yonker YK-80A Fingertip Pulse Oximeter User Manual

: June 5, 2024
: yonker

Table of Contents

yonker YK-80A Fingertip Pulse Oximeter
General Description
Intended use
Features
Operation Instructions
Classification
Maintenance and Preservation
FCC Caution
After-sales service
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

yonker YK-80A Fingertip Pulse Oximeter

General Description

Haemoglobin Saturation is the percentage between the capacity of Oxyhemoglobin (HbO2) that is compounded with oxygen and that of all combinative hemoglobin (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 hemoglobin saturation in human blood. Moreover, factors such as Automatic Organic Regulation Malfunction caused by anesthesia, trauma resulting from major operations and some medical examinations 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 and portability. It is only necessary for patient to put one finger into fingertip photoelectric sensor for diagnosis, and the display screen will directly show the 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 ：

The image in the instruction may have slight differences with the actual instruments.
Technical parameters and appearance change, without prior notice.

Product include ： main machine and SPO2 sensor.

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

Red-ray and Infrared-ray receiving diode
Red-ray and Infrared-ray transmitting diode

Precautions for use

Do not use the Fingertip Pulse Oximeter together with MRI or CT equipment.
Explosion hazard: Do not use the Fingertip Pulse Oximeter in an explosive atmosphere.
The Fingertip Pulse Oximeter is intended only as an adjunct in patient assessment. Doctors should make diagnosis in conjunction with clinical manifestation and symptoms.
Check the Fingertip Pulse Oximeter sensor application site frequently to make sure that the circulation and skin integrality of patient are under good condition.
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.
Please read the manual carefully before your operation.
The Fingertip Pulse Oximeter has no SpO2 alarm, it is not for continuous monitoring.
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.
Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid.
Significant levels of dysfunctional hemoglobins (such as carboxyl-hemoglobin or methemoglobin) may cause inaccurate reading.
Intravascular dyes such as indocyanine green or methylene blue may cause inaccurate reading.
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.
Unexpected action may cause inaccurate reading.
Medical signal with high frequency or interference caused by defibrillator may lead to inaccurate reading.
Venous pulsations may cause inaccurate reading.
It may cause inaccurate reading when the positions of sensor and blood pressure cuff are on the same arterial catheter or intravascular line.
Hypotension, severe vasoconstriction, severe anemia, or hypothermia may cause inaccurate reading.
It may cause inaccurate reading by giving use of cardiotonic to patient after his cardiac arrest or when he is in quiver.
Bright nail or painted nail may cause inaccurate SpO2 reading.
Do not use this product if you are allergic to ABS, black silicone pad and other materials.
If the performance is inconsistent with the description or changes, stop using immediately and contact the manufacturer.
Measuring function should not be used to evaluate oximeter accuracy.
The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade performance or cause other problems.
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.
The height of the oximeter should not exceed two meters.
Do not use beyond the service life of the product, otherwise the accuracy of the instrument will be affected
No modification of this equipment is allowed.
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.
Oximeter should be avoided in places with poor ventilation and high dust and lint content.
Avoid direct sunlight and strong light sources.
Oximeter cannot be serviced and maintained during use.
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.
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
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

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
Low-power consumption, continuously work for more than six hours with two AAA batteries
Low voltage indicator
In the absence of signals, the product will be in after 8 seconds to enter standby state.
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

Install two AAA batteries into battery cassette before covering its cover.
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.
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
Don’t tremble your finger when the Oximeter is working. Your body is not recommended on moving status.
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.
Read relevant datum from display screen.
The instrument has the function of sleep, no signal 8 seconds will enter standby state of sleep;
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 use the 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

According to the positive and negative identity right will be two AAA batteries into the battery
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

Put the lanyard thin end through the hole.
Put the lanyard coarser end through its already wearing thin end part and tighten.

Brief Description of Front Panel 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 only 1, 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：

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.
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.

Menu ① Menu ②

Note: If the matching refers to clamp oximeter is basic, not equipped with parameter setting function.

Detailed descriptions of product functions:

Display Type ：OLED display
SpO2 ：Measurement range：70%～100%
Accuracy ：80%～100%:±2% (Including 80%);70%～79%: ±3% ;Below 70% no requirement;
Resolution ：1%
PR：Measurement range： 30BPM～254BPM
Accuracy： ≤100BPM ,±1BPM＞100BPM ,±2BPM
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.

PI index ：measurement scope：0~20 （optional）
Power ： two AAA 1.5V alkaline batteries
Automatic standby ：the product shuts off by itself when no finger is in the product about 8 seconds
Automatic start up: every 5 s instrument will automatically detect the signal, after the hole with my finger, timely automatically boot;(optional)
Gravity sensing function: finger movement, the screen display will change with the gravity sensing changes (optional)
Dimension： 58mm×36mm×33mm
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.
Declaration： EMC of this product comply with IEC60601-1-2 standard.
This equipment has no alarm function.
Data averaging and signal processing delay the display and transmission of SpO2 data.
The date update period :＜12S
About 30min required for oximeter to warm from the minimum storage temperature between uses until it is ready for intended use
About 30min required for oximeter to cool from the maximum storage temperature between uses until it is ready for intended use
Applied parts specified: Probe and its circuit
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

Management Class for Medical Devices: Ⅱequipment
Anti-electric Shock Type: Internally powered equipment
Anti-electric Shock Degree: Type BF equipment
Overvoltage category classification:Class I
Pollution degree:
Pollution degree 2: Micro-environment with non-conductive pollution,expect occasional conductivity caused by condensation

Maintenance and Preservation

Replace the batteries timely when the low battery indicator flashes
Clean the surface of fingertip pulse oximeter before use.
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.
It would be better to preserve the product in -10~40℃ (14-104℉) and humidity is 10%-95%.
It is recommended that the product should be kept dry anytime. A wet ambience might affect its lifetime and even damage the product.
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.
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.
The oximeter can display functional arterial oxygen saturation and pulse rate after calibration.
The name of the simulator is FLUKE Index2 simulator, and the version number is 3.00.
The Blood oxygen simulator is calibrated to display functional oxygen saturation.
The maximum temperature of the contact surface between the product and human body does not exceed 41 ℃.

Waste disposal

Please follow local laws to dispose of waste scrap.
Follow local ordinances and recycling instructions regarding to disposal or recycling of the device and device components, including used batteries and packaging box

Product Accessories

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:

This device may not cause harmful interference
(2) This device must accept any interference received, including interference that may cause undesired operation.

FCC RF Radiation Exposure Statement:

This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment.

The device has been evaluated to meet general RF exposure requirements. The device can be used in portable exposure conditions without restriction.

Manufacturer’s Declaration of the EUT

Statement:

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.
Fingertip Pulse Oximeter is table-top equipment， it is suitable for medical unit and home use.
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 the oximeter ,including cables specified by the manufacturer.Otherwise, degradation of the performance of this Fingertip Pulse Oximeter could result
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.
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

EQUIPMENT AND SYSTEMS

1	Guidance and manufacturer´s declaration – electromagnetic emission
2	The Fingertip Pulse Oximeter is intended for use in the electromagnetic

IEC 61000-3-2

| N/A
7| Voltage fluctuations /

flicker emissions

IEC 61000-3-3

| N/A

Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS

G uidance 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| C ompliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact ±15 kV air| ±8 kV contac ±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
Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

| 30 A/m| 30 A/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| C ompliance 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)

Distance (m)

| I MMUNITY

TEST LEVEL

---|---|---|---|---|---|---
385| 380 -390| TETRA 400| Pulse modulation b)| 1,8| 0.3| 27
450| 430 – 470| GMRS 460, FRS 460| FMc) ±5 kHz deviation| 2| 0.3| 28
710| 704 – 787| LTE Band 13, 17| Pulse b) 217 Hz|

0,2

|

0.3

| 9
745
780

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 b) 217 Hz| 2| 0,3| 28
1 845
1 970

2 450

| 2 400- 9 570| 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.

For some services, only the uplink frequencies are included.
The carrier shall be modulated using a 50 % duty cycle square wave signal.
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

Finger is not plugged correctly
Patient’s Oxyhemoglobin value is too low to be measured

|

Retry by plugging the finger
Try more times. If you can make sure there is no problem in the product, please go to hospital timely for exact diagnosis

SpO2 or PR is shown unsteady|

The finger might not be plugged deep enough
Finger is trembling or the patient is on movement status

|

Retry by plugging the finger
Please remain at rest

---|---|---

The Oximeter can not be turned on

|

Inadequate power or power off
Batteries might be installed incorrectly
The Oximeter might be damaged

|

Please replace the batteries
Please reinstall the batteries
Please contact with local customer service centre

Indication lamps are suddenly off|

The product automatically shuts off when no signal is detected in 8 seconds
Inadequate power

|

Normal
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)

| 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

| | | 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:

If you need maintenance, please contact the manufacturer
The company can be in the form of email or other electronic files provide users with random files.
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: +86-516-87892766 -601 FAX : +86-516-87892755-606
Web site : www.yonker.cn 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:

Documents / Resources

| yonker YK-80A Fingertip Pulse Oximeter [pdf] User Manual
FPO, 2A2X3FPO, 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, Fingertip Pulse Oximeter, YK-80A Fingertip Pulse Oximeter
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