2AM8O-F34XElectronic Thermometer

1 / 20 INSTRUCTION MANUAL Electronic Thermometer AET-F341/ AET-F342/AET-F343 Version:1.0 Date modified: 2022-09-29 Please read this instruction manual before use 2 / 20 Contents 1. Intended use/ Indications For Use ............................................................................................................... 3 2. Before start .................................................................................................................................................. 3 3. PRODUCT INFORMATION ............................................................................................................................. 3 4. CLASSIFICATION ........................................................................................................................................... 3 5. SAFETY PRECAUTIONS.................................................................................................................................. 4 6. Disposal ........................................................................................................................................................ 7 7. Important Safety Instructions ...................................................................................................................... 7 8. Unit description ........................................................................................................................................... 8 9. Display .......................................................................................................................................................... 8 10. Correct Measurement Posture ................................................................................................................ 9 11. Directions for Use .................................................................................................................................... 9 12. NOTE ...................................................................................................................................................... 10 13. Recall record .......................................................................................................................................... 11 14. Access to the thermometer ................................................................................................................... 11 15. Charing mode......................................................................................................................................... 11 16. Replace battery of Charging box ............................................................................................................ 12 17. Error Messages ...................................................................................................................................... 13 18. Care and Cleaning .................................................................................................................................. 13 19. Guarantee .............................................................................................................................................. 14 20. Technical Specifications ......................................................................................................................... 15 21. Included in delivery ................................................................................................................................ 15 22. EMC information .................................................................................................................................... 15 23. Bluetooth connect ................................................................................................................................. 19 24. FCC Warning ........................................................................................................................................... 20 3 / 20 1. Intended use/ Indications For Use The Electronic Thermometers are intended to measure human body temperature under the arm. The devices are reusable for clinical or home use on people of all ages. Contraindications: no. Intended users: Trained and qualified professionals and lay person. Intended use environment: Clinics and home. 2. Before start -For safe and proper use of this product, be sure to read and fully understand Safety Precautions contained in this user manual. - Keep this manual with you for a convenient reference. - Keep this manual in a proper way and avoid any loss. - If you need other information, please contact the manufacturer. 3. PRODUCT INFORMATION Product name: Electronic Thermometer , Product model: AET-F341, AET-F342, AET-F343, Software version: A.01.00.00 Standard: The product is made under the ISO80601-2-56. Manufacturer Company name: Alicn Medical Shenzhen, Inc Address: Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Jinsha Community, Kengzi Street, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Web: www.alicn-med.com Tel: +86 755 26501548 Fax: +86 755 26504849 Email: [email protected] Authorized European Representative Company name: CMC Medical Devices & Drugs S.L. Address: C/ Horacio Lengo Nº 18, CP 29006, Málaga, Spain Web: www.cmcmedicaldevices.com Tel: +34951214054 Email: [email protected] 4. CLASSIFICATION （1）Internally powered equipment; （2）Type BF applied part; （3）IP classification: IP65; （4）Disinfection of 70% medical alcohol; （5）Not Category AP / APG equipment; （6）Mode of operation: continuous operation. 4 / 20 5. SAFETY PRECAUTIONS - Warning marks and symbols are contained for your safe and proper use of this product and prevention of any injury to you and others. - See Table below for description of warning marks and symbols: Warning Means a possibility of personal injury in case of improper use. Notice Means a possibility of personal injury or property damage in case of improper use. 【*…

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Alien Medical Shenzhen, Inc U.S. Agent Designation for Service of Process - Certification Attestation Letter March 29, 2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1H2 Canada ATTN.: Reviewing Engineer FCC ID: 2AM8O-F34X Per section 2.911(d)(7) of the FCC rules, Alien Medical Shenzhen, Inc certifies that the equipment for which authorization is sought is designated to the following U.S. Designated agent* for service of process: Company Name: Physical U.S. Company Address: Agent name: Agent Email Address: FRN: Global Product Services & Consultation LLC 328 W Palm Ave, Monrovia. CA91016 Chi S. Chan [email protected] 0033406703 The above contact person accepts the obligation for service of process. SC3031782 * the applicant must designate a contact located in the United States for purposes of acting as the applicant's agent for service of process, regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as the agent for service of process. Designated Agent Signed: (Required, if different to Applicant) : March 29, 2023 Signed: Printed name: Title: Company Name: Date: Chi S. Chan Global Product Services & Consultation LLC March 29, 2023 Technical Director

EXTERNAL PHOTOS

(01) 069537756XXXXX (17) 2027-11-02 (11) 2022-11-03 (10) 22L020 (21) 0000001 Measurement range: 32.00°C-43.00°C(89.60°F-109.40°F) Accuracy（Laboratory）:±0.10°C /±0.18°F Battery (Thermometer): DC 3.7V li-ion battery, 20mAh Battery (Charging box): DC 3V, 2×AAA batteries Alicn Medical Shenzhen,Inc Electronic Thermometer Model:AET-F341 Measuring site: Axillary Alicn Medical Shenzhen,Inc FCC ID: 2AM8O-F34X Electronic Thermometer Model:AET-F342 Measuring site: Axillary Alicn Medical Shenzhen,Inc FCC ID: 2AM8O-F34X Electronic Thermometer Model:AET-F343 Measuring site: Axillary Alicn Medical Shenzhen,Inc FCC ID: 2AM8O-F34X

INTERNAL PHOTOS

FCC ID: 2AM8O-F34X RF Exposure Evaluation REQUIREMENT KDB447498 D01 General RF Exposure Guidance v06, Clause 4.3.1(a) [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 Where -f(GHz) is the RF channel transmit frequency in GHz -Power and distance are rounded to the nearest mW and mm before calculation -The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 4.1 f) is applied to determine SAR test exclusion. TEST RESULT Passed Not Applicable Radio Type Frequency range (MHz) Conducted Power (dBm) Maximum Tune-up (dBm) Calculating data Limit Result Bluetooth 2402-2480 1.68 2.00 0.4923 3.00 Pass Note: 1) The maximum antenna gain is 0dBi 2) The exposure evaluation safety distance is 5mm.

Page: 1 of 35 TEST REPORT For Bluetooth-LE Report No. ...................................... : CHTEW23010013 Report Verification: Project No.................................： SHT2208212702EW FCC ID ............................................. : 2AM8O-F34X Applicant’s name ........................... : Alicn Medical Shenzhen, Inc Address ............................................. : Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Product Name ................................ : Electronic Thermometer Trade Mark ....................................... : - Model No. ......................................... : AET-F342 Listed Model(s) ................................. : AET-F341, AET-F343 Standard ......................................... : FCC CFR Title 47 Part 15 Subpart C Section 15.247 Date of receipt of test sample..........: Dec. 15, 2022 Date of testing.............................: Dec. 16, 2022- Jan. 03, 2023 Date of issue...............................: Jan. 04, 2023 Result .................. ........................: PASS Compiled by ( Position+Printed name+Signature): File administrator Silvia Li Supervised by (Position+Printed name+Signature): Project Engineer Weiyang Xiang Approved by (Position+Printed name+Signature): RF Manager Hans Hu Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. The test report merely correspond to the test sample. Report No.: CHTEW23010013 Page: 2 of 35 Date of issue: 2023-01-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) Contents 1. TEST S T AN D AR D S A N D R E P O R T V E R S I O N 3 1.1. Test Standards 3 1.2. Report version 3 2. TEST DESCRIPTION 4 3. SUMMARY 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Radio Specification Description 5 3.4. Testing Laboratory Information 6 4. TEST CONFIGURATION 7 4.1. Test frequency list 7 4.2. Descriptions of Test mode 7 4.3. Test sample information 7 4.4. Support unit used in test configuration and system 8 4.5. Testing environmental condition 8 4.6. Statement of the measurement uncertainty 8 4.7. Equipment Used during the Test 9 5. TEST CONDITIONS AND RESULTS 11 5.1. Antenna Requirement 11 5.2. AC Conducted Emission 12 5.3. Peak Output Power 13 5.4. Power Spectral Density 14 5.5. 6dB bandwidth 15 5.6. 99% Occupied Bandwidth 16 5.7. Duty Cycle 17 5.8. Conducted Band edge and Spurious Emission 18 5.9. Radiated Band edge Emission 19 5.10. Radiated Spurious Emission 22 6. TEST SETUP PHOTOS 28 7. EXTERNAL AND INTERNAL PHOTOS 30 8. APPENDIX REPORT 35 Report No.: CHTEW23010013 Page: 3 of 35 Date of issue: 2023-01-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 1. TEST STAND ARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: ‒ FCC Rules Part 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation within the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz ‒ ANSI C63.10:2013: American National Standard for Testing Unlicensed Wireless Devices ‒ KDB 558074 D01 15.247 Meas Guidance v05r02: Guidance for Compliance Measurements on Digital Transmission System, Frequency Hopping Spread Spectrum System, and Hybrid System Devices Operating under Section 15.247 of The FCC Rules 1.2. Report version Revision No. Date of issue Description N/A 2023-01-04 Original Report No.: CHTEW23010013 Page: 4 of 35 Date of issue: 2023-01-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 2. TEST DESCRIPTION Report clause Test Items Standard Requirement Result Test Engineer 5.1 Antenna Requirement 15.203/15.247(c) PASS Xiaoqin Li 5.2 AC Conducted Emission 15.207 N/A N/A 5.3 Peak Output Power 15.247(b)(3) PASS Xiaoqin Li 5.4 Power Spectral Density 15.247(e) PASS Xiaoqin Li 5.5 6dB Bandwidth 15.247(a)(2) PASS Xiaoqin Li 5.6 99% Occupied Bandwidth - PASS *1 Xiaoqin Li 5.7 Duty cycle - PASS *1 Xiaoqin Li 5.8 Conducted Band Edge and Spurious Emission 15.247(d)/15.205 PASS Xiaoqin Li 5.9 Radiated Band Edge Emission 15.205/15.209 PASS Quanhai Deng 5.10 Radiated Spurious Emission 15.247(d)/15.205/15.209 PASS Quanhai Deng Note: ‒ The measurement uncertainty is not included in the test result. ‒ *1: No requirement on standard, only report these test data. Report No.: CHTEW23010013 Page: 5 of 35 Date of issue: 2023-01-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 3. SUMMARY 3.1. Client Information Applicant: Alicn Medical Shenzhen, Inc Address: Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Manufacturer: Alicn Medical Shenzhen, Inc Address: Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, No. 22 Jinxiu East Road, Pingshan District, 518118 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA 3.2. Product Description Main unit information: Product Name: Electronic Thermometer Trade Mark: - Model No.: AET-F342 Listed Model(s): AET-F341, AET-F343 Power supply: DC 3.7V from Battery Hardware version: …

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Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 1 of 22 APPENDIX REPORT Project No. SHT2208212702EW Radio Specification Bluetooth BLE Test sample No. YPHT22082127001 Model No. AET-F342 Start test date 2022-12-22 Finish date 2022-12-22 Temperature 20.7°C Humidity 20% Test Engineer Xiaoqin Li Auditor Appendix clause Test item Result A Peak Output Power PASS B Power Spectral Density PASS C 6 dB Bandwidth PASS D 99% Occupied Bandwidth PASS E Duty cycle PASS F Band edge and Spurious Emissions (conducted) PASS Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 2 of 22 Appendix A：Peak Output Power Test rate Channel Peak Output power (dBm) Average Output power (dBm) Limit (dBm) Result 1Mbps 00 0.64 0.61 ≤ 30.00 Pass 19 1.47 1.42 39 1.29 1.26 2Mbps 00 0.76 0.54 ≤ 30.00 Pass 19 1.68 1.36 39 1.46 1.18 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 3 of 22 Test rate: 1Mbps CH00 Date: 22.DEC.2022 12:55:52 CH19 Date: 22.DEC.2022 12:57:52 CH39 Date: 22.DEC.2022 12:59:23 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 4 of 22 Test rate: 2Mbps CH00 Date: 22.DEC.2022 13:01:54 CH19 Date: 22.DEC.2022 13:03:59 CH39 Date: 22.DEC.2022 13:06:06 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 5 of 22 Appendix B：Power Spectral Density Test rate Channel Power Spectral Density(dBm/3KHz) Limit (dBm/3KHz) Result 1Mbps 00 -14.68 ≤8.00 Pass 19 -13.84 39 -14.25 2Mbps 00 -17.22 ≤8.00 Pass 19 -16.53 39 -17.24 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 6 of 22 Test rate: 1Mbps CH00 Date: 22.DEC.2022 12:56:06 CH19 Date: 22.DEC.2022 12:58:06 CH39 Date: 22.DEC.2022 12:59:37 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 7 of 22 Test rate: 2Mbps CH00 Date: 22.DEC.2022 13:02:09 CH19 Date: 22.DEC.2022 13:04:14 CH39 Date: 22.DEC.2022 13:06:20 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 8 of 22 Appendix C：6dB bandwidth Type Channel 6dB Bandwidth(kHz) Limit (kHz) Result 1Mbps 00 686.00 ≥500 Pass 19 702.00 39 698.00 2Mbps 00 1185.00 ≥500 Pass 19 1175.00 39 1195.00 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 9 of 22 Test rate: 1Mbps CH00 Date: 22.DEC.2022 12:55:33 CH19 Date: 22.DEC.2022 12:57:36 CH39 Date: 22.DEC.2022 12:59:07 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 10 of 22 Test rate: 2Mbps CH00 Date: 22.DEC.2022 13:01:39 CH19 Date: 22.DEC.2022 13:03:43 CH39 Date: 22.DEC.2022 13:05:50 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 11 of 22 Appendix D：99% Occupied Bandwidth Test rate Channel 99% Occupied Bandwidth(MHz) Limit (kHz) Result 1Mbps 00 1.02 - Pass 19 1.02 39 1.02 2Mbps 00 2.06 - Pass 19 2.06 39 2.05 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 12 of 22 Test rate: 1Mbps CH00 Date: 22.DEC.2022 12:55:43 CH19 Date: 22.DEC.2022 12:57:44 CH39 Date: 22.DEC.2022 12:59:15 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 13 of 22 Test rate: 2Mbps CH00 Date: 22.DEC.2022 13:01:46 CH19 Date: 22.DEC.2022 13:03:51 CH39 Date: 22.DEC.2022 13:05:57 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 14 of 22 Appendix E：Duty cycle Test Rate: 1Mbps Test Frequency （MHz） Ton time for single burst (ms) Tperiod (ms) Duty cycle 1/Ton time (kHz) 2440 0.40 0.63 63.5% 2.5 Date: 22.DEC.2022 12:57:24 Test Rate: 2Mbps Test Frequency （MHz） Ton time for single burst (ms) Tperiod (ms) Duty cycle 1/Ton time (kHz) 2440 0.20 0.62 32.3% 2 Date: 22.DEC.2022 13:03:31 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 15 of 22 Appendix F：Band edge and Spurious Emissions (conducted) Test Item: Band edge Test Rate: 1Mbps CH00 Date: 22.DEC.2022 12:56:15 CH39 Date: 22.DEC.2022 12:59:46 Test Item: Band edge Test Rate: 2Mbps CH00 Date: 22.DEC.2022 13:02:18 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 16 of 22 CH39 Date: 22.DEC.2022 13:06:29 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 17 of 22 Test Item: SE Test Rate: 1Mbps CH00 Reference level Date: 22.DEC.2022 12:56:23 CH00 30MHz~1000MHz Date: 22.DEC.2022 12:56:38 CH00 1GHz~26GHz Date: 22.DEC.2022 12:56:55 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 18 of 22 CH19 Reference level Date: 22.DEC.2022 12:58:12 CH19 30MHz~1000MHz Date: 22.DEC.2022 12:58:27 CH19 1GHz~26GHz Date: 22.DEC.2022 12:58:42 Project No.: SHT2208212702EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 19 of 22 CH39 Reference level Date: 22.DEC.2022 13:00:24 CH39 30MHz~1000MHz Date: 22.DEC.2022 13:00:39 CH39 1GHz~26GHz Da…

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1 Antenna describe 1. Antenna describe; Antenna plate Monopole antenna Make name/model name 17H66 Antenna gain 0dBi Frequency range 2.4GHZ—2.484GHZ Connector type Direct Location of measurement (company name and address) Shenzhen ZhiBaoyuan Electronic Technology Co., Ltd Address：Room 310, Youyi Base Building, Xingye Road, Baoan District, Shenzhen 2. External view drawing; Picture of antenna 2 3 4

TEST SETUP PHOTOS Radiated Emission