Reddot M2 User manual

User Manual
ECG-Enhanced Smart Pillbox M2
Thank you for purchasing our company's products. For your safety,
please read this user manual carefully before using the product.
winner 2021

CATALOGUE
1.Production Information.................................................
2.Instruction for use........................................................
3.Application scope & Contraindications.........................
4.Precautions..................................................................
5.Product Features.........................................................
6.Product performance indicators...................................
7.Working and storage conditions...................................
8.Cleaning and disinfection.............................................
9.Electromagnetic Compatibility Information...................
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1. Production Information
2. Instruction for use
Product structure and appearance
Model No
Weight
Bluetooth Version
Input Voltage
Rated Power
Battery Capacity
M2
105g (Battery included, battery weight about 10g)
Bluetooth 5.0BLE
DC 3.7V
0.75VA
570mAh Lithium Battery
Product structure and appearance: Finger Induction Area.
Charging Port
The device lights up in orange and starts charging, the device
does not working while charging.
The device lights up green, charging completed.
Please refer to the operation card for specific product usage.
ECG-Enhanced Smart Pillbox
L R
Finger
Induction
Area
Finger
Induction
Area
Charging interface
1

3. Application scope and contraindications
1. Application: used for single-lead acquisition, display, and
recording of human ECG data. Automatic analysis and diagnosis
functions are not included.
2. Contraindications:
1) Those who are allergic to ECG electrodes are prohibited;
2) Those who have a pacemaker are prohibited;
3) People who have allergic reactions to this product are prohibited;
4) Use with caution in patients with contact dermatitis;
5) Infants weighing <10kg are not applicable;
6) When only for diagnosis, evaluation and monitoring of cardiac
ischemic diseases.
Special instructions for safe use:
1. Do not immerse the product in water or other liquids.
2. Do not place or store the product in places where it may fall
into the bathtub, shower, etc.;
3. If the product is damaged due to severe impact or falling from a
high place, please do not repair it by yourself;
4.The product is not suitable for infants, children and those who
cannot operate alone, unless they are supervised or instructed
by their guardians in the use of this product. Please place it out
of reach of children and babies, and it cannot be used as a toy.
2

4. Precautions
1) Please read this manual carefully before use.
2) When the product is not going to be used for a long time,
please charge and discharge the product once every 3 months.
3) The built-in battery should be discarded according to the
regulations of relevant departments.
4) Electromagnetic interference above 3V/m should be avoided
during measurement. Possible sources of interference are TV,
microwave oven, X-ray, etc.
5) Do not use this product in a dry environment, especially in a
dry environment with artificial materials (artificial fabrics,
carpets, etc.), which may cause damaging electrostatic
discharges and lead to wrong conclusions.
6) It is forbidden to use this product near strong radiation sources,
otherwise it may interfere with the normal operation of the device.
The user ensures the electromagnetic compatibility environment
of the equipment when using it, so that the equipment can work
normally.
7) If the device is used and stored beyond the temperature and
humidity range specified in this manual, the safety performance
may be invalidated or even damaged. For the specified
temperature and humidity range, please refer to the instruction
manual "Working and Storage Conditions".
8) Please avoid sharing equipment with others to avoid
cross-infection.
9) Patients with sensitive skin who may experience local redness,
cancer itching or even allergic dermatitis due to allergies to the
electrodes, please stop using it and consult a doctor. If severe
allergies or skin damage occurs, you need to see a dermatologist.
3

10) For the disposal of the ECG-Enhanced Smart Pillbox and its
accessories and packaging (plastic bags, foam and paper
boxes, etc.), please comply with local laws and regulations to
avoid environmental pollution.
11) In the environment of strong magnetic field such as nuclear
magnetic resonance (MRI) and CT examination, it is strictly
forbidden to wear and use the ECG-Enhanced Smart Pillbox
at the same time.
12) It is strictly forbidden to immerse in liquid, and avoid placing
the product where it may fall into liquid.
13) Do not use this product for babies weighing less than 10kg.
14) The measurement should be carried out in a quiet state.
During the measurement process, please try not to exercise
violently to avoid rubbing the electrodes and causing the
electrodes to fall off.
15) If the ECG-Enhanced Smart Pillbox does not work normally or
is damaged, please stop using it immediately and contact the
after-sales service in time, and do not disassemble it by
yourself.
16) The electrodes of the equipment must not be in contact with
any conductive parts including the ground.
17) The battery of the device cannot be disassembled and
replaced by yourself.
18) Replacement of parts needs to contact the manufacturer to
determine the correctness before implementation.
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1) Classification by type of protection against electric shock:
internal power supply;
2) Classified according to the degree of protection against electric
shock: CF type;
3) Classified according to the degree of protection against ingress
of liquid: IPXO
4) Classified according to the degree of safety when used with
flammable anesthetic gas mixed with air or flammable anesthetic
gas mixed with oxygen or nitrous oxide: Equipment that cannot
be used with flammable anesthetic gas mixed with air or
flammable anesthetic gas mixed with oxygen or nitrous oxide;
5) Classification by operating mode: continuous operation.
6) Does the equipment have an applied part protected against
defibrillation discharge effects: No
7) Whether the device has a signal output or input part: No
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5. Product features

1) Dynamic input range: For a differential mode voltage with an
amplitude of 10mV (peak-to-valley) (when the gain is set to
5mm/mV) that is superimposed with a 300mV DC bias voltage
and changes at a rate of 125mV/s, the digital recorder should
have the ability to respond and display. The amplitude of the
time-varying output signal equivalent to the input should not
exceed 10% or 50uV, whichever is the maximum.
2) Input impedance Under the specified test signal (10Hz, 5mV
sinusoidal signal), the input impedance should be higher than
10M. This requirement shall also be met when a DC bias
voltage of ±300mVim is superimposed. (The steady-state output
amplitude must not be reduced by more than 6%).
3) Common mode rejection: For sinusoidal signals at the mains
frequency, the common mode rejection is at least 60dB, and for
signals twice the mains frequency, at least 45dB.
4) Gain accuracy: The output signal is equivalent to the input test
signal, and the maximum amplitude error is ±10%.
5) System noise: When all the input terminals are connected in
series to each patient electrode through a resistance-capaci
tance parallel network of 51kQ capacitor and 47nF capacitor,
the internal noise equivalent to the input cannot exceed 0uV
(peak-valley value) within any 10s.
6) Frequency response For sinusoidal signals with frequencies
between 0.67 Hz and 40 H, the response amplitude should be
between 140% and 70% (+3dB-3dB) of the response amplitude
at 5H.
7) Minimum detection signal: for a 10HZ, 50V (peak-valley)
sinusoidal signal, it should be able to produce a clearly visible
deflection.
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6. Product performance indicators

1. Working conditions
Temperature: 5C~40°C: Humidity: ≤80% (non-condensing);
Altitude: 700hPa~1060hPa
2. Storage conditions:
Storage and transportation temperature: -20C~55C.
Storage and transportation humidity: <93% (no condensation);
transportation stability requirements: transportation under normal
temperature conditions; air pressure range: 700hPa~1060hPa;
Note: No corrosive gas, strong mechanical vibration and strong
electromagnetic field, clean and well-ventilated room.
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7. Working and storage conditions
It can be cleaned and disinfected by wiping with water or 75%
medical alcohol, and then aired naturally or cleaned with a clean,
dry cloth.
8. Cleaning and sterilization
Unable to power : check whether the battery power is too low.
No Bluetooth connection: check whether the collection of
Bluetooth is turned on.
The indicator light is off: Check whether the taking settings are
correct, Check whether the battery power is too low.
No sound:
Check whether the Do-Not-Disturb mode is turned on.
Check whether the taking settings are correct.
Check whether the battery power is too low.
Others: Product performance failures and solutions.

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This form is prepared according to the provisions of SJ/T11364.
O: Indicates that the content of the hazardous substance in all
homogeneous materials of the part is below the limit
requirement specified in GBT26572
×: indicating that the content of the hazardous substance in at
least one homogeneous material of the part exceeds the limit
requirement specified in GBT26572.
The name and content of harmful substances
in the product
Part
Name Lead
Pb
Case
Storage box
Circuit
board
Fastener
Battery
Mercury
Ilg
Pot Cd
Hexavalent
chromium
Cr(VI)
Polymeric
Biphenyl
(PBB)
Diphenyl
ether
(PBDE)
Harmful Substance
X

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1. The product contains a radio frequency transmitter.
2. This chapter is a special reminder for electromagnetic compatibility.
The M2 ECG-Enhanced Smart Pillbox should be used according
to the electromagnetic compatibility information in this chapter.
3. Portable and mobile radio frequency communication equipment
may affect the use of M2 ECG-Enhanced Smart Pillbox. When
using M2 ECG-Enhanced Smart Pillbox normally, it is recommended
to stay away from portable and mobile radio frequency
communication equipment or keep it turned off.
4. Warning: In addition to the accessories provided by our
company, the use of other manufacturers' accessories may
lead to an increase in the emission of the M2 ECG-Enhanced
Smart Pillbox or a decrease in the immunity to interference.
5. See Table 1.
7. The M2 ECG-Enhanced Smart Pillbox should not be used
close to or stacked with other devices with the same or similar
operating frequency. If it must be used close to or stacked, you
should observe and verify that it can operate normally under
the configuration it uses.
8. This product is also suitable for equipment and system
requirements including radio frequency transmitters, and the
transmission frequency is: 2.4GHZ, the frequency band:
2.40~2.485GHZ, the receiving bandwidth is 1MHz, the
modulation type: GFSK, and the effective radiation power is
-10dBm.
9. See Table 2.
10. The basic performance is: the equipment can collect, record
and transmit signals normally. Connect to USB, charge normally
9.Electromagnetic Compatibility Information

10
11. See Table 3 and Table 4.
12. In order to ensure that the M2 ECG-Enhanced Smart Pillbox
can be used normally and that its transmission will not be
increased and its immunity will not be reduced, please use the
relevant accessories provided by our company.
13. The use of accessories other than the specified ones together
with the M2 ECG-Enhanced Smart Pillbox may lead to an
increase in equipment or system emissions or a decrease in
immunity.
14. Warning: Even if other devices meet the emission requirements
of the corresponding national standards, the device or system
may still be interfered by other devices.
Guidance and Manufacturer's Declaration - Electromagnetic
Emissions
(Table1)
The M2 ECG-Enhanced Smart Pillbox is intended for use in the electromagnetic
environment specified below, and the purchaser or user should ensure that it is used
in such an electromagnetic environment:
Launch test Compliance
Electromagnetic Environment
Guidelines
Radio frequency
emission GB 4824
Radio frequency
emission GB 4824
Harmonic emission GB
17625.1
Voltage fluctuation/flicker
emission GB 17625.2
Group 1
Class B
Class A (compliance is
provided by the power
adapter used with it)
Compliance is provided
by the power adapter
used with it
The ECG-Enhanced Smart
Pillbox uses RF energy only
for its internal functions.
Therefore, its RF emissions
are very low and there is
little potential for interference
with nearby electronic
equipment.
This product is suitable for
use in all installations
including the following
facilities, including domestic
and residential public
low-voltage power supplies
directly connected for
domestic use.

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Immunity test IEC 60601 test
leveling
Compliance
Level
Electromagnetic
Environment
Guidelines
Electrostatic
discharge
GB/T 17626.2
Electrical Fast
Transient Burst
GB/T 17626.4
Surge GB,T 17626.5
Voltage dips, short
interruptions and
voltage changes on
power input lines
GB/T 17626.11
compliance is
provided by the
power adapter used
in conjunction with it
The power
frequency magnetic
field should be
characteristic of the
power frequency
magnetic field levels
of a typical location
in a typical
commercial or
hospital
environment.
<5% UT for 0.5
cycles (>95% dip in
UT) 40% UT for 5
cycles
(on UT, 60% dip)
70% UT, last 25
cycles (on UT, 30%
dip) <5%UT, last 5s
(on UT, >95% dip)
<5% UT for 0.5
cycles (on UT,
>95% sag 40% UT,
lasting 5 cycles (on
UT, 60% sag 70%
UT, lasting 25
cycles (on UT, 30%
sag <5% UT, lasting
5s (on UT, >95%
sag)
Power frequency
magnetic field
(50Hz/60Hz) GB/T
17626.8
3A/m 3A/m
±1kV line to lin
±1kV line to line
±2kV line to ground
±2KV to power line
±1KV to input/output
line
±2k pair power
corde
±6 kV contact
discharge
±8kV air discharge
±6 kV contact
discharge
±8kV air discharge
Floors should be
wood, concrete or tile,
and if floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Guidance and manufacturer's declaration — Electromag-
netic immunity
The M2 ECG-Enhanced Smart Pillbox is intended to be used in
the electric shock environment specified below, and the purchaser
or user should ensure that it is used in this electromagnetic
environment.
(Table 2)
NOTE: UT refers to the AC network voltage before the test voltage is applied.

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Immunity
test
IEC 60601
test level
compliance
level Electromagnetic Environment
Guidelines
Portable and mobile RF communications
equipment should not be used closer to
any part of the wireless ECG recorder,
including cables, than the recommended
separation distance. This distance should
be calculated by the formula
corresponding to the frequency of the
transmitter. Recommended separation
distance:
Formula:
P-—the maximum rated output power of
the transmitter provided by the
transmitter manufacturer, in watts (W):
d—the recommended isolation distance,
in meters (m) The field strength of the
fixed radio frequency transmitter is
determined by surveying the
electromagnetic field a, and in each
frequency range b should be lower than
the compliance level. Interference may
occur in accessories marked with the
following symbol
Guidance and manufacturer's declaration — Electromag-
netic immunity
The M2 ECG-Enhanced Smart Pillbox is intended for use in the
electromagnetic environment specified below, and the
purchaser or user should warrant that it is used in such an
electromagnetic environment.
(Table 3)
Radio
frequency
conduction
GB/T
17626.6
Radio
frequency
radiation
GB/T
17626.3
Note 1:
At 80 MHz and 800 MHz, the formula for the higher bands applies.
Note 2: These guidelines may not be suitable for all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a: Field strengths from fixed transmitters such as: base stations for radio
(cellular/none) telephones and land mobile radios, business radios, AM and FM
radio broadcasts, and TV broadcasts cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment for fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location where the product is located is above the applicable RF compliance
level above, the product should be observed to verify proper operation. If abnormal
performance is observed, supplementary measures may be necessary, such as
reorientation or repositioning of the product.
b: In the entire frequency range from 150 kHz to 80 MHz, the field strength should
be lower than [3]V/m.
3 V
(RMS)150
kHz~80
MHz3 V/m
80MHz~2.5G
Hz
[3] √ (RMS)
[3] V/m
d=1.2
d=1.2 80 MHz~800 MH z
d=2.3 800 MHz~2.5 GH z
P
P
P

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(Table 4)
Recommended Isolation Distance Between Portable and Mobile RF Communication
Devices and M2 ECG-Enhanced Smart Pillboxes
The M2 ECG-Enhanced Smart Pillbox is intended for use in electromagnetic
environments where RF emissions are controlled. Depending on the maximum
output power of the communication device, the purchaser or user can prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communication devices (transmitters) and the M2 ECG-Enhanced
Smart Pillbox.
For transmitters with maximum rated output power not listed in the table above, the
recommended separation distance d, in meters (m), can be determined using the
formula in the column for the frequency of the corresponding transmitter, where P is
the maximum rated output power of the transmitter in watts (W) as provided by the
transmitter manufacturer.
Note 1: At 80 MHz and 800 MHZ frequency points, the formula for the higher
frequency band is used
Note 2: These guidelines may not be suitable for all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
d=1.2 P
Maximum rated
output power of the
transmitter W
Separation distance corresponding to different
frequencies of the transmitter /m
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
150 MHz~80 MHz
d=1.2 P
80 MHz~800 MHz
d=2.3 P
800 MHz~2.5 GHz