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stemoscope PRO LITE STEMO500 Instruction Manual

Smart wireless stethoscope
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Smart Wireless Stethoscope
(Model: STEMO500)
Instruction Manual
(DRAFT)
1

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Summary of Contents for stemoscope PRO LITE STEMO500

  • Page 1 Smart Wireless Stethoscope (Model: STEMO500) Instruction Manual (DRAFT)

  • Page 2: Safety Warnings And Precautions

    SAFETY WARNINGS AND PRECAUTIONS Consult your physician before using the device if you are not a medical professional. Keep Stemoscope PRO LITE at least 1 meter away from all radio frequency (RF) emitters, including WIFI routers and radios. DO NOT use Stemoscope PRO LITE near strong RF signals or portable and/or mobile RF devices.
  • Page 3 DO NOT move, slide or push the switch button when Stemoscope PRO LITE is wet. If you do so, liquid droplets may go into the device and damage the internal electrical circuitry. Recharge the battery using only the provided charging cable with a UL-certified charger (not provided).

  • Page 4: Table Of Contents

    CONTENT SAFETY WARNINGS AND PRECAUTIONS ....2 Introduction ............... 5 1.1. Indications for use ............. 5 1.2. Specifications and technical data ....6 1.3. Signs and symbols ............. 7 1.4. Package contents ............8 Hardware identif ication ..........8 Basic steps to listen to the sounds ..... 10 Record a video composed of the auscultatory sounds and the camera view ..........

  • Page 5: Introduction

    1.1. Indications for use The Stemoscope PRO LITE is designed for medical professionals or lay users to auscultate, record, and transmit sounds from the heart, lungs, abdomen, arteries, veins, and other internal organs. The...

  • Page 6: Specifications And Technical Data

    +10 °C to +40 °C / 15 %RH to conditions 85 %RH / 800 hPa to 1060 The time required for Stemoscope PRO LITE to warm from the minimum storage temperature （ -25°C ） between uses until it is ready for intended use when the ambient temperature is 20°C: 1 hour.

  • Page 7: Signs And Symbols

    1.3. Signs and symbols Follow operating instructions Indicates the manufacturer of the unit, including manufacturer’s name and address The device must be disposed of properly when it will no longer be used. Dispose medical waste based on local regulations and comply with applicable laws.

  • Page 8: Package Contents

    1.4. Package contents Stemoscope PRO Charging cable Quick start guide LITE Hardware identification Notification light Charge port Switch Diaphragm in the left position is the OFF state. switch Slide the switch to the right to start Stemoscope PRO LITE.
  • Page 9 To charge Stemoscope PRO LITE, plug one end of into the charging cable charge port another end to a UL-certified USB charger (not provided in the package). The device status can be identified by the notification light.

  • Page 10: Basic Steps To Listen To The Sounds

    Basic steps to listen to the sounds Here are the basic steps for you to use Stemoscope PRO LITE. Step 1. Open the “DrStemo” app. If you haven’t installed the “DrStemo” app, please search and install it from Apple’s App Store or Google’s Play Store.
  • Page 11 Find the QR code on your Stemoscope PRO LITE After registration, you will see the home user interface as shown below. This user interface shows that there is no Stemoscope PRO LITE connected yet. Before Stemoscope PRO LITE is...
  • Page 12 LITE is connected Step 2. Slide the switch button of Stemoscope PRO LITE to the right. The notification light will start to smoothly fade in and out and the app will start to search for and connect to the Stemoscope...
  • Page 13 PRO LITE. When the Stemoscope PRO LITE is connected, notification light Stemoscope PRO LITE will blink. Bluetooth pairing in the phone settings is NOT needed. The home user interface will be updated once connected. The “listen” button will start to animate.
  • Page 14 Stemoscope PRO LITE stable can give better quality). Please consult your doctor on where to listen and record. The battery level of the connected stethoscope Animated “listen” button after connection. Press it to listen. Home user interface (after Stemoscope PRO LITE is connected)
  • Page 15 Battery power level Bluetooth signal strength Select one of the themes by pressing the button. “video” is selected in this example Switch the front and back camera Record button Option to screen record The sound Noise waveform cancelling switch The “video” theme of the “listen” user interface...

  • Page 16: Record A Video Composed Of The Auscultatory Sounds And The Camera View

    A video can record the sounds and associated location of the Stemoscope PRO LITE. When you do the recording, please make sure the location of the Stemoscope PRO LITE can be determined in the camera view.
  • Page 17 The following picture shows the “heart” theme. You can place Stemoscope PRO LITE on one of the body spots shown in this user interface and press the corresponding “red dot” recording button to record the corresponding sounds.

  • Page 18: More Features For Medical Professionals

    Record button. Place your device on one of the heart listening spots and press this button to record the sound associated with this location. The “heart” theme of the “listen” user interface More features for medical professionals Two extra features were provided in the “listen” user interface for medical professionals.
  • Page 19 ⚫ Choose Stemoscope PRO LITE frequency modes The auscultatory sounds can be filtered in three different frequency modes: bell mode, diaphragm mode, and extended range mode respectively. The following table shows the frequency ranges of these modes.
  • Page 20 Non- predefined recording spot Stethoscope frequency modes for medical professionals Extra features for medical professionals in the “listen” user interface ⚫ Record non-predefined auscultation spots...

  • Page 21: Live Stream The Auscultatory Sounds

    Stemoscope PRO LITE to the doctor. During the video call, the doctor can instruct the patient on where and how to place Stemoscope PRO LITE so that the doctor can listen to the desired spots of the patient’s body remotely. Here is the process flow.
  • Page 22 The patient follows the doctor’s can ask the patient to start stop instructions on the Stemoscope use of Stemoscope LITE sound PRO LITE. transmission. Hang up the call when the session is completed. The doctor can ask the patient to register an...
  • Page 23 has not done that. To add a contact, the doctor needs to press “livestream” in the home user interface, and then on the “livestream” page, press the button on the top left to enter the invitation page. Type the email address that your patient used for the video call account registration and an invitation email will be sent to this email address.
  • Page 24 user interface as shown below. On the “my patients” page, the doctor needs to make sure the status is ONLINE. If it is OFFLINE, a “log on” button will show up and the patient can press it to go ONLINE. The doctor can see if a patient is online. If the patient to call is OFFLINE, the doctor may fail to call the patient.
  • Page 25 If the video call is disconnected for some reason, to reconnect, the doctor needs to call the patient because the patient cannot call the doctor. If you feel the audio quality is not good, please do not livestream the sounds of the Stemoscope PRO...
  • Page 26 Stemoscope PRO LITE is connected. Here is the list of the statuses of the Stemoscope PRO LITE. No Stemoscope PRO LITE is connected. Stemoscope PRO LITE is connected but not transmitting audio. Press it to start transmission.

  • Page 27: Share (Send) A Recording

    When the sound of the Stemoscope PRO LITE is being transmitted, the doctor may ask the patient to mute the microphone. The patient can toggle the microphone button. Microphone is toggled on. Press to toggle off. Microphone is toggled off. Press to toggle on.

  • Page 28: Care, Cleaning, And Disinfection

    “history”. If you use the “DrStemo” app as a non-medical professional user and use the premium cloud service, you can save the data online and share the data with your doctors. Care, cleaning, and disinfection The stethoscope should be wiped clean and disinfected with 70% isopropyl alcohol wipes.

  • Page 29: Trouble Shooting

    Trouble shooting Symptom Possible Solution cause Charge Stemoscope notification battery PRO LITE before use. light power. consistently when Hardware Contact customer the device is malfunction. service. switched ON. Open the app → Settings → Search for Permissions STEMO-700, check if...
  • Page 30 are not used. not good at playing sufficiently body sounds. Please loud. earphones listen. Please increase the phone volume. Body sounds are mainly composed of low- phone pitched sounds that volume is set less audible. low. Higher volume needed than that for other sounds such as music.

  • Page 31: Electrical Safety

    Electrical Safety Guidelines and manufacturer's declaration - electromagnetic emissions This STEMO500 stethoscope is expected to be used in the following electromagnetic environment. The purchaser or user should ensure that it is used in this electromagnetic environment: Electromagnetic environment - Emissions test Compliance guidance STEMO500...
  • Page 32 Electrostatic ± 2 kV for power transient supply lines burst 100 kHz repetition 61000-4-4 frequency Not applicable ± 1 kV for input/output lines Surge ± 0.5 kV, ± 1 kV, IEC 61000-4- Line-to-line Not applicable ± 0.5 kV, ± 1 kV,±...
  • Page 33 RF IEC 150 kHz to 80 applicable communications equipment should be used 61000-4-6 no closer to any part of the product, including cables, than recommended separation distance calculated from Radiated 3 V/m 3 V/m equation applicable to the 80 MHz to 2.7 80 MHz to frequency 61000-4-3...
  • Page 34 Recommended isolation distance between portable or mobile RF communication equipment and this product This STEMO500 stethoscope is expected to be used in an electromagnetic environment where RF radiation disturbances are controlled. According to the maximum output power of the communication equipment, the purchaser or user can prevent electromagnetic interference by maintaining a minimum distance between the portable or mobile RF communication equipment (transmitter) and the product.
  • Page 35 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Modulation Maximu Dista IMMUNITY frequency m power TEST LEVEL (MHz) (V/m) (MHz) 380 –390 TETRA 400 Pulse modulation 18 Hz 430 – 470 GMRS 460, FRS 460 FM ±...

  • Page 36: Fcc Statement

    FCC Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 37: Warranty

    Warranty A limited warranty is provided for Stemoscope PRO LITE. Please visit stemoscope.com/warranty for a full description of the warranty. Contact information...

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