2A9TZ-VEN8MPositive Airway Pressure Device

User Manual for 8 Series Positive Airway Pressure Device Version: A/0 DOC No.: UM-VEN8-02 Table of Contents Read Before Use .................................................................................................... 3 Check the Supplied Parts ....................................................................................... 4 Chapter 1 Safety Guide .......................................................................................... 6 Chapter 2 Overview .............................................................................................. 11 Chapter 3 Product brief introduction ..................................................................... 17 Chapter 4 Menu parameter settings ..................................................................... 23 Chapter 5 Cleaning and Maintenance .................................................................. 28 Chapter 6 Product Service Life ............................................................................. 38 Chapter 7 After-sales Service ............................................................................... 39 Chapter 8 Symbol Instructions .............................................................................. 41 Annex A Technical Specifications .......................................................................... 43 Annex B EMC Information .................................................................................... 52 3 / 57 Read Before Use This manual describes the operating methods, technical parameters and maintenance instructions of the product. Please read this manual carefully for instructions of use. Your particular attention is required to the following:  Put the manual at a place within your easy reach for reference at any time;  Safekeeping the manual when it is not needed. This manual defines the following warning signs for the purpose of safe and correct operation: Warning: A warning indicates the possibility of injury to the user or the operator. Neglecting of the “Warning” information may result in potential safety hazard or product damage. Caution: A Caution indicates the possibility of damage to the device. 4 / 57 Check the Supplied Parts After unpacking, please check whether all the parts mentioned are present and intact. If some of the parts are missing or damaged, please contact your provider immediately. The parts are as follows:  Main Unit  Humidifier  Power Adapter  User Manual  SD Card  Air Filter  Qualification Certificate  Heating Tube (Optional) Caution: Please retain the packing material so that it can be reused when you transport the device. Caution: This device is not equipped with a mask. Users need to buy a legally marketed mask by themselves. If you have any questions, please consult a doctor or manufacturer 5 / 57 6 / 57 Chapter 1 Safety Guide Please read the entire instruction manual before using Positive Airway Pressure Device. It will give you a better understanding of how the product works. If you are unsure whether a medical condition should preclude you from using the device, consult your medical practitioner. Warning 1.1 1) This product consists of the main unit, humidifier, heating tube(optional) and the power adapter. The adapter HY90 should be used with Hypnus heating tube, and adapter HY52 should be used with the common air tubing without heating function. The use of unauthorized accessories such as the humidifier, adapter or heating tube can weaken the therapy effect, or cause other potential safety hazards. 2) If you are using a full-face mask, the mask must be equipped with a safety (anti-asphyxia) valve, to minimize CO 2 respiration when the device is not functioning. 3) Do not add any attachments or accessories to the humidifier that are not listed in the instruction for use of the humidifier or accessory or the humidifier might not function correctly affecting the quality of the therapy or injuring the patient. 4) Do not use the humidifier at an altitude above 2000m or outside a temperature of 5°C~35°C. Using the humidifier outside of this temperature range or above this altitude can affect the quality of the therapy or injure the patient. 5) To prevent disconnection of the tubing or tubing system during use, especially during ambulatory use, only tubes in compliance with ISO 5367 or ISO 80601‐2‐74 should be used. 6) Covering breathing tubes with a blanket or heating them in an incubator or with an overhead heater can affect the quality of the therapy or injure the 7 / 57 patient. 7) Incompatible parts can result in degraded performance. 8) The responsible organization is accountable for the compatibility of the humidifier and all of the parts and accessories used to connect to the patient before use. 9) The conditions under which the HUMIDIFIER maintains the accuracy of controlled and displayed variables as disclosed in the instructions for use. 10) Do not use this device in a magnetic resonance environment. 11) Do not use this device in a polluted environment. 12) Do not use this device in an environment with flammable and explosive gases. 13) Do not operate the device without enclosure, avoid personal injury and electric shock hazard. 14) Do not place the device directly on carpets, fabrics or other flammable materials. 15) Do not immerse the device in water. Do not let any fluids enter the device. 16) Keep away from any heating or cooling appliances, such as radiators, air conditioners, indoor vents, etc., so as not to increase the temperature of the air coming out of the device. 17) Do not perform any maintenance and disassembly when the device is running. 18) Do not place the device in or on any container that can collect condensation. 19) The device must not be covered or placed in a position where its operation or performance may be adversely affected. 20) Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or permits spontaneous breathing can cause asphyxiation. 21) Sources of …

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Guangzhou Hypnus Healthcare Co., Ltd. Attestation Statement Letter I Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Date: 2023-02-09 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC Application for FCC ID: 2A9TZ-VEN8M Guangzhou Hypnus Healthcare Co., Ltd. certifies that the equipment for which authorization is sought is not “covered” equipment prohibited for receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Sincerely, Applicant’s Signature: Applicant's Name: Runping Liang

Guangzhou Hypnus Healthcare Co., Ltd. Attestation Statement Letter II Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 2023-02-09 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC Application for FCC ID: 2A9TZ-VEN8M Guangzhou Hypnus Healthcare 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. Sincerely, Applicant’s Signature: Applicant's Name: Runping Liang

Guangzhou Hypnus Healthcare Co., Ltd. FCC Attestation Statement US Agent For Service Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Date: 2023-02-09 Ref: Attestation Statements Part 2.911(d)(7) Filing FCC Application for FCC ID: 2A9TZ-VEN8M Guangzhou Hypnus Healthcare Co., Ltd. certifies that, as of the date of the filing of the application, SHARE INFO INC. is our designated U.S. agent for service of process for the above reference FCC ID: 2A9TZ-VEN8P. Guangzhou Hypnus Healthcare Co., Ltd. agrees to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceedings involving the equipment. SHARE INFO INC. accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service of process for above referenced FCC ID. Designated U.S. Agent Information: Name: SHARE INFO INC. (FRN: 0033426495) Address: 3557 158th St Flushing, NY 11358, USA Contact Person: Nora Xi Telephone: (1) 323-6333 Email: [email protected] Sincerely, Applicant’s Signature: Agent’s Signature: Applicant’s Name: Runping Liang Agent’s Name: Nora Xi

Guangzhou Hypnus Healthcare Co., Ltd. Rm.201-02, No.3 Tianfeng Rd., Science City, Development District, Guangzhou, China Federal Communications Commission Family Model Similarity Declaration Date: 2022-12-01 SUBJECT: Family Model Similarity Declaration Letter To Whom It May Concern: We declare that the family models listed below are electrically identical. Product Information Brand Name: / Product Description: Positive Airway Pressure Device Model (s): CA820M, BA825M, ST830M, SV825M The only difference between these models are: model name and the delivered air pressure. Hence the difference on these variants does not affect any product RF or EMC performance. Regards, Applicant’s signature: Applicant Information Company Name: Guangzhou Hypnus Healthcare Co., Ltd. Company Address: Rm.201-02, No.3 Tianfeng Rd., Science City, Development District, Guangzhou, China Contact Name: Runping Liang Job Title: Manager Phone: 13430338105 Email: [email protected]

Page1of11 ExternalPHOTO: FCCID:2A9TZ-VEN8P Page2of11 Page3of11 Page4of11 Page5of11 Page6of11 Page7of11 Page8of11 Adapter:HY52 Page9of11 Adapter:HY52 Page10of11 Adapter:HY90 Page11of11 Adapter:HY90

Page 1 of 5 Internal PHOTO: FCC ID: 2A9TZ-VEN8M Page 2 of 5 BT antenna Page 3 of 5 Page 4 of 5 Page 5 of 5 LTE Antenna

MPE Evaluation Applicant: Guangzhou Hypnus Healthcare Co., Ltd. FCC ID: 2A9TZ-VEN8M Model: ST830M MPE Evaluation RF Exposure Compliance Requirement Standard Requirement According to KDB447498D01 General RF Exposure Guidance v06 and FCC 1.1310 Radiofrequency radiation exposure limits for General Population/Uncontrolled Exposure EUT RF Exposure Pd=PG/4πR 2 Pd = power density in mW/cm2 P = output power to antenna in mW G = gain of antenna in linear scale π=3.14 R = distance between observation point and center of the radiator in cm Bluetooth (BLE mode): The Max Output Power is 0.626 dBm in Middle channel (2.480GHz); Antenna gain: 1.5 dBi, gain of antenna in linear scale: 1.41 R=20cm Pd =PG/(4πR2)=0.00033 mW/cm2<1(limits)mW/cm 2 --END--

RainSun Corporation 1of 9 Jan, 2012 Ver.3.2 AN9520 Multilayer Chip Antenna for 2.4GHz Wireless Communication RainSun Corporation 2of 9 Jan, 2008 Ver.2.2 AN9520 Multilayer Chip Antenna ◆Features yLight weight and low profile 9.5mm(L)X2.1mm(W)X1.0mm(H) yOmni‐directional in azimuth yLead (Pb) Free ◆Applications y2.4GHz wireless communications y2.4GHz Modules yBluetooth System y802.11b/g Wireless LAN System Specifications 2.45GHz 1.5dBi ‐40 ~ +85 °C ‐40 ~ +85 °C 2.0 (max) 50 Ohm 3W (max) 200MHz Omni‐directional Linear Center frequency Peak gain Operation temperature Storage temperature VSWR Input Impedance Power handling Bandwidth Azimuth beamwidth Polarization RainSun Corporation 3of 9 Jan, 2008 Ver.2.2 Pin configuration 1.00 ±0.20H 0.50 ±0.05C 2.10 ±0.10B 9.50 ±0.10A Dimensions(mm)Symbol Dimensions Solder termination3 Feed point mark2 Feed termination1 Pin assignmentPin No 3 2 1 Top view PCB foot printer RainSun Corporation 4of 9 Jan, 2008 Ver.2.2 Recommended Test Board Pattern Testing Setup Measurement Board thickness : 0.6mm Board material : FR4 Unit : mm Ground Plane 50 Ohm Transmission line SMA connector Top view Bottom view Testing Instrument: Anritsu 37369C VNA(Vector Network Analyzer) VNA calibrate with 1 path reflection only calibration sequence on test board feed point. The test board dimension and it’s layout is the same as Fig‐1. Fig-1 RainSun Corporation 5of 9 Jan, 2008 Ver.2.2 Return loss Typical Electrical Characteristics Smith Chart Marker data: 1 : f=2.567 GHz 2 : f=2.365 GHz 3 : f=2.447 GHz RainSun Corporation 6of 9 Jan, 2008 Ver.2.2 Typical Radiation Patterns 2.45 GHz H‐Plane 2.45 GHz E‐Plane RainSun Corporation 7of 9 Jan, 2008 Ver.2.2 Typical Soldering Profile for Lead‐free Process Temperature ( °C ) Time (sec.) 340°C 300°C 150°C Peak temp 340°C Do not exceed 30 secs. 25 sec. 5 sec. Pre-heating Temperature ( °C ) Time (sec.) 260°C 230°C 180°C 10 sec, max Reflow Soldering 60 sec. 30 sec. Pre-heating RainSun Corporation 8of 9 Jan, 2008 Ver.2.2 Packing Blister Tape Specifications mm±0.101.20K 0 mm±0.050.30t mm±0.1010.00B 0 mm±0.102.20A 0 mm±0.102.00P 2 mm±0.108.00P mm±0.104.00P 0 mm + 0.25 ‐0.00 1.50D 1 mm + 0.10 ‐0.00 1.50D mm±0.107.50F mm±0.101.75E mm±0.3016.00W UnitToleranceDimensionSymbol RainSun Corporation 9of 9 Jan, 2008 Ver.2.2 Reel Specifications 16±0.5 W (mm) 20±0.22.2±0.562±0.513.0±0.5180±1161,500 W 1 (mm) E (mm) B (mm) C (mm) A (mm) Tape Width (mm) Quantity Per Reel

ITL Page 1 of 49 Report No.: D230306003 TEST REPORT Applicant: Guangzhou Hypnus Healthcare Co., Ltd. Address of Applicant: Rm.201-02, No.3 Tianfeng Rd., Science City, Development District, Guangzhou, China Manufacturer: Guangzhou Hypnus Healthcare Co., Ltd. Address of Manufacturer: Rm.201-02, No.3 Tianfeng Rd., Science City, Development District, Guangzhou, China Product name: Positive Airway Pressure Device Model(s): CA820M, BA825M, ST830M, SV825M Rating(s): Main: DC24V, 2.2A Adapter: Input: AC 100-240V, 50/60Hz, 2.2A Max Output: DC 24V, 3.75A (For Adapter HY90) DC 24V, 2.2A (For Adapter HY52) Trademark: Standards: 47 CFR Part 15 Subpart C section 15.247 FCC ID: 2A9TZ-VEN8M Data of Receipt: 2022-11-21 Date of Test: 2022-11-21~2022-12-09 Date of Issue: 2022-12-09 Test Result Pass* * In the configuration tested, the test item complied with the standards specified above. Authorized for issue by: Test by: Reviewed by: Dec.09, 2022 Chivas Tsang Dec.09, 2022 Victor Meng Project Engineer Project Manager Date Name/Position Signature Date Name/Position Signature ITL Page 2 of 49 Report No.: D230306003 Testing Laboratory information: Testing Laboratory Name ........... : ITL Co., Ltd Address : No. 8 Jinqianling Street 5, Huangjiang Town, Dongguan, Guangdong, 523757 P.R.C. Testing location : Same as above Tel : 0086-769-39001678 Fax : 0086-20-62824387 E-mail : [email protected] Possible test case verdicts: - test case does not apply to the test object . : N/A - test object does meet the requirement ....... : P (Pass) - test object does not meet the requirement . : F (Fail) General remarks: The test results presented in this report relate only to the object tested. The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report. This report would be invalid test report without all the signatures of testing technician and approver. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. General product information: All the models are identical to each other except for the model designations and the delivered air pressure. All tests were performed on the model ST830M as representative. The EUT has 2 adapters Adapter Model: HY90 Input: AC 100-240V, 50/60Hz, 2.2A Max Output: 24Vdc , 3.75A Adapter Model: HY52 Input: AC 100-240V, 50/60Hz, 2.2A Max Output: 24Vdc , 2.2A ITL Page 3 of 49 Report No.: D230306003 1 Test Summary Test Test Requirement Test method Result Antenna Requirement FCC PART 15 C section 15.247 (c) and Section 15.203 FCC PART 15 C section 15.247 (c) and Section 15.203 PASS Occupied Bandwidth FCC PART 15 C section 15.247 (a)(2) ANSI C63.10:2013 PASS Maximum Peak Output Power FCC PART 15 C section 15.247(b)(3) ANSI C63.10: 2013 PASS Peak Power Spectral Density FCC PART 15 C section 15.247(e) ANSI C63.10:2013 PASS Conducted Spurious Emission (30MHz to 25GHz) FCC PART 15 C section 15.209&15.247(d) ANSI C63.10:2013 PASS Radiated Spurious Emission (30 MHz to 25 GHz) FCC PART 15 C section 15.209&15.247(d) ANSI C63.10:2013 PASS Radiated Emissions which fall in the restricted bands FCC PART 15 C section 15.209 ANSI C63.10:2013 PASS Band Edges Measurement FCC PART 15 C section 15.209&15.247(d) ANSI C63.10:2013 PASS Conducted Emissions at Mains Terminals FCC PART 15 C section 15.207 ANSI C63.10:2013 PASS ITL Page 4 of 49 Report No.: D230306003 2 Contents Page TEST REPORT ....................................................................................................................................................................... 1 1 TEST SUMMARY ......................................................................................................................................................... 3 2 CONTENTS ................................................................................................................................................................... 4 3 GENERAL INFORMATION ........................................................................................................................................ 5 3.1 CLIENT INFORMATION ............................................................................................................................................ 5 3.2 GENERAL DESCRIPTION OF E.U.T. ....................................................................................................................... 5 3.3 DETAILS OF E.U.T. ................................................................................................................................................ 5 3.4 DESCRIPTION OF SUPPORT UNITS ........................................................................................................................ 6 3.5 TEST LOCATION ..................................................................................................................................................... 6 3.6 DEVIATION FROM STANDARDS .............................................................................................................................. 6 3.7 ABNORMALITIES FROM STANDARD CONDITIONS.................................................................................................. 6 3.8 OTHER INFORMATION REQUESTED BY THE CUSTOMER ....................................................................................... 6 3.9 TEST FACILITY ....................................................................................................................................................... 6 3.10 MEASUREMENT UNCERTAINTY .............................................................................................................................. 6 4 INSTRUMENTS USED DURING TEST .................................................................................................................... 7 5 TEST RESULTS .....…

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