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OsteoSys BeeTLe User Manual

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User's Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation: BeeTLe
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT
Doc. version : 2.3 (2024.04.05)
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BeeTLe APP
BeeTLe
User's Manual
AND OF THE COUNCIL
http://www.osteosys.com
OsteoSys Co., Ltd.
DOC. No. : OT-IFU-BT

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Summary of Contents for OsteoSys BeeTLe

  • Page 1 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT BeeTLe User’s Manual REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Doc. version : 2.3 (2024.04.05) Scan here http://www.osteosys.com OsteoSys Co., Ltd. BeeTLe APP...
  • Page 2 CAUTION ! 1. You must be well acquainted with this manual before using the equipment. 2. This manual should be placed where the user could read it whenever necessary. Thank you for purchasing BeeTLe Ultrasound Bone Densitometer. １ A4(210 × 297)
  • Page 3 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 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: BeeTLe DOC. No. : OT-IFU-BT The noticed information when the device is operated The reference page or section Applied Part Type B I and O on power switch represent ON and OFF, respectively The Attention symbol that marks warning and important information in the user’s manual...
  • Page 5 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Manufacturer Serial Number Authorized representative in the EUROPEAN COMMUNITY Indicates the item is a medical device 3) Protecting the equipment from external electromagnetic waves This device’s accuracy and normal operation can be affected by external electromagnetic waves.
  • Page 6 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 5) Cautionary Notes (1) Environmental Condition To prevent possible performance loss or malfunction of device components caused by sudden and excessive environmental changes, as well as the resultant shortening of their life cycle, the environmental conditions below must be met.
  • Page 7 Guidance and manufacturer’s declaration – Clinical information A or Contents Description The BeeTLe 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 8 Ages: 20 – 100 years old Patient b) The patient condition: Osteopenia, Osteoporosis or Normal healthy bone Disposable device BeeTLe is not a disposable device. Invasive device Not intended to be invasive Implantable Not intended to be implantable device BMD measurement is performed once a year or once every two years (It depends on the patient's situation).
  • Page 9 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT It's just below the area of the ankle, where you should apply enough amount of ultrasound gel just like the below instructions. (need to apply to both sides of feet)
  • Page 10 Mains terminal disturbance Group 1 Class B voltage according to CISPR 11 Harmonic current The BeeTLe is suitable for use in all emission Class A establishments other than domestic and those IEC 61000-3-2 directly connected to the public low-voltage Voltage...
  • Page 11 30% Radiated RF Electromagnetic 10 V/m 10 V/m The BeeTLe is suitable to Field immunity 80 MHz-2.7 GHz 80 MHz-2.7 GHz use in home healthcare according to IEC 80% AM at 1 kHz 80% AM at 1 kHz environment.
  • Page 12 134.2 kHz, 13.56 134.2 kHz, 13.56 equipment is used on Proximity magnetic MHz in according to MHz in according to closer than 5 cm to any fields according to table 11 table 11 part of the BeeTLe １１ A4(210 × 297)
  • Page 13 For safe use, you must use part of device supplied or approved by Osteosys NOTE ! If you use part of device which is not approved by Osteosys, we do not guarantee safety to user. Moreover, it become dangerous and prone to producing to producing errors and wrong results to users or patients.
  • Page 14 RF exposure requirements. 9) 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. １３ A4(210 × 297)
  • Page 15 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT The exchange and usage period of consumable goods The method of exchange The period Name Part number for exchange expandable products FOOT SUPPORTER 1 : 10 years...

  • Page 16: Table Of Contents

    2.1.2 Installation of BeeTLe....................２１ Before Turning on Power ..................２２ Connection of AC adaptor ................２２ 2.3.1 Chapter 3. Using BeeTLe ......................２４ Daily Test ......................... ２４ Shutting down the product ..................２８ Shut down sequence ..................２８ 3.2.1 Using H/W .......................
  • Page 17 OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT `Printing History/Result ................. ７４ 3.4.14 Chapter 4. Maintenance and Repair of BeeTLe ................ ８２ 4 ............................８２ Resolution to Problems ................... ８２ Maintenance and Repair ..................８３ Cleaning, Disinfection, Sterilization .............. ８３...

  • Page 18: Chapter 1. Introduction

    DOC. No. : OT-IFU-BT Chapter 1. Introduction BeeTLe is a bone densitometry device to measure and prevent osteoporosis by measuring the bone mineral density of Calcaneus using ultrasound. This device measures SOS (Speed Of Sound) and BUA (Broadband Ultrasound Attenuation) using ultrasound with a center frequency of 0.5 MHz and calculates the BQI to show the degree...
  • Page 19 The user of this device must understand the hazards of electronic medical devices and be aware of the precautions to be taken when an emergency occurs. BeeTLe should be located more than 20cm away from the wall when measuring the patient. In any case, do not disassemble the device at your discretion.

  • Page 20: Chapter 2. Configuration Of Device

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Chapter 2. Configuration of Device 2.1 Composition of Device 2.1.1 Shape and Components of Device NO Name Function It functions as the top cover of the device when not in use CALF SUPPORTER and as the calf supporter when in use.

  • Page 21: Accessories List

    Check the location of the device power switch. 2.1.2 Accessories List Check the following accessories before installing the system. If they are not in good condition, contact to OsteoSys or its authorized dealer for this service. Names of Products Number Uses Make sure to keep it at a designated place so that users User’s Manual...

  • Page 22: Installation Of Beetle

    DOC. No. : OT-IFU-BT 2.2 Installation of BeeTLe NOTE ! Since BeeTLe is made up of precise components, you should install the device according to instructions below. Do not install and keep BeeTLe at excessively Do not install or keep BeeTLe in the place high or low temperatures.

  • Page 23: Before Turning On Power

    AC adaptor Connector cover NOTE ! Before you start up the BeeTLe for the first time, fully charge BeeTLe’s battery so that the battery performance can be used effectively. ※ Check the power switch is off when charging the battery.
  • Page 24  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 BeeTLe from being affected. ２３...

  • Page 25: Chapter 3. Using Beetle

    Daily check is performed once every day before starting the first measurement. Preparation of the Daily test 1) Items to be prepared BeeTLe, daily check phantom, ultrasound gel Perform the Daily test 1) Device Connection [Using App] – [Device Connection]...
  • Page 26 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT On the bottom of the phantom, one of two types of labels is shown below. Confirm the contents listed below and confirm the following two items. 1. Make sure that the SOS value and the BUA range that are listed in the phantom label to be correctly shown in the Phantom Info section of Settings.
  • Page 27 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Bottom label Check Type 1 Type 2 3) Phantom Installation Apply ultrasound gel to the phantom. The position to apply the gel is the position on both sides of the phantom where the probe touches the phantom, that is, the contact area of the probe.
  • Page 28 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Place the phantom on the Foot Supporter 1 in the measuring position of the device. (The phantom must be on the edge of the Foot Supporter as shown below.) The Foot Supporter 2 is not used for Daily test.

  • Page 29: Shutting Down The Product

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT  Daily test should be performed at an operating temperature conditions of the unit. (Recommended operating temperature: 15 to 30 degrees Celsius).  Phantom should always be kept close to the device.
  • Page 30 Model Designation: BeeTLe DOC. No. : OT-IFU-BT Once you exit the App, press the power button on the BeeTLe to shut down the device. NOTE ! In iOS, you can exit BeeTLe app with iOS home button method. Press home button twice, and swipe to remove app from the list.

  • Page 31: Using H/W

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.3 Using H/W 3.3.1 LED indicator The LED display on both sides of the device shows different colors according to each operation. The contents are as follows.

  • Page 32: Power Saving Mode

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.3.2 Power saving mode When the battery is not used for a long time, you can use the power saving mode to increase the usage time. The power saving mode and standby mode can be switched by simple operation of cover closing/openinng.

  • Page 33: Patient Measurement Procedure

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.3.3 Patient Measurement Procedure Clean the surface of the Coupling Pad with an alcohol pad. Clean the both side of patient’s heel with an alcohol pad and apply gel.

  • Page 34: How To Use The Toe Holder

    When the toe crosses the handle of the device (red line), push forward the toe folder as shown in the image on the right. Put patient’s foot on the BeeTLe and fix the foot by adjusting both wings. ３３ A4(210 × 297)

  • Page 35: Selection Of Foot Supporter

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.3.5 Selection of Foot Supporter (Foot Supporter 1) (Foot Supporter 2) (Foot Supporter P) Put the foot supporter according to the size of patient’s foot as below.

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

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Where and How to Apply Gel to the Patient’s Heel 3.3.6 Swipe patient's heel with alchol pad and apply gel. Apply sufficient amount of gel to the heel to remove air remaining between the probe and the patient's heel.

  • Page 37: Position Of Foot And Body

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.3.7 Position of foot and body Place heel in the device and make sure that the 3 points of the foot are attached to the device as below.

  • Page 38: Using App

    DOC. No. : OT-IFU-BT 3.4 Using App 3.4.1 Install the program NOTE ! BeeTLe APP installation can be done in two ways as follows. 1) Install using QR code 2) Install using Play store search How to install using QR code. →...
  • Page 39 DOC. No. : OT-IFU-BT → → (5) Start the QR scanner APP. (6) Scan the QR Code of (7) Smartphone screen → → (7) QR code of BeeTLe APP (8) When the scan is completed, Touch “Open Link”. ３８ A4(210 × 297)
  • Page 40 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT → → (9) When the BeeTLe APP screen (10) If login screen appears, touch appears, touch the ‘Install’ button. ‘Install’ button again after login. → → (11) When the device selection screen (12) Touch the OK button.
  • Page 41 (14) On the home screen, exit to the home screen. touch the Install APP List icon. → → (15) Check the BeeTLe APP icon (16) Once the installation is and touch. completed successfully, you can see the home screen of BeeTLe APP.
  • Page 42 (1) Start the Play store. (2) When the Play store screen appears, touch the search box. → → (3) Enter ‘OSTEOSYS BEETLE’ (4) Check the APP name and in the search box and touch developer name and touch the ‘Install’ button.
  • Page 43 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT → → (5) When installation is completed, (6) Once the installation is touch ‘Open’ button. completed successfully, you can see the home screen of BeeTLe APP. ４２...

  • Page 44: Execution Of The Program

    3.4.2 Execution of the program Select the BeeTLe icon on the app selection screen to run the program. After about 5 ~ 15 seconds of preparation, the start screen appears. A description of each icon is shown below. Status icons...

  • Page 45: Registration Of Beetle (Bluetooth)

    OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.3 Registration of BeeTLe (Bluetooth) Register your Bluetooth device on your smart device for seamless connection with BeeTLe. → → (1) Touch Setting icons (2) Touch the Bluetooth entry (3) Touch BeeTLe →...
  • Page 46 Device (BeeTLe) Connection Once the device registration is complete, run APP and proceed to connect the device. NOTE ! For Android phone, proceed with ‘Registration of BeeTLe’ first and then with the connection. For iOS(iPhone), registation process is not required. NOTE ! The distance that BeeTLe can be connected with Bluetooth is as follows.
  • Page 47 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT NOTE ! In case of iOS, proceed as below. → → (1) Touch the Bluetooth icon (2) Touch BeeTLe (3) Check the connection Notification window. ４６ A4(210 × 297)
  • Page 48 2) How to connect by NFC tagging. NOTE ! In iOS, BeeTLe App does NOT provide NFC connect method. After launching the BeeTLe APP, proceed as follows. (1) Place your smart device near the NFC mark on the BeeTLe → Before pairing After pairing ４７...

  • Page 49: Device Serial Number Verification

    If the device serial number is not verified, the app disconnects the device connection. If the device is not connected, you will not be able to use most of the features of the BeeTLe app. ４８...

  • Page 50: Inspector Selection

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.5 Inspector Selection When the device serial number is verified, the inspector selection window appears. Touch the inspector and a password entry window will appear. If an incorrect password is...

  • Page 51: Adding An Inspector

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.6 Adding an Inspector In the inspector selection window, you can add an inspector by pressing the button marked with a yellow circle. After filling the contents, press the Save button marked with a red circle to save and move back to the inspector selection screen.

  • Page 52: Setting

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.9 Setting Click the <Setting> button on the <Home> screen to display the Setting window. <Settings> window - Setup: Set the default settings related to the software.
  • Page 53 - Language: Change your app's language setting. The app will not take effect until you restart it. - Device Location Tracking: Show the locations of the BeeTLe device. A location map window is popped out when the button is clicked.
  • Page 54 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3) Cleaning Move the probe of the device to an easy-to-clean position. Setting > Cleaning tab - Narrow: This is a button marked with a yellow circle. Pressing this button while the deviced is connected, the gap between the probes get narrowed, and exposes the probe.
  • Page 55 Model Designation: BeeTLe DOC. No. : OT-IFU-BT NOTE ! Import function is available between Android and iOS. Import function supports importing database from BeeTLe beta app. However, BeeTLe beta app can not import the database of BeeTLe app. ５４ A4(210 × 297)

  • Page 56: Measurement

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.10 Measurement NOTE ! Measurements may not be accurate if patient information is entered incorrectly. Patient registration From the initial screen, select the <Patient List> tab at the top to go to the "Patient List"...
  • Page 57 Then, when you click the <start measurement> button marked with a red circle, a message box asks the measurement area as follows. After selecting the measurement site, BeeTLe device will start measurement. If you disable the <Temperature Auto Adjustment> function with <Temperature Compensation>...
  • Page 58 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Scan Site selection window [Measuring foot selection screen] When you start measurement, the <Start> button changes to the <Stop> button. If an emergency occurs during the ultrasonic emission, clicking this button will stop the ultrasonic emission. After a certain period of time (about 10 seconds), the result of the measurement of bone density is shown as below.
  • Page 59 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Press the <Print> button marked with a red circle at the top of the screen to print the results. Press the PACS <image transfer> button marked with a yellow circle to transfer the results to the Storage server.
  • Page 60 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT [History] [Detail] ５９ A4(210 × 297)
  • Page 61 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT ※ Current Height and Predicted Height Results [History] [Detail] ※ Current Weight Results [History] [Detail] ６０ A4(210 × 297)
  • Page 62 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT ※ BMI Results [History] [Detail] ※ If you select an adult patient, you will see the following screen. ６１ A4(210 × 297)
  • Page 63 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT [History] [Detail] ６２ A4(210 × 297)

  • Page 64: Frax

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.11 FRAX If the patient is between 40 and 90 years old, the FRAX is available. FRAX is a function that predicts fracture risk developed by WHO. If you know the femoral neck BMD, you can calculate more accurate fracture risk.
  • Page 65 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT You can see FRAX Menu button with each patient. But FRAX Menu button works only when the patient’s age belong to FRAX available age (40 ~ 90).
  • Page 66 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT To delete patient information, select the patient to be deleted from the "Patient List" screen and click the <Delete> button at the bottom(on Android). In iOS, swipe the patient to delete and touch the <Delete>...
  • Page 67 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Updating the worklist: If you select the subject you want to measure from the subject list, you will be able to carry out measurements or show patient’s medical history.
  • Page 68 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 4) Searching patient If you want to search for a patient, click the <Search> button at the top of the "Patient List" screen and the "Search" window will appear as shown below.
  • Page 69 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Listing and deleting patient history 1) Listing Patient History If you want to view the history of the patient, select the patient in the "Patient List" screen and click on the <History>...
  • Page 70 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 2) Detailed Patient History Result It appears when you select a result from a list on the History screen. Full details of the result selected on the History screen are shown in full screen.
  • Page 71 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3) Deleting Patient History Result If you want to delete a patient's history, press and hold the result you want to delete from the list of history screen, the delete button will appear.

  • Page 72: System Check Of Device (Daily Test)

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.12 System check of device (Daily test) To reduce the error in measuring the patient's bone density and to obtain accurate values, a DailyTest of a system should be performed. This is to increase the reliability of the measurement results by checking the stability of the system on a daily basis.
  • Page 73 DOC. No. : OT-IFU-BT NOTE ! In case of the screen shows the calibration has failed, do not use the system and execute “Daily test” once again. If calibration fails continually, contact to OsteoSys or its authorized dealer. ７２ A4(210 × 297)

  • Page 74: Quick Measure

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 3.4.13 Quick Measure Touch the icon[ ] at the top of the home screen and the measurement window will appear. The measurement screen will be displayed first. After entering the patient data, the result screen will appear.

  • Page 75: Printing History/Result

    DOC. No. : OT-IFU-BT 3.4.14 `Printing History/Result BeeTLe supports thermal printers and normal printers. The printer settings can be set in the Setup tab of the Setting Screen. If you have not set the default printer, the printer selection window will appear as shown below.
  • Page 76 5V IN User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT How to connect a Thermal printer → → (2) Touch ‘Setting icon’ (1) Find the icon [ ] (3) Touch tab SETUP → → →...
  • Page 77 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT → → (7) Registered thermal (8). Touch save icon[ printer Thermal printer output method. → → (1) Touch the print icon (2) If you set it as the def...
  • Page 78 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT → → (4) When the pairing window (5) Output printer. appears, enter '0000' and touch [OK]. Print of History Print of Detail ７７ A4(210 × 297)
  • Page 79 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Normal Printer Before using a regular printer, make sure that the printer service you want to print is installed on smart device. To use regular printer output, the printer service for that printer must be installed on smart device.
  • Page 80 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Standby(waiting) mode Power save mode ７９ A4(210 × 297)
  • Page 81 (1) How to check on the System tab. (Check with touch to battery button.) NOTE ! You can check the remaining battery charge only when BeeTLe is connected to Bluetooth. Battery markings and the meaning of each shape are as follows.
  • Page 82 3.4.15 Setting of the incipient environment Language : The language can be changed in the language settings. NOTE ! Contact Osteosys or its authorized dealer if you need to make changes or select your language using language option. ８１ A4(210 × 297)

  • Page 83: Chapter 4. Maintenance And Repair Of Beetle

    Despite measurement according to 24~25 page : Where and How Much the instructions, its result turns out to Apply to the Patient’s Heel be abnormal CAUTION! If you cannot resolve the problem, contact to OsteoSys or its authorized dealer. ８２ A4(210 × 297)

  • Page 84: Maintenance And Repair

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 4.2 Maintenance and Repair 4.2.1 Cleaning, Disinfection, Sterilization CAUTION! Turn off the power before cleaning the device. Product Instructions The device should be cleaned with clean soft cloth wrung a water every day, because gel remains around the probe or below the device.

  • Page 85: Storage

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 4.2.2 Storage Unplug the AC adapter. If the hardened gel remains in the device, it can affect BMD results. Please Daily clean the device every day. Storage 4.2 Maintenance and Repair...

  • Page 86: Safe Use Of Beetle

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 4.3 Safe Use of BeeTLe 4.3.1 Safety Rules The followings are instructions for safe use of the device. Make sure to comply with the instructions when you activate the system.
  • Page 87 If you hear a strange noise or if you find any abnormality on the screen after turning on the device, contact OsteoSys or an authorized distributor. If damage is visible on the exterior, do not operate and contact OsteoSys or an authorized distributor.

  • Page 88: Specifications

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Specifications & Chapter 5. S/W Update 5.1 Specifications Grade and type Internal Power, Class II, Type B AC 100-240 V, Free Voltage(Single Phase), Input voltage 50 Hz/60 Hz...
  • Page 89 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Bluetooth Manufacturer IOT747 Model name IDC747 Standard Bluetooth 5.2 Class2 Frequency used and data rate 2.4GHz / 3Mbps (typical 1.6Mbps) Sensitivity 0.1% BER at -96dBm (Typical) Operating voltage 3.3V ~ 4.7V DC...

  • Page 90: Environmental

    Excessive dust and other airborne debris Dust, Fumes, Airborne debris contaminants can impair sensitive parts. 5.3 S/W Update Updates to BeeTLe software are irregular For software update, please contact your Osteosys office or an authorized distributor. ８９ A4(210 × 297)

  • Page 91: Label

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 5.4 Label ９０ A4(210 × 297)

  • Page 92: Chapter 6. Reference

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Chapter 6. Reference 6.1 Definition of Parameter Terminology  BUA(Broadband Ultrasound Attenuation) Parameter which reflects bone density and structure by reduction analysis of ultrasound pulse intensity through the bone.
  • Page 93 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT - T- Score’s meaning in the view of probability -Score represents the patient’s BQI above or below a reference “Young adult” mean and is expressed in standard deviation(SD) units.

  • Page 94: Reference Data

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 6.2 Reference Data  Reference Data We achieved reference data from several group with different environment in Korea. And the data is analyzed by statistical method. Ages Mean 76.0...

  • Page 95: Chapter 7. Product Warranty

     Scope and Period of Warranty - All OsteoSys products can benefit from free warranty repair for failure and defects caused in normal transportation/operation environment for 1 year from the purchase - For the following cases, a certain amount of service fee will be billed (1) Product failure after warranty period (2) Failure due to natural disasters including fire, earthquake, lightning, flood, etc.

  • Page 96: Chapter 8. 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. This section also covers the expected software usage environment.
  • Page 97 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Access control is a comprehensive mechanism used to determine and enforce the following: • Access subject • How to secure access • When to grant access • Access information Access control includes electronic as well as physical aspects, and includes authentication and authorization.
  • Page 98 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT SEC.4. Audit Control Capability to record and examine system activity by creating audit trails on a device to track system and HEALTH DATA access, modification, or deletion.
  • Page 99 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 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 100 Trojan horses, denial of service attacks, and other malware, continue to grow. Various levels of careful defense are necessary to prevent system damage from malicious software. Effective protection requires the cooperation and partnership of OsteoSys and its customers. ９９ A4(210 × 297)
  • Page 101 In addition, new security patches load automatically each time you update your software. 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 １００...
  • Page 102 OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 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 103 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT 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 104 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT You must install and run a virus protection program on the smartphone that uses the BMD. However, virus protection programs have the following disadvantages: • Do not start a virus scan while using the device. Certain files are marked read-only.
  • Page 105 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 106 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT SEC.19. Security operations Security operations are best implemented as part of an overall "depth defense" information assurance strategy used through information technology systems that address personal, physical security, and technology. The hierarchical approach to defense in depth limits the risk that a system can be compromised by the failure of a single security safeguard.
  • Page 107 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 108 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 109 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: BeeTLe DOC. No. : OT-IFU-BT Connection name PC Motherboard NIC Physical network connection IEEE 802.3 10/100 / 1000BASE-T type Ethernet 10 Mbps Half and Full Duplex 100 Mbps Half and Full Duplex...
  • Page 110 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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