Yuwell YX3 Series User manual

730600-0A
All specifications and product configurations are subject to
change without notification.
Fingertip Pulse Oximeter
Please read the user's manual closely before using!
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
Sales Center Address: Huanyuan East Road No.1, Xuzhuang
Software Park, Nanjing, Jiangsu Province, P.R. China, 210000
Manufacturing Address: YunYang Industrial Park, DanYang,
Jiangsu Province, P.R. China, 212300
http://www.yuwell.com
General Description
03 04
Haemoglobin saturation is percentage of Oxyhemoglobin (HbO2) capacity, compounded with oxygen, by all
combinativable haemoglobin (Hb) Oxyhemoglobin (Hbo2) capacity in blood. In other words, it is
consistence of Oxyhemoglobin in blood. It is a very important ecological parameter for Respiratory
circulation System. Many respiratory diseases can result in haemoglobin Saturation being lowered in
human blood. Moreover, the following factors can also lead to problems in oxygen supply, so that human
haemoglobin saturation might be reduced: Automatic Organic Regulation Malfunction caused by
Measurement Principle
Principle of the Oximeter is as follows: An experience formula of data process is established taking use of
Lambert Beer law according to Spectrum Absorption Characteristics of Reductive hemoglobin (R Hb) and
Oxyhemoglobin (O2 Hb) in glow and near-infrared zones. Operation principle of the instrument is
Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse
Scanning and Recording Technology, so that two beams of different wavelength of light (660nm glow and
940nm near infrared light) can be focused onto human nail tip through perspective clamp finger-type
9.Warning, The water protection grade of device is IPX 1.
10.Warning，Please take out the batteries and do not burn or bury if the product is scrapped or
discarded.
11.Warning, Device conforms to the requirement of RoHS directive.
12.Warning, Device application component materials are certified for biological compatibility.
13.Warning, A low battery remind please replace the battery after use.
14.Warning, Nail polish will affect measurement accuracy.
YX3 Series(YX300、YX301、YX302)
Anesthesia, intensive Postoperative Trauma, hurts resulted in by some medical examination and etc. In the
situation, illnesses, such as light head, asthenia, vomitory and etc, might happen to patients and even
endanger the patient’s life. Therefore, it is very important to know Hemoglobin saturation of patient timely
in clinical medical aspects. So that doctors can find problems in times.
The fingertip pulse oximeter features in small volume, low power consumption, convenient operation and
being portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor
for diagnosis, and a display screen will directly show measured value of hemoglobin Saturation. It has been
proved in clinical experiments that it features in rather high precise and repeatability.
European Representative:
Name: Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone]
Fax: [phone]
Notified Bodies:

Warning
1.Warning, Do not modify this equipment without authorization of manufacture.
2.Warning, The device has no Alarm System.
3.Warning，As far as possible away from the wet medical equipment such as drip or other similar liquid
simulation.
4.Warning，Do not use the oximeter for more than 30 minutes without relocation the device to another
finger, long term clip on the finger may lead to hand acid.
5.Warning，Except replacing batteries, devices do not require routine maintenance and calibration,
etc. Daily measure ten times, ten minutes every time, devices can be used for five years.
6.Warning，The pulse oximeter simulation can not be used to verify the accuracy of the calibration of
the production.
7.Warning，Alkaline battery of long service life is recommended and do not use rechargeable batteries
and battery reverse error operation will lead to the normal operation of the boot. Please follow local
disposal and recycling laws for the oximeter and its components, including the battery.
8.Warning，With the increasing number of radio devices or other noise sources from electric
equipments in health care departments , our product may be interrupted when working because of
their interference. The closer distance between each other or the more powerful sources, the more
serious interference. The electromagnetic interference sources in health care departments may
include:
(1).Electronic surgical instruments (2).Mobile Phones (3).Automotive two-way wireless
communications equipment (4).Electronic apparatus (5).High-definition television
In this interference, the measurement values may deviate, or it does not work. When interfered, the
product may produce abnormal performances: unstable reading values, outages or other functions of
error. If such a case, the use of the site should be checked to identify interference and the elimination
of the following measures:
(1)The vicinity of the equipment shut down and then re-opens in order to identify interference
equipment;
(2)To change the direction of interference with equipment or location;
(3)To increase the distance between the product and interference sources.
Red and Infrared- ray
Emission Tube
Red and Infrared-ray
Receipt Tube
Figure 1: Work Principle
01 02
05 06
sensor. Then measured signal can be obtained
by a photosensitive element, information
acquired through which will be shown on two
groups of LEDsthrough process in electronic
circuits and microprocessor.
Symbol Definitions Symbol Definitions
Type BF applied part
Batteries and electronic instruments must
be disposed of In accordance with the
locally applicable regulations , not with
domestic waste
This Pulse Oximeter is protected against
harmful effects of dripping water per
IEC60529
IPX1
Power button
Manufacturer The device has no Alarm System
Date of effective use of the product
Temperature for transportation and
storage
%SpO2The Pulse Oxygen Saturation(%) Recycle
Humidity for transportation and storage
Atmospheric pressure for transportation
and storage
Equipment Symbols and explain
Symbol Definitions Symbol Definitions
Serial Number
Consult the manual
Caution, consult accompanying
documents
This item is compliant with Medical
Device Directive 93/42/EEC

Product Properties
Figure 5: Testing sketch diagram
1.Operation of the product is simple and convenient.
2.The product is small in size, light in weight (total weight is about 54g including batteries) and portable.
3.The power of two AAA batteries can last for 45 hours.
4.Low voltage warning will be indicated in visual window when battery voltage is too low than normal
operation of the oximeter might be influenced.
5.The product will automatically shut down when there is no finger entering for eight seconds.
07 08
11 12
Display
Product Operation Scope
The fingertip Oximeter can be used to measure human Haemoglobin Saturation and heart rate through
finger, the product is suitable forfamily, hospital (including clinical use in internist/surgery, Anaesthesia,
paediatrics, intensive sports (It can be used before or aftersport. Operation in sport is not recommended)
and etc.
The product is not suitable to monitor patient continuously.
Product Operation Scope
1.Installing two AAA batteries into battery cassette before closing the cover.
2.Nip the clamp as diagram.
3.Plug one finger into rubber hole of the Oximeter (it is best to plug the finger
thoroughly) before releasing the clamp.
4.Press the switch button one time on the front panel.
5.Do not tremble while the oximeter is working. It's better that the whole
body be in silent status.
6.Read corresponding data form display screen.
Product scope of application
Contraindications: None.
Intended Use: The Fingertip Pulse Oximete is a kind of non-invasive detection adults and children spo2
and heart-rate detection of medical instrument which is expected for home and hospital inspection.
Applicable People：Normal adults and children，Vascular disease crowd，The respiratory system
disease crowd，Middle-aged and old old man over the age of 60，athlete.
Figure 2 Button mode
Symbol of Oxygen saturation
Battery level
Pulse strength Pulse rate Pulse rate
Pulse volume
wave Pulse volume wave
Oxygen
saturation Oxygen
saturation
99 75
SpO
2
%PRbpm
Symbol of Oxygen saturation
Pulsestrength
Figure 3 Gravity sensing mode
Battery level
Symbol of PRSymbol of PR
Symbol of Gravity
sensing mode
99 75
SpO
2
%PRbpm
Technical Parameters
1.Display Type: OLED
SPO2 Measurement rang: 70-100%, Accuracy: ±2%, Pulse Rate Measure rang: 25-250BPM/min,
Accuracy:±1BPM or±1% (larger)
2.Power: Two AAA 1.5V alkaline Batteries, Voltage range: 2.6-3.6V
3.Working Current: Less than 30mA.
4.Measurement accuracy:
Figure 4 Wave wrong mode
OLED display wrong mode when finger out or product failure.
Wrong Mode Display
SpO
2
%
PRbpm
acquired through which will be shown on screen through treatment in electronic circuits and
microprocessor.
The pulse oximeter is intended for use in hospital, clinical institution, healthcare community
1) data averaging and other signal processing
2) the data update period

1.Put the two AAA batteries into battery cassette in right polarities.
2.Pull the battery cover horizontally.
Notes: Battery polarities must be correctly installed .Otherwise, damage might occur to device.
Please put or remove batteries in right order, or it willdamage the device bracket.
Please remove the battery if the oximeter will not be used for long time.
3.Install as the figures show. (SeeFigure 6~9)
Battery Installation
09 10
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Figure 6: Along the direction of the arrow to open the battery cover Figure 7: Open the battery cover
Figure8: Close the battery cover Figure 9: Along the direction of the narrow to Close the battery cover
1.Thread thinner end of the lanyard through the hanging hole.
2.Thread thicker end of the lanyard through the threaded end before pulling it tightly.
3.Install as the figures show. (See Figure 10, 11, 12)
Lanyard installation
Spo2 Accuracy: ±2% in the range of 70%-99%of Spo2
No definition for Spo2 under70%, Pulse rate:±1% or ±1BPM/min( larger)
5.Measurement Performance in Low Perfusion Condition: Correct Spo2, and pulse rate can be displayed
when the simulation pulse wave amplitude is at 6%.
6.Anti-interference ability of ambient light: Deviation in blood oxygen content is less than ± 1% when
measured under indoor nature light / existinglighting and measuredin the dark room.
7.The product will automatically shut down when there is no finger entering for eight seconds.
8.Dimension: 58mm*32mm*34mm(LWH), Weight: 54g approximately(including two AAA batteries).
9.Working Environments:
Ambient Temperature: 5~40℃, Relative humidity: <80％, Atmospheric pressure: 860hPa~1060hPa.
Transportation And Storage Environments :-40℃～55℃(OLED Use: -20℃～+55℃),
Relative humidity: <93％, Atmospheric pressure: 500hPa~1060hPa.
10.Operation mode: Continue operation.
11.Patient population：The personal application are adult patient(weight:>30kg) and pediatric patients
(weight:20~30kg).We recommend index finger, middle finger and ring finger are suitable position for
monitor. The pulse oximeter is NOT design for newborn and infant.
For adults, it recommended that the finger thickness should between 8-25.4mm. The probe is the hole in
the middle of the equipment to which the finger insert. The device is intended for spot-checking or
attended-care monitoring.
12.Peak wavelengths and light output power：
The wavelength range of Red light is from 619nm to 659 nm and the luminous intensity is 27 mcd.
The wavelength range of Infrared light is from 895nm to 989 nm and the luminous intensity is 0.6 mW/sr
(20mA).
13.Transmitted SpO2 and Pulse rate data value：
Principle of the oximeter is as follows: An experience formula of data process is established taking use of
Lambert Beer Law according to Spectrum Absorption Characteristic of Reductive hemoglobin(Hb) and
oxyhemoglobin(Hb02) in glow & near-infrared zones. Operation Principle of the device is: Photoelectric
Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning Recording
Technology, So that two beams of different wavelength of lights by a photosensitive element, information

Maintenance and Storage
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Figure 11 Figure 12Figure 10
Clean the surface of the fingertip oximeter before it is used in diagnosis for patients.
The most commonly used hospital cleaning and non-corrosive liquid detergent can be used to clear
the oximeter. Pay attention to diluting cleaning detergent cleaning before use, by following the
manufacturer's instructions.
Avoid the use of ethanol-based, amino-or acetone-based cleaning agent.
Oximeter shell should be maintained from dust pollution, using a soft cloth or lint-free cleaning agent
with the sponge to wipe infiltration. Make sure no liquid inside the equipment.
Avoid the use of metals such as steel wire brush or polishing agent abrasive material which will
damage the oximeter panel .
Under normal conditions there in no need for special protection and maintenance when using, please
pay attention to the following points:
Using oximeter in required environment.
Avoid direct sunlight exposure.
Avoid extreme infrared radiation or ultraviolet radiation.
Avoid organic solvent vapors, dust, and corrosive gas exposure.
Warning: Do not put oximeter in disinfection or in liquid.
Please remove the battery if the oximeter will not be used for long time.
Transportation and storage conditions：
Temperature range: -20℃～+55℃ Relative humidity: ≤93％, no condensation
Atmosphere pressure: 500hPa～1060hPa
Possible cases and solutions
Warning:
Oximeter cover can only be opened by a professional maintenance staff. No internal parts require
opening by end users.
If you are not sure about the measurement precision, please use other methods to check patient's
pulse, to determine whether oximeter works.
Note: Do not splash, dump any liquid into the oximeter and attachments, switch and connections
which may damage the oximeter.
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1. Normal
2. Replace the batteries
1. The product is automatically powered
off when no signal is detected longer
than 8 seconds
2. Finger quantity of the batteries is start
being inadequate
Indication
lamp are
suddenly
off
Problems Possible reason Solution
3. Nail polish or paste Manicure
1. Do not put finger correctly
2. Try some more times, if you can make sure about no problem exiting
in the product, please go to a hospital timely for exact diagnosis
3. When measuring the nail polish remover or discharge Manicure
2. Patient Oxyhemoglobin value is too
low to be measured
1. Try again
SPO2 or PR
can not be
shown
normally
1. Retry by plugging the finger
2. Try not to move
2. Finger is trembling or patients body is in
movement status
1. Please replace batteries
2. Please reinstall the batteries
SPO2 or PR
is shown
unstably
1. Finger might not be plugged deep
enough
1. Power of batteries might be inadequate
or not be there at all
2. Batteries might be installed incorrectly
3. The Oxyhemoglobin might be damage 3. Please contact with local customer service center
The
Oxyhemog
lobin can
not be
power on

Cleaning and disinfecting
It is recommended that the product should be kept in a dry environment anytime. Moisture might affect
its lifetime and even might damage the product.
Electrical schematics and component list is only available to the professional manufacturer or
qualified repair station personnel.
Do not use the new batteries with the old ones. Alkaline battery of long service life is recommended,
and do not use rechargeable batteries. Batteries must be disposed of in accordance with the locally
applicable regulations, not with domestic waste. Batteries must be disposed of in accordance with the
locally applicable regulations, not with domestic waste.
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Cleaning
The recommended cleaning agents include: water
1. Shut down the pulse oximeter and remove the battery.
2. Clean the oximeter with cotton or soft cloth moistened with water.
3. After cleaning, wipe off the water with a soft cloth.
4. Allow the oximeter to air dry
Disinfecting
The recommended disinfectants include: ethanol 70%, is oppropanol 70%
1. Shut down the pulse oximeter and remove the battery.
2. Clean the oximeter as instructed above
3. Disinfect the oximeter with cotton or soft cloth moistened with one of the recommended disinfectants.
4. After disinfection, be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with
water.
5. Allow the oximeter to air dry.
4. The sensor component is not cleaned and disinfected during testing.
Warning:
1. Never immerse or soak the oximeter.
2. We recommend that the oximeter be cleaned and disinfected after use every time or determined by
your hospital’s policy, to avoid long term damage to the oximeter.
3. Never use cleaning agents/disinfectants other than the recommended.
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As a result of radio frequency transmission devices and noise of electrical source, the machine may
stopworking, interfered by strong radio frequency, or because of close distance. Medical places may have
thefollowing EMI pollution sources:
1. Electronic surgical instruments
2. Mobile phones
3. Automotive two-way wireless communications equipment
4. Electronic apparatus
5. High-definition television
In the designed oxygen using environment, EMI may make the pulse not obvious. In this interference,
themeasurement values may become too large, or oximeter does not work. Performance under
interference:unstable reading, interruption, other function errors. As to the above mentioned cases, please
check theplaces to find out the interferences, and take the following measures:
1. Turn off the nearby equipment, and restart, to find out interference equipment.
2. Change the direction and location of interference equipment.
Electromagnetic interference
Guidance and manufacture’s declaration – electromagnetic emissions
The [Finger Pulse OximeterYX300, YX301, YX302] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [Finger Pulse Oximeter YX300, YX301, YX302] should assure
that it is used in such an environment.
Emissions test
RF emissions
CLSPR 11
RF emissions
CLSPR 11
Compliance
Group 1
Class B
Electromagnetic environment - guidance
The [Finger Pulse Oximeter YX300, YX301, YX302] uses RF energy
only forits internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic equipment.
The [Finger Pulse Oximeter YX300, YX301, YX302] is suitable for use in
all establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
3. Keep a distance between our equipment and interference equipment.
Oximeter and radiation generates radio frequency energy and if we do not press the "Manual" use, mayalso
be other devices in the vicinity of harmful interference.
Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all ME
EQUIPMENT and ME SYSTEMS

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Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC IMMUNITY – for all ME
EQUIPMENT and ME SYSTEMS
The [Finger Pulse Oximeter YX300, YX301, YX302] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [Finger Pulse Oximeter YX300, YX301, YX302] should assure
that it is used in such an environment.
IMMUNITY test IEC60601 test level Compliance level Electromagnetic environment - guidance
±6KV contact
±8KV air ±6KV contact
±8KV air
Floors should be wood, oncrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Power frequency
(50/60Hz)
magnetic field C
3A/m 3A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital
environment.
Electrostatic
discharge(ESD)
IEC61000-4-2
Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC IMMUNITY – for ME
EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
IMMUNITY test IEC60601 test level Compliance level Electromagnetic environment - guidance
3V/m
80MHz to 2.5GHz 3V/m
Radiated RF
IEC61000-4-3
The [Finger Pulse Oximeter YX300, YX301, YX302] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [Finger Pulse Oximeter YX300, YX301, YX302] should
assure that it is used in such an environment.
Guidance and manufacture’s declaration – electromagnetic immunity
Portable and mobile RF communications
equipment should be used no closer to any part of
the [Finger Pulse OximeterYX300, YX301,
YX302] including cabled, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter
Recommended separation distance
d = 1.2 x square root (P), 80MHz to 800 MHz
d = 2.3 x square root (P), 800MHz to 2.5GHz

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Thank you very much for using our products.
Product name: Fingertip pulse oximeter Model: YX300, YX301, YX302
Please reserve the warranty card carefully.
S/N: MFG.DATE:
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Sales Center Address: Huanyuan East Road No.1, Xuzhuang Software Park, Nanjing, Jiangsu
Province, P.R. China, 210000
Manufacturing Address: YunYang Industrial Park, DanYang, Jiangsu Province, P.R. China, 212300
http://www.yuwell.com
Warranty Card
1. Fingertip Pulse Oximeter: 1pc
2. Lanyard: 1pc
3. AAA batteries: 2pcs
4. User's Manual, Warranty card: 1pc
Of waste, waste handling should be consistent with the corresponding national laws and regulations.
Waste, residue from processing
NOTE1 At 80MHz and 800MHz the higher frequency range applies
NOT2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.