MinttiHealth Smartho-D2 User manual

Wherever!you!are!
We!Care!
Electronic Stethoscope User’s Manual
006_User Manual
1/16

!
! !
!
Contents
Contents...................................................2
Introductio.................................................3
Safety Information.....................................3
EMC Compliance......................................9
Indications for Use/Intended Use ............5
Brief Introduction......................................5
Function Description.................................5
Chapter 01 Instructions for Use................12
Chapter 02 Product Specification.............16
Chapter 03 Maintenance and Warranty ....18
Appendix EMC Declarations......................21
006_User Manual
2/16

!
! !
!
Introduction
Thank you for chossing 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 auscultating infant, pediatric or adult patients, 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 users manual for future reference.
U.S.A. Only
Caution: Federal laws restrict the sale by or on the order of a physician.
Safety-related Labels and Symbols Description
Fragile -do not drop, to reduce the impact of the stethoscope components.
This side up, Do not put the stethoscope upside down.
Stacking layer limit, in order to reduce the risk, do not exceed the stacking layer number.
Keep dry, do not place in a humid and rainy environment.
Keep from sunlight, do not expose to the sun.
This product contains electrical and electronic components, standard handling and garbage collection are
not permitted. Refer to local instructions for disposal of electrical and electronic equipment.
Name and address of manufacturer
Product serial number
date of manufacture
Please refer to the manual
BF application part
Level of protection of electrical equipment housing against foreign body intrusion
EC Representative
CE mark
Rx Only
For prescription use only
MR unsafe
Explanation of Signal Word Consequences
CAUTION
Indicates a dangerous situation, may result in minor injury and/or adverse damage if unavoidable
NOTICE
In dangerous situations, may result in property losses if unavoidable.
510(K) Response to Deficiency on K191667-S001
006_User Manual
3/16

!
! !
!
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 standard (e.g.,IEC
60601 series for medical electrical equipment). If, in doubt, contact qualified technician or your local representative.
2.Please charge it firstly 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 the quite environment, stay as much calm as possible during measuring to have steady monitoring and
reliable record data.
6.If stethoscope is not used for several days or months, please turn off the power supply of 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, 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 battery will explode.
9.Incorrect battery replacement will cause battery damage, damage (or even explosion), the user is forbidden to
replace the battery itself. If necessary, please contact our consultant and 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.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 electromagnetics, 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
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 patients’ discomfort.
20.Store the device out of strong sunlight or any substances which causes corrosion and in a good ventilated space.
21.Properly handle the device to avoid dropping from the table or pocket.
22. This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone,
transceiver 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 cord 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 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 the privacy protection.
510(K) Response to Deficiency on K191667-S001
006_User Manual
4/16

!
! !
!
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
006_User Manual
5/16

!
! !
!
Chapter 01 Instructions for Use
1.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.
2.Monitor battery information
The battery information is displayed by the OLED frame, it is black if the battery is full, the blank in the battery grid
indicates that there is no electricity, it needs to be charged in time. smartho-D2 electronic stethoscope use the
rechargeable lithium battery, which can be continuous 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.
3.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 full 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.
510(K) Response to Deficiency on K191667-S001
006_User Manual
6/16

!
! !
!
4.Mode Switch
There are two kinds of auscultation modes (heart sound mode, lung sound mode), the switch of auscultation mode can
be realized in two ways:
1) under the main interface, by pressing "return / mode key", the mode 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.
5.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” “Menu-/Volume-"; 2) adjust the volume by sub-menu on the menu page.
6.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.
7. Monitor Patient 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)
Location!when!Heart!
sound!detection!
Location!when!Lung!
sound!detection!
510(K) Response to Deficiency on K191667-S001
006_User Manual
7/16

!
! !
!
8. Data Storage and Review
Please refer to the Application designated by the Mintti for data storage and review. The device cannot store any data
without the Application.
8.1 Download the application named “Mintti” in the phone or other electronic device, and installed following the
instructions in the phone.
8.2 Open the Application and registration.
8.3 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
connect.
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.
510(K) Response to Deficiency on K191667-S001
006_User Manual
8/16

!
! !
!
8.4 Connection with smartho-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
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.
8.5 Data Filling
Fill in the information and save it after detection.
8.6 Data Review
The data collected by smartho-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 "Mintti" folder of your mobile phone.
510(K) Response to Deficiency on K191667-S001
006_User Manual
9/16

!
! !
!
Chapter 02 Product Specification
ITEM
Parameter
Battery Specifications
Battery Type
3.7V/2000mAh lithium ion 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
* Note:The Sound Attenuation is the essential performance.
510(K) Response to Deficiency on K191667-S001
006_User Manual
10/16

!
! !
!
Chapter 03 Maintenance and Warranty
1.Cleaning
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 outer casing are wiped clean with alcohol.
Use the edge of the alcohol cotton swab to sliding 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.
2.Service and Warranty
This device is guaranteed for 12 months from the date of purchase.
The smartho-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 Mintti.
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
510(K) Response to Deficiency on K191667-S001
006_User Manual
11/16

!
! !
!
3.Trouble Shooting
No.
Fault Type
Occurrence
Solutions
1
Battery Exhausted
No response while press the on/off key.
Charging the 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
Guidance and manufacturer´s declaration – electromagnetic emission
The model smartho-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.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The Model smartho-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
510(K) Response to Deficiency on K191667-S001
006_User Manual
12/16

!
! !
!
Guidance and manufacturer´s declaration – electromagnetic immunity
The Model smartho-D2 are 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.
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.
510(K) Response to Deficiency on K191667-S001
006_User Manual
13/16

!
! !
!
Guidance and manufacturer’s declaration – electromagnetic immunity
The smartho-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the
smartho-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
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
6 Vrms 150 kHz
to 80 MHz
outside ISM
bandsa
10 V/m
80 MHz to
2.7 GHz
N/A
10 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the Models smartho-D2, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
P
V
dú
û
ù
ê
ë
é
=
1
5.3
P
E
dú
û
ù
ê
ë
é
=
1
5.3
80MHz to 800MHz
P
E
dú
û
ù
ê
ë
é
=
1
7
800MHz to 2.7GHz
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:
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 broadcast and TV broadcast 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 smartho-D2 is used exceeds the applicable RF
compliance level above, the smartho-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 smartho-D2.
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
510(K) Response to Deficiency on K191667-S001
006_User Manual
14/16

!
! !
!
Recommended separation distances between
portable and mobile RF communications equipment and the model smartho-D2
The Model smartho-D2 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Model smartho-D2 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
Model smartho-D2 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output of
transmitter
(W)
Separation distance according to frequency of transmitter (M)
150 kHz to 80 MHz
P
V
d]
5.3
[
1
=
80 MHz to 800 MHz
P
E
d]
5.3
[
1
=
800 MHz to 2.7 GHz
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 transmitter,
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.
P
E
d]
7
[
1
=
510(K) Response to Deficiency on K191667-S001
006_User Manual
15/16

!
! !
!
Hefei Mintti Medical Technology Co., Ltd
Address: C309, National University Science Park, 602 Huangshan Road, High-tech Zone,
Hefei City, 230088, Anhui Province, China
Contact: 86 0551-63638810
■ Version:V 1.0
■ P/N:D.H1.026
■ Edition Date: 2018/11/01
Hefei Mintti Medical Technology Co., Ltd!
510(K) Response to Deficiency on K191667-S001
006_User Manual
16/16

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 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 requirement. The device can be used
in portable exposure condition without restriction.
Other manuals for Smartho-D2
2
Table of contents
Other MinttiHealth Medical Equipment manuals
Popular Medical Equipment manuals by other brands

Getinge
Getinge Arjohuntleigh Nimbus 3 Professional Instructions for use

Mettler Electronics
Mettler Electronics Sonicator 730 Maintenance manual

Pressalit Care
Pressalit Care R1100 Mounting instruction

Denas MS
Denas MS DENAS-T operating manual

bort medical
bort medical ActiveColor quick guide

AccuVein
AccuVein AV400 user manual