Yongkang Yk-80a User manual

1

User Manual

Version：Ver 1.3

Revision date：05-2022

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, BPX800US, YK-81CEU, BPX800CA.

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 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 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.

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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

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

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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

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 by giving 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

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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

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 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

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

door.

2.Push the battery cover horizontally in the direction of the arrow at the bottom.

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.

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2, 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 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 ①Menu ②

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 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：about 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

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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

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:

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Pollution degree2:Micro-environment with non-conductive pollution,expect occasional

conductivity caused by condensation

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. A wet 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

Product Accessories

Inventory list

Quantity

The host

1 set

Lanyard

1 pcs

One user manual

1 pcs

AAA battery（optional）

2pcs

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

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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

EQUIPMENT AND SYSTEMS

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

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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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

< 5 % UT(>95 % dip in UT)

for 0.5 cycle

40 % UT(60 % dip in UT)

N/A

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IEC 61000-4-11

for 5 cycles

70 % UT(30 % dip in UT)

for 25 cycles

< 5 % UT(>95 % dip in UT)

for 5 sec

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

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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

2

0.3

28

710

704 - 787

LTE Band 13,

17

Pulse

modulation 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

modulation b)

217 Hz

2

0,3

28

1 845

1 970

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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

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

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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(15º tilted)

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

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.

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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

YONGKANG YK-80A User manual

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