

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

  • Page 31: Shutting Down Processing

    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 ３１...

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

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 1.1 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.
  • Page 33 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.

  • Page 34: Patient Measurement Procedure

    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. Clean the both side of patient’s heel with an alcohol pad and apply gel.

  • Page 35: Selection Of The Foot Supporter

    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. If the foot of patient is belong to * Section 1 : use only foot supporter 1.

  • Page 36: Where And How Much Apply To The Patient's Heel

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 3.3.5 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.

  • Page 37: Correct Position For Patient's Foot & Body

    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 38: Osd (Auto Screen Alignment)

    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 width 58mm.
  • Page 39 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 is scrolled In automatically.

  • Page 40: Using S/W

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 1.2 Using S/W 3.4.1 Progress Table of Program ４０...

  • Page 41: Execution Of Program

    DOC. No. : OT06-2R7124 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. 15 seconds after splash screen that checks functions of the system and memory...

  • Page 42: Setting Of The Incipient Environment

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 43 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 44 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 - 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.
  • Page 45 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 46 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 - 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.
  • Page 47 : 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.

  • Page 48: Registration, Modification & Deletion Of Users

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 3.4.4 Registration, Modification & Deletion of Users (1) As soon as you configure the user environment, the “Doctor Selection” window appears as shown below. If you are a registered user(doctor), click the “Doctor Select”...
  • Page 49 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 NOTE ! After login, it is automatically locked 15 minutes after the last touch. (2) If you are a new user(doctor), click the “Add” button in the “Doctor Selection”...
  • Page 50 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 the “Modify” button of the “Doctor Selection” window. And then if you enter the password in the edit box “Password Enter”...
  • Page 51 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 the “Delete” button of the “Doctor Selection” window. And then if you enter the password in the edit box “Password Enter”...

  • Page 52: Measurement Of Bone Mineral Density

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 3.4.5 Measurement of Bone Mineral Density 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.
  • Page 53 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 - Ethnicity : Insert the patient’s ethnicity. - Foot Supporter : Choose the Foot Supporter according to the foot size. - Height : Input the height of patient.
  • Page 54 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 55 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 Ultrasound waves are generated from the probe. 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”...

  • Page 56: Revision And Deletion Of Patient's Information

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 3.4.6 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.
  • Page 57 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 58 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 ５８...

  • Page 59: Inquiry And Deletion Of Clinical History Of Existing Patients

    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 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”...
  • Page 60 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.

  • Page 61: Dailytest Of Sonost 3000

    OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 3.4.8 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.
  • Page 62 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.

  • Page 63: Printing Of Clinical History And Result

    Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 3.4.9 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.
  • Page 64 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 65 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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] –...

  • Page 66: Customize The Logo In Printing

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 3.4.10 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)

  • Page 67: Setup The Worklist

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

  • Page 68: Setup And Sending Function Of Pacs

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 69 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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’...
  • Page 70 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 hospital. When Command board appeared, you should input CMD. Next, you can see DOS mode.
  • Page 71 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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’...
  • Page 72 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 The alarming message whether when sending disease history to server success or not. Sending successful Sending failure When it comes to sending failure message, you should check below parts.

  • Page 73: Frax

    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 74 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 shownas below.
  • Page 75 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 The amount of one cup varies slightly from country to country, but corresponds to 8- 10 grams of alcohol. This is equivalent to a standard-sized beer (285ml), a cup of distilled liquor (30ml), a medium-sized wine (120ml), or a pre-drinking glass (60ml).

  • Page 76: Chapter 4. Maintenance And Repair Of Sonost 3000

    Despite measurement according Is the desired part of the body properly placed? to the instructions, its result turns 4.2.1. Cleaning, Disinfection, out to be abnormal Sterilization CAUTION ! If you cannot resolve the problem, contact to OsteoSys or its authorized dealer. ７６...

  • Page 77: 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, Disinfection, Sterilization. CAUTION ! Turn off the power before cleaning the device. Product Instructions After using the device, wash with Alcohol swap.

  • Page 78: Product's Life

    - Unplug the power cord. - Put cover on the product to avoid dust. Storage - Keep the product according to instructions described in “2.2 for a Installation of SONOST 3000” long time period 2.2 Installation of SONOST 3000 ７８...

  • Page 79: Safe Use Of Sonost 3000

    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 80: Cautions Related To Use Electronic Medical Equipment

    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.
  • Page 81 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.
  • Page 82 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.
  • Page 83 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.

  • Page 84: Chapter 5. Specifications & Software

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 Chapter 5. Specifications & Software Updates 5.1 Specifications *General Ⅰ Classification Class , Type B Applied part *Device 310mm × 615mm × 387mm Dimensions (W x D x H) Weight 12.6 Kg...
  • Page 85 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 *Environmental Operating Temperature 10~ 40℃ -5~ 50℃ Transport / Storage Temperature Operating Humidity 20 ~ 80% relative humidity Transport / Storage Humidity 0 ~ 90% relative humidity, non-condensing...

  • Page 86: 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 87: Chapter 6. Reference

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.
  • Page 88 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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.

  • Page 89: 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 90: Chapter 7 . 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 91 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.

  • Page 92: Chapter 8. Security

    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 93 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 SEC.3. Access control Access control is a comprehensive mechanism used to determine and enforce the following: • Access subject • How to secure access • When to grant access •...
  • Page 94 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 Securing of audit data as appropriate (especially if they contain personal data themselves). 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 95 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 with the password so that it expires before the password is cracked. You must mix This is a set of attributes used to increase the number of...
  • Page 96 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. 2. The patch can be downloaded from Microsoft's website (https://support.microsoft.com).
  • Page 97 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. Information security requirements should also consider: a) the level of confidence required towards the claimed identity of users, in order to derive user authentication requirements;...
  • Page 98 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. Users should not use unauthorized programs while using the UI program, but should only use the program in an approved manner.
  • Page 99 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 viruses and other bad attacks. Owners and operators of networked medical devices are responsible for protecting their computers from these malicious attacks. SEC.14. Virus protection software You can protect your computer by following the standard computer running procedures.
  • Page 100 To ensure the integrity and authenticity of HEALTH DATA, authorized users must access and modify the health information in an approved manner. SEC.18. HEALTH DATA Storage and Confidentiality To provide security of health data stored in products or media, OsteoSys uses a database and a specific file system. １００...
  • Page 101 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 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 102 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 103 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.
  • Page 104 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R7124 Connection name PC Motherboard NIC Physical network connection type IEEE 802.3 10/100 / 1000BASE-T Ethernet 10 Mbps Half and Full Duplex 100 Mbps Half and Full Duplex...
  • Page 105 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.

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