2AWXOXO201Pulse Oximeter

1 / 24 Operation Manual of Pulse Oximeter Note Read this manual carefully for correct operation before using the Pulse Oximeter. Keep the manual properly for reference at any time when necessary. Product Name: Pulse Oximeter Specification and model: OX201 Product structure and component: the equipment is composed of host, battery and display screen. Dongguan Lingxin Technology Co., LTD Address: Room 301,No.3 Liantang Road,aoshitang,Dongcheng Street,Dongguan City,Guangdong Province,China. Tel: +86 189 2646 3069 Email:[email protected] MADE IN CHINA Name: MedPath GmbH Address: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany Telephone: +49(0)89 189174474 Fax: +49(0)89 5485 8884 E-Mail: [email protected] User manual Edition: V1.0 Printed on: Jul. 2020 2 / 24 Table of Content 1 Safety Information ............................................................................................................ 3 1.1 Safety Information ..................................................................................................... 3 1.2 Symbol of Equipment ................................................................................................ 5 2 Overview ......................................................................................................................... 6 2.1 Product Introduction .................................................................................................. 6 2.2 Product Structure and Appearance ............................................................................... 7 2.3 Product Display ......................................................................................................... 8 3 Basic Operation ................................................................................................................ 9 3.1 Installment ................................................................................................................ 9 3.2 ON/OFF .................................................................................................................. 10 4 Measurement .................................................................................................................. 10 4.1 Alarm ..................................................................................................................... 10 4.2 Measurement Procedures .......................................................................................... 10 4.3 Measurement Precautions ......................................................................................... 11 4.4 Bluetooth and APP ................................................................................................... 12 5 Product Specification ...................................................................................................... 15 5.1 Specification of host ................................................................................................ 15 5.2 List of Functions ...................................................................................................... 16 5.3 Performance Index ................................................................................................... 16 6 Maintenance ................................................................................................................... 16 3 / 24 6.1 Cleaning and Disinfection ........................................................................................ 16 6.2 Maintenance ............................................................................................................ 17 6.3 Troubleshooting ....................................................................................................... 17 7 Accessories .................................................................................................................... 18 8 EMC Specification .......................................................................................................... 18 FCC Statement ................................................................................................................... 24 1 Safety Information 1.1 Safety Information 1.1.1 Warning (1) Only qualified personnel designated by the manufacturer is allowed to maintain the equipment. Users themselves are not allowed to repair the equipment. (2) Explosion hazard: not use the equipment in environment with inflammable substances such as anesthetics. (3) Not use the equipment in MRI and CT examination. (4) When used with electrosurgical equipment together, the user shall ensure the safety of the monitored patient. (5) Users who are allergic to silicone rubber is forbidden to use this equipment. (6) The equipment, accessories and packaging (batteries, plastic bags, foam and cartons, etc.) shall be scrapped in compliance with local laws and regulations. (7) Forbid to use the equipment once the equipment is found damaged, or have material deterioration. 4 / 24 (8) Do not use the equipment under the application conditions beyond its declared specification scope. (9) When using the equipment for long-term continuous monitoring, check and replace measured parts at least every 2 hours. It is necessary for more frequent examinations in some scenarios, such as perfusion disorders and skin sensitivity. Prolonged monitoring may increase unpredictable skin changes, such as allergies, reddening, blistering, or compressive necrosis. (10) For the special patients, there should be a more prudent inspecting in the placing process.The device cannot be clipped on the edema and tender tissue. (11) The light (the infrared is invisible) emitted from the device is harmful to the eyes, so theuser and the maintenance man should not stare at the light. (12) Testee cannot use enamel or other makeup. (13) Testee’s fingernail cannot be too long. (14) Ensure that the environment in which the device is operated is not subject to any sources of strong electromagnetic interference, such as radio transmitter…

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2020-09-03 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 Dong Guan Lingxin Technologies Co., Ltd. / Room 301,No.3Liantang Road, aoshitang,Dongcheng Street,Dongguan,Guangdong, China. Agency agreement expiration date: Sep. 02, 2021 By: Cony Tang Signature Printed Title: Manager On behalf of : Dong Guan Lingxin Technologies Co., Ltd. Telephone: +86 13989425898

2020-09-03 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AWXOXO201 Product Name: Pulse Oximeter 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:  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. By: Cony Tang Signature Printed Title: Manager On behalf of : Dong Guan Lingxin Technologies Co., Ltd. Telephone: +86 13989425898

Differences Declaration To whom concern, We company Dong Guan Lingxin Technologies Co., Ltd. Here by declares: The product model(s) OX301,OX501,OX601,OX701,OX801, OX203,OX303,OX503,OX603,OX703,OX803 is the same PCB layout, electronic schematic and Antenna with OX201, which tested in Shenzhen Huatongwei International Inspection Co., Ltd., the difference is different model names, appearance and different screen for commercial purpose. Sincerely yours, Name (in print): Cony Tang Company name: Dong Guan Lingxin Technologies Co., Ltd. Company address: Room 301,No.3Liantang Road,aoshitang,Dongcheng Street,Dongguan,Guangdong, China. Tel: +86 13989425898 E-Mail: [email protected]

7.EXTERANAL AND INTERNAL PHOTOS External photos of EUT M odel:OX201

Internal photos of EUT M odel:OX201

Page: 1 of 14 TEST REPORT Report Reference No. .................... : CHTEW20080077 Report Verification: Project No.................................： SHT2006118601EW FCC ID ............................................. : 2AWXOXO201 Applicant’s name ........................... : Dong Guan Lingxin Technologies Co., Ltd. Address ............................................ : Room 301,No.3Liantang Road,aoshitang,Dongcheng Street,Dongguan,Guangdong, China. Manufacturer......................................: Dong Guan Lingxin Technologies Co., Ltd. Address...............................................: Room 301,No.3Liantang Road,aoshitang,Dongcheng Street,Dongguan,Guangdong, China. Test item description ..................... : Pulse Oximeter Trade Mark....................................... : - Model/Type reference ...................... : OX201 Listed Model(s) ................................ : OX301,OX501,OX601,OX701,OX801,OX203,OX303,OX503,OX603, OX703,OX803 Standard ......................................... : 47 CFR FCC Part 15 Subpart B Date of receipt of test sample...........: Jul. 09, 2020 Date of testing..............................: Jul. 10, 2020- Aug. 10, 2020 Date of issue.................................: Aug. 11, 2020 Result .................. ........................: Pass Compiled by ( position+printed name+signature) . : File administrators Silvia Li Supervised by ( position+printed name+signature) . : Project Engineer Xiao Cheng 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 corresponds to the test sample. Report No : CHTEW20080077 Page 2 of 14 Issued: 2020-08-10 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) Contents 1. TEST STANDARDS AND REPORT VERSION ........................................... 3 1.1. Test Standards 3 1.2. Report version information 3 2. TEST DESCRIPTION .................................................................... 4 3. SUMMARY ............................................................................... 5 3.1. Client Information 5 3.2. Product Description 5 3.3. EUT operation mode 5 4. TEST ENVIRONMENT ................................................................... 6 4.1. Address of the test laboratory 6 4.2. Test Facility 6 4.3. Environmental conditions 7 4.4. Statement of the measurement uncertainty 7 4.5. Equipments Used during the Test 8 5. TEST CONDITIONS AND RESULTS ..................................................... 9 5.1. Conducted Emissions Test 9 5.2. Radiated Emissions Test 10 6. TEST SETUP PHOTOS OF THE EUT .................................................. 14 7. EXTERNAL AND INTERNAL PHOTOS OF THE EUT .................................. 14 Report No : CHTEW20080077 Page 3 of 14 Issued: 2020-08-10 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 1. TEST STANDARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: 47 CFR FCC Part 15 Subpart B - Unintentional Radiators ANSI C63.4: 2014 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40GHz 1.2. Report version information Revision No. Date of issue Description N/A 2020-08-10 Original Report No : CHTEW20080077 Page 4 of 14 Issued: 2020-08-10 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 2. TEST DESCRIPTION Test Item Section in CFR 47 Result Test Engineer Conducted Emissions 15.107(a) N/A N/A Radiated Emissions 15.109(a) PASS Jian Li Note: The measurement uncertainty is not included in the test result. Report No : CHTEW20080077 Page 5 of 14 Issued: 2020-08-10 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 3. SUMMARY 3.1. Client Information Applicant: Dong Guan Lingxin Technologies Co., Ltd. Address: Room 301,No.3Liantang Road,aoshitang,Dongcheng Street,Dongguan,Guangdong, China. Manufacturer: Dong Guan Lingxin Technologies Co., Ltd. Address: Room 301,No.3Liantang Road,aoshitang,Dongcheng Street,Dongguan,Guangdong, China. 3.2. Product Description Name of EUT: Pulse Oximeter Trade Mark: - Model No.: OX201 Listed Model(s) OX301,OX501,OX601,OX701,OX801,OX203,OX303,OX503,OX603,OX703,OX803 Model Description: All models are just different in appearance and display, others are the same，and all models are tested, and the report only records the worst data. Power supply: DC 3V，2*AAA batteries Adapter information: - 3.3. EUT operation mode Test mode Describe Working normal work Report No : CHTEW20080077 Page 6 of 14 Issued: 2020-08-10 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 4. TEST ENVIRONMENT 4.1. Address of the test laboratory Laboratory: Shenzhen Huatongwei International Inspection Co., Ltd. Address: 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Phone: 86-755-26748019 Fax: 86-755-26748089 4.2. Test Facility The test facility is recognized, certified, or accredited by the following organizations: CNAS-Lab Code: L1225 Shenzhen Huatongwei International Inspection…

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6.TEST SETUP PHOTOS OF THE EUT Radiated Emissions (30MHz-1GHz) Radiated Emissions (Above 1GHz) Model:OX201