Smart Wireless Stethoscope (Model: STEMO700) Instruction Manual (DRAFT) 1
SAFETY WARNINGS AND PRECAUTIONS Consult your physician before using the device if you are not a medical professional. Keep Stemoscope PRO at least 1 meter away from all radio frequency (RF) emitters, including WIFI routers and radios. DO NOT use Stemoscope PRO near strong RF signals or portable and/or mobile RF devices. If sudden or unexpected sounds are heard, move away from any radio transmitting antennas. Bluetooth Class 2 is used for data transmission.
DO NOT move, slide or push the switch button when Stemoscope PRO 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). DO NOT use Stemoscope PRO when it is being charged. DO NOT subject the device to extreme temperatures, humidity, or direct sunlight. DO NOT subject the device to strong shocks, such as dropping the unit on the floor.
CONTENT SAFETY WARNINGS AND PRECAUTIONS ............... 2 1. Introduction ....................................................................... 6 1.1. Indications for use ..................................................... 7 1.2. Specifications and technical data ................... 7 1.3. Signs and symbols .....................................................8 1.4. Package contents ...................................................... 9 2. Hardware identif ication ..........................
6. Data security ................................................................... 33 7. Trouble shooting ......................................................... 34 8. Disposal .............................................................................. 36 9. Electrical Safety ............................................................ 37 10. Warranty ............................................................................. 42 11. Contact information ...................................
1. Introduction Stemoscope PRO (Model: STEMO700) is a smart dual-wireless-mode noise-cancelling stethoscope. It has two Bluetooth working modes: Mode I II Function Transmit audio directly to Bluetooth earphones. Transmit audio to the “DrStemo” app installed on a smartphone. In Mode I, the Stemoscope PRO directly works with Bluetooth earphones and no smartphone is needed. In Mode II, the “DrStemo” app provides rich functions such as amplification, visualization, filtering, recording, sharing, etc.
1.1. Indications for use The smart wireless stethoscope 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 device is intended for medical diagnostics purposes but not for self-diagnosis. 1.2. Specifications and technical data Item Description Supported iOS: 9.0 or above phones Android: 7.
ambient temperature is 20°C: 1 hour. The time required for Stemoscope PRO to cool from the maximum storage temperature（70°C）between uses until it is ready for intended use when the ambient temperature is 20°C: 1 hour. 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.
1.4. Package contents Stemoscope PRO Charging cable Quick start guide x1 x1 x1 2. Hardware identification Switch Notification light Diaphragm Front side The switch in the middle position is the OFF state. Slide the switch to the left to start Stemoscope PRO in Mode I. Slide the switch to the right to start Stemoscope PRO in Mode II.
The diaphragm makes contact with the human body to pick up body sounds. Charge port Ambient sound sensing hole Back side The ambient sound sensing hole picks up the ambient sounds for noise cancelling. DO NOT block it. To charge Stemoscope PRO, plug one end of the charging cable into the charge port and another end to a UL-certified Type C charger (not provided in the package). The device status can be identified by the combination of the switch position and the notification light in the following table.
Switch position Notif -ication Mode I light Pulsing Waiting for (smoothly Bluetooth fading in connection. and out) OFF Mode II N/A Waiting for Bluetooth connection. Blinking N/A Connected but not transmitting sound. Consistent -ly on Off N/A The battery Connected is still being and charged transmitting and is not sounds. full. The battery Out of is fully battery charged if power. charging. Connected and transmitting sounds. Out of battery power.
3. Use Stemoscope PRO in Mode I 3.1. Connect new Bluetooth earphones To use Stemoscope PRO in Mode I, you need to have Bluetooth earphones and get the Stemoscope PRO and the earphones paired. Step 1. Let your Bluetooth earphones enter pairing mode. You may need to check the user manual of your Bluetooth earphones to see how to let your Bluetooth earphones enter pairing mode. Bluetooth earphones from different brands might have different ways to enter pairing mode. Step 2.
You may check if it is working normally by gently tapping the diaphragm of the Stemoscope PRO. If you can hear the tapping sounds from the earphones, it is working. 3.2. Second time to connect Bluetooth earphones Stemoscope PRO can only store one piece of pairing information. When a new set of Bluetooth earphones are connected to Stemoscope PRO, the pairing information of the old one will be wiped out.
3.3. Adjust the volume or switch off/on noise cancelling for Mode I Adjusting the volume and changing noise cancelling settings for Mode I can only be done in the “DrStemo” app. Please refer to Section 4 to see how to use the app. After you connect the device to the app, please find the settings following the path: “menu button” → “settings” → “settings for mode I,” as shown in the picture below. The change will take effect when the Stemoscope PRO is used under Mode I next time.
4. Use Stemoscope PRO in Mode II 4.1. Basic steps to listen to the sounds Here are the basic steps for you to use Stemoscope PRO in Mode II. 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. The “DrStemo” App The app user interface is customized for medical professionals and lay users. The first time you use the app, you will be asked to set your role.
diaphragm of your Stemoscope PRO as shown in the picture below. Just follow the simple steps to register. Find the QR code on your Stemoscope PRO After registration, you will see the home user interface as shown below. This user interface shows that connected there yet. is no Before Stemoscope Stemoscope PRO PRO is connected, the “listen & record” button is not active.
Menu button “listen & record” button “livestream” button Home user interface before Stemoscope PRO is connected Step 2. Slide the switch button of Stemoscope PRO 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 PRO.
notification light of the Stemoscope PRO will blink. In mode II, Bluetooth pairing in the phone settings is NOT needed or supported. The home user interface will be updated once connected. The “listen & record” button will start to animate. The battery power level of the Stemoscope PRO is displayed. When the power is low, please charge it timely. You can press the “livestream” button to make a video call to your doctor/patient if you have access to the cloud service. Step 3.
just want to record the sounds, you may use earphones to monitor the sounds (for example, holding Stemoscope PRO stable can give better quality). Please consult your doctor on where to listen and record. The battery level of the connected stethoscope Animated “listen & record” button after connection. Press to listen.
Battery power level Bluetooth signal strength Select one of the themes by pressing the button.
4.2. Record a video composed of the auscultatory sounds and the camera view You can use the “video” theme of the “listen & record” user interface to record a video composed of the video showing where Stemoscope PRO is placed and the sounds transmitted from this Stemoscope PRO. Sounds from different body spots may have different characteristics, so it is critical to know what part of the body emitted those sounds. A video can record the sounds and associated location of the Stemoscope PRO.
interface, there are another two themes: “heart” and “lung,” providing some predefined spots to save heart sounds and lung sounds respectively. The following picture shows the “heart” theme. You can place Stemoscope PRO on one of the body spots shown in this user interface and press the corresponding “red dot” recording button to record the corresponding sounds. You may choose to screen record so that the sounds and the waveform displayed on the screen can be composed into a single video file.
Record button. Place your device on one of the heart listening spots and press this button to record the sound associated with this location. Option to record screen The “heart” theme of the “listen” user interface 4.4. More features for medical professionals Two extra features were provided in the “listen” user interface for medical professionals.
for better interpretation or record the sounds from some body spots that are not commonly used. ⚫ Choose Stemoscope PRO 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.
Nonpredefined recording spot Stethoscope frequency modes for medical professionals Extra features for medical professionals in the “listen” user interface ⚫ Record on non-predefined auscultation spots If you want to record the sounds emitted from the 25
body spots other than those predefined red dots, you can use the non-predefined recording spot button. After you record, you can add some notes to describe the spot when you save the audio. 4.5. Live stream the auscultatory sounds As a part of premium cloud services, the app lets a patient make a video call with a doctor, and in the video call the patient can livestream the sounds of the Stemoscope PRO to the doctor.
4 On the scheduled call Before the scheduled time, call starts, the patient the doctor opens the app, enters switches on the “livestream” user Stemoscope PRO in interface, finds the Mode II and connects patient’s name in “my it to the app. Enter patients,” and presses “livestream” the patient’s name to make sure the status call. is ONLINE. Then wait and for the other side to call. 5 The doctor talks with The patient talks with the patient in the the video call.
needs to press “livestream” in the home user interface, and then on the “my patients” 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. Please remind your patient to accept the invitation by clicking the link in the invitation email.
user interface as shown below. 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. In case this happens, contact the patient to check if the patient has opened the app. The doctor needs to call the patient to initiate the video call. The patient does not have the option to call the doctor.
Incoming audio signal quality indicator Toggle the selfview and incoming view Toggle the front and back camera Toggle ON/OFF the microphone Stethoscope The visualized sounds state and toggle The video call user interface 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.
because the sounds of the Stemoscope PRO can be damaged. You can learn the audio signal quality by looking at the audio signal quality indicator and the associated texts. Here is the list of signal quality indicators and their meaning. Audio signal receiving quality is good. Audio signal receiving quality is bad. Audio signal receiving quality is very bad. By default, the sounds of the Stemoscope PRO are not transmitted even if the Stemoscope PRO is connected.
When the sound of the Stemoscope PRO 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. It is recommended that both sides wear earphones for the video call. 4.6. Share (send) a recording A recording can be shared or sent in two ways: share the audio or video files or share through the cloud service.
“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. 5. Care, cleaning, and disinfection The stethoscope should be wiped clean and disinfected with 70% isopropyl alcohol wipes. DO NOT immerse the device in any liquid or subject it to any high-pressure/autoclave sterilization processes. 6.
7. Trouble shooting Symptom Possible Solution cause The Out notification battery light is of Charge Stemoscope PRO before use. power. consistently OFF when the device is Hardware Contact malfunction. service. customer switched ON. The earphones are not paired or the Can’t connect paired to Bluetooth information earphones. has been wiped out. Let your Bluetooth earphones enter pairing mode and pair it with Stemoscope PRO again. See Section 3.1.
smartphone to the mobile STEMO-700, check if in app. right Wireless Mode II. permissions have been allowed. If not, please allow and try again. Smartphone compatibility issue. Other issue. Find another phone or tablet to try again. Contact customer service. Internal speaker is Earphones are not used. The sounds are not II. body sounds. Please use earphones to listen. Please increase the phone volume.
music. Please check if your earphones are loud Earphones in listening to other compatibility sounds with the phone. Try another smartphone. set of earphones or on this another smartphone to confirm. 8. Disposal The device must be disposed properly after they will no longer be used. Dispose medical waste based on local regulations and comply with applicable laws.
9. Electrical Safety Guidelines and manufacturer's declaration electromagnetic emissions This STEMO700 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: Emissions test RF emissions CISPR 11 RF emissions Electromagnetic environment guidance Group 1 The STEMO700 stethoscope uses RF energy only for its internal function.
Electrostatic transient / burst IEC 61000-4-4 ± 2 kV for power supply lines 100 kHz repetition frequency Not applicable ± 1 kV for input/output lines Surge ± 0.5 kV, IEC 61000-45 Line-to-line ± 1 kV, ± 0.
RF IEC 150 kHz to 80 61000-4-6 MHz applicable Radiated RF IEC 61000-4-3 3 V/m 3 V/m 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz communications equipment should be used no closer to any part of the product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance PVd]5.3 [ 1 = PEd]5.3 [ 1 = 80 MHz to 800 MHz PEd]7[ 1 = 800 MHz to 2.
Recommended isolation distance between portable or mobile RF communication equipment and this product This STEMO700 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.
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency Band Service Modulation Maximu m power (W) Dista nce (m) IMMUNITY TEST LEVEL (V/m) (MHz) (MHz) 385 380 –390 TETRA 400 Pulse modulation 18 Hz 1.8 0.3 27 450 430 – 470 GMRS 460, FRS 460 FM ± 5 kHz deviation 1 kHz sine 2 0.3 28 710 704 – 787 LTE Band 13, 17 Pulse modulation 217 Hz 0.2 0.3 9 800 – 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation 2 0.
10. 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. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
