ChestPal Pro Manuel utilisateur

ChestPal™Pro

User Manual

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

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.

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.

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.

● 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.

● 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

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.

2.1 CHESTPAL™ PRO STETHOSCOPE

Stethoscope part

LED light

Control button

Micro-USB port (covered by a protective flap)

Silicone ring around the membrane

The cross-reference to the stethoscope part numbers is indicated in parentheses in this manual.

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

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