YONGKANG K1 User manual

User Manual
Ver 2.2 revision date：06-2022
Product name：Fingertip Pulse Oximeter K1
This Fingertip Pulse Oximeter is a kind of innovated medical device with non-invasive
features for artery SPO2 and PR detection. Being portable, it is able to measure SPO2 and 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.
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 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 905nm 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.
Diagram of Operation Principle
1. Infrared-ray receiving tube
2. Infrared-ray transmitting tube
Precautions for use
1. Do not use the pulse oximeter together with MRI or CT equipment.
2. Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
3. The 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 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 pulse oximeter sensor. This may
cause inaccurate reading or skin blisters.
6. Please read the manual carefully before your operation.
7. The pulse oximeter has no SpO2 alarm, 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.
Scope of application / Intended use
The fingertip pulse oximeter can be used to measure human haemoglobin saturation and heart
rate through finger , it can be used in hospitals, families, schools and medical centers.
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。
Features
OLED display
Product adopts double color OLED display，can show the six different display
mode
Low-power consumption, continuously work for more than six hours with one
rechargeable lithium battery
Battery power indicator
In the absence of signals, the product will be in after 8 seconds to power-off
automatically
Small in volume, light in weight, and convenient to carry
Operation Instructions
1. 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.
2. Press button on the front panel;
3. Don’t tremble your finger when the Oximeter is working. Your body is not recommended on
moving status.
4. Press the button on the front panel, if we want change display direction;
5 .Read relevant datum from display screen.
6. Please charge batteries in time 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 ).
Hang rope installation
1, Put the rope thin end through the hole.

2, Put the rope 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 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 1 ,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
Detailed descriptions of product functions:
1. Display Type：OLED display
2. SpO2：Measurement range：70%～100%
Accuracy：±2% on the stage of 80%～100%;
±3% on the stage of 70%～79%;
Below 70% no requirement
Resolution：1%
3. PR：Measurement range：30BPM～240BPM
Accuracy：±1BPM or ±1%（the larger one）
Parameters of LED probe
wavelength
radiation power
RED
660±2nm
1.8mW
IR
905±10nm
2.0mW
This parameter can be especially useful to clinicians.
4 Power：rechargeable lithium battery
5 Automatic standby ：the product shuts off by itself when no finger is in the product about 8
seconds
6.Dimension：44mm×28.3mm×26.5mm
7. Operation Environment：Operation Temperature：5℃～40℃
Storage Temperature：-10℃～40℃
Ambient Humidity：15%～80% on operation
10%～80% in storage
Air Pressure：86kPa～106kPa
8. Declaration：EMC of this product comply with IEC60601-1-2 standard.
Classification
1. Management Class for Medical Devices: Ⅱequipment
2. Anti-electric Shock Type: Internally powered equipment
3. Anti-electric Shock Degree: Type BF equipment
Maintenance and Preservation
1. Charge batteries timely when the battery power is too low.
2. Clean the surface of fingertip oximeter before it is used to diagnose patients.
3. It would be better to preserve the product in -10~40℃(14-104℉) and humidity is
10%-80%.
4. It is recommended that the product should be kept dry anytime. A wet ambience might
affect its lifetime and even damage the product.
Product Accessories
1. One hang lace
2. One user manual
3. One charging line
4. One adapter（optional）
Guidance and manufacture’s declaration-electromagnetic radiation-for
other EQUIPMENTS and SYSTEMS
The Pulse Oximeter is designed to be used in specified electromagnetic environment .
Users of the Pulse Oximeter must use it in the following environments.
Radiation Test
Compliance
Electromagnetic environment-guidance
RF interference
CISPR 11
Group 1
RF signal of 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.
RF interference
CISPR 11
Class B
The 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
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.The Oximeter might be
damaged
1. Please charge the batteries
timely
2. 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. Please charge the batteries
timely
Symbols and Definitions
BF type application part
Serial number
OLED display:
start/mode key
Charging jack
OLED display modes：

Separate collection
Date of manufacture
Reference manual
Manufacturer
Cautions
European union
representative
IP22
IP degree
Standby
Humidity range
Temperature range
Keep dry
Avoid sunlight
Product certification
Up toward
Lot number
Reserves the right to technical change appearance, our products are subject to change
without prior notice, please forgive me!
Statement:
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.
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 time
Monday to Friday 9 am 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 disassembling 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：400-806-1899
Company information
Using life：5 years
TEL: [phone] -601 FAX: [phone]-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: