minttihealth Smartho-D2 Electronic Stethoscope User Manual

Mint health Smartho-D2 Electronic Stethoscope

Introduction

Thank you for choosing the Smartho-D2 Electronic Stethoscope.
The Model Smartho-D2 brings you the very latest in advanced auscultation and wireless electronics technology in a highly ergonometric and easy-to-use format.
Whether you are an auscultating infant, pediatric or adult patient, in quiet or noisy environments, or picking up difficult-to-hear heart and body sounds, you’ll appreciate the technology that’s been built into this latest electronic stethoscope bearing the Smartho-D2 brand.
Don’t miss the sounds you need to hear.

Safety Information

Please read, understand, and follow all safety information in this user manual before using this electronic stethoscope, keep this user’s manual for future reference.
The U.S.A. Only
Caution: Federal laws restrict the sale by or on the order of a physician.

CAUTION
Before using the device, please pay attention to and follow all safety & security instructions in these instructions, keep these instructions so that you can refer to them.
Safety：

1. External equipment intended for connection to cable for charging, shall comply with relevant IEC standards (e.g.,IEC 60601 series for medical electrical equipment). If, in doubt, contact a qualified technician or your local representative.
2. Please charge it first before your first use. And any operation is not allowed when being charged.
3. Do not drop but handle it with care. Otherwise, damages or measuring errors will occur.
4. While in use, please use it strictly as instructed in this manual.
5. Please test in a quiet environment, stay as calm as possible during measuring to have steady monitoring and reliable record data.
6. If the stethoscope is not used for several days or months, please turn off the power supply of the stethoscope. If the battery power is blank or 0%, please use if after charging; In order to maintain the battery performance of the product, it is recommended to charge it once a month when it is not used for a long time.
7. If any problem with the electronic stethoscope, do not attempt to repair it, and don’t disassemble the main unit. Please inform us of the after-sales hotline. The after-sales service will give instructions.
8. Never throw the device into the fire, or the battery will explode.
9. Incorrect battery replacement will cause battery damage, damage (or even an explosion), the user is forbidden to replace the battery itself. If necessary, please contact our consultant who will be trained by our qualified personnel for battery maintenance or replacement.
10. In order to prolong the life of the stethoscope, avoid high temperatures, low temperatures, humidity, solvents and grease.
11. An adapter with EMC accreditation is recommended.
12. The device do not need regular maintenance, please contact our customer services department for our technical and business support.
13. Check before each use: Check whether the equipment is damaged or stained, and clean it in time; check whether the base of the device is removed; check whether the connected mobile phone or tablet speaker or media volume is turned on.
14. If the headset is lost or damaged, you can contact the sales service personnel to purchase the original charging cable, you can purchase the mid-bass headset by yourself. If the USB charging cable is lost, you can contact the sales service personnel to purchase the original cable or purchase the charging cable by yourself.
15. In order to reduce the risk associated with infection, please follow all instructions contained in this manual for cleaning, the system and the schedule for cleaning.
16. In order to reduce the risk associated with strong electromagnetic, avoid using stethoscopes close to strong radio frequency signals or portable/or mobile radio frequency devices. If you listen to unusual sounds, stay away from any radio transmitting antenna.
17. In order to reduce the risk associated with incorrect result storage, simply follow the instruction in this manual to operate the stethoscope. The stethoscope has a sound amplification mode (three gears) which can be adjusted by a sound button. Please charge the battery in time if the battery grid on the OLED display is empty, do not immerse the stethoscope in the liquid, and do not disinfect the stethoscope.
18. In order to reduce the risk associated with electric shock, do not disassemble the stethoscope unit and do not use the disassembled stethoscope for the user.
19. Do not to press the device by a force bigger than 10N to avoid any damage and any patient discomfort.
20. Store the device out of strong sunlight or any substances which cause corrosion and in a well-ventilated space.
21. Properly handle the device to avoid dropping it from the table or pocket.
22. This device should not be used in the vicinity or on top of other electronic equipment such as cell phones, transceivers, or radio control products. If you have to do so, the device should be observed to verify normal operation.
23. The use of accessories and power cords other than those specified, with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.

Security：

1. Before using the application, please choose the appropriate device and deploy the network configuration for security.
2. The phone with the application installed is recommended to install anti-virus software and open the system automatic patch upgrade.
3. In order to ensure data security, the phone with the application installed is recommended to set the access password.
4. When using the application, please pay attention to privacy protection.
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 Minotti 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 selected frequency. It can be used on any person undergoing a physical assessment for medical diagnostic purposes only.

Brief Introduction
The smart-D2 Electronic stethoscope adopts an acoustic sensor to convert the analog signal into a digital signal of auscultation, and improve the quality of the 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 a smartho-D2 electronic stethoscope, so no additional operational training is required.

Function Description
The smart-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, the stethoscope can transmit auscultation data to external devices (such as personal mobile phones, computers) by the reserved Bluetooth wireless connection.

Serial Number
Each smart-D2 electronic stethoscope has a unique serial number for easy identification, please record the serial number in this manual for future reference:

Instructions for Use

Turn on/off
Manual Turn on When the device is off, press the power button, OLED display will be activated, which indicates the device is on and will enter the home interface.
Manual Turn off: When the device is on, press the power button for two seconds, OLED display will shut off, which indicates the device is off.

Monitor battery information
The battery information is displayed by the OLED frame, it is black if the battery is full, and the blank in the battery grid indicates that there is no electricity, it needs to be charged in time. smart-D2 electronic stethoscope uses the rechargeable lithium battery, which can be continuously used for more than 48 hours after each full charge, when charging, place the device on the base, plug in the USB cable, plug the 5V adapter on the other end, or directly plug into the computer USB interface, the device will jump to the charging interface.

Battery charging
When charging, place the device on the base. Then plug one end of the charging cable into the charging hole and the other end to connect to an external electronic device for charging when the device will switch over to the charging interface.
When fully charged, the charging interface will be off and the device enters into the shutdown status.
When the battery is used up or the battery grid is blank or 0%, the stethoscope can’t work, please charge in time. Keep the equipment dry and clean when charging to prevent electric shock.

Mode Switch
There are two kinds of auscultation modes (heart sound mode, and lung sound mode), the switch of auscultation mode can be realized in two ways:

1. under the main interface, by pressing the “return/mode key”, the model can be switched; 2) under the menu interface, the mode sub-menu can select the auscultation mode, and the current auscultation mode can be seen as the mode icon under the main interface.

Adjust Volume
The volume of the auscultation signal could be adjusted. There are two ways to adjust the volume: 1) On the home interface, adjust by “Menu +/Volume” or “Menu-/Volume-“; 2) adjust the volume by sub-menu on the menu page.

Adjust Display Brightness
The backlight under the menu page adjusts the brightness of the display. The factory default is 80%. The OLED displays the backlight brightness for a long time during long standby time.

Monitor Patient’s Heart Rate
The hand-held stethoscope is placed in the red circle of the human body to mark the position to hear the sounds of lungs, heart, each time the auscultation time should be more than 30 seconds (as shown below)

Data Storage and Review
Please refer to the Application designated by Mintti for data storage and review. The device cannot store any data without the Application.

• Download the application named “Minotti” in the phone or other electronic device, and installed it following the instructions on the phone.
• Open the Application and register.

Device binding
When the device is connected for the first time, device binding should be finished before use. Click the Setting icon in the upper left corner of the Application to enter the setting interface. Select “Binding Device”. When the “Bound” is displayed, the binding is successful. After the binding is successful. It will be automatically bound the next time when connected.

Note:

1. Bluetooth can be turned on by the phone’s settings, or you can open it by tapping the Bluetooth button directly on the application.
2. The connection process is slow and requires a few seconds. When the application and the device fail to connect, restart both the application and the device and try again until the connection is successful.

Connection with smart-D2
Go back to the main interface and click ”Connect Core” to connect the device. After the connection is successful, it will automatically jump to the playback interface. The upper right corner of the playback interface will display the device’s power in real-time. After clicking the play button, you can hear the signal collected by the device and see the detection time, and display the waveform and heart rate in real-time on the software.

Data Filling
Fill in the information and save it after detection.

Data Review
The data collected by smart-D2 will be saved in real-time on the mobile phone, and all the data can be reviewed under the “Local Record” on the “Setting”. Click on the data files to play back the historical data. During playback, drag the progress bar of the playback file to perform fast forward and backward operations. All the data files can be found in the “Minotti” folder of your mobile phone.

Product Specification

Battery Specifications
Battery Type| 3.7V/2000mAh lithiumion polymer battery
Battery Operation Time| 60 Hours
Battery Use-life| 300 cycles
Charging Time| 4 hours
Technical Specifications
Binaural headset| YES
Chest-piece| YES
Sound processing| Digital signal processor
Display Screen| 1.3’ Color OLED
Low Battery Indicator| YES
Automatic Power Off| No
Volume Control| 1-3 level
Sound Amplifier| Amplifies up to 4X
Signal Sampling Rate| 8 kHz
Frequency Response| Heart Sound Mode:20-500Hz
Lung Sound Mode: 200-2000Hz
Total harmonic distortion| ＜3%
*Sound Attenuation| 100-500 Hz: ≦12dB

500-1000 Hz: ≦20dB

Intuitive keypad| NO
Direct Listening| Only transferred via headset
Recording and Playback| Not on the device itself
Wireless Technology| Bluetooth® at 2.4GHz
Dimension| Ø58mm×78mm
Safety Classification
Electric Shock Protection Type| Internal power supply equipment (A rechargeable 3.7V/2000mAh lithium-ion polymer battery), or

Input 0.2A/5VDC

Electric Shock Protection Level| BF
Liquid Access Proof Level| IP22
Bluetooth Specification
Version| Bluetooth® 4.0
RF frequency| 2.4GHz
Maximum Output Power| -20-4dBm
Frequency Range| 2402-2480 MHz
Transmission rate| 1M/S
Single-channel bandwidth| 1Mbps
Transmission Distance(Max.)| 3 m

Maintenance and Warranty

Cleanin g
The stethoscope should be cleaned every time after use.
Cleaning method: Under normal circumstances, it is not necessary to disassemble the stethoscope base and the upper cover for cleaning. The contact parts of the stethoscope’s outer casing are wiped clean with alcohol. Use the edge of the alcohol cotton swab to slide wipe the Myra, top cover, the outer casing, and silicone rubber sleeve of the stethoscope.

Note: The stethoscope should not be invaded into any solution, nor should it be disinfected. Excessive liquid during cleaning may cause moisture to enter the internal components, wipe dry and use again.

Service and Warranty
This device is guaranteed for 12 months from the date of purchase.
The smart-D2 electronic stethoscope provides excellent service and warranty policies. If the product quality problems are found during the warranty period, except the detailed damage or accidental damage, the device will be repaired free of charge when it is returned to Minotti.
Please put your name, address, email address, and phone number in it together with the stethoscope.
Please send the stethoscope directly to the Hefei Mintti Medical Technology Co., Ltd. Or the local authorized distributor for maintenance and repair information.

Maintenance & Service Card

Model

| |

Products name

|
Serial No.| | Manufacturer|
Price| | Acceptance|
Date of manufacture| |

Date of purchase

|

Date of Maintenance & Service

|

Maintenance Instructions

|

Maintenance Cost

|

Maintenance Person

| | |
| | |
| | |

Trouble Shooting

device

2

| ****

Poor Battery

| ****

The battery indicator in the device is blank or the battery indicator in the APP is 0%

| ****

Charging the device

3

| ****

Charging Problem

| ****

The charging indicator icon is shown in the device

| ****

Normal

4

| ****

Full Battery

| ****

No charging indicator icon, device power off.

| ****

Turn off the device and connect the charging dock

Appendix EMC Declarations

The model smart ho-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the model smartho-D2 should assure that it is used in such an environment.

Guidance and manufacturer´s declaration – electromagnetic emission

The model smart-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the model smart-D2 should assure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The Model smart-D2 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B|
Harmonic emissions

IEC 61000-3-2

| Not applicable|
Voltage fluctuations / flicker emissions

IEC 61000-3-3

| Not applicable
Guidance and manufacturer´s declaration – electromagnetic immunity

The Model smart-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the Model smart-D2 should assure that it is used in such an environment.

Immunity test

| IEC 60601

test level

| ****

Compliance level

| Electromagnetic environment – guidance
Electrostatic discharge (ESD)

IEC 61000-4-2

| ± 8 kV contact

±2 kV, ±4 kV, ±8 kV,

±15 kV air

| ± 8 kV contact

±2 kV, ±4 kV, ±8 kV,

±15 kV air

| ****

Floors should be wood, concrete or

ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrostatic transient / burst

IEC 61000-4-4

| ± 2 kV for power supply lines

100 kHz repetition frequency

± 1 kV for input/output lines

| N/A| N/A
Surge

IEC 61000-4-5

| ± 0.5 kV, ± 1 kV

differential mode line-line

| N/A| N/A
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0 % UT

(100 % dip in UT ) for 0.5 cycle at 0°, 45°,

90°, 135°,180°, 225°,

270°, and 315°

0 % UT

(100 % dip in UT ) for 1 cycle at 0°

70 % UT

(30 % dip in UT ) for 25/30 cycles at 0°

0 % UT

(100 % dip in UT ) for 250/300 cycle at 0°

| N/A| N/A

Power frequency (50/60 Hz)

magnetic field

IEC 61000-4-8

| 30 A/m, 50/60Hz| 30 A/m, 50/60Hz| ****

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a. c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity

The smart-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the smart-D2 should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6| 3 Vrms

150 kHz to 80 MHz

6 Vrms 150 kHz

to 80 MHz outside ISM bandsa

| ****

N/A

| Portable and mobile RF communications equipment should be used no closer to any part of the Models smart ho-D2, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = é3.5ù  P

ê V ú

ë 1 û

d = é3.5ù  P 80MHz to 800MHz

ê E ú

ë 1 û

d = é 7 ù  P 800MHz to 2.7GHz

ê E ú

ë 1 û

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b

Interference may occur in the vicinity of equipment marked with the following symbol:

Radiated RF

| ****

10 V/m

|
IEC 61000-4-3| 80 MHz to

2.7 GHz

| ****

10 V/m

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to

10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to

29,7 MHz and 50,0 MHz to 54,0 MHz.

b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.

c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the smart ho-D2 is used exceeds the applicable RF compliance level above, the smart-D2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the smart-D2.

d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between

portable and mobile RF communications equipment and the model smartho-D2

The Model smart-D2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model smart-D2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model smart-D2 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output of the transmitter

(W)

| Separation distance according to the  frequency of the  transmitter (M)
150 kHz to 80 MHz

d = [3.5] P V 1

| 80 MHz to 800 MHz

d = [3.5] P E 1

| 800 MHz to 2.7 GHz

d = [ 7 ] P E 1

0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Recommended separation distances between RF wireless communications equipment

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF wireless communications equipment and the device as recommended below, according to the

maximum output power of the communications equipment.

Frequency MHz| Maximum Power

W

| Distance| IEC 60601

Test Level

| Compliance Level| Electromagnetic Environment – Guidance
385| 1.8| 0.3| 27| 27| RF wireless communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Where P is the maximum output power rating of the ransmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

450| 2| 0.3| 28| 28
710| ****

0.2

| ****

0.3

| ****

9

| ****

9

745
780
810| ****

2

| ****

0.3

| ****

28

| ****

28

870
930
1720| ****

2

| ****

0.3

| ****

28

| ****

28

1845
1970
2450| 2| 0.3| 28| 28
5240| ****

0.2

| ****

0.3

| ****

9

| ****

9

5500

5785

Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

FCC Statement

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Caution: Any changes or modifications to this device not explicitly approved by the manufacturer could void your authority to operate this equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

RF Exposure Information
The device has been evaluated to meet general RF exposure requirements. The device can be used in portable exposure conditions without restriction.

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