ProLinx YK-80B User manual

1. Infrared-ray receiving tube
2. Infrared-ray transmitting tube
Operation Instructions
Battery installation
User Manual
Fingertip Pulse Oximeter
General Description
Measurement principle
Features
Scope of application / Intended use
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Brief Description of Front Panel
Diagram of Operation Principle
OLED display:
Power button / Mode switch
OLED display:
Battery cover
OLED display modes：
1. 2.
3. 4.
5. 6.
Precautions for use
This manual is written in accordance with the council directive MDD93/42/EEC
for medical device and harmonized standards.
English
Ver 1.0
This Fingertip Pulse Oximeter is a kind of innovated medical device with
non-invasive and continuous features for artery SPO2 and PR detection.
Being portable, it is able to measure SPO2 and PR values quickly and
precisely.
Haemoglobin Saturation is the percentage between the capacity of
Oxyhemoglobin (HbO2) that compounded with oxygen and that of all
combinativable haemoglobin (Hb) obin (HbO2) 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.
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(R Hb) and
oxyhemoglobin (O2 Hb) in glow and near-infrared 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 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 LEDs through process in electronic
circuits and microprocessor.
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.Do not stretch the adhesive tape while applying the Fingertip Pulse
Oximeter sensor. This may cause inaccurate reading or skin blisters.
6.Please read the manual carefully before your operation.
7.The Fingertip Pulse Oximeter has no SpO2 prompt, it is not for
continuous monitoring.
8.Prolonged use or the patient’s condition may require changing the
sensor site periodically. Change sensor site and check skin integrality,
circulatory status, and correct alignment at least every 2 hours.
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 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.
Follow local ordinances and recycling instructions regarding to disposal
or recycling of the device and device components, including batteries.
Hang rope installation
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.
contraindication：not found
Product include：main machine and SPO2 sensor。
note：1.The image in the instruction may have slight differences with
the actual instruments。
2.Technical parameters and appearance change, without prior notice。
OLED display
Product adopts double color OLED display，can show the six different
display mode
★If the hand movements, under the effect of accelerometer, the
interface can have four different kinds of display mode (suitable for
matching accelerometer 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)
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 accelerometer function of instrument then don't
press the button, hand movements, the instrument with the accelerometer
has four corresponding interface switch)
6.Read relevant datum from display screen.
7. The instrument has the function of sleep, no signal will enter standby
state of sleep;
8.Please replace new batteries when OLED indicates the batteries are
in low power.
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 ).
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.
1, Put the rope thin end through the hole.
2, Put the rope coarser end through its already wearing thin end part and
tighten。

Detailed descriptions of product functions:
Guidance and manufacture’s declaration-electromagnetic
radiation-for other EQUIPMENTS and SYSTEMS
Classification
1.Management Class for Medical Devices: Ⅱequipment
2.Anti-electric Shock Type: Internally powered equipment
3.Anti-electric Shock Degree: Type BF equipment
1.One hang lace
2.One user manual
1.Replace the batteries timely when low voltage lamp is on.
2.Clean the surface of fingertip pulse oximeter before it is used to
diagnose patients.
3.Remove the batteries inside if you will not operate the Oximeter
for a long time.
4.It would be better to preserve the product in -10~40℃(14-104℉)
and humidity is 10%-80%.
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.Please follow the law of the local government to deal with used batteries.
Maintenance and Preservation
Product Accessories
Xuzhou Yongkang Electronic Science Technology Co., Ltd
4F Building C8 , 40 Jingshan Road , Economic and
Technological Development Zone,
221000 Xuzhou , PEOPLE’S REPUBLIC OF CHINA
MDL MEDICAL
2 Route de Californie - 07100 Annonay - France
Juin 2020
Model: YK-80B
ENSM81202006043/19102910.000/3.09.03.0093
IP22
Settings
Alm Setup
Alm off
off
off
OK
3
Beep
Demo
Restore
Brightness
Exit
*
Settings
Spo2 Alm Hi
Sounds Setup
Spo2 Alm Lo
PR Alm Hi
PR Alm Lo
+/- Exit
100
85
130
50
+
*
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：instruments equipped with accelerometer function , OLED
display mode only1. 2.3.4, no large font interface according to 5.6
note：The machine profile picture only for your reference use, specific
in kind prevail
Menu 1 Menu 2
wavelength
660±2nm
905±10nm
radiation power
1.8mW
2.0mW
RED
IR
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 alarm ,beep,de-
mo 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.
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.
Attention:
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.
Note: If the matching refers to clamp oximeter is basic, not equipped with
parameter setting function
1.Display Type：OLED display
2.SpO2：Measurement range：70%～99%
Accuracy：80%～99%:±2% (Including 80%);
70%～79%: ±3% ; Below 70% no requirement;
Resolution：1%
3.PR：Measurement range：30BPM～240BPM
Accuracy：±1BPM or ±1%（the larger one）
4.Parameters of LED probe
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 startup: every 5 s instrument will automatically detect the signal,
after the hole with my finger, timely automatically boot;(optional)
9. Accelerometer function: finger movement, the screen display will change
with the accelerometer changes (optional)
10. Dimension：58mm×36mm×33mm
11. Operation environment:
temperature: 5 ℃~ 40 ℃
Humidity: 15% ~ 80%
Atmospheric pressure: 86kPa ~ 106kPa
Transport, storage environment:
Temperature: -10 ℃~ 55 ℃
Humidity: ≤95%
Atmospheric pressure: 50kPa ~ 106kPa, non-corrosive gas and
well-ventilated environment.
12. Declaration：EMC of this product comply with IEC60601-1-2 standard.
The Fingertip Pulse Oximeter is designed to be used in specified electromag-
netic environment . Users of the Fingertip Pulse Oximeter must use it in the
following environments.
Radiation Test
RF interference
CISPR 11
RF interference
CISPR 11
Compliance
Group 1
Class B
Electromagnetic environment-guidance
RF signal of Fingertip Pulse Oximeter is simply
created by its internal function. Therefore, its
RF interference is very low and is not likely to
cause any interference to nearby electronic
equipment.
The Fingertip Pulse Oximeter applies to all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Possible Problems and Resolutions
Problem Possible reason Solution
SpO2 or PR is
shown unsteady
The Oximeter
can not be
turned on
Indication lamps
are suddenly off
1. Finger is not plugged
correctly
2.Patient’s Oxyhemo-
globin value is too low
to be measured
1. The finger might not
be plugged deep enough
2. Finger is trembling or
the patient is on
movement status
1. Inadequate power or
power off
2. Batteries might be
installed incorrectly
3. The Oximeter might be
damaged
1. The product
automatically shuts off
when no signal is
detected in 8 seconds
2. Inadequate power
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
1. Retry by plugging the finger
2. Please remain at rest
1. Normal
2. Replace the batteries
1. Please replace the batteries
2. Please reinstall the batteries
3. Please contact with local customer
service centre
SpO2 or PR can
not be shown
normally
Symbols and Definitions
BF type
application part IP degree
Serial number
Standby Temperature range
Avoid sunlight
Up toward Date of manufacture
Manufacturer
European union
representative
Humidity range
Keep dry
Product certification
Separate collection
Reference manual
Cautions
Reserves the right to technical change appearance, our products are
subject to change without prior notice, please forgive me!
1, Maintenance with data such as circuit diagram, components list, figure
and the detailed rules of correction, injection, available only to the repair
factory training qualified personnel and units.
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.
● 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 time
Monday to Friday 9 to 17:30pm, except for the national legal holiday
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 disassem-
bling or repairing damaged;
Products beyond the warranty period.
● 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
Statement:
After-sales service
Ensure that users
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Prolinx GmbH
Brehmstr . 56 , 40239 , Duesseldorf
Germany
0123