OsteoSys SONOST-2000 User Manual
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OsteoSys SONOST-2000 User Manual

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User's Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000
DOC. No. : OT-IFU-S2K
SONOST-2000
User' Manual
Model: SONOST-2000
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.
1

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  • Page 1 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K SONOST-2000 User’ Manual Model: SONOST-2000 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-2000 DOC. No. : OT-IFU-S2K SONOST-2000 User’ Manual CAUTION ! You must be well acquainted with this manual before using it. This manual should be placed where the user could read it whenever necessary.
  • Page 3 Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K Thank you for purchasing SONOST-2000 Ultrasound Bone Densitometer. To ensure safe operation and long-term performance stability, it is essential that you fully understand the functions and operating, and maintenance instructions by reading this manual before operating the equipment.
  • Page 4 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K The symbols which are shown in this manual or SONOST-2000 NOTE ! Check the symbol before using the SONOST-2000. The noticed information should be concerned with explanation in this manual.
  • Page 5 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K 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 6 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K - Working Humidity: Within 20~ 80% - Air Pressure: Within 800 ~ 1060hPa (2) Pre-operation Checklist - Check the switch connection and polarity indicator status to ensure the device works properly.
  • Page 7 Guidance and manufacturer’s declaration – Clinical information A or Contents Description The SONOST-2000 system supports the doctor's activities for the diagnosis of osteoporosis and the prevention of future fractures to the Intended Use patient through the measured BMD results. The measurement sites is calcaneus/ Heel bone.
  • Page 8 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K chemotherapeutically induced castration Individuals with medical conditions that could alter BMD: • Chronic renal failure • Rheumatoid arthritis and other inflammatory arthritis • Eating disorders, including anorexia nervosa and bulimia •...
  • Page 9 Ages: 20 – 100 years old b) The patient condition: Osteopenia, Osteoporosis or Normal healthy Patient bone SONOST-2000 has silicon balloon on the probe part which can keep the water inside of balloon as media for path of ultrasound wave more Disposable device efficiently.
  • Page 10 Guidance and manufacturer’s declaration – electromagnetic emissions The model SONOST-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the model SONOST-2000 should assure that it is used in such an environment. Emissions test...
  • Page 11 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K Voltage fluctuations/ Complies flicker emissions IEC 61000-3-3...
  • Page 12 Guidance and manufacturer’s declaration – electromagnetic immunity The model SONOST-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the model SONOST-2000 should assure that it is used in such an environment. Electromagnetic environment – guidance...
  • Page 13 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT-IFU-S2K 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)

  • Page 14: Table Of Contents

    EFORE URNING ON OWER USING SONOST-2000 ................24 H/W ................................24 SING S/W ................................34 SING MAINTENANCE AND REPAIR OF SONOST-2000 ......... 78 ............................78 ESOLUTION TO PROBLEMS ............................ 79 AINTENANCE AND EPAIR SONOST-2000 ..........................82 AFE USE OF SPECIFICATION & SOFTWARE UPDATES ........... 87 ................................

  • Page 15: Introduction

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 Introduction 1.1 General product information Osteoporosis is one of the serious diseases. This device is a bone densitometer which estimates bone mineral density of the calcaneus by using ultrasound It takes about 15 seconds to measure the density and to display the shape of ultrasonic waves by computing simulation on the monitor.
  • Page 16 When you give appropriate commands in SONOST-2000 software, ultrasonic waves are generated. The generated ultrasonic waves pass through the patient’s calcaneus and the electric signals are treated by SONOST-2000 algorithm. SONOST-2000 measures speed of sound(SOS) and the frequency-dependent attenuation of the sound waves(BUA), and combines them to form a clinical...

  • Page 17: Configuration Of Sonost-2000

    OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 Configuration of SONOST-2000 2.1 Composition of SONOST-2000 2.1.1 Shape and componennts of SONOST-2000 Name Function TOP COVER Protection for internal circuit BOTTOM PLATE Fixation for device position & top cover...
  • Page 18 Check the location and contents of the label attached to the product. Check the location of the product power switch. 2.1.2 Keyboard Activate SONOST-2000 by pressing a key on the keyboard according to the instructions shown on the monitor. The manual shows keys required to activate SONOST-2000 are as shown below.
  • Page 19 Use accessories which are defined in the user‘s manual. Check the following accessories before installing the system 2.1.3 Accessories list Check the following accessories before installing the system. If they are not in good condition, contact OsteoSys or local authorized dealer for service. Names of Products Number Uses Make sure to keep it at a designated place so User’s Manual...
  • Page 20 DOC. No. : OT01-2R7123 2.1.4 Articles list Check the following accessories before installing the system. If they are not in good condition, contact to OsteoSys or local authorized dealer for this service. 4.2.2 Stockpiles and Replacement of Articles Names of...

  • Page 21: Installation Of Sonost-2000

    Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 2.2 Installation of SONOST-2000 NOTE ! Since SONOST-2000 is made up of sensitive components, you should install the product according to instructions below. NOTE ! Do not install and keep SONOST-2000 at Do not install or keep SONOST-2000 in excessively high or low temperatures.

  • Page 22: Before Turning On Power

    Plug in the cable. Plug into the connector. When you disconnect the any cable from the main body of SONOST-2000, do not hold the cable, instead hold the connector. Otherwise the cable can break. (2) Connection of power cable (with the oulet)
  • Page 23  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 a power outlet in order to prevent SONOST-2000 from being affected.

  • Page 24: Using Sonost-2000

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 Using SONOST-2000 3.1 Using H/W 3.1.1 Applying the Balloon to the Measuring Device Clean the surface of the probe with an alcohol pad. NOTE ! To remove debris from the...
  • Page 25 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 Fill water into the balloon using an injector until it is full (65~70cc).. Close it with the stopper. Tap the balloon to remove bubbles inside of the balloon.
  • Page 26 Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.1.2 Using the QC phantom 3.2.2.8 Daily Test of SONOST-2000 Insert the standard block positioner. Apply gel on the both sides of the QC Phantom. Put the QC Phantom between the balloons and press the phantom until the phantom touches the bottom.
  • Page 27 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.1.3 Patient Measurement procedure Put the foot positioner in accordance with a patient’s foot size - Ex) Using the #1foot positioner - Ex) Using the #2 foot positioner...
  • Page 28 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 Clean the both sides of the patient’s heel with an alcohol pad. Apply plenty of gel on both sides of patient’s heel. Insert patient’s foot Let a patient move his foot up and down for the balloons to be covered with ultrasound gel sufficiently.
  • Page 29 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 CompleteComplete and ready for a measurement. Start measurement after adhering patient’s calf to the calf supporter. 3.1.4 Disposing water Dispose water inside the device. ▶ Replacement period : 1 ~ 3(week) ▶...
  • Page 30 Good Not good CAUTION ! To prevent damage to skin and cells, the gel used with Sonost-2000 must be commercially available ultrasound gels that have passed ISO 10993-5(Cytoxicity), ISO 10993-10(Skin sensitization) and ISO 10993-23(Skin irritation) tests. Do not forget to apply the gel before measuring.
  • Page 31 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.1.6 Correct position for patient’s foot & body Adhere a heel to the measuring device closely as shown below. Make sure measuring device and body should be one line as shown below.
  • Page 32 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.1.7 Seection 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 belongs to * Section 1: use only foot supporter 1.
  • Page 33 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.1.8 Shutting down processing Turning off the main switch of the system  NOTE ! Push the power switch to "0" to power off the machine.

  • Page 34: Using S/W

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2 Using S/W 3.2.1 Progress table of program...
  • Page 35 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2 Using program 3.2.2.1 Setup program (1) Execute the Setup.exe file for installation (2) Click [Next] (3) Click [Next] (4) Click [Next]...
  • Page 36 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (5) Click [Next] (6) Click [Next]...
  • Page 37 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (7) Click [Finish], Program installation is finished...
  • Page 38 (2) Select [Install from a list or specific location(Advanced)] and Click [Next] (3) Select [Include the location in the search] and Click [Browse]. (4) Select the folder that contains the driver files and Click [Next] ' My computer > C > Program Files > OsteoSys > SONOST-...
  • Page 39 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 2000 > USB Driver > WinXP' (5) Select [SONOST-2000+XP] and Click [Next] (6) Click [Continue Anyway]...
  • Page 40 DOC. No. : OT01-2R7123 (7) Click [Browse] (8) Go to the folder indicated below, select a SonostXP.sys file and click [OK]. ' My computer > C > Program Files > OsteoSys > SONOST- 2000 > USB Driver > WinXP '...
  • Page 41 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (9) Click [Finish] (10) You must check if [SONOST-2000+XP] appears under Universal serial bus controller. (Exclamation mark[!] must be removed)
  • Page 42 ※ If not installed properly, you can refer to the instructions below. ※ The following is the instruction for Windows 7 driver How to install the SONOST-2000 driver for Windows 10 in next chapter. ※ The following is the instruction for Windows 10 driver (1) Insert the SONOST-2000 driver CD (2) Go to the folder in which the SONOST-2000 program is installed.
  • Page 43 Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (5) Click [Finish] and installation is complete. (6) Connect the USB cable from PC to SONOST-2000. (7) The drivers are installed automatically and the following window appears, click Close. (8) You must check whether [s2k_usb Device] is shown under Universal Serial Bus devices.
  • Page 44 3.2.2.3 Execution of Program and Configuration of the Incipient Environment 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.
  • Page 45 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (4) Hospital : Set the name, address and phone number of your hospital. (5) Comment: Enter the comment information to be displayed according to the T-score in the patient measurement result.
  • Page 46 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (6) DICOM  NOTE ! Using DICOM, which related to storage/worklist server IP, Port, Modality should be requested to the server manager in the hospital. You must input server information exactly which can be only obtained from the hospital.
  • Page 47 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (2) If you are a new user(doctor), click the “New Doctor” button in the “Doctor Selection” window, and then the “New Doctor” window appears. If you enter your information (name, phone number, department and password) and click “OK”...
  • Page 48 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123...
  • Page 49 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (3) If you want to delete registered users, select a user to delete and click “Doctor Delete” button of the “Doctor Selection” window. If there are two or more registered users, the message box “Patients Shifting”...
  • Page 50 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (4) If you click the “OK” or “NO” button, the message box “Surely delete doctor?” appears to reconfirm your intention to delete the selected doctor. If you click “OK” button the user information is deleted.
  • Page 51 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2.5 BQI Measurement <Registration & Retrieval of Patients> (1) If you click the “BQI Measurement” button in the default screen, you can move to the “Patient List” screen that contains all information of the registered patients.
  • Page 52 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (2) If you want to register new patients, click “New Patient” button on the bottom of the “Patient List” screen. Then on the “New Patient” window, you can enter information of a new patient and click “OK”...
  • Page 53 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 <Worklist Usage and Searching Patient> (1) If you press the “Worklist” button to use Worklist, the screen is converted while the patient registration, patient information change, and patient deletion buttons are deactivated.
  • Page 54 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 <Measurement of patients> (1) If you want to measure BQI, select a desired patient from “Patients List”, Click “Measurement” on the right side of the screen. Then the “Measurement” screen appears as shown...
  • Page 55 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (2) Click “Measurement Start” bottom “Measurement” window. Then the “Measurement Start” window appears and you are asked to select measuring site and some basic information on the patient. When you are ready to measure your patient, click “Measurement Start”,...
  • Page 56 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (4) If you click the “OK”, the results appears in the screen as shown below.
  • Page 57 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (5) If you need to write or modify comment, click “Comment Edit” on the bottom of the screen. Then the “Comment Edit” window will appear and you can write or modify comments.
  • Page 58 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 < Send PACS > (1) Measurement results can be transmitted to the PACS Server. PACS transmission transmit results troop transmission respectively. Bone density mode and pediatric bone density mode are supported.
  • Page 59 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2.6 Revision & Deletion of patient’s information If you want to revise the registered patients’ information, select a desired patient using the mouse and click “Info Change”...
  • Page 60 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 After selecting a desired patient, click the “Patient Delete” on the bottom of the screen. Then the message box “Patient Deletion” appears to confirm whether or not to delete...
  • Page 61 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2.7 Inquiry & Deletion of clinical history of existing patients (1) If you want to retrieve the clinical history of existing patients, select a desired patient and click “Patient Info” on the right side of the “Patients List”...
  • Page 62 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 If you click “Print Preview” on the right side, the result you ① selected appears in the “Patient’s Info” screen. If you click “Print Preview” on the left side, all results of the ②...
  • Page 63 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 [ Print Sample ① ]...
  • Page 64 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 [ Print Sample ② ]...
  • Page 65 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (2) After revising patients’ information(menopause state, taking drug, etc.), if you click “Result Update” on the Patient's Info window, the message box “Result Updating” appears to confirm whether or not to apply the changes.
  • Page 66 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2.8 Daily test of SONOST-2000 NOTE! Daily Test Recommendation The daily test should be performed within operating temperature.  (Recommended temperature: 18 ~ 27 ℃) The phantom should be kept beside of device closely.
  • Page 67 Daily Test. Click “OK” to finish the Daily Test. NOTE ! In case of Daily Test failure, do not use the system and execute “Daily Test” once again. If Daily Test fails continuously contact to OsteoSys or your local authorized dealer.
  • Page 68 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2.9 Data Backup (1) If you need to save the data, click “Backup” from the main menu. When clicked, the default screen of “Backup” menu appears as shown below.
  • Page 69 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (3) Retrieve : If you click this button, you can exchange all users’ DB into others (4) Clear : If you click this button, the message box “Surely clear doctor?”...
  • Page 70 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (5) Recover : If you click this button, you can recover all users’ DB. All records related to the DB are written in this field. After selecting the record and clicking the “OK” button in this...
  • Page 71 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2.10 Configuration of environment If you want to configure the user environment again, click the “Configuration” button from the main menu. There are three sub-menus from “Settings” to “Doctor”.
  • Page 72 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (4) Comment: Enter the comment information to be displayed according to the T-Score in the patient measurement result. (5) DICOM : Set the storage server and worklist server...
  • Page 73 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 (6) Doctor: You can set your name, phone number and department. If you click the “PW Change” button, you can change your password. 3.2.2.11 Inactivation of SONOST-2000 If you click the “Exit”...
  • Page 74 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3.2.2.12 FRAX FRAX Mode predicts the risk of fractures within the next ten years using the patient's lifestyle and use of medication. The FRAX results predict the risk of femoral fractures and major osteoporotic fractures (vertebral, wrist, femur, and shoulder fractures) within ten years.
  • Page 75 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 If your patient is over 40 years old and below 90 years old, the FRAX button becomes activated and you can enter FRAX information. (2) Entering from Patient Info In the Patient Info screen, select FRAX button and input FRAX information.
  • Page 76 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123  CAUTION ! Before calculating the FRAX value, check that the questionnaire items are correct. ① You can select the risk factor value of each individual...
  • Page 77 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 mellitus, adult osteogenesis imperfecta, untreated long-term hyperthyroidism, hypogonadism premature menopause (before age 45), chronic malnutrition or absorption disorders, chronic liver disease. ② You can select the Ethnicity of the patient to be measured.

  • Page 78: Maintenance And Repair Of Sonost-2000

    Is the hardened gel stuck on the surface of the balloons 4.2.1 Cleaning Is there any material on the surface of QC The balloons tears easily phantom? CAUTION ! If you cannot resolve the problem, contact to OsteoSys or your local authorized dealer.

  • Page 79: Maintenance And Repair

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 4.2 Maintenance and Repair 4.2.1 Cleaning CAUTION ! Turn off the power before cleaning the system. Product Example Instructions After using the device, remove the balloons from the device and wash with water.
  • Page 80 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 4.2.2 Stock pile and replacement of articles Make sure to keep following articles of consumption all the time. 2.1.5 Articles List Articles Specifications Purchase ones at our authorized dealer when it needs to be used.
  • Page 81 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 4.2.3 Storage 1) Unplug the power cord. 2) Dust on the product can damage the system. After use, make sure to cover it with a vinyl cover.

  • Page 82: Safe Use Of Sonost-2000

     If you hear a strange noise or if you find any abnormality on the screen after turning on the product, contact OsteoSys or your local authorized distributor.  If damage is visible on the exterior, do not operate and contact OsteoSys or your local authorized distributor.
  • Page 83 4.3.1 Safety Rules 1) Nobody can handle SONOST-2000 except for doctors and authorized personnel 2) Comply with followings in times of installation of SONOST-2000. Do not install it in following places. A) Places where the product is exposed to water vapor.
  • Page 84 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 connecting a third party devices to SONOST-2000, contact OsteoSys or its authorized dealer for instructions.
  • Page 85 Otherwise, it may lead to abnormal result. An independent circuit and a safely grounded outlets are strongly recommended for SONOST-2000. Poor or abnormal images may occur if the system shares a power source with other electrical or electronic equipment.
  • Page 86 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 this service. 11) Others Read the user’s manual carefully and use the product accordingly.

  • Page 87: Specification & Software Updates

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 Specification & Software Updates 5.1 Specifications *General Classification ClassⅠ, Type B Applied part *Device 523(W) × 286(D) × 254(H) (Calf Dimensions (W x D x H) supporter folded) 523(W) ×...

  • Page 88: Software Updates

    We recommend instituting a “No Smoking” policy in system area. 5.2 Software updates 1) Updates to SONOST-2000 software are available at our homepage (http://www.osteosys.com). 2) Updates to SONOST-2000 software are free, regardless of the product warranty.

  • Page 89: Labels

    OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 3) Updates to SONOST-2000 software are irregular, we will inform you through your email whenever SONOST-2000 software needs to be updated. 4) For details, call the OsteoSys Co., Ltd Customer Service Department, or your OsteoSys Co., Ltd distributor.
  • Page 90 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 <packing label>...
  • Page 91 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123...

  • Page 92: 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 93 OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 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.

  • Page 94: 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 95 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 • 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 96 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 SEC.5. Certification Authentication is the process of providing an individual's identity and is a key component of an access control system. A password inspector account is required to restrict access to patient health information to authorized personnel.
  • Page 97 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 98 Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 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 99 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 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 100 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 • If a virus protection program uses too much memory or system resources, the software may not work properly. CAUTION ! The user needs to use anti-malware software to protect the whole system.
  • Page 101 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. 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 is unable to 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. OsteoSys software requires separate TeamViewer remote access. In no case is the instrument activated remotely.
  • Page 104 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation : SONOST-2000 DOC. No. : OT01-2R7123 Connection name PC Motherboard NIC IEEE 802.3 10/100 / 1000BASE-T Physical network connection type Ethernet 10 Mbps Half and Full Duplex 100 Mbps Half and Full Duplex...
  • Page 105 DOC. No. : OT01-2R7123 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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