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Summary of Contents for Yuwell YX110
- Page 1 YUWELL® Finger Pulse Oximeter YX110 Please read the user manual carefully before using!(The picture is for reference only, please refer to the actual product.)
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Page 2: Warning And Caution
Warning and Caution Safety： 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. - Page 3 electrosurgey. 14.Warning, Do not use the finger pulse oximeter in the presence of flammable anesthetics or other flammable substances, oxygen-enriched environments, or nitrous 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.
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Page 4: General Description
25.Warning, Properly apply and avoid using the oximeter in strong ambient light sources, fluorescent lights, infrared heat lamps, and direct sunlight to minimize interference that may result in unreadable or inaccurate readings. 26.Caution, The display may not read clearly when exposed to direct sunlight or bright light. -
Page 5: Measurement Principle
So that doctors can find problems in time. 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. -
Page 6: Indication For Use
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 SpO pulse rate through finger. It is intended for adults and children (weight > 30kg) and is expected for home and hospital inspection. - Page 7 ± 1% when measured under indoor nature light / existing lighting and measured in the dark room. 6. The product will automatically shut down when there is no signal detected for about eight seconds. 7. Dimension(YX110):60mm*38mm*35mm(LW H),Weight:38g approximately (without batteries). 8. Working Environments: Ambient temperature:...
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Page 8: Technical Description
15. TYPE BF APPLIED PARTS 16. Degrees of protection provided by enclosures (IP code)：IP22. 17. Description of oximeter application management YX110 is equipped with Bluetooth function. Bluetooth communication protocol module enables the oximeter to be equipped with Bluetooth connection and the function of date exchange ,which does not involve patient privacy, mainly including pulse rate, blood oxygen and other information. - Page 9 measured values of oxygen saturation and the reference value. The formula is as follows: : accuracy. n: test sample quantity. : measured value of pulse oxygen saturation during the first measurement using the finger pulse Oximeter. : reference value of pulse oxygen saturation during the ith measurement using the carbon-monoxide-blood-gas analyzer.
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Page 10: Product Properties
Product Operation Scope The YUWELL® Finger Pulse Oximeter is designed for fingers(not thumb) between 0.3 and 0.9 inch (0.8-2.3cm) thick. And the finger shall be inserted into the sensor position which is in the middle of the device. -
Page 11: Lanyard Installation
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. - Page 12 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.
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Page 13: Electromagnetic Interference
Note: Do not splash, dump any liquid into the oximeter and attachments, switch and connections, which may damage the oximeter. Problems Possible reason Solution 1.Put finger incorrectly 1.Try again 2.Try some more times, if you can or PR 2.Not used according to make sure about no problem exiting can not be recommended steps... - Page 14 (e.g.deviation from the performance indicated in the instructions for use during IMMUNITY testing) and the finger pulse oximeter can recover from any interference within 30 seconds without affecting basic safety or performance without operator intervention.The following degradations, if associated with BASIC SAFETY or ESSENTIAL PERFORMANCE shall not be allowed: - component failures;...
- Page 15 Table 2 - For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer's declaration – Radiated Emission Emissions test IEC60601 test level Compliance level Result 40dB(μV/m) 40dB(μV/m) RF emissions 30MHz-230MHz； 30MHz-230MHz； Pass CISPR 11 47dB(μV/m) 47dB(μV/m) 230MHz-1000MHz 230MHz-1000MHz Table 3 - For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer's declaration –...
- Page 16 frequency (MHz) power Test LEVEL (MHz) (V/m) Pulse 380-390 TETRA 400 modulation 18 Hz GMRS 460, ±5 kHz 430-470 FRS 460 deviation 1 kHz sine Pulse LTE Band 704-787 modulation 13,17 217Hz 800/900, Pulse TETRA 800, 800-960 modulation iDEN 820, 18Hz CDMA 850, LTE Band 5...
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Page 17: Warranty Card
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. FCC Radiation Exposure Statement: The device has been evaluated to meet general RF exposure requirement. - Page 18 Manufacturer Address:No.1 Baisheng Road Development Zone, Danyang, Jiangsu 212300 CHINA For information about any YUWELL product, please contact:www.yuwell.com Due to the limited size of the label, the font is too small, please put it at a suitable location for viewing. All specifications and product configurations are subject to change without notification.
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