2ASLFGZHX-A9Pulmonary Function Tester

Product user manual Pulmonary Function Tester Model: A9 PLEASE READ ALL THE INFORMATION IN THE PACKAGE INSERT BEFORE USING THE PULMONARY FUNCTION TESTER. IF YOU DO NOT UNDERSTAND THE INSTRUCTIONS, CONSULT HOMESUN, CALL 400-030-1510 (Working Time: from Monday to Friday, Beijing time 9:00-18:00), OR WRITE TO [email protected]. Guangzhou Homesun Medical Technology Co., Ltd Version: Release date: Foreword This product manual contains important content that must be understood for the safe and correct use of this product, and is a part of this product. Therefore, during the entire service life of this product, the instruction manual must be placed at the operating location of the equipment at any time for reference. This product must be operated by personnel who have received relevant training and have relevant knowledge and experience. All personnel must read this manual carefully before using this product. This instruction manual should be forwarded to the subsequent owners or users of this product. This manual contains copyright information, and Guangzhou Homesun Medical Technology Co., Ltd reserves all rights. Without the prior written approval of Guangzhou Homesun Medical Technology Co., Ltd copying or translating this manual into any language is not allowed. Guangzhou Homesun Medical Technology Co., Ltd reserves the right to modify the information included in this document without Caution. This product is safe and reliable to use, except for the dangers caused by special factors, such as: caused by non-professional operations or used for other purposes. Therefore, please observe the following rules when using them to avoid accidents. This product must be instructed or authorized to operate. Equipment maintenance must be performed by Guangzhou Homesun Medical Technology Co., Ltd technicians or skilled users and authorized operations. If you have any operational problems that are not mentioned, please contact Guangzhou Homesun Medical Technology Co., Ltd in time. Content 1. Product description ........................................................................................................... 1 1.1 Product brief description ............................................................................................. 1 1.2 Intended use / indications for use................................................................................ 1 1.3 Requirements for patients ........................................................................................... 1 1.4 Product main structure ................................................................................................ 1 1.5 Product performance ................................................................................................... 2 1.6 Contraindications ........................................................................................................ 4 1.7 Product list .................................................................................................................. 5 1.8 Site requirements during use ....................................................................................... 6 1.9 Other usage specifications .......................................................................................... 6 2. Label symbol description .................................................................................................. 6 3. Precautions, warnings, and prompt instructions ............................................................... 7 4. Installation and use instructions ........................................................................................ 9 4.1 Check the equipment list ............................................................................................. 9 4.2 Equipment installation and preparation ...................................................................... 9 4.3 Equipment use ............................................................................................................. 9 4.4 Pulmonary ventilation function measurement method ............................................. 10 4.5 Shutdown .................................................................................................................. 11 4.6 Charging .................................................................................................................... 12 5. Instructions for using mobile software (see Annex 1 for details) ................................... 12 6. Instructions for using computer software (see Annex 2 for details) ............................... 12 7. Cleaning and disinfection methods ................................................................................. 12 7.1 Removal steps of flow sensor head ........................................................................... 13 7.2 Cleaning and disinfection of the parts of the flow sensor head ................................ 13 8. Equipment maintenance .................................................................................................. 14 8.1 Maintenance .............................................................................................................. 14 8.2 Work, storage and transportation requirements ........................................................ 15 9. Failure analysis and resolution........................................................................................ 16 10. Product quality information .......................................................................................... 17 10.1 Warranty service ..................................................................................................... 17 10.2 Post-maintenance .................................................................................................... 17 10.3 Production date and expiry date .............................................................................. 18 11. Cybersecurity instructions ..........................................…

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2022- 11-09 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification Authority to Act as Agent On our behalf, I appoint Shenzhen Huatongwei International Inspection Co., Ltd./ 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China / Hans Hu,. to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the Federal Communications Commission’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Guangzhou Homesun Medical Technology Co., Ltd / Floor 7th,TianxiangBusiness Building, No.28, Li Fu Road, Haizhu District, Guangzhou,GD .China. Dated this Nov.09, 2022 Agency agreement expiration date: Nov.09, 2023 By: Adam Zhao Signature Printed Title: Manager On behalf of : Guangzhou Homesun Medical Technology Co., Ltd Telephone: 13660537279

2022- 11-09 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2ASLFGZHX-A9 Product Name: Pulmonary Function Tester Request for Confidentiality Pursuant to Sections 0.457 and 0.459 of the commissions rules, we hereby request that the following documents be held confidential: (List here the documents for which you are seeking confidentiality – for example ...)  Schematics  Block diagram  Operation description These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Dated this Nov.09, 2022 By: Adam Zhao Signature Printed Title: Manager On behalf of : Guangzhou Homesun Medical Technology Co., Ltd Telephone: 13660537279

External Photos

Pulmonary Function Tester Model:A9 Internal Battery:3.7V1500mAh DC Input: 5V1A Floor 7th,TianxiangBusiness Building, No.28, Li Fu Road,Haizhu District,Guangzhou,GD.China FCC ID: 2ASLFGZHX-A9 Guangzhou Homesun Medical Technology Co., Ltd A922030049

Internal Photos

FCC ID: 2ASLFGZHX-A9 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 Type Channel(MHz) Average Output power (dBm) Maximum Tune-up (dBm) Calculating data Limit Result BT BLE 00 -3.33 -3.00 0.1554 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. ...................................... : CHTEW22050062 Report Verification: Project No.................................： SHT2201102103EW FCC ID ............................................. : 2ASLFGZHX-A9 Applicant’s name ........................... : Guangzhou Homesun Medical Technology Co., Ltd Address ............................................. : Floor 7th,TianxiangBusiness Building, No.28, Li Fu Road, Haizhu District, Guangzhou,GD .China Product Name ................................ : Pulmonary Function Tester Trade Mark ....................................... : - Model No. ......................................... : A9 Listed Model(s) ................................. : - Standard ......................................... : FCC CFR Title 47 Part 15 Subpart C Section 15.247 Date of receipt of test sample..........: Apr.28, 2022 Date of testing.............................: Apr.28, 2022- May 10, 2022 Date of issue...............................: May 11, 2022 Result .................. ........................: PASS Compiled by ( Position+Printed name+Signature): File administrator Echo Wei 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.: CHTEW22050062 Page: 2 of 35 Date of issue: 2022-05-11 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 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 20 5.10. Radiated Spurious Emission 22 6. TEST SETUP PHOTOS 27 7. EXTERANAL AND INTERNAL PHOTOS 29 8. APPENDIX REPORT 35 Report No.: CHTEW22050062 Page: 3 of 35 Date of issue: 2022-05-11 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 2022-05-11 Original Report No.: CHTEW22050062 Page: 4 of 35 Date of issue: 2022-05-11 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 PASS Xiaoqin Li 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 Xiaoqin Li 5.10 Radiated Spurious Emission 15.247(d)/15.205/15.209 PASS Xiaoqin Li Note: ‒ The measurement uncertainty is not included in the test result. ‒ *1: No requirement on standard, only report these test data. Report No.: CHTEW22050062 Page: 5 of 35 Date of issue: 2022-05-11 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 3. SUMMARY 3.1. Client Information Applicant: Guangzhou Homesun Medical Technology Co., Ltd Address: Floor 7th,TianxiangBusiness Building, No.28, Li Fu Road, Haizhu District, Guangzhou,GD .China Manufacturer: Guangzhou Homesun Medical Technology Co., Ltd Address: Floor 7th,TianxiangBusiness Building, No.28, Li Fu Road, Haizhu District, Guangzhou,GD .China Factory: Guangzhou Homesun Medical Technology Co., Ltd Address: Floor 7th,TianxiangBusiness Building, No.28, Li Fu Road, Haizhu District, Guangzhou,GD .China 3.2. Product Description Main unit information: Product Name: Pulmonary Function Tester Trade Mark: - Model No.: A9 Listed Model(s): - Power supply: DC 3.7V Hardware version: V1.0.1 Software version: V1.0.0.20220309 3.3. Radio Specification Descript…

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ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 1 of 14 APPENDIXREPORT ProjectNo.SHT2201102103EWRadioSpecificationBluetoothBLE TestsampleNo.YPHT22011021005ModelNo.A9 Starttestdate2022-05-06Finishdate2022-05-06 Temperature24.7°CHumidity42% TestEngineerXiaoqinLiAuditor Appendix clause TestitemResult APeakOutputPowerPASS BPowerSpectralDensityPASS C6dBBandwidthPASS D99%OccupiedBandwidthPASS EDutycyclePASS FBandedgeandSpuriousEmissions(conducted)PASS ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 2 of 14 AppendixA ： PeakOutputPower TypeChannelPeakOutputpower(dBm) Average Outputpower (dBm) Limit(dBm)Result BT-BLE 00-3.32-3.33 ≤30.00Pass19-3.61-3.63 39-3.48-3.49 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 3 of 14 CH00 Date: 6.MAY.2022 09:02:10 CH19 Date: 6.MAY.2022 09:04:47 CH39 Date: 6.MAY.2022 09:06:34 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 4 of 14 AppendixB ： PowerSpectralDensity TypeChannel PowerSpectral Density(dBm/3KHz) Limit(dBm/3KHz)Result BT-BLE 00-18.26 ≤8.00Pass19-18.29 39-18.31 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 5 of 14 CH00 Date: 6.MAY.2022 09:02:46 CH19 Date: 6.MAY.2022 09:05:01 CH39 Date: 6.MAY.2022 09:06:49 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 6 of 14 AppendixC ： 6dBbandwidth TypeChannel6dBBandwidth(kHz)Limit(kHz)Result BT-BLE 00696.00 ≥500Pass19684.00 39708.00 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 7 of 14 CH00 Date: 6.MAY.2022 09:01:50 CH19 Date: 6.MAY.2022 09:04:31 CH39 Date: 6.MAY.2022 09:06:19 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 8 of 14 AppendixD ： 99%OccupiedBandwidth TypeChannel 99%Occupied Bandwidth(MHz) Limit(kHz)Result BT-BLE 001.04 -Pass191.04 391.05 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 9 of 14 CH00 Date: 6.MAY.2022 09:02:02 CH19 Date: 6.MAY.2022 09:04:39 CH39 Date: 6.MAY.2022 09:06:26 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 10 of 14 AppendixE ： Dutycycle TestFrequency （MHz） T ontime for singleburst (ms) T period (ms)Dutycycle 1/T ontime (kHz) 24400.420.6267.7%2.38 Date: 6.MAY.2022 09:04:19 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 11 of 14 AppendixF ： BandedgeandSpuriousEmissions(conducted) TestItem:Bandedge CH00 Date: 6.MAY.2022 09:02:55 CH39 Date: 6.MAY.2022 09:06:58 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 12 of 14 TestItem:SE CH00 Referencelevel Date: 6.MAY.2022 09:03:03 CH00 30MHz~1000MHz Date: 6.MAY.2022 09:03:18 CH00 1GHz~26GHz Date: 6.MAY.2022 09:03:34 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 13 of 14 CH19 Referencelevel Date: 6.MAY.2022 09:05:07 CH19 30MHz~1000MHz Date: 6.MAY.2022 09:05:22 CH19 1GHz~26GHz Date: 6.MAY.2022 09:05:37 ProjectNo.:SHT2201102103EWRadioSpecification:BluetoothBLE ShenzhenHuatongweiInternationalInspectionCo.,Ltd.Appendixreportpage: 14 of 14 CH39 Referencelevel Date: 6.MAY.2022 09:07:03 CH39 30MHz~1000MHz Date: 6.MAY.2022 09:07:18 CH39 1GHz~26GHz Date: 6.MAY.2022 09:07:34 --------EndofReport--------

Antenna Specification Specifications Summary ITEM SPEC. Model Name IBM 2.4 GHz Center Frequency 2400 MHz 2430 MHz 2480 MHz -0.01 dBi 0.00 dBi -1.61 dBi MAX.GAIN 0.00 dBi Polarization Vertical Azimuth Beam Pattern Omni-directional Impedance 50Ω Antenna Length 3.3cm Antenna Photo&Length(mm) Name and address of the antenna manufacturer Shen Zhen Dx-Smart Technology Co.,Ltd 601, 6th Floor, Block A, Huafeng Zhigu (Hangcheng High-tech Industrial Park), Hangcheng Road, Hangcheng Street, Baoan District, Shenzhen Test Address Floor 5, Building 3, Langwei Jingzhong Industrial Zone, Pingshan Street, Pingshan New District, Shenzhen City Tes tDate 2022/9/21 Test Instrument Vector network analyzer - R&S ZVB20 1. Mainantenna:2400MHz 1.1 Horizontal Frequency(MHZ):2400 Antenna Polarity: Horizontal MaximumValue(dBi): -0.99 AverageGain(dBi):-4.73 MinimumGain(dBi):-25.89 1.2 Vertical Frequency(MHZ):2400 Antenna Polarity: Vertical MaximumValue(dBi):-0.01 AverageGain(dBi):-1.59 MinimumGain(dBi):-13.25 2. Mainantenna:2430MHz 2.1 Horizontal Frequency(MHZ):2430 Antenna Polarity: Horizontal MaximumValue(dBi):-0.68 AverageGain(dBi):-3.01 MinimumGain(dBi):-26.54 2.2 Vertical Frequency(MHZ):2430 Antenna Polarity: Vertical MaximumValue(dBi):0.00 AverageGain(dBi):-0.89 MinimumGain(dBi):-11.08 3. Mainantenna:2480MHz 3.1 Horizontal Frequency(MHZ):2480 Antenna Polarity: Horizontal MaximumValue(dBi):-2.65 AverageGain(dBi):-5.08 MinimumGain(dBi):-26.93 3.2 Vertical Frequency(MHZ):2480 Antenna Polarity: Vertical MaximumValue(dBi):-1.61 AverageGain(dBi):-3.30 MinimumGain(dBi):-16.98

TEST SETUP PHOTOS Radiated Emission AC Conducted Emission