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User's Manual

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Summary of Contents for inbody 380

  • Page 1 User’s Manual...
  • Page 2 • The InBody device is not a diagnostic device. To make an accurate diagnosis, the physician needs to commission thorough examinations and take their results into account in addition to the results of the InBody.
  • Page 3 3. Contraindication Individuals with medical implant devices such as pacemakers, or essential support devices such as patient monitoring systems, must not use this equipment. Safe, low-level currents will flow through the body during the test, which may cause malfunctioning of the device or endanger lives. Individuals with known metal allergies against stainless steel materials shall not use the equipment.
  • Page 4 Please read before use and keep it in a safe place. By following the manual instructions, InBody BWA Inc. [USA] you will be able to use the InBody more safely and effectively. 2550 Eisenhower Avenue, Suite C 209, Audubon, PA 19403 TEL: +1-610-348-7745 Website: inbodybwa.com...
  • Page 5: Table Of Contents

    Regarding the Device ......24 4 Setting ..........11 Regarding of Serious Incidents ..24 Initial Setup ..........11 Regarding the InBody Test ....24 Setup............11 Residual Risks and Undesirable Side Effects....... 25 Overview of the Setup Menu ....12 9 Classifications and Specifications ...
  • Page 6: Safety

    • When storing the device for a long period of time, store it test, but this may cause malfunctioning of the device or endanger lives. InBody Co., Ltd. shall not be liable for any on a flat surface after turning off the device, unplugging damages to an individual or an equipment that occurred the adapter, and packing the device.
  • Page 7: Product Overview

    • The specifications of power cables can vary by country.  Delete: Used to delete the saved data.  Hand Electrode: Sends a weak current to the upper body and measures the voltage for the InBody test. Optional Product  Smart Reader: InBody App user can transfer the personal information needed for the test with QR code.
  • Page 8 Electrode: Sends a weak current to the lower  9-pin Serial Port (Female, RS-232C): Connect to body and measures the voltage for the InBody test. LookinBody120 installed on the PC, a stadiometer, a  Level Indicator: Shows the level status of the footplate.
  • Page 9: Installation

    3 Installation 3.1 Installation Environment Raise the upper part of the device and remove the protective packaging vinyl. Caution Protective • If you are operating the device in a place where the Packaging Vinyl altitude is 2,000m or higher, the weight measurement may be affected.
  • Page 10 If you are connecting the InBody device to compatible device then turn on the compatible device first. On the contrary, turn off the power of InBody device first, and then turn off the power of the compatible device when turning off the power.
  • Page 11: Setting

    InBody test. When InBody device is booted for the first time, the initial setting screen appears. Complete the initial setup selecting the appropriate item. Select whether to use the Self Mode.
  • Page 12: Overview Of The Setup Menu

    Menu stepping on the footplate. Set your InBody device fits to your facility and manage the data. General • Date and Time: Set the date and time displayed at the test standby screen and on the result sheet.
  • Page 13 • Export Data as a MS Excel File: This option allows • Member Management Method: You can choose copying the test result saved in the InBody device to USB flash drive as an Excel file format. You can check the test whether to use the ID or mobile number for the member results opening the Excel file on your computer.
  • Page 14: Connecting Compatible Device

    Connect the serial cable supplied with the stadiometer printer is required. to the right serial port on the rear of the InBody device. Connect the other end of the cable to the serial port of Turn off the InBody device.
  • Page 15: Barcode Reader

    Connect the serial cable provided with LookinBody120 • Bluetooth may not operate normally if the compatible to the right serial port on the rear of the InBody device. device is more than 10m away from InBody device. Connect the other end of the cable to the serial port of •...
  • Page 16 Launch LookinBody120 installed on your PC and follow its instructions to connect to InBody device. Turn the device (stadiometer or blood pressure monitor) that you want to connect with InBody device. Note The compatible device’s Bluetooth ID consists of • Refer to the “Product Name-Serial Number”.
  • Page 17: Connecting Internet

    Connecting Wi-Fi on the test standby screen or Setup Press Setup Once InBody device is connected to the Internet, you can use button on the keypad of the operation panel before it to connect the Cloud Services or LookinBody120. stepping on the footplate.
  • Page 18: Optional Device's Specification

    Interfaces and network protocol 5.11 IT security measures Interfaces Protocol InBody would like to clarify that the user access to the IEEE 802.11 b/g/n 2.4GHz InBody380 is only granted for the authorized users, who have Wi-Fi IEEE 802.11 a/n/ac 5GHz(under CH. 100) appropriately registered the passcode in the system setting menu of the InBody380.
  • Page 19: Inbody Test

    Stand onto the footplate with bare feet on the endanger lives. InBody Co., Ltd. shall not be liable for any standby screen. damages to an individual or a device that occurred by not complying with the content above.
  • Page 20 Maintain test posture. • For proper test posture, refer to “6.3 Test Posture”. • The InBody test automatically starts when the body and the electrode are in precise contact. Self Mode Professional Mode The result screen is displayed after completing the test.
  • Page 21: Test Posture

    InBody Test 6.3 Test Posture The subject must maintain proper posture to have accurate test results. • The InBody test automatically starts when the body and the electrode are in precise contact. Your arms must not touch the sides of your body.
  • Page 22: Maintenance And Storage

    Precautions for Caution Maintenance • When repacking the device, the protective packaging materials provided by InBody must be used. Caution • Do not bend the handle or turn it in the opposite direction. Turn off the device. • Do not place anything on the footplate when the device is Turn off the device.
  • Page 23: Storage Environment

    Maintenance and Storage 7.5 Storage Environment The device should be stored under the following conditions. ‒10 - 70 ℃ (14 ~ 158°F) Temperature range Relative humidity 10 - 80 % RH (No Condensation) Atmospheric pressure 50 - 106 kPa...
  • Page 24: Frequently Asked Questions (Faq)

    Member State in which the user 8.1 Regarding the Device and/or patient is established. The set deadlines in accordance with the MDR (EU) 2017/745 Question: InBody Result is not sent to the App. are: Answer: • Check whether the Internet connection Question:...
  • Page 25: Residual Risks And Undesirable Side Effects

    Question: I have limited mobility and cannot maintain contacting material of the stainless steel has been evaluated proper posture for the InBody Test. How can I still with ISO-10993 biocompatibility testing, particularly with the be tested? skin sensitization testing, which has resulted in the favorable biocompatibility test results.
  • Page 26: Classifications And Specifications

    9 Classifications and Specifications • This device was produced according to InBody's quality • Body Composition Analysis (Total Body Outputs control procedures. InBody complies with ISO9001 and Water, Protein, Minerals, Body Fat (InBody Result ISO13485, international quality management systems. Mass,Soft Lean Mass, Fat Free Mass,...
  • Page 27 LCD Screen, LookinBody Web, • Whole Body Phase Angle (50kHz: the LookinBody120 right side of the body) Types of InBody Result Sheet, InBody Result Sheet • Impedance Graph (Each segment and Result Sheets for Children, Thermal Result Sheet each frequency)
  • Page 28: Symbols Used On The Product

    Classifiaaiiossaons Spiifiaaiios 9.3 Symbols used on the Other specifications Product Applied Rating 200 μA (±20 μA) Current Indicators Power Input AC 100-240 V, Adapter ① 50/60 Hz, 1.2 A (Bridge Power) Power Output DC 12 V, 3.4 A 9-pin Serial Port (Female, RS-232C) Power Input AC 100-240 V, Adapter ②...
  • Page 29 Classifiaaiiossaons Spiifiaaiios Operating instructions Catalogue number Importer Country of manufacture Disposal of old Electrical & Electronic Equipment (Application in the European Union and other European countries with separate collection system.) This symbol indicates that this product shall not be treated as household waste. Instead, it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment.
  • Page 30: Guidance And Manufacturer's Declaration

    Classifiaaiiossaons Spiifiaaiios 9.4 Guidance and Manufacturer’s Declaration The InBody device is intended for use in the electromagnetic environment specified below. The customer or the user of the InBody device should ensure that it is used in such an environment. Electromagnetic emissions...
  • Page 31 Recommended separation distances between portable and mobile communication equipment and InBody device The InBody device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the InBody device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the InBody device as recommended below, according to the maximum output power of the communications equipment.
  • Page 32 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the InBody device is used exceeds the applicable RF compliance level above, the InBody device should be observed to verify normal operation. If abnormal performance is observed, additional measures maybe necessary, such as re-orienting or relocating the InBody device.
  • Page 33 The InBody device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Portable RF communications equipment should be used no closer than 30 cm (12 inches) to any part of the InBody device. Otherwise, the performance of this equipment could be impaired.
  • Page 34 Classifiaaiiossaons Spiifiaaiios Follow instructions for use DANGER Suivez les instructions d’utilisation • Do not use this equipment with electrical medical device such as a pacemaker. • Ne pas utiliser cet équipement avec des appareils WARNING médicaux électriques comme un stimulateur cardiaque. •...
  • Page 35: Key Performance Claims Of Inbody380

    InBody (Models: InBody380). The Body Composition Analyzer of InBody (Models: InBody380) provides clinical benefits to support the aforementioned intended use, as the of InBody (Models: InBody380) in mainly used for healthy and acute or chronically ill populations in hospitals, medical practices and inpatient care facilities in accordance with national regulations.
  • Page 36 © 2024 InBody Co., Ltd. All rights reserved. IM-ENG-P9-B-240111...

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