ProLinx YK-80A User manual

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User Manual
Version：Ver 1.2
Revision date：01-2021
Product name：Fingertip Pulse Oximeter
Doc.:IFU-FPO
Model：
YK-80A, YK-80B, YK-80C, YK-81A, YK-81B, YK-81C, YK-82A, YK-82B, YK-82C, YK-83A,
YK-83B, YK-83C, YK-84A, YK-84B, YK-84C.
This Fingertip Pulse Oximeter is a kind of innovated medical device with non-invasive features for
artery SPO2and PR detection. Being portable, it is able to measure SPO2and PR values quickly and
precisely.
General Description
Haemoglobin Saturation is the percentage between the capacity of Oxyhemoglobin (HbO2) that
compounded with oxygen and that of all combinativable haemoglobin (Hb) in blood. In other words,
it is the saturation of Oxyhemoglobin in blood. It is a very important physiological parameter for
Respiratory and Circulation Systems. Many respiratory diseases could reduce haemoglobin
saturation in human blood. Moreover, factors such as Automatic Organic Regulation Malfunction
caused by anaesthesia, trauma resulted from major operation and some medical examination can
also cause problems in oxygen supply, which might reduce human haemoglobin saturation. As a
result, such symptoms as megrim, vomiting and asthenia might appear to patients. Hence, it is very
important to know hemoglobin saturation of patient timely in clinical medical aspects.
The fingertip pulse oximeter features in small volume, low power consumption, convenient
operation andportability. It is onlynecessaryfor patient to put one finger into fingertip photoelectric
sensor for diagnosis, and the display screen will directly show measured value of hemoglobin
saturation. It has been proved in clinical experiments that it possesses rather high precision and
repeatability.
Intended use
The fingertip pulse oximeter can be used to measure human haemoglobin saturation and pulse rate
through finger , it can be used in hospitals, families, schools and medical centers.
User Group
-People who need blood oxygen measurement .
Contraindication：not found
Note ：
1.The image in the instruction may have slight differences with the actual instruments.
2.Technical parameters and appearance change, without prior notice.
Product include：main machine and SPO2 sensor。

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Measurement principle
The principle of the oximeter is as follows:An experience formula of data process is established by
exerting Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive
hemoglobin and oxyhemoglobin （HbO2 ) in red light and infrared light zones. Operation
principle of the instrument is to combine Photoelectric Oxyhemoglobin Inspection Technology with
Capacity Pulse Scanning and Recording Technology, so that two lights with different wavelength
(660nm red light and 940nm infrared light) can be focused onto human nail through perspective
clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element,
information acquired through which will be shown on two groups of diodes through process in
electronic circuits and microprocessor.
Diagram of Operation Principle
1. Red-ray and Infrared-ray receiving diode
2. Red-ray and Infrared-ray transmitting diode
Precautions for use
1. Do not use the Fingertip Pulse Oximeter together with MRI or CT equipment.
2. Explosion hazard: Do not use the Fingertip Pulse Oximeter in an explosive atmosphere.
3. The Fingertip Pulse Oximeter is intended only as an adjunct in patient assessment. Doctors
should make diagnosis in conjunction with clinical manifestation and symptoms.
4. Check the Fingertip Pulse Oximeter sensor application site frequently to make sure that the
circulation and skin integrality of patient are under good condition.
5. The sensor of the oximeter is not suitable for contacting the adhesive tape, which may lead to
the error of measurement data or mistaking that there are blisters on the tested skin.
6. Please read the manual carefully before your operation.
7. The Fingertip Pulse Oximeter has no SpO2 alarm, it is not for continuous monitoring.
8. When used for a long time, it will produce discomfort or tenderness, especially for patients
with microcirculation disorders.Please change the test sites periodically according to different
situations of patients.The test site must be changed and the skin integrity and circulation
condition of the patient must be checked at least every 2 hours, and the correct adjustment
must be made.
9. Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing, or
immersing the sensors in liquid.
10. Significant levels of dysfunctional hemoglobins (such as carboxyl-hemoglobin or
methemoglobin) may cause inaccurate reading.
11. Intravascular dyes such as indocyanine green or methylene blue may cause inaccurate reading.
12. SpO2 measurements may be adversely affected in the presence of high ambient light. Please
shield the sensor area (with a surgical towel or direct sunlight, for example) if it is necessary.
13. Unexpected action may cause inaccurate reading.
14. Medical signal with high frequency or interference caused by defibrillator may lead to

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inaccurate reading.
15. Venous pulsations may cause inaccurate reading.
16. It may cause inaccurate reading when the positions of sensor and blood pressure cuff are on the
same arterial catheter or intravascular line.
17. Hypotension, severe vasoconstriction, severe anemia, or hypothermia may cause inaccurate
reading.
18. It may cause inaccurate reading bygiving use of cardiotonic to patient after his cardiac arrest or
when he is in quiver.
19. Bright nail or painted nail may cause inaccurate SpO2 reading.
20. Do not use this product if you are allergic to ABS, black silicone pad and other materials.
21. If the performance is inconsistent with the description or changes, stop using immediately
and contact the manufacturer.
22. Measuring function should not be used to evaluate oximeter accuracy.
23. The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade
performance or cause other problems.
24. Please place the oximeter in a place where children, pets, etc. can not be touched, so as to
prevent falling, biting and affecting the product performance.
25. The height of the oximeter should not exceed two meters.
26. Do not use beyond the service life of the product, otherwise the accuracy of the instrument
will be affected
27. No modification of this equipment is allowed.
28. Warning：Portable RF communications equipment (including peripherals such as
antenna cables and external antennas )should be used no closer than 30cm(12 inches)to any
part of theoximeter ,including cables specified by the manufacturer.Otherwise, degradation of
the performance of this Fingertip Pulse Oximeter could result.Otherwise,degradation of the
performance of this oximeter could result.
29. Oximeter should be avoided in places with poor ventilation and high dust and lint content.
30. Avoid direct sunlight and strong light sources.
31. Oximeter cannot be serviced and maintained during use.
32. The internal structure of the Fingertip Pulse Oximeter adds magnetic rings, magnetic beads,
and conductive cloth to spray conductive paint to avoid electromagnetic interference, so as to
prevent adverse events to patients and operators due to electromagnetic interference.
33. The Fingertip Pulse Oximeter can be maintained and calibrated once every two years, and the
basic safety and basic performance of the Fingertip Pulse Oximeter have been guaranteed
34. It is necessary to change the placement position of the oximeter regularly, check the placement
position of the oximeter every 2 hours, check the impact of the oximeter on the skin, and
move the oximeter to different positions.
Features
OLED display
1. Product adopts double color OLED display，can show the six different display mode.
【If the hand movements, under the effect of gravity induction, the interface can have four
different kinds of display mode (suitable for matching gravity induction function instrument)】
2. Low-power consumption, continuously work for more than six hours with two AAA batteries
3. Low voltage indicator

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4. In the absence of signals, the product will be in after 8 seconds to enter standby state.
5. Small in volume, light in weight, and convenient to carry
【Instrument has 5s automatic signal detection function, when you insert finger, timely will
automatically start;Automatic startup function instrument (applicable to Automatic startup
function instrument)】
Operation Instructions
1. Install two AAA batteries into battery cassette before covering its cover.
2. Plug one finger into rubber hole of the Oximeter (it is best to plug the finger thoroughly) before
releasing the clamp with the nail upwards.
3. Press button on the front panel;
【Note: if equipped with automatic startup function refers to clamp oximeter, need not press
the button, the instrument has 5 s automatic signal detection function, directly inserted into
the finger, instrument is automatically switched on timely】
4. Don’t tremble your finger when the Oximeter is working. Your body is not recommended on
moving status.
5. Press the button on the front panel, if we want change display direction;
【Note: if equipped with gravity sensing function of instrument then don't press the button,
hand movements, the instrument with the gravity sensing has four corresponding
interface switch】
6. Read relevant datum from display screen.
7. The instrument has the function of sleep, no signal 8seconds will enter standby state of sleep;
8. Please replace new batteries when OLED indicates the batteries are in low power.
Note: When plugging your finger into the Oximeter, your nail surface must be upward.
Declaration: Please usethe medical alcohol to clean the rubber before each test and clean the tested
finger with alcohol before and after the test. (The rubber inside of the Oximeter adopts medical
rubber, which has no toxin, no harm, and brings no side effect such as allergy to the our skin ).
Battery installation
1.According to the positive and negative identity right will be two AAA batteries into the battery
2. In the direction of the arrow at the bottom of the level of battery back cover.
Please note: pay attention to the battery positive and negative polarity, must be installed
correctly, otherwise it may cause damage to instrument.
Lanyard installation
1, Put the lanyard thin end through the hole.
2, Put the lanyard coarser end through its already wearing thin end part and tighten。
Brief Description of Front Panel

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Keys function description: in standby mode, start the key instrument into the working state, push
down this button under working state, can change the display mode.
Note ：The instruments equipped with gravity sensing function , OLED display mode only1.
2.3.4, figure 5 and 6 are not shown
Note ：The machine profile picture only for your reference use, specific in kind prevail
Parameter setup：
Press start button（＞3s），into parameter setup .As menu ①：
1. In menu ①，When the “*” signal is shown on the “Alm Setup”, press the button（＞3s）and
enter into the menu ②. Press the button（<1s）can select item，then press button（＞3s）to set
the on/off for prompt ,beep,demo and screen brightness adjustment (optional "1" ," 2 "," 3 "and" 4 ").
When the “*” signal is shown on the “Restore”,press the button（＞3s）and all the settings are
back to the factory settings.
Attention
Using devices outdoors or under strong light, please adjust the screen brightness to a higher
proper level for observation.
It’s better for user to choose a lower brightness to conserve battery power.
2. In menu ②，When the “*”signal is shown on the “Sounds Setup”, press the
button（＞3s）and enter into the menu ②,Press the button（<1s）can select item ,then press the
button（＞3s）to setup data.choose “+”or“-” to plus or minus values.
OLED display:
start/mode key
OLED display modes：
Battery cover

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Menu ①Menu②
Note: If the matching refers to clamp oximeter is basic, not equipped with parameter setting
function
Detailed descriptions of product functions:
1. Display Type：OLED display
2. SpO2：Measurement range：70%～100%
Accuracy：80%～100%:±2% (Including 80%);
70%～79%: ±3% ;
Below 70% no requirement;
Resolution：1%
3. PR：Measurement range：30BPM～254BPM
Accuracy：≤100BPM ,±1BPM
＞100BPM ,±2BPM
4. Parameters of LED probe
wavelength
radiation power
RED
660±5nm
1.8mW
IR
940±10nm
2.0mW
This parameter can be especially useful to clinicians.
5. PI index：measurement scope：0~20 （optional）
6. Power：two AAA 1.5V alkaline batteries
7. Automatic standby：the product shuts off by itself when no finger is in the product about 8
seconds
8. Automatic start up: every 5 s instrument will automatically detect the signal, after the hole with
my finger, timely automatically boot;(optional)
9. Gravity sensing function: finger movement, the screen display will change with the gravity
sensing changes (optional)
10. Dimension：58mm×36mm×33mm
11. Operation environment:
Temperature: 5 ℃~ 40 ℃
Humidity: 15% ~ 80%,no condensing
Atmospheric pressure: 70kPa ~ 106kPa
Transport, storage environment:
Temperature: -10 ℃~ 40 ℃
Humidity: 10%~ 95%,no condensing
Atmospheric pressure: 70kPa ~ 106kPa, non-corrosive gas and well-ventilated
environment.
12. Declaration：EMC of this product comply with IEC60601-1-2 standard.
13. This equipment has no alarm function.
14. Data averaging and signal processing delay the display and transmission of SpO2 data.
The date update period :＜12S
15. About 30min required for oximeter to warm from the minimum storage temperature between
uses until it is ready for intended use

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16. About 30min required for oximeter to cool from the maximum storage temperature between
uses until it is ready for intended use
17. Applied parts specified: Probe and its circuit
18. Use specification
Expected medical instructions
The fingertip pulse oximeter can be used to
measure human haemoglobin saturation and
pulse rate through finger
Expected patient population
-People who need blood oxygen measurement .
Expected use or interaction with body parts
tissue type
Finger
Expected user profile
People who need blood oxygen measurement ,
doctors, etc
Application environment
Avoid electromagnetic interference
Extreme temperature
Avoid pollution and dust
Avoid direct sunlight, etc
Operating principle
Operation principle of the instrument is to
combine Photoelectric Oxyhemoglobin
Inspection Technology with Capacity Pulse
Scanning and Recording Technology, so that
two lights with different wavelength (660nm
glow and 940nm near infrared light) can be
focused onto human nail through perspective
clamp finger-type sensor. Then measured signal
can be obtained by a photosensitive element,
information acquired through which will be
shown on two groups of diodes through process
in electronic circuits and microprocessor.
Classification
1. Management Class for Medical Devices: Ⅱequipment
2. Anti-electric Shock Type: Internally powered equipment
3. Anti-electric Shock Degree: Type BF equipment
4. Overvoltage category classification:Class I
5. Pollution degree:
Pollution degree2:Micro-environment with non-conductive pollution,expect occasional
conductivity caused by condensation

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Maintenance and Preservation
1. Replace the batteries timely when the low battery indicator flashes
2. Clean the surface of fingertip pulse oximeter before use.
3. Remove the batteries when the oximeter is not likely to be used for some time when leakage
from batteries would result in an unacceptable risk.
4. It would be better to preserve the product in -10~40℃(14-104℉) and humidity is 10%-95%.
5. It is recommended that the product should be kept dry anytime. Awet ambience might affect its
lifetime and even damage the product.
6. Cleaning frequency
If the oximeter is dirty when used at home, it is recommended to clean the enclosure and
silicone pad after each use.If the oximeter is not dirty, simply clean the black silicone pad
before and after each use.
When used in a medical institutions, clean it after each use.
7. Cleaning method
When the oximeter is used at home, wipe and disinfect with 75% alcohol, then dry naturally or
clean the product with dry cloth. Clean at least twice a week.
When using in medical institutions, clean the tested finger with 75% alcohol before use. After
each measurement, wipe and disinfect the contact part between black silicone and enclosure
with 75% alcohol.
8. The oximeter can display functional arterial oxygen saturation and pulse rate after calibration.
9. The name of the simulator is FLUKE Index2 simulator, and the version number is 3.00.
10. The Blood oxygen simulator is calibrated to display functional oxygen saturation.
11. The maximum temperature of the contact surface between the product and human body does
not exceed 41 ℃.
Waste disposal
1.Please follow local laws to dispose of waste scrap.
2. Follow local ordinances and recycling instructions regarding to disposal or recycling of the
device and device components, including used batteries and packaging box
ProductAccessories
Inventory list
Quantity
The host
1 set
Lanyard
1 pcs
One user manual
1 pcs
AAA battery（optional）
2pcs
FCC Caution:
Any Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the 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

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(2) This device must accept any interference received, including interference that may cause
undesired operation.
FCC RF Radiation Exposure Statement:
1. This Transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter.
2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled
environment.
The device has been evaluated to meet general RF exposure requirement. The device can be used
in portable exposure condition without restriction.
Manufacturer’s Declaration of the EUT
Statement:
1. The Fingertip Pulse Oximeter or user should use the product in the electromagnetic
environment specified in the following table, otherwise it may cause abnormal operation of the
product.
2. Fingertip Pulse Oximeter is a table-top equipment，it suitable for medical unit and home use.
3. Warning：Portable RF communications equipment (including peripherals such as
antenna cables and external antennas )should be used no closer than 30cm(12 inches)to any part
of theoximeter ,including cables specified by the manufacturer.Otherwise, degradation of the
performance of this Fingertip Pulse Oximeter could result
4. Warning: Use of this Fingertip Pulse Oximeter adjacent to or stacked with other equipment
should be avoided because it could result in improper observed to verify that they are operating
normally.
5 .Warning：Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in impropre operation.
Guidance and manufacturer´s declaration –electromagnetic emission –for all
EQUIPMENTAND SYSTEMS
1
Guidance and manufacturer´s declaration –electromagnetic emission
2
The Fingertip Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of Fingertip Pulse
Oximeter should assure that it is used in such an environment.
3
Emissions test
Compliance
4
RF emissions
CISPR 11
Group 1
5
RF emissions
CISPR 11
Class B
6
Harmonic emissions
IEC 61000-3-2
N/A
7
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
N/A

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Guidance and manufacturer's declaration –electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fingertip Pulse Oximeter is intended for use in the electromagnetic environment specified
below. The customer or the user of the Fingertip Pulse Oximeter should assure that it is used in
such an environment.
Immunity test
EN 60601
test level
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15kV air
Electrostatic
transient / burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lnes
N/A
Surge
IEC 61000-4-5
± 1 kV differential mode
±2 kV common mode
N/A
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
< 5 % UT(>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
< 5 % UT(>95 % dip in UT)
for 5 sec
N/A

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Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30A/m
Guidance and manufacturer´s declaration –electromagnetic immunity –
for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
Guidance and manufacturer´s declaration –electromagnetic immunity
The Fingertip Pulse Oximeter is intended for use in the electromagnetic environment
specified below. The customer or the user of the Fingertip Pulse Oximeter should assure that
it is used in such an environment.
Immunity test
EN 60601 test level
Compliance level
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
N/A
Table 9 - Test specifications for enclosure port immunity to RF wireless
communications equipment
Test
frequency
(MHz)
Banda)
(MHz)
Servicea)
Modulation b)
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST
LEVEL
(V/m)
385
380 -390
TETRA 400
Pulse
modulation b)
18 Hz
1,8
0.3
27
450
430 - 470
GMRS 460,
FRS 460
FMc) ±5 kHz
deviation
1 kHz sine
2
0.3
28
710
704 - 787
LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2
0.3
9
745
780

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810
800 - 960
GSM 800/900.
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
870
930
1 720
1 700-1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3
4, 25; UMTS
Pulse
modulation b)
217 Hz
2
0,3
28
1 845
1 970
2 450
2 400-9570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2
0,3
28
5 240
5 100-5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2
0.3
9
5 500
5 785
NOTE:
If necessary to achieve the immunity test level, the distance between the transmitting antenna and the
me
equipment or me system may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it
does not represent actual modulation, it would be worst case.
Possible Problems and Resolutions
Problem
Possible reason
Solution
SpO2 or PR can not
be shown normally
1. Finger is not plugged
correctly
2.Patient’s Oxyhemoglobin
value is too low to be measured
1. Retry by plugging the finger
2. Try more times. If you can make
sure there is no problem in the
product, please go to hospital timely
for exact diagnosis

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SpO2 or PR is shown
unsteady
1. The finger might not be
plugged deep enough
2. Finger is trembling or the
patient is on movement status
1. Retry by plugging the finger
2. Please remain at rest
The Oximeter can
not be turned on
1. Inadequate power or power
off
2. Batteries might be installed
incorrectly
3. The Oximeter might be
damaged
1. Please replace the batteries
2. Please reinstall the batteries
3. Please contact with local
customer service centre
Indication lamps are
suddenly off
1. The product automatically
shuts off when no signal is
detected in 8 seconds
2. Inadequate power
1. Normal
2. Replace the batteries
Symbols and Definitions
BF type application part
Serial number
To protect the environment, dispose
of empty
batteries at appropriate collection
sites according
to national or local regulations.
Date of manufacture
Reference manual
Manufacturer
Cautions
European union
representative
IP22
First characteristic numeral 2:
Against ingress of solid foreign
objects:≥12.5mm diameter
Second characteristic numeral 2
Against ingress of water with
harmful effects:dripping(15ºtilted)
Standby
Humidity range
Temperature range
Keep dry
Avoid sunlight
Product certification
Up toward
Lot number
This device has no alarm
function
signal inadequacy
①Indication of probe faults
(open circuit condition or
close circuit condition)
②Indication of Probe cable

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faults
③Indication of Probe cable
extender faults
Reserves the right to technical change appearance, our products are subject to change
without prior notice, please forgive me!
Statement:
1, If you need maintenance, please contact the manufacturer
2, The company can be in the form of email or other electronic files provide users with random
files.
3, The instrument is not used for evaluation of blood oxygen probe pulse and pulse blood oxygen
monitor accuracy.
After-sales service
Ensure that users
● Please read user manual before using the instrument;
● According to the requirement of the instruction manual for the operation and daily maintenance,
and make sure the machine power supply, and environmental requirements
Maintenance regulations
●To conform to the regulations, free maintenance within the scope of products, with warranty card
for free maintenance.All that is beyond the scope of free maintenance product, provide paid
services.
● With warranty card and shopping invoice,main machine for a year, accessories for three months
are under free maintenance services from the date of purchase.
● Following does not belong to the scope of free maintenance
☞The fault caused by human factors, the damage;
☞Due to the use to be inconsistent with the provisions of our company work environment to
cause damage;
☞Due to the product in the our company authorized personnel disassembling or repairing
damaged;
☞Products beyond the warranty period.
Maintenance Time
● If any problem，please call us in 9：00 am to 5：30 pm from Monday to Friday(except national
holiday),call us：400-828-6667
Company information
Using life：5 years
TEL: [phone] -601 FAX: [phone]-606
Web site：www.yonker.cn

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Date：see product label
Xuzhou Yongkang Electronic Science Technology Co., Ltd
1st&2nd Floor,6#01,6#02,No.6 Building 1st Phase Economic Development Manufacturing
Zone,LIANDO U Valley, No.6 Leye Road ,Xuzhou ETDZ,221000 Xuzhou,PEOPLE'S
REPUBLIC OF CHINA
The authorized representative of European Union: