2AQVU0021Fingertip Pulse Oximeter

Size:480*297mm Fingertip Pulse oximeter XM-103 Document No.: JDXM-0304-052 Version: Z Diagram of Operation Principle Measurement Principle General Description 1.Red and infrared-ray emission tube 2.Red and infrared-ray receipt tube CAUTION: Federal (U.S.) Law restricts this device to sale by or on the order of a physician. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. It is transported throughout the body as arterial blood. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage(%)of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. A pulse oximeter also measures and displays the pulse rate at the same time it measures the SpO2 level. The oximeter is for prescription use or prescription home use. This device conforms to IEC6061-1, IEC60601-1-2, IEC60601-1- 11, ISO 80601-2-61, IEC 62304, 47 FCC part 15C, ANSI C63.27 . PRINCIPLE of the oximeter is as follows: The pulse oximeter works by applying a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light the other is 905nm, which is infrared-red light skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. Safety Notice 1. Before use,carefully read the manual. 2. Do not use the pulse oximeter: -if you are allergic to rubber products. -if the device or finger is damp. -during MRI or CT scan. -while taking a blood pressure measurement on the arm. -nail polish, dirty, coating fingers and false nails applied fingers. -fingers with anatomical changes, edemas, scars or burns. -Too big finger: the width of finger is over than 20mm and the thickness is over than 15mm. -Too small finger: the width of finger is less than 10mm and the thickness is less than 5mm. -Minors under 18 years old. -The environmental light changes strongly. -near flammable or explosive gas mixtures. 3. Extended use may cause pain for people with circulatory disorders. Do not use the pulse oximeter for longer than two hours on one finger. 4. Measurements are for your information only - they are no substitute for a medical examination. 5. Check the pulse oximeter regularly before use to ensure that there is no visible damage and the batteries are still sufficiently charged. In case of doubt, do not use the device and contact customer services or authorized retailer. 6. Do not use any additional parts that are not recommended by the manufacturer. 7. Any circumstances do not open or repair the device by yourself. Failure to comply will result in voiding of the warranty. For repairs, please contact customer services or authorized retailer. 8. Do not look directly inside the housing during the measurement. The red light and the invisible infrared light in the pulse oximeter are harmful to your eyes. 9. This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Children should be supervised around the device to ensure they do not play with it. 10. If the unit has been stored at temperatures below 0°C, leave it in a warm place for about two hours before using it. 11. If the unit has been stored at temperatures above 40°C, leave it in a cool place for about two hours before using it. 12. Neither of the displays for the pulse wave and pulse bar allows the strength of the pulse or circulation to be evaluated at the measurement site. Rather, they are exclusively used to display the current visual signal variation at the measurement site and do not enable diagnostics for the pulse. 13. Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU). 14. Follow local ordinances and recycling instructions regarding disposal or recycling or the device and device components, including batteries. 15.This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical electrical equipment and systems. In healthcare center or other environment, their radio transmission equipment and electromagnetic interference may affect the performance of the oximeter. 16.The oximeter contains radio communication function, it may affect other electronic medical equipment, so it should not be used close to or stacked with other equipment. 17. This equipment is not intended for use during patient transport outside the healthcare facility. 18. When the signal is not stable, the reading may inaccurate. Please do not reference. 1.Non-observance of the following instructions can lead to incorrect or failed measurements -There must not be any nail polish, artificial nails or other cosmetics on the finger to be measured. - Ensure that the finger nail on the finger to be measured is short enough that the fingertip covers the sensor element in the housing. - Keep your hand, finger and body steady during the measurement. - In cases of carbon monoxide poisoning, the pulse oximeter will display a measurement value that is too high. - To avoid incorrect results, there should not be any strong light sources( e.g. fluorescent lamps or direct sunlight ) in the immediate vicinity of the pulse oximeter. - Protect the pulse oximeter from dust, shocks, moisture, explosive materials. - Excessive patient movement. 2.The following sit…

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Report No.: 2207RSU031-UE 1 of 3 External Photograph (1) EUT Photo (2) EUT Photo Report No.: 2207RSU031-UE 2 of 3 (3) EUT Photo (4) EUT Photo Report No.: 2207RSU031-UE 3 of 3 (5) EUT Photo (6) EUT Photo

Size: 25mm x18mm Fingertip Pulse Oximeter Manufacturers by JOYTECH Healthcare Co., Ltd. No. 365, Wuzhou Road, Yuhang Economic Development Zone, 311100 ZhejiangChina Hangzhou City, , Power: 2X1.5V Batteries AAA Size Series number: 10321090000001 Manufacturing Date: 2021.09 FCC ID:2AQVU0021 Model: XM-103 Made in China IP22

Label pasting position: side sticker, example is as follows, the label is based on the actual situation.

Report No.: 2207RSU031-UE 1 of 4 Internal Photograph (1) EUT Photo (2) EUT Photo Report No.: 2207RSU031-UE 2 of 4 (3) EUT Photo (4) EUT Photo Report No.: 2207RSU031-UE 3 of 4 (5) EUT Photo (6) EUT Photo Report No.: 2207RSU031-UE 4 of 4 (7) EUT Photo (8) EUT Photo

MRT Technology (Suzhou) Co., Ltd Report No.: 2207RSU031-U3 Phone: +86-512-66308358 Report Version: V01 Web: www.mrt-cert.com Issue Date: 2022-09-09 1 of 10 RF Exposure Evaluation Declaration FCC ID: 2AQVU0021 Applicant: JOYTECH HEALTHCARE CO., LTD. Address: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China Product: Fingertip Pulse oximeter Model No.: XM-103 FCC Rule Part(s): FCC Part 2.1093 Result: Complies Reviewed By: Sunny Sun Approved By: Robin Wu The test results relate only to the samples tested. The test results shown in the test report are traceable to the national/international standards through the calibration of the equipment and evaluated measurement uncertainty herein. The test report shall not be reproduced except in full without the written approval of MRT Technology (Suzhou) Co., Ltd. Report No.: 2207RSU031-U3 2 of 10 Revision History Report No. Version Description Issue Date Note 2207RSU031-U3 Rev. 01 Initial Report 2022-09-09 Valid Report No.: 2207RSU031-U3 3 of 10 CONTENTS Description Page 1. General Information ................................................................................................................................ 4 1.1. Applicant ........................................................................................................................................ 4 1.2. Manufacturer ................................................................................................................................. 4 1.3. Testing Facility ............................................................................................................................... 4 1.4. Product Information ....................................................................................................................... 5 1.5. Applied Standards ......................................................................................................................... 5 1.6. Device Classification ..................................................................................................................... 5 2. RF Exposure Evaluation ......................................................................................................................... 6 2.1. Test Limits ..................................................................................................................................... 6 2.1. MPE Exemptions ........................................................................................................................... 7 2.2. Calculated Result ........................................................................................................................ 10 Report No.: 2207RSU031-U3 4 of 10 1. General Information 1.1. Applicant JOYTECH HEALTHCARE CO., LTD. No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China 1.2. Manufacturer JOYTECH HEALTHCARE CO., LTD. No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China 1.3. Testing Facility Test Site – MRT Suzhou Laboratory Laboratory Location (Suzhou - Wuzhong) D8 Building, No.2 Tian’edang Rd., Wuzhong Economic Development Zone, Suzhou, China Laboratory Location (Suzhou - SIP) 4b Building, Liando U Valley, No.200 Xingpu Rd., Shengpu Town, Suzhou Industrial Park, China Laboratory Accreditations A2LA: 3628.01 CNAS: L10551 FCC: CN1166 ISED: CN0001 VCCI: R-20025 G-20034 C-20020 T-20020 R-20141 G-20134 C-20103 T-20104 Test Site – MRT Shenzhen Laboratory Laboratory Location (Shenzhen) 1G, Building A, Junxiangda Building, Zhongshanyuan Road West, Nanshan District, Shenzhen, China Laboratory Accreditations A2LA: 3628.02 CNAS: L10551 FCC: CN1284 ISED: CN0105 Test Site – MRT Taiwan Laboratory Laboratory Location (Taiwan) No. 38, Fuxing 2nd Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.) Laboratory Accreditations TAF: L3261-190725 FCC: 291082, TW3261 ISED: TW3261 Report No.: 2207RSU031-U3 5 of 10 1.4. Product Information Product Name Fingertip Pulse oximeter Model No. XM-103 Bluetooth Version V5.0 (BLE only) Antenna Type PCB Antenna Antenna Gain 0 dBi Hardware Version Ver Z Software Version V1.0 Power Supply 2 x 1.5v AAA batteries Remark: The information of EUT was provided by the manufacturer, and the accuracy of the information shall be the responsibility of the manufacturer. 1.5. Applied Standards According to the specifications of the manufacturer, the EUT must comply with the requirements of the following standards: ⚫ FCC Part 2.1093 & KDB 447498 D04 Interim General RF Exposure Guidance v01 1.6. Device Classification According to the user manual, the device can be used in the portable exposure condition without restriction. This device is classified as a Portable Device. So, the RF exposure evaluation requirements of § 2.1093 for portable device exposure conditions subject to MPE limits. Report No.: 2207RSU031-U3 6 of 10 2. RF Exposure Evaluation 2.1. Test Limits According to FCC §1.1310: The criteria listed in the following table shall be used to evaluate the environment impact of human exposure to radio frequency (RF) radiation as specified in §1.1307(b) Limits For Maximum Permissible Exposure (MPE) Frequency Range (MHz) Electric Field Strength (V/m) Magnetic Field Strength (A/m) Power Density (mW/cm 2 ) Average Time (Minutes) (A) Limits for Occupational/ Control Exposures 0.3-3.0 614 1.63 *(100) ≤6 3.0-30 1842/f 4.89/f *(900/f 2 ) <6 30-300 61.4 0.163 1.0 <6 300-1,500 -- -- f/300 <6 1,500-100,000 -- -- 5 <6 (B) Limits for General Population/ Uncontrolled Exposures 0.3-1.34 614 1.63 *(100) <30 1.34-30 824/f 2.19/f *(180/f 2 ) <30 30-300 27.5 0.073 0.2 <30 300-1,500 -- -- f/1500 <30 1,500-100,000 -- -- 1.0 <30 f= frequency in MHz. * = Plane-wave equivalent power density. Report No.: 2207RSU031-U3 7 of 10 2.1. MPE Exemptions For single RF sources (i.e., any single fixed RF source, mobile device, or portable device, as defined in paragraph §1.1307(b)(2) of this…

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MRT Technology (Suzhou) Co., Ltd Report No.: 2207RSU031-U2 Phone: +86-512-66308358 Report Version: V01 Web: www.mrt-cert.com Issue Date: 2022-09-09 1 of 46 RF MEASUREMENT REPORT FCC ID: 2AQVU0021 Applicant: JOYTECH HEALTHCARE CO., LTD. Address: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China Product: Fingertip Pulse oximeter Model No.: XM-103 FCC Classification: Digital Transmission System (DTS) FCC Rule Part(s): Part 15 Subpart C (Section 15.247) Result: Complies Test Date: 2022-07-27 ~ 2022-07-28 Reviewed By: Sunny Sun Approved By: Robin Wu The test results relate only to the samples tested. This equipment has been shown to be capable of compliance with the applicable technical standards as indicated in the measurement report and was tested in accordance with the measurement procedures specified in ANSI C63.10-2013. Test results reported herein relate only to the item(s) tested. The test report shall not be reproduced except in full without the written approval of MRT Technology (Suzhou) Co., Ltd. Report No.: 2207RSU031-U2 2 of 46 Revision History Report No. Version Description Issue Date Note 2207RSU031-U2 Rev. 01 Initial Report 2022-09-09 Valid Report No.: 2207RSU031-U2 3 of 46 CONTENTS Description Page 1. General Information ................................................................................................................................ 5 1.1. Applicant ...................................................................................................................................... 5 1.2. Manufacturer ................................................................................................................................ 5 1.3. Testing Facility ............................................................................................................................. 5 1.4. Product Information ...................................................................................................................... 6 1.5. Radio Specification under Test .................................................................................................... 6 1.6. Working Frequencies ................................................................................................................... 7 2. Test Configuration ................................................................................................................................... 8 2.1. Test System Connection Diagram................................................................................................ 8 2.2. Test Software ............................................................................................................................... 8 2.3. Applied Standards ........................................................................................................................ 9 2.4. Test Environment Condition ......................................................................................................... 9 3. Antenna Requirements ......................................................................................................................... 10 4. Measuring Instrument ........................................................................................................................... 11 5. Decision Rules and Measurement Uncertainty .................................................................................. 12 5.1. Decision Rules ........................................................................................................................... 12 5.2. Measurement Uncertainty .......................................................................................................... 12 6. Test Result .............................................................................................................................................. 13 6.1. Summary .................................................................................................................................... 13 6.2. 6dB Bandwidth Measurement .................................................................................................... 14 6.2.1. Test Limit .................................................................................................................................... 14 6.2.2. Test Procedure ........................................................................................................................... 14 6.2.3. Test Setting ................................................................................................................................ 14 6.2.4. Test Setup .................................................................................................................................. 14 6.2.5. Test Result ................................................................................................................................. 14 6.3. Output Power Measurement ...................................................................................................... 15 6.3.1. Test Limit .................................................................................................................................... 15 6.3.2. Test Procedure ........................................................................................................................... 15 6.3.3. Test Setting ................................................................................................................................ 15 6.3.4. Test Setup .................................................................................................................................. 15 6.3.5. Test Result ................................................................................................................................. 15 6.4. Power Spectral Density Measurement ...................................................................................... 16 6.4.1. Test Limit ....…

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蓝牙天线规格 1：Antenna Description Antenna Type Microtrip Antenna Antenna peak gain 0dBi Frequency range 2.402GHz～2.480GHz Connect type Simulation 2：Antenna pictu re on the PCB borad 3：Antenna radiation of 3D polar Solution frequency at 2.453G 3：Antenne radiation pattern

Report No.: 2207RSU031-UT Test Setup Photo Description: Radiated Spurious Emission Test Setup Below 1GHz Description: Radiated Spurious Emission Test Setup Above 1GHz Report No.: 2207RSU031-UT Description: RF Conducted Test Setup