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Imediplus DS101 User Manual

Special submission electronic stethoscope
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IMEDIPLUS INC.
Special Submission
Electronic Stethoscope
DS101
Section 13
Document Title: Electronic Stethoscope DS101 User Manual
File Name: 003_Electronic Stethoscope DS101 User Manual

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  • Page 1 IMEDIPLUS INC. Special Submission Electronic Stethoscope DS101 Section 13 Document Title: Electronic Stethoscope DS101 User Manual File Name: 003_Electronic Stethoscope DS101 User Manual...
  • Page 2 Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 2 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Model name: DS101 Feature Auscultation for heart, Anterior/Posterior chest, neck, bowel, limbs arteries, veins and internal organs.

  • Page 3: Table Of Contents

    Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 3 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Content Introduction ....................4 Safety Information ..................4 Symbol Definitions .................. 5 Important Safety Information ..............

  • Page 4: Introduction

    Electronic Stethoscope DS101 was innovated from a group of healthcare professionals. Therefore, the user experience is an important factor of designing the stethoscope. We appreciate for your adoption of Electronic Stethoscope DS101 and look forward to your valuable feedback 2.

  • Page 5: Symbol Definitions

    Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 5 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 2.1 Symbol Definitions Explanation of Safety Markings and Symbols Warning Consult instructions for use.

  • Page 6: Important Safety Information

    No modification of this device is allowed. Use only authorized service personal to repair this electronic stethoscope. If user modify by self, solely responsibility for the consequence. The Electronic Stethoscope DS101 is MR unsafe. Do not use the Electronic Stethoscope DS101 in Magnetic Resonance Imaging (MRI) environment. WARNING...
  • Page 7 Do not immerse the stethoscope in a liquid or subject it to any sterilization process. The device might be damaged. Do not use the Electronic Stethoscope DS101 in Magnetic Resonance Imaging (MRI) environment. Because of Electronic Stethoscope DS101 contain conductive, metallic and magnetic materials. Those materials include headset, wire, connectors and inductors, which are assembled in Electronic Stethoscope.

  • Page 8: Product Description

    Date: 2017/8/26 3. Product Description When you turn on the Electronic Stethoscope DS101 for the first time, your authorization to operate this handheld electronic stethoscope is necessary for the normal mode of operation. The Electronic Stethoscope DS101 picks up the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body.

  • Page 9: Intended Use

    5. Operator Profile The Electronic Stethoscope DS101 is designed to be used by anyone who wishes to listen to the sounds as described in the Intended Use section above. The user manual provides complete information on how to operate the Electronic Stethoscope DS101.

  • Page 10: Instructions For Use

    Page: 10 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 use of patient name, date of birth, and/or patient ID #. By entering this information, the user assumes any and all risks of and liabilities incurred with using or transmitting such information.

  • Page 11: Removing And Applying The Eartube

    Please turn off the system before taking out the battery. NOTICE: The Electronic Stethoscope DS101 is available to install alkaline or Ni-MH batteries, the chart below is voltage that alkaline and Ni-MH battery contained. We highly recommended using rechargeable batteries which contained in the box for longer operational period.

  • Page 12: Removing And Applying The Ear-Tip

    Page: 12 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 marks on the device and directly insert it into the device. Make sure the ear tubing completely insert into the device with the arrow mark are matching.

  • Page 13: Adjust Headset For Comfort

    Document No.: DS101-SDUS01-01303 Page: 13 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 The user can push ear-tip firmly onto eartube to apply new ear-tips, as shown in Figure 4.

  • Page 14: Replacing The Chestpiece

    Document No.: DS101-SDUS01-01303 Page: 14 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 7.6 Replacing the chestpiece As the Figure 6 shows the position of the chestpiece. Please tightly hold the device for replacing the chestpiece.
  • Page 15 Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 15 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 DIAPHRAGM CHESTPIECE Figure 7 As shown in the Figure 8, please hold the device and chestpiece tightly for removing the diaphragm.

  • Page 16: Stethoscope Construction

    Document Title: Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 16 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 7.8 Stethoscope construction RECORDING BUTTON VOLUME RIGHT ORGAN POSITION LEFT...

  • Page 17: Oled Display Shows Information

    Document Title: Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 17 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 7.9 OLED display shows information Bluetooth Date and Time Battery Status...

  • Page 18: Operation Description

    Document No.: DS101-SDUS01-01303 Page: 18 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 8. Operation Description Power Button (Switch On / Sleep Mode) Power ON/OFF: As the diagram 1 shows the position of power button.
  • Page 19 Page: 19 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 In the menu, press “UP”/”DOWN” to scroll to the “SLEEP SET”, then press the “OK” button. Here has “two minutes” , ”five minutes” and ”ten minutes”...
  • Page 20 Document No.: DS101-SDUS01-01303 Page: 20 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Diagram 3 Record time set In the menu, press “UP /DOWN” button to scroll to the “RECORD TIME SET”.
  • Page 21 Document No.: DS101-SDUS01-01303 Page: 21 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Diagram 5 Battery set In the menu, press “UP /DOWN” button to scroll to the “BATTERY SET”...
  • Page 22 Document No.: DS101-SDUS01-01303 Page: 22 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Default In the menu, press “UP /DOWN” button to scroll to the “DEFAULT RESET” then press ”OK” to enter to default reset page, as shown in the diagram 7.
  • Page 23 Document No.: DS101-SDUS01-01303 Page: 23 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Diagram 8 Organs setting “ORGAN” button is used for organs setting. As shown in diagram 9, press and release the “ORGAN”...
  • Page 24 Page: 24 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 “BDW” is used for sound frequency mode. As shown in diagram 10, press and release the “BDW” button to switch the frequency mode. For example:...
  • Page 25 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 As shown in the diagram 12, when DS101 successfully connected with the device, the red box in the Bluetooth icon will disappear. Diagram 12 Recording the Auscultation Sound The recording button is on the top of the display. Press the recording...

  • Page 26: Ds101_Dm Software (Data Management)

    Page: 26 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 In the menu, press “UP /DOWN” button to scroll to the “PLAYBACK” then press”OK” to enter playlist. File name is YYYYMMDD_HHMMSS. As shown in the diagram 13, press “UP/DOWN”...
  • Page 27 Document Title: Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 27 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 own user name and password.
  • Page 28 Document No.: DS101-SDUS01-01303 Page: 28 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Sign in After create a first account, use that account to sign-in. Please type your user name and password correctly.
  • Page 29 Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 29 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Bluetooth Pairing Bluetooth must be enabled in the device Bluetooth settings in the DS101_DM Software App.
  • Page 30 Page: 30 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 The system will pop-up, asking to pair with the stethoscope, if it is the true one, tap “Pair” to confirm.
  • Page 31 DS101. Tap “RECEIVE” button and the DS101_DM Software (Data Management) start to receive recordings from DS101. If Bluetooth pairing is unsuccessful, the Bluetooth mark will flash on the OLED screen of DS101 and no sounds will be recorded. If the Bluetooth connection is successful the mark...
  • Page 32 Using the app to transmit recordings to DS101 Turn on the DS101_DM Software (Data Management) and log in. Ensure that the DS101 Device is paired to the mobile device (See Section 8). In the home screen, press “Transmit” and the original record will transmit back to DS101.
  • Page 33 The Main Recording Page The Main Recording Page allows users to view audio data captured by DS101, begin the recording process, retrieve patient specific data, or adjust settings. Audio data is represented in real-time as a phonocardiogram. A period of recording is 10-second intervals.
  • Page 34 34 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Records Page The recordings received from DS101 will save to records page. Tab on any recording to review the detail information.
  • Page 35 Document No.: DS101-SDUS01-01303 Page: 35 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Review Page More information on a specific recording can be viewed by tapping on a recording listing. This page displays the recording number, organ mark, recording time, operator ID, and clinical opinion.
  • Page 36 Document No.: DS101-SDUS01-01303 Page: 36 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 This also includes a waveform of the recording with zoom in / zoom out, and playback the sound.
  • Page 37 NOTICE ： ： ： ： If you experience any problems with the Electronic Stethoscope DS101, do not attempt to repair it yourself. Please notify our customer service center for directions on shipping and receiving.

  • Page 38: Product Parts List

    Document No.: DS101-SDUS01-01303 Page: 38 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 10. Product Parts List 1. DS101 Device: It consists of chest-piece 2. DS101 Headset: Including eartube ,...

  • Page 39: Cleaning

    Page: 39 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 6. Accessary Package(includes two pairs of ear tips, two AAA Alkaline rechargeable batteries) WARNING: Do not use the unauthorized accessories which would lead to unexpected hazards.

  • Page 40: Warranty

    Page: 40 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 1) Before start to cleaning, please check the tubbing connector and all structure of stethoscope are stable to avoid liquid infiltration.
  • Page 41 Document Title: Electronic Stethoscope DS101 User Manual Document No.: DS101-SDUS01-01303 Page: 41 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 Item Questions Answer No “Powered”, after “Turn ON”. Please check battery whether properly installed, and then try again after reinstall the battery.

  • Page 42: Maintenance And Repair

    General transportation of the unit should correspond to the conditions outlined in the 'Other Operating Considerations' section of this manual. The Electronic Stethoscope DS101 needs to be sent to an authorized service center for inspection and repair. The storage environment conditions must be follow the 'Other Operating Considerations' section of this manual.

  • Page 43: Specification

    Page: 43 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 You shall properly dispose of the Electronic Stethoscope and follow the local regulations. The AAA 1.2V rechargeable battery must be disposed of separately or recycled from regular waste.
  • Page 44 17. Appendix: Guidance and Manufacturer’s Declaration Manufacturer’s declaration-electromagnetic emissions The DS101 is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the DS101 should assure that it is used in such an environment. Emission test Compliance...
  • Page 45 Manufacturer’s declaration-electromagnetic immunity The DS101 is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the DS101 should assure that it is used in such an environment. Immunity test IEC 60601...
  • Page 46 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DS101 is used exceeds the applicable RF compliance level above, the DS101 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DS101 b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
  • Page 47 RF communications equipment and the DS101 The DS101 is intended for use in an electromagnetic environment (for professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the DS101 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DS101 as recommended below, according to the maximum output power of the communications equipment.
  • Page 48 RF wireless communications equipment ENCLOSURE PORT IMMUNITY The DS101 is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the DS101 should assure that it is used in such an environment. Compliance Test...

  • Page 49: Fcc And Ic Compliance Statement

    Document No.: DS101-SDUS01-01303 Page: 49 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 18. FCC and IC Compliance Statement 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the...
  • Page 50 Page: 50 of 50 Product Name: Electronic Stethoscope DS101 Ver.: 510(k) File Name: 003_Electronic Stethoscope DS101 User Manual Date: 2017/8/26 2) For body worn operation, this device has been tested and meets FCC RF exposure guidelines. When used with an accessory that contains metal may not ensure compliance with FCC RF exposure guidelines.

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