Instructions for Use

Diagnostika na Domu LLP (ТОО «Диагностика на Дому») INSTRUCTIONS FOR USE Electronic Phonendoscope TU 7500 RK 11739547 TOO-001-2023 English translation of the Russian-language original dated 07.10.2026. In case of any discrepancy, the Russian version prevails. Screenshots show the Russian-language interface of the app.

Contents 1. General information............................................................................................3 Device name.........................................................................................................3 Intended purpose.................................................................................................. 3 Field of application.............................................................................................. 3 Contraindications.................................................................................................3 Possible side effects.............................................................................................4 Intended users.......................................................................................................4 2. Device description, principle of operation and specifications.........................4 3. Cleaning and disinfection..................................................................................28 4. Disposal...............................................................................................................28 5. Symbols used on the device, its components and packaging.........................28 6. Transport and storage conditions....................................................................29 7. Service life and shelf life....................................................................................29 8. Warranty............................................................................................................29 9. Complaints..........................................................................................................29 10. Applicable standards....................................................................................... 30 2

1. General information Device name Electronic Phonendoscope, TU 7500 RK 11739547 TOO-001-2023 Composition: • Electronic phonendoscope • USB-C to USB 2.0 cable • Software • Instructions for use Scope of delivery: Item Quantity, pcs Electronic phonendoscope 1 USB-C to USB 2.0 cable 1 Software The «Диагностика на дому» (Diagnostika na Domu) app is available for download from Google Play for Android devices or from the App Store for iOS devices Instructions for use 1 Intended purpose The electronic phonendoscope is intended for recording sounds of the heart, lungs and other parts of the body. Field of application Use at home and in medical organisations. Indications for use: detection and amplification of extremely faint body sounds that are difficult to perceive with a mechanical stethoscope. The device can distinguish between sound tones and emphasise one of them relative to another. The results can be listened to in real time on a smartphone or later on any device that supports audio file playback. Contraindications None. 3

Possible side effects Individual intolerance to the device materials; re-infection or cross-infection. Intended users The device is used by individual consumers at home and by specialists in medical organisations. Precautions: • Read these instructions before using the phonendoscope! • Avoid storage in very hot, cold or humid conditions. • In the event of a malfunction, contact the manufacturer or the manufacturer's authorised representative. 2. Device description, principle of operation and specifications By its principle of operation, the phonendoscope is an acoustic device (without energy conversion) for listening to natural sounds associated with the activity of human internal organs and for transmitting the sound vibrations by means of dedicated software used to record auscultation data and send it to a doctor. The phonendoscope is made of materials and substances that do not contain medicinal products for medical use or materials of animal or human origin. Schematic information on the principle of use Instructions for using the phonendoscope: Step 1 (before first use) To switch the phonendoscope on, move the slide switch to the "ON" («ВКЛ») position. When the slide switch is closer to the edge of the housing, the device is off. When the slide switch is moved closer to the centre of the housing, the device is on. There are two LED indicators on the phonendoscope housing: D1: power indicator, located closer to the centre of the housing; D2: operating status and battery charge level indicator, located closer to the edge of the housing. 4

When the phonendoscope is on, the first indicator (D1) is lit continuously. Immediately after switching on, the second indicator (D2) first flashes once, then gives two series of two short flashes, and then starts flashing faster at a steady rate. This means that the device is ready to connect via Bluetooth. Step 2 Turn on Bluetooth on your phone and connect to the phonendoscope via the app. When connecting the phonendoscope for the first time, you may need to pair it manually in the phone's Bluetooth settings. Select the device CSR8635 and connect to it. Once connected to the phone, indicator D2 repeatedly gives series of 3 short flashes. Done! After the first successful connection, the phonendoscope should connect to the phone automatically. Step 3 When reconnecting to a "familiar" device, the indicators on the phonendoscope should likewise show: D1 lit continuously and D2 giving series of 3 short flashes. If indicator D1 is lit continuously but D2 flashes ONCE or does not light up at all, the phonendoscope battery is discharged. Put the device on charge! If neither indicator is lit, the phonendoscope is switched off, fully discharged or faulty! Check the battery level of the device: if it is below 30%, charge it for 20-30 minutes using the USB-C cable (supplied). The battery level can be seen in the app; on most Android phones it is also shown in the Bluetooth devices menu while the phonendoscope is connected. IMPORTANT: • Before connecting the phonendoscope, make sure to switch off Bluetooth headphones, headsets and other devices completely, as they may interfere with the correct operation of the system. 5

• If you want to connect the phonendoscope to another phone nearby, be sure to switch off Bluetooth on your own phone. The phonendoscope must then be switched off and on again. You may also need to "forget", i.e. remove, the phonendoscope (CSR8635) from the list of Bluetooth devices on your phone in order to connect it to another phone. • It is recommended to charge the device when the battery level is below 30%. • In cold conditions, the phonendoscope battery may discharge spontaneously. • Put the device on charge and wait until it has warmed up to room temperature. D1 lit continuously; D2 flashes once, then gives two series of two short flashes, then flashes rapidly at a steady rate Device is ready to connect via Bluetooth D1 lit continuously; D2 repeatedly gives series of 3 short flashes Device is connected D1 lit continuously; D2 flashes once or is off Battery is discharged D1 off; D2 off Device is switched off, fully discharged or faulty Performing auscultation Step 1 To perform auscultation, follow the instructions on the phone and place the phonendoscope on the points shown on the diagram (see "Using the app"). While recording each point, observe the following simple rules: • Perform auscultation on bare skin • Start recording only after placing the phonendoscope on the required point • Press the phonendoscope firmly and do not move it during recording • Do not talk and avoid loud noises • Try to carry out the examination in a quiet room When listening to the heart, hold your breath or breathe shallowly and try to avoid extraneous sounds; this is important so that the heart sounds can be heard. When listening to the lungs, take several normal breaths in and out, and several deep breaths in and out through the mouth. 6

If extraneous noise occurs while a point is being recorded, the point should be re￾recorded. Each point can be re-recorded up to 3 times. If the phonendoscope disconnects or the app is closed during recording, the recordings will be lost and the auscultation will have to be repeated. Step 2 After all points have been recorded, send them by tapping the corresponding button. Do not send audio recordings if extraneous noise significantly interferes with hearing the breath or heart sounds. On the sending screen, untick the "defective" audio recordings and they will be deleted. Step 3 At the end of the examination, it is important to switch the phonendoscope off, as it does not switch off by itself and keeps working until the battery is fully discharged. A charging cable is supplied. Charge the phonendoscope so that it is ready for the next use. 7

Using the app Step 1. Install the «Диагностика на дому» (Diagnostika na Domu) app. The app is available for download from Google Play for Android devices or from the App Store for iOS devices. Launch the «Диагностика на дому» app. 8

Step 2. Add a patient by tapping "+ Add patient" («+ Добавить пациента») at the top of the screen. 9

Fill in the fields with the required information. Tap "Next" («Далее»). 10

After the patient has been added, a message appears confirming that the patient has been created successfully. 11

Step 3. After the patient has been created, you will be invited to get acquainted with a doctor. 12

Step 4. Once one or more patients have been added, the main menu displays a list of all patients. 13

Step 5. You can now proceed to the examination: tap the required patient in the list. Tap "Start examination!" («Начать обследование!»). The other functions become available after the examination has been completed. 14

Step 6. Select the required examination by tapping the phonendoscope icon. 15

Then select the type of examination. Step 7. Switch the phonendoscope on. To do so, move the slide switch to the "ON" («ВКЛ») position. See "Instructions for using the phonendoscope". 16

Step 8. Next, connect the phonendoscope to the phone. 17

After switching the phonendoscope on, tap the "arrow" in the bottom right-hand corner. Go to your phone's settings and connect a new device; it will be recognised as a headset. On subsequent connections, the phonendoscope will connect to your device automatically via Bluetooth. Once connected, the second indicator on the phonendoscope cover will light up. 18

Step 9. To record sound correctly, follow the 3 basic rules for using the phonendoscope. 19

Step 10. For lung auscultation, 14 points will be shown in sequence at which the phonendoscope must be placed. For heart auscultation, 5 points will be shown. 20

To record sound, tap the green microphone icon in the middle of the screen. During recording, the microphone icon turns red. Recording stops automatically after 9 seconds. Use the "-" and "+" icons to adjust the volume. Volume control works only when headphones are connected. 21

Step 11. When selecting an examination, you can also choose "Free auscultation" («Произвольная аускультация»). To start recording, likewise tap the microphone icon in the middle of the screen. During recording, the microphone icon changes colour to red. In this type of auscultation, you choose the points to record and the recording duration for each point yourself. To stop recording, tap the red microphone icon in the middle of the screen. 22

Step 12. After all auscultation points have been recorded, you can re-record the auscultation: tap the "Record again" («Записать заново») button or the "|←" button. After the auscultation points have been re-recorded, a screen appears showing all recorded points (from both the first and the repeated recording). Select the points you want to send to the doctor. 23

Step 13. If you are satisfied with the quality of the auscultation recording, tap the "Next" («Следующий») button or the "→|" button, and a new active visit will appear in the patient menu. 24

Tap the "Active visit" («Визит активный») button. The examinations performed on the patient will then be displayed. All recordings can be opened and listened to again. 25

Step 14. After the examination, you can contact the doctor from the patient menu and receive a consultation on the examination. To do so, tap the "Chat with doctor" («Чат с врачом») button. In addition to messages from the doctor and the patient, the chat also shows notifications about completed examinations. Check the phonendoscope battery level: if it is below 30%, charge it for 20-30 minutes using the USB-C cable (supplied). The battery level can be seen in the app. On most Android smartphones, the battery level is also shown in the Bluetooth devices menu while the phonendoscope is connected. 26

Phonendoscope specifications: Parameter Value Phonendoscope length 59.3 mm ± 10% Phonendoscope base diameter 31.4 mm ± 10% Phonendoscope cover Cover diameter 27.4 mm ± 10% Cover thickness 1.5 mm ± 10% Phonendoscope head Head diameter 43.5 mm ± 10% Phonendoscope slide switch Slide switch diameter 6.7 mm ± 10% Slide switch height 3.2 mm ± 10% Phonendoscope weight 35 g ± 15% USB-C cable length Not more than 2 m Operating frequency range 2.412 ~ 2.484 GHz Software version 2.0 or later Degree of protection against ingress of water and solid particles IP21 Battery Battery capacity 100 mAh Supply voltage 5 V Current consumption 500 mA Minimum continuous recording time on a full charge 30 min Group 1, Class B product. The phonendoscope is not repairable and is not subject to maintenance. In the event of errors or malfunctions, contact the manufacturer or the manufacturer's authorised representative in your country. 27

Mobile device requirements: Android 9.0 or later. Storage of at least 32 GB. RAM of at least 4 GB. iOS 15 or later. Storage of at least 32 GB. RAM of at least 4 GB. The device must be equipped with Bluetooth. 3. Cleaning and disinfection Cleaning and disinfection must be carried out after each use by wiping with an alcohol wipe soaked in a 70% ethyl alcohol solution. The phonendoscope is not sterile and must not be sterilised! 4. Disposal The phonendoscope shall be disposed of in accordance with the local legislation of the country of use as epidemiologically safe waste, similar in composition to municipal solid waste. The packaging may be disposed of as household waste. In the Russian Federation, disposal of unused devices shall be carried out in accordance with the requirements of SanPiN 2.1.3684-21. 5. Symbols used on the device, its components and packaging Symbol Description Symbol Description Date of manufacture (the date on which the product was manufactured) Batch code Manufacturer Consult instructions for use Type BF applied part Caution! Consult the instructions for use Keep dry Keep away from sources of heat and radioactive radiation IP21 Degree of protection against ingress of water and solid particles 28

6. Transport and storage conditions The device must remain operational when used under the following climatic conditions: temperature from -10 °C to +40 °C, relative humidity not more than 80% at 25 °C. Devices packed in accordance with the requirements of these technical specifications must withstand the following climatic factors during transport and storage: temperature from -10 °C to +40 °C, relative humidity not more than 80% at 25 °C. 7. Service life and shelf life The warranty period of operation and storage is 2 years from the date of manufacture. 8. Warranty The manufacturer guarantees that the quality of the device complies with the requirements of these technical specifications, provided that the user observes the conditions and rules of storage, transport and operation. The warranty period of operation and storage of the device is 2 years from the date of manufacture. During the warranty period, the manufacturer guarantees the replacement of a device that has failed. Replacement by the manufacturer is not guaranteed if the device fails as a result of mechanical damage or failure to observe the restrictions imposed on its operation. 9. Complaints Developer / Manufacturer: Diagnostika na Domu Limited Liability Partnership (ТОО «Диагностика на Дому») Building 7/9, non-residential premises 174, Yegizbayev Street, Bostandyk District, Almaty, 050046, Republic of Kazakhstan Authorised representative of the manufacturer in the Russian Federation: Diagnostika na Domu Limited Liability Company (ООО «ДнД») Domovladenie 2, building 4, Belyakova Street, Lianozovo municipal district, Moscow, 127253, Russian Federation Tel.: +7 (495) 369 38 94 Email: info@mydnd.ru 29

10. Applicable standards TU 7500 RK 11739547 TOO-001-2023; GOST 14254-2015; GOST 15150-69; GOST 14192-96; GOST 9142-2014; GOST R 50444-2020; GOST R IEC 60601-1- 2010; GOST R IEC 60601-1-6-2014; GOST IEC 62304-2022; GOST R IEC 62366-1-2023; GOST R ISO 15223-1-2023; GOST R IEC 60601-1-2-2014; GOST 10993 series. 30