YIMI Life YM201 User manual

Pulse Oximeter User Manual
Product Model:YM201/YM301
Version: 2.0
Date: 2020-07-08

1. Product Introduction and Operation Guide
1.1 Front View
Figure 1 Front View of YM201/YM301
1.2 Operation Method
A. Open the battery cover, and put the two AAA batteries into the battery compartment
in correct polarities, then replace the cover;
B. Press the bottom of the equipment and open the probe, then insert one finger into the
probe;
C. Press the button to turn the equipment on, and the measure interface will appear;
D. After about 8 seconds, the measurement result can be read directly from the display
screen;
E. Before reading the parameters, make sure that stable numbers of the pulse oximeter
interface has sustained more than 4 second;
F. The equipment will turned off automatically within 8 seconds when the finger left the
probe.
1.3 Battery Installation
A. Put the two AAA batteries into battery compartment in correct polarities (Figure2).
B. Push the batter y cover horizontally along the arrow shown as right.

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WARNINGS:
Battery polarities should be correctly installed, otherwise, damage may be caused to
the equipment.
Please remove the batteries if the equipment will not use for a long time.
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Figure 2 Battery Installation
1.4 Lanyard installation
A. Pass the thinner end of the lanyard through the hanging hole;
B. Pass the thicker end of the lanyard through the thinner end and tighten the
lanyard(Figure3).
Figure3 Lanyard Installation

1.5 Attention for Operation
A. Before use check and confirm that the people or finger size were applicable;
B. Before use check and confirm that the environment should be non- combustible
material, as well as to avoid high or low temperature and humidity, but also need to pay
attention to the following:
a) To avoid glare and direct sunlight exposure;
b) To avoid radiation infrared or ultraviolet radiation;
c) Avoid contact with the organic solvent, mist, dust, corrosive gases;
C. The equipment should not be used at a location or limb tied with arterial canal or
blood pressure cuff or receiving intravenous injection;
D. The equipment may not work normally on microcirculation barrier patients,Warm or
rub the finger, or re-position the equipment could improve the measurement.
E. The ray between photo detector and light emitting diode should across patient's
arteriole.
F. The patient should not use enamel or other makeup;
G. Avoid to insert a wet finger into the probe.
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Notes:
A. The user should fully insert the finger into the probe;
B. It is recommended to let the LED light shine directly on the nail(Figure 4);
C. Don't shake the finger and try to keep still during the measurement.

Figure4 Finger Placement Diagram
1.6 Function and menu operation
After turning on the oximeter, press and hold the power button for about 2 seconds.
The oximeter will call up the parameter setting interface and set it by pressing the
button. Defined here, long- press indicates that the button hold time reaches 1-2s,
shor t-press indicates that the button hold time is less than 0.5s.
On parameter interface 1
Move"*" to the corresponding option, and hold the button to set Alm or Beep to
on or off.
When Alm is set to on and the measured SpO2 or PR Values go beyond the upper
limit or lower limit, the oximeter gives off an alert sound.
When Alm is set to off and the measured values go beyond the limit, the Oximeter
will not give any alert sound.
When Beep is set to on, a ticking sound synchronized with the pulse is emitted

during the measurement, and when Beep is set to off, no sound is output.
While the "*" symbol stays on the Restore option, hold the button to restore
factory settings.
Press the button to select a Brightness level ranging from 1 to 5. The greater the
value, the greater the brightness of the screen.
On parameter interface 2
Press the button to switch between options. On this interface, you can set the
upper limit and lower limit of SpO2 Alm and PR Alm.
While the "*" symbol stays on the +/- option, hold the button to set the option to +
or -. In + mode, select the corresponding option and hold the button to increment
the upper or lower limit; in - mode, hold the button to decrement the upper or
lower limit.
Move "*" to the Exit option, and hold the button to return to the monitoring
interface.
Interface 1 Interface 2
Settings Settings
Alm setup * Sounds setup *
Alm on SpO2 Alm Hi 100
Beep off SpO2 Alm Lo 94
Demo off PR Alm Hi 120
Restore ok PR Alm Lo 50
Brightness 1 +/- +
Exit Exit
Figure5 The setting interfaces of the oximeter

2. Specification
2.1 Classification
Type of protection against electric shock....Ⅱ(Internally powered equipment)
Degree of protection against electric shock......................Type BF-Applied part
Operating mode .........................................................................Spot checking
Degree of protection against hazards of explosion........................................P22
2.2 Power Requirements
Specification of alkaline batteries...........................................Two AAA (LR03)
Operating current..................................................................................25-50mA
2.3 Physical Specifications
Width*Height*Depth................................................................57×30×31 mm
Weight...................................................................................28g (Bare machine)
2.4 Measurement Specifications
Spo2 declared accuracy ..................................................70%~100%: ±2digits
0% ~ 69%: unspecified
SpO2 Display Range...........................................................................30%~99%
SpO2 Resolution.............................................................................................1%
PR declared accuracy ......................................................25-250bpm: ±3digits
PR Resolution..............................................................................................1bpm

2.5 Environmental Specifications Temperature
Temperature
Operating.........................................................+50~+104°F / +10~ +40°C
Storage/Transportation.........................................-4~+140°F / -20~+60°C
Humidity
Operating.................................................................15~95%, noncondensing
Storage/Transportation............................................10~95%, noncondensing
Atmosphere Pressure
Operating.......................................................................................70~106kpa
Storage/Transportation...............................................................50~107.4kpa
2.6 Display
Display Color ................................................................................
YM201: 0.96",Yellow&Blue
YM301: 1.3",Blue
Display content: SpO2%, Pulse Rate, PI%, Bar Graph Battery Indicator,Pulse Wave
Notes:
1) The claim for oxygen saturation accuracy should be supported by clinical studies
covering the entire claimed range,The fraction of inspired oxygen (FiO2) delivered to
test subjects is varied to achieve a series of targeted steady-state saturation periods
over the specified SpO2 accuracy range (e.g. 70 % to 100 % ),then the SpO2 accuracy
is calculated by comparing SpO2 readings of the pulse oximeter to the values of
SpO2 determined with a Co- Oximeter.

2) The clinical trial included 11 subjects, including 6 males and 5 females, with an
age range of 18 to 46 years, the subjects skin color included dark black, medium
black, light color and white.
3. Maintenance, Cleaning, Disinfection
3.1 Maintenance
The equipment's design life expectancy is about 2 years, keep your equipment and
accessories free of dust and dirt, and follow these rules:
A. Please clean the equipment before use according to chapter 6.2; Remove the
batteries inside the battery cassette if the equipment will not be operated for a long
time;
B. Replace the batteries in time when the battery voltage indicate lamps were empty;
C. It is recommended that the equipment should be kept in a dry environment with no
corrosive gases and good ventilation anytime. The moisture and high-light
environments will affect its lifetime and even might damage the equipment.
D. It is best to preserve the product in a place where the temperature is between -20 to
60℃and the relative humidity is less than 95%.
E. The packed equipment can be transported by ordinary conveyance. The equipment
not be transported mixed with toxic, harmful, corrosive materials.
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WARNINGS:
No modification of this equipment is allowed.
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3.2 Cleaning
Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots
of dust and sand in your place, the equipment should be cleaned more frequently. Before
cleaning the equipment, consult your hospital's regulations for cleaning the equipment.
Recommended cleaning agents are:
a) Mild soap (diluted).
b) Ethanol (70%).
To clean your equipment, follow these rules:
a) Shut down the pulse oximeter;
b) Clean the display screen using a soft, clean cloth dampened with a glass cleaner;
c) Clean the exterior surface of the equipment and probe using a soft cloth dampened
with the cleaner;
d) Wipe off all the cleaning solution with a dry cloth after cleaning if necessary;
e) Dry your equipment in a ventilated, cool place. To avoid damage to the equipment,
follow these rules:
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CAUTIONS:
Always dilute according the manufacturer's instructions or use lowest possible
concentration.
Do not immerse part of the equipment in the liquid.
Do not pour liquid onto the equipment or accessories.
Never use abrasive materials (such as steel wool or silver polish), or erosive
cleaners (such as acetone or acetone-based cleaners).
If you spill liquid onto the equipment, contact us or your service personnel.

3.3 Disinfection
Clean the pulse oximeter before disinfecting it. The recommend disinfectant is ethanol
70%. Disinfection step are the same as cleaning.
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CAUTION
Never use ETO or formaldehyde for disinfection.
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3.4 Disposal
Dispose of the pulse oximeter in accordance with local environment and waste disposal
laws and regulations.
4. Accessories
One lanyard.
Two AAA batteries(Optional).
One user manual.
One certificate card.

5. Troubleshooting
Trouble
Possible Reason
Solution
The
equipment
can’t be
turned on.
The battery is drained away or almost
drained away.
Please replace batteries.
The battery installation is incorrect.
Install the battery over again.
The device works abnormally.
Please contact the product distributor.
The Spo2
and PR are
not
displayed
normally
The finger size is too big or small.
Select the suitable size finger to
measure.
Excessive ambient light.
Aviod the excessive ambient light
irradiation.
User's blood perfusion is very low.
Warm the finger and try again.
The display
is off
suddenly.
The equipment is set to shut down
automatically in 8 seconds when there
is no correct physiological Signals.
Normal.
The battery is almost drained away.
Replace batteries.
The Spo2
and Pulse
Rate are not
displayed
stably.
The finger is not inserted deep enough.
Replace the finger and try again.
The finger is shaking or the body is
moving.
Try to keep still.
Not used in the work environment
required by this manual.
Please use in normal working
environment.
The device works abnormally.
Please contact the product distributor.

6. Appendix A EMC
The equipment complies with the requirement of standard EN 60601-1-2:2014
“Electromagnetic Compatibility –Medical Electrical Equipment”.
1
Guidance and manufacturer´s declaration – electromagnetic emission
2
The model YM201/YM301 is intended for use in the electromagnetic environment
specified below. The customer or the user of the model YM201/YM301 should assure that
it is used in such an environment.
3
Emissions test
Compliance
Electromagnetic environment – guidance
4
RF emissions
CISPR 11
Group 1
The Model YM201/YM301 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.
5
RF emissions
CISPR 11
Class B
The Model YM201/YM301 is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
6
Harmonic
emissions
IEC 61000-3-2
Not applicable
7
Voltage
fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable

Guidance and manufacturer´s declaration – electromagnetic immunity
The Model YM201/YM301 are intended for use in the electromagnetic environment specified
below. The customer or the user of the Model YM201/YM301 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
0 % UT (100 % dip in UT )
for 0.5 cycle at 0°, 45°, 90°,
135°,180°, 225°, 270°, and
315°
N/A
N/A

input lines
IEC 61000-4-11
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°
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m, 50/60Hz
30A/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 YM201/YM301 is intended for use in the electromagnetic environment specified below.
The customer or the user of the YM201/YM301 should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted
3 Vrms 150
N/A
Portable and mobile RF communications

RF
IEC
61000-4-6
kHz to 80
MHz
6 Vrms 150
kHz to 80
MHz outside
ISM bandsa
equipment should be used no closer to any part
of the Models YM201/YM301, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Radiated RF
IEC
61000-4-3
10 V/m
80 MHz to
2.7 GHz
10 V/m
Recommended separation distance
80MHz to 800MHz
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 YM201is used exceeds
the applicable RF compliance level above, the YM201should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the YM201/YM301.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
MANUFACTURER
Shenzhen Yimi Life Technology Co.,Ltd
Add: 305, Building A, Tengbo Industrial Park, Changshangjiang street, Longbei
Village, Pingshan District,518118,Shenzhen, China
Tel: [phone]
Web: www.yimilife.com

EC REPRESENTATIVE
Shanghai International Holding corp. Gmbh(Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany
Email: [e-mail]
M-PO-Y1E 0520 EN
Certificates

PN: Finger Pulse Oximeter
Date: