2A6LY-0003RXiBreeze 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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External Photos

Internal Photos

FCC ID: 2A6LY-0003 RF Exposure Evaluation LIMIT 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 ) Averaging time (minutes) (A) Limits for Occupational/Controlled 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 6 300–1500 - - f/300 6 1500–100,000 - - 5 6 (B) Limits for General Population/Uncontrolled Exposure 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 30 300–1500 - - f/1500 30 1500–100,000 - - 1.0 30 Note: f = frequency in MHz EVALUATION METHOD Transmission formula: Pd = (Pout*G)/(4*pi*r 2 ) Where Pd = power density in mW/cm 2 , Pout = output power to antenna in mW, G = gain of antenna in linear scale; Pi = 3.1416, R = distance between observation point and center of the radiator in cm TEST RESULT Passed Not Applicable Radio Type Frequency range (MHz) Conducted Average Power (dBm) Maximum Tune-up (dBm) Power Density (mW/cm2) Limit (mW/cm2) Result WIFI 2412-2472 13.94 14.00 0.0099 1.0000 Pass Note: 1) The maximum antenna gain is 2.96dBi 2) The exposure evaluation safety distance is 20cm.

Page: 1 of 42 TEST REPORT For WiFi-2.4GHz Band Report No. ...................................... : CHTEW23070102 Report Verification: Project No.................................： SHT2305054201EW FCC ID ............................................. : 2A6LY-0003 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 C § 15.247 Date of receipt of test sample..........: May.31,2023 Date of testing.............................: May.31,2023- Jul.27,2023 Date of issue...............................: Jul.28,2023 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 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.: CHTEW23070102 Page: 2 of 42 Date of issue: 2023-07-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-0 3) ` Contents 1. TEST STANDARDS AND REPORT VERSION 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 6 3.4. Testing Laboratory Information 6 4. TEST CONFIGURATION 7 4.1. Test frequency list 7 4.2. Test mode 7 4.3. Test sample information 8 4.4. Support unit used in test configuration and system 8 4.5. Testing environmental condition 8 4.6. Statement of the measurement uncertainty 9 4.7. Equipment Used during the Test 10 5. TEST CONDITIONS AND RESULTS 11 5.1. Antenna Requirement 11 5.2. AC Conducted Emission 12 5.3. Peak Output Power 14 5.4. Power Spectral Density 15 5.5. 6dB bandwidth 16 5.6. 99% Occupied Bandwidth 17 5.7. Duty Cycle 18 5.8. Conducted Band edge and Spurious Emission 19 5.9. Radiated Band edge Emission 21 5.10. Radiated Spurious Emission 26 6. TEST SETUP PHOTOS 34 7. EXTERNAL AND INTERNAL PHOTOS 36 7.1. External Photos 36 7.2. Internal Photos 39 8. APPENDIX REPORT 42 Report No.: CHTEW23070102 Page: 3 of 42 Date of issue: 2023-07-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-0 3) ` 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 C § 15.247: Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz ‒ ANSI C63.10:2020: 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 2023-07-28 Original Report No.: CHTEW23070102 Page: 4 of 42 Date of issue: 2023-07-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-0 3) ` 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 PASS Junman Wang 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 Yifan Wang 5.10 Radiated Spurious Emission 15.247(d)/15.205/15.209 PASS Yifan Wang Note: ‒ The measurement uncertainty is not included in the test result. ‒ *1: No requirement on standard, only report these test data. Report No.: CHTEW23070102 Page: 5 of 42 Date of issue: 2023-07-28 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-0 3) ` 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:…

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Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 1 of 35 APPENDIX REPORT Project No. SHT2305054201EW Radio Specification WIFI 2.4G Test sample No. YPHT23050542002 Model No. RXiBreeze 30STA Start test date 2023-06-13 Finish date 2023-06-13 Temperature 24.9°C Humidity 68% Test Engineer Xiaoqin Li Auditor Appendix clause Test item Result A Conducted 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.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 2 of 35 Appendix A：Conducted Peak Output Power Type Channel Peak Output power (dBm) Average Output power (dBm) Limit (dBm) Result 802.11b 01 16.13 13.94 ≤ 30.00 Pass 06 15.18 13.28 11 13.94 11.74 802.11g 01 16.22 12.50 ≤ 30.00 Pass 06 15.58 12.04 11 14.06 10.48 802.11n (HT20) 01 16.25 12.64 ≤ 30.00 Pass 06 15.51 12.00 11 13.98 10.52 802.11n(HT40) 03 16.08 12.32 ≤ 30.00 Pass 06 15.85 12.12 09 15.01 11.32 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 3 of 35 Appendix B：Power Spectral Density Type Channel Power Spectral Density (dBm/30KHz) Limit (dBm/3KHz) Result 802.11b 01 -2.76 ≤8.00 Pass 06 -4.35 11 -5.33 802.11g 01 -7.39 ≤8.00 Pass 06 -7.80 11 -9.64 802.11n(HT20) 01 -8.03 ≤8.00 Pass 06 -8.63 11 -10.27 802.11n(HT40) 03 -10.91 ≤8.00 Pass 06 -10.89 09 -12.09 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 4 of 35 Type: 802.11 b CH01 Date: 13.JUN.2023 09:56:23 CH06 Date: 13.JUN.2023 09:59:38 CH11 Date: 13.JUN.2023 10:01:25 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 5 of 35 Type: 802.11 g CH01 Date: 13.JUN.2023 10:05:04 CH06 Date: 13.JUN.2023 10:07:16 CH11 Date: 13.JUN.2023 10:09:12 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 6 of 35 Type: 802.11n(HT20) CH01 Date: 13.JUN.2023 10:12:14 CH06 Date: 13.JUN.2023 10:14:24 CH11 Date: 13.JUN.2023 10:16:09 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 7 of 35 Type: 802.11n(HT40) CH03 Date: 13.JUN.2023 10:19:02 CH06 Date: 13.JUN.2023 10:21:03 CH09 Date: 13.JUN.2023 10:22:35 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 8 of 35 Appendix C：6dB bandwidth Type Channel 6dB Bandwidth (MHz) Limit (MHz) Result 802.11b 01 9.24 ≥0.5 Pass 06 9.60 11 10.11 802.11g 01 16.41 ≥0.5 Pass 06 16.62 11 16.59 802.11n(HT20) 01 17.67 ≥0.5 Pass 06 17.67 11 17.64 802.11n(HT40) 03 33.12 ≥0.5 Pass 06 32.34 09 32.52 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 9 of 35 Type: 802.11 b CH01 Date: 13.JUN.2023 09:55:41 CH06 Date: 13.JUN.2023 09:59:00 CH11 Date: 13.JUN.2023 10:00:39 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 10 of 35 Type: 802.11 g CH01 Date: 13.JUN.2023 10:04:27 CH06 Date: 13.JUN.2023 10:06:33 CH11 Date: 13.JUN.2023 10:08:24 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 11 of 35 Type: 802.11n(HT20) CH01 Date: 13.JUN.2023 10:10:45 CH06 Date: 13.JUN.2023 10:13:39 CH11 Date: 13.JUN.2023 10:15:20 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 12 of 35 Type: 802.11n(HT40) CH03 Date: 13.JUN.2023 10:17:45 CH06 Date: 13.JUN.2023 10:20:26 CH09 Date: 13.JUN.2023 10:21:56 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 13 of 35 Appendix D：99% Occupied Bandwidth Type Channel 99% Bandwidth (MHz) Limit (kHz) Result 802.11b 01 12.98 - Pass 06 12.92 11 12.92 802.11g 01 17.35 - Pass 06 17.41 11 17.68 802.11n(HT20) 01 18.16 - Pass 06 18.19 11 18.13 802.11n(HT40) 03 34.83 - Pass 06 34.89 09 34.89 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 14 of 35 Type: 802.11 b CH01 Date: 13.JUN.2023 09:55:53 CH06 Date: 13.JUN.2023 09:59:07 CH11 Date: 13.JUN.2023 10:00:46 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 15 of 35 Type: 802.11 g CH01 Date: 13.JUN.2023 10:04:35 CH06 Date: 13.JUN.2023 10:06:41 CH11 Date: 13.JUN.2023 10:08:32 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 16 of 35 Type: 802.11n(HT20) CH01 Date: 13.JUN.2023 10:10:53 CH06 Date: 13.JUN.2023 10:13:47 CH11 Date: 13.JUN.2023 10:15:28 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 17 of 35 Type: 802.11n(HT40) CH03 Date: 13.JUN.2023 10:17:52 CH06 Date: 13.JUN.2023 10:20:34 CH09 Date: 13.JUN.2023 10:22:03 Project No.: SHT2305054201EW Radio Specification: WIFI 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 18 of 35 Appendix E：Duty Cycle Modulation Type Test Frequency （MHz） T on time for single burst (ms) T period (ms) Duty cycle 1/T on time (kHz) 11b 2437 32.90 32.94 99.9% 0.03 11g 2437 5.46 5.49 99.5% 0.18 11n20 2437 5.05 5.07 99.6% 0.20 11n40 2437 2.45 2.48 98.8% 0.41 11b Date: 13.JUN.2023 09:58:51 11g Date: 13.JUN.2023 1…

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Shenzhen Zonke Melly Technology Co., Ltd 1 / 12 Approval Sheet Customer Resvent Medical Technology Co., Ltd Project Model HR01 Product Name 2.4G Wifi Cable Custome P/N 09901-010006-00 Internal P/N RX-001 Sample Version A Customer Marketing Design Signature Qinghua Mao Deshu Qi Date 2022/5/1 2022/4/30 Shenzhen Zonke Melly Technology Co., Ltd 2 / 12 Change History Version Date Description Comments A 2022/4/18 First Version Shenzhen Zonke Melly Technology Co., Ltd 3 / 12 1. Description The approval sheet is for the Wifi cable on HR01 project a) WIFI cable working frequency range 2400~2500MHz b) The kind of WIFI cable takes FPC material 2. WIFI Cable Picture 3. Parameters A. Electrical Characteristics Frequency VSWR Efficiency Impedance Polarization Peakgain Type 2400 MHz ~2500 MHz <3 >47% 50 Ohm ±15% Linear 2.96dbi Shenzhen Zonke Melly Technology Co., Ltd 4 / 12 Line Loss 2400 MHz ~2500 MHz 0.5db B. Material & Mechanical Characteristics Materical of Radiator Cable Type Connetor Type FPC Black Cable ∅0.81mm black Gen3 Terminal C. Environmental Operation Temperature Storage Temperature -40° C ~ + 80° C -45° C ~ + 90° C 4. Adjust and Test Equipment 4.1 Test Instrument Agilent E5071B is applied to test VSWR by connecting to mobile phone fi xture, the test condition is free space 4.2 Test Environment and Method Test Environment: Temperature 22°C±3°C，Humidity 50%±15% Anechoic Chamber Spec：7*4*3; 5*3*3 TD-SCDMA Test Equipment：Agilent 8960 LTE-TDD/FDD-SCDMA Test Equipment：StarPoint SP8011/CMW500/Anritsu MT8820C WCDMA/GSM/CDMA Test Equipment：Agilent 8960 Passive Efficiency Test Equipment：Agilent Technologies E5071B Shenzhen Zonke Melly Technology Co., Ltd 5 / 12 Test Equipment Pictures： Shenzhen Zonke Melly Technology Co., Ltd 6 / 12 5. WIFI Cable Test Data 5.1 SWR 5.2 Passive Test Result for Frequency Band 5.3 Apple Diagram Shenzhen Zonke Melly Technology Co., Ltd 7 / 12 5.4 Field Pattern XY Axis XZ Axis YZ Axis 5.5 TRP & TIS 5.6 UUT Picture Shenzhen Zonke Melly Technology Co., Ltd 8 / 12 5.7 WIFI Cable Installation Notice The antenna need to be sticked along with the instrument edge 5.8 Ambient Environment Suggestion The power line need to be away from antenna as far as possible, and keep the good consistence Shenzhen Zonke Melly Technology Co., Ltd 9 / 12 6. Mechanical 6.1 2D Drawing Shenzhen Zonke Melly Technology Co., Ltd 10 / 12 6.2 WIFI Cable Inspection Shenzhen Zonke Melly Technology Co., Ltd 11 / 12 6.3 ROHS 6.4 BOM Shenzhen Zonke Melly Technology Co., Ltd 12 / 12 7. Package Package Requirement Customer Resvent Project Model HR01 Customer P/N 09901-010006-00 Date 2022-4-18 Product Name 2.4 G WIFI Cable Internal P/N RX-001 Storage： Temperature 20° C & Humidity 75% Package Material MOQ：100PCS/ a small bag No Description Spec 1 Sealable Bag 250*170mm 2 Carton 300*200*180mm 100pcs for a small bag 10 small bags for 1 big bag Package instruction 1000PCS/a big bag and labelling Packed according to order Outer box label

TEST SETUP PHOTOS Radiated Emission AC Conducted Emission