A49AIVIEWPatient Monitor

AIView Series Patient Monitor Operator’s Manual I I Preface Copyright This manual contains proprietary information protected by copyright law. All rights reserved. Without the prior written consent of the manufacturer, no part of this manual shall be copied or reproduced in any form or by any means. Manual Purpose The instructions for safe operation of the product in keeping with its function and intended use are contained in this manual. In order to operate the product properly, and protect patient and operator from injury, compliance with this manual is first priority. This manual is based on the maximum configuration and therefore some contents may not apply to your product. Please keep in touch with the manufacturer or your local distributor if you have any questions. As an indispensable portion of the product, this manual should always be placed near the device so that it can be got easily when needed. Intended Audience This manual applies to clinical professionals with knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients. Only clinical professionals, anyone who are under their guidance or people who have been trained adequately can use this monitor. The unauthorized or the untrained are forbidden to operate the product. About this Manual P/N: 3502-2530019 Release Date: October 2021 Revision: V1.2 Software Version: V1 Contact Information Manufacturer: Shenzhen Creative Industry Co., Ltd. Address: Floor 5, BLD 9, BaiWangXin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, II 518110 Shenzhen, PEOPLE’S REPUBLIC OF CHINA Website: www.creative-sz.com E-mail: [email protected] Tel: +86 755 26431658 Fax: +86 755 26430930 EC Representative: Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg Germany UK Responsible Person Etheria Medical Ltd Address: The Old Brush Factory Unit 2d Whickham Industrial Estate, Swalwell, Newcastle Upon Tyne, United Kingdom, NE16 3DA Tel: +44-191-4889922 Fax: +44-191-4889922 E-mail: [email protected] II Manual Conventions Illustrations Setup or data displayed on your monitor may not be necessarily showed in all illustrations in this manual, because they are used only as examples. All names mentioned in this manual and illustrations are fictitious. Any similarity is purely coincidental. General Notes  Italic text is used to indicate prompt information or quote the referenced chapters or sections.  [XX] is used to indicate the character string in the software.  → is used to indicate operational procedures. Special Notes III The warnings, cautions and notes in this manual are used to remind readers of some specific information. Warning Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. Caution Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.  Note Provides application tips or other useful information to ensure that you get the most from your product. IV This page intentionally left blank. V Table of Contents Chapter 1 Safety .................................................................................. 1-1 1.1 Safety Information .................................................................. 1-1 1.1.1 Warnings ..................................................................... 1-1 1.1.2 Cautions ...................................................................... 1-4 1.1.3 Notes ........................................................................... 1-4 1.2 Device Symbols ..................................................................... 1-5 Chapter 2 Product Introduction ............................................................ 2-1 2.1 Product Name and Model ...................................................... 2-1 2.2 Intended Use ......................................................................... 2-3 2.3 Contraindication ..................................................................... 2-3 2.4 Date of Manufacture and Service Life ................................... 2-3 2.5 Function Features .................................................................. 2-3 2.6 Product View .......................................................................... 2-4 2.6.1 Front View ................................................................... 2-5 2.6.2 Rear View ................................................................... 2-7 2.6.3 Left View ..................................................................... 2-8 2.6.4 Right View ................................................................... 2-9 2.6.5 Bottom View .............................................................. 2-10 Chapter 3 Getting Started .................................................................... 3-1 3.1 Unpacking and Checking ....................................................... 3-1 3.2 Installation Precautions .......................................................... 3-1 3.3 Environment Requirements ................................................... 3-2 3.4 Connecting to Power Source ................................................. 3-3 3.4.1 Using AC Power Source ............................................. 3-3 3.4.2 Using the Battery ........................................................ 3-3 3.5 Turning on the Monitor ........................................................... 3-4 3.6 Checking the Recorder/Printer .............................................. 3-4 3.7 Operating and Navigating ...................................................... 3-4 3.7.1 Using the Touchscreen ............................................... 3-5 3.7.2 Using the On-Screen Keyboard .................................. 3-5 3.7.3 Using Keys .................................................................. 3-5 3.8 Screen Views ..................................................…

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Shenzhen Creative Industry Co., Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Date: 2022/01/17 Subject; Request for Confidentiality FCC ID: A49AIVIEW To Whom It May Concern, Pursuant to the provisions of the Commission’s rules Title 47 Sections §0.457 and §0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. Schematic Diagram Block Diagram Operational Description NII security information In additional to above mentioned documents, in order to comply with the marketing regulations in Title 47 CFR §2.803 and the importation rules in Title 47 CFR §2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices, we request Short Term Confidentiality of the following attachment(s); External Photos Test Setup Photos Internal Photos User Manual For 45 days, pursuant to Public Notice DA 04-1705. OR For 180 days pursuant to KDB 726920 D01. It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature: Name: Wangui Zhu Title: Quality Management Department Manager

Declaration Letter Dear Sir, For our business issue and marketing requirement, we would like to list below model numbers on the certificates and reports, as following: Main Model: AIView V10 Serial Model No.:, AIView V12 We declare that the difference is only the model name for different market: Contact Person: Zhu wanggui Company Name: Shenzhen Creative Industry Co., Ltd. Address: Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, Shenzhen, China E-mail: [email protected]

BT/WIFI ANT

RF Exposure FCC ID: A49AIVIEW Applicant: Shenzhen Creative Industry Co., Ltd. Exposure category: General population/uncontrolled environment EUT Type: Patient Monitor Refer Standard: FCC Part 2.1091: Radio Frequency (RF) Exposure Compliance of Radio communication Apparatus (All Frequency Bands) FCC MPE Limited: Limits for General Population/Uncontrolled Exposure Frequency Range (MHz) Electric Field Strength (V/m) Magnetic Field Strength (A/m) Power Density (mW/cm2) Averaging Time (minutes) 0.3-1.34 614 1.63 *(100) 30 1.34-30 824/f 2.19/f *(180/f2) 30 30-300 27.5 0.073 0.2 30 300-1500 / / f/1500 30 1500-100,000 / / 1.0 30 Test Data Predication of MPE limit at a given distance Where: S = power density P = power input to the antenna G = power gain of the antenna in the direction of interest relative to an isotropic radiator, the power gain factor, is normally numeric gain. R = distance to the center of radiation of the antenna (appropriate units, e.g., cm) 2.4GHz Antenna Gain information: Antenna type Gain(dBi) Internal 4.87 5GHz Antenna Gain information: Antenna type Gain(dBi) Internal 4.87 Worst-Case mode Conducted Output Power Results for2.4G WIFI 802.11b mode Frequency (MHz) Output Power(dBm) Tune Up tolerance(dBm) 2412 13.51 14±1 Worst-Case mode Conducted Power Test results of band U-NII-2C 802.11n (20MHz) mode Frequency (MHz) Conducted Output Power (dBm) Tune Up tolerance(dBm) 5600 8.54 9±1 Calculation results (for 2.4G WIFI): Worst-case mode Frequency (MHz) Maximum tune up power(dBm) ANT Gain(dBi) RF distance(cm) Result (mW/cm2) Limit (mW/cm2) 2412 15.0 4.87 20 0.019 1.0 Calculation results (for 5G WIFI): Worst-Case mode Frequency (MHz) Maximum tune up power(dBm) ANT Gain(dBi) RF distance(cm) Result (mW/cm2) Limit (mW/cm2) 5600 10 4.87 20 0.006 1.0 Simultaneous Transmission Calculation No. Transmitter Combinations Scenario Supported or not 1 2.4G WLAN+5G WLAN No

Report No.: SET2021-17272 CCIC-SET/ TRF:IRF(2019-05-23) Page 1 of 43 RF TEST REPORT Report No.: SET2021-17272 Product Name: Patient Monitor Model No. : AIView V10, AIView V12 FCC ID: A49AIVIEW Applicant: Shenzhen Creative Industry Co., Ltd. Address： Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, Shenzhen, China Dates of Testing: 10/28/2021 - 12/08/2021 Issued by: CCIC Southern Testing Co., Ltd. Lab Location: Electronic Testing Building, No. 43 Shahe Road, Xili Street, Nanshan District, Shenzhen, Guangdong, China. Tel: 86 755 26627338 Fax: 86 755 26627238 This test report consists of 45 pages in total. It may be duplicated completely for legal use with the approval of the applicant. It should not be reproduced except in full, without the written approval of our laboratory. The client should not use it to claim product endorsement by CCIC-SET. The test results in the report only apply to the tested sample. The test report shall be invalid without all the signatures of testing engineers, reviewer and approver. Any objections must be raised to CCIC-SET within 15 days since the date when the report is received. It will not be taken into consideration beyond this limit. Report No.: SET2021-17272 CCIC-SET/ TRF:IRF(2019-05-23) Page 2 of 43 Test Report Product Name ....................... : Patient Monitor Brand Name .......................... : LEPU MEDICAL Trade Name ........................... : LEPU MEDICAL Applicant ............................... : Shenzhen Creative Industry Co., Ltd. Applicant Address ................ : Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, Shenzhen, China Manufacturer......................... : Shenzhen Creative Industry Co., Ltd. Manufacturer Address ......... : Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, Shenzhen, China Test Standards ...................... : 47 CFR Part 15 Subpart C 15.247 ANSI C63.10-2013 Test Result ............................ : PASS Tested by ............................. : 2021.12.28 Sun, Test Engineer Reviewed by ......................... : 2021.12.28 Chris You, Senior Engineer Approved by ......................... : 2021.12.28 ShuangwenZhang, Manager Report No.: SET2021-17272 CCIC-SET/ TRF:IRF(2019-05-23) Page 3 of 43 TABLE OF CONTENTS RF TEST REPORT ....................................................................................................................... 1 1. GENERAL INFORMATION ................................................................................................. 4 1.1. EUT Description .................................................................................................................... 4 1.2. Test Standards and Results ..................................................................................................... 5 1.3. Table for Supporting Units ..................................................................................................... 6 1.4. EUT Operation Test Setup ..................................................................................................... 6 1.5. Facilities and Accreditations .................................................................................................. 6 2. TEST REQUIREMENTS ....................................................................................................... 7 2.1. Antenna requirement .............................................................................................................. 7 2.2. Maximum Conducted Output Power ..................................................................................... 8 2.3. 6dB Occupied Bandwidth ...................................................................................................... 9 2.4. Conducted Band Edges and Spurious Emissions ................................................................. 10 2.5. Power spectral density (PSD) .............................................................................................. 11 2.6. Radiated Band Edge and Spurious Emission ....................................................................... 12 2.7. AC Power Line Conducted Emission .................................................................................. 23 3. LIST OF MEASURING EQUIPMENT .............................................................................. 27 4. UNCERTAINTY OF EVALUATION .................................................................................. 28 APPENDIX A ............................................................................................................................... 29 Change History Issue Date Reason for change 1.0 2021.12.28 First edition Report No.: SET2021-17272 CCIC-SET/ TRF:IRF(2019-05-23) Page 4 of 43 1. General Information 1.1. EUT Description EUT Type Patient Monitor Model No. AIView V10, AIView V12 EUT supports Radios application WLAN2.4GHz 802.11b/g/n (HT20) Frequency Range 802.11b/g/n-20MHz: 2.412GHz - 2.462GHz Channel Number 802.11b/g/n-20MHz: 11 Bit Rate of Transmitter 802.11b: 11/5.5/2/1 Mbps 802.11g: 54/48/36/24/18/12/9/6 Mbps 802.11n : up to 72.2Mbps Modulation Type DSSS (802.11b), OFDM (802.11g/n) MIMO Not support Antenna Type Internal Antenna Antenna Gain 4.87 dBi Power supply Model No.: HYLB-2260 Rated Voltage: DC 10.95V Capacitance: 2750mAh Model No.: HYLB-2261 Rated Voltage: DC 10.95V Capacitance: 5500mAh Note 1: For a more detailed description, please refer to Specification or User’s Manual supplied by the applicant and/or manufacturer. Note 2: The EUT was programmed to be in continuously transmitting mode and the transmit duty cycle is not less than 98%. Note 3: The antenna gain and RF adapter/cable insert loss provided by manufacture. Report No.: SET2021-17272 CCIC-SET/ TRF:IRF(2019-05-23) Page 5 of 43 1.2. Test Standards and Results The objective of the report is to perform testing according to FCC Certif…

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