2A6LY-0005RXiBreeze PAP System

UserManual RXiBreezePAPSystem Contents 1Welcome.........................................................................................................................................................1 2IndicationsforUse..........................................................................................................................................1 3Contraindications............................................................................................................................................1 4SafetyInformation..........................................................................................................................................1 5SymbolsGlossary...........................................................................................................................................7 6SystemContents............................................................................................................................................9 7SystemOverview..........................................................................................................................................10 7.1PlacingtheDevice..........................................................................................................................12 7.2SupplyingACPower.......................................................................................................................12 7.3ConnectingtheBreathingCircuitorHeatedTube........................................................................13 7.4Water-fillingOperation....................................................................................................................15 8NavigatingtheDeviceScreens....................................................................................................................16 9Operation......................................................................................................................................................18 9.1StartingtheDevice..........................................................................................................................18 9.2PatientMenuNavigationSettings..................................................................................................18 9.2.1PatientStandbyInterface............................................................................................................18 9.2.2PatientTherapyInterface............................................................................................................20 9.2.3PatientComfortSetting................................................................................................................22 9.2.4PatientSystemSetting.................................................................................................................24 9.2.5PatientReportMenu....................................................................................................................26 9.2.6SDCard........................................................................................................................................27 9.2.7Wirelessmodule...........................................................................................................................27 10DeviceAlert.................................................................................................................................................30 11Troubleshooting..........................................................................................................................................33 12CleaningandMaintaining...........................................................................................................................36 12.1CleaningandDisinfectionProcessandScheduleforDeviceSurface.......................................36 12.2CleaningandDisinfectionProcessandSchedulefor(Watertank,airoutletadaptor,airoutlet ofwatertank).........................................................................................................................................37 12.3CleaningSchedule........................................................................................................................38 12.4DisinfectionSchedule....................................................................................................................38 12.5Installing/ReplacingtheAirFilter..................................................................................................38 12.6TravelingwiththeDevice..............................................................................................................39 12.7DeviceMaintenance......................................................................................................................39 13Maintenance................................................................................................................................................39 14StorageandDisposal.................................................................................................................................40 14.1Storage..........................................................................................................................................40 14.1.1StorageInformation....................................................................................................................40 14.1.2Storingthetherapydevice.........................................................................................................40 14.2Disposal.........................................................................................................................................40 15Specification................................................................................................................................................41 16EMCDeclaration.....................................................................................................................................…

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Resvent Medical Technology Co., Ltd. Covered Equipment Certification Attestation Letter 4/29/2024 Nemko N orth America, Inc 303 River Road Ottawa K1V 1 H2 C anada ATTN.: Reviewing E ngineer FCC 1D:2A6LY-0005 (Resvent Medical Technology Co., Ltd.) certifies that the equipment for which authorization is sought is not "covered" equipment prohibited from receiving an e quipment authorization pursuant to section 2.903 of the FCC rules. Note: If the equipment for which the applicant seeks authorization is produced by any of the entities iden的edon the current Covered List, the applicant should include an explanation on why the equipment is not "covered" equipment. (Resvent Medical Technology Co., Ltd.) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing "covered" equipment. Signed: 心妇勹 Printed name: Martin.Wong Title: Regulatory Director Company Name: manager Resvent Medical Technology Co., Ltd. Date:2024/04/29

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Page: 1 of 16 TEST REPORT For FCC Part15B Report No. .......................................: CHTEW23090004 Report verification: Project No. ..................................: SHT2308012301EW FCC ID ............................................. : 2A6LY-0005 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 30STA Listed Model(s) ................................. : RXiBreeze 25S,RXiBreeze 25ST,RXiBreeze 30ST,RXiBreeze 25A,RXiBreeze 25STA Standard ......................................... : FCC CFR Title 47 Part 15 Subpart B Date of receipt of test sample...........: Aug.03, 2023 Date of testing..............................: Aug.03, 2023- Sep.01, 2023 Date of issue.................................: Sep.04, 2023 Result .................. ........................: Pass Compiled by (position+printed name+signature) ... : File administrator Kiki Kong Supervised by (position+printed name+signature) ... : Project Engineer Kiki Kong Approved by (position+printed name+signature) ... : RF 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.: CHTEW23090004 Page: 2 of 16 Date of issue: 2023-09-04 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 6 4. TEST CONFIGURATION ................................................................. 7 4.1. Descriptions of test mode 7 4.2. Support unit used in test configuration 7 4.3. Environmental conditions 7 4.4. Statement of the measurement uncertainty 7 4.5. 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.: CHTEW23090004 Page: 3 of 16 Date of issue: 2023-09-04 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 2023-09-04 Original Report No.: CHTEW23090004 Page: 4 of 16 Date of issue: 2023-09-04 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 Chuanfeng Li Note: #1: The test result does not include measurement uncertainty value Report No.: CHTEW23090004 Page: 5 of 16 Date of issue: 2023-09-04 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 30STA Listed Model(s): RXiBreeze 25,RXiBreeze 25ST,RXiBreeze 30ST,RXiBreeze 25A,RXiBreeze 25STA 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 Report No.: CHTEW23090004 Page: 6 of 16 Date of issue: 2023-09-04 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05 (2023-03) 3.3. Testing Laboratory Information Laboratory Name Shenzhen Huatongwei International Inspection Co., Ltd. Laboratory Location 1/F, Bldg 3, Hongfa Hi-tech Industri…

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TEST SETUP PHOTOS OF THE EUT Conducted Emissions (AC Mains) R adiated Emissions (30MHz-1GHz) R adiated Emissions (Above 1GHz)