MinttiHealth Vision User manual

■ Version：A2
■ No.：WI-Vision-0024
■ Release Date: 2021/05/12
Suzhou Melodicare Medical Technology Co., Ltd

Vital Signs Monitor
User Manual
Model: Vision

Contents
WARNING··················································01
I COMPANY PROFILE········································03
II PRODUCT DESCRIPTION···································03
Ⅲ PRODUCT SPECIFICATION·································06
Ⅳ SETUP AND OPERATING···································07
V MAINTENANCE···········································17
VI OBSOLETE EQUIPMENT MANAGEMENT·······················18
VII QUALITY ASSURANCE·····································19
VIII ELECTROMAGNETIC COMPATIBILITY INFORMATION············19

01
Warning
1.Do not replace the battery without training, to avoid a series of
dangerous situations such as battery over-heating, 󽗉re or explosion.
2.Do not calibrate it yourselves. The calibration is done before delivery.
Please contact the manufacturer when calibration is needed.
3.The patient is the intended operator.
4.Do not disassemble or modify the device by yourselves.
5.For patients with a pacemaker, the heart rate monitor may count the
pacemaker pulse when the heart is in cardiac arrest or arrhythmia.
Please do not rely solely on the heart rate monitor to alarm.
6. Do not place the cu󽗈 over any wounds to avoid more serious injury.
7.Do not use the cu󽗈 on the limb with any implants or surgeries,
otherwise it will cause harm to the patient due to the obstruction of
blood 󽗊ow.
8.The cu󽗈 should not be worn on the limb on the side of mastectomy
or lymph node removal.
9.The compression of the cu󽗈 will cause any other monitoring
equipment on the same limb to fail.
10.It is necessary to check whether the operation of the automatic
sphygmomanometer will cause long-term damage to the patient's
blood circulation.
11.Please contact your doctor immediately when you get an abnormal
reading.
12.The device can only monitor one patient at a time.
13.The processing and reprocessing of thermometers, probes and
accessories comply with the requirements of ISO 17664:2004 and ISO
14937:2009
14.Do not put the cu󽗈 or USB cable on the neck, to avoid any
dangerous accidents and cause su󽗈ocation.
15. If the device has been in extreme heat or cold, place the device in
an ambient environment of 20 degree Celsius for 2 hours before use.
16.Some materials on the equipment may cause sensitive reactions to
some patients who are allergic to it. Please pay attention.

02
【Contraindications】
1.People who have an implanted pacemaker should use the device with
caution.
2.Patients should be cautious to use the device when su󽗈ering serious
heart disease.
3.Do not use the blood pressure function with an injured arm.
4.Children or the people who cannot express their thoughts shall use the
device under supervision.
5.Patients su󽗈ering from blood circulation disorders and blood diseases,
please use it under the guidance of a doctor.

03
Ⅰ COMPANY PROFILE
II PRODUCT DESCRIPTION
1.Company Name: Suzhou Melodicare Medical Technology Co., Ltd
Address: Room 301, Building F2, No.32 Hongxi road, Suzhou high-tech
zone, Jiangsu province,China.
2.Contact: Email: [e-mail]
Tel: [phone]
3.Website: www.minttihealth.com
1.Product Features
The unit has multi functions of measuring heart rate, body
temperature, blood pressure and blood oxygen. The monitor works
with your mobile device to test, track and share data.
Equipment application part: device and cu󽗈
2.Indications for Use
Intended Use:
1.The unit is intended for the use in measuring heart rate,ECG, body
temperature, blood pressure and blood oxygen at home or monitoring
of the hypertensives, fever patients and anoxic patients. It is intended
to be used at home or healthcare facilities. And this device cannot be
used in ICU.
2.Side e󽗈ects: N/A
3.User pro󽗉le (Patient pro󽗉le):The device is intended to be used by
lay persons, nurses, physicians who are able to read and understand
English.
4. Do not use the device on body part with injury and skin infection.
5.Blood pressure measurement is intended to be used for person over 12
years old.
6.Body temperature measurement is intended to be used for person over
5 years old.
7.Heart Rate and SpO2 measurements are intended to be used for person
over 6 years old.
8.The operator must be able to read English.

04
3.Product Classi󽗉cation
According to the protection of the risk of electric shock, this product is
classi󽗉ed as class Ⅱ type equipment.
Type BF: Cu󽗈；Type CF: ECG electrode, temperature probe, blood oxygen
probe.
4.Operating Environment
Vital Signs Monitor operating environment as follows:
a) Environment temperature: +5℃ ~+ 40℃
b) Relative humidity: 0%~80%
c) Barometric pressure: 86 kPa~106 kPa
d) Ambient temperature test: when the ambient temperature is 25.5℃ ,
temperature of the cu󽗈 is 27.1℃ , the ECG metal plate is 27.2℃ , and the
blood oxygen probe is 26.1℃ .
e) When the ambient temperature is 40℃ , temperature of the cu󽗈 is
41.6℃ , the ECG metal plate is 41.7℃ , and the blood oxygen probe is
40.6℃ . At this time, the ECG application part exceeds 41℃ , and the
patient should use it without any skin damage, such as burns, scalds, or
wounds. It is recommended that each use should not exceed 5 minutes.
f) Supply voltage: 5V±0.25V ; DC Power Supply 3.7V, Battery
capacity:400mAh
g) Communication protocol: Bluetooth 4.0; Bluetooth working frequency:
2.4000 ～ 2.4835GHz.
5.Structure and Components
The Vital Signs Monitor is made up of the main unit, arm cu󽗈, USB
charging cable and mobile APP
On/O󽗈

05
Note:
1. ECG electrodes part should not be placed near conductive materials
such as magnets.
2.If the electrode and sensor of the device are loose or damaged, the
corresponding function will not work properly, please contact our sta󽗈
for return to the factory for repair.
6.Explanation of Symbols on Unit
BF type application
device
Scrap electrical
equipment
Warning sign Please refer to user
manual
Serial Number See below for
explanation
Lot number Class II
Anti-electronic type
Manufacturer European
Representative
CE mark Production date
Keep dry Upward
Fragile, handle with
care Keep from sunlight
Recycle Do not step on it with
your feet
CF type application
device DC mark
LOT
IP22:The 󽗉rst number 2: Protected against solid foreign objects of 12,5
mm Ф and greater. The second number: Protected against vertically
falling water drops when enclosure tilted up to 15° . Vertically falling
drops shall have no harmful e󽗈ects when the enclosure is tilted at any
angle up to 15° on either side of the vertical.

06
Ⅲ PRODUCT SPECIFICATION
Model: Vision
Power voltage: DC3.7V
Size: 70mm*70mm*18.4mm
Weight: approximately 70g
Wireless communication: Bluetooth 4.0 operating frequency:
2.4000GHz-2.4835GHz
Blood pressure/heart rate
Measuring method: oscillometric method
Cu󽗈 perimeter: 22-35cm
Measuring range: Blood pressure 0-300mmHg
Systolic pressure: 60-260mmHg
Diastolic pressure: 40-199mmHg
Heart rate: 40-180bpm
Measuring error: blood pressure ±3 mmHg Heart rate ±5%
Blood oxygen
Measuring method: re󽗊ective Method Measuring range: 90%-99%
Measuring error: ±2%
Temperature
Temperature measurement Measuring method: infra-red
Measuring part: forehead
Measuring range: 32℃ - 42℃
Measuring error: 36-39℃ ±0.2℃
＞ 39℃ or ＜ 36℃ ±0.3℃
ECG measurement
Measurement mode: Single lead Input impedance: ＞ 10MΩ
Input circuit current: ＜ 0.1uA
Calibration voltage: 1mV±0.05mV
Sensitivity tolerance: ＜ 10%
50Hz interference suppression 󽗉lter: ＞ 20dB
Maximum input range:±4.7mV
Polarization resistance voltage: ±300mV，
Amplitude variation ＜ 10%
Frequency response: 0.5~40Hz
Overshoot: not more than 20%
Environmental humidity for storage and transport:-40℃ -+55℃ ,
≤ 93%RH
Environmental pressure: 86-106kPa

07
Safety classi󽗉cation: this product should not be used under
mixed gases of 󽗊ammable anaesthetics and air mixture of oxygen or
nitrous oxide environment.
Ⅳ SETUP AND OPERATING
PROCEDURES
Set up Requirements
The Vital Signs Monitor is designed to be used with the following
required device:
a)Bluetooth 4.0
b)Android 5.0 system or newer, iOS 9.0 or newer system.
Charge the Battery
a)Please charge the battery when the low battery warning appears in
the APP.
b)Please use the cable provided together with the unit to charge the
battery.
c)The oxygen LED indicator will 󽗊ash when battery is being charged.
d)The oxygen LED indicator will remain on when battery is fully charged.
e)DO NOT use the unit when charging it.
f) The battery can only be replaced by maintenance personnel. It
is warned that the replacement of the battery by personnel without
adequate training will cause danger.
g) Please use the adapter complying with IEC60601-1 standard to
charge the device.
h)Battery maintenance method:
·Do not leave the device in a state where the battery power is too low
for a long time, otherwise the lithium-ion battery will be damaged,
and it should be charged occasionally.
·Keep the device away from high temperature, otherwise it will a󽗈ect
the charging point of the battery.
·The battery just can be replaced by the Maintenance personal only,
otherwise it will cause danger.
I) When the device is in di󽗈erent measurement functions, the battery
usage time is di󽗈erent; however the battery cycle life is estimated to
last more than 300 times of charging.
j) Battery leakage may lead to unacceptable risks. Regular inspection
or maintenance of the battery is required.

08
Turn on/o󽗈 the Unit
a)Turn on: long press the power button for 2s, the unit will gently
vibrate. The power LED indicator is 󽗊ashing blue light.
b)Turn o󽗈: long press the power button for 2s, the unit will gently
vibrate. The power indicator is dark.
c)Connected and measuring: the power LED indicator is steady blue.
App Download
1.Search "MinttiVision" on Google Play or Apple Store,
download and install MinttiVision APP
Connect the Device
Long press the power button to start the unit. Open the APP, the device
will be automatically connected to the app. The unit is connected when
the power LED indicator is steady blue. If the LED 󽗊ashes, please click
the Bluetooth icon to connect manually.
APP NOTICES
Make sure that the smartphone operation system is suitable before
download the App.
Turn on the unit 󽗉rst then login to the App. Ensure your phone's
bluetooth connection is switched on. This will automatically connect
the unit to the APP.

09
Troubleshooting
PROBLEM POSSIBLE CAUSE SOLUTION
Can not
download the APP
The smart
phone does not
conform with the
requirements
Please check whether
the smart phone's
Bluetooth and operation
system conforms with the
requirements.
Can not
be automatically
connected
Incorrect operation
Turn on the unit 󽗉rst then
login in the app, or connect
manually
Can not
be connected or
󽗉nd the unit
Low Bluetooth
sensitivity
Re-login in the app or
restarting the unit
Maybe should move up to the troubleshooting table.
Blood Pressure/ Heart Rate Measurement Instruction
1. The working principle of blood pressure: The blood pressure
function algorithm of this software is based on the third generation
technology, adopting high-precision 󽗉ltering algorithm to obtain
systolic blood pressure, diastolic blood pressure, heart rate, composed
of cu󽗈, air pump, vent valve, blood pressure sensor and other devices.
The air pump is used to in󽗊ate the cu󽗈 and the vent valve is used to
quickly exhaust after the measurement is completed. The mobile
phone sends a measurement command to BLE, and BLE receives the
command from the mobile phone to control the working status of the
air pump and the vent valve. The blood pressure sensor (MMR901) is
used to collect the cu󽗈 pressure and transmit it to BLE via SPI. BLE will
package the data and send it to the mobile phone according to the
communication protocol.
The 󽗉ltering algorithm is the core of the project, and the quality of
the algorithm directly a󽗈ects the accuracy of blood pressure. Three
󽗉ltering algorithms are used to calculate blood pressure, which are
limiting 󽗉ltering, mean 󽗉ltering and band-pass 󽗉ltering.
2.The blood pressure and heart-rate measurement are easily
in󽗊uenced by the tester's (spacing) body gesture, cu󽗈 wearing way,
physiologic condition and the surrounding environment; therefore

10
please make sure the middle of the cu󽗈 should be placed at the same
level as your heart.
1） Stay calm and rest for at least 5 minutes before blood pressure
measurement. Remove clothes from your arm or wear thin clothes to test.
2）Put the multifunctional Vital Signs Monitor to the cu󽗈 in a
correct position, making sure that the bottom edge of the cu󽗈 is
approximately 1 to 2 cm above the elbow, loosen or tighten it as long
as it's comfortable.
3）Stay still and place the measuring arm on a table, palm-side up and
relax so that the middle of the cu󽗈 is at the same level as your heart.
4）Select blood measurement on the APP and you can enter the page
of blood measurement, press 'Start' to start measure; please keep
calm when taking measurement.
5） Take the cu󽗈 o󽗈 after completing the measurement
Relax and
sitting up
straight
Remove clothing on the upper
arm or wear thin clothes
Cu󽗈 center and heart be at the same height
Rest your hand, plam-up,
on a table
the di󽗈erence in heights
between the table and
chiar should be
25cm to 30cm
The bottom of cu󽗈 approximately
1-2cm above the elbow

11
CAUTION
Avoid eating, drinking, co󽗈ee, smoking, exercising and showering for
at least 30 minutes before taking a measurement, please rest at least 5
minutes.
Please ensure testing under a resting state, maintain emotional
balance and make sure you do not need to urinate, and then take the
measurement in a correct gesture.
Always use the same arm for the measurement.
Please stay calm during measurement. DO NOT move your body
or arm. DO NOT measure under too cold, too hot or dramatically
changing environments.
DO NOT take the measurement in a the moving vehicle. This product
can only be applied to arms, please do not use it on other body parts.
DO NOT take continuous measurement on one arm. If multiple
measurements are needed, wait at least 30 seconds before taking
another measurement.
Cannot be used in occasions where electrosurgical equipment is used.
The pressure of arm cu󽗈 may cause paralysis to your arms, therefore
children and the person with injured arm should use with caution.
This arm cu󽗈 is specially designed, please do not remove or replace by
yourself; if replacement is needed, please contact the factory.
If there is a questionable reading, the measurement should be
repeated.
The expected service life of this cu󽗈 is more than 2000 times.
Do not attempt to in󽗊ate your arm multiple times as the pressure
exerted from the cu󽗈 can injure your arm.
When common arrhythmia occurs (E.g. atrial and ventricular
premature and atrial 󽗉brillation), the measured value may be incorrect
or unable to test.
Young children or people who cannot express their thinking should
not use this device, if yes this may cause accidents or disputes.
The patients with blood circulation disorder or any blood diseases
should use this monitor under guidance of doctor.
The highly anxious patients are not advised to do self-test. The
hypertension reference standard for this product complies with the
family hypertension value ≥ 140/90 mmHg of the ‘guidelines for
prevention and control of hypertension (2020 version)’.

12
Troubleshooting for blood pressure/heart rate
PROBLEM POSSIBLE CAUSE SOLUTION
Abnormal result (too
low value)
The cu󽗈 position was
not correct; speaking
or body movement
during testing; body
posture was incorrect.
Review the body
posture, apply the cu󽗈
correctly, and please
stay calm during
the process. For
detailed operation,
please consult the
instruction.
Unable to in󽗊ate
Cu󽗈 leakage or
incorrect device
placement
Review the device
position; please
replace the cu󽗈 if
there is a problem
with cu󽗈 and contact
the manufacture for a
replacement.
Unable to test
Incorrect device
placement or low
battery
Check if the monitor
is placed correctly
and check the device
battery. Please consult
the instruction for
detailed operation.
Body Temperature Testing Guidance
1.Maintain the forehead dry and clean; align the monitor probe on the
middle of forehead and above eyebrows with the monitor in the hand,
the interval between monitor probe and forehead should be 1 to 2 cm.
2.Select “TEMPERATURE” on the APP then click “START” to
measure.
3.Read the measuring value when the measurement is complete.
4.The measuring environment temperature should be > 16℃ (60.8° F)
5.The temperature value is not displayed when beyond the display
range.

13
Sensor of temperature
aim to forehead
The interval between monitor probe and forehead should be 1 to 2cm
CAUTION
Clean your forehead before measuring.
Do not use temperature probe to directly touch your forehead skin.
Please try to take measurement under a stable environment; do not
measure in the direction of the Spacing or air-condition wind 󽗊ow or
places under direct sunlight.
The measurement takes about 2 seconds.
It is normal to have temperature di󽗈erences when you take multiple
measurements of di󽗈erent body parts. The thermometer uses
an adjustment algorithm which may cause a 0.2 degrees Celsius
󽗊uctuation when you take multiple measurements.
CAUTION(General)
1.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.
2.Use of accessories, transducers and cables other than those
speci󽗉ed or provided by the manufacturer of this device could result
in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
3. Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the device, including
cables speci󽗉ed by the manufacturer. Otherwise, degradation of the
performance of this equipment could occur.

14
Blood Oxygen Measuring Guidance
Troubleshooting
PROBLEM POSSIBLE CAUSE SOLUTION
Measured error
Sweat/oil/ dirt on
forehead
Clean the forehead before
measurement, stay dry and
clean for the measuring part
Measured distance
was too far
The interval between
monitor probe and
forehead should be 1 to
2 cm according to the
requirement
1.Place the multifunctional Vital Signs Monitor on the desk, stay still
and calm, put the middle 󽗉nger above the blood oxygen probe and
use the 󽗉nger pulp to touch the probe.
2.Select “Oximetry” on the APP and click “Start” to measure.
3. The uptake/upload of blood oxygen data is 4 seconds.
Adjust sitting
position and
keep quiet

15
Troubleshooting
PROBLEM SYMPTOM POSSIBLE CAUSE SOLUTION
Data changed a lot in
a short period
Measured way or body
gesture was wrong
Re-measure according
to the instruction
Unable to get
measured results
Finger overexerted
Lightly press the
middle 󽗉nger on the
device, do not
overexert
Finger is too thin
Use another 󽗉nger to
measure, ensure the
󽗉nger is covering the
blood-oxygen light
during the process
CAUTION
The Vital Signs Monitor should be horizontally placed during the
measurement.
It's recommended to measure using the middle 󽗉nger, with nails facing
upwards.
DO NOT move the 󽗉nger during the measurement. There are some
di󽗈erences on the blood pressure, blood circulation, physiological
features on di󽗈erent 󽗉ngers, hence try to use the same 󽗉nger to take
measurements. The paralysis state caused by the continuous blood-
pressure measurements can in󽗊uence the blood circulation, which may
a󽗈ect the oximetry values, so do not measure the blood oxygen after
󽗉nishing the blood pressure measurement.
DO NOT use a 󽗉nger that has nail polish on it for measurement.
DO NOT take measurement under strong light.
DO NOT measure after exercising.
The temperature of the probe of the oximeter on the skin surface should
not exceed 41℃ . If it exceeds 41℃ , special attention should be paid
The measured blood-oxygen value may be incorrect if the tester's 󽗉nger
skin is too thick or has pigment deposition. If there are foreign matters
between the probe and the measured parts, it may in󽗊uence the result.
The function tester cannot be used to evaluate the accuracy of the blood
oxygen monitor.
Cold 󽗉ngertip skin or poor peripheral circulation caused by low
temperature treatment or prolonged exposure to low-temperature
environment can result in insu󽗋cient pulse signal, out of range
measurements or inability to measure.
The functional oxygen saturation displayed by the pulse oximetry device
is calibrated.

16
To avoid the external disturbance, please do the measurement in a
quiet environment.
DO NOT do the measurement when the device is being charged. Please
place two hands in correct position.
DO NOT perform the measurement with wet hands.
During the measurement, two hands DO NOT touch each other.
ECG measurement can get the results of Heart rate, HRV and Breathing
rate at the same time.
ECG signal is extremely weak, so please sit still during the
measurement.
In the process of measuring, keep steady DO NOT shake.
The test results are for reference only and need to be con󽗉rmed by the
doctor.
Troubleshooting
ECG Measuring Guidance
Basic Knowledge of ECG
Heart rate variability: means to monitor the autonomic nervous
activity of the heart.
Instruction
1.Hold the deivce by left hand, and the thumb touches the metal part
on the top of blood oxygen sensor, other 󽗉ngers touch the metal label
at the back of device. The power button faces the palm.
2.Right hand touches the body temperature sensor. Two hands do not
touch each other.
3.Press the “start” button on the APP to start measurement. The
results will contents ECG diagram, heart rate, HRV and Breathing rate.
CAUTION
PROBLEM POSSIBLE CAUSE SOLUTION
ECG diagram reverse The position of two
hands are reverse
Please correctly place
both hands, according
to instructions.

17
Ⅴ MAINTENANCE
Maintenance under the following principles
1.Do not rinse the cu󽗈 with running water, clean the cu󽗈 with a dry and
soft cloth if it is needed.
2.Do not use moistened cloth to wipe the Vital Signs Monitor because
it is not waterproof.
3.Do not wipe the product with alcohol, gasoline, diluents.
4.This product is electronic product, including a battery, please do not
put it close to 󽗉re source or heat source.
5.Every component of this product has been strictly tested by the
manufacturer before leaving the factory, it is recommended to check
the product once a year.
6.Do not disassemble or repair the product by yourself, if there is any
problem with product quality or any doubts with measured results,
please consult the customer service hotline.
7.It is recommended to calibrate the machine (at least once a year). Do
not calibrate by yourself. Please contact the manufacturer or use the
manufacturer's authorized service center to perform the calibration.
Storage under the following principles
1.Do not store the Vital Signs Monitor under the high temperature,
humid, direct sunlight, dust, salty environment.
2. Do not store the monitor in a tilted position or on a surface which
produces vibration and strike.
3.Do not store the monitor in a place with chemicals or corrosive
gases.
4.Do not drop the monitor from high height.
5.Do not tightly fold the blood-pressure measurement cu󽗈.
Repair under the following principles
1.Do not disassemble or repair the monitor by yourself, if there is any
problem with product quality or any doubts with measured results,
please consult the customer service hotline.
2.The cu󽗈 is specially designed, please contact the manufactured
factory to repair or purchase if it is damaged, do not replace by
yourself.