ProLinx YK-80B Operation & User’s Manual

2. Infrared-ray transmitting tube Operation Instructions Battery installation User Manual Fingertip Pulse Oximeter General Description Measurement principle Features Scope of application / Intended use       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。

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     Prolinx GmbH Brehmstr . 56 , 40239 , Duesseldorf Germany 0123