Dr. Senst YK-80B - Fingertip Pulse Oximeter Manual

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 hemoglobinand oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation principle of the instrument is to combine Photoelectric Oxyhemoglobin Inspection Technology with Cpacity 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.

Diagram of Operation Principle

1. Infrared-ray receiving tube
2. Infrared-ray transmitting tube

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. 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. 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 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.

Scope of application / 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.

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
  ★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)

Operation Instructions

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
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.
   

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。

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
• 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 alarm ,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.

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

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

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×33m
11. 11.Operation environment: temperature: 5 ℃ ~ 40 ℃
    Humidity: 15% ~ 80%
    Atmospheric pressure: 70kPa ~ 106kPa
    Transport, storage environment: Temperature: -10 ℃ ~ 40 ℃
    Humidity: 10%~95%
    Atmospheric pressure: 70kPa ~ 106kPa, non-corrosive gas and well-ventilated environment.
12. 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. 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%~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. Please follow the law of the local government to deal with used batteries.

Symbols and Definitions

	BF type application part		This device has no alarm function	IP22	First characteristic numeral 2: Against ingress of solid foreign objects: ≥ 12.5mm diameter Second characteristic numeral 2 Against ingree of water with harmful effects: dripping(15º tilted)
	Up toward	95% 10%	Humidity range
	Reference manual		Keep dry	一一	signal inadequacy
	Cautions		Product certification		Grüner Punkt Recycling
	According to French Decree No. 2014-1577,The symbol indicates recycling by category.

	Serial number		Lot number		To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations.
	Date of manufacture	40℃ -10℃	Temperature range
	Manufacturer		Avoid sunlight	一一	①Indication of probe faults (open circuit condition or close circuit condition) ②Indication of Probe cable faults ③Indication of Probe cable extender faults
	Stand-By		European union r epresentative

Product Accessories

1. One hang lace
2. One user manual