2A2R4WIT-S400Oximeter

Instructions for use of positive pressure ventilation treatment About this manual The manual mainly introduces the installation and application method of postive airway pressure device .Users should read carefully before application (include warnings, contraindications and notes). Manufacturer Shenzhen Hingmed Medical Instrument Co., Ltd. Manufacturing address: 4 th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, People’s Republic of China Tel: +86 755 23730601 Fax: +86 755 23730602 Post code: 518102 After-sales service Company: Shenzhen Hingmed Instruments Co., Ltd. Address: 4 th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, People’s Republic of China Tel: +86 755 23730601 Fax: +86 755 23730602 Post code: 518102 European Representative Company Name:Wellkang Ltd Company Address: Enterprise Hub, NW Business Complex, 1 Beraghmore Road,Derry, BT48 8SE, Northern Ireland,UK. Te l :+44(20)3287 6300 Fax:+44(20)76811874 Web:www.wellkang.ltd.uk & www.CE-marking.eu Email: [email protected] Version Information This manual may upgrade due to software upgrading. User will not be notified further. ■ Version: A/0 ■ Issue date: Feb. 2023 Software version:V1 Shenzhen Hingmed Medical Instruments Co., Ltd. owns and reserves the copyright. Note: This is a generic versi on of the manual, which contains the positive pressure ventilation machine and oximeter A certified wireless module is built into the positive pressure ventilator, which has a label artwork that shows "contains FCC ID: 2AHMR-ESP32-S". Table of Content 1 Safety .................................................................................................................. 5 1.1 Purpose ..................................................................................................... 5 1.2 Safety information ................................................................................... 5 1.3 Terms and definitions ............................................................................. 13 1.4 Graphs and symbols ............................................................................... 15 2 Equipment brief introduction ............................................................................ 18 2.1 Equipment list ........................................................................................ 18 2.2 Equipment introduction ......................................................................... 18 3. Equipment installation ..................................................................................... 21 3.1. Change of the air inlet filter element with it ......................................... 22 3.2, and the humidifier ................................................................................. 23 3.3 Respiratory line ...................................................................................... 24 3.4 TF card ................................................................................................... 25 3.5 Power supply .......................................................................................... 25 3.6 Blood Oxygen module ........................................................................... 25 3.7 The carbon dioxide module ................................................................... 26 3.8 Preparation before use ............................................................................ 26 4 Equipment operation ......................................................................................... 26 4.1 Start the machine.................................................................................... 26 4.2 Setting-up ............................................................................................... 27 4.3 Sleep report interface ............................................................................. 27 4.4 Treatment Interface ................................................................................ 28 4.5 Set up options and description ............................................................... 29 5. Equipment maintenance and cleaning ............................................................. 39 5.1 Equipment disassembly ......................................................................... 39 5.2 Maintenance of the equipment ............................................................... 40 5.3 Cleaning of the equipment ..................................................................... 41 5.4 Equipment handover .............................................................................. 42 5.5. Carry ..................................................................................................... 42 5.6 Common fault analysis .......................................................................... 42 5.7 Service.................................................................................................... 46 6 Appendix List .................................................................................................... 47 appendix ............................................................................................................... 47 A technical specifications ............................................................................ 47 B Pressure capacity curve: ........................................................................... 51 C. Electromagnetic compatibility information is in compliance with radio management ................................................................................................. 76 1 Safety 1.1 Purpose Suitable for patients weighing above 30kg. Suitable for patients with obstructive sleep apnea hypopnea syndrome; double level positive pressure therapy is also used for the treatment of sleep apnea with chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS). None of these equipment is available for life support. Could not be used for …

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UNITED STATES DESIGNATED AGENT LETTER TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Applicant Company Name: Shenzhen Hingmed Medical Instrument Co., Ltd. Grantee Code: Contact Name: Address: Telephone: Email: 2A2R4 Huang Yongban 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District Shenzhen China 518102 +86755234206946 [email protected] Applicable Equipment: FCC ID:2A2R4WIT-S400 ATTN: Director of Certification: Date: 2023-10-12 U.S. designated agent Company Name : United Consulting Technology Services Co., Ltd. FRN: 0033495714 Contact Name: Address: Telephone: Email: David Wu 17800 CASTLETON ST STE 665 CITY OF INDUSTRY CA 91748 United States (626) 217-4022 David芦ts.com We, < Shenzhen Hingmed Medical Instrument Co., Ltd.> and< United Consulting Technology Services Co., Ltd. > understand and acknowledge the applicants consent and the designated agent's obligation to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and e-mail of the designated agent listed above. We, < Shenzhen Hingmed Medical Instrument Co., Ltd.> and < United Consulting Technology Services Co., Ltd. > acknowledge the applicant's acceptance of its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Applicant Name (Printed): H Title: Manager Signature: U.S. designated agent Name (Printed): David Wu T itle: CEO Signature:

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A02 Rev.A/0 Page: 1 of 4 Appendix External Photos for SZCR2305001355ME FCC ID:2A2R4WIT-S400 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A02 Rev.A/0 Page: 2 of 4 EUT Constructional Details (EUT Photos) SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A02 Rev.A/0 Page: 3 of 4 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A02 Rev.A/0 Page: 4 of 4 - End of the Appendix -

Wellkang LtdWellkang Ltd YYYY-MM YYYY-MM Model: HM-ST30Pro Shenzhen Hingmed Medical Instrument Co.,Ltd.Shenzhen Hingmed Medical Instrument Co.,Ltd. Shenzhen Hingmed Medical Instrument Co.,Ltd. 4F,Zhonghangfeixiang Building, NO.371,4F,Zhonghangfeixiang Building, NO.371, Guangshen Road, Baoan District,Shenzhen,China.Guangshen Road, Baoan District,Shenzhen,China. xxxxxxxxxxxx Power: DC 3.0V (2*1.5V AAA battery) Oximeter FCC ID : 2A2R4WIT-S400

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A03 Rev.A/0 Page: 1 of 5 Appendix Internal Photos for SZCR2305001355ME FCC ID:2A2R4WIT-S400 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A03 Rev.A/0 Page: 2 of 5 EUT Constructional Details (EUT Photos) Label Location SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A03 Rev.A/0 Page: 3 of 5 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A03 Rev.A/0 Page: 4 of 5 Antenna SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A03 Rev.A/0 Page: 5 of 5 - End of the Appendix -

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135503 Page: 1 of 9 Keny Xu EMC Laboratory Manager 1 Cover page RF Exposure Report Application No.: SZCR2305001355ME Applicant: Shenzhen Hingmed Medical Instrument Co., Ltd. Address of Applicant: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Manufacturer: Shenzhen Hingmed Medical Instrument Co., Ltd. Address of Manufacturer: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Factory: Shenzhen Hingmed Medical Instrument Co., Ltd. Address of Factory: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Equipment Under Test (EUT): EUT Name: Oximeter Model No.: HM-ST30Pro Trade mark: HINGMED FCC ID: 2A2R4WIT-S400 Standards: FCC Rules 47 CFR §2.1093 KDB 447498 D04 interim General RF Exposure Guidance v01 Date of Receipt: 2023-05-08 Date of Test: 2023-06-26 to 2023-07-18 Date of Issue: 2023-07-18 Test Result : Pass* * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135503 Page: 2 of 9 2 Version Revision Record Version Chapter Date Modifier Remark 01 2023-07-18 Original Authorized for issue by: Edison Li/Project Engineer Eric Fu/Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135503 Page: 3 of 9 3 Contents Page 1 Cover page ............................................................................................................................................. 1 2 Version ................................................................................................................................................... 2 3 Contents ................................................................................................................................................ 3 4 General Information............................................................................................................................... 4 4.1 General Description of E.U.T. .......................................................................................................... 4 4.2 General Description of EUT ............................................................................................................. 4 4.3 Separation Distance ........................................................................................................................ 4 4.4 Test Location .................................................................................................................................. 5 4.5 Test Facility ..................................................................................................................................... 5 4.6 Deviation from Standards ................................................................................................................ 5 4.7 Abnormalities from Standard Conditions .......................................................................................... 5 4.8 Other Information Requested by the Customer ................................................................................ 5 5 FCC Radiofrequency radiation exposure limits ................................................................................... 6 5.1 Blanket 1 mW Blanket Exemption .................................................................................................... 6 5.2 MPE-based Exemption .................................................................................................................... 6 5.3 SAR-based Exemption .................................................................................................................... 7 6 Measurement and Calculation .............................................................................................................. 9 6.1 Maximum transmit power ................................................................................................................ 9 6.2 RF Exposure Calculation ................................................................................................................. 9 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135503 Page: 4 of 9 4 General Information 4.1 General Description of E.U.T. Product Type: Portable device Mobile device Fixed device 4.2 General Description of EUT Power supply: DC 3V Operation Frequency: 2402MHz to 2480MHz Bluetooth Version: V4.2 Modulation Type: GFSK Number of Channels: 40 Channel Spacing: 2MHz Data rate: 1Mbps Antenna Type: PCB Antenna Antenna Gain: -7.16dBi Remark:The information in this section is provided by the applicant or manufacturer, SGS is not liable to the accuracy, suitability, reliability or/and integrity of the information. 4.3 Separation Distance Minimum test separation distance: 5mm Remark: This minimum test separation distance is determined by the smallest distance from the antenna and radiating structures or outer surface of the device, according to the host form factor, exposure conditions and platform requirements, to any part of the body or extremity of a user or bystander. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135503 Page: 5 of 9 4.4 Test Location All tests were performed at: SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch No. 1 Workshop, M-10, Middle Section, Science & Technology Park, Nanshan District, Shenzhen, Guangdong, China. 518057. Telephone: +86 (0) 755 2601 2053 Fax: +86 (0) 755 2671 0594 No tests were sub-contracted. 4.5 Test Facility The test facility is recognized, certified, or accredited by the following organ…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135504 Page: 1 of 17 Keny Xu EMC Laboratory Manager ANTENNA PASSIVE TEST REPORT Application No. SZCR2305001355ME Applicant Shenzhen Hingmed Medical Instrument Co., Ltd. Manufacturer Shenzhen Hingmed Medical Instrument Co., Ltd. Product Name Oximeter Model No. HM-ST30Pro Standards ANSI/IEEE Std 149-2008 Date Initial Sample(s) Received 2023-05-08 Testing Start Date 2023-10-16 Testing Finish Date 2023-10-17 Report Issue Date 2023-10-17 *In the configuration tested, the EUT detailed in this report complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135504 Page: 2 of 17 Revision Record Version Chapter Date Modifier Remark 01 2023-10-17 Original Authorized for issue by: Reviewed by Mark Mao Approved by Eric Fu SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135504 Page: 3 of 17 2 Revision Version Report No. Version Date Memo SZCR2305001355ME 00 10/17 Initial creation of report SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135504 Page: 4 of 17 3 Contents Page 1 COVER PAGE ..................................................................................................................................... 1 2 REVISION VERSION ........................................................................................................................... 3 3 CONTENTS ......................................................................................................................................... 4 4 GENERAL INFORMATION .................................................................................................................. 5 4.1 TESTING LABORATORY .................................................................................................................... 5 4.2 DETAILS OF APPLICANT ................................................................................................................... 5 4.3 DETAILS OF MANUFACTURER ........................................................................................................... 5 4.4 GENERAL DESCRIPTION OF EUT ...................................................................................................... 5 4.5 TEST PROCEDURE .......................................................................................................................... 6 4.6 TEST SPECIFICATION ...................................................................................................................... 6 4.7 LABORATORY ENVIRONMENT ........................................................................................................... 6 4.8 TEST LOCATION ............................................................................................................................. 7 4.9 TEST FACILITY ............................................................................................................................... 7 4.10 DEVIATION FROM STANDARDS ......................................................................................................... 7 4.11 ABNORMALITIES FROM STANDARD CONDITIONS ................................................................................. 7 5 OTA MEASUREMENTS SYSTEM CONFIGURATION ......................................................................... 8 5.1 TEST CONFIGURATION .................................................................................................................... 8 6 EQUIPMENT LIST ............................................................................................................................... 9 7 MEASUREMENT UNCERTAINTY.......................................................................................................10 8 TEST RESULT ....................................................................................................................................11 8.1 TEST SUMMARY .............................................................................................................................11 8.2 BT ANTENNA TEST RESULTS ..........................................................................................................11 9 PATTERN PLOTS ...............................................................................................................................12 10 3-D ANTENNA PATTERN ...................................................................................................................14 11 THE EUT AND TEST CONFIGURATION ............................................................................................16 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135504 Page: 5 of 17 4 General Information 4.1 Testing Laboratory Test Lab SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Address No.1 Workshop, M-10, Middle section, Science & Technology Park, Nanshan District, Shenzhen, Guangdong, China 518057 Contact Mark Mao Tel. +86 (0) 755 2532 8628 Fax +86 (0) 755 2671 0594 E-mail [email protected] 4.2 Details of Applicant Applicant’s Name Shenzhen Hingmed Medical Instrument Co., Ltd. Applicant’s Address 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Contact Huang yongban Tel. +86755234206946 E-mail [email protected] 4.3 Details of Manufacturer Manufacturer’s Name Shenzhen Hingmed Medical Instrument Co., Ltd. Manufacturer’s Address 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Contact Huang yongban Tel. +86755234206946 E-mail [email protected] 4.4 General Description of EUT Device Description: finger oximeter Device Manufacturer: Shenzhen Hingmed M…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135502 Page: 1 of 51 Keny Xu EMC Laboratory Manager TEST REPORT Application No.: SZCR2305001355ME Applicant: Shenzhen Hingmed Medical Instrument Co., Ltd. Address of Applicant: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Manufacturer: Shenzhen Hingmed Medical Instrument Co., Ltd. Address of Manufacturer: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Factory: Shenzhen Hingmed Medical Instrument Co., Ltd. Address of Factory: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen, 518102, China Equipment Under Test (EUT): EUT Name: Oximeter Model No.: HM-ST30Pro Trade mark: HINGMED FCC ID: 2A2R4WIT-S400 Standard(s) : 47 CFR Part 15, Subpart C 15.247 Date of Receipt: 2023-05-08 Date of Test: 2023-06-26 to 2023-07-18 Date of Issue: 2023-07-18 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135502 Page: 2 of 51 Revision Record Version Chapter Date Modifier Remark 01 2023-07-18 Original Authorized for issue by: Edison Li/Project Engineer Eric Fu/Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135502 Page: 3 of 51 2 Test Summary Radio Spectrum Technical Requirement Item Standard Method Requirement Result Antenna Requirement 47 CFR Part 15, Subpart C 15.247 N/A 47 CFR Part 15, Subpart C 15.203 & 15.247(b)(4) Pass Radio Spectrum Matter Part Item Standard Method Requirement Result Conducted Peak Output Power 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.9.1 47 CFR Part 15, Subpart C 15.247(b)(3) Pass Minimum 6dB Bandwidth ANSI C63.10 (2013) Section 11.8.1 47 CFR Part 15, Subpart C 15.247a(2) Pass Power Spectrum Density ANSI C63.10 (2013) Section 11.10.2 47 CFR Part 15, Subpart C 15.247(e) Pass Conducted Band Edges Measurement ANSI C63.10 (2013) Section 11.13.3.2 47 CFR Part 15, Subpart C 15.247(d) Pass Conducted Spurious Emissions ANSI C63.10 (2013) Section 11.11 47 CFR Part 15, Subpart C 15.247(d) Pass Radiated Emissions which fall in the restricted bands ANSI C63.10 (2013) Section 6.10.5 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Radiated Spurious Emissions Below 1GHz ANSI C63.10 (2013) Section 6.4,6.5 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Radiated Spurious Emissions Above 1GHz ANSI C63.10 (2013) Section 6.6 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/0 Aug01,2022 Report No.: SZCR230500135502 Page: 4 of 51 3 Contents Page 1 Cover Page ......................................................................................................................................... 1 2 Test Summary ..................................................................................................................................... 3 3 Contents ............................................................................................................................................. 4 4 General Information............................................................................................................................ 6 4.1 Details of E.U.T. ........................................................................................................................... 6 4.2 Description of Support Units ......................................................................................................... 6 4.3 Measurement Uncertainty ............................................................................................................ 6 4.4 Test Location ............................................................................................................................... 7 4.5 Test Facility .................................................................................................................................. 7 4.6 Deviation from Standards ............................................................................................................. 7 4.7 Abnormalities from Standard Conditions ....................................................................................... 7 5 Equipment List ................................................................................................................................... 8 6 Radio Spectrum Technical Requirement ..........................................................................................10 6.1 Antenna Requirement .................................................................................................................10 6.1.1 Test Requirement: ..................................................................................................................10 6.1.2 Conclusion ..............................................................................................................................10 7 Radio Spectrum Matter Test Results ................................................................................................11 7.1 Conducted Peak Output Power ...................................................................................................11 7.1.1 E.U.T. Operation .....................................................................................................................11 7.1.2 Test Mode Description ............................................................................................................11 7.1.3 Test Setup Diagram ................................................................................................................11 7.1.4 Measurement Procedure and Data ..........................................................…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A04 Rev.A/0 Page: 1 of 3 Appendix Test Setup Photos for SZCR2305001355ME FCC ID:2A2R4WIT-S400 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A04 Rev.A/0 Page: 2 of 3 Test Setup Photo Radiated Spurious Emissions Below 1GHz Radiated Spurious Emissions Above 1GHz SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-A04 Rev.A/0 Page: 3 of 3 Radiated Emissions which fall in the restricted bands - End of the Appendix -