YUWELL® Finger Pulse Oximeter YX310 Please read the user manual carefully before using!(The picture is for reference only, please refer to the actual product.
Warning 1.Warning,Do not modify this equipment without authorization of manufacturer. 2.Warning,Keep away from the wet medical equipment such as drip or other similar liquid simulation as far as possible. 3.Warning, Check the sensor site every half an hour to ensure adequate blood circulation, intact skin, and appropriate sensor location. Otherwise, it may cause skin damage, compressive necrosis, or inaccurate measurement readings. 4.
oxide to avoid the risk of explosion. 15.Caution,When using this product, you only need to fix it on your fingers. Excessive pressure on your fingers may cause skin damage. 16.The maximum skin surface temperature is below 41℃(106℉) when measured in a 35℃(95℉)environment, which has been verified by measuring the skin surface temperature via a Finger Pulse Oximeter under the reasonable worst conditions. 17.Please pay attention to product storage to prevent damage caused by pets, pests or children.
26.Caution, The display may not read clearly when exposed to direct sunlight or bright light. 27.Caution, Do not use a functional tester to evaluate the accuracy of the Finger Pulse Oximeter. The functional tester shall only be used to check whether a unit is working properly. 28.Caution, SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin(COHb) and methemoglobin(MetHb). 29.Warning, Please replace the battery when a low battery remind appears.
The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of pulse oxygen saturation and pulse rate. It has been proved in clinical experiments that it features in rather high precise and repeatability.
Type BF applied part The device System Manufacturer Humidity limitation Medical device Atmospheric pressure limitation Temperature limit Pulse rate (bpm:1/min) The Pulse Oxygen Saturation(%) This way up Stand-by Fragile, handle with care Rx only For prescription use Use-by date has no Alarm Keep dry Bluetooth Indication for Use Intended use: The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate throu
Display Technical Parameters 1.Display Type: OLED SpO2 Display range: 0%~100%. Pulse Rate Display range: 25bpm~250bpm. 2.Power: Two AAA 1.5V alkaline batteries. 3.Working Current: Less than 40mA at rated voltage 3V. 4.
11.Peak wavelengths and light output power: Emission wavelength range 600nm-1000nm, radiation intensity is less than 15mW/sr (20mA). Information of wavelength range may be of especial use to clinical doctors. 12.Description of the effect on displayed and transmitted SpO2 and Pulse rate data value: 1) data averaging and other signal processing. 2) the data update period: ≤3 pulse rate cycles, less than 30s. Note: Data processing and update will not affect pulse rate and SpO2. 13.
Arms: accuracy. n: test sample quantity. SpO2i : measured value of pulse oxygen saturation during the first measurement using the finger pulse Oximeter. SRi: reference value of pulse oxygen saturation during the ith measurement using the carbon-monoxide-blood-gas analyzer. 4. Characteristics of Population under Clinical Research The group of healthy adult volunteers for the study consisted of 12 subjects - 4 women and 8 men, The ages ranged from 18 to 50 years. The subject weights ranged from 48 to 90kg.
Product Properties 1.Operation of the product is simple and convenient. 2.The product is small in size, light in weight and portable. 3.The product can operate continuously for 17 hours with two brand new AAA batteries.(The operation time may vary due to the different performance of batteries) 4.Low voltage prompt will appear on the display when the battery voltage is lower than the minimum value of normal working voltage range. 5.
damage might occur to device. Please put or remove batteries in right order, or it will damage the device bracket. Please remove the battery if the oximeter is not used for long time. 3. Install as the figures show. (See Figure) Remove the battery from the product if it is not required for extended periods of time in order to avoid damage to the oximeter resulting from a leaking battery. Do not use the new batteries with the old ones.
Cleaning and disinfecting This product is a reusable non-sterile device. Please clean and disinfect according to the following methods. Warning: 1.Never immerse or soak the oximeter. 2.We recommend cleaning and disinfecting the oximeter before or after each use, or in accordance with the policies established by the hospital, to avoid long-term damage to the oximeter and avoid cross-infection. 3.Never use cleaning agents/disinfectants other than the recommended. 4.
Possible cases and solutions Warning: Caution: Oximeter cover can only be opened by a professional maintenance staff. No internal parts require opening by end users. If you are not sure about the measurement precision, please use other methods to check patient's pulse, to determine whether oximeter works. Note: Do not splash, dump any liquid into the oximeter and attachments, switch and connections, which may damage the oximeter. Problems Possible reason 1Put finger incorrectly SpO2 or PR 2.
Electromagnetic interference The EM environment for this product is the home healthcare environment and professional healthcare facility environment. The essential performance of this product is the accuracy of SpO2 and pulse rate (SpO2 Accuracy: ±2% in the range of 70%-100% of SpO2, No definition for SpO2 under 70%;Pulse rate: 25bpm~250bpm, accuracy: ±1% or ±1bpm(larger)).When used directly near strong electromagnetic interference (for example: near mobile phones, microwave ovens, etc.
IEC/EN 61000-4-2 IEC/EN 61000-4-3 IEC/EN 61000-4-4 IEC/EN 61000-4-5 IEC/EN 61000-4-6 IEC/EN 61000-4-8 IEC/EN 61000-4-11 Immunity Measurements Electrostatic Discharge Radio-frequency Electromagnetic Field Fast transients, Common Mode Surges Radio-frequency Common Mode Power-frequency Magnetic Fields Voltage Dips and Interruptions Pass Pass N/A N/A N/A Pass N/A Table 1 - For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration – Radiated Emission Emissions test Compliance RF emissions CIS
Table 5 - For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer's declaration – Power-frequency Magnetic Fields IMMUNITY test IEC60601 test level Compliance level Result Power frequency (50/60Hz) magnetic field IEC 61000-4-8 30 A/m 50Hz or 60Hz 30 A/m 50Hz and 60Hz Pass Table 6 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency (MHz) Banda) (MHz) Service a) 385 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 704-787 LTE Band 1
LTE Band 7 5240 Pulse 5100-58 WLAN 802.11 5500 modulationb) 0.2 0.3 9 00 a/n 217Hz 5785 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 singal.
User Manual, Warranty card: 1 pc APP Quick Usage Guide After unpacking, check the items according to the accessories list, and check whether the oximeter is mechanically damaged. If you find any problems, please contact the local customer service center immediately. During the warranty service, if you need to provide circuit diagrams, necessary materials, and if there are any problems with the maintenance of electrical circuits, please contact the manufacturer.