2A6LY-0006RXiBreeze PAP System

User Manual RXiBreeze PAP System Contents 1 Welcome ................................................................................................................................................................. 1 2 Intend Use ............................................................................................................................................................... 1 3 Contraindications .................................................................................................................................................... 1 4 Safety Information .................................................................................................................................................. 2 5 Symbol .................................................................................................................................................................... 6 6 System Contents ..................................................................................................................................................... 9 7 System Overview .................................................................................................................................................... 9 7.1 Placing the Device ..................................................................................................................................... 10 7.2 Supplying AC Power .................................................................................................................................. 10 7.3 Connecting the Breathing Circuit ............................................................................................................... 11 7.4 Water-filling Operation .............................................................................................................................. 12 8 Navigating the Device Screens ............................................................................................................................. 14 9 Operation .............................................................................................................................................................. 14 9.1 Starting the Device ..................................................................................................................................... 14 9.2 Patient Menu Navigation Settings .............................................................................................................. 15 9.2.1 Patient Standby Interface ................................................................................................................ 15 9.2.2 Patient Therapy Interface ................................................................................................................ 16 9.2.3 Patient Report Menu ....................................................................................................................... 17 9.2.4 Mask Fit .......................................................................................................................................... 18 9.2.5 Patient Comfort Setting ................................................................................................................... 18 9.2.6 Patient System Setting ..................................................................................................................... 20 9.2.7 TF Card ........................................................................................................................................... 21 9.3 Wireless transmission module (Optional) .................................................................................................. 21 9.3.1 WiFi module connection ................................................................................................................. 21 9.3.2 WiFi Status Sign .............................................................................................................................. 22 9.3.3 Mobile NetWork Module ................................................................................................................ 22 9.3.4 Mobile NetWork Status Sign ........................................................................................................... 22 10 Device Alert ........................................................................................................................................................ 23 11 Troubleshooting .................................................................................................................................................. 25 12 Reprocessing ....................................................................................................................................................... 27 12.1 Cleaning Schedule .................................................................................................................................... 27 12.2 Disinfection Schedule .............................................................................................................................. 27 12.3 Cleaning and Disinfection Process for Device Surface ............................................................................ 27 12.3.1 Cleaning (Weekly) ......................................................................................................................... 27 12.3.2 Disinfection (Monthly) .................................................................................................................. 28 12.3.3 Drying ........................................................................................................................................... 28 12.3.4 Inspection ...................................................................................................................................... 28 12.4 Cleaning and Disinfection Process for (water tank, air outlet adaptor, air outlet of water tank) .........…

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Page: 1 of 16 TEST REPORT For FCC Part15B Report No. .......................................: CHTEW23090007 Report verification: Project No. ..................................: SHT2307026501EW FCC ID ............................................. : 2A6LY-0006 Applicant’s name ........................... : Resvent Medical Technology Co., Ltd. Address ............................................. : BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community,Xin’an Street, Bao’an District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Product Name ................................ : RXiBreeze PAP System Trade Mark ....................................... : - Model No. ......................................... : RXiBreeze III APAP Pro Listed Model(s) ................................. : RXiBreeze III CPAP, RXiBreeze III CPAP Pro, RXiBreeze III APAP Standard ......................................... : FCC CFR Title 47 Part 15 Subpart B Date of receipt of test sample...........: Aug. 05, 2023 Date of testing..............................: Aug. 06, 2023- Aug. 22, 2023 Date of issue.................................: Aug. 31, 2023 Result .................. ........................: Pass Compiled by (position+printed name+signature) ... : File administrators Xiaodong Zhao Supervised by (position+printed name+signature) ... : Project Engineer Xiaodong Zhao Approved by (position+printed name+signature) ... : Manager Xu Yang 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 corresponds to the test sample. Report No.: CHTEW23090007 Page: 2 of 16 Date of issue: 2023-08-31 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) Contents 1. TEST STANDARDS AND REPORT VERSION ........................................... 3 1.1. Test Standards 3 1.2. Report version information 3 2. TEST DESCRIPTION .................................................................... 4 3. SUMMARY ............................................................................... 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Testing Laboratory Information 5 4. TEST CONFIGURATION ................................................................. 6 4.1. Descriptions of test mode 6 4.2. Configuration of Tested System 6 4.3. Support unit used in test configuration 7 4.4. Environmental conditions 7 4.5. Statement of the measurement uncertainty 7 4.6. Equipments Used during the Test 8 5. TEST CONDITIONS AND RESULTS ..................................................... 9 5.1. Conducted Emissions 9 5.2. Radiated Emissions 11 6. TEST SETUP PHOTOS OF THE EUT .................................................. 15 7. EXTERNAL AND INTERNAL PHOTOS OF THE EUT .................................. 16 Report No.: CHTEW23090007 Page: 3 of 16 Date of issue: 2023-08-31 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 1. TEST STANDARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: FCC CFR Title 47 Part 15 Subpart B - Unintentional Radiators ANSI C63.4: 2014 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40GHz 1.2. Report version information Revision No. Date of issue Description N/A 2023-08-31 Original Report No.: CHTEW23090007 Page: 4 of 16 Date of issue: 2023-08-31 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 2. TEST DESCRIPTION Section Test Item Section in CFR 47 Result #1 Test Engineer 5.1 Conducted Emissions 15.107(a) PASS JUNMAN.WANG 5.2 Radiated Emissions 15.109(a) PASS YIFAN,WANG JUNMAN.WANG Note: #1: The test result does not include measurement uncertainty value Report No.: CHTEW23090007 Page: 5 of 16 Date of issue: 2023-08-31 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 3. SUMMARY 3.1. Client Information Applicant: Resvent Medical Technology Co., Ltd. Address: BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community,Xin’an Street, Bao’an District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Manufacturer: Resvent Medical Technology Co., Ltd. Address: BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community,Xin’an Street, Bao’an District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Factory: Resvent Medical Technology Co., Ltd. Address: BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community,Xin’an Street, Bao’an District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA 3.2. Product Description Main unit information: Product Name: RXiBreeze PAP System Trade Mark: - Model No.: RXiBreeze III APAP Pro Listed Model(s): RXiBreeze III CPAP, RXiBreeze III CPAP Pro, RXiBreeze III APAP Power supply: DC 24.0V from adapter Hardware version: 1.0 Software version: V01.00.00 Accessory unit information: Adapter information: Model: LXCP61(II)-024300 Input:100-240Va.c., 50/60Hz 1.5Amax. Output:24.0Vd.c., 3.0A 3.3. Testing Laboratory Information Laboratory Name Shenzhen Huatongwei International Inspection Co., Ltd. Laboratory Location 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Contact information: Tel: 86-755-26715499 E-mail: c…

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Test setup photos-Part15B Conducted Emissions (AC Mains) Radiated Emissions (30MHz-1GHz) Radiated Emissions (Above 1GHz)