ChestPal Pro User manual

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ChestPal™Pro
User Manual

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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

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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.

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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.

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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.