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Smart Wireless Stethoscope

(Model: STEMO500)

Instruction Manual

(DRAFT)

Содержание PRO LITE STEMO500

Страница 1: ...1 Smart Wireless Stethoscope Model STEMO500 Instruction Manual DRAFT ...

Страница 2: ...sounds are heard move away from any radio transmitting antennas Bluetooth Class 2 is used for data transmission Its maximum radio frequency field strength is considered safe to use with other medical devices However audio video and other similar equipment may cause electromagnetic interference If such devices are encountered and cause interference immediately move Stemoscope PRO LITE away from tha...

Страница 3: ... device to extreme temperatures humidity or direct sunlight DO NOT subject the device to strong shocks such as dropping the unit on the floor The working distance will be reduced when objects walls furniture people etc are between Stemoscope PRO LITE and the connected phone or earphones To improve Bluetooth connection reduce the distance and or allow a line of sight between Stemoscope PRO LITE and...

Страница 4: ...the sounds 10 4 Record a video composed of the auscultatory sounds and the camera view 16 5 Record the sounds on a predefined body spot 16 6 More features for medical professionals 18 7 Live stream the auscultatory sounds 21 8 Share send a recording 27 9 Care cleaning and disinfection 28 10 Data security 28 11 Trouble shooting 29 12 Electrical Safety 31 13 FCC Statement 36 14 Disposal 36 15 Warran...

Страница 5: ...ess premium cloud services including video call service and cloud data storage Before your first use please read the manual carefully and follow all the instructions Please contact us if you encountered any problems 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 ...

Страница 6: ...060 hPa Operating conditions 10 C to 40 C 15 RH to 85 RH 800 hPa to 1060 hPa 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 The time required for Stemoscope PRO LITE to cool from the maximum storage temperature 70 C between uses until it is ready for intended use...

Страница 7: ...f 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 Indicates the Batch Code Attention see instructions for use MR Unsafe Bluetooth ...

Страница 8: ...e PRO LITE Charging cable Quick start guide x1 x1 x1 2 Hardware identification The switch in the left position is the OFF state Slide the switch to the right to start Stemoscope PRO LITE Switch Diaphragm Notification light Charge port ...

Страница 9: ... provided in the package The device status can be identified by the notification light Notification light Device status Pulsing smoothly fading in and out Waiting for Bluetooth connection Blinking Connected but not transmitting sound Consistently on Connected and transmitting sounds Off The battery is fully charged if the device is turned off and being charged Out of battery power if the device is...

Страница 10: ...he 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 Please choose the right one because a wrong choice can prevent you from using the device correctly If you want to change later you need to re install the app The app needs to read the QR code on the diaphragm of your Stemoscope PRO LITE as sh...

Страница 11: ...our 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 connected the listen button is not active ...

Страница 12: ...he 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 Menu button listen button see my doctor or see my patient button depending on your role selection ...

Страница 13: ...nt button to make a video call to your doctor patient if you have access to the cloud service Step 3 Press the listen button in the app to start listening The listen user interface is customized for non medical professionals and medical professionals respectively The listen user interface has three themes video heart and lung You can listen to the sounds in any of these three themes Internal phone...

Страница 14: ...emoscope PRO LITE stable can give better quality Please consult your doctor on where to listen and record Home user interface after Stemoscope PRO LITE is connected The battery level of the connected stethoscope Animated listen button after connection Press it to listen ...

Страница 15: ...ace The sound waveform Select one of the themes by pressing the button video is selected in this example Bluetooth signal strength Battery power level Switch the front and back camera Record button Noise cancelling switch Option to record screen ...

Страница 16: ...f the body emitted those sounds 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 For example a doctor may determine the spot based on its relative location to the neck Using the video theme for recording is the preferred recording option if you are...

Страница 17: ...s 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 To do so toggle on the screen recording option button before you press the red dot recording button When you look at the picture that shows the interested body spots red dots pay attention to the orientation of the human body marked with right hand side and left ha...

Страница 18: ...ls Two extra features were provided in the listen user interface for medical professionals Medical professionals sometimes need to filter the sounds Record button Place your device on one of the heart listening spots and press this button to record the sound associated with this location ...

Страница 19: ...ing table shows the frequency ranges of these modes The Bell mode emphasizes the low frequency sound which makes the major part of normal heart sounds while the Diaphragm mode weakens the low frequency sounds which may reduce the interference of heartbeat when you listen to the lung sounds The Extended range mode covers the whole frequency range from 20 2000 Hz You may switch among these modes bas...

Страница 20: ...20 Extra features for medical professionals in the listen user interface Record on non predefined auscultation spots Stethoscope frequency modes for medical professionals Non predefined recording spot ...

Страница 21: ... call the patient can livestream the sounds of the 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 Step Doctor Patient 1 Both the doctor and the patient install the app and the patient has a Stemoscope P...

Страница 22: ...livestream and then the waiting room page in the app to wait for the call 5 The doctor talks with the patient in the video call The doctor can ask the patient to start or stop Stemoscope PRO LITE sound transmission The patient talks with the doctor in the video call The patient follows the doctor s instructions on the use of Stemoscope PRO LITE 6 Hang up the call when the session is completed The ...

Страница 23: ...t the invitation by clicking the link in the invitation email Several minutes before the scheduled time and date the patient needs to open the app and enter the waiting room page after pressing the livestream button in the home user interface as shown below The patient 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 ON...

Страница 24: ...l is OFFLINE the doctor may fail to call the patient In case this happens contact the patient to check if the patient is in the waiting room of 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 Once the doctor calls the patient and the patient successfully accepts the call the video call user interface will show up The d...

Страница 25: ...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 Incoming audio signal quality indicator Toggle the front and back camera Toggle the self view and incoming view Toggle ON OFF the microphone Stethoscope state and toggle The visualized sounds ...

Страница 26: ...s bad Audio signal receiving quality is very bad By default the sounds of the Stemoscope PRO LITE are not transmitted even if the Stemoscope PRO LITE is connected You need to press the button to start or stop transmission if a 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 tra...

Страница 27: ...s wear earphones for the video call 8 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 After you record an audio or a video you can choose to share send an audio file or a video file or both To do so in the recorded sounds user interface after the recording was finished press the share button at the top right cor...

Страница 28: ...lean 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 10 Data security When using the DrStemo App enable device and networking security features to protect your data or patient data that is created and stored using this software in addition to security features embedded in the system Update ...

Страница 29: ...ardware malfunction Contact customer service Can t connect to a smartphone Permissions are not given to the mobile app Open the app Settings Search for STEMO 700 check if right permissions have been allowed If not please allow and try again Smartphone compatibility issue Find another phone or tablet to try again Other issue Contact customer service The sounds Earphones Internal speaker is ...

Страница 30: ...e the phone volume Body sounds are mainly composed of low pitched sounds that are less audible Higher volume is needed than that for other sounds such as music Earphones compatibility with the smartphone Please check if your earphones are loud in listening to other sounds on this phone Try another set of earphones or another smartphone to confirm ...

Страница 31: ...other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Guidelines and manufacturer s declaration electromagnetic immunity This STEMO500 stethoscope is expected to be used in the following elec...

Страница 32: ...ower frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT refers to the AC network voltage before the test voltage is applied Guidelines and manufacturer s declaration electromagnetic immunity This STEMO700 stethoscope is expected to be used in t...

Страница 33: ... central frequency of 80 MHz and 800 MHz the formula for higher frequency band shall be used Note 2 These guidelines may not be suitable for all situations Electromagnetic propagation is affected by absorption and reflection from buildings objects and humans a Fixed transmitters such as base stations for wireless cellular cordless phones and terrestrial mobile radios service radios AM and FM radio...

Страница 34: ...fferent transmitter frequencies m 150 kHz 80 MHz d 1 2 𝑃 80 MHz 800MHz d 1 2 𝑃 800 MHz 2 5GHz d 2 3 𝑃 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For the maximum rated output power of the transmitter not listed in the above table the recommended isolation distance d in meters m can be determined by the formula in the corresponding transmitter frequency column w...

Страница 35: ...deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217...

Страница 36: ...dential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be d...

Страница 37: ...37 15 Warranty A limited warranty is provided for Stemoscope PRO LITE Please visit stemoscope com warranty for a full description of the warranty 16 Contact information ...

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