ChestPal Pro User manual

1
ChestPal™Pro
User Manual

2
1.1 INDICATIONS FOR USE....................................................................................................................... 3
1.2 BEFORE YOU START USING CHESTPAL™ PRO........................................................................ 3
1.3 WARNINGS .............................................................................................................................................. 4
1.4 PRECAUTIONS........................................................................................................................................ 5
2.1 CHESTPAL™ PRO STETHOSCOPE..................................................................................................9
2.2 LED GUIDE ON THE STETHOSCOPE ...........................................................................................10
2.3 CHARGING THE STETHOSCOPE................................................................................................... 11
2.4 INSTALLING THE CHESTPAL™ PRO APP .................................................................................. 11
2.5 CONNECTING THE STETHOSCOPE TO THE APP .................................................................. 11
2.6 CONDUCTING A LUNG EXAM ........................................................................................................ 12
2.7 LUNG SOUND ANALYSIS.................................................................................................................14
2.8 PATIENT MANAGEMENT USING THE APP ............................................................................... 15
2.9 TURNING THE STETHOSCOPE OFF ............................................................................................ 15
2.10 CLEANING THE STETHOSCOPE....................................................................................................16
2.11 ACCOUNT MANAGEMENT USING THE APP ............................................................................16
2.12 TROUBLESHOOTING ......................................................................................................................... 17
2.13 FOR HELP AND ASSISTANCE......................................................................................................... 17
2.14 TECHNICAL SPECIFICATION..........................................................................................................18
2.15 DESCRIPTION OF THE SYMBOLS.................................................................................................19
2.16 ELECTROMAGNETIC COMPLIANCE............................................................................................ 21
2.17 DISPOSAL CONSIDERATIONS .......................................................................................................25
4.1 PRIVACY POLICY .................................................................................................................................25
4.2 DISCLAIMER ..........................................................................................................................................25
4.3 WARRANTY .......................................................................................................................................... 26

3
1.1 INDICATIONS FOR USE
ChestPal™ Pro is a prescription device intended to monitor and record lung sounds and automatically detect crackles and wheezes. When
interpreted by healthcare providers, ChestPal™ Pro aids in diagnosis and patient management.
ChestPal™ Pro is intended to be used in healthcare settings on adults, adolescents, and/or children over 3 years old.
1.2 BEFORE YOU START USING CHESTPAL™ PRO
Important:
To ensure that you use this product safely and effectively, please follow the safety information provided in this user manual. ChestPal™ Pro
should be set up and operated according to the instructions laid out here. Retain these instructions for future reference.
Before each use, check for visible damage to the stethoscope, packaging, or accessories. Remove all packaging material. Check if all the
required contents are present. If you have any doubts, do not use the stethoscope, and contact your local distributor.
What's in the box:
• 1 ChestPal™ Pro electronic stethoscope
● 1 Micro-USB cable for charging
● 1 Pouch for storage
● 1 Quick Start Guide
System Requirements:
To use ChestPal™ Pro, users must connect their ChestPal™ Pro electronic stethoscope with an Internet-enabled smartphone using the
ChestPal™ Pro app. The app can be used with iOS 12 and newer models, Android 6.0 and more recent models. The smartphone must support
Bluetooth 5.

4
1.3 WARNINGS
● ChestPal™ Pro does NOT provide a diagnosis and cannot be used for diagnosis and clinical decision making without a healthcare
professional’s over-read of the findings and consultation.
● Do NOT rely on stethoscope readings as the sole means of diagnosis. The system serves as one source of data, which holds significance
only when used in conjunction with clinician oversight and the consideration of other relevant patient information.
● ChestPal™ Pro cannot be used for cancer detection or diagnosis.
● Only a doctor can provide a diagnosis and prescribe or introduce changes to one’s treatment.
● Proper administration and usage of the product is the healthcare professional’s responsibility. The quality of the lung sound analysis
depends heavily upon the quality of the input data. Always make sure the instructions on conducting a lung exam using ChestPal™ Pro
are followed and that the recording is of high quality (by listening to the recording).
● The patient must be capable of breathing in and out deeply through an open mouth during the lung sound recording process.
● ChestPal™ Pro is not intended for children less than 3 years old.
● If the manual is not followed, hyperventilation of the lungs may occur.
● MR-unsafe! Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury due
to the presence of ferromagnetic materials that can be attracted by the MR magnet core. Thermal injury and burns may occur due to the
metal components of the device that can heat during MR scanning. The device may generate artefacts in the MR image. The device may
not function properly due to the strong magnetic and radio frequency fields generated by the MR scanner.
● Keep packaging material, small parts, and the USB cable away from children and pets to avoid the danger of choking, suffocation, and
device damage.
● Children must not play with or use the device.
● Do not use the device on pets.

5
1.4 PRECAUTIONS
General:
● Always check the stethoscope before each use and do not use it if the stethoscope is damaged in any way.
● Do not use the stethoscope in or near water, including in a bathtub, shower, hot tub, or swimming pool. Never use the stethoscope if it has
fallen into the water.
● In the event of a fault, stop using ChestPal™ Pro, do not open or shake the stethoscope under any circumstances. Refer to the
"Troubleshooting" chapter. If you need additional help, please contact your local distributor.
● If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.
● Repairs must only be carried out by ChestPal Ltd Customer Service or authorized retailers. Under no circumstances should you open,
modify and/or attempt to repair the device yourself, as faultless functionality can no longer be guaranteed after that. Failure to comply
will result in the voiding of the warranty.
● To reduce the risks associated with environmental contamination, please follow applicable regulations when disposing of the stethoscope.
Cleaning:
● To reduce risks associated with infections, follow cleaning instructions carefully as explained in this instruction for use.
● Using the stethoscope to examine multiple patients without disinfection may cause cross-contamination.
● Keep this device clean and protected from dust and lint.
● Do not attempt to sterilize the stethoscope. This may cause device damage. Refer to Section 2.10 CLEANING THE STETHOSCOPE, page
16.
Do not apply your stethoscope:
● On skin that is not normal, intact, clean, or healthy.
● On skin where body hair may be touching the stethoscope’s membrane.

6
● On open wounds or rashes, or over swollen, red, infected, or inflamed areas.
● Over any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne.
During charging:
● For all users, including those with impaired sensory capabilities, the stethoscope should not be handled at any time during the charge
cycle.
● Before using the device for the first time, ensure that the technical specifications of the mains output of power adapter match with the
technical specification of this instruction for use. Only use power adapters that comply with the IEC 60601 medical electrical equipment
standard. The use of a different power adapter can be unsafe.
● Unwind the cable fully to avoid overheating.
● Once the battery is fully charged, let the stethoscope cool down for a couple of minutes as the battery may heat up during charging.
● Always ensure that the charger is positioned so that it is easy to unplug it from the power outlet. To disconnect the power cord, pull it out
by the plug. Do not drag the cord itself. Doing so may result in damage to the cord or the plug socket leading to fire or electric shock.
● Remove the charger block from the power outlet immediately if the stethoscope has fallen into the water during charging.
● It is highly recommended to recharge the battery as soon as possible once the yellow LED lights start blinking.
Electrical interference:
● To reduce the risk of device interference, keep the stethoscope at least 1 meter (3.3 feet) away from all RF emitters, including Wi-fi routers
and radios.
● To reduce the risks associated with strong electromagnetic fields, avoid using the stethoscope near strong radio frequency (RF) signals
or portable and/or mobile RF devices. If such devices start making sudden noises, move away from those devices.
● Avoid using the ChestPal™ Pro system when it is in the presence of equipment with known electromagnetic interference, such as MRI, CT,
and ultrasound machines. Such equipment may affect the quality of signals recorded by the stethoscope.

7
● Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
● Disperse any static electricity before using the unit.
● Never place the unit or USB cord in the microwave.
● Never touch the unit with wet or damp hands.
● The unit and cables must not come into contact with hot surfaces or sharp-edged objects.
● Protect the device and its accessories against impacts, humidity, dirt, marked temperature fluctuations and direct sunlight.
● To reduce risks associated with inaccurate data collection, store and operate ChestPal™ Pro according to these instructions.
● The product is not suitable used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
● Never throw the device into a fire, this can cause an explosion.
Connections and accessories:
● Use of accessories, transducers and cables other than those specified or provided by the manufacturer of ChestPal™ Pro could result in
increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
App related:
● To transmit and record lung sounds the stethoscope and the mobile device must be paired via Bluetooth, and the mobile device must be
connected to the Internet. Otherwise, data cannot be saved and may be lost.
● The device uses a Class 2 Bluetooth wireless connection to transfer data. To ensure Bluetooth connection, make sure that the distance
between the stethoscope and the mobile device is free of objects (e.g., wall, furniture, mobile device cover). To improve Bluetooth
connection, reduce the distance between the stethoscope and your smartphone. The recommended distance between the stethoscope
and your smartphone should not be more than 5 meters.
● To protect patient data stored in the software use networking security features such as strong passwords, biometric authorization, and

8
two-factor authentication when available.
● For cybersecurity purposes, it is highly recommended to run regular virus checks on the mobile device and enable a firewall when using
a web browser.
● Always use the latest version of the ChestPal™ Pro App available at Google Play Store and Apple App Store. Downloading software and
firmware updates from other unauthorized channels could cause cybersecurity risks.
● Users are notified about new app or firmware versions available unless disabled in the app store settings.
● The minimum recommended upload speed for the mobile app is 4000 Kbps. 4G cellular data service or similar is recommended for the
app.

9
2.1 CHESTPAL™ PRO STETHOSCOPE
#
Stethoscope part
1
LED light
2
Control button
3
Micro-USB port (covered by a protective flap)
4
Silicone ring around the membrane
The cross-reference to the stethoscope part numbers is indicated in parentheses in this manual.

10
2.2 LED GUIDE ON THE STETHOSCOPE
LED color
Stethoscope status
blinking blue
searching for a connection with the app
blinking yellow when searching for a
connection with the App
the battery is running low (20%)
glowing blue
connection with the app established; ready
for recording
blinking white
audio recording/transmission in progress
blinking yellow when charging
charging in process
glowing green when charging
fully charged
glowing pink when updating firmware
firmware update mode activated
glowing green when updating firmware
firmware update in progress

11
2.3 CHARGING THE STETHOSCOPE
Before using ChestPal™ Pro for the first time, please charge the stethoscope for at least 30 minutes:
1. Connect the micro-USB cable provided to the stethoscope’s micro-USB port (3) for charging.
2. Connect the micro-USB cable provided to a USB power source (output: 5 V/0.1A min, not included in the package).
3. The stethoscope will start charging automatically. Blinking yellow LED (1) will turn on, indicating that the device is charging.
4. The LED light (1) will change to glowing green once fully charged. Disconnect the stethoscope from the charger.
Note:
Do not use the stethoscope or attempt to record lung sounds while charging.
Recharge the battery periodically at least every six months when not in use. The battery slowly loses charge when not in use. If the charge
falls to an unacceptably low level the battery will be damaged.
2.4 INSTALLING THE CHESTPAL™ PRO APP
1. Search for ChestPal™ Pro in the Google Play Store (for Android) and Apple App Store (for iOS) on a smartphone.
2. Follow the instructions to download the app and wait until it has finished installing.
3. Open the app and create a new account – use the email address added by your organization to the list of active users
(see https://chestpal.com/sign-up/). Or enter your existing credentials to log in.
2.5 CONNECTING THE STETHOSCOPE TO THE APP
To use ChestPal™ Pro, you need to connect the stethoscope to the ChestPal™ Pro app.
When establishing a such connection and accessing respective app functionality for the first time, you will be asked to grant specific
permissions to the app (e.g., storage access required to save audio recordings) and turn on Bluetooth on your smartphone (in case it is turned

12
off). These are mandatory for the proper functioning of the product.
Steps to connect the stethoscope to the app:
1. In the app, start a lung exam by tapping on a respective button on the main screen.
2. You will be taken to a ‘Connect the device’ screen.
3. Press and hold the Control button (2) on the stethoscope for 3 seconds, then let go.
4. The stethoscope will search for the app (blinking blue LED (1)) and connect automatically (glowing blue LED (1)).
5. You will be taken to the lung sound recording screen.
2.6 CONDUCTING A LUNG EXAM
Getting ready:
● The stethoscope should be sufficiently charged (the LED (1) is not blinking yellow during the connection process) and cleaned before use.
● Lung sounds should be recorded in a quiet environment. Close-proximity conversation, loud background noises and other external sounds
will affect the record quality, analysis and a repeat sound recording may be required.
● Remove clothing and accessories from the upper body of the patient whose lung sounds you will be recording.
Steps to conduct a lung exam:
1. In the app, start a lung exam by tapping on a respective button on the main screen.
2. Connect the stethoscope to the app (see section 2.5).
3. Place the stethoscope firmly onto a patient's clean, intact, unbroken skin at a generally accepted placement position for listening to the
lungs:

13
4. Instruct the patient to take deep breaths in and out through an open mouth during the recording.
5. Press and hold the Control button (2) on the stethoscope for 1 second, then let go to start the recording.
● It is recommended that the recording start coincides with the patient’s inspiration.
● It is recommended that 1 recording contains 2 complete breathing cycles.
6. Once a recording is complete, you will see the lung sound analysis result for that recording displayed in the app. Listen to the recording
you made to ensure it is of high quality, i.e., you can clearly hear the breathing cycle, and no artifacts are present. You can re-do, save, or
discard the recording made.
● Re-do the recording if you do not believe the recording made is of high quality.
7. Follow steps 3 – 6 to further record lung sounds at required placement positions.
8. Once you have completed the exam, tap on Save the exam button in the app to save it. A Results screen will be displayed. Note that once
the exam is saved, it is impossible to modify the recordings made.
9. To assign the saved exam to a patient profile, tap on Assign exam button at the bottom of the Results screen in the app.

14
10. You can access all saved exams through the Journal tab.
Important:
Do not move your fingers on the stethoscope while recording.
Do not move the stethoscope while recording.
Do not talk while recording.
Avoid clothing, skin folds, or hair touching the stethoscope’s case or membrane while recording.
If the patient starts feeling out of breath or lightheaded due to deep breathing during the recording process, the recording process should
be stopped immediately, and the patient should get some rest. Do not continue recording until the patient feels better.
In case of artifact detection or presence, ask the patient to breathe deeper through an open mouth, making 2 complete breathing cycles
within one recording. Make sure to eliminate the possible causes of artifacts when doing a recording.
In case of heartbeat detection, reposition the stethoscope further away from the heart and ask the patient to breathe deeper through an
open mouth, making two complete breathing cycles within one recording.
For patients with low BMI, especially young children, the heartbeat analysis might be constantly present in the exam.
2.7 LUNG SOUND ANALYSIS
The app provides an automatic computer analysis of lung sound recordings using a neural network algorithm. It differentiates between 5
types of sounds:
● Normal breathing, Wheezes, Crackles, Artifacts, and Heartbeat.
The algorithm uses spectrograms – a visual representation of sounds, to do such analysis.
Normal breathing, wheezes, crackles, and heartbeat analysis is provided when the spectrogram you created received the highest match
with a respective class of spectrograms derived from recordings labelled by respiratory specialists.
Artifacts analysis is provided when the spectrogram you created received the highest match with a class of spectrograms derived from

15
recordings of skin or hair rubbing against the stethoscope membrane, fingers moving across the stethoscope during the recording,
stethoscope repositioning during the recording, electromagnetic interference, background noise, etc.
Important:
Note that the neural network algorithm has been trained and tested on a limited number of lung sound recordings. Misclassification of some
lung sound recordings is to be expected. A high-quality lung sound recording must be present for an analysis to be run successfully.
For information on ChestPal™ Pro performance metrics and published research, please visit chestpal.com.
2.8 PATIENT MANAGEMENT USING THE APP
To manage your patients’ profiles and records, use the Profiles and the Journal tabs, accessible through the main screen.
On the Patients tab, you can:
● See the list of created patient profiles.
● Search through the list for a particular patient profile.
● Create a new patient profile, by listing their ID (mandatory), name, sex, date of birth, chronic conditions, etc.
On the Journal tab, you can:
● See the list of all saved lung exams in chronological order.
● Filter the list by period or by a patient’s profile to see the list of respective lung exams.
● Open a lung exam card to access the recordings made, incl. their analysis. It is possible to share these recordings with other healthcare
providers.
2.9 TURNING THE STETHOSCOPE OFF
1. Press and hold the Control button (2) on the stethoscope for 4 seconds until the LED (1) is off; or

16
2. Exit the Lung exam screen. The stethoscope will go into search mode for 30 seconds (blinking blue LED (1)) and then turn off automatically.
2.10 CLEANING THE STETHOSCOPE
Before cleaning, the stethoscope must be switched off and disconnected from the USB charging block. Clean before first use and after each
use. Use disinfectant wipes that incorporate 1:10 sodium hypochlorite solution (bleach) to disinfect all external parts.
Note:
Use disposable lint-free wipes or cloth.
Use only an Environmental Protection Agency (EPA) approved disinfectant.
Follow instructions given on the cleaning product labelling.
Wear personal protective equipment recommended on the cleaning product labelling.
Do not reuse cloths or wipes.
The stethoscope must be operated only when it is completely dry.
Slight discoloration after exposure to sodium hypochlorite solution can be expected.
Do NOT soak or immerse the stethoscope in any liquid or subject it to any high-pressure/autoclave sterilization processes.
Do not wash the stethoscope in a dishwasher. This might result in device damage.
2.11 ACCOUNT MANAGEMENT USING THE APP
To manage your (provider) account, select the Settings icon on the top right of the main screen. On the Settings screen, you can:
● Change password.
● Log out from the app.
● Send a delete account request to your organization’s admin.

17
2.12 TROUBLESHOOTING
If you keep receiving analysis results inconsistent with the perceived patient’s health status, listen to the recordings made using headphones.
If you cannot clearly hear two complete breathing cycles in a recording, make sure to eliminate factors that may contribute to the reduction
of recording quality:
● It is crucial that the patient takes full deep breaths in and out through an open mouth during the recording.
● The stethoscope is sensitive to noises created due to friction at its surface. Do not move your fingers across the stethoscope, and do
not move the stethoscope itself during the recording.
● Nothing should be touching the stethoscope’s membrane or case during the recording, e.g. hair, skin, clothes, accessories.
You can find further support by selecting the Settings icon on the top right of the main screen and choosing one of the following resources:
● Interactive guide – interactive in-app guidance on how to use ChestPal™ Pro.
● Online FAQ – a web resource with frequently asked questions and answers.
● Contact customer support – an option to contact our specialists directly (see section ‘’FOR HELP AND ASSISTANCE’’).
2.13 FOR HELP AND ASSISTANCE
Should you have any questions about your ChestPal™ Pro device, please visit https://chestpal.com or contact your local distributor. We will
be happy to help.

18
2.14 TECHNICAL SPECIFICATION
Model/type:
ChestPal
™
Pro Electronic Stethoscope (LUS110)
Recording frequency range
from 50 Hz to 4 kHz
Power input
5Vdc – 0,1A (min)
External power supplier (not
included)
Input: 100 – 240VAC, 50 – 60Hz 0.5 A max
Output: 5V DC, 0,1A (min) Micro USB plug
Internal Power source
Li-Po battery 80mAh, nominal voltage 3.7 V
Battery operation times from
fully charged
>100 sound recordings
Expected service life:
1500h
Dimensions:
2.6 x 2.6 x 1.3 in
Weight:
2.8 oz
Permissible operating
conditions
50°F to 113°F (+10°C to +35°C), 10% to 95% relative humidity,
70kPa to 106kPa ambient pressure
Permissible storage and
transport conditions
-4°F to 140°F (-20°C to +60°C), 10% to 95% relative humidity,
70kPa to 106kPa ambient pressure
Audio Sensitivity
-44 dBFS
Bit Rate
16 bit per sample
Input impedance
2200ohm
GAIN
+27dB
Classification
Internally powered equipment, IP22, No sterilization, not
category AP / APG equipment
Equipment conditions of use
Continuous operation
Application part:
Type BF applied part

19
Technical information is subject to change without notification to allow for updates.
2.15 DESCRIPTION OF THE SYMBOLS
There are several technical markings on your stethoscope. These can be explained as follows:
Manufacturer (ISO 7000-3082)
Refer to the instruction manual/booklet (ISO 7010-M002)
The serial number (ISO 7000-2498)
Non-ionizing electromagnetic radiation (IEC 60417 - 5140)
Contains Bluetooth® wireless technology
IP22
Indicates protection against access to hazardous parts with a finger, solid
Data transfer via
Bluetooth® low energy technology, frequency band
2.40-2.48 GHz maximum transmission power radiated in
the frequency band <20dBm. Data transmission range <
10 meters (32.8 feet). Compatible with Bluetooth® ≥5
smartphones.
Li-ion battery (non-replaceable)
3,7 V - 80 mA/h
Materials
The body of the electronic stethoscope is made of the
biocompatible material POLYLAC ® ABS. Electronic
stethoscope ring made of biocompatible silicone.
®

20
objects ≥12.5mm diameter, and vertically falling water drops when the
enclosure tilted up to 15 degrees
Type BF Applied Part (IEC 60417-5333)
This way up (ISO 7000-0623)
Fragile (ISO 7000-0621)
Keep dry (ISO 7000-0626)
Caution: Federal law restricts this device to sale or use by or on the order of a
physician or other practitioner licensed by the laws of the state in which they
practice