A49PC-60FWFingertip Oximeter

Fingertip Oximeter User Manual Shenzhen Creative Industry Co., Ltd. I Instructions to User Dear Customers, Thank you for purchasing this quality product. Please read the manual very carefully before using this device. Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter. The manual is published in English and we have the ultimate right to explain the Manual. No part of this manual may be photocopied, reproduced or translated into another language without the prior written consent. We reserve the right to improve and amend it at any time without prior notice. II For user's convenience, we share the latest version analysis software of the Oximeter on our website, the user can enter into our website ( www.creative-sz.com) to download the corresponding latest version data manager software. Please contact the manufacturer or your local distributor if anything about software downloading. Version of the Manual: Ver 1.3 Revised date: April 13 th , 2020 All rights reserved. 3502-1290163 III Notes  The contents contained in this manual are subject to change without notice.  Information furnished by our company is believed to be accurate and reliable. However, no responsibility is assumed by us for its use, or any infringements of patients or other rights of third parties that may result from its use. Instructions for Safe Operation  Check the device to make sure that there is no visible damage that may affect user’s safety or measurement performance with regard to sensors and clips. It is IV recommended that the device should be inspected minimally before each use. If there is obvious damage, stop using the device.  Special attention should be paid while the Oximeter is used constantly at ambient temperature above 37°C, burns may occur because of over-heating of the sensor at this situation.  Necessary maintenance must be performed only by qualified service technicians. Users are not permitted to service this device.  The Oximeter must not be used with devices and accessories not specified in User Manual. V Cautions  Explosive hazard—DO NOT use the Oximeter in environment with inflammable gas such as some ignitable anesthetic agents.  DO NOT use the Oximeter while the patient is under MRI or CT scanning. This device is NOT MRI Compatible. Warnings  Discomfort or pain may appear if using the Oximeter continuously on the same location for a long time, especially for patient with poor microcirculation. It is recommended that the Oximeter should not be VI applied to the same location for longer than 2 hours. If any abnormal condition is found, please change the position of Oximeter.  DO NOT clip this device on edema or tender tissue.  The light (the infrared light is invisible) emitted from the device is harmful to the eyes. Do not stare at the light.  The Oximeter is not a treatment device.  The Local laws and Regulations must be followed when disposing of the device. Attentions VII  Keep the Oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.  The device should be kept out of the reach of children.  If the Oximeter gets wet, please stop using it and do not resume operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for Oximeter to reach ambient temperature.  DO NOT operate the button on the front panel with sharp materials or sharp point. VII  DO NOT use high temperature or high pressure steam disinfection on the Oximeter. Refer to Chapter 7 for instructions regarding cleaning and disinfection.  The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid. So that means the equipment is protected against solid foreign objects of 12.5mm and greater, and protected against vertically falling water drops when enclosure tilted up to 15°.  Please pay attention to the effects of lint, dust, light (including sunlight), etc. IX Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards: IEC 60601-1: 2005 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance; BS/EN/ISO 9919:2009 or the equivalent ISO 80601-2-61:2011 - Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse Oximeter equipment. And it also follows the provisions of the council directive MDD 93/42/EEC. X FCC Rules are specifically for PC-60FW This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This equipment complies with FCC radiation exposure limit without restriction XI Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged XII to try to correct the interference by one or more of the following measures: -Reorient or relocate the receiving antenna. -Increase the separation…

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C5266091_X8_Ed.1 1/1 Letter of Authorization Company: Shenzhen Creative Industry Co., Ltd. Address: Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China Product Name: Fingertip Oximeter Model Number: PC-60FW FCC Identifier: A49PC-60FW We authorize LGAI Technological Center S.A., Ronda de la Font del Carme, s/n, 08193 Bellaterra, Spain, to act on our behalf on all matters concerning the above named equipment. Any individual within LGAI Technological Center S.A. is authorized to act on our behalf and take action on the application. We declare that authorize LGAI Technological Center S.A., Ronda de la Font del Carme, s/n, 08193 Bellaterra, Spain, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by LGAI Technological Center S.A. on our behalf shall have the same effect as acts of our own. Name: Wangui Zhu Date: 2020-07-20 Title: Quality Management Department Manager Signature of applicant:

C5266091_X10_Ed.2 1/1 Shenzhen Creative Industry Co., Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Date: 2020-07-20 Subject: Request for Confidentiality FCC ID: A49PC-60FW To Whom It May Concern, Pursuant to the provisions of Sections 0.457 and 0.459 of Commission's rules (47CFR0.457, 0.459), we are requesting the Commission to withhold the following attachment(s) as confidential document from public disclosure. Exhibits Long-Term Confidentiality Short-Term Confidentiality NOTE 2 ID Label/Location No No Attestation Statement No No External Photos No ☐ Block Diagram ■☐ Schematics ■☐ Test Report No No Test Setup Photos No ☐ User’s Manual ☐ NOTE 1 ☐ Internal Photos ☐ NOTE 1 ☐ Parts List / Tune Up ☐ ☐ RF Exposure Info No No Operational Description ■ ☐ Cover Letter(s) No No SDR Software / Security Info ☐ No NOTE 1: Long‐Term Confidentiality may be permitted under special conditions (See II. LONG‐TERM CONFIDENTIALITY, Section 3 of KDB 726920, use last in force) NOTE 2: Short‐Term Confidentiality can be requested for a maximum of 180 days from the date of the grant. Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In case of short-term Confidentiality, the applicant requests the exhibits selected above are withheld from public view for a period of ______ days from the date of the Grant of Equipment Authorization and prior to marketing. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. C5266091_X10_Ed.2 1/1 Sincerely, Signature: Name: Wangui Zhu Title: Quality Management Department Manager

External Photo FCC ID: A49PC-60FW

Internal Photo FCC ID: A49PC-60FW BLE ANT

FCC RF Exposure FCC ID: A49PC‐60FW Applicant: Shenzhen Creative Industry Co., Ltd. Exposure category: General population/uncontrolled environment EUT Type: Fingertip Oximeter Device Type: Portable Device FCC Part 2 §2.1093 Evaluation method According to KDB447498 D01 General RF Exposure Guidance v06 Section 4.3.1 Standalone SAR test exclusion considerations:“ Unless specifically required by the published RF exposure KDB procedures, standalone 1‐g head or body and 10‐g extremity SAR evaluation for general population exposure conditions, by measurement or numerical simulation, is not required when the corresponding SAR Test Exclusion Threshold condition, listed below, is satisfied. These test exclusion conditions are based on source‐based time‐averaged maximum conducted output power of the RF channel requiring evaluation, adjusted for tune‐up tolerance, and the minimum test separation distance required for the exposure conditions.22 The 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 (see 5) of section 4.1). To qualify for SAR test exclusion, the test separation distances applied must be fully explained and justified by the operating configurations and exposure conditions of the transmitter and applicable host platform requirements, typically in the SAR measurement or SAR analysis report, according to the required published RF exposure KDB procedures. When no other RF exposure testing or reporting is required, a statement of justification and compliance must be included in the equipment approval, in lieu of the SAR report, to qualify for the SAR test exclusion. When required, the device specific conditions described in the other published RF exposure KDB procedures must be satisfied before applying these SAR test exclusion provisions; for example, handheld PTT two‐way radios, handsets, laptops & tablets etc.23 “[(max. power of channel, including tune‐up tolerance, mW)/ (min. test separation distance, mm)] ∙ [√f (GHz)]≤ 3.0 for 1‐g SAR and ≤ 7.5 for 10‐g extremity SAR, 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 result is rounded to one decimal place for comparison • 3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below 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 5) in section 4.1 is applied to determine SAR test exclusion. Maximum Conducted Power Results Bluetooth BLE Channel Channel 0 Channel 19 Channel 39 Test Results(dBm) -9.212 -8.772 -7.119 Target (dBm) ‐9 ‐8 ‐7 Tolerance ±(dB) ±1 ±1 ±1 Maximum Evaluation Results Bluetooth Channel Fre.(MHz) Antenna Distance （mm） RF output power (including tune‐up tolerance) SAR Test Exclusion Threshold SAR Test Exclusion dBm mW 39 2480 5 ‐6 0.05 0.079＜3.0 Yes Conclusion The measurement results comply with the FCC Limit per 47 CFR 2.1093 for the uncontrolled RF Exposure and SAR Exclusion Threshold per KDB447498 D01 General RF Exposure Guidance v06.

Report No.:SET2020-05313 CCIC-SET/ TRF:IRF(2019-05-23) Page 1 of 36 RF TEST REPORT Report No.: SET2020-05313 Product Name: Fingertip Oximeter FCC ID: A49PC-60FW Model No. : PC-60FW Applicant: Shenzhen Creative Industry Co., Ltd. Address: Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China. Dates of Testing: 05/10/2020 —05/27/2020 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 36 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.:SET2020-05313 CCIC-SET/ TRF:IRF(2019-05-23) Page 2 of 36 Test Report Product Name ...................... : Fingertip Oximeter Brand Name ......................... : N/A Trade Name .......................... : N/A Applicant .............................. : Shenzhen Creative Industry Co., Ltd. Applicant Address ............... : Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China. Manufacturer ........................ : Shenzhen Creative Industry Co., Ltd. Manufacturer Address ........ : Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China. Test Standards ..................... : 47 CFR Part 15 Subpart C：Radio Frequency Devices ANSI C63.10-2013：American National Standard for Testing Unlicensed Wireless Devices KDB558074 D01 DTS Meas Guidance v05r02 Test Result ........................... : PASS Tested by ............................ : 2020.07.20 Vincent, Test Engineer Reviewed by ......................... : 2020.07.20 Chris You, Senior Engineer Approved by ........................ : 2020.07.20 Shuangwen Zhang, Manager Report No.: SET2020-05313 CCIC-SET/ TRF:IRF(2019-05-23) Page 3 of 36 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. Facilities and Accreditations .................................................................................................. 7 2. 47 CFR PART 15C REQUIREMENTS ................................................................................. 8 2.1. Antenna requirement .............................................................................................................. 8 2.2. Peak Output Power................................................................................................................. 9 2.3. 6dB Bandwidth .................................................................................................................... 10 2.4. Conducted Band Edges and Spurious Emissions ................................................................. 11 2.5. Power spectral density (PSD) .............................................................................................. 13 2.6. Radiated Band Edge and Spurious Emission ....................................................................... 15 3. LIST OF MEASURING EQUIPMENT .............................................................................. 23 4. UNCERTAINTY OF EVALUATION .................................................................................. 24 APPENDIX A ............................................................................................................................... 25 Change History Issue Date Reason for change 1.0 2020.07.20 First edition Report No.: SET2020-05313 CCIC-SET/ TRF:IRF(2019-05-23) Page 4 of 36 1. General Information 1.1. EUT Description EUT Type Fingertip Oximeter Frequency Range Bluetooth LE 5.2 2402MHz~2480MHz Channel Number Bluetooth LE 5.2 40 Bit Rate of Transmitter Bluetooth LE 5.2 1/2Mbps Modulation Type Bluetooth LE 5.2 GFSK Antenna Type PCB Antenna Gain -1dBi 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%. Report No.: SET2020-05313 CCIC-SET/ TRF:IRF(2019-05-23) Page 5 of 36 1.2. Test Standards and Results The objective of the report is to perform testing according to 47 CFR Part 15 Subpart C (Bluetooth, 2.4GHz ISM band radiators) for the EUT FCC Certification: No. Identity Document Title 1 47 CFR Part 15 Subpart C Radio Frequency Devices 2 ANSI C63.10-2013 American National Standard for Testing Unlicensed Wireless Devices Test detailed items/section required by FCC rules and results are as below: No. Section in CFR 47 Description Result 1 15.203 Antenna Requirement PA S S 2 15.247(b) Peak Output Power PASS 3 15.247(a) Bandwidth PASS 4 15.247(d) Conducted Band Edges and Spurious Emission PA S S 5 15.247(e) Power spectral…

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15C Setup Photo FCC ID: A49PC-60FW