User's Manual

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5. When sending or sharing auscultation data, please pay attention to the protection of private data and ensure the
facticity of the person.
6. When not using the application anymore, please delete the sensitive data stored in the idle or scrapped application
device.
Notice
In order to reduce the risk associated with the environment, the stethoscope and battery should be properly disposed of
or recycled in accordance with the local regulations.
This device is not allowed to be disassembled and modified. Only the authorized service personnel of Hefei Mintti
Medical Technology Co., Ltd can repair the stethoscope. Read, understand, and follow all the safety information on the
package.
EMC Compliance
This device complies with Part 15 of the FCC Rules, the operation of this device complies with the following two
conditions:
(1) The equipment shall not cause toxic interference.
(2) This device must accept any interference received, including interference that may lead to poor operation.
The equipment shall not be modified without the written consent of the Mintti company. Unauthorized modifications may
invalidate the authority granted by the Federal Communications Commission rules to allow the device to operate.
EMC conforms to Europe
The device complies with electromagnetic compatibility requirements of the international standard IEC60601-1-2.
Indications for Use/Intended Use
The Electronic Stethoscope is intended for the detection and amplification of sounds from the heart, lungs and other
internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment
for medical diagnostic purposes only.
Brief Introduction
The smartho-D2 Electronic stethoscope adopts acoustic sensor to convert the analog signal into a digital signal of
auscultation, improve the quality of auscultation signal by increasing signal amplification to achieve the sounds
described in the intended use section.
This manual provides complete information on how to operate smartho-D2 electronic stethoscope, so no additional
operational training is required.
Function Description
The smartho-D2 electronic stethoscope can receive voices, such as heart and lung sounds from the patient's body,
after amplification and filtering, transmit the sound by headset to the user.
The user interface of the stethoscope consists of five buttons and one OLED display screen, the sound processor is
carried out with the help of a digital signal processor, the power supply of the stethoscope is provided by the
rechargeable built-in lithium battery, including power management system to extend battery life, stethoscope can
transmit auscultation data to external devices (such as personal mobile phones, computers) by the reserved Bluetooth
wireless connection.
Serial Number
Each smartho-D2 electronic stethoscope has a unique serial number for easy identification, please record the serial
number in this manual for future reference:
510(K) Response to Deficiency on K191667-S001
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